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"We are extremely pleased to report a series of important clinical andscientific advances achieved by our Company," said James S. Manuso, Ph.D.,SuperGen's President and Chief Executive Officer. "In addition to MP-470'sprogress in the clinic, before year-end, we expect to enter SGI-1776, our PIMkinase inhibitor, into Phase 1 clinical trials. This will be our second noveldrug in clinical development."
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In a poster presentation (Abstract #403) entitled, "Clinical responses ofhighly refractory solid tumor patients to oral MP-470, a multi-targetedtyrosine kinase inhibitor, in combination with standard of care chemotherapyregimens. Preliminary report from a multi-institutional phase 1b clinicaltrial," Dr. A. Tolcher, Director of Clinical Research at START (South TexasAccelerated Research Therapeutics) in San Antonio, Texas, highlighted datashowing tumor regression in four patients in the two arms, indicating thatMP-470 may sensitize/re-sensitize tumors to the anticancer effects of SOCregimens of DNA-damaging agents. Of note, MP-470 did not increase the types orseverity of adverse events. However, a primary endpoint of the trial -determining the maximum tolerated dose of MP-470 co-administered with SOCregimens - has not been reached and dose escalation continues.
"These compelling results strengthen the rationale for combining MP-470with DNA-damaging agents due to MP-470's purported ability to suppress theRad51 DNA repair mechanism, which is important in various malignancies," saidDr. Gregory Berk, SuperGen's Chief Medical Officer. "We look forward topresenting updated results on MP-470 in combination with these platinumdoublets, as well as the other three standard of care arms of the trial in thefuture."
Earlier this year, U.S. Food and Drug Administration granted orphan drugdesignation for MP-470 in the treatment of glioblastoma multiforme (GBM) afternon-clinical studies showed more than two-fold effect of increased cell deathwhen used synergistically with ionizing radiation. Orphan drug designationfor GBM, an often fatal form of brain cancer, can entitle SuperGen to sevenyears of market exclusivity. SuperGen's lead product candidate has also shownpromise in preclinical testing across a wide spectrum of cancers, includingnon-small cell lung cancer.
Furthermore, SuperGen presented four additional posters at the Symposiumthat reviewed clinical and non-clinical advances of the compounds MP-470,SGI-1776 and SGI-1252. These include:
Copies of the 20th EORTC-NCI-AACR Symposium poster presentations will beavailable in the pipeline section of SuperGen's Web site www.supergen.com.
About SuperGen
Based in Dublin, Calif., SuperGen, Inc. is a pharmaceutical companydedicated to the discovery and development of novel cancer therapies. SuperGenis developing a number of therapeutic anticancer products focused on kinaseand cell signaling inhibitors and DNA methyltransferase inhibitors. For moreinformation about SuperGen, please visit http://www.supergen.com.
Forward-Looking Statements
This news release contains certain "forward-looking" statements within themeaning of the Private Securities Litigation Reform Act of 1995. Thesestatements are typically preceded by words such as "believes," "expects,""anticipate," "intends," "will," "may," "should," or similar expressions.These forward-looking statements are not guarantees of future performance andinvolve a number of risks and uncertainties that may cause actual results todiffer materially from the results discussed in these statements. Factorsthat might cause the company's results to differ materially from thoseexpressed or implied by such forward-looking statements include, but are notlimited to, the ability to discover, develop and move target compounds intoclinical development and other risks and uncertainties detailed from time totime in the company's filings with the Securities and Exchange Commissionincluding its most recently filed Form 10-Q and 10-K. SuperGen, Inc.undertakes no duty to update any of these forward-looking statements toconform them to actual results.Abstract 332: In vivo activity of SGI-1776, an orally active PIM kinase inhibitor Abstract 426: Effects of food on the single-dose pharmacokinetics of oral MP-470 capsules Abstract 480: MP-470, a novel multi-targeted tyrosine kinase inhibitor targeting Rad51 is not toxic to human primary marrow stem cells at clinically relevant concentrations Abstract 571: Modulation of JAK2 signaling pathways in vitro and in vivo
SOURCE SuperGen, Inc.
