SUPG Supergen, Inc. (MM)

Two Multicenter Clinical Studies Cite Activity of Nipent(R) Combination Therapy in Non-Hodgkin's Lymphoma (NHL) Results presented at the 45th Annual Meeting of the American Society of Hematology (ASH) DUBLIN, Calif., Dec. 8 /PRNewswire-FirstCall/ -- SuperGen, Inc. announced today that data from two multicenter clinical studies demonstrated the activity of the anticancer drug Nipent(R) (pentostatin for injection), as part of combination therapy, in Non-Hodgkin's Lymphoma (NHL). Results from these studies were recently presented at the 45th Annual Meeting of the American Society of Hematology (ASH) in San Diego. Nipent is currently approved as a single-agent treatment for patients with hairy cell leukemia and is not approved as either a single agent or as part of a combination treatment for NHL. The first clinical study is a Phase II trial, conducted by Pharmatech Oncology Research Network at 25 sites across the United States, which enrolled 60 patients with previously treated and untreated NHL. Each patient received a combination therapy consisting of Nipent and rituximab. Of the 52 evaluable patients, the objective response rate at day 60 was 59.6 percent (12 complete responses and 19 partial responses) and the objective response rate at day 115 was 50.9 percent (17 complete responses and 9 partial responses). One patient died while on study from causes not believed to be related to study treatment. No other toxicity data was reported [Abstract no. 2373]. The second clinical study is a multi-center pilot trial that registered 26 patients with previously untreated, Stage III or Stage IV low-grade NHL. One patient was deemed ineligible for treatment and another patient did not receive treatment. A total of 24 patients received a combination therapy consisting of Nipent, mitoxantrone, and rituximab. There were nine complete responses (37.5 percent), three additional unconfirmed complete responses (12.5 percent), eight partial responses (33.3 percent) and four patients with stable disease (16.7 percent) for an overall response rate of 83.3 percent. The median duration of response to date was 5.9 months and four patients progressed between 2.7 and 7.9 months after receiving treatment. Two patients died -- one of disease progression and one of cardiopulmonary arrest (not treatment related) -- at 3.2 and 5.5 months, respectively, after receiving treatment. Grade 3 toxicities were observed in 19 patients, including neutropenia (66.7 percent), constitutional symptoms (25 percent), leukopenia and febrile neutropenia (16.7 percent each), gastrointestinal symptoms (12.5 percent), sepsis (8.3 percent) and anemia and dyspnea (4.2 percent each) [Abstract no. 4920]. "A growing number of clinical studies suggest that combination therapy including Nipent may be active against Non-Hodgkin's Lymphoma," said Karl Mettinger, M.D., Senior Vice President and Chief Medical Officer of SuperGen. "Presenting Nipent clinical data at the ASH Annual Meeting allows us to share our findings with the medical community and plan future studies." 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 is subject to the safe harbor created thereby. Such forward-looking statements include statements regarding the results of clinical trials for Nipent and its activity and potential benefits and effectiveness in treating Non-Hodgkin's Lymphoma (NHL) in combination with other chemotherapeutic drugs. The actual results could differ materially from those discussed in the forward-looking statements as a result of known and unknown risk factors and uncertainties associated with initiating, conducting and completing clinical trials and drug development, including, but are not limited to: risks and uncertainties related to any benefit that Nipent may have in NHL, whether results of additional large scale clinical trials, if initiated and completed, will be consistent with findings in earlier studies, whether the Company will seek approval from regulatory authorities for this indication, and/or in combination with other drugs, the timing, if any, of the submission of a supplemental NDA with the FDA, how lengthy the FDA review process will be, if the application will be approved or if the drug will ever be approved for this use and/or in combination with other drugs. 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 of SuperGen, Inc., 1-800-353-1075, ext.111 Web site: http://www.supergen.com/

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