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Biotech / Medical : Alseres Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Dr. John M. de Castro who wrote (544)	1/21/1998 4:13:00 PM
From: JMarcus	Read Replies (1) \| Respond to of 975

CYPB's new RA drug, Prosorba, looks close to FDA approval (see 1/12/98 news release reprinted below), but not as close as BLSI's therafectin. If, however, Prosorba proves to be much more effective, will there likely be much of a market left for therafectin? biz.yahoo.com Monday January 12, 8:02 am Eastern Time Company Press Release Cypress Bioscience Successfully Completes Pivotal Trial in Rheumatoid Arthritis Independent Data Safety and Monitoring Board Recommends Trial Halt Due to Favorable Safety and Efficacy Results SAN DIEGO--(BW HealthWire)--Jan. 12, 1998--Cypress Bioscience, Inc. (NASDAQ:CYPB - news) announced that its Phase III pivotal trial evaluating the efficacy of the PROSORBA(R) column in Rheumatoid Arthritis has been stopped early due to achieving favorable safety and statistically significant efficacy results on an intent-to-treat basis. The trial data was reviewed by an independent Data Safety and Monitoring Board (DSMB) which recommended the cessation of the trial as the results met all criteria for stopping that the Company had established. ''We are very pleased to have been advised to conclude this trial a full year earlier than anticipated,'' said Jay D. Kranzler, M.D., Ph.D., Vice-Chairman and CEO of the Company. ''This is the most positive possible scenario and provides us with data sufficient for FDA submission. We have begun preparing our strategy with respect to filing for Pre-Market approval of the PROSORBA(R) column for the treatment of Rheumatoid Arthritis. The Company, which had been blinded to the data, will review the data internally and with its scientific advisors over the next few days, as well as communicate the results to the physician investigators and their patients who participated in the study. ''We will shortly announce a time for a conference call during which we will be able to disclose the results, along with our timetable for filing for regulatory approval and our commercialization plans,'' said Debby Jo Blank, M.D., President and COO of Cypress Bioscience. ''The strength of data makes it possible for us to accelerate our commercialization plans for the treatment of Rheumatoid Arthritis in patients refractory to other treatments.'' Cypress develops, manufactures and markets medical devices and therapeutics for the treatment of certain types of immune disorders and is engaged in the development of novel therapeutic agents for the treatment of blood platelet disorders. The Company's leading product, the PROSORBA (R) column, is approved by the FDA for sale in the treatment of patients with Idiopathic Thrombocytopenic Purpura (ITP), an immune-mediated bleeding disorder. A recently acquired product, Cyplex (TM), (infusible Platelet Membranes), is positioned to become an alternative for traditional platelet infusions, an estimated $1.5 billion market worldwide. Except for historical information contained herein, this news release contains forward-looking statements that involve risks and uncertainties, including, but not limited to, the Company's ability to accelerate its commercialization of the PROSORBA (R) column; and the ability of the Company to receive regulatory approval on a timely basis if at all; as well as other risks detailed from time to time in the Company's SEC reports, including its report on Form 10-K for the year ended December 31, 1996. Contact: Cypress Bioscience, Inc. Debby Jo Blank, M.D., 619/452-2323 or StartUp Solutions LLC Steven Rouhandeh & Jeff Davis, 212/554-4158