Independent Review of Orathecin(TM) Phase III Trial Supports Drug's Activity in Pancreatic Cancer Patients who Failed Prior Treatments Data presented at "Innovative Cancer Therapy for Tomorrow" symposium to be used as basis for registrational filing with FDA DUBLIN, Calif., Nov. 17 /PRNewswire-FirstCall/ -- SuperGen Inc. announced today that the long-term follow-up and independent review of results from the previously announced Phase III clinical program of its investigational oral anticancer compound Orathecin(TM) (rubitecan) capsules supports the drug's activity in patients with refractory pancreatic cancer who have failed prior treatments. The data, previously presented at a symposium during the 2003 Annual Meeting of the American Society of Clinical Oncology (ASCO), has been reviewed by an independent third-party expert radiology review panel and was recently presented by Howard A. Burris, III, M.D. at the "Chemotherapy Foundation Symposium XXI - Innovative Cancer Therapy for Tomorrow" in New York City. The Chemotherapy Foundation(R), The Page and William Black Post-Graduate School for Continuing Medical Education and the Mount Sinai School of Medicine jointly sponsored the event. The study randomized 409 patients, most of whom had previously failed two or more chemotherapies, to Orathecin or 'best choice'. Approximately 90 percent of patients in the 'best choice' group received a chemotherapeutic agent such as gemcitabine, 5-FU, mitomycin C, capecitabine, or docetaxel. The primary study end-point was overall survival with secondary end-points of tumor response and time to disease progression. As previously reported, statistical significance of survival was confounded by the high percentage of patients failing 'best care' and then receiving Orathecin. However, both secondary end-points were statistically achieved. Response rate (6 percent vs. 1 percent), time to progression (58 days vs. 48 days) and median survival (109 days vs. 94 days) were all improved with Orathecin compared to 'best choice', despite the fact that patients who failed best alternative therapy were allowed to crossover to Orathecin at disease progression. In patients who demonstrated an objective response to Orathecin, the median time to progression and survival was 269 and 338 days respectively. Additionally, 22 percent (44/198) of patients randomized to Orathecin achieved stable disease (less than 50 percent shrinkage without new disease), versus 13 percent (27/211) for patients receiving 'best choice'. This finding is also statistically significant and independently verified. The total number of patients achieving 'disease control', defined as complete response plus partial response plus stable disease, was 28 percent (56/198) versus 13 percent (28/211), for 'best choice'. Dr. Burris also presented an overview of the observed toxicities, which were generally manageable for patients with advanced stage pancreatic cancer. Less that 5 percent of patients in either arm discontinued therapy for drug related toxicity. Severe or life-threatening adverse events with an incidence greater than 5 percent in patients who received Orathecin versus the 'best choice' included: asthenia (19 percent vs. 16 percent), abdominal pain (15 percent vs. 11 percent), pain (4 percent vs. 6 percent), sepsis (5 percent vs. 7 percent), nausea (12 percent vs. 8 percent), anorexia (7 percent vs. 9 percent), diarrhea (9 percent vs. 4 percent), vomiting (11 percent vs. 5 percent), leucopenia (19 percent vs. 10 percent), anemia (15 percent vs. 7 percent), thrombocytopenia (9 percent vs. 8 percent), dehydration (11 percent vs. 9 percent) and bilirubinemia (6 percent vs. 2 percent) respectively. "This data suggests that Orathecin may offer clinical benefits to pancreatic cancer patients with no current therapeutic options," said Dr. Burris, Director of Drug Development at the Sarah Cannon Cancer Center in Nashville, Tenn. Based in Dublin, California, SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapeutic anticancer products. The Company's website can be reached at http://www.supergen.com/. 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 forward-looking statements include statements regarding expectations about Orathecin(TM) and the clinical benefits it may offer The success of Orathecin could differ materially from those projected in the forward-looking statements as a result of known and unknown risk factors and uncertainties associated with drug development. Such factors include, but are not limited to: risks and uncertainties related to interpretation of clinical trial data for Orathecin, whether results from the other large scale Orathecin studies currently being analyzed will be consistent with the results presented here, how quickly study data can be analyzed, whether an NDA will be submitted to, as anticipated or at all, and filed by the FDA, how long the FDA review process will take, and if Orathecin will ever be approved by the FDA and reach the market. References made to the discussion of the risk factors are detailed in the company's filing with the Securities and Exchange Commission including the report on Form 10-Q for the quarter ended September 30, 2003. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise. Contact: Tim Enns, Vice President, Investor Relations & Business Development, SuperGen, Inc., 800-353-1075, ext. 111 DATASOURCE: SuperGen Inc. CONTACT: Tim Enns, Vice President, Investor Relations & Business Development, SuperGen, Inc., +1-800-353-1075, ext. 111 Web site: http://www.supergen.com/

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