Esperance initiates enrollment in EP-100 and paclitaxel Phase 2 combination trial for ovarian cancer

Esperance Pharmaceuticals today announced that it has begun enrollment of a Phase 2, randomized, multi-center trial of EP-100 in combination with paclitaxel for the potential treatment of advanced ovarian cancer. EP-100 is a targeted membrane-disrupting peptide (tMDP) designed to seek and destroy cancer cells that over-express luteinizing hormone releasing hormone (LHRH) receptors on their surfaces. LHRH receptors are over-expressed in a wide range of cancers including ovarian cancer. The Phase 2 study design is based on the recent successful completion of a Phase 1 study of EP-100 in advanced solid tumors, the results of which will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June this year.

"Based on our successful Phase 1 study and results of preclinical studies, we believe there is a compelling rationale for the study of EP-100 in ovarian cancer -- which is known to over express LHRH receptors," said Hector Alila, PhD, Chief Executive Officer of Esperance. "We are hopeful EP-100 may hold promise for this patient population with very few treatment options."

The EP-100 phase 2 study is enrolling five to eight patients in a run-in to confirm the maximum safe dose of EP-100 to be combined with paclitaxel. The randomized study will then enroll 40 patients randomized in a 1:1 ratio to receive either the standard weekly dose of 80 mg/m(2) paclitaxel or the same regimen of paclitaxel plus twice weekly EP-100 for 3 of 4 weeks during each of six cycles. The primary outcome of the study will be objective response rate and secondary outcome measures include quality and duration of response, time to progression and follow-up for survival as well as the safety of this new doublet regimen. Details of the trial are provided on clinicaltrials.gov, NCT 01485848.

SOURCE Esperance Pharmaceuticals