AEGiS-PRn: Celgene Completes Phase II/III Trial Of Synovir PRNewswireImportant note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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Celgene Completes Phase II/III Trial Of Synovir

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Tuesday, 8 October 1996


WARREN, N.J., Oct. 8 /PRNewswire/ -- Celgene Corporation announced successful completion of its pivotal Phase II/III clinical trial of Synovir (thalidomide) for severe weight loss (cachexia) associated with HIV infection, the virus which causes AIDS. The Company anticipates that it will announce results of the trial early in the first quarter of 1997, followed shortly by submission of a New Drug Application (NDA). The approximately 100,000 patients who suffer from AIDS-related weight loss would be candidates for therapy with Synovir.

The trial utilized a number of clinical sites, including San Francisco General Hospital, Kaiser Permanente (San Francisco), The Rockefeller University, and St. Michaels Hospital in Newark, NJ. Sixty- five patients completed the placebo-controlled study, which evaluated the effect of different doses of Synovir on the patients' weight as a percentage of their baseline weight. Enrollment in the trial was restricted to patients who are infected with HIV and who had lost 10 percent or more of their baseline weight in the preceding six months. Evaluation of the study will include a review of patients' response to a 12-week course of Synovir therapy. The company also noted that approximately 80% of the patients completing the pivotal trial elected to participate in an open label compassionate use follow-on program. "The trial was completed on schedule, and we appreciate the guidance and support of our chief investigators, the participating medical institutions, as well as that of the Food and Drug Administration," said John Jackson, Chairman and CEO of Celgene.

In October 1995, Celgene announced that the Food and Drug Administration had approved the Company's request to authorize expanded access of Synovir, broadening the drug's availability. The expanded access program complemented the Phase II/III clinical trial enrollment. Synovir is the lead product in Celgene's immunotherapeutic program which is developing and evaluating thalidomide and its analogs for possible clinical use in rheumatoid arthritis, inflammatory bowel disease and other major unmet needs.

Celgene Corporation, headquartered in Warren, NJ, uses proprietary expertise in small molecule chemistry to serve the pharmaceutical, agricultural, and allied industries.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties or other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include, but are not limited to, those detailed in the Company's periodic filings with the Securities and Exchange Commission.

SOURCE Celgene Corporation


Keywords: CLINICAL TRIAL; HIV; CAUSES AIDS; AIDS RELATED

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