SuperGen interim results of Orathecin trial show six-month median survival rate in pancreatic cancer

By Lisa Kerner

Erie, Pa., April 26 - SuperGen, Inc. said it completed the pre-specified interim analysis of its a topoisomerase I inhibitor, Orathecin (rubitecan) capsules in a phase 2 clinical study of Orathecin plus gemcitabine as first-line combination therapy for 39 patients with advanced pancreatic cancer patients who have not undergone chemotherapy.

In the multi-center trial, patients received 1,000 mg/m2 gemcitabine every week for three out of four weeks with concurrent 1.5 mg/m2 Orathecin given daily for five of the seven days each week. The cycle was repeated every four weeks until progression or patient withdrawal, according to a company news release.

Interim analysis, conducted after half of the patients had died, resulted in an estimated median survival of six months, with a Kaplan-Meier one-year survival to be 27%.

SuperGen said the study did not meet the pre-specified threshold for median survival in order to proceed to a phase 3 randomized study.

The safety profile was similar to prior studies of Orathecin as a single agent or in combination with gemcitabine.

While SuperGen closed enrollment, the study will remain open for patient follow-up.

"We are working with our clinical advisors, investigators and potential partners to evaluate the best options for Orathecin that will maximize this product's potential to help patients in need and realize its commercial value for our stockholders," president and chief executive officer James S. Manuso said in a news release.

Located in Dublin, Calif., SuperGen develops therapies for solid tumors, hematological malignancies and blood disorders.

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