The receipt of FDA clearance triggers a milestone payment to the previous Montigen shareholders of $10 million, to be paid in SuperGen common stock.
The phase I accelerated titration dose-escalation trial will assess the safety and tolerability of MP470 and determine the maximum tolerated dose. 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. The compound was developed using a fragment-based approach with the aid of company's CLIMB technology.
“Today signifies our complete transition to a discovery and development company,” said Dr James Manuso, SuperGen's president and CEO. “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 US. The first patient is expected to be treated later this quarter.