SuperGen Reports Dosing Of First Patient In Phase I Trial Of Novel Tyrosine Kinase Inhibitor

Researchers have dosed the first patient in a Phase I clinical trial of MP470, a novel, oral, multi-targeted tyrosine kinase inhibitor (TKI).

The study is also open to accrual at South Texas Accelerated Research Therapeutics (START) in San Antonio, Texas. The trial is expected to enroll up to 30 patients at the two study centers.

The Phase I trial is an accelerated titration dose-escalation study designed to assess the safety and tolerability of MP470, and to determine the maximum tolerated dose of the compound in patients with advanced-stage solid tumors. Additionally, the Company will assess pharmacokinetic and biomarker data from the study to assist in designing follow-on clinical studies for the use of MP470 as a single agent and in combination treatment modalities.

"We have reached a significant milestone in the development of MP470 with the initiation of a first-in-human trial," said Dr. Gregory Berk, Chief Medical Officer of SuperGen. "This demonstrates the strength of our drug discovery process, and marks the first of our clinical programs focused on key mechanisms of cancer cells," said Dr. James Manuso, Chairman, President and CEO of SuperGen. "We will continue to advance novel compounds for cancer patients into clinical development, furthering our transition to an integrated discovery and development organization."

In addition to MP470, SuperGen is moving MP529, a selective aurora-A kinase inhibitor, closer to the clinic with an Investigational New Drug application planned for later this year. The Company optimized MP529 using its proprietary CLIMB(TM) technology, an iterative process that involves modeling cancer targets and their interactions with potential drug candidates to identify "drug-like" lead compounds.

MP470 is an oral, selective multi-targeted tyrosine kinase inhibitor that suppresses c-MET, c-RET and the mutant forms of c-KIT, PDGFR and FLT3. MP470 also suppresses Rad51 protein, a critical component of double-stranded DNA repair in cancer cells. Preclinical testing of MP470 has identified anti-tumor activity against a wide spectrum of cancers.

START is dedicated to the conduct of Phase I Clinical Trials of novel anticancer agents in San Antonio, Texas. The mission of START is to accelerate the development of new therapies with the purpose of improving quality of life and survival for patients with cancer. START is headed by Dr. Anthony Tolcher and consists of a team of highly trained physicians and staff, with extensive experience in Phase I clinical trials research.