Swiss-based biopharmaceutical company Debiopharm has begun the clinical Phase II trial to evaluate the company’s inhibitor of apoptosis proteins (IAP) inhibitor, Debio 1143, to treat epithelial ovarian cancer (EOC).
The trial will assess the efficacy of Debio 1143, which is administered in combination with Carboplatin and Paclitaxel in a neo-adjuvant setting compared to chemotherapy alone.
Following the positive results of the therapy exhibited in the clinical Phase I (NCT01930292), this trial intends to showcase the chemosensitiser effect of the compound in a double-blind design and identify biomarkers to be used for patients’ stratification in pivotal studies.
The study will also assess the safety and tolerability of Debio 1143 based on the conventional endpoints.
Debiopharm international clinical research and development vice-president Dr Nigel McCracken said: "We are pleased to announce the start of this second phase II trial with Debio 1143 shortly after establishing the recommended dose and encouraging observations for the utility of Debio 1143 in EOC.
"It is another illustration of Debiopharm’s commitment to improve treatment outcomes for patients suffering from severely debilitating and life threatening conditions."
Debio 1143 is an oral, small molecule inhibiting IAPs operating on a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo / radio-sensitiser in oncology.
Debiopharm is exploring options to extend the application of the therapy to patients with ovarian cancer.
Image: CT scan displaying ovarian cancer. Photo: courtesy of James Heilman, MD.