SuperGen, Inc. Reports Dosing of First Patient in Phase I Trial of Novel Tyrosine Kinase Inhibitor
DUBLIN, Calif., July 5 /PRNewswire-FirstCall/ -- SuperGen, Inc. today announced that collaborators at The Translational Genomics Research Institute (TGen) and TGen Clinical Research Services (TCRS) at Scottsdale Healthcare in Scottsdale, Arizona, 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.
Based in Dublin, Calif., SuperGen, Inc. 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 and cell signaling inhibitors, and DNA methyltransferase inhibitors. For more information about SuperGen, please visit http://www.supergen.com
TGen Clinical Research Service (TCRS) is a strategic alliance between the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare that provides a direct clinical research site for TGen in the fields of oncology and hematology. Dr. Daniel Von Hoff serves as Medical and Research Director of TCRS and Dr. Stephen Anthony serves as the Director of Clinical Research. TCRS is located in the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Arizona. TCRS moves basic science findings from research organizations into translational-based medicine as treatment options for patients. The alliance between TGen and Scottsdale Healthcare allows for molecular and genomic discoveries to reach the patient bedside as quickly as possible.
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.
This press release contains "forward-looking" statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created thereby. The actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. These forward-looking statements include statements regarding the ability of our products to enter clinical trials and the potential validation of our discovery process to produce new compounds. SuperGen's products may not enter clinical trials, and even if these products do enter clinical testing, there is no assurance that these tests will be successful. Additionally, the early successes in preclinical work may not be a validation of our discovery process and past success may not predict future success. Other factors that could cause actual results to differ materially from expectations include, but are not limited to, the risk factors detailed in the Company's filings with the Securities and Exchange Commission including reports on its most recently filed Form 10-K and Form 10-Q. These forward- looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward- looking statements, whether as a result of new information, future events or otherwise.
Contacts: SuperGen Timothy L. Enns S.V.P., Corporate Communications & Business Development (925) 560-0100 firstname.lastname@example.org SuperGen Mary M. Vegh Manager, Investor Relations (925) 560-2845 email@example.comSuperGen, Inc.
CONTACT: Timothy L. Enns, S.V.P., Corporate Communications & BusinessDevelopment, +1-925-560-0100, or firstname.lastname@example.org, or Mary M. Vegh,Manager, Investor Relations, +1-925-560-2845, or email@example.com,both of SuperGen, Inc.
Web site: http://www.supergen.com/