Healthcare Industry News: CoFactor
News Release - March 13, 2007
ADVENTRX Appoints Vice President of Regulatory AffairsSAN DIEGO, March 13 (HSMN NewsFeed) -- ADVENTRX Pharmaceuticals, Inc., (Amex: ANX ), a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, announced today that it appointed Michele L. Yelmene to the new position of vice president of regulatory affairs. Ms. Yelmene will direct the execution of the Company's ongoing global regulatory strategy and be responsible for all regulatory submissions for the Company's product candidates.
"Michele brings tremendous experience in regulatory affairs management and product submissions for a range of highly successful pharmaceutical and biological therapies," said Evan M. Levine, ADVENTRX chief executive officer. "Her role will be instrumental as we advance the development of CoFactor® (ANX-510) and vinorelbine emulsion (ANX-530), and, pending appropriate approvals, anticipate moving additional products into the clinic this year."
Michele Yelmene brings over 25 years of operational and project management, clinical and scientific research and regulatory affairs experience in the biotechnology and pharmaceutical industries. From 2002-2006, she was Executive Director, Clinical and Regulatory Affairs and Corporate Secretary for Perlan Therapeutics, a privately-held company focused on development of recombinant protein-based drugs. From 1998-2002, Ms. Yelmene was Director in Biomedical Operations for Genzyme Corporation and from 1996-1998 she was Manager of Medical and Regulatory Affairs for Mallinckrodt. During her career, Ms. Yelmene was responsible for clinical development, preparation, and presentation of 14 FDA-approved products and over 25 investigational new drug applications (INDs) for both pharmaceutical and biologics-based therapies in the areas of viral infections, respiratory, CNS, metabolic and endocrine diseases, and lysosomal storage disorders. She has participated in meetings with the FDA at all phases (pre-IND through Advisory Committee) of clinical development. Ms. Yelmene is a member of the Regulatory Affairs Professional Society, Drug Information Association and Co-Chair of the FDA Committee at BIOCOM in San Diego. She received a BS degree in Biology and BA degree in English Writing, both from Rider University.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems, such as drug metabolism and bioavailability, excessive toxicity and treatment resistance. The Company's lead product candidate, ANX-510 (CoFactor), is in Phase III and Phase IIb clinical trials for the treatment of metastatic colorectal cancer, as well as in a Phase II clinical trial for the treatment of advanced breast cancer. More information can be found on the Company's web site at http://www.adventrx.com.
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: successfully educating new executives and integrating new executives with existing executives and management; uncertainties inherent in the drug development process; the timing and success of clinical trials; the validity of research results; the receipt of necessary approvals from the FDA and other regulatory agencies; and other risks and uncertainties more fully described in ADVENTRX's press releases and public filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov. ADVENTRX does not intend to update any forward-looking statement, including as set forth in this press release, to reflect events or circumstances arising after the date on which it was made.
Source: ADVENTRX Pharmaceuticals
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