To: Tupulak who wrote (56 ) 7/7/1999 9:21:00 PM From: tnsaf Read Replies (1) | Respond to of 164
A little old ------------- Monday June 7, 1:00 pm Eastern Time Company Press Release SOURCE: Ophidian Pharmaceuticals, Inc. Ophidian Expanding Clinical Development and Drug Applications of Its Core Antibody Technology SAN FRANCISCO, June 7 /PRNewswire/ -- Ophidian Pharmaceuticals, Inc. (Ophidian) (Nasdaq: OPHD; Pacific Exchange, Inc.: OPD), disclosed today that it is moving ahead with its plans to begin Phase II clinical testing of its lead drug, OPHD001, for Clostridium difficile-associated disease. This trial is planned to begin this summer. The company also disclosed its plan to submit an Investigational New Drug to the Food & Drug Administration by the end of the first quarter of 2000 for approval to begin clinical trials for a second gastrointestinal product, OPHD002. OPHD002 is an oral anti-cytokine antibody formulation designed for the treatment of inflammatory bowel disease. Douglas Stafford, Ophidian's President and Chief Executive Officer, made these statements at the 11th Annual International Life Sciences Partnering Conference hosted in San Francisco. This conference is an international forum to promote strategic partnerships among biotechnology and pharmaceutical firms for the development and commercialization of new drug products. Mr. Stafford said, ''We have learned a great deal about orally-delivered antibodies through the development of OPHD001. From this knowledge and extensive new laboratory studies, we have found that the oral delivery of our avian antibodies is effective in treating inflammatory intestinal diseases in animals. This creates a new significant therapeutic application for our core technology in the area of inflammatory bowel diseases.'' The company's technology allows for topical delivery of therapeutic antibodies to diseased regions of the intestinal tract with oral dosing techniques. ''The topical delivery is a unique strategy to localize the drug effect to the intestinal tract without side effects associated with systemic administration,'' he added. This document may contain certain forward-looking statements based on current management expectations. There are certain key factors that could cause future results to differ from those anticipated by management. Such factors include, but are not limited to, technical risks associated with the development of new products, the continued progress of clinical trials of the company, the company's ability to continue to establish collaborative agreements with third parties, the competitive environment of the biotechnology and pharmaceutical industries, and general economic conditions. Additional information on potential factors that could affect the company's financial results are included in the company's prospectus dated 7 May 1998, and other reports filed with the Securities and Exchange Commission. SOURCE: Ophidian Pharmaceuticals, Inc.