DUBLIN, Calif., Nov. 20 /PRNewswire-FirstCall/ -- SuperGen, Inc. (Nasdaq: SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that it has received clearance to initiate clinical trials with SGI-1776, an inhibitor of Pim kinases. The clearance of its Original Investigational New Drug Application ("IND") triggers a $5.2 million milestone payment to the former stockholders of Montigen Pharmaceuticals, Inc. The milestone payment will consist of $2.8 million in cash payments and the issuance of approximately $2.4 million in equity, representing approximately 1.5 million shares of SuperGen common stock.
SuperGen will initiate a Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of SGI-1776, a novel, orally administered, small molecule anticancer compound. The first in human clinical trial program will enroll patients with solid tumors with specific emphasis on hormone refractory prostate cancer and refractory non-Hodgkin's lymphomas. These solid tumor types have been reported to overexpress the Pim kinase family of proteins at a high frequency. Overexpression of Pim-1 kinase has been shown to be a marker of poor prognosis in these tumors. A second Phase I/II study is being planned in patients with refractory leukemias in which Pim kinases are also overexpressed, and correlated with poor prognosis and drug resistance.
"We are pleased to acknowledge FDA's clearance of our IND application to
enter what we believe is the world's first investigational product targeted to
inhibit PIM kinases into Phase I clinical trials," said Dr. James Manuso,
SuperGen's President and Chief Executive Officer. "The clearance of the
SGI-1776 IND application represents a validation of our Company's CLIMB(TM)
technology platform and its ability to
|SOURCE SuperGen, Inc.|
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