SuperGen, Inc. Says Phase II Cancer Drug Fails To Meet Goal
This protocol included a prospectively defined interim analysis (to be conducted after half of the patients had died) to estimate median survival. The analysis result is an estimated median survival of 6.0 months, with a Kaplan-Meier one year survival to be 27%. Although the estimated one year survival is encouraging compared to similar studies in this indication, the study did not meet the pre-specified threshold for median survival in order to proceed to a phase III randomized study. The safety profile for this patient group was very similar to prior studies of Orathecin as a single agent or in combination with gemcitabine. The study will remain closed to enrollment, but open for patient follow-up.
"We are working with our clinical advisors, investigators and potential partners to evaluate the best options for Orathecin that will maximize this product's potential to help patients in need and realize its commercial value for our stockholders," said James S. Manuso, President and Chief Executive Officer.
Orathecin(TM) (rubitecan) Capsules, an orally active camptothecin, is a topoisomerase I inhibitor that is being developed for the treatment of pancreatic cancer.
Orathecin has Orphan Drug status in both the U.S. and EU. The Orathecin phase III clinical program is believed to be the largest program in pancreatic cancer ever initiated worldwide, with more than 1,800 patients. Orathecin has also been evaluated in numerous other cancers and blood disorders.
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. SuperGen's marketed products include Nipent® (pentostatin for injection); Mitomycin (generic brand of Mutamycin®); and SurfaceSafe® cleaner. SuperGen is currently developing additional anticancer therapies based on inhibition of a variety of cell signaling pathways. These include but are not limited to aurora kinase, tyrosine kinase, Axl, Pim-1 kinases and DNMT. For more information about SuperGen, please visit http://www.supergen.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions, and include statements regarding the expected timeline for review of the interim results of the Orathecin clinical trial. These forward-looking statements are not guarantees of SuperGen's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements Factors that might cause results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether the drug will be partnered, whether any addition clinical trials will be conducted, if future trials will produce significant results and whether product will ever reach the commercial market; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, including their most recently filed Forms 10-Q or 10-K. SuperGen undertakes no duty to update any of these forward-looking statements to conform them to actual results.
Contacts: Timothy L. Enns Sharon Weinstein SuperGen, Inc. Noonan Russo SVP Corporate Communications Director Investor Relations & Business Development Tel: (925) 560-0100 x111 Tel: (212) 845-4271 E-mail: firstname.lastname@example.org E-mail: email@example.com
Source: SuperGen, Inc.