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Cystic Fibrosis
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my personal edition > cystic fibrosis > news

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DGNews
Demegen Receives Orphan Drug Designation for P113D For Treatment of Cystic Fibrosis
PITTSBURGH, PA -- November 5, 2002 -- Demegen, Inc. (OTC Bulletin Board: DBOT), a biotechnology company specializing in the development of peptides for the treatment of infectious diseases, announced today it had been granted orphan drug status for the Company's patented P113D peptide for the treatment of cystic fibrosis (CF) infections by the U.S. Food and Drug Administration.
Orphan drug designation is granted when a disease occurs in less than 200,000 patients in the United States. Benefits from orphan drug status can include a period of marketing exclusivity, tax credits for clinical research expenses and clinical development assistance.
Cystic fibrosis is a genetic disease, which affects approximately 30,000 children and young adults in the United States and another 40,000 worldwide. The gene defect causes thickened mucous in the lungs that creates an ideal environment for bacterial infections, particularly Pseudomonas aeruginosa. These lung infections can lead to mortality in CF patients.
P113D is derived from histatins, which are compounds found naturally in human saliva. P113D has demonstrated activity against CF patient clinical isolates of bacteria that are resistant to traditional antibiotics. The compound is stable and maintains activity in sputum of CF patients. A number of preclinical toxicology evaluations need to be completed before human trials can be authorized.
Mr. Ekstrom, President of Demegen said: "There is a very real need for new treatment options for CF patients with chronic infections. Demegen is actively seeking to solidify partnerships with parties that have expressed interest in developing P113D. The orphan drug designation should help that effort. The Company also appreciates the funding support it has received from the Cystic Fibrosis Foundation."
Demegen develops novel peptides for the treatment of bacterial and fungal infections. Other products under development include treatment for oral candidiasis and mucositis, infected burns and wounds, and sexually transmitted infections. Demegen's website is http://www.demegen.com.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 (as amended, the "Act"). In particular, when used herein, the words "plan," "estimates," "should," "confident that," "believe," "expect," or "intend to," and similar expressions are intended to identify forward-looking statements within the meaning of the Act and are subject to the safe harbor created by the Act. Such statements are subject to certain risks and uncertainties and actual results could differ materially from those expressed in any of the forward- looking statements. Such risks and uncertainties include, but are not limited to, market conditions, general acceptance of the Company's products and technologies, possible delays or failures to develop and/or commercialize any technology, possible risks related to adverse clinical results, impact of alternative technology advances, inherent risks in early stage development of such technology, competitive factors, the ability to successfully complete additional financings, continuing to function as a viable going-concern, and other risks described in the Company's reports and filings with the Securities and Exchange Commission.
SOURCE: Demegen, Inc.
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