October 23, 2008
SuperGen’s MP-470 Demonstrates Clinical Tumor Regression When Combined With Standard of Care Chemotherapy
DUBLIN, Calif., Oct. 23 /PRNewswire-FirstCall/ -- SuperGen, Inc. , a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today presented data on MP-470, its lead product candidate, and four additional posters, at the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" in Geneva, Switzerland. MP-470, an orally bio-available multi-targeted tyrosine kinase inhibitor, showed encouraging tumor regression results in the first two arms (paclitaxel/carboplatin and carboplatin/etoposide) of its current Phase 1b clinical trial examining MP-470 combined with five standard of care (SOC) anticancer treatments.
"We are extremely pleased to report a series of important clinical and scientific advances achieved by our Company," said James S. Manuso, Ph.D., SuperGen's President and Chief Executive Officer. "In addition to MP-470's progress in the clinic, before year-end, we expect to enter SGI-1776, our PIM kinase inhibitor, into Phase 1 clinical trials. This will be our second novel drug in clinical development."
In a poster presentation (Abstract #403) entitled, "Clinical responses of highly refractory solid tumor patients to oral MP-470, a multi-targeted tyrosine kinase inhibitor, in combination with standard of care chemotherapy regimens. Preliminary report from a multi-institutional phase 1b clinical trial," Dr. A. Tolcher, Director of Clinical Research at START (South Texas Accelerated Research Therapeutics) in San Antonio, Texas, highlighted data showing tumor regression in four patients in the two arms, indicating that MP-470 may sensitize/re-sensitize tumors to the anticancer effects of SOC regimens of DNA-damaging agents. Of note, MP-470 did not increase the types or severity of adverse events. However, a primary endpoint of the trial - determining the maximum tolerated dose of MP-470 co-administered with SOC regimens - has not been reached and dose escalation continues.
"These compelling results strengthen the rationale for combining MP-470 with DNA-damaging agents due to MP-470's purported ability to suppress the Rad51 DNA repair mechanism, which is important in various malignancies," said Dr. Gregory Berk, SuperGen's Chief Medical Officer. "We look forward to presenting updated results on MP-470 in combination with these platinum doublets, as well as the other three standard of care arms of the trial in the future."
Earlier this year, U.S. Food and Drug Administration granted orphan drug designation for MP-470 in the treatment of glioblastoma multiforme (GBM) after non-clinical studies showed more than two-fold effect of increased cell death when used synergistically with ionizing radiation. Orphan drug designation for GBM, an often fatal form of brain cancer, can entitle SuperGen to seven years of market exclusivity. SuperGen's lead product candidate has also shown promise in preclinical testing across a wide spectrum of cancers, including non-small cell lung cancer.
Furthermore, SuperGen presented four additional posters at the Symposium that reviewed clinical and non-clinical advances of the compounds MP-470, SGI-1776 and SGI-1252. These include:
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
Copies of the 20th EORTC-NCI-AACR Symposium poster presentations will be available in the pipeline section of SuperGen's Web site http://www.supergen.com/.
Based in Dublin, Calif., SuperGen, Inc. is a pharmaceutical company dedicated to the discovery and development of novel cancer therapies. 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 news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements 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 and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability to discover, develop and move target compounds into clinical development and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q and 10-K. SuperGen, Inc. undertakes no duty to update any of these forward-looking statements to conform them to actual results.
Contacts: SuperGen, Inc. Dorland Global Public Relations Timothy L. Enns Michael Beckerich (Media) SVP, Corporate Communications Tel: (212) 677-7632 & Business Development [email protected] Tel: (925) 560-0100 Email: [email protected] Mary M. Vegh Manager, Investor Relations Tel: (925) 560-2845 E-mail: [email protected]
CONTACT: Timothy L. Enns, SVP, Corporate Communications & BusinessDevelopment, +1-925-560-0100, [email protected], or Mary M. Vegh, Manager,Investor Relations, +1-925-560-2845, [email protected], both of SuperGen,Inc.; or Media, Michael Beckerich of Dorland Global Public Relations forSuperGen, Inc., +1-212-677-7632, [email protected]
Web site: http://www.supergen.com/