Archive for the ‘FDA News’ Category
FDA Clears Abbott’s Confirmatory Chagas Disease Assay
Last Updated on Tuesday, 22 November 2011 03:11 Written by admin Tuesday, 22 November 2011 03:10
FDA approved Abbott’s in vitro enzyme strip assay for Chagas disease. The Abbott ESA Chagastest detects antibodies to the causative pathogen Trypanosoma cruzi in serum or plasma samples. It is indicated for use as an additional, more specific test on human samples that have been found to be repeatedly reactive using a licensed screening test.
The T. cruzi parasite is transmitted through contact with the feces of an infected triatomine bug, but infection can also occur congenitally, through transfusions of contaminated blood products, or through an organ transplant from an infected donor.
U.S. Centers for Disease Control and Prevention (CDC) estimates suggest that as many as 11 million people worldwide are infected with Chagas disease, including over 300,000 in the U.S. alone. Concerns about Chagas disease transmission through blood led FDA to implement mandatory Chagas disease screening of donated blood back in 2007. “The new Abbott ESA Chagas test provides organizations that screen blood with an approved testing method help the blood supply safe and enable them to confidently counsel infected donors,” remarks John Coulter, divisional vp for Abbott’s diagnostics business.
Source: http://www.genengnews.com/gen-news-highlights/fda-clears-abbott-s-confirmatory-chagas-disease-assay/81245981/
Posted under Cell Analysis, DNA Reasearch, FDA News, Genetics & Pharmacogenetics, R & D, Reports | Comments Off
Genentech to Appeal to F.D.A. for Breast Cancer Drug
Last Updated on Monday, 27 June 2011 11:10 Written by admin Monday, 27 June 2011 11:10
Genentech this week will step up its efforts to keep the drug Avastin available as a treatment for breast cancer, urging the Food and Drug Administration to give it one more chance to prove the medicine works.
At a hearing on Tuesday and Wednesday in suburban Washington, Genentech will ask the F.D.A. to reconsider its proposal last December to revoke the approval of Avastin for breast cancer on the grounds that new studies did not confirm that the drug helped patients.
Genentech’s approach seems intended to broaden the terms under which Avastin can remain available. The company is arguing that even if the F.D.A. reaffirms that data do not support Avastin’s effectiveness, the approval should be retained while Genentech does one more clinical trial. Avastin has remained available for breast cancer pending the appeal process.
Avastin was put on the market under an accelerated program begun in the early 1990s that allows drugs for serious diseases to be approved with less than the usual amount of evidence, subject to further studies. Dozens of drugs have been approved this way, and in at least a couple of cases approvals have been withdrawn. But this is the first time the F.D.A. will hold a hearing to consider a company’s appeal.
The debate over Avastin has evoked passions on both sides among those involved in women’s health issues. Some patient advocates argue that the F.D.A. needs to revoke the approval to maintain the integrity of the accelerated process and to ensure that cancer patients receive drugs that work.
But some breast cancer patients are expected to testify at the hearing that the drug should be kept available because it helps some women, even if not all.
“It’s so depressing to think that a federal agency can make a decision that can potentially cause me to die,” said Crystal Hanna, 35, a mother of two from Parkersburg, W.Va., who said Avastin has kept her cancer under control for almost a year.
The public comments sent to the F.D.A. before the hearing at its campus outside Washington, overwhelmingly support retaining the approval. Many of them, using virtually identical language, cite the case of Ms. Hanna, who drafted a comment for friends that circulated widely on the Internet.
Even if approval as a breast cancer treatment is ultimately rescinded, Avastin will retain approval to treat lung, colon, kidney and brain cancers. So doctors will be able to use it “off label” to treat breast cancer. But insurers might no longer pay for it for that use, putting the drug, which can cost $88,000 a year, out of reach for many women.
The Avastin issue has become caught up in the politics of overhauling health care, with some critics saying the decision not to pay for it represents rationing and others saying that Medicare should not pay for a drug that does not work. The F.D.A. maintains that it is not permitted to consider costs.
The ultimate decision will be made by the F.D.A. commissioner, Dr. Margaret A. Hamburg, who appears to have some latitude. The rules say that the F.D.A. “may” revoke the approval of a drug, but does not have to.
“Even where F.D.A. determines that confirmatory trials do not establish clinical benefit, withdrawal is not required and instead should be based on the public health considerations that motivate the accelerated approval statute,” Genentech argues in a summary of its arguments filed before the hearing.
But the F.D.A.’s drug division views the company’s request as a stalling tactic. “How many bites of the apple do you get?” Dr. Richard Pazdur, the director of the agency’s oncology drug division, said in an interview at a cancer conference early this month.
The agency, in a summary of its arguments, says that because it has already determined that the benefits of Avastin do not outweigh the risks, retaining the approval while the new study is conducted “would not be in the interest of the public health and would jeopardize the integrity of the accelerated approval program.”
Genentech and its parent company, Roche, could lose as much as $1 billion in annual sales if the breast cancer approval were revoked. Already Avastin sales for treatment of breast cancer have started declining. The drug is the world’s best-selling cancer drug, with sales last year of roughly $7 billion.
The F.D.A. approved the drug for advanced breast cancer in February 2008, after one clinical trial showed that combining Avastin with another drug, paclitaxel, delayed the median time before tumors worsened by 5.5 months, compared with using paclitaxel alone. But the women who got Avastin did not live significantly longer than those who got only paclitaxel, which is also known by the brand name Taxol.
Subsequent trials, in which Avastin was combined with different chemotherapy drugs, showed a much smaller delay in tumor progression, ranging from less than 1 month to 2.9 months. And again there was no improvement in survival for those receiving Avastin.
Based on those results and on the fact that Avastin has some life-threatening side effects, including bowel perforation and hemorrhaging, the F.D.A.’s cancer drug advisory committee voted 12 to 1 last July that the approval for the treatment of breast cancer be revoked.
The hearing this week will be before the same committee, which will make recommendations to the F.D.A. commissioner. Of the six voting committee members expected to attend, five voted to revoke the approval last July. The sixth was not at that earlier meeting. Since the data have not changed, Genentech, in the summary of its arguments, concedes it is not likely to change the committee’s mind about the benefits of Avastin.
Instead it will argue that the drug with which Avastin is combined matters. Therefore, the company should be given a chance to do another trial in which Avastin is combined with paclitaxel, as in the original trial that led to the drug’s approval.
Source: http://www.nytimes.com/2011/06/27/health/27drug.html
Posted under Cancer Research, Drug Development, FDA News, New Drugs, New Products, North America, Oncology Research, Press Releases, R & D, USA and Canada | Comments Off
Pfizer’s Remoxy Fails to Win FDA Approval
Last Updated on Friday, 24 June 2011 11:13 Written by admin Friday, 24 June 2011 11:13
WASHINGTON — The latest attempt at an abuse-resistant formulation of oxycodone (Remoxy) failed to win approval from the FDA, according to a statement from Pfizer.
Late Thursday, the company said it had received a complete response letter from the FDA, which described the reasons for the FDA’s decision.
The FDA had turned down an earlier version of the drug in 2008, but Pfizer’s King Pharmaceuticals re-submitted the new drug application in January.
Olivier Brandicourt, Pfizer president and general manager, said in the statement that the company was “working to understand and address the issues in the FDA Complete Response Letter. Pain is an important strategic disease area for Pfizer. We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue.”
Pfizer was, however, successful with another abuse-resistant product — its short-acting oxycodone product, Oxecta, which was approved earlier in the week. An earlier formulation of that drug, too, had been turned down by an FDA advisory panel, but was okayed after the company removed the niacin from its recipe, which was meant to deter oral abuse.
The Oxecta only deters crushing, chewing, snorting, and injecting — not pill-popping.
Making drugs harder to abuse has been one key strategy for some companies in an attempt to control what the government has deemed an epidemic of prescription painkiller abuse.
Source: http://www.medpagetoday.com/PainManagement/PainManagement/27252
Posted under Drug Development, FDA News, New Drugs, New Products, North America, R & D, USA and Canada | Comments Off
New Drug Effectively Treats Hepatitis C
Last Updated on Thursday, 23 June 2011 04:36 Written by admin Thursday, 23 June 2011 04:36
WEDNESDAY, June 22 (HealthDay News) — The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease, two new studies show.
The drug works not only in patients just starting treatment, but in those who failed earlier treatment, the research found.
The hepatitis C virus can lurk in the body for years, causing liver damage, cirrhosis and even liver failure.
“This is a significant advance in the treatment of hepatitis C,” said Dr. David Bernstein, chief of the division of gastroenterology, hepatology and nutrition at North Shore University Hospital in Manhasset, N.Y., who was not involved in either study.
“We know that if we can get rid of the hepatitis C, we can prevent the progression of [liver] disease,” he said. “This means we can prevent the progression of cirrhosis, we can prevent the development of cancer and also prevent the need for liver transplantation in a large number of people.”
Incivek (telaprevir) was approved by the U.S. Food and Drug Administration in May and is the second drug in a class of drugs called protease inhibitors to be approved to fight hepatitis C. The other drug, called Victrelis (boceprevir), was also approved in May.
The standard treatment for hepatitis C has been a combination of two drugs, pegylated-interferon and ribavirin, which are given for a year. If protease inhibitors such as Incivek are added to the mix, the “viral cure” rate improves and the treatment time is reduced to six months, researchers found.
Both reports were published in the June 23 online edition of the New England Journal of Medicine.
In one study, a Phase 3 trial known as ADVANCE, patients were randomly assigned to either a placebo or the treatment in a double-blind study, which means that neither the patients nor the researchers know who’s getting the drug and who’s getting a sham treatment. This type of study is considered the gold standard for clinical research.
In the ADVANCE trial, 1,088 patients with hepatitis C who had never been treated for the condition were randomly assigned to standard therapy for 48 weeks, or telaprevir combined with standard therapy for eight or for 12 weeks, followed by standard therapy alone for a total treatment time of either 24 or 48 weeks.
The researchers found that 79 percent of those receiving Incivek for the longest period (24 weeks) had a “sustained response,” which basically means their hepatitis C was contained. Among those receiving standard care, 44 percent had a sustained response, the researchers noted.
“We have entered a new era of therapy for hepatitis C, which enables us to cure many more patients than we could before,” said lead researcher Dr. Ira M. Jacobson, from Weill Cornell Medical College in New York City.
Incivek needs to be given along with pegylated-interferon and ribavirin, Jacobson said. The researchers learned early on that Incivek alone reduces the level of the virus, but later the virus can become resistant to the drug, he said.
For the second study, called the REALIZE trial, 663 patients with hepatitis C who had failed standard therapy were divided into three groups. One group received Incivek plus standard therapy, another group was started on pegylated-interferon and ribavirin and then had Incivek added. The third group received standard therapy alone.
Here, the researchers found up to an 88 percent sustained response in patients receiving Incivek, compared with a 24 percent sustained response in the standard treatment group.
“These drugs represent a real milestone in the treatment of this disease,” said lead researcher Dr. Stefan Zeuzem, a professor of medicine at J.W. Goethe University Hospital in Frankfurt, Germany.
“There were very limited treatment options in the past, but now many patients have excellent chances to be cured, even if they already have advanced disease,” he said.
Bernstein noted that in the past, these patients could only be treated with more of the standard therapy for a longer period and the “cure” rate was only 10 percent. “Now you can treat these patients for six months with cure rates approaching 90 percent,” he said. “You are really offering hope to a large number of patients.”
The side effects of the medications include skin rashes, anemia, fatigue, itching, nausea, diarrhea, vomiting and taste changes. Some side effects were serious enough to cause a few participants to drop out, according to the study.
Incivek, made by Vertex Pharmaceuticals Inc., is sold to wholesalers for $49,200 for a four-week course of treatment, said Vertex spokeswomen Nikki Levy.
While both Incivek and Victrelis are important breakthroughs in the treatment of hepatitis C, new drugs with even fewer side effects and perhaps shorter treatment times are in clinical trials, Bernstein said.
Hepatitis C affects almost 4 million Americans, most of whom don’t know they’re infected. Often there are no symptoms, but it is the leading cause of liver transplantation in the United States and is linked to as many as 12,000 deaths a year, the researchers say.
Source: http://health.usnews.com/health-news/family-health/digestive-disorders/articles/2011/06/23/new-drug-effectively-treats-hepatitis-c?PageNr=1
Posted under Discoveries, Innovations and Patents, Drug Development, FDA News, Hepatitis Research, Medicinal Chemistry, New Drugs, New Products, R & D | Comments Off
Pfizer, Acura Say FDA Clears Painkiller Oxecta
Last Updated on Tuesday, 21 June 2011 11:02 Written by admin Tuesday, 21 June 2011 11:02
Pfizer Inc. and Acura Pharmaceuticals Inc. said Monday the Food and Drug Administration approved a powerful painkiller that is designed to be harder to abuse.
The FDA cleared marketing of Oxecta as an immediate-release treatment for moderate to severe pain. The drug is designed to discourage common methods of abuse like crushing or dissolving, and it contains a compound that irritates the nose if it is snorted.
Shares of Acura, based in Palatine, Ill., rose 78 cents, or 20.2 percent, to $4.65 in afternoon trading. Earlier in the day its shares surged as much as 75.7 percent. Pfizer stock was unchanged at $20.26.
Oxecta is similar to Purdue Pharma LP’s OxyContin, the top-selling painkiller in the U.S. Regulators and health officials have pushed hard to get alternatives on the market after reports showed millions of people were abusing OxyContin and other prescription painkillers.
Acura and King Pharmaceuticals developed Oxecta under the name Acurox. Pfizer of New York bought King for $3.6 billion, and Oxecta is the first of King’s drugs to be approved since the deal closed in March. A second approval could come Thursday, as Pfizer is waiting for the FDA to return a decision on the drug candidate Remoxy.
OxyContin is an extended-release painkiller, however, and Citi Investment Research analyst John Boris said those drugs represent a larger market. Boris said annual sales of Oxecta could rise as high as $100 million, but Remoxy sales could reach $500 million a year.
Unlike those drugs, Oxecta is designed to start working right away.
Boris said he does not believe Remoxy will be approved this week, as Pfizer has disclosed a manufacturing issue that could delay approval. Remoxy was developed by Durect Corp. and licensed by Pain Therapeutics Inc. Pfizer now holds a sublicense from Pain Therapeutics.
Source: http://abcnews.go.com/Business/wireStory?id=13883837
Posted under Drug Development, FDA News, North America, USA and Canada | Comments Off
UPDATE 1-Pfizer stop-smoking pill raises heart risk-FDA
Last Updated on Friday, 17 June 2011 11:13 Written by admin Friday, 17 June 2011 11:13
WASHINGTON, June 16 (Reuters) – Pfizer Inc’s (PFE.N) stop-smoking drug Chantix can lead to a small increase in cardiovascular problems such as heart attacks for patients who already have cardiovascular disease, U.S. drug regulators said on Thursday.
The Food and Drug Administration is changing the label for Chantix after reviewing the results of a clinical trial.
An independent randomized trial of 700 smokers with cardiovascular disease who were treated with Chantix or a placebo showed that Chantix was effective in helping paients quit smoking for as long as one year.
However, patients who took the pill were also slightly more likely to have a heart attack or other adverse cardiovascular event versus patients on a placebo.
Many smokers who try to quit do so to prevent the risk of heart attacks, which may now be associated with Chantix.
“The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease,” the FDA said in a statement.
The FDA said it is also requiring Pfizer to evaluate the cardiovascular safety of Chantix by conducting a large, combined analysis of randomized, placebo-controlled trials.
Pfizer’s non-nicotine pill has already come under fire for psychiatric side effects, which have crimped global sales and prompted the FDA to issue a restrictive “black box” warning label for the drug.
Investors had high hopes for the drug — called Champix in Europe — when Pfizer first launched its smoking-cessation aid in 2006, but reports of serious side effects have prevented strong sales growth.
Annual sales are now about $800 million, making the pill a moderate-sized product for the world’s biggest drug maker.
Chantix has been associated with agitation, depression and suicidal thoughts, and, in clinical trials, linked with nightmares. Psychiatric symptoms have occurred in people without a history of mental illness and have worsened in people who already had mental illness.
Source: http://www.reuters.com/article/2011/06/16/drugs-fda-chantix-idUSN1618502520110616
Posted under Cancer Research, FDA News, New Products, North America, Oncology Research, USA and Canada | Comments Off
Blood pressure drugs not linked to cancer risk, says FDA
Last Updated on Friday, 3 June 2011 03:05 Written by admin Friday, 3 June 2011 03:05
A type of blood pressure-lowering medication known as angiotensin receptor blockers won’t increase a patient’s risk for cancer, the Food and Drug Administration said this week. So those taking the drugs for high blood pressure can just…relax.
Concern about the drugs’ possible link to cancer risk arose last year after an analysis of several studies suggested that angiotensin receptor blockers, or ARBs, might be associated with a slightly increased risk of cancer.
But the FDA’s own research found no such connection, the agency said in an announcement Thursday:
“This analysis included 31 trials and approximately 156,000 patients, far more than the approximately 62,000 in the published analysis. FDA’s more comprehensive meta-analysis did not show an increased risk of cancer in the patients taking an ARB medication.”
Such medications include: losartan (Cozaar), olmesartan (Benicar) and valsartan (Diovan). The drugs lower blood pressure by blocking the effects of angiotensin II, a chemical that narrows vessels.
There are other ways to lower blood pressure. Beta blockers, ACE inhibitors, calcium channel blockers and renin inhibitors all lower pressure through different mechanisms, according to a blood pressure guide from the Mayo Clinic.
Of course, lifestyle changes can sometimes obviate the need for blood pressure-lowering drugs. Not smoking, eating a low-sodium diet, exercising regularly and limiting alcohol can all help control blood pressure — and there was never any concern about their cancer risk.
Source: http://www.latimes.com/health/boostershots/la-heb-fda-arb-cancer-20110603,0,4559969.story?track=rss
Posted under Cancer Research, FDA News, North America, Oncology Research, USA and Canada | Comments Off
WHO Says Cell Phones May Cause Cancer
Last Updated on Tuesday, 31 May 2011 04:09 Written by admin Tuesday, 31 May 2011 04:09
A work group of the World Health Organization has declared the radiofrequency electromagnetic fields emitted by cell phones to be “possibly carcinogenic to humans.”
The declaration was made after a week-long meeting of the International Agency for Research on Cancer (IARC) in Lyon, France, which involved 31 scientists from 14 countries, who decided there was enough evidence linking use of cellphones to an increased risk of glioblastoma.
The declaration puts these energy fields into the IARC’s group 2B for carcinogenic agents — one notch above compounds “not classifiable” as cancer-causing because of inadequate evidence.
Other agents in group 2B include progestins and anti-epileptics such as phenytoin and phenobarbital.
Jonathan Samet, MD, of the University of Southern California and chair of the work group, said the “evidence, while still accumulating, is strong enough to support a conclusion and the 2B classification.”
“The conclusion means that there could be some risk, and therefore we need to keep a close watch for a link between cellphones and cancer risk,” Samet said in a statement.
The IARC’s group 2A classification — probably carcinogenic to humans — includes shift work involving circadian changes and high-temperature frying.
Benzene, hexavalent chromium, mustard gas, solar radiation, and other radioactive elements are among the agency’s highest class of carcinogens, group 1, those with “sufficient evidence of carcinogenicity.”
The WHO work group did not find that there was sufficient evidence linking cancer and environmental or occupational exposures with microwave energy.
The latest large-registry study on cancer and cellphone use — the Interphone study, sponsored by both government and industry sources and reported last year — found no conclusive link between talk time and glioblastoma. There was a significant increase associated with the highest levels of use, but researchers said spending that amount of time on the phone was “implausible.”
In addition, odds ratios for other categories of cellphone use appeared to be protective.
Still, a recent study by researchers at the National Institute on Drug Abuse — known for their fMRI studies of the brains of addicts — found that active cellphones changed glucose metabolism in the parts of the brain closest to the antenna.
Although the clinical significance of the findings is still unclear, it provides some of the first evidence that the brain is sensitive to radiofrequency electromagnetic fields.
Antonio Chiocca, MD, chair of neurosurgery at Ohio State University, who was not involved in the work group, said in an email to MedPage Today and ABC News that the evidence tying cell phones to brain cancer is “still pretty circumstantial.”
“The follow-up hasn’t been long enough,” he said. “If it takes 20-plus years for the effects to be seen, we may still not have enough time to really know whether the use is linked to brain cancer.”
Still, he said that it wouldn’t do any harm if the public were to hold their phones further from their heads, or use ear pieces.
An estimated five billion people around the world use cellphones.
The wireless industry group Cellular Telecommunications Industry Association (CTIA) emphasized that the IARC classification “does not mean cellphones cause cancer.”
The group pointed out that in the past, IARC has given the same classification to “pickled vegetables and coffee,” and highlighted that the Federal Communications Commission and the FDA have concluded that there’s no firm evidence linking cellphones and cancer.
Posted under FDA News, Oncology Research | Comments Off
FDA Okays New HIV Drug
Last Updated on Friday, 20 May 2011 01:56 Written by admin Friday, 20 May 2011 01:56
WASHINGTON — The FDA has approved rilpivirine (Edurant) for the treatment of HIV patients who have not yet begun therapy.
The drug, a non-nucleoside reverse transcriptase inhibitor, is intended to be used as part of highly active anti-retroviral therapy (HAART) with at least two other medications, the agency said.
Rilpivirine, also known as TMC278, is to be taken once a day with food and offers another medication alternative for physicians and patients, the FDA said in a release.
The agency approved the drug on the basis of safety and effectiveness data from two phase III clinical trials with 1,368 adult participants who had not received prior HIV therapy, as well as an extension trial.
They were randomly assigned to treatment with rilpivirine or efavirenz (Sustiva), as well as other anti-HIV drugs.
In the two trials, the proportion of patients who were able to suppress their virus to undetectable levels was 84.3% for rilpivirine and 82.3% for efavirenz.
Those who started the trials with a high viral load and were assigned to rilpivirine were more likely to fail therapy than those who got efavirenz and the converse was true for those who started with a low level of virus, the researchers reported.
On the other hand, patients were more likely to drop out because of side effects if they were taking efavirenz, leading some observers to call the medication a trade-off.
Posted under FDA News, HIV Research, Medicinal Chemistry, New Drugs, New Products | Comments Off
Hazardous and untested flame retardants pervasive in baby products
Last Updated on Thursday, 19 May 2011 04:48 Written by admin Thursday, 19 May 2011 04:48
A study of products designed for babies and toddlers – including car seats, nursing pillows, changing pads, bassinet mattresses and other items made with polyurethane foam – found that 80% of products tested contained chemical flame retardants considered toxic, according to a peer-reviewed study published today in the Environmental Science & Technology Journal. The same flame retardants are also found in children’s bodies and widely dispersed throughout the environment and in food.
The study analyzed 102 products for the presence of halogenated flame retardants. Interior foam samples were tested from nursing pillows, baby carriers, car seats, changing table pads, high chairs, bassinets, portable cribs, walkers, changing pads, baby carriers, sleeping wedges, a baby tub insert, stroller, bath slings, glider rockers, and other essential child care items. Samples were submitted from locations around the United States, including two samples from Maine.
Tracy Gregoire and Steve Taylor of Topsham sent samples to the national study from the nursing pillow and bassinet mattress they used for their now two-year old son Jasiah. The nursing pillow tested positive for Tris 2-chloro-ethyl phosphate (TCEP). TCEP was found in ten out of eleven nursing pillows analyzed. Newborn babies often spend hours each day lying on nursing pillows; thus there is a high level of contact to babies and their mothers to this product and the flame retardants which readily escape from the pillows.
“It’s heartbreaking to think that the pillow I used to cradle my son contains chemicals that can cause long term harm to his health. I am a well informed mother, yet given the lack of regulation, there’s just no way for parents like me to ensure toxic chemicals aren’t in the products I buy for my son,” said Tracy Gregoire, the Healthy Children’s Project Director for the Learning Disabilities Association of Maine.
The nursing pillow from Maine was one of fourteen products tested that contained TCEP, a carcinogenic flame retardant on California’s Proposition 65 list of cancer-causing chemicals. Laboratory animal studies show TCEP causes tumors in the kidney and thyroid glands. In other laboratory animal studies, TCEP has been shown to cause reductions in fertility and poor sperm quality and to interfere with brain signaling, causing hyperactivity. TCEP is no longer produced in Europe and has been identified by Canada as posing a risk to human health.
“This study clearly shows the need for chemical policy reform at the federal level,” said Steve Taylor, Program Director of the Environmental Health Strategy Center, a Maine based public health organization that has led successful campaigns to phase out use of flame retardants known as Penta, Octa and Deca in electronics, mattresses, shipping pallets, and other products sold in Maine. “Maine lawmakers have taken important steps to protect people from exposure to toxic flame retardants however we can’t go it alone. We’re asking Senators Snowe and Collins to support the Safe Chemicals Act of 2011 to ensure there’s a federal law that works to ensure common consumer products are safe for our families.”
The Toxic Substances Control Act (TSCA) is the federal law tasked with regulating use of chemicals in the U.S. but TSCA is widely perceived to have failed to protect public health, having regulated only 5 chemicals in its 35 years of existence out of the 80,000 chemicals in use in the U.S.
An effort to strengthen TSCA is underway in Congress in the form of the Safe Chemicals Act of 2011 sponsored by Senator Lautenberg. This bill would require basic health and safety data for chemicals, reduce exposure to the most harmful chemicals, identify and address “hot spots” where people are more exposed to toxic chemicals, and prevent new harmful chemicals from hitting the marketplace unless they are tested and found to be reasonably safe.
The baby products study, Identification of Flame Retardants in Polyurethane Foam Collected from Baby Products, is available in the current issue of the Environmental Science & Technology Journal. Other results from the new baby product testing include:
- Four products contained penta-BDE, a substance so toxic it is banned in 172 countries and 12 U.S. states including Maine, and subject to a national phaseout.
- 29 products contained TDCPP or chlorinated Tris, a possible human carcinogen that was removed from children’s pajamas over health concerns in the late 1970s. In animal studies, chlorinated Tris has been associated with cancer of the liver, kidney, brain and testis, among other harmful effects.
- 16 products contained Firemaster 550/600 flame retardants for which EPA has predicted toxicity concerns and required additional testing.
- 14 products contained TCPP, which is similar in chemical structure to Chlorinated Tris and TCEP and has limited health information.
“Toxic or untested flame retardants like the ones found in this study can migrate out of products and end up in our homes and our bodies. These chemicals are associated with reduced IQ, increased time to pregnancy, endocrine and thyroid disruption, and impaired child development,” says Arlene Blum, PhD, a co-author of the study and executive director of the Green Science Policy Institute. Blum’s early research contributed to the removal of Tris flame retardants from children’s pajamas in the 1970’s. “I was surprised to find Tris back in high levels in the foam in baby products.”
According to Environmental Health News, researchers have found that adults in the United States have average levels of flame retardant chemicals in their bodies that are 20 times higher than Europeans. A study in California found households tested had 200 times more brominated flame retardants in household dust than European homes. Meanwhile, the Centers for Disease Control & Prevention report that over 90% of the U.S. population carries flame retardants in their bodies.
Posted under FDA News, Press Releases | Comments Off
Soy food safe for breast cancer
Last Updated on Wednesday, 6 April 2011 09:46 Written by admin Wednesday, 6 April 2011 09:46
A new study has revealed that soy food consumption does not increase the risk of cancer recurrence or death among survivors of breast cancer.
Researchers investigated the association between soy food intake and breast cancer outcomes among survivors, using data from a multi-institution collaborative study, the After Breast Cancer Pooling Project.
“There has been widespread concern about the safety of soy food for women with breast cancer,” said lead researcher Xiao Ou Shu, professor of medicine at Vanderbilt Epidemiology Center, Vanderbilt University Medical Center.
“Soy foods contain large amounts of isoflavones that are known to bind to estrogen receptors and have both estrogen-like and anti-estrogenic effects.”
“There are concerns that isoflavones may increase the risk of cancer recurrence among breast cancer patients because they have low estrogen levels due to cancer treatment.
“We’re particularly concerned that isoflavones may compromise the effect of tamoxifen on breast cancer treatment because both tamoxifen and isoflavones bind to estrogen receptors,” he said.
Together study included 18,312 women between the ages of 20 and 83 years who had invasive primary breast cancer.
Soy isoflavones intake was assessed for 16,048 of these women on average of 13 months after breast cancer diagnosis using food frequency questionnaires for a group of soy isoflavones in three cohorts and on tofu and soy milk consumption in one cohort.
Breast cancer outcomes were assessed, on average, nine years after cancer diagnosis.
Outcomes among the survivors who consumed the highest amounts of soy isoflavones (more than 23 mg per day) were compared with the outcomes of those whose intake was lowest (0.48 mg per day or lower).
Women in the highest intake category of more than 23 mg per day had a 9 per cent reduced risk of mortality and a 15 per cent reduced risk for recurrence, compared to those who had the lowest intake level.
“Our results indicate it may be beneficial for women to include soy food as part of a healthy diet, even if they have had breast cancer,” said Shu.
The study was presented at the AACR 102nd Annual Meeting 2011, held April 2-6.
Source: http://timesofindia.indiatimes.com/life-style/health-fitness/health/Soy-food-safe-for-breast-cancer/articleshow/7884289.cms
Posted under Cancer Research, FDA News, Oncology Research, Reports | Comments Off
UPDATE 1-US panel says Optimer’s antibiotic effective
Last Updated on Tuesday, 5 April 2011 02:51 Written by admin Tuesday, 5 April 2011 02:51
Optimer Pharmaceuticals Inc’s (OPTR.O) experimental antibiotic is safe and effective in treating a bacterial infection that causes diarrhea, a U.S. advisory panel said on Tuesday.
The advisory panel of 13 independent experts voted unanimously that the drug was effective but said there were concerns regarding the drug’s use in pregnant women and children.
However, the panel was divided on whether the oral drug, fidaxomicin, was also effective in lowering the risks of recurrence of infection-related diarrhea.
Last week, the U.S. Food and Drug Administration staff said the drug was effective in fighting an infection that causes a life-threatening diarrhea. [ID:nN01111028]
The FDA is expected to give its decision on the drug by May 30. A positive vote by the panel does not guarantee an approval, but the agency usually follows panel recommendations.
The drug aims to treat diarrhea caused by C. difficile infection (CDI,) a serious illness caused by infection of the lining of the colon. It afflicts more than 700,000 people each year in the United States, according to the company.
Late-stage trials of the drug had shown that it was as effective as the only FDA-approved drug for treating CDI — ViroPharma Inc’s (VPHM.O) Vancocin.
Optimer has a deal with Japan’s Astellas Pharma Inc (4503.T) on the drug. Astellas holds the rights to develop and sell the drug in Europe and parts of the Middle East and Africa.
Trading in the company’s shares was halted pending news of the panel’s decision.
Source: http://www.reuters.com/article/2011/04/05/optimerpharma-idUSN0515361620110405
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Higher bleeding risk seen in J&J, Bayer clot drug
Last Updated on Tuesday, 5 April 2011 02:44 Written by admin Tuesday, 5 April 2011 02:44
A blood clot preventer from Johnson & Johnson and Bayer caused a surprisingly high rate of bleeding in a trial of patients with acute illnesses, representing a significant setback for the drugmakers.
Bayer AG shares fell 3.6 percent in Frankfurt on Tuesday. J&J slid 0.6 percent on the New York Stock Exchange.
Industry analysts had predicted the trial of the drug rivaroxaban, if successful, would create a potential $2.8 billion annual market among the study’s population of patients who are susceptible to blood clots while hospitalized for illnesses such as cancer and pneumonia.
“This will surely impact the chances of admission of the drug and is a serious disappointment,” said Markus Huber, a senior trader at ETX Capital, adding that it could have financial repercussions for Bayer.
A lead investigator for earlier North American trials of rivaroxaban in patients getting knee replacements also took a pessimistic view of the new data.
“The data today would not be approvable …. Why approve something with no overall benefit” for patients like those in the trial, said Alexander Turpie, professor of medicine at McMaster University in Hamilton, Ontario.
Turpie and industry analysts said the results do not preclude other big opportunities for the drug, which is already sold in Europe by Bayer under the brand name Xarelto to prevent blood clots in patients undergoing hip and knee surgery.
The drugmakers are developing the pill to prevent stroke in patients with an irregular heartbeat called atrial fibrillation. Analysts see that market having the potential for $3 billion in annual sales.
“There is disappointment given the recent (Bayer) share price rally and expectations that this was going to start off a positive run of news flow,” said Emmanuel Papadakis at Collins Stewart in London. “But this is a small subset of Xarelto’s total market opportunities.”
Development of new blood clot preventers has been one of the hottest areas in cardiology. Several pharmaceutical companies are vying to come up with a drug of choice to displace decades-old warfarin and other medicines.
Potential rivals to rivaroxaban include apixaban by Pfizer Inc and Bristol-Myers Squibb, edoxaban from Japan’s Daiichi Sankyo and Pradaxa, already being sold by privately held Boehringer Ingelheim.
BLEEDING RISK
The 8,101-patient study released on Tuesday compared the bleeding risk and effectiveness of rivaroxaban with that of the standard injectable treatment enoxaparin in patients hospitalized for acute medical conditions, including heart failure, infectious disease and breathing difficulty.
Injections of enoxaparin, sold by Sanofi-Aventis under the brand name Lovenox, are typically given in the hospital, with treatment lasting no more than two weeks.
After 10 days of treatment in the study, rivaroxaban and enoxaparin were deemed equally effective in preventing dangerous blood clots in the extremities and in the lungs.
But patients taking the J&J drug had a significantly higher rate of bleeding at both 10 and 35 days, which researchers said was a surprising finding that negated the value of the drug for this patient population.
“We did not see a consistently positive benefit-risk balance with rivaroxaban use,” said lead researcher Alexander Cohen of King’s College Hospital in London.
Some 2.8 percent of patients taking rivaroxaban had clinically relevant bleeding at 10 days, compared with 1.2 percent of those receiving enoxaparin — a difference that was highly statistically significant.
At 35 days, 4.1 percent of the rivaroxaban group experienced bleeding, compared with 1.7 percent taking enoxaparin.
Peter DiBattiste, vice president of cardiovascular development for J&J, said the company will conduct additional analyses to see if rivaroxaban can be used more selectively in patients hospitalized with acute medical illness.
He noted the J&J/Bayer drug had similar bleeding risk to enoxaparin in a group of earlier studies involving patients undergoing orthopedic surgery.
Source: http://www.reuters.com/article/2011/04/05/us-heart-rivaroxaban-idUSTRE7343CV20110405
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Panel calls for new safety review of mercury dental fillings
Last Updated on Wednesday, 15 December 2010 05:33 Written by Editor Wednesday, 15 December 2010 10:21
Updated data on mercury amalgam dental fillings may indicate possible medical problems for patients, a Food and Drug Administration advisory committee said Wednesday.
The panel — after hearing two days of testimony from experts, members of the public and dental professionals — recommended the FDA look at information updated since the agency ruled in 2009 that the mercury in dental fillings is not harmful.
Committee members noted, however, that the FDA’s decision was solid, based on information available at the time. The committee also stressed that more studies need to be done on amalgam fillings, especially in children.
Public pressure prompted the panel’s review, initiated less than 18 months after the agency’s decision.
Committee members listened to testimony by consumer and dental groups claiming the FDA used flawed science when it set the current guidelines for mercury safety levels.
“We need to see where the science is and if there are gaps.” said the panel’s chairwoman, Dr. Marjorie Jeffcoat, a dentist and researcher with the University of Pennsylvania.
In its final rule, the FDA concluded clinical studies did not establish a causal link between dental amalgam and health problems in people age 6 and older. But it did add that developing fetuses and young children may be more sensitive to the neurotoxin.
Amalgam tooth fillings are an alloy made up of various metals and 50 percent mercury,
Mercury toxicity has been well documented, but when it comes to amalgam fillings there isn’t a lot of data. Many dentists favor these fillings because they are cheap, easy to put in place and durable.
Dental professionals also argue that mercury fillings last longer than resin composites, and are easier on the tooth. The American Dental Association agrees with the FDA that amalgam fillings are safe.
Yet, some experts say mercury from these fillings penetrates into the body and damages human cells, especially in the brain, bones and kidneys. How much damage it is unknown, which is why the advisory committee is revisiting the issue.
In Wednesday’s public hearing, 30 people testified for and against the use of amalgam fillings.
Jessica Kerger, an attorney from Toledo, Ohio, said she was a healthy child until she started getting amalgam fillings. As she got older, she faced numerous health problems and a variety of diagnoses. She even had her amalgam fillings removed. It wasn’t until a doctor tested her for mercury poisoning that she realized her problem, she said.
Now, after being treated for excess mercury in her body, Kerger said, “I’m an active mother, attorney and I have a black belt in karate. I blame my fillings and I am begging the FDA to get rid of them.”
While others testified that mercury in their fillings caused such health problems as loss of memory, impaired vision, miscarriages and paralysis, many dental professionals asked that amalgam fillings remain.
Addressing the board, Dr. Vincent Mayher, a former president of the Academy of General Dentistry, said public accusations that dentists force patients to receive amalgam fillings is exaggerated.
“It’s Inflammatory. No dentist I know of forces a patient at any time to get amalgam fillings these days, especially pregnant women and little children.” Mayher testified
Andrew Read Fuller, a dental student at UCLA and member of the American Student Dental Association, noted there is no scientific data that amalgam fillings cause the problems some attribute to them, and said that, as a future dentist, he would use amalgam fillings on any of his patients as well as himself.
“In the absence of new evidence there is no reason to question the FDA’s decision.” Fuller said.
Yet some dentists did say they would avoid using amalgam fillings because of numerous public reports of mercury poisoning.
“I always wondered why we were told by the (American Dental Association) to be careful when disposing of mercury. If it’s so dangerous to the environment, why not my patients?” asked Dr. Stephen Markus, a dentist in the Philadelphia area.
The committee also recommended that the FDA come up with models that could be used to look at the effects of mercury vapor exposure from dental fillings. And when designing these models, it said, the agency should take into consideration age, health history and physical makeup of individuals.
There was also discussion that more data needs to be looked at to come up with stronger models, especially those based on younger children and unborn fetuses.
More information on amalgam fillings should be posted for both for patients and dentists, the committee said.
It also noted the FDA’s biomarker using urine to detect mercury exposure is not perfect but is the best available for adults. Members also noted that more updated data is needed before the agency can make stronger guidelines on amalgam fillings.
Although the committee’s recommendations will go to the FDA board for consideration, the board does not have to follow them. Traditionally, however, it does.
Source: CNN.com
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Consumers Union Raises Concerns About Mercury in Tuna
Last Updated on Monday, 13 December 2010 05:15 Written by Editor Monday, 13 December 2010 05:15
Younger women and children should limit the amount of tuna they eat and pregnant women should not eat tuna at all, because of mercury levels found in the canned and packaged fish, says new report in the January 2011 issue of Consumer Reports.
Albacore or white tuna usually contains far more mercury than light tuna, according to Consumer Reports , and canned tuna is the most common source of mercury in our diet.
In order to test current levels, investigators for the periodical tested 42 samples from cans and pouches of tuna bought mostly in the New York City area. They found all the samples contained measurable levels of mercury, ranging from 0.018 to 0.774 parts per million. Samples of white tuna had 0.217 to 0.774 ppm of mercury and averaged 0.427 ppm. According to Consumer Reports, if a woman of childbearing age ate about half a can of any of the tested samples, she would exceed the daily mercury intake the Environmental Protection Agency considers safe.
The Food and Drug Administration and the EPA guidelines indicate women of childbearing age and young children may eat up to 12 ounces a week of light tuna or other “low in mercury” seafood, including, within that limit, up to 6 ounces per week of white tuna. But Consumer Reports believes that may be too much. Because mercury can cause defects to the nervous system during fetal development, Consumers Union, the nonprofit publisher of Consumer Reports, advises pregnant women, as a precaution, to avoid eating tuna. It also advises that children who weigh more than 45 pounds limit their intake to 12.5 ounces of light tuna or 4 ounces of white tuna per week, and children who weigh less than 45 pounds consume no more than 4 ounces of light tuna or 1.5 ounces of white tuna.
Some critics, including fish producers, say Consumer Reports is overblowing the research.
“Consumer Reports’ suggestion that pregnant women limit the amount of fish they eat, outside of the FDA’s four fish to avoid, is reckless and has the potential to harm public health,” says the National Fisheries Institute in a statement “Peer-reviewed science shows that pregnant women who limit or avoid seafood may actually be introducing risks from omega-3 deficiency. Advising pregnant women to cut canned tuna out of their diet and for others to limit their consumption based merely on a magazine’s editorial opinion is irresponsible.”
But Consumer Reports is asking for change. Due to the results of the investigation, the publication’s editors are asking the FDA strengthen its current guidance and advise pregnant women to avoid tuna altogether. The group also believes the FDA should continue to test for mercury in seafood across the country, and provide U.S. consumers updated information on mercury levels in fish, as well as diet alternatives
“Fortunately, it’s easy to choose lower-mercury fish that are also rich in healthful omega-3 fatty acids,” says Dr. Urvashi Rangan, director of Technical Policy, at Consumers Union. “That’s especially important for women who are pregnant or might become pregnant, nursing mothers, and young children, because fetuses and youngsters are still developing their nervous systems and are therefore at particular risk from methylmercury’s neurotoxic effects.”
Lower mercury seafood includes shrimp, crab and cod.
Source: CNN.com
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US launches new regulatory science programm
Last Updated on Thursday, 13 May 2010 10:05 Written by Editor Thursday, 13 May 2010 10:05
Two major US government agencies have partnered to create a new regulatory science programme to ensure better integration between cutting edge science and regulatory processes in assessing new medical products or compounds flowing from biomedical research.
Announced on 24 February, the effort is a joint venture of the US National Institutes of Health (NIH) and the Food and Drug Administration (FDA), who will create a joint ‘Leadership Council’ to spearhead the collaborative work. The new body will be charged with ensuring that regulatory considerations form an ‘integral component of biomedical research planning’, and that ‘the latest science is integrated into the regulatory review process’, according to the two agencies.
Under the new endeavour, the NIH and FDA are also making a total of $6.75 million (£4.45 million) available over three years for work that can yield new methods, models or technologies that will provide better approaches to evaluating safety and efficacy in medical product development. The lion’s share of the money – $6 million – will come from the NIH.
‘Scientific advances will reduce the need for large animal studies to predict how humans will respond to chemical exposure,’ FDA spokesperson Karen Riley tells Chemistry World. ‘Some assessments will be able to be done using cell culture or genomic microarrays, which might be done more quickly and at lower cost.’
Among a range of activities, the agencies want to support work involving the implementation of assessment tools for emerging fields like nanomedicine and RNA interference therapy, and also support the development of novel manufacturing technologies to enhance product safety.
‘Weak and under-developed’Â
‘We have allowed the arm of regulatory science to become weak and under-developed,’ FDA commissioner, Margaret Hamburg, said during a 24 February briefing. If this ‘imbalance’ persists, she cautioned, the full potential of the biomedical research revolution will not be realised.
The American Chemistry Council (ACC) – an industry trade association for US chemical companies – supports harnessing new advanced molecular screening methods, but warns that many are premature.
‘Although these methodologies hold great promise, many aren’t yet ready for regulatory use,’ Rick Becker, an ACC senior toxicologist, tells Chemistry World.
Becker says additional research is needed to ‘develop confidence’ in these molecular screening techniques. ‘At some point, we believe data can be used to augment existing regulatory science and perhaps in the future replace existing animal testing in product safety assessment,’ he states.
Posted under FDA News, Press Releases | Comments Off
Slow procedure
Last Updated on Monday, 14 December 2009 05:29 Written by Editor Monday, 14 December 2009 05:29
Slow procedure
It takes 15 years on average for a drug discovery to make it to a patient’s medicine cabinet. Throughout the process, the U.S. Food and Drug Administration requires drug companies to submit applications to proceed to the next step.
1 Drug discovery and preclinical research (three to six years) – Researchers search for candidate drugs by screening chemical compounds that contain thousands or millions of potential medicines. They test the candidates against the disease target.
Once a compound has shown some activity against the drug target, it undergoes extensive testing in the lab – both in test tubes and animals. Years of preclinical testing must establish that the candidate medicine is likely to be safe and effective in humans before clinical testing can begin.
2 Clinical trials (six to seven years) – When a company is ready to begin clinical trials, it submits an Investigational New Drug Application to the FDA showing the data it has gathered in preclinical tests, as well as a clinical studies plan or protocol. Testing occurs in three phases:
Phase 1 – A small group of healthy people is tested to see how the chemical compound affects the body.
Phase 2 – The drug is tested in patients who have the disease in question.
Phase 3 – The drug is tested in hundreds or thousands of patients to find any rare or adverse side effects.
3 FDA review and manufacturing (two years) – Upon successful completion of clinical trials, the company submits a New Drug Application to the FDA.
Teams of engineers, biologists, chemists and physicists work to develop ways to produce the medicine on a large scale.
SOURCE: Pharmaceutical Research and Manufacturers of America
Source: Dallasnews.com
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PharmaGap Reports That GAP-107B8 Showed Strong and Consistent Anti-Cancer Activity in a Wide Range of Cancers in NCI Test
Last Updated on Wednesday, 2 December 2009 12:26 Written by Editor Wednesday, 2 December 2009 12:26
OTTAWA, ONTARIO, Oct 27, 2009 (MARKETWIRE via COMTEX) —-PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF) (“PharmaGap” or “the Company”) is pleased to announce highly positive results from the United States National Cancer Institute (“NCI”) 5-dose in vitro anti-cancer screen of PharmaGap drug GAP-107B8. These results confirm and extend results announced in August from the single-dose study and provide definitive independent validation of GAP-107B8 as an active pharmaceutical ingredient against a wide range of cancers.
GAP-107B8 is a novel peptide protein kinase inhibitor that was designed to specifically target molecular signaling pathways in cancer cells. Targeted therapies are designed to target cancer cells while sparing surrounding normal, healthy, cells, thus causing less toxic effects than many standard chemotherapeutic agents currently in use.
Within a dose concentration range of 10 to 100 micromolar (u M), GAP-107B8 caused 100% growth inhibition (measured against cancer cell growth in untreated groups) in 51 of 56 cancer cell lines and caused at least 50% cancer cell death (measured against the number of cancer cells at the beginning of the test period) in 29 of 56 cancer cell lines.
The standard NCI test methodology generates three values that are used to measure the drug compound’s activity against the cancer cell-line panel. These are: the GI50, the dose that causes an average 50% growth inhibition in the cell lines; the TGI, the dose that causes an average 100% growth inhibition in the cell lines; and the LC50, the dose that causes an average 50% cell death in the cell lines. For GAP-107B8, the GI50 was determined to be 23 u M, the TGI was 51 u M, and the LC50 was 89 u M. These data provide a very clear range of focus for all future studies.
These results provided a large amount of data, from the NCI testing which will be used by the Company to select specific cancer types and to determine an optimum dosing range for future animal studies and subsequent clinical trials. Based on these and prior results, the Company will be focusing its immediate development program on ovarian cancer and melanoma. The first of these animal studies is currently underway at the Ottawa Hospital Research Institute (“OHRI”) in ovarian cancer. Further testing of GAP-107B8 on melanoma is about to commence under the guidance of Dr. Gary Schwartz at Memorial Sloan Kettering Cancer Center in New York. GAP-107B8 showed a strong effect in both melanoma and ovarian cancers in both single-dose and 5-dose testing at the NCI. In addition, the Company and NCI staff will meet in late November to discuss these results and ways in which the NCI may participate in various aspects of the development program for GAP-107B8.
The results across such a wide range of cancer cell lines, including a number which are known to be resistant to standard chemotherapy, indicate that GAP-107B8 has the potential to become a new cancer drug with less toxic side effects than common chemotherapeutic regimens.
Robert McInnis, President of the Company, stated “We are very pleased with the extent of activity in the NCI panel, as this activity against all cell lines provides a wide range of development opportunities for us, and provides us with additional support for a focus on ovarian cancer and melanoma. Our objective of the testing at the NCI – independent and verifiable validation of activity – has been fully realized. Over the past 12 months we have made significant progress in moving our lead drug to clinical trials: generating quality- controlled gram-scale production of the compound; achieving verifiable independent validation of compound activity at both the NCI and here in Ottawa at the OHRI; and programs underway in the area of bioassay development, understanding of signalling pathways involved, and continued testing programs at Memorial Sloan Kettering. This progress is very encouraging to me and to our team. Most importantly, results so far indicate a potential for new hope for the future of patients suffering from several types of cancer”.
About The National Cancer Institute
The National Cancer Institute (NCI), located in Bethesda, MD is an institute of the National Institutes of Health, the primary U.S. Federal Agency for conducting and supporting medical research. The NCI has a mandate to select and screen novel drug compounds that could potentially make a material difference in the “war against cancer”. Selection to the NCI screening program is through a competitive application process. Details on the NCI’s compound screening program can be found at http://dtp.nci.nih.gov/. More general information on the NCI is found at www.cancer.gov.
About PharmaGap Inc.
PharmaGap Inc. (TSX VENTURE: GAP)(OTCBB: PHRGF), based in Ottawa, ON, is a biotechnology company with a core focus on developing novel peptide therapeutics for the treatment of cancer. PharmaGap’s GAP-107B8 is a novel peptide drug designed to inhibit the activity of protein kinase C (PKC), a cell signalling enzyme implicated in certain types and stages of cancer. Independent peer-reviewed research has demonstrated that over-expression of PKC plays a role in the development of many cancer types. For more information please visit www.pharmagap.com.
Note: Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. No Securities Commission or other regulatory authority having jurisdiction over PharmaGap has approved or disapproved of the information contained herein. This release contains forward looking statements that may not occur or may change materially.
Contacts: PharmaGap Inc. Robert McInnis President & CEO 613-990-9551 bmcinnis@pharmagap.com www.pharmagap.com
SOURCE: PharmaGap Inc.
Posted under Cancer Research, Discoveries, Innovations and Patents, FDA News, New Products, Oncology Research, Press Releases | Comments Off
CytRx Unveils Clinical Development Plan for Pipeline Assets
Last Updated on Friday, 12 December 2008 02:47 Written by Editor Friday, 12 December 2008 02:47
Names World-Renowned Cancer Drug Expert Dr. Joseph Rubinfeld as Chief Scientific Advisor
LOS ANGELES–(BUSINESS WIRE)–CytRx Corporation (NASDAQ: CYTR) today unveiled its corporate strategy to focus its internal resources on the clinical development of oncology drug candidates tamibarotene and INNO-206, which the Company believes offer the greatest mix of near-term and medium-term revenue potential among its clinical assets. CytRx will pursue partnerships to advance the clinical development of INNO-406 (bafetinib) and its clinical molecular chaperone portfolio, where it continues to see significant future revenue potential. The Company further intends to use its proprietary high-throughput, high-content drug screening Master Chaperone Regulator Assay (MaCRA) platform to discover additional molecular chaperone drug candidates, including those that may inhibit cancer growth, which will support internal efforts to build an oncology drug franchise or future out-licensing possibilities.
CytRx also announced that Board of Directors’ member Dr. Joseph Rubinfeld has accepted the additional responsibility of Chief Scientific Advisor, and will consult on all aspects of the Company’s oncology development programs while serving as an important interface between the Company and investors, clinicians and industry thought leaders. Dr. Rubinfeld brings substantial expertise in oncology and drug development through his distinguished career. Dr. Rubinfeld was employed at Bristol-Myers Company International Division as Vice President and Director of Research and Development. While at Bristol-Myers, Dr. Rubinfeld was instrumental in licensing the original anticancer line of products, including Mitomycin and Bleomycin. Among other accomplishments, he was among the four co-founders of Amgen, Inc., and founded SuperGen, Inc., where he previously served as CEO, President and Chief Scientific Officer. In his career he has been instrumental in the development of several blockbuster cancer drugs including cisplatinum, etoposide, erythropoietin, decibitene and pentostatin, and the antibiotics amoxicillin and cefadroxil.
Steven A. Kriegsman, CytRx President and CEO said, “We feel that our stockholders are best served by a focus on potential therapeutics for cancer. We believe tamibarotene has strong potential as a revenue generator with a high likelihood for rapid U.S. approval as a third-line treatment for acute promyelocytic leukemia (APL). Our view is based on the substantial clinical history of tamibarotene as an approved treatment of relapsed APL, in Japan and the existing special protocol assessment (SPA) in place with the U.S. Food and Drug Administration (FDA) for our ongoing U.S. registration clinical trial. We are accelerating enrollment in this clinical trial, with the expectation of filing an NDA with the FDA as early as 2010. We are also taking steps to move into a Phase 2 clinical trial with INNO-206, our highly promising targetable pro-drug for the commonly prescribed chemotherapeutic doxorubicin. We believe that INNO-206 could be effective in a wide variety of cancers, including small cell lung cancer, sarcoma, breast and ovarian cancer and Non-Hodgkins Lymphoma.
“Importantly, we expect that we have ample financial resources with our current cash position and investment in RXi Pharmaceuticals Corporation to support this strategy,†according to Mr. Kriegsman. “We have strong oncology expertise within CytRx and are delighted that Dr. Joseph Rubinfeld, our long-time board member who has enjoyed an illustrious career developing cancer drugs, will be taking a leadership role in our oncology programs.â€
Dr. Rubinfeld said, “Having reviewed the extensive data on tamibarotene and INNO-206, I am excited about the potential for these two cancer drug candidates and look forward to working closely with the CytRx management team to advance their clinical development to potential commercialization. I am also encouraged by the Phase 1 data we announced earlier this month with INNO-406, now known as bafetinib, which demonstrated positive, clinical responses in 35% of patients with refractory chronic myeloid leukemia. I believe these results will be instrumental in our search for a partnership for bafetinib.â€
Mr. Kriegsman added, “We also stand behind our view that our orally administered molecular chaperone drug candidates, arimoclomol and iroxanadine, provide enormous potential in addressing large, underserved markets and are convinced that the prudent course to maximize stockholder value in this economic climate is to pursue pharmaceutical partners to share additional development costs for these longer-term programs. We intend to complete our ongoing arimoclomol animal toxicology studies and work aggressively toward lifting the current clinical hold in order to enable this drug candidate to move back into the clinic. At that point, we will seek partners for further development of arimoclomol as a therapeutic treatment for both ALS and stroke recovery. Additionally, iroxanadine has shown significant potential as a therapeutic treatment for diabetic foot ulcers and other diabetic complications, and based on Phase 2 data, we will pursue potential partnerships in cardiovascular conditions.â€
CytRx’s drug portfolio includes the following:
Oncology Drug Candidates:
Tamibarotene: CytRx holds the North American and European rights to tamibarotene, a rationally designed, synthetic retinoid compound designed to potentially avoid toxic side effects of the current first-line APL treatment trans-retinoic acid (ATRA). CytRx is actively enrolling patients in a Phase 2 registration clinical trial, known as STAR-1, with tamibarotene to evaluate its efficacy and safety as a third-line treatment for APL. The registration study is being conducted under a Special Protocol Assessment. The FDA has granted Orphan Drug Designation and Fast Track Designation for the use of tamibarotene in patients with relapsed or refractory APL following treatment with ATRA and arsenic trioxide.
There are currently no approved third-line treatment options for refractory APL patients. CytRx estimates the U.S. market opportunity for tamibarotene in refractory APL at approximately $20 million annually. CytRx scientists are also evaluating clinical strategies for developing tamibarotene as a first-line or second-line APL therapy. The estimated annual market potential in the U.S. and Europe for an expanded label including refractory, maintenance and front-line therapy is $150 million. CytRx also retains an option to expand its licenses for the use of tamibarotene in other cancers including multiple myeloma, myelodysplastic syndrome and certain solid tumors in the U.S., and multiple myeloma, myelodysplastic syndrome and solid tumors, other than hepatocellular carcinoma, in Europe.
INNO-206: This pro-drug derivative of the commonly prescribed chemotherapeutic agent doxorubicin is designed to reduce adverse events by controlling drug release and preferentially targeting the tumor. In a Phase 1 study, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. Objective clinical responses were seen in patients with sarcoma, breast and lung cancers. The Company plans to evaluate further clinical development of INNO-206 in a wide variety of cancers, including sarcomas, breast and ovarian cancer, and Non-Hodgkins Lymphoma.
INNO-406 (bafetinib): INNO-406 (bafetinib), a potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, is being evaluated for the treatment of patients with chronic myeloid leukemia (CML) and other leukemias that have a certain mutation called the Philadelphia Chromosome (Ph+) and are intolerant of or resistant to imatinib (Gleevec®) and second-line tyrosine kinase inhibitors (i.e. dasatinib (Sprycel®) and nilotinib (Tasigna®)). In November 2008, CytRx announced that bafetinib demonstrated positive, clinical responses in 35% of patients with CML in Phase 1 clinical testing. The Phase 1 clinical trial was used to determine the optimal dose prior to Phase 2 clinical efficacy testing.
CML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood. In 2007, the American Cancer Society estimated that approximately 4,600 new cases of CML were diagnosed in the U.S. and that the number will increase as the population ages. Current estimates are that worldwide CML prevalence will increase by 10,000 patients a year, reaching a population of 110,000 in 2010. The global market will grow to an estimated $5.5 billion by 2012.
Molecular Chaperone Regulation
CytRx is a leader in molecular chaperone regulation technology. The Company currently has two orally administered, clinical-stage, drug candidates and recently discovered a series of additional compounds that may provide a pipeline for additional drug candidates. The Company’s drug candidates are believed to function by regulating a normal cellular protein repair pathway through the activation or inhibition of “molecular chaperones.” Because damaged proteins are thought to play a role in many diseases, activation of molecular chaperones that help to reduce the accumulation of misfolded proteins may have therapeutic efficacy in a broad range of disease states. Similarly, CytRx believes that the inhibition of molecular chaperones that normally help protect cancer cells from toxic misfolded proteins may result in the selective destruction of cancer cells.
- Arimoclomol: This molecular chaperone regulator drug candidate is being considered as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) and stroke recovery. Arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events. CytRx’s Phase 2b clinical trial with arimoclomol as a treatment for ALS was placed on clinical hold by the FDA in January 2008, unrelated to any data generated by human studies, and additional preclinical toxicology studies are underway to resolve this issue.
- Iroxanadine: CytRx believes that this orally available small molecule compound represents a potentially powerful breakthrough in the treatment of vascular diseases that are caused in part by damage to “vascular endothelium” that lines the inside of blood vessels. CytRx believes that endothelial dysfunction plays a key role in the development of various vascular diseases or their complications including diabetic ulcers, thrombosis, retinopathy, and peripheral artery disease. Preclinical and clinical studies with iroxanadine indicate that it has therapeutic potential for the treatment of cardiovascular atherosclerosis. According to the National Heart, Lung & Blood Institute, atherosclerosis is a leading cause of illness and death in the U.S. and affects approximately 4.6 million people annually.
CytRx San Diego Laboratory: The CytRx San Diego Laboratory is using the Company’s proprietary Master Chaperone Regulator Assay (MaCRA), a cell image-based screening tool that enables the rapid and quantifiable screening of large numbers of small molecule compounds. This technology is used to identify potential drug candidates that modify the activity of a protein known as heat shock transcription factor 1 (Hsf1) and consequently control entire groups of molecular chaperone proteins that repair or degrade toxic misfolded proteins present in diseased cells. Evaluation of the compounds identified in the screen has shown that they exhibit cytoprotective properties in cell culture models of disease. This platform has broad applicability to a range of therapeutic areas, through its ability to identify drug candidates that can either inhibit or amplify molecular chaperone activity. Information related to the development of MaCRA for compound screening was published in the November 2008 issue of the peer-reviewed Journal of Biomolecular Screening.
CytRx Oncology Expertise
Collectively, CytRx’s management and its Board of Directors have brought numerous cancer drugs to market. In addition to Dr. Rubinfeld, the senior managers and directors of CytRx who hold significant oncology experience include: Max Link, Ph.D., Chairman of the Company’s Board of Directors since 1996, who served for a number of years as Chairman and CEO of Sandoz Pharma as well as a director of Alexion Pharmaceuticals, Inc., Celsion Corporation and Discovery Laboratories, Inc.; Jack R. Barber, Ph.D., Chief Scientific Officer, who has significant R&D experience in oncology at Immusol and Viagene, where he most recently served as Head of Oncology; and Shi Chung Ng, Ph.D., Senior Vice President of Research and Development, who has substantial R&D experience at companies such as Abbott and ArQule, Inc., and most recently served as Vice President of Molecular Oncology at Ligand Pharmaceuticals.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The CytRx drug development pipeline includes programs in clinical development for cancer indications, including tamibarotene in a registration study for the treatment of acute promyelocytic leukemia (APL). CytRx is developing two drug candidates based on its industry-leading molecular chaperone technology, which aims to repair or degrade misfolded proteins associated with disease. The Company owns and operates a research and development facility in San Diego. CytRx also maintains a 45% equity interest in publicly traded RXi Pharmaceuticals, Inc. (NASDAQ: RXII). For more information on the Company, visit www.cytrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome or results of any pre-clinical or clinical testing of CytRx’s potential oncology or molecular chaperone drug candidates, including tamibarotene as a third-line treatment for APL, risks related to CytRx’s ability to enter into partnerships to advance the clinical development of INNO-406 and its clinical molecular chaperone portfolio, uncertainties related to the impact of the FDA’s clinical hold on the Company’s arimoclomol clinical trial for ALS on the timing and ability to resume clinical testing at the desired dosage of arimoclomol, the risk that any requirements imposed on the Company’s planned clinical trial designs for ALS or stroke recovery by the FDA as a result of the concerns expressed in their clinical hold of the Company’s ALS program might adversely affect the Company’s ability to demonstrate that arimoclomol is efficacious in treating ALS or stroke patients or cause the Company to cancel one or both of those trials, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, risks related to the future market value of CytRx’s investment in RXi and the liquidity of that investment, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
FDA Issues Public Health Advisory on Chantix
Last Updated on Wednesday, 9 April 2008 11:59 Written by admin Wednesday, 9 April 2008 11:59
The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking.
On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals and patients informed of new and emerging safety data.
“Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” said Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug.”
Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.
In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:
Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.
Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.
Patients should immediately report changes in mood and behavior to their doctor.
Vivid, unusual, or strange dreams may occur while taking Chantix.
Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.
FDA will continue to update health care professionals with new information from FDA’s continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency’s continuing reviews and conclusions warrant.
For more information:
http://www.fda.gov/cder/drug/infopage/varenicline/default.htm
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