SuperGen wins clearance to initiate Phase I cancer trial

SuperGen will initiate a Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic profile of SGI-1776, an 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.

The clearance of its original investigational new drug application (IND) triggers a $5.2 million milestone payment to the former stockholders of Montigen Pharmaceuticals. 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.

Treatment with SGI-1776 produces significant tumor regressions in animal models of acute myeloid leukemia and suppression of solid tumor growth and biomarker modulation in models of prostate adenocarcinoma and non-Hodgkin’s lymphoma, the company said.

James Manuso, SuperGen’s president and CEO, said: “The clearance of the SGI-1776 IND represents a validation of our company’s Climb technology platform and its ability to generate first-in-class drug candidates. We look forward to rapidly advancing the development of this novel drug in the years ahead.”