To: JohnO who wrote (2942 ) 5/18/1998 12:56:00 PM From: Leman Read Replies (1) | Respond to of 25711
SUPG news SuperGen's RFS 2000 Shows 64% Response or Stable Disease in Pancreatic Cancer Patients Clinical Study Results Presented at the American Society of Clinical Oncology Meeting SAN RAMON, Calif., May 18 /PRNewswire/ -- SuperGen, Inc. (Nasdaq: SUPG - news, SUPGW - news), a pharmaceutical company, today announced that interim results from an ongoing Phase II trial of its proprietary drug RFS 2000 for the treatment of pancreatic cancer were presented today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Los Angeles, California. Data shows that among 53 patients, 32% were responders, 32% were stable and 26% were non-responders following treatment with RFS 2000. Responses were evaluated by improvement in CT scan, tumor markers and clinical symptomatology. Median survival to date is 9.1 months among responders, and 8.8 months among stable patients. Pancreatic cancer is the fifth leading cause of cancer deaths in the U.S. Each year approximately 29,000 people develop pancreatic cancer and about 28,900 die from the disease. The median survival after diagnosis is only three to four months. ''The unmet medical need in pancreatic cancer is profound,'' said Dr. Joseph Rubinfeld, Chief Executive Officer of SuperGen. ''It is our responsibility to rapidly expand these human trials into additional sites and get data to the FDA with the greatest possible sense of urgency.'' Fifty-three patients completed at least two courses of RFS 2000 therapy, 34 in whom the cancer already had metastisized beyond the pancreas. Twenty-two of the patients already had failed conventional treatment for pancreatic cancer. A course of therapy consisted of oral administration of RFS 2000 for five consecutive days, followed by two days rest, repeated four times. Drug-related toxicities were generally not clinically significant, and included cystitis and hematological toxicities, all of which were rapidly reversible after discontinuing treatment. In another study presented at the meeting, RFS 2000 demonstrated impressive activity in a variety of different tumor types, including breast cancer, lung cancer, ovarian cancer, prostate cancer, stomach cancer, melanoma and leukemia. In these preclinical studies, all tumors responded, defined as 100% or more growth inhibition. Many of the tumors were completely eliminated with RFS 2000. This data correlates to Phase I human clinical studies showing similar results. Based in San Ramon, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer. SuperGen is developing an anti-cancer portfolio of proprietary new drugs and enhanced Extra(TM) products, and currently is marketing its initial line of drugs for the treatment of cancer patients, primarily Nipent(R). The company also is sponsoring Phase II human clinical trials for drugs targeting anemias, obesity and diabetes. This press release contains forward looking statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such statements, including those regarding the ongoing clinical development of RFS 2000, involve certain risks and uncertainties associated with an emerging pharmaceutical company. Actual results could differ materially from those projected in the forward looking statements as a result of failure to develop or obtain regulatory approval, as well as other risk factors discussed in SuperGen's reports on file with the U.S. Securities Exchange Commission (including but not limited to the report on Form 10-Q for the quarter ended March 31, 1998).