DUBLIN, Calif., December 17 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG) today announced that investigators have dosed the first patient in a multi-arm Phase 1b clinical trial of MP470, a novel, oral, multi-targeted tyrosine kinase inhibitor (TKI). The trial will evaluate MP470 in combination with several standard of care chemotherapy regimens, including carboplatin/paclitaxel, carboplatin/etoposide, docetaxel, topotecan, and erlotinib. The trial is expected to enroll up to 105 patients at five study centers.
The Phase 1b trial is an open label, dose-escalation study designed to assess the safety and tolerability of MP470 in combination with these standard of care chemotherapy regimens, and to define the dose of MP470 to advance into Phase 2 combination studies. Additionally, the Company will assess pharmacokinetic and biomarker data from the study. The trial is open to chemotherapy nave or treatment experienced patients with a variety of solid tumors irrespective of previous lines of therapy.
"MP470 shows significant preclinical synergy with all of these well established chemotherapy agents. Its preclinical toxicology profile, as well as preliminary safety data from our ongoing Phase 1 trial suggests it will be safe to combine it with these regimens," said Dr. Gregory Berk, Chief Medical Officer of SuperGen. "In preclinical models, MP470 also suppresses Rad51, a protein that plays a key role in the mechanism of resistance to these treatments. We believe this offers the potential for MP470 to improve on the efficacy of these therapies. The multi-arm, Phase 1b design allows us to accelerate the clinical development of MP470 which will expedite the timeline to our Phase 2 program."
MP470 is an oral, multi-targeted tyrosine kinase inhibitor that inhibits the mutant forms of c-KIT, PDGFR and FLT3, and suppresses c-MET and c-RET. MP470 also suppresses the 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 and is synergistic with a variety of chemotherapy agents as well as radiation therapy. MP470 is currently being evaluated in a single agent Phase 1 trial in patients with solid tumors.
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
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
Timothy L. Enns
S.V.P., Corporate Communications& Business Development
Mary M. Vegh
Manager, Investor Relations
|SOURCE SuperGen, Inc.|
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