GAITHERSBURG, Md., Sept. 21 /PRNewswire/ -- 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.
About PAN-811
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.
CONTACT: Stephen N. Keith, MD, MSPH, President & COO of Panacea
Pharmaceuticals, Inc., +1-240-243-8000, Fax: +1-240-465-0450, or
skeith@panaceapharma.com.
SOURCE Panacea Pharmaceuticals, Inc.
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Related links:
http://www.panaceapharma.com/
CONTACT:
Stephen N. Keith, MD, MSPH, President & COO
of Panacea Pharmaceuticals, Inc., +1-240-243-8000, Fax:
+1-240-465-0450, or skeith@panaceapharma.com
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