SuperGen Announces Interim Data from Dacogen™ Phase III Clinical Study in Myelodysplastic Syndrome

SuperGen Announces Interim Data from Dacogen(TM) Phase III Clinical Study in Myelodysplastic Syndrome Conference call scheduled for Friday, Feb. 13th at 12:00 p.m. (EST) / 9:00 a.m. (PST) DUBLIN, Calif., Feb. 13 /PRNewswire-FirstCall/ -- SuperGen Inc. (Nasdaq: SUPG - ) today announced that it has released and will discuss a preplanned interim analysis of the Dacogen ™ (decitabine for injection) Phase III clinical study in patients with myelodysplastic syndrome (MDS). The Company also announced that it will hold a conference call to discuss these results today, Friday, February 13th at 12:00 p.m. (EST) / 9:00 a.m. (PST). Dr. James Manuso, President and Chief Executive Officer, and Edward L Jacobs, Chief Operating Officer, will host the call with participation by Craig Rosenfeld, M.D., Chief Scientific Officer; Dr. Audrey Jakubowski, Senior Vice President, Regulatory Affairs; Karl Mettinger, M.D., Ph.D., Senior Vice President and Chief Medical Officer; and, Michael Molkentin, Chief Financial Officer. To participate in the call, please dial 888 -343-7239 approximately ten minutes prior to the scheduled start time (international callers dial 415 - 537-1805). Those who do not wish to participate may listen to the 'web cast' of the conference call by visiting www.supergen.com. An audio recording of the call will be available on the web site for 90 days. The study protocol allowed for a predefined interim analysis after data from forty -five patients was available, which occurred in July, 2003. At that time, the interim analysis was discussed with the FDA, and it was decided that release of the analysis would have jeopardized final study results. The trial is now in its final stages of analysis. The interim analysis of the first forty -five patients revealed that those receiving Dacogen had an increased time to acute myelogenous leukemia (AML) or death (median 105 days verses 92 days, P=0.036), which is the primary end point of the study. This analysis was based on data from 19 high -risk, 19 intermediate 2, and 8 intermediate 1 patients, as defined by the International Prognostic Scoring System (IPSS) that is used to classify MDS patients. Data from 92 patients have been collected to date, allowing for a final analysis. However, the final analysis will not begin until all primary data points are verified and there can be no assurance that the final results will be consistence with the interim analysis. The Company believes final study results will be available prior to the end of March. Recent discussions with the FDA have focused on the format and content of a planned submission of the clinical data. "The interim analysis is based on limited preliminary data representing less than half of the currently available data and is not predictive of the final outcome of the trial. We are working diligently to complete final data analysis within this quarter," said Dr. James Manuso, President and Chief Executive Officer of SuperGen. 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 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. 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 completing the Phase III clinical trial in patients with myelodysplastic syndrome, whether the interim analysis will be consistent with the final study results, whether Dacogen will demonstrate any clinical benefit in this Phase III trial or any future study in this patient population and whether the company will submit or receive regulatory approval for Dacogen for any indication. 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

The release as fetched from its publisher. astx.com ↗