Bio Screening Industry News

Archive for October, 2009

October 29, 2009

Eurogentec Announces Agreement to Acquire AnaSpec, Inc.

Liège, Belgium—October 23, 2009.
Eurogentec S.A. (“Eurogentec”) announces today a final agreement for the acquisition of AnaSpec Inc (“AnaSpec” or the “Company”), a privately held proteomics company based in Fremont, California. Founded in 1993, AnaSpec is a leading provider of integrated proteomics solutions for life science research and diagnostics with expertise in peptides synthesis, labeled peptides and antibodies, fluorescent dyes and enzyme activity assays. AnaSpec has developed one of the world’s largest collections of catalog and dye-labeled peptides in the fields of Alzheimer Disease, Multiple Sclerosis and enzyme inhibitor screening. Leveraging its expertise in peptide, antibodies and fluorescent dyes, AnaSpec has established a leading edge portfolio of integrated proteomics solutions such as FRET based assays and SensoLyte™ assays for basic research, high-throughput screening and drug discovery.  Furthermore, AnaSpec’s proprietary fluorescent dyes are being used by the world’s leading diagnostic companies to enhance their diagnostic solutions.
“Bringing AnaSpec into the Eurogentec Group is a strategic decision for our company,” explains Jean-Pierre Delwart, CEO of Eurogentec. “Through this acquisition, Eurogentec  becomes a leading integrated solution provider for the Life Science and Diagnostics sectors. Our combined expertise enables Eurogentec to provide innovative solutions in the fields of Genomics and Proteomics for basic research in the biotech and pharmaceutical sectors, as well as applied solutions in the diagnostics sector. As an example, the HiLyte Fluor™ dyes and QXL™ quenchers that are part of AnaSpec’s high performance detection assays will be integrated into Eurogentec’s comprehensive portfolio of oligonucleotides. This will establish a license-friendly alternative to most dye-labeled oligonucleotides from competitors for commercial and diagnostic applications. Moreover, AnaSpec considerably strengthens Eurogentec’s geographical presence in the US and Eurogentec will directly market and support AnaSpec’s products in the EU.” The founders of AnaSpec, Anita Hong, President, and Frank Hong, CEO, comment: “It is important for the sustained development of AnaSpec to integrate into a larger organization where its current assets and competencies can bring real added value. The total complementarities between Eurogentec’s and AnaSpec’s existing businesses and the cross-fertilization opportunities for future developments are a key factor for the success of this partnership. We are very much looking forward to closely working with the Eurogentec Team from this perspective.”
AnaSpec’s founders and senior management, Anita and Frank Hong, will remain aboard the Company in leading roles in continuing to grow AnaSpec’s businesses, further expanding the high value detection reagents focus and facilitating integration with Eurogentec.  Eurogentec intends to maintain the Company’s state-of-the-art Fremont facility, to which AnaSpec recently moved operations, and its valued employees.
Troutman Sanders LLP served as legal counsel, and Achelous Partners, LLC, served as financial advisers to AnaSpec.  DLA Piper LLP served as legal counsel to Eurogentec on this transaction.

About Eurogentec
Eurogentec is a leading global supplier of innovative reagents, kits, specialty products and custom services to scientists in the life science, biotechnology, pharmaceutical and diagnostic markets. Eurogentec provides a wide range of expertize in small- and large-scale DNA, RNA, PCR and qPCR kits, peptide synthesis and antibody supply for research applications. Our ISO13485:2003-certified manufacturing facilities in Belgium provides a wide range of high value oligonucleotide-based components for diagnostic and therapeutic applications. Eurogentec’s Belgium manufacturing facility is complemented by additional production facilities in North America and Japan. Eurogentec is also an experienced Contract Manufacturing Organization (CMO) for Biopharmaceuticals, operating a full-service, state-of-the-art GMP facility in Belgium.
Eurogentec is a privately held company headquartered in Liège, Belgium, with subsidiaries in North America, France, Germany, the UK, the Netherlands and Switzerland and has additional production facilities in North America, Japan and Singapore. Eurogentec employs 400+ people globally.
Contact Information:
Jean-Pierre Delwart
Chief Executive Officer, Eurogentec
Ph: +32-475-607-884

Philippe Cronet
Chief Scientific Officer, Eurogentec
Ph: +32-4-372-7411

Albert Hong
Business Development Specialist, AnaSpec Inc.
Ph: (800) 452-5530 x243

October 22, 2009

ERGONEX Pharma receives Frost & Sullivan’s European Orphan Diseases Entrepreneurial Company Award 2009

Filed under: Grants and Awards, Industry News, Press Releases — Editor @ 12:02 pm

Appenzell, Switzerland, October 19, 2009 / b3c newswire / - ERGONEX Pharma received one of the prestigious ‘European Orphan Diseases Entrepreneurial Company Award’ on the occasion of Frost & Sullivan’s ‘2009 Excellence in Healthcare Awards Banquet,’ held in London on 8th October 2009. The highly competitive award was presented to ERGONEX Pharma in recognition of the company’s innovative therapeutic concept, its impressive display of technological know-how and targeted vision.

ERGONEX Pharma is focused on the clinical development and commercialisation of Terguride for the treatment of distinct orphan diseases. Terguride is currently being evaluated for the treatment of pulmonary arterial hypertension (PAH) in a Phase II trial in Europe and headline results are expected in 2010.

Dr. Rudolf Reiter, CEO of ERGONEX Pharma comments: “This award comes at an exciting and challenging time for ERGONEX Pharma. I see it as recognition of the vision, the commitment and work of the company, which would not have been possible without the continued support, expertise and out-of-the-box thinking of our partners in the on-going clinical trial. We believe that Terguride has the potential to contribute a new quality to emerging combination therapies for patients, who do not tolerate, have become resistant to or are insufficiently controlled by current treatment options in PAH.”

The Frost & Sullivan Healthcare Awards Banquet honours Europe’s best healthcare companies for their achievements over the course of this year. Frost & Sullivan’s highly competitive awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

Link to the news release

About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension is a disorder of the blood vessels in the lung, in which the pressure in large blood vessel rises above normal. Walls of the blood vessels are thickened and hardened, becoming less elastic. Hence, the decrease in lumen leads to increases in pressure. Patients with PAH suffer from extreme shortness of breath as the heart struggles to pump against these high pressures causing such patients to ultimately die of heart failure.

About Terguride
Terguride acts as a potent antagonist on 5-HT2B and 5-HT2A receptors: It has anti-proliferative and anti-fibrotic activities and drives reverse remodelling processes. Serotonin is a signal molecule in the body with many functions. In the blood vessel walls of the lung, it stimulates proliferation of smooth muscle cells and narrowing of the blood vessels, which has been implicated in PAH. Furthermore, trophic effects of serotonin on the heart contribute to right heart hypertrophy and progression towards heart failure. Terguride is approved in Japan for hyperprolactinemia acting as a partial dopamine agonist on the pituitary gland.

About ERGONEX Pharma - www.ergonex.com
ERGONEX Pharma is a pharmaceutical company focused on developing and commercialising well-tolerated and effective products for novel and typically underserved indications. This is being achieved by forging collaborations with commercial and academic partners with expertise in the field of interest and through outsourcing activities to service providers.


Contact

ERGONEX Pharma GmbH
Ruetistr. 20
CH-9050 Appenzell
Switzerland
Phone: +41 71 788 4065
E-mail: info@ergonex.com
www.ergonex.com

GenoLogics and CLC bio to Provide End-to-End Genomics Informatics and Analysis for Next Generation Sequencing

Filed under: Collaborations, Press Releases — Editor @ 12:01 pm

Victoria, BC, Canada and Aarhus, Denmark — October 19, 2009 — GenoLogics and CLC bio today announced they will provide an end-to-end informatics and analysis solution, optimized for Next Generation Sequencing research that addresses both lab and data management and data analysis all within one integrated system.

This end-to-end solution will significantly impact researchers’ ability to aggregate raw data across Next Generation Sequencing experiments to get to biological meaningful results faster. From initial sample submission to final analysis, GenoLogics’ lab and data management system for genomics, Geneus, and CLC bio’s CLC Genomics Server, CLC Genomics Workbench and CLC NGS Cell integrate seamlessly to help researchers get the most out of their Next Generation Sequencing instruments.

Thomas Knudsen, CEO at CLC bio, states  “With this collaboration, our Enterprise Platform expands with an end-to-end workflow that couples world-class LIMS functionalities like tracking of samples and data as well as reporting, with our comprehensive Next Generation Sequencing analysis capabilities, to the obvious benefit of our customers. This way researchers can keep up with the vast volumes of sequencing data being churned out by high-throughput sequencing machines, and quickly turn the massive amounts of raw data into meaningful results.”

Sal Sanci, Vice President Products for GenoLogics, continues “We continually strive to provide our customers with solutions that marry best-in-class analytics tools and informatics to accelerate the path to meaningful results and discovery. This collaboration combines two proven systems, into one unified environment for data management and comprehensive analysis. We know our customers need a unified end-to-end solution and have asked for an integration between Geneus and CLC bio’s NGS platform – and now it’s available!”

Combined, these two systems offer a comprehensive solution to researchers using next generation sequencing instruments. Researchers can keep pace with the growing volume of sequence data, and quickly turn massive amounts of raw data into meaningful results.

This powerful informatics and analysis solution offers researchers extensive sample tracking, project, and workflow management capabilities, as well as streamlined data pipelining, and comprehensive results analysis. Furthermore it provides users with a well organized and intuitive graphical interface for carrying out an extensive range of high-performance computing accelerated analyses within genomics, transcriptomics, and epigenomics.

About GenoLogics
http://www.genologics.com/about-us

About CLC bio
http://www.clcbio.com/about

Contact GenoLogics
Tanis MacSween, Manager, Marketing Communications
Phone: +1 250-483-7063
E-mail: tanis.macsween@genologics.com

Contact CLC bio
Thomas Knudsen, CEO
Phone: +45 7022 5509
E-mail: info@clcbio.com

BioServe to Test for Swine Flu in India

Filed under: Events, Press Releases, Swine Flu Research — Editor @ 10:59 am

Beltsville, MD; and Hyderbad, AP, India, October 21, 2009 – BioServe, a leading provider of clinical bio-samples and research services, today announced that it has been selected by the Government of the State of Andhra Pradesh in India and The Institute of Preventive Medicine (IPM) Hyderabad as one of two private diagnostic centers to test samples of Influenza A - H1N1 (Swine Flu) in afflicted patients. BioServe’s ISO 9001:2008 and ISO 17025:2005 (NABL) certified genomic laboratory in Hyderabad, India is one of the most advanced full-service reference laboratories in the country.

In addition, to help prepare the Indian health system for a robust response to pandemic outbreaks of swine flu, BioServe is also developing a powerful one-step PCR diagnostic test for effective identification of swine flu, at a price point that makes it possible to carry out mass screenings of large populations in India. The test will be certified in accordance with the prevailing guidelines for diagnosis of virus strains, and is scheduled for a market launch upon due validation and verification.

According to the Indian Government’s most recent data, there have been 12,880 confirmed cases of swine flu and 415 deaths from the virus. The country’s Ministry of Health views the addition of BioServe’s new diagnostic center as critical to expediting the testing of swine flu samples, which will enable the authorities to diagnose more cases and start treatment immediately, thus mitigating the risks of spreading the disease further throughout the population.

Rama Modali, President, BioServe, said, “We are proud to be a key part in India’s fight against the pandemic outbreaks of swine flu. BioServe’s clinical testing labs, as well as our indigenous swine flu diagnostic test currently in development, will help provide the rapid and accurate diagnoses that are critical to disease containment and treatment in  India and countries around the world.”

About BioServe

BioServe provides pharmaceutical, biotechnology, clinical and academic research markets with comprehensive ‘biomaterial to validated data’ genomic research services that generate pre-clinical data needed for breakthroughs in drug discovery and molecular diagnostics.  BioServe’s services feature over 600,000 high quality, well-annotated and clinically relevant biological specimens from its Global Repository® and a suite of complimentary CLIA-certified genomic research services. Used together or separately BioServe’s genomic services enable biomedical researchers to efficiently conduct genomic and proteomic research,  validate drug and diagnostic targets  and correlate clinical data with molecular data for the development of improved drugs and diagnostics.  BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

October 20, 2009

Scripps Research scientists awarded $3.9 million grant to develop new compound screening platform

Bicoastal effort could help revolutionize the search for new therapies

La Jolla, CA, and Jupiter, FL, October 5, 2009 –A pair of scientists from The Scripps Research Institute, one on each coast, has been awarded a five-year $3.9 million grant from the National Institutes of Health (NIH) to develop a new technology to accelerate the search for new protein ligands – compounds that bind to proteins and alter their function.

Current screening technology, which is slow and expensive, has caused what the NIH calls a “major bottleneck” in the search for these basic tools that are key for the broader study of biological processes and that lay the groundwork for development of most drugs.

The grant, awarded as part of the NIH’s new Roadmap Transformative R01 Program, will be shared between the laboratories of Tom Kodadek, Ph.D., a professor in the Scripps Research Departments of Chemistry and Cancer Biology in Jupiter, Florida, and Benjamin Cravatt III, Ph.D., professor and chair of the Department of Chemical Physiology and member of The Skaggs Institute for Chemical Biology and Helen L. Dorris Child and Adolescent Neuro-Psychiatric Disorder Institute at Scripps Research in La Jolla, California.

“Ben and I are extremely pleased to win this highly competitive award and to be among the first selected for the new Transformative Grant program from the NIH,” Kodadek said. “This is a perfect example of the tremendous collaborative possibilities available within Scripps Research. We worked on the proposal together and the fact that we’re both part of the same national institution will make the work that much easier as we move ahead.”

Cravatt added, “This project is a good reflection of what those of us at Scripps Research in La Jolla and in Florida are trying to accomplish – fostering collaborative interaction and working on complimentary research projects. This will help cement the strong working relationship between our two campuses.”

The NIH Roadmap Transformative R01 (T-R01) Program awards were launched this year to support exceptionally innovative, high risk, original, and/or unconventional research projects that have the potential to create or overturn fundamental scientific paradigms.

“The appeal of the Pioneer, New Innovator, and now the T-R01 programs, is that investigators are encouraged to challenge the status quo with innovative ideas, while being given the necessary resources to test them,” said NIH Director Francis S. Collins, M.D., Ph.D. “The fact that we continue to receive such strong proposals for funding through the programs reflects the wealth of creative ideas in science today.”

Two Innovative Methods and a Cab Ride

The new Scripps Research project will combine two separate technologies from each laboratory – a peptoid library synthesis and screening platform developed in the Kodadek laboratory and an activity-based protein profiling system developed in the Cravatt laboratory.

Kodadek’s screening platform involves the creation of vast libraries of peptoids (peptoids are synthetic molecules that are similar to peptides, compounds that when joined together make up proteins) displayed on microscopic beads that are screened against fluorescently tagged proteins that light up after binding with a high affinity, highly selective ligand.

“Our screening technology simulates the cellular environment,” Kodadek said, “because the tagged proteins, which represent only a small fraction of the total, are mixed in with un-tagged competitors. There is a specificity filter built into the process from the beginning.”

The Cravatt Laboratory has pioneered the Activity-Based Protein Profiling technology, which allows scientists to identify protein classes based on their activity. The basic technology attaches a single label or probe to proteins from a particular subset of the proteome, which allows access to what are considered low abundance proteins and makes it ideal for massive parallel screening experiments. So far, Activity-Based Protein Profiling probes have been developed for more than a dozen distinct enzyme classes.

Cravatt’s technology makes it possible to target what he calls “interesting classes of proteins” but in a highly parallel fashion – hundreds of screens at a time of those multi- million member peptoid libraries. Although both scientists have known one another for some time, many of the details of the collaboration were worked out on a cab ride from England’s Heathrow airport to London last summer.

“Tom and I had an editorial board meeting in London, and shared a cab from the airport,” Cravatt said. “The fact that Tom had recently joined Scripps Florida helped get us energized about the project.”

“It’s true,” Kodadek added. “The ideas behind the grant proposal just popped out of that ride.”

A Transformational Marriage

The combination of the Kodadek and Cravatt advanced technologies will allow the screening of massive peptoid libraries (1-10 million synthetic compounds) in parallel fashion, a novel strategy that the scientists predict will increase the rate of ligand discovery by several hundred times over current methods.

“The gist of our proposal is quite simply marrying these two beautifully worked out technologies,” Kodadek said. “We have a good track record on both sides, plus we’re building off these innovative platforms, so if this works, and I’m certain it will, it will definitely be transformational.”

That transformation, when it comes, should result in more lead drug candidates, Kodadek said, because while the scientists’ success rate has been lower than those using current high throughput screening technology, the quality of the ligands identified has been significantly better. Some of this is due to the fact that simple synthetic compounds like peptoids have many advantages over other ligands such as antibodies. They can be modified easily for attachment to surfaces and can be produced in relatively large amounts at lower cost and rather quickly – a multi-million member peptoid library, for example, can be created in around three days.

“The way most science works today,” Cravatt said, “is that researchers tend to huddle around those areas where there are tools available. By combining our technologies, we will have a streamlined, unbiased way to identify high quality protein ligands and that will give us access to a large part of the proteome that others can’t study right now because the current technology is inadequate.”

###

About The Scripps Research Institute

The Scripps Research Institute is one of the world’s largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Scripps Florida is located in Jupiter, Florida.

Source: eurekalert.org

MALDI-Based Method May Reduce Cost of Rx-Screening Assays, Speed Drug Development

Filed under: Industry News, Press Releases, HT Screening, Compound Screening — Editor @ 9:44 am

This story originally ran on Oct. 6.

By Tony Fong

Researchers from the University of Cincinnati and MDS Analytical Technologies have used mass spectrometry to develop a high-throughput screening method for drug discovery they say can be more precise and cost-effective than existing techniques.

The technique is based on a MALDI triple-quadrupole platform and exploits the selective multiple-reaction monitoring transition features of the platform. By doing so, the new method is able to lower the cost of high-throughput screening for drug compounds to pennies per well from as much as $1 per well currently, Ken Greis, associate professor of cancer and cell biology and director of proteomics and mass spectrometry at the University of Cincinnati College of Medicine, told ProteoMonitor recently.

A study detailing the method was published Sep. 15 in the online edition of Rapid Communications in Mass Spectrometry.

In the paper, Greis and his co-authors said that drug discovery typically begins with a validated target enzyme “with the initial goal of finding appropriate molecular scaffolds with inhibitory activity via high-throughput screening.” The scaffolds are then subsequently used for lead compound optimization, and “ideally for the development of a safe and effective therapeutic compound.”

The most common methods of high-throughput screening have been fluorescence- and chemiluminescence-based approaches. Such approaches, Greis said, have been “very successful” because the same reagents can be used for many different enzymes.

But that same characteristic also creates a risk for interference.

“When one’s evaluating a compound repository for inhibitors, you often have a series of compounds that will fluoresce themselves,” Greis said. “If they fluoresce, they’re going to give you a false signal. Alternatively … there are compounds that inhibit the fluorescent properties, or what’s called quenching fluorescence, [that] also give false read-outs.”

Another problem is in the way the assays get generalized so that the reagents work for a wide range of enzymes. Such assays are called coupled assays: “You have a product being formed from your enzyme reaction but that’s not what actually triggers the fluorescence,” Greis said. “That product gets converted to another enzyme to another product through another enzyme to another product that then can be fluoresced.”

This series of enzyme step, or coupled assays, ultimately results in a read-out. “The problem is any compound that interferes with any of those steps along the way also gives you false read-outs,” which tend to be false positives, he added.

But by using mass spectrometry to measure enzyme activity, Greis and his colleagues are able to get a direct read-out, “so a mass spectrometer effectively can give you a quantitation and a mass of a compound.”

By taking a ratio of the substrate being converted to a product — the essence of an enzyme assay, Greis said — and measuring that directly on a mass spec, there is no interference either from quenching or auto-fluorescence.

“And what we’ve found thus far is we’ve not seen any false positive read-outs. If we get a compound that shows that it’s active, even in single-point assays, it’s been demonstrated that it’s a dose-dependent inhibitor.”

And because the method uses native peptides or small-molecule substrates, the method can be done for “at most, pennies per sample well,” Greis said. By comparison, fluorescent and chemiluminescence reagents cost between 50 cents to $1 per well.

“So if you run a million compounds, you can run up a half-million dollars of reagents costs right away, whereas the label-free read-out is going to cost you maybe a couple thousand dollars for the reagents,” he said. “That’s a mass spec advantage.”

A prior study by researchers in China had demonstrated the utility of a MALDI-Fourier transform mass spectrometer for high-throughput screening of small-molecule substrate/product conversion.

In their work, though, Greis and his co-researchers wanted to extend the application to a small-molecule, non-peptide substrate to demonstrate the flexibility and technical range of their method. While a large number of therapeutic targets, including kinases and phosphatases, contain peptide substrates, some important targets don’t, such as HMG CoA reductase, the target of statin drugs, and AChE, a target for neurodegenerative therapeutics.

The researchers chose AChE because of its long history of enzyme assay development, including colorimetric assays, pH-change assays, and most recently aggregation-induced fluorescence assays and mass-spec assays.

Speed is of the Essence

They also chose a MALDI platform, rather than an electrospray platform, because of the higher speed that can be achieved on the MALDI. Most enzymatic reactions contain salts that can interfere with mass spectrometry. An ESI platform requires a desalting step, which limits the throughput to five to 10 seconds per sample. A MALDI-based approach skips the desalting step, however, because the technology is less sensitive to salts.

“Essentially all that we do is run the enzyme reaction on a 384-well format,” Greis said. “We transfer all at once into a matrix plate mix and onto our MALDI target plate.”

Because there are no cleanup steps on the MALDI triple-quad, samples can be scanned at up to three samples per second, he said.

Greis acknowledged that the MALDI technology, especially the MALDI triple-quad, is not a popular tool for drug discovery. In his opinion, that’s because drug-discovery researchers were trained on electrospray mass specs and are comfortable with them.

“To then move them into a MALDI platform that they don’t understand, they’ve got a bias that it can’t be quantitative, and all these sorts of things from earlier studies using MALDI-based approaches that have been demonstrated time and time again to not be true anymore — I think there’s a cultural thing,” he said.

A criticism of a MALDI approach is that while it works well for peptide substrate screening, it doesn’t for small-molecule substrate products because of matrix interference in the low mass range.

“And we show very directly … that by taking advantage of the transition,” a chemical fragmentation that is diagnostic of a substrate or product “that one can do in a triple-quad, that matrix interference completely goes away,” Greis said.

The researchers tested their method by screening a library of 1,008 structurally diverse compounds across 384-well microtiter plates as an example of a single-dose primary screen, and reported that all known AChE inhibitors resulted in complete inhibition of enzyme activity, as expected. The hits were then validated “by demonstrating concentration-dependent inhibition and the rank order of inhibitory potency in hit follow-up assays,” they said in their study.

The technique they’ve developed can also be used on a simple MALDI instrument, though it works best for peptide substrate enzymes. With low molecular-weight enzymes, sensitivity can be an order of magnitude lower on a simple MALDI “because you’d have to be using enough enzyme substrate product to see your substrate products down in those low mass ranges in amongst all of the matrix peaks,” Greis said.

Also, Greis said there will be enzymes — such as fatty acids and long-chain hydrocarbons —that will not be amenable to a MALDI-based approach.

“The fact of the matter is that any mass spectrometry-based technique is only as good as the molecule that it’s trying to evaluate,” he said. “We have to be able to ionize the substrate and/or the product to be able to measure and quantify it.”

In ongoing work, he and his team members are developing multiplex assays. The typical screening approach is to take a target enzyme and pass the whole repository across it to look for inhibitors, and then validate the inhibitors. The next therapeutic target is then set up and the process is repeated.

With a mass spec-based approach, “as long as your enzymes reactions are compatible … you can run multiple enzymes in one pot and pass your repository against it once and get hits for all those different enzymes,” Greis said.

In conferences, Greis and his colleagues have presented proof-of-concept studies that show that “this in fact works quite well using a kinase and acetylcholinesterase or a kinase with a protease all in the same part,” he said. “We’ve shown that we can get selective inhibitors for each of them individually without interference in the multiplex format.”

Source: genomeweb.com

October 19, 2009

EPA seeks broad powers to regulate chemical industry

Filed under: Industry News, Press Releases, Biotech & Pharma Law — Editor @ 3:49 pm

By RANDY LEE LOFTIS / The Dallas Morning News
rloftis@dallasnews.com
The Obama administration announced Tuesday that it is seeking broad new powers to regulate toxic substances in commerce, products and the environment, including clear authority to ban unsafe chemicals.

Environmental Protection Agency Administrator Lisa Jackson laid out the administration’s principles for rewriting the nation’s main toxic chemicals law, which has not been revised significantly in 33 years.

During that time, thousands of new chemicals, processes and even types of substances have entered the economy, many with little or no health and safety review by manufacturers or the government. Researchers have found the chemicals in millions of Americans’ bodies; one study found big increases in the levels of a widely used flame retardant in the blood of Dallas residents.

“Today, everything from our cars to the cellphones we all have in our pockets are constructed with plastics and chemical additives,” Jackson said. “Chemicals are ubiquitous in our economy and our products as well as our environment and our bodies.”

House and Senate Democrats are expected to introduce bills to strengthen the Toxic Substances Control Act soon. Among the anticipated changes is one that Jackson endorsed: letting the EPA act on its own to restrict or outlaw chemicals that do not meet health and safety standards.

1991 ruling on asbestos

A 1991 federal appeals court ruling on asbestos essentially gutted the agency’s power to ban chemicals under the existing law. Congress banned further use of polychlorinated biphenyls, or PCBs, when it passed the toxic substances law in 1976, but the 1991 asbestos ruling has kept the EPA from acting against other risky chemicals.

Jackson said new chemicals and scientific breakthroughs had rendered the law weak and obsolete. Those include the discovery that some chemicals can disrupt the human endocrine system, new knowledge of the risks of some flame retardants, and increasing production of extremely small nanoscale materials that have undergone virtually no health screening.

While some substances might be proved harmless, Jackson said, the widespread discovery of many synthetic chemicals in virtually the world’s entire population demands safety assurances that an outdated law cannot provide.

“Over the years, not only has [the toxics law] fallen behind the industry it’s supposed to regulate, it’s been proven an inadequate tool for providing the protection against chemical risks that the public rightly expects,” she said in remarks prepared for delivery in San Francisco on Tuesday evening.

The administration wants to change the current chemical safety system, which puts new chemicals under more scrutiny than the 80,000 already believed to be in use, Jackson said. Sorting through all existing chemicals could take decades at the current pace, with the public possibly facing undue risk while the process drags on.

Jackson said the EPA would prioritize reviews of existing chemicals by requiring more information from industry on health and safety, use and human exposure. She added, however, that the agency would not skip over possible risks in the interest of speed.

“None of the 80,000 should be exempt,” Jackson said. “I think industry understands that.”

Texas is the heart of the U.S. chemical industry, especially along the Gulf Coast from Beaumont-Port Arthur to Corpus Christi. The federal toxics law regulates chemicals as they come into contact with people through products or industrial uses. Risks from chemical emissions into the air fall under the Clean Air Act.

Industry seeking validation

The chemical industry has endorsed reform of the toxics law along the general lines that Jackson mentioned, in part to boost confidence among consumers worried about compounds in their bodies and their children’s. The industry said its principles include imposing more stringent requirements for health and safety information from manufacturers and giving more weight to risks for children and other vulnerable groups, both mirroring the EPA’s goals

“We are convinced today, through our own testing in the industry, that our products are safe,” Cal Dooley, president and CEO of the American Chemistry Council, the trade group that represents most Texas chemical manufacturers, told reporters. “But we need that validation by the government regulatory agency that is doing the scientific assessments.”

While Congress works to rewrite the law, Jackson said, the EPA plans special reviews of chemicals that have raised particular human health concerns since the law was passed. They include bisphenol A, or BPA, used in polycarbonate plastics and epoxy resins; polybrominated diphenyl ether (PBDEs), used as flame retardants; perfluorinated compounds, used in soil- and water-repellant coatings on many consumer products; and phthalates, used in many plastics.

The EPA will issue action plans for managing risks from four of the compounds in December and will publish others in four-month intervals, Jackson said.

“This is very good news,” said Dr. Arnold Schecter of the University of Texas School of Public Health, Dallas, who studies persistent organic pollutants such as the ones the EPA singled out for special review. He has found PBDEs in 100 percent of American mothers’ breast milk tested, with some women carrying “orders of magnitude” more than women in Europe, where the compounds have been phased out since 2004.

A joint study by the School of Public Health, where Schecter is professor of environmental sciences, and the UT Southwestern Medical Center found a “very large increase” in the PBDEs in Dallas residents’ blood in 2003 compared with blood tested in 1993, Schecter said.

Schecter said stronger federal action on risks from persistent organic compounds was overdue.

“What a refreshing change,” he said.

Source: Dallas News

October 14, 2009

AIDS Study Flushes Out Hidden Virus, Pointing to Possible Cure

Oct. 2 (Bloomberg) — Scientists, moving closer to a cure for AIDS, identified a way to find medicines that would help rid patients of the hardest-to-treat pockets of HIV.

Current anti-HIV drugs reduce the virus to undetectable levels without eradicating it. The virus survives by lying dormant in immune-system cells, where the medicines don’t reach them. Scientists from Johns Hopkins University and the Howard Hughes Medical Institute reported yesterday that they developed a way of luring out these cells in laboratory experiments, an achievement they said may lead to a cure if repeated in humans.

In 2007, about 2.7 million people were newly infected with HIV, the virus that causes AIDS, and 2 million died of the disease, making it the world’s deadliest infectious malady, according to the Geneva-based World Health Organization, an arm of the United Nations. Scientists looking to stop HIV have turned to attacking so-called latent reservoirs of the virus after efforts to prevent infection, such as vaccines and gels, largely failed.

“This is a way in which you could envision finding a drug that would, in conjunction with existing treatment, allow us to cure patients,” said Robert Siliciano, the professor who led the study at Johns Hopkins’s medical school in Baltimore. More research is needed, he said.

For about 12 years, doctors have known that HIV, or human immunodeficiency virus, can lie dormant in immune-system cells called resting CD4s found in the lymph nodes, spleen and blood. There the virus stops replicating, avoiding the drugs designed to kill it.

Roaring Back

Studies have shown latent HIV comes roaring back when treatment is interrupted, condemning patients to a lifetime on drugs such as Abbott Laboratories’ Kaletra that can cause side effects including nausea, liver damage and fat buildup. Eliminating the last vestiges of the virus could cure patients of the disease, allowing them to stop treatment.

Siliciano’s team mimicked HIV latency in a lab dish using a gene called Bcl-2 to turn normal CD4s into resting cells capable of hosting the dormant form of HIV.

The researchers used the model to test 2,400 chemicals, finding 17 that coaxed the virus out of hiding, kick-starting its normal process of replication. In a human, that would make the virus susceptible to drugs. The best performer was a compound called 5HN found in the leaves, bark and roots of the black walnut tree.

‘Key Thing’

“They’ve found a way to find drugs — that’s the key thing,” said Stephen Kent, a professor of immunology at the University of Melbourne, in a telephone interview yesterday. “We’ve really just been guessing up to this point about ways to get at this. Having a system for screening drugs is a big advance over what we’ve had so far.”

The result was achieved without rousing non-infected CD4 cells, avoiding a potentially fatal scenario called a cytokine storm in which the body’s immune system overreacts.

The study has limitations, Siliciano said. First, 5HN may be too toxic for use in humans, he said by phone.

“It’s going to require additional research to find something that does the same thing but doesn’t have lots of other effects,” Siliciano said. “We’re pretty confident that we’ll find lots of compounds that work, but whether any of those will be sufficiently free of other effects — that’s not clear,” he said.

Second, recent studies have pointed to another reservoir of latent HIV that has yet to be identified, Siliciano said.

No Test

“We may have to find another drug to target that reservoir,” he said. “First we have to identify what it is.”

There’s no test for identifying whether a patient has latent HIV, meaning the only way to be sure a drug has polished off the virus is to cease treatment and see if it returns, the University of Melbourne’s Kent said.

The findings are an advance that may allow researchers to come up with a drug they could start testing in humans, Kent said.

“To get something like that into clinical trials is only a few short years — it’s not decades,” he said. “Then it’s got to work.”

The study was published yesterday in the Journal of Clinical Investigation, a peer-reviewed journal published by the American Society for Clinical Investigation, of Ann Arbor, Michigan.

The research was funded by the National Institutes of Health in Bethesda, Maryland; the Doris Duke Charitable Foundation in New York; and the Howard Hughes Medical Institute in Chevy Chase, Maryland.

To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

Source: bloomberg.com

October 12, 2009

Trophos launches the new generation of its fast plate imaging instrument, the Plate RUNNER HD

Marseille, FRANCE, 2009 September 29 - Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics for indications with under-served needs in neurology and cardiology, announced today the launch of the new generation of its fluorescence fast plate imaging system, the Plate RUNNER HD(R).

Trophos originally developed the Plate RUNNER HD(R) to speed up its own screening campaigns for drug discovery and development. The company has now implemented an improved version which offers much better resolution and allows imaging of the 7mm well of the standard 96 plate in matrices of up to 8192 x 8192 pixels. This positions it as the superior alternative to the traditional automated microscope in a wider area of cellular and small organism imaging applications such as neurite outgrowth or C.elegans screens. The Plate RUNNER HD(R) is protected by patents granted in the USA and Europe.

“The Plate RUNNER HD(R) has now reached both a performance and an operational level that allows it to be widely used in various imaging platforms,” said Damian Marron, CEO of Trophos. “We have optimized it by regular use in our screening and research platforms. Use in other labs such as the Neuronal Cell Biology & Pathology research unit directed by Dr Christian Neri at the Inserm Psychiatry and Neurosciences Centre (Paris, France) and the Laboratory of Motor Neuron Biology directed by Dr Alvaro G. Estévez at the Burke Medical Research Institute (NY, USA) has confirmed its performance.” (For further information, see http://www.broca.inserm.fr and http://www.burke.org).

The Plate RUNNER HD(R) fills the gaps between the low sensitivity/low resolution/cell consuming fluorescence plate readers, the high sensitivity but non-imaging flow cytometer, and the slow, poorly automated and small field fluorescence microscope. It does this by allowing whole well/full plate imaging in just 2 minutes 40 seconds for 96 images of 1024 x 1024 pixels, 8 minutes at 4096 x 4096 resolution and 25 minutes at the extremely powerful 8192 x 8192 resolution. The maximum resolution gives details as fine as 1 micron, which covers the vast majority of cellular imaging applications.

“The instrument is not only the source of our pipeline - nearly 1 million compounds screened in eight years - but also an everyday research tool that does in two minutes a job that usually requires a week manually,” said Pierre Delaage, Head of Development of Trophos Instruments. “Using exclusively open data formats, the Plate RUNNER HD(R) integrates smartly and smoothly with all existing imaging and data processing environments with no hidden extra costs. It is also a “green product” using at least ten times less electrical power for illumination than its competitors. It has the important advantage of having a lower price and TCO than the traditional microscope-based instruments.”

Dr Christian Neri, Research Director at the Psychiatry and Neuroscience Center of Inserm in Paris, stated “We have been using the Trophos screening system since its first commercial version; it allowed us to simply and rapidly automate our screening protocols on C.elegans worms and on cells. To move further in C.elegans screens we needed a far higher resolution without sacrificing light, sensitivity and field. We have now seen that Trophos’ latest instrument meets perfectly our very stringent requirements.”

“We continue to directly sell and support the Plate RUNNER HD(R) and are now looking to set up a commercial and industrial partnership to address more widely the global market opportunity,” added Marron. “The Plate RUNNER HD(R) offers unique performance and can be a great fit for imaging solutions manufacturers and vendors, to exploit opportunities for example in the area of small organism or angiogenesis screens as well as cellular screens.”

About the Plate RUNNER HD(R): Developed by Trophos since 1999 initially for its own HTS platform, The Plate RUNNER HD(R) is a rapid fluorescence 96-plate imager giving full 7mm well images in single snapshots (ie no mosaic reconstruction), embedding three commonly used wavelength illumination lamps using fast-switching LED technology, thus leading to more homogeneous light, very long life time (100 000 hours against 5000 hours for xenon or mercury lamps), higher speed and dramatically reduced maintenance costs. Images are given in standard 1024 x 1024 definition but also in higher 2048 x 2048, 4096 x 4096 and even 8192 x 8192 pixels definition, leading to details of about 1 micron in size.

Compared to classic automated microscopes, The Plate RUNNER HD(R) is much more simple, integrated, automated, robust and fast; it has no oculars (eyepieces), no huge frame, no complicated auto focus system, no complicated settings, no complicated software, and does not need any cooling/heating delay between illumination sessions nor painful recalibration between sessions. Built on modular, open and interoperable design and data formats, it is compatible with any existing image processing platform. Training for common tasks is achieved in less than 1 hour, and there is no need of high skilled people to install or set it up.

Driven by Trophos proprietary software running on standard low cost PCs and using advanced real time programming techniques coming from the industry, the device reliably acquires 96 images at 1024 x 1024 definition in just 2 minutes 40 seconds (for a standard 488nm excitation and 200ms exposure time), 8mn for 4096 x 4096 images and 25mn for 8192 x 8192 images.

The device is patent protected in France, Europe and USA. Patent is pending in Canada and Japan. Detailed specifications are available here (http://www.trophos.com/download/pr_datasheet.pdf).

About Trophos: http://www.trophos.com Trophos is a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology. The Company has a novel and proprietary cholesterol-oxime based chemistry platform generating a pipeline of drug candidates, with the lead product, olesoxime (TRO19622), in phase II clinical trials and a second product, TRO40303, planned to enter the clinic in 2010. Trophos’ mitochondrial pore modulator compounds enhance the function and survival of stressed cells via modulation of dysfunctional mitochondria through interactions at the permeability transition pore (mPTP). Recently published clinical studies support the therapeutic rationale for mitochondria targeted drugs in neurology (Alzheimer’s disease) and cardiology (ischemia-reperfusion injury), which Trophos is uniquely placed to exploit.

Trophos has not only invested in science but also in technology such as the Plate RUNNER HD(R), which is a key reason why Trophos was able to bring products into phase II clinical trial after only 8 years, instead of the 12-15 or even 20 years commonly observed”.

For further information, please contact:

Andrew Lloyd & Associates Andrew Lloyd / Neil Hunter Tel: +44 1273 675100 allo@ala.com

Source: medadnews.com

GENFIT identifies compounds which modulate clock genes for the treatment of cardiometabolic disease and CNS disorders

Lille (France), Cambridge (Massachusetts, United States), September 28, 2009 - GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and neurodegenerative diseases, today announces the successful identification of Hit compounds for an orphan nuclear receptor which plays a key role in the regulation of circadian cycle in different organs. These Hits were identified through the screening of chemical libraries performed at GENFIT facilities in Lille.

In humans, many aspects of behavior and physiology are coordinated by an endogenous circadian rhythm (circa diem, meaning approximately one day) that is generated by an internal clock system which synchronizes daily variations in gene expression to rhythms such as sleep and wake alternance, variations in body temperature, blood pressure, heart rate, as well as cognition, attention and mood.

A large body of evidence from both human and animal studies now points to a relationship between circadian disorders and altered metabolic response, suggesting that circadian and metabolic regulatory networks are tightly interconnected.

As a consequence, misalignment of the internal timing system versus environmental stimuli, such as day/night cues, as experienced during jetlag or shift work, may result in dysregulation of physiological cycles of fuel utilization and energy storage, and has been associated with increased risk to develop obesity, type 2 diabetes, hyperlipidemia, high blood pressure and cardiovascular disease. As well, modulating, resetting and stabilization of central circadian rhythms have been proposed as therapeutic strategies for certain CNS disorders.

“This is an important milestone in our drug discovery programs in the field of cardiometabolic disease and CNS disorders”, says Dean Hum (CSO of Genfit). “Deorphanisation of this nuclear receptor further demonstrates our expertise in this class of therapeutic targets, and provides novel series of compounds to address the focus therapeutic areas of Genfit with a very innovative approach via modulation of clock genes and the circadian rhythm”.

About GENFIT:

GENFIT is a biopharmaceutical company focused on the Discovery and Development of drug candidates in strategic therapeutic fields linked to cardiometabolic and neurodegenerative disorders (prediabetes/diabetes, atherosclerosis, dyslipidemia, obesity, Alzheimer’s…). GENFIT uses a multi-pronged approach based on early diagnosis, preventive solutions, and therapeutic treatments to address these major public health concerns and their unmet medical needs. GENFIT’s proprietary research programs and its partnerships with leading pharmaceutical companies, including Sanofi-Aventis, Solvay Group, Pierre Fabre, and Servier, have resulted in the creation of a rich and diversified pipeline of drug candidates at different stages of development. GENFIT’s lead proprietary compound, GFT505, is currently in Phase II and two other compounds, in partnership with Sanofi-Aventis (AVE0897) and SOLVAY (SLV341), are in the advanced stages of Phase I.

With facilities in Lille, France, and Cambridge, MA (USA), the Company has about 130 employees, including over 100 scientists. GENFIT is a public company listed on the Alternext trading market by Euronext(TM) Paris (Alternext: ALGFT; ISIN: FR0004163111). www.genfit.com

Contacts:

GENFIT
Jean-François Mouney - Chairman of the Management Board
+33 (0)3 20 16 40 00

Milestones - Press Relations
Bruno Arabian
+33 (0)1 75 44 87 40 / +33 (0)6 87 88 47 26 - barabian@milestones.fr

Copyright Hugin

The appendixes relating to the press release are available on:
http://www.hugingroup.com/documents_ir/PJ/CO/2009/158601_88_7960_20090928-PR-GENFIT.pdf

This announcement is originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

Source: euronext.com

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