SuperGen Inc. announced that the Food and Drug Administration has 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 tumour 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 CEO. "Strategically, we remain focused on becoming a key player in the haematology 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 centres in the US. 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.