SUPG Supergen, Inc. (MM)

Published Clinical Data Suggests that Dacogen(TM), Administered Subcutaneously, is Active as a Treatment for Sickle Cell Anemia Data appearing in current issue of Blood to be presented at symposium preceding Annual Meeting of the American Society of Hematology DUBLIN, Calif., Dec. 4 /PRNewswire-FirstCall/ -- SuperGen, Inc. announced today that results of a clinical study, published in the current issue of the journal Blood (vol. 102, no. 12, pp. 3855-56), suggest that the investigational anticancer compound Dacogen(TM) (decitabine for injection) is active in treating sickle cell anemia. Updated data from the clinical study will be presented Friday, December 5th at a SuperGen-sponsored symposium preceding the 45th Annual Meeting of the American Society of Hematology (ASH) in San Diego. Principal Investigator Yogen Saunthararajah, M.D., at the University of Illinois at Chicago led the Phase I/II clinical study. The primary objective of the study was to test whether subcutaneously administered Dacogen could safely reactivate fetal hemoglobin. Eight patients diagnosed with sickle cell anemia and resistant or intolerant to hydroxyurea (the current standard of care) were enrolled. Each patient received Dacogen administered subcutaneously, one to three times per week, in two cycles of six-week duration. Each patient treated with Dacogen had increases in levels of fetal hemoglobin. Fetal hemoglobin interacts with sickle hemoglobin to reduce the complications of sickle cell disease. Some debilitating complications of sickle cell disease include severe pain, pneumonia, stroke, and renal failure. Surrogate (laboratory) indicators of sickle cell disease also improved in Dacogen treated patients. In addition, levels of total hemoglobin increased an average of 26 percent. Researchers reported that the subcutaneous regimen was well tolerated, with the only significant toxicity and most frequent event being neutropenia. Standard NCI criteria for toxicity were used. No local toxicity was noted at the subcutaneous injection site and no nausea, vomiting, diarrhea, constipation or loss of appetite was reported. "The preclinical and clinical data continue to be very encouraging and help to validate our belief that Dacogen could become an important agent in the treatment of sickle cell disease," said Dr. Saunthararajah, Assistant Professor of Medicine and Director of the Adult Sickle Cell Clinic at the University of Illinois at Chicago. Dr. Saunthararajah was the lead author of the paper that was published in Blood and will present updated results at the symposium. "The publication of these encouraging clinical results in the peer- reviewed medical journal Blood is a further indication that Dacogen may be useful as a treatment for sickle cell disease," said Craig Rosenfeld, M.D., Senior Vice President and Chief Scientific Officer of SuperGen. The primary mechanism of action for Dacogen in sickle cell disease is thought to be reduction of DNA methylation at the gamma globin gene promoter. In the publication, Dr. Saunthararajah directly demonstrates reduction in gamma globin gene promoter methylation by two molecular techniques. Dacogen previously received orphan-drug designation from the Food and Drug Administration (FDA) for the treatment of sickle cell anemia, which may provide seven years of market exclusivity if, among other conditions, the drug is approved for this indication. Sickle cell anemia is an inherited disorder of the red blood cells. Red blood cells carry oxygen to all parts of the body using a protein called hemoglobin. Normal red blood cells contain mostly Hemoglobin A and are shaped like discs. Normal red cells are very flexible and move easily through small blood vessels. However, in sickle cell anemia, the red blood cells contain sickle hemoglobin, which causes them to change to a curved shape (sickle shape) and become less flexible after oxygen is released. 'Sickled' cells therefore may become stuck and form blockages in small blood vessels. Because these vessel blockages can occur in all parts of the body, damage can occur in any part of the body. Elevations in fetal hemoglobin are associated with reduced complication from sickle cell anemia. Sickle cell anemia is most common among people whose ancestors come from Africa, the Middle East, the Mediterranean basin, and India. In the United States, it affects primarily African Americans, more than 50,000 of whom have the disease, according to the Center for Disease Control and Prevention. One in 12 African-Americans carries the sickle cell trait. The median age at death of patients with sickle cell anemia is reduced by 25-30 years, compared to African-Americans in general. 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 related to our expectations regarding Dacogen as a treatment for sickle cell disease. The success of such product could differ materially from those discussed in the forward-looking statements as a result of known and unknown risk factors and uncertainties. Such factors include, but are not limited to: risks and uncertainties related to conducting clinical trials, whether Dacogen be studied in expanded clinical trials in patients with sickle cell disease, if expanded trials are conducted, whether Dacogen will be safe and effective in treating patients with sickle cell disease, and whether the company will submit Dacogen for regulatory approval for any indication, or if the drug will ever be approved or 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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