Morphotek initiates Phase II ovarian cancer study

The randomized, controlled trial will compare farletuzumab plus paclitaxel with a placebo plus paclitaxel. The primary objective of the study is to assess the efficacy of farletuzumab as determined by progression-free survival in patients with platinum-resistant (PR) ovarian cancer. Secondary objectives include safety and anti-tumor activity of farletuzumab as determined by objective response rate and overall survival.

The patient population includes individuals with ovarian cancer who have relapsed and are no longer sensitive to the frequently used platinum-containing chemotherapy. Morphotek expects to enroll up to 126 patients in this clinical study, which is being conducted at clinical centers in North America, South America and Europe.

The Phase II clinical trial is supported by safety data and clinical observations from a Phase I trial of farletuzumab in patients with PR ovarian cancer as well as data derived from preclinical models using PR ovarian tumor cells. Preclinical studies have shown that farletuzumab works with taxanes such as paclitaxel to suppress tumor growth.

Martin Phillips, chief medical officer of Morphotek, said: We are excited to have initiated this Phase II study of farletuzumab in platinum-resistant ovarian cancer. Physicians and patients do not have many good choices at this stage of ovarian cancer for treatment and we hope that farletuzumab will one day bring a benefit and hope to women with this disease.