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SuperGen will initiate a Phase I clinical trial to evaluate the safety,tolerability and pharmacokinetic profile of SGI-1776, a novel, orallyadministered, small molecule anticancer compound. The first in human clinicaltrial program will enroll patients with solid tumors with specific emphasis onhormone refractory prostate cancer and refractory non-Hodgkin's lymphomas.These solid tumor types have been reported to overexpress the Pim kinasefamily of proteins at a high frequency. Overexpression of Pim-1 kinase hasbeen shown to be a marker of poor prognosis in these tumors. A second PhaseI/II study is being planned in patients with refractory leukemias in which Pimkinases are also overexpressed, and correlated with poor prognosis and drugresistance.
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"We are pleased to acknowledge FDA's clearance of our IND application toenter what we believe is the world's first investigational product targeted toinhibit PIM kinases into Phase I clinical trials," said Dr. James Manuso,SuperGen's President and Chief Executive Officer. "The clearance of theSGI-1776 IND application represents a validation of our Company's CLIMB(TM)technology platform and its ability to generate first-in-class drugcandidates. We look forward to rapidly advancing the development of thisnovel drug in the years ahead."
"Pim kinases mediate a variety of critical cellular processes in cancer,making it an important target for cancer therapeutics," said Greg Berk, MD,SuperGen's Chief Medical Officer. "Inhibition of Pim kinases thus represents anovel therapeutic approach and we believe SGI-1776 represents a first-in-classagent."
Treatment with SGI-1776 produces significant tumor regressions in animalmodels of acute myeloid leukemia and suppression of solid tumor growth andbiomarker modulation in models of prostate adenocarcinoma and non-Hodgkin'slymphoma. In non-clinical studies, SGI-1776 has shown good oralbioavailability and sustained inhibition of Pim kinase targets in vivofollowing both single and repeated oral dosing.
About Pim as a Target
The three Pim kinases (Pim-1, Pim-2 and Pim-3) are highly conservedserine-threonine kinases that are key regulators in many signaling pathwaysimplicated in cancer. Pim kinases can induce progression of the cell cycle,inhibition of apoptosis, and modulation of other signal transduction pathways.Transformation of Pim kinase in conjunction with other oncogenes is thought tocontribute to malignancies including Burkitt's lymphoma, prostate cancer,diffuse large cell lymphoma, as well as several types of human leukemias.
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,""anticipates," "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, whether and when the first patients will be enrolled in the trial,the overall success of the Phase I trial protocol for SGI-1776, our ability todiscover, develop and move target compounds into clinical development andother risks and uncertainties detailed from time to time in the company'sfilings with the Securities and Exchange Commission including its mostrecently filed Form 10-Q and 10-K. SuperGen, Inc. undertakes no duty to updateany of these forward-looking statements to conform them to actual results.Contacts Timothy L. Enns SuperGen, Inc. SVP, Corporate Communications & Business Development Tel: (925) 560-2810 E-mail: [email protected]
SOURCE SuperGen, Inc.
