BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Wednesday, 13 November 1996.
These studies are part of the company's clinical development plan and registration strategy to investigate DOXIL as single-agent therapy and in combination therapy for the treatment of ovarian cancer. Developed and owned by SEQUUS, DOXIL is a long-circulating STEALTH(R) liposome formulation of doxorubicin, an anticancer drug.
One such trial, underway in the United States and Europe, is studying single-agent DOXIL therapy in patients with refractory ovarian cancer after failure of prior standard chemotherapy with platinum- and/or paclitaxel-based regimens as well as salvage chemotherapy with other drugs, including topotecan. Several additional studies are underway to evaluate DOXIL in combination with a variety of cytotoxic agents in the treatment of patients with advanced malignancies, including ovarian cancer.
The current clinical trials follow a study in which DOXIL was administered to patients with gynecologic malignancies who experienced disease progression despite prior chemotherapy with cytotoxic drugs. The majority of these patients had ovarian cancer and each had failed platinum- and paclitaxel-based chemotherapy regimens. In that 35-patient study, 9 patients (26%) responded to therapy (1 complete and 8 partial responses). The median progression-free survival was 5.7 months, with an overall survival of 1.5 to 24+ months (median of 11 months). An additional 29% achieved disease stabilization. Thirteen (37%) patients experienced non-hematologic skin and mucosal toxicities (either hand-foot syndrome or stomatitis); however, with dose modifications the treatment was well tolerated in this particular patient population. Additional clinical data are needed to determine if DOXIL has an acceptable risk/benefit profile in gynecologic malignancies.
DOXIL is marketed in the United States by SEQUUS for the treatment of Kaposi's sarcoma in people with AIDS whose disease has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy. Full prescribing information may be obtained from the SEQUUS Professional Services group at 1-800-323-9049. Outside of the United States, Japan and certain small markets subject to prior distribution agreements, Schering-Plough Corp. will distribute, market and sell DOXIL under the tradename CAELYX(TM).
Established in 1981 and headquartered in Menlo Park, Calif. (with offices in London), SEQUUS is developing proprietary pharmaceutical products to treat cancer and infectious diseases.
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CONTACT: SEQUUS Pharmaceuticals Inc. I. Craig Henderson, M.D. Chairman and CEO Scott Minick President and COO Don Stewart VP. Finance and Treasurer 415/323-9011 or Ogilvy, Adams & Rinehart (Media) Susan Eckstein 212/880-5207 or Burns McClellan (Investors) John Nugent 212/505-1919
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Copyright © 1996 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.com.
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