SuperGen, Inc. Receives FDA Clearance to Initiate Phase I Clinical Trial With MP470

DUBLIN, Calif., April 25 /PRNewswire/ -- SuperGen Inc. today announced that the Food and Drug Administration cleared MP470, a novel oral multi-targeted tyrosine kinase inhibitor (TKI), for a first-in-human Phase I clinical trial.

The Phase I accelerated titration dose-escalation trial will assess the safety and tolerability of MP470 and determine the maximum tolerated dose (MTD). Pharmacokinetic and biomarkers data will also be collected and assessed to assist in designing follow-on clinical studies for the use of MP470 as a single agent and in combination treatment modalities. Up to 30 patients with advanced stage solid tumor cancers will be enrolled.

"Today signifies our complete transition to a discovery and development company." said Dr. James S. Manuso, SuperGen's Chairman, President and Chief Executive Officer. "Strategically, we remain focused on becoming a key player in the hematology and oncology markets. Not only will we enter the clinic with MP470 this quarter, we anticipate advancing MP529, our selective Aurora-A kinase inhibitor, into clinical trials later this year."

The Phase I study protocol is undergoing final approval by Institutional Review Boards at two study centers in the U.S. The first patient is expected to be treated later this quarter.

The receipt of FDA clearance for the MP470 first-in-human use triggers a milestone payment to the previous Montigen shareholders of $10 million dollars to be paid in SuperGen common stock.

About MP470

MP470 is an oral selective multi-targeted TKI that inhibits MET, RET and the mutant forms of KIT, PDGFR and FLT3 as well as suppresses the Rad51 protein, a critical component of double-stranded DNA repair in cancer cells. The compound was developed using a fragment-based approach with the aid of company's CLIMB(TM) technology.

About SuperGen

Based in Dublin, Calif., SuperGen is a pharmaceutical company dedicated to the discovery, rapid development and commercialization of therapies for solid tumors and hematological malignancies. SuperGen is developing a number of therapeutic anticancer products focused on kinase inhibitors and DNA methyltransferase inhibitors. 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. These forward-looking statements are not guarantees of 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 the company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, whether and when the first patients will be enrolled in the trial, the overall success of the Phase I trial protocol for MP470 and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission, including its most recently filed Form 10- K. SuperGen Inc. undertakes no duty to update any of these forward-looking statements to conform them to actual results.

Contacts: SuperGen Noonan Russo Timothy L. Enns Greg Geissman S.V.P., Corporate Director of Media Relations Communications & Business Development (619) 814-3510 (925) 560-0100 x111 greg.geissman@eurorscg.comtenns@supergen.com

CONTACT: Timothy L. Enns, S.V.P., Corporate Communications& BusinessDevelopment, +1-925-560-0100, ext. 111, tenns@supergen.com; Greg Geissman,Director of Media Relations of Noonan Russo, +1-619-814-3510,greg.geissman@eurorscg.com

Web site: http://www.noonanrusso.com//