Healthcare Industry News: idiopathic pulmonary fibrosis
News Release - April 18, 2007
Pipex Pharmaceuticals Appoints Kay E. Stremler, Ph.D. as Vice President of Manufacturing
ANN ARBOR, MI--(Healthcare Sales & Marketing Network)--Apr 18, 2007 -- Pipex Pharmaceuticals, Inc. (OTC BB:PPXP.OB ), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has appointed Dr. Kay E. Stremler as Vice President of Manufacturing."Kay has a strong background in biopharmaceutical manufacturing and product commercialization with over 17 years of experience in the pharmaceutical and biotechnology industries. Her addition to our senior management team comes at an important time as we advance our lead product candidate, COPREXA, through the NDA preparation process and build upon our GMP pharmaceutical manufacturing presence here in Ann Arbor, Michigan," said Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex.
Prior to joining Pipex, Dr. Stremler was the Director, Bioprocess R&D and Clinical Supply, Pharmaceutical Sciences for Esperion Therapeutics - A Pfizer Inc. Company. There, she was pharmaceutical sciences team leader for the development of the apoA-I analogue peptide-lipid complex (ETC-642) used in human clinical trials. Prior to joining Esperion, she was with Boehringer-Ingelheim Pharma KG where she was responsible for GMP manufacturing managing over 90 persons. Prior to joining Boehringer-Ingelheim Pharma, she spent 11 years at Immunex Corporation, where she ultimately held the position of Director, International Quality Operations, responsible for oversight of Enbrel® production at Immunex's European partner.
Dr. Stremler earned a B.S. in Chemistry from University of Utah and a Ph.D. in Bioorganic Chemistry from the University of Utah.
About COPREXA
COPREXA is an oral, small-molecule, anti-copper agent that is highly specific for the reduction of free copper in serum, the most toxic form of copper in the body, and is thus ideally suited for the treatment of central nervous system (CNS) diseases in which abnormal serum and CNS copper homeostasis are implicated. We are also developing COPREXA for fibrotic disorders based upon the rationale that the fibrotic disease process is dependent upon the availability of free copper in the body. COPREXA has demonstrated the ability to inhibit fibrosis in a number of well established animal models through the sequestration of available copper and inhibition of key fibrotric cytokines, including secreted protein acid rich in cysteine (SPARC), NF-kappaB, TGF-beta, FGF-2, IL-1, IL-6, IL-8, and connective tissue growth factor (CTGF).
COPREXA has also completed a one-year open label phase II clinical trial for the treatment of idiopathic pulmonary fibrosis (IPF), a deadly lung disease and is also in a phase II clinical trial for the treatment of primary biliary cirrhosis (PBC), a fibrotic disease of the hepatic system. This phase II clinical trial is being supported by a $850,000 grant from the FDA's Orphan Drug Group.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the U.S. and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information, please visit: www.pipexpharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. and Pipex Therapeutics, Inc. ("we" or "our") current expectations about its future results, performance, prospects and opportunities, including statements, as well as its the prospects for regulatory filings in the treatment of neurologic Wilson's disease. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA(TM), TRIMESTA(TM), SOLOVAX(TM), EFFIRMA(TM) or Anti-CD4 802-2, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements.
Source: Pipex Pharmaceuticals
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