SAN FRANCISCO, Aug. 7, 2012 -- Nektar Therapeutics (NASDAQ: NKTR) announced today the start of a Phase 2 study of etirinotecan pegol in patients with bevacizumab (Avastin)-resistant high-grade glioma being conducted at Stanford Cancer Institute. The Phase 2 study is an investigator-sponsored trial being conducted under the direction ofLawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigators Seema Nagpal, M.D. and Pamela Kunz, M.D.
"Patients with bevacizumab-resistant high-grade glioma currently have little to no treatment options to help them manage their disease," said Dr. Recht. "We know that the mechanism of topoisomerase I inhibition has resulted in anti-tumor activity in gliomas in the past. As a result, we are interested in evaluating etirinotecan pegol, this new targeted topoisomerase I inhibitor, which provides sustained exposure of drug metabolite to tumor cells."
The primary endpoint of the Phase 2 study is the six-week progression free survival (PFS) rate. Secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date of pathologic diagnosis or confirmation of high-grade glioma, and the safety profile of etirinotecan pegol in patients with bevacizumab-resistant high-grade glioma. The open label, single-arm trial is expected to enroll approximately 20 patients who will receive etirinotecan pegol once every three weeks as monotherapy.
"Etirinotecan pegol has demonstrated promising results in drug-resistant solid tumors, such as advanced and heavily pre-treated breast and ovarian cancers," said Robert Medve, M.D., Senior Vice President and Chief Medical Officer of Nektar Therapeutics. "Recognizing the high unmet need in glioma, we are very pleased to support Dr. Recht and his colleagues with this study of single-agent etirinotecan pegol in this setting."
PR Newswire