drugset / Press release

SuperGen Reports Results of Ongoing Studies of Nipent® in Combination Therapies for Chronic Lymphocytic Leukemia and Low Grade B-cell Lymphomas

2004-06-10 · Astex Pharmaceuticals, Inc. · original astx.com ↗

SuperGen Reports Results of Ongoing Studies of Nipent(R) in Combination Therapies for Chronic Lymphocytic Leukemia and Low Grade B -cell Lymphomas DUBLIN, Calif., June 10 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) announced that results from three ongoing studies of its anticancer compound Nipent ® (pentostatin for injection) were reported this week during the annual meeting of the American Society of Clinical Oncology. The three studies and their conclusions, which were presented in the General Poster Session, demonstrated that pentostatin used in combination with other chemotherapeutic agents was active, well -tolerated and did not increase the toxicity of the combination regimen. A study at Memorial Sloan Kettering of pentostatin and cyclophosphamide as compared to pentostatin, cyclophosphamide and rituximab as a salvage therapy in 45 patients with chronic lymphocytic leukemia (CLL) concluded that pentostatin and cyclophosphamide is highly active and well tolerated in CLL patients, and the addition of rituximab to the regimen does not appear to substantially increase toxicity (Weiss MA, et al. Proc ASCO 2004; 23:572, abstract #6568). A study of pentostatin and rituximab in 143 previously treated and untreated patients with low grade B -cell non Hodgkin's lymphoma (including CLL with lymph node involvement) concluded that this regimen appears to be well tolerated and active, with Grade 3-4 toxicity similar to that observed when pentostatin and rituximab are used as single agents. Additionally, there appears to be an improvement in response with continued treatment (Mena RR, et al. Proc ASCO 2004; 23:572, abstract #6569). A study of pentostatin and cyclophosphamide in 18 previously treated patients with B -cell chronic lymphocytic leukemia, and pentostatin and cyclophosphamide followed by rituximab in 11 Waldenstrom's macroglobulinemia (WM) found that these combinations are well-tolerated and active for previously treated patients with these cancers. Compared to other combinations of purine analogs and cyclophosphamide, pentostatin and cyclophosphamide demonstrated lower hematological toxicity. Additionally, maintenance therapy with rituximab in WM patients as a single infusion every three months is well -tolerated, and may convert patients with partial response to complete response (Hensel M, et al. Proc ASCO 2004; 23:569, abstract #6557). About Nipent 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 regimen for treatment for any other indication. About SuperGen Based in Dublin, Calif., SuperGen is a pharmaceutical company dedicated to the acquisition, rapid development and commercialization of therapies for solid tumors, hematological malignancies and blood disorders. 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 Nipent's potential use in the treatment of low grade B - cell non Hodgkin's lymphoma and chronic lymphocytic leukemia (CLL). Whether or not Nipent may be commercialized in the treatment of low grade B-cell non Hodgkin's lymphoma and chronic lymphocytic leukemia (CLL) will depend on a number of known and unknown risk factors and uncertainties. Such factors include, but are not limited to, risks and uncertainties related to conducting and completing clinical trials in patients with low grade B -cell non Hodgkin's lymphoma and chronic lymphocytic leukemia (CLL), and whether the company will submit or receive regulatory approval for Nipent for the treatment of low grade B-cell non Hodgkin's lymphoma and chronic lymphocytic leukemia (CLL). 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 March 31, 2004. These forward -looking statements are made only as of the date hereof, and the company disclaims 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. Contacts: SuperGen, Inc. Euro RSCG Life NRP Timothy L. Enns Sharon Weinstein (925) 560-0100 x111 (212) 845-4271 [email protected] [email protected] SOURCE SuperGen, Inc. 06/10/2004 Web site: http://www.supergen.com

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