Healthcare Industry News: chronic myelogenous leukemia
News Release - September 21, 2006
Panacea Pharmaceuticals Announces Appointments of Christine L. Brauer, Ph.D. as Vice President, Regulatory Affairs; and Jefferey Jones, M.S., as Director of QualityGAITHERSBURG, Md., Sept. 21 (HSMN NewsFeed) -- Panacea Pharmaceuticals, Inc. today announced the appointments of Christine L. Brauer, Ph.D. as Vice President, Regulatory Affairs, and Jefferey Jones, M.S., as Director of Quality. Dr. Brauer will assume responsibility for determining the strategies and managing all U.S. and foreign regulatory filings for the Company's therapeutic and diagnostic products. Mr. Jones will assume responsibility for managing all quality assurance and quality control functions, including those related to Panacea Laboratories, the Company's recently established diagnostic testing laboratory.
"We are very pleased to add Chris and Jeff to the team at Panacea," commented Hossein Ghanbari, Ph.D., Chairman, CEO and Chief Scientific Officer at Panacea Pharmaceuticals. "Chris brings a breadth of regulatory experience related to a range of diagnostic and therapeutic products. And Jeff has considerable experience in all areas of quality including manufacturing, project planning, budget forecasting and management, GMP/GLP inspection and training, regulatory submissions, and implementation and monitoring of analytical laboratory test methods, instrumentation and data analysis. Panacea is continuing to strengthen its senior management team as we progress our therapeutic and diagnostic product development efforts."
Just prior to joining Panacea, Dr. Brauer was Founder and President of Brauer Device Consultants where she worked with a wide variety of large and small life science companies. Dr. Brauer has worked with medical device manufacturers to assess regulatory pathways for new products, and how to best position new products to meet U.S. FDA regulatory requirements. She has assisted manufacturers in understanding FDA policies and past decisions, and prepared FDA regulatory submissions for investigational studies and for commercial marketing including Investigational Device Exemption (IDE) applications, Premarket Notifications (510(k)s), and Premarket Approval Applications (PMAs). From 1990 to 1994, Dr. Brauer served as a Scientific Reviewer in the Obstetrics and Gynecology Devices Branch, Office of Device Evaluation, Center for Devices and Radiological Health, at FDA. Prior to this she worked for the Division of Cancer Treatment and Evaluation Program of the National Cancer Institute, National Institutes of Health. Dr. Brauer received her Ph.D. from the University of Maryland, in Women's Health and Research Methods, and her M.S. from the University of Virginia, in Microbiology and Molecular Biology.
Most recently, Mr. Jones was a Manager, Quality Assurance, at MedImmune, where he was responsible for quality oversight of commercial manufacturing operations at their Frederick Manufacturing Center. Prior to this, he held positions in Quality Control at both MedImmune and Human Genome Sciences. Mr. Jones received his Master of Science in Biotechnology from Johns Hopkins University, and his Bachelor of Science in Biology from Virginia Polytechnic Institute and State University.
"I am excited to welcome Chris and Jeff to Panacea. Their expertise and experience will be critically important as we move toward clinical development of our cancer and CNS therapeutic products," commented Stephen N. Keith, MD, MSPH, President and Chief Operating Officer. "We will continue to strengthen our management team, and look to exceed expectations with the launch of our diagnostic testing through Panacea Laboratories. I am confident that Chris and Jeff will play important roles in facilitating the success of our therapeutic and diagnostic products."
About Panacea's Oncology Platform
Panacea is pursuing the development of antibodies directed against Human aspartyl (asparaginyl) Beta-hydroxylase (HAAH) as novel agents for the treatment of patients with liver cancer as its first intended indication. The Company is exploring both naked anti-HAAH antibodies, as well as antibody conjugates with various chemotherapeutic agents as lead candidates. Panacea is also pursuing the development of diagnostic products based on HAAH gene expression and anti-HAAH antibodies. A test to determine responsiveness to a current therapy of choice in patients with chronic myelogenous leukemia utilizing HAAH gene expression is available through Panacea Laboratories. A proprietary blood-based assay has shown high sensitivity and specificity in the detection of a range of cancers, thus facilitating the diagnosis and therapeutic management of disease. Initial targets for the blood-based diagnostic products include prostate and liver cancers.
PAN-811 is a small-molecule that fully blocks hypoxic and ischemic neuronal cell death at a dose of 1 micromolar in vitro and reduces infarct volume by up to 59% in the middle cerebral artery occlusion rat model of stroke. It manifests dual mechanistic functions including both Ca2+ -chelation and free radical-scavenging (Jiang, Z-G., et al., "A multifunctional cytoprotective agent that reduces neurodegeneration after ischemia," PNAS, Vol. 103, No. 5, 1581-1586, 2006). The toxicology and pharmacokinetics of the drug candidate have been demonstrated, and it is currently in Phase II clinical trials at NIH for a cancer indication. Panacea expects to begin in 2007 a Phase Ib human clinical trial to assess PAN-811 as a treatment for transient ischemic stroke.
About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is a privately-held biopharmaceutical company focused on the development and commercialization of therapeutics and diagnostics for diseases with substantial, unmet clinical needs. The Company's product development strategy is based on novel therapeutic agents and approaches for cancer treatment, as well as acute and chronic neurodegenerative conditions, such as hypoxia-induced neurological insult, Parkinson's Disease, and Alzheimer's disease. Panacea has an extensive patent portfolio covering its neurodegenerative and oncology technologies.
More information about the Company is available at http://www.PanaceaPharma.com.
Except for historical information presented in this press release, matters discussed herein may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward- looking statements are based on the opinions and estimates of management only as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance, or achievements expressed or implied by such statements. Factors that might cause such a difference include, but are not limited to, uncertainties related to our access to capital, the progress, costs, and results of any clinical trials undertaken by us, progress of our research and development projects, and uncertainties related to whether our product candidates would ultimately achieve commercial success. We do not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.
Source: Panacea Pharmaceuticals
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