SuperGen's MP-470 Demonstrates Clinical Benefit in Small Cell Lung Cancer and Neuroendocrine Tumor Patients
DUBLIN, Calif.--(BUSINESS WIRE)--Aug 3, 2009 - SuperGen Inc., (NASDAQ: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that preliminary results from Phase Ib data of MP-470, its multi-targeted, tyrosine kinase inhibitor and RAD51 suppressor, demonstrated an overall clinical benefit rate of 54 percent when the drug is given in combination with standard of care (SOC) carboplatin containing doublet chemotherapy in patients with small cell lung cancer (SCLC) and neuroendocrine malignancies (NE). The data was presented on August 2, at the International Association for the Study of Lung Cancer (IASLC), 13th World Conference on Lung Cancer in San Francisco, CA.
The Phase I dose titration study enrolled four patients with SCLC and nine patients with NE as of February 28, 2009. As measured by the Response Evaluation Criteria in Solid Tumors (RECIST), five of thirteen patients achieved a confirmed partial response and two additional patients demonstrated stable disease greater than twelve weeks for an overall clinical benefit rate of 7/13 patients or 54% (95% CI, 25% - 81%). There were no clinically significant adverse events attributable to the addition of MP-470 to SOC. “We continue to be encouraged by the clinical data resulting from our MP-470 trials and the potential benefit of its addition to standard of care treatment regimens,” said Mohammad Azab, MD, SuperGen's Chief Medical Officer. “We are looking forward to completing enrollment and analysis of the full data set from this trial to guide our partnering discussions and future Phase II clinical development efforts for this promising novel agent.”
About the Study
The primary objectives were to estimate the maximum tolerated dose (MTD) in combination with SOC regimens, as well as define safety profiles of specific MP-470 combinations. Secondary objectives included estimating the therapeutic response rate (RECIST), and defining the effect of MP-470 on the pharmacokinetic profile of SOC. MP-470 is administered in combination with SOC regimens in a 21-day cycle. Adults with ECOG PS of 0–2 and malignant disease appropriate for the SOC regimens consisting of carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, and erlotinib were enrolled. Each arm follows a 3+3 design in which MP-470 is escalated based on the modified Fibonacci sequence until the MTDs and dose limiting toxicities (DLTs) in combination with SOC are determined. MP-470 doses were started at 100 mg orally once per day. The MTDs and DLTs have not been reached.
A copy of the IASLC, 13th World Conference on Lung Cancer MP-470 poster is available in the pipeline section of SuperGen's website, www.supergen.com.
Based in Dublin, California, SuperGen 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," "anticipates," "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, our 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.
Posted: August 2009