SuperGen Announces Publication of Phase II Studies of Dacogen™ in Advanced MDS Patients

SuperGen Announces Publication of Phase II Studies of Dacogen(TM) in Advanced MDS Patients Low-Dose Therapy Had Clinically Significant Effect on Platelet Count DUBLIN, Calif., July 9 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) announced publication of results from three consecutive Phase II clinical trials of Dacogen ™ (decitabine) for injection in patients with myelodysplastic syndromes (MDS). The principle investigator for these European studies was Professor Pierre W. Wijermans, MD. The manuscript was published in the August 2004 issue of the journal Leukemia Research (van den Bosch et al., Leuk. Res. 2004 August; 28 (8):785 -90). An editorial entitled, "Myelodysplasia, megakaryocytes, and methylation" was also published in the same issue of Leukemia Research (Steensma, Leuk Res. 2004 August; 28(8):775 - 776). The combined Phase II trials enrolled 170 patients with intermediate and high -risk MDS. Investigators retrospectively analyzed the effect of low-dose Dacogen therapy on platelet response in 162 of the 170 patients. Platelets are a type of blood cell that prevents and stops bleeding. Seventy -eight percent of the patients analyzed had low platelet counts associated with their MDS at baseline. All patients had an IPSS risk score of Intermediate I or higher. Platelet responses occurred in 63% of patients. Platelet responses occurred quickly and were usually (58%) observed after only one cycle of Dacogen. Furthermore, platelet response predicted for favorable overall survival (p<0.0001). The study concludes that Dacogen has a clinically significant, often long lasting, effect on the platelet count in a substantial number of high-risk MDS patients. "This analysis provides additional clinical evidence that Dacogen might have a positive effect on survival outcome in MDS patients," said Karl Mettinger MD, Ph.D., Chief Medical Officer and Senior VP. "These data demonstrate that Dacogen's clinical activity in MDS patients should be recognizable early in the treatment cycle, and will further support the Phase III data being submitted, as part of our rolling NDA for Dacogen, later this quarter." About Decitabine Decitabine is an investigational drug. It has not yet been approved for marketing in the U.S. or by other regulatory agencies in their respective countries; therefore, safety and efficacy have not yet been established in any patient population. Currently, SuperGen is in the process of filing an NDA for Dacogen in MDS. Decitabine has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors. Decitabine belongs to a new class of drugs called hypomethylating agents, with a unique mechanism of action. Methylation is a process in which methyl (CH3) groups are added to DNA to inactivate or "silence" genes. Previously reported data from the randomized Phase III study of Dacogen in MDS patients demonstrated that adverse events observed were more common in patients receiving Dacogen than supportive care alone. These adverse events included leucopenia, febrile neutropenia, nausea, constipation, diarrhea, vomiting, pneumonia, arthralgia, headache and insomnia. About SuperGen Based in Dublin, California, 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 is 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 expectations about Dacogen, the effect of low -dose Dacogen therapy on platelet response and the Company's rolling NDA for Dacogen in the treatment of MDS. The success of Dacogen™ 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 the Dacogen NDA filings, how long the FDA review processes will take, and if Dacogen 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 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. For further information about SuperGen, please contact: Timothy L. Enns Sharon Weinstein SuperGen, Inc. Euro RSCG Life NRP Tel: 1 (925) 560-0100 x111 Tel: 1 (212) 845-4271 Fax: 1 (925) 551-6491 Fax: 1 (212) 845-4260 [email protected] [email protected] SOURCE SuperGen, Inc. Web site: http://www.supergen.com

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