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The Big Bang: IMPROVEMENT OVER 70% INCL Enbrel Failures...
Cypress Bioscience Updates Clinical Results for Treatment of Rheumatoid Arthritis With the Prosorba Column
Improvement in Over 70% of Patients Completing Therapy, Including Enbrel(R) Failures
SAN DIEGO--(BW HealthWire)--Feb. 24, 2000-- Cypress Bioscience Inc. (Nasdaq:CYPB - news) today announced results from a survey of clinical usage of the PROSORBA® Column in rheumatoid arthritis (RA).
The outcome of treatments to date supports the efficacy of the PROSORBA Column treatment, even in severe cases that have been resistant to available pharmaceutical treatments, including Enbrel. The survey results will be presented at a meeting for rheumatologists to be held on Feb. 25-27, 2000, jointly sponsored by Cypress and Fresenius Hemotechnology Inc., Cypress' marketing and manufacturing partner.
In April 1999, Cypress and Fresenius launched the PROSORBA column for the treatment of moderate to severe rheumatoid arthritis, following marketing clearance in March 1999 by the U.S. FDA. This update is the first new clinical data released since the Column's market introduction as a treatment for the RA application.
In January 2000, surveys were sent to physicians responsible for approximately 125 of the patients treated since the product became commercially available. The patients were at various stages of treatment at the time of the survey request. To date, demographic, treatment and outcome data have been obtained on 90 patients who had begun treatment, not all of whom had completed 12 weeks of therapy at the time of the survey. A positive ''response'' was based on an assessment of clinical improvement by the physician and patient after at least 7 weeks of therapy. Unlike the Phase III controlled trial, patients treated with the PROSORBA column since its commercial launch may have been receiving other treatments for RA along with the PROSORBA column. Therefore, these results cannot be directly compared to the published Phase III data and may not be as reliable as those collected in controlled clinical trials.
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Highlights from the survey results include:
-- The patients surveyed had a disease profile consistent with
those treated in the pivotal trial. Surveyed patients
generally had long-standing disease, and had failed an
average of approximately five Disease Modifying
Anti-Rheumatic Drugs (DMARDs) and/or biologic treatments.
Over 75% of the surveyed patients were classified as either
"refractory," "severe," or both.
-- The treatment withdrawal rate was skewed toward early
treatment; that is, patients who failed to complete the
standard course of 12 treatments tended to withdraw within
the first few weeks of treatment. Overall, the withdrawal
rate as reported has been under 20%.
-- Reported clinical outcomes from this group are encouraging,
with 74% of surveyed patients who had completed seven or
more treatments of the total 12-week treatment course
reported as "responders".
-- There was no difference in response rate noted between those
patients who had a history of having failed one of the new
"TNF blocker" drugs such as Enbrel® (manufactured by
Immunex (Nasdaq:IMNX - news) and distributed by Wyeth-Ayerst, a
division of American Home Products (NYSE:AHP - news) and those with
no previous exposure to "TNF blockers".
-- Safety results to date are consistent with those seen in the
pivotal trial; most adverse events seen were transient and
manageable.
In commenting on the significance of these preliminary survey results, Dr. R. Michael Gendreau, M.D., Ph.D., executive vice president, research and development, chief scientific officer and chief medical officer for Cypress Bioscience Inc. stated, ''We are particularly gratified by the excellent response rates seen in patients who had failed treatment with the newer anti-TNF agents. Our previous clinical trial results had suggested that the PROSORBA column response rate would be unaffected by a patient's prior therapeutic failure history, and these survey findings are consistent with that belief. Since 25% of patients fail therapy with TNF blockers, most having also previously failed standard disease modifying agent (DMARD) therapy, the PROSORBA column may represent a significant advance for this population with the greatest medical need.''
About Cypress Bioscience Inc.
Cypress Bioscience Inc. develops 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. In March 1999, the company entered into an agreement that granted Fresenius AG and Fresenius Hemotechnology Inc. an exclusive license to manufacture and distribute the PROSORBA column in the U.S., Europe and certain other territories.
In April 1999, Cypress and Fresenius launched sale of the PROSORBA column for the treatment of moderate to severe rheumatoid arthritis. The PROSORBA column was previously cleared by the FDA in 1987 for use in Idiopathic Thrombocytopenic Purpura (ITP), an immune bleeding disorder. In addition, Cypress is developing Cyplex(TM) (Infusible Platelet Membranes), which is positioned to become an alternative for traditional platelet infusions. For more information about the PROSORBA column and Cypress, please visit the company's Web site at www.cypressbio.com.
Except for historical information contained herein, this news release contains forward-looking statements regarding Cypress Bioscience Inc. that involve risks and uncertainties, including, but not limited to the company's and Fresenius' ability to market successfully the PROSORBA column for use as a treatment for rheumatoid arthritis; whether the company will be successful in collaborating with Fresenius; whether the final survey data related to the clinical use of the Prosorba Column as a treatment for rheumatoid arthritis will confirm the preliminary data; and the company's ability to develop and receive regulatory clearance for Cyplex(TM) 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 Annual Report on Form 10-K for the year ended Dec. 31, 1998 and its most recent Quarterly Report on Form 10-Q.
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