Wednesday December 6, 9:30 am Eastern Time
Press Release
SOURCE: SuperGen Inc.
SuperGen's Decitabine 'Highly Effective' for Treatment of Refractory Sickle Cell Anemia
Results of 36-week clinical study presented at American Society of Hematologys 42nd Annual Meeting, in San Francisco
SAN RAMON, Calif., Dec. 6 /PRNewswire/ -- SuperGen Inc. (Nasdaq: SUPG & SUPGZ) announced today that its anticancer compound decitabine generated a 100 percent response rate in patients tested during a 36-week, Phase I/II clinical study designed to establish safety and efficacy in the treatment of sickle cell anemia. Data from this study was recently presented at the 42nd Annual Meeting of the American Society of Hematology (ASH), in San Francisco.
The study, headed by Dr. Mabel Koshy of the University of Illinois at Chicago, enrolled a total of six sickle cell patients: five of whom had shown no response to Hydroxyurea (HU), the current standard of care, after one year of treatment and one patient who was not treated with HU. Each of the six patients treated with decitabine experienced elevated levels of fetal hemoglobin, which prevents 'sickle-shaped' cells from congregating, allowing them to move freely throughout the body. (The clustering of such 'sickle cells' can result in severe pain, stroke, renal failure, loss of sight, and substantial organ damage.)
After systemic administration of six cycles (36 weeks) of decitabine, average fetal hemoglobin levels increased from three percent to 14 percent, and average hemoglobin levels increased over 22 percent. There were no reports of any sickle cell episodes during the course of treatment. There were also no reports of toxicity, and side-effects were minimal. These results compare favorably to results of a 6-week clinical study reported on November 2nd, 2000.
``This study concludes that decitabine is a highly effective alternate drug for the treatment of sickle cell anemia, especially for non-responders,'' said Joseph DeSimone, Ph.D., from the University of Illinois, Chicago, who presented the data.
``The results of this 36-week study are extremely impressive,'' said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. ``Data generated after one cycle (six weeks) provided an indication that decitabine could be an effective, non-toxic treatment for sickle cell anemia. These expanded data on six cycles (36 weeks) appear to validate that belief. In addition, with all of the patients being free of sickle cell episodes for the duration of treatment, the results reported by Dr. DeSimone far exceeded our original expectations.''
``The exciting data generated by decitabine underscores the breadth of the SuperGen portfolio, which includes four drugs that will be in Phase III clinical studies in the near-term,'' added Dr. Rubinfeld.
Sickle cell anemia is an inherited disorder of the red blood cells. Red blood cells carry oxygen to all parts of the body by using a protein called fetal hemoglobin. Normal red blood cells contain only normal hemoglobin and are shaped like discs. These cells are very flexible and move easily through small blood vessels. But in sickle cell anemia, the red blood cells contain sickle hemoglobin, which causes them to change to a curved shape (sickle shape) after oxygen is released. 'Sickled' cells become stuck and form plugs in small blood vessels. This blockage of blood flow can damage the tissue. Because there are blood vessels in all parts of the body, damage can occur anywhere in the body.
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 and most sickle cell patients commonly die in their thirties and forties.
Based in San Ramon, California, SuperGen is a pharmaceutical company dedicated to the development and commercialization of products intended to treat life-threatening diseases, particularly cancer.
Statements relating to SuperGen's decitabine trials are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby. Such statements involve certain risks and uncertainties associated with an emerging pharmaceutical company actively involved in clinical trials. Actual results could differ materially from those projected in the forward-looking statements as a result of failure to obtain the clinical data necessary to support marketing approval of its products under development, unforeseen delays in clinical-trial management, adverse FDA actions, as well as other risks discussed in SuperGen's reports on file with the U.S. Securities and Exchange Commission (including, but not limited to, the report on Form 10-K for the fiscal year ended December 31, 1999, and its report on Form 10-Q for the quarter ended September 30, 2000). |
