The latest study will assess Apristor’s safety plus pharmacological profile in patients, besides the biomarker analyses, for exploring the drug’s predictive response factors.

Context Therapeutics, a U.S.-based clinical stage biopharmaceutical company, has reportedly announced a Phase 2 trial for studying the safety and efficacy of Apristor^® (onapristone extended release) in patients with advanced gynecological tumors and are PgR+ (progesterone receptor positive). Context will conduct the study in close collaboration with the world-leading MSKCC (Memorial Sloan Kettering Cancer Center), whose MD, Rachel N. Grisham, is the Prime Investigator of the study.

According to reliable sources, the Phase 2 trial will be including patients with different PgR+ solid tumors at advanced stages, that include low grade serous ovarian cancer, granulosa cell tumor and endometrioid endometrial cancer, who have also sought prior chemotherapy treatment. Apristor will be evaluated in around 84 cancer patients, with the primary endpoint to be the ORR (overall response rate). Sources added that the secondary endpoints, for further characterizing Apristor’s activity, will include clinical benefit rate, response duration and PFS (progression-free survival). The preliminary trial results are expected by mid-2020.

Tarek Sahmoud, M.D., Ph.D., the Chief Medical Officer at Context Therapeutics, was quoted stating that there is availability of limited therapeutic options at present for treating these cancers within an advanced setting. Apristor is promising to help treat women with the PgR+ gynecological cancers, given the recent preclinical findings, along with the Phase 1 study outcomes. He went on to comment that Apristor has the potential to make an impactful difference for patients enrolled in the trial. 

For the record, Apristor is a new investigational drug – an orally administered, complete progesterone receptor antagonist. In the recent Phase 1 trial, the drug exhibited clinical benefits and was well tolerated in patients suffering from PgR+ ovarian, endometrial and breast cancer. As per preclinical data, Apristor’s anticancer activity helps block the activation of progesterone receptor signaling with mitogenic growth factors, inhibits mammosphere formation and downregulates gene signatures linked with cancer stem cell mobilization & metastasis.

Source Credits: https://www.businesswire.com/news/home/20190502005076/en/Context-Therapeutics-World-Renowned-Cancer-Center-Announce-Phase