Bio Screening Industry News

The obstacles to successful drug discovery and development are numerous and well appreciated. In discovery, from target identification through lead optimization and validation, and in development, from first-in-man studies through large registration trials, inefficiencies and uncertainties complicate even well-funded efforts by sophisticated and industrious scientists and clinicians. Despite huge outlays by the worldwide pharmaceutical research enterprise, the number of new chemical entities brought to market has actually declined in recent years, even as the cost of developing them has increased significantly.

Against this backdrop, biomedical imaging is poised to play an increasingly powerful role in enhancing the efficiency of the drug discovery and development process. Multiple modalities, including optical imaging, ultrasound, nuclear imaging (both positron and single photon tomography), x-ray computed tomography, and the many flavors of magnetic resonance imaging are all being integrated ever more fundamentally in the various phases of drug discovery and development. In CNS, oncology, rheumatology/inflammation, and many other clinical settings, imaging is proving invaluable.

The 3rd Imaging in Pre-clinical & Clinical Drug Development Conference will be held March 17-18, 2008, in San Diego, CA. This conference will survey a wide range of topics in the field, from the latest advances in the modalities themselves to their application to cutting-edge preclinical and clinical problems. Presentations will be made from numerous distinguished contributors to the field’s advancement on both scientific topics and subjects of interest to the regulatory, data management and investment communities.

Topics include:

- Novel Imaging Methods & Technology
+ Novel Imaging Tools for Inflammation and Arthritis Drug Development
+ Dynamic Contrast MRI
+ Optical Imaging

- Imaging in Drug Development and Therapy
+ Molecular Imaging Approaches to In Vivo Pharmacokinetic and Pharmacodynamic Studies: A Pharmaceutical Prospective
+ PET for In-Vivo Distribution and Pharmacokinetics, Including Novel Dosage Forms
+ Translational Nuclear Molecular Imaging in Drug Development
+ Using MRI to Monitor Cellular Therapy

- Imaging Applications in CNS, Oncology, and the Cardiovascular System
+ Novel Imaging Applications in CNS Drug Development
+ PET Imaging for Efficacy of Anticancer Drugs
+ Non-invasive Imaging of Atherosclerosis: MRI versus CT
+ Atheroma: Developments in Imaging Surrogates of Risk with MRI

Click here for a FULL AGENDA

Register today to reserve your spot! Team Registration: Register 2, the 3rd goes free! For more information call 626-256-6405 or visit www.gtcbio.com.

PRESENTERS
Marc Berridge, President, 3-D Imaging
Janet Eary, Director, Nuclear Medicine Program, University of Washington Medical Center
Joseph Frank, Chief, Laboratory of Diagnostic Radiology Research, NIH
Jonathan Gillard, Department of Radiology, University of Cambridge
Hisataka Kobayashi, Chief Scientist, Molecular Imaging Program, NCI
Richard Margolin, Vice President & Global Head, CNS, i3 Research [Chair]
Raymond Nunnally, Vice President, InvivoMetrics
Michael Paulus, VP, Product Management, Siemens Preclinical Solutions
Roderic Pettigrew, Director, National Institute of Biomedical Imaging and Bioengineering, NIH
Paul Picot, Chief Scientist, Pre-clinical Imaging, GE Healthcare
Simon Robinson, Bristol Myers-Squibb
Stefan Ruehm, Director, Diagnostic Cardiovascular Imaging, CT, UCLA
Susanta Sarkar, Molecular Imaging Center of Excellence, GlaxoSmithKline
Werner Scheuer, Research Leader, Preclinical Imaging, Roche Diagnostics GmbH
Jan Schnitzer, Sci. Dir., Prof., Cellular & Molecular Bio, Kimmel Cancer Center
David Shalinsky, Associate Director, Translational Medicine, Pfizer
Mark Tengowski, Director, Clinical Affairs, VirtualScopics Inc.
David Vera, Professor, Radiology, UCSD
Jingsong Wang, Director, Bristol Myers-Squibb
Yumin Zhang, Research Investigator, Abbott Laboratories

(Amherst, NH) - The success of recombinant protein drugs such as Enbrel, Remicade, and Herceptin in treating refractory conditions is fueling the search for protein and peptide-based therapeutic agents in oncology, inflammation and a host of other disease classes. Led by the proliferation of antibody-based drug candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and - ultimately - pharmaceutical marketers.

Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones and other biological drugs also increase the need for safety and compliance.

Compliance with drug therapy and disease management protocols has been and is a primary concern within the healthcare and pharmaceutical industries. Efforts to enhance compliance are having a non-negligible effect on drug formulations and delivery decisions, and can be a significant factor in the prescribing decisions of most physicians. Compliance concerns have driven and continue to drive investment in new drug delivery technologies.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.

New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Reusable injectors designed to accept prefilled syringes or drug cartridges will improve ease-of-use and increase alternative device share of the growing self-injection market. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

These findings are contained in a comprehensive report, Injectable Drug Delivery: Evolving Markets, Emerging Opportunities. More information is available at www.greystoneassociates.org .

About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

Patients with FDA-defined Valvulopathy Permitted to Enroll in 2nd and 3rd Pivotal Trials - Echocardiogram Screening Requirement Eliminated

SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ — Arena Pharmaceuticals, Inc. today announced the initiation of patient screening in the second and third Phase 3 pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for weight management in overweight and obese patients. Known as BLOSSOM (Behavioral modification and Lorcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), these one-year, double-blind, randomized and placebo-controlled trials are expected to collectively enroll approximately 3,750 overweight and obese patients. Consistent with Arena’s proposal, the Food and Drug Administration, or FDA, is allowing patients with FDA-defined valvulopathy to enroll in both BLOSSOM and BLOOM-DM. This is different from the design of the initial lorcaserin pivotal study known as BLOOM, in which echocardiography was used to screen for patients with FDA-defined valvulopathy and exclude those patients from enrolling in the trial. Instead, in BLOSSOM and BLOOM-DM, there are no such echocardiographically defined exclusion criteria, although serial echocardiograms will be obtained to extend the lorcaserin safety database. BLOOM, BLOSSOM and BLOOM-DM comprise the entire planned pivotal trial program for lorcaserin.

“Eliminating the requirement of screening echoes, and receiving permission from the FDA to expand the patient population of the lorcaserin pivotal trial program to include patients with FDA-defined valvulopathy, is a significant and positive variation in the protocol for the second two pivotal trials,” commented Steven R. Smith, M.D., principal investigator in the study and Professor at the Pennington Biomedical Research Center. “This change will allow the pivotal trial program to more fully explore, and develop a more complete understanding of, lorcaserin’s selective mechanism and its safety profile.”

“Given the prevalence and impact of obesity, patients and their physicians need new treatment options,” commented Lee M. Kaplan, M.D., Ph.D., an investigator in the BLOOM, BLOOM-DM and BLOSSOM pivotal trials, Director of the Massachusetts General Hospital Weight Center and Associate Professor of Medicine at Harvard Medical School. “Including a broader representation of overweight patients and patients with obesity as part of the pivotal trial program for lorcaserin, including individuals with more significant valvulopathy and type 2 diabetes, is important for providing a more complete assessment of the safety and efficacy of this agent,” concluded Dr. Kaplan.

The BLOSSOM trial will evaluate 10 mg and 20 mg daily doses (10 mg dosed once or twice daily) of lorcaserin versus placebo over a one-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to 29.9) with at least one co-morbid condition at about 100 sites in the United States. The BLOOM-DM trial will evaluate 10 mg and 20 mg daily doses of lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus at about 45 sites in the United States.

Consistent with the BLOOM trial, diet and exercise will also be included in the BLOSSOM and BLOOM-DM trials in accordance with current FDA guidelines, and the proportion of patients with a 5% or greater weight reduction from baseline at week 52 will be the primary efficacy endpoint. Secondary endpoints include changes in serum lipids and HbA1c and, in the BLOOM-DM trial, other indicators of glycemic control will also be evaluated. In both of these additional studies, all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the ongoing BLOOM trial, however, there will be no independent monitoring by an Echocardiographic Safety Monitoring Board. The complete lorcaserin Phase 3 pivotal program is planned to enroll a total of approximately 7,000 patients in these three trials. In addition to the planned pivotal trial program, several additional small studies, such as drug interaction and abuse potential studies, will be conducted.

“As we continue advancing our lorcaserin clinical program, we are looking forward to March 2008 when we expect the BLOOM Echocardiographic Safety Monitoring Board’s review of echocardiograms for patients completing 12 months of treatment. We will continue to work with the FDA as we implement the final non-pivotal trial elements of the complete Phase 3 program,” stated William R. Shanahan, M.D., Arena’s Vice President and Chief Medical Officer.

An earlier estimate of the total external clinical costs of the Phase 3 trial program was updated from approximately $125 million to approximately $160 million. The increased estimate is primarily due to the increased number of patients Arena plans to enroll, and to Arena’s initiative to expand the echocardiographic monitoring program by including patients with FDA-defined valvulopathy in the BLOSSOM and BLOOM-DM trials.

Innovating kinase inhibitor development is the key to successful clinical development. At Informa Life Sciences 7th Annual Protein Kinases Congress hear the latest thinking and strategies towards creating a selective inhibitor. Learn about new targets, industry trends in structure-based drug design, clinical case-studies and discuss the issue of cardiotoxicity.

For more information visit: http://www.iir-events.com/IIR-Conf/page.aspx?id=9547

‘Safecode’ is a new system for clinical trials represents a significant enhancement over traditional CODEBREAK product identification
methods.

Our system allows confidential information to be printed using industry standard inkjet technology.

The printed information is illegible unless a tamper evident strip is removed. This ensures that any effort to compromise the security of data is immediately apparent.

http://www.acs-labels.co.uk/Safecode.htm

BioServe’s fully annotated clinical samples across many diseases to be tagged with ancestry information using DNAPrint’s genetic ancestry tests

BELTSVILLE, MD., Oct. 9, 2007 – BioServe today announced the formation of strategic alliance with DNAPrint® Genomics, Inc. (OTCBB: DNAG) to provide biomedical researchers with clinical DNA samples that for the first time will include genetic ancestry data for each sample. With the added dimension of ancestry information to clinical samples, medical researchers will be able to determine whether certain biological markers are artifacts of genetic ancestry or are true markers for a disease or drug response in a disease. To create the genetic ancestry data, DNAPrint® Genomics will analyze and categorize BioServe’s Global Repository® of nearly 600,000 human biological samples using its ANCESTRYbyDNA(TM) validated genetic ancestry test.

“Our relationship with BioServe is highly synergistic. Both companies believe that any epidemiological program will be more productive with access to high quality validated clinical samples that have been effectively categorized across a validated genetic ancestry platform,” said Richard Gabriel, CEO and President of DNAPrint® Genomics. “By removing the question of ancestry from a clinical sample researchers can more readily evaluate which medicines will produce side effects within certain ethnic groups, and which medicines will work for the widest spectrum of a population.”

“Through this partnership with DNAPrint Genomics we can provide the medical research community with the best defined clinical sample set in the world,” said Dr. Kevin Krenitsky, CEO of BioServe. “Additionally, we are able to uniquely support the application of our samples with services that include sample extraction and preparation, genotyping, and gene expression. Now that we are able to add the genetic ancestry component to our samples, a new layer of sample data quality and analysis can be provided that was not previously available to researchers.”

Both companies are also capable of providing genotyping services, and between the two companies the following platforms are available: Beckman Ultra High Throughput SNP Platform, Illumina SNP Golden Gate, and Sequenom iPLEX. In addition, several gene RNA expression analysis platforms are available including Differential Expression Pattern Display Technology which has an RNA expression sensitivity 10 to 100 times greater than either of Affymetrix or Illumina gene expression profile technologies.

DNAPrint™ Genomics, Inc.

DNAPrint™ Genomics, Inc. (www.dnaprint.com) is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company’s proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company’s first theranostic product is PT-401, a “Super EPO” (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (with end stage renal disease). Preclinical and clinical development of all the Company’s drug candidates will benefit from simulated pre-trials to design actual trials better and are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM). DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.

About BioServe

BioServe (www.bioserve.com) is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository®, a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com, e-mail info@bioserve.com or call 301-470-3362.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint’s products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.

Scientists have developed a novel strategy for tackling neurodegenerative diseases such as Huntington’s disease: encouraging an individual’s own cells to “eat” the malformed proteins that lead to the disease.

Huntington’s disease is one of a number of degenerative diseases marked by clumps of malformed protein in brain cells. Symptoms include abnormal movements, psychiatric disturbances like depression and a form of dementia. The gene responsible for the disease was discovered in 1993, leading to a better understanding of the condition and to improved predictive genetic testing, but it has yet to lead to any treatments that slow the neurodegeneration in Huntington’s patients.

Professor David Rubinsztein, a Wellcome Trust Senior Clinical Fellow at the University of Cambridge, has been studying the molecular biology underlying Huntington’s and other neurodegenerative diseases. Huntington’s occurs when a protein known as huntingtin builds up in the brain cells of patients, mainly in neurons in the basal ganglia and in the cerebral cortex. Normally, cells dispose of or recycle their waste material, including unwanted or mis-folded proteins, through a process known as autophagy, or “self-eating”.

“We have shown that stimulating autophagy in the cells , in other words, encouraging the cells to eat the malformed huntingtin proteins , can be an effective way of preventing them from building up,” says Professor Rubinsztein. “This appears to stall the onset of Huntington’s-like symptoms in fruit fly and mice, and we hope it will do the same in humans.”

Autophagy can be induced in mouse and fly models by administering the drug rapamycin, an antibiotic used as an immunosuppressant for transplant patients. However, administered over the long term, the drug has some side effects and Rubinsztein and colleagues are aiming to find safer ways of inducing autophagy long term.

Now, Professor Rubinsztein, together with Professor Stuart Schreiber’s lab at the Broad Institute of Harvard/MIT, Boston in the US, and Dr Cahir O’Kane’s group in the Department of Genetics at the University of Cambridge have found a way of identifying novel “small molecules” capable of inducing autophagy. The research is published today in the journal Nature Chemical Biology.

The screening process involves identifying small molecules that enhance or suppress the ability of rapamycin to slow the growth of yeast, though the selected molecules have no effects on yeast growth by themselves. Yeast is a single-celled organism and therefore less complex to study for initial screening purposes.

Three of the molecules that enhanced the growth-suppressing effects of rapamycin in yeast were also found to induce autophagy by themselves in mammalian cells independent of the action of rapamycin. These molecules enhanced the ability of the cells to dispose of mutant huntingtin in cell and fruit fly models and protect against its toxic effects.

“These compounds appear to be promising candidates for drug development,” says Professor Rubinsztein. “However, even if one of the candidates does prove to be successful, it will be a number of years off becoming available as a treatment. In order for such drugs to be useful candidates in humans, we will need to be able to get them into right places in the right concentrations, and with minimal toxicity. These are some of the issues we need to look at now.”

http://www.wellcome.ac.uk
Source: Medical Research News