SuperGen, Inc.
(Nasdaq: SUPG) 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.
About MP470
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.
About SuperGen
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 supergen
About TCRS
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.
About START
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.
SuperGen, Inc.
supergen
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