FDA OKs Phase 2 Trial Evaluating 2X-121 in Advanced Ovarian Cancer Patients

FDA OKs Phase 2 Trial Evaluating 2X-121 in Advanced Ovarian Cancer Patients
The U.S. Food and Drug Administration has green-lighted a Phase 2 clinical trial that will assess the safety and effectiveness of the small molecule 2X-121 in advanced ovarian cancer patients, Oncology Venture has announced. The trial will also use the 2x-121 Drug Response Predictor biomarker to identify patients likely to respond to and benefit from treatment with 2X-121. The 2x-121 Drug Response Predictor is a screening platform that uses gene expression (protein production) signatures from patient biopsies to identify their likelihood of responding to or resisting specific cancer-fighting therapies. The platform is able to screen over 400 genes. 2X-121 inhibits several members of the Poly(ADP-Ribose) Polymerase (PARP) enzymes, key factors involved in DNA damage repair in cancer cells. PARPs act as DNA damage sensors, binding to the sites of DNA damage and leading to its repair. Cancer cells rely on PARPs to survive and proliferate. 2x-121 targets the PARP-1 and PARP-2 members, as well as the tankyrases (TNKS1 and TNKS2), also members of the PARP family. The Phase 2 trial will take place in the U.S. and Germany and expects to recruit up to 30 advanced ovarian cancer patients. The participants will receive 2X-121, administered orally as a daily 600 mg dose. Treatment will continue until signs of disease progression. The study's primary objective (its endpoint) is to assess patients' response to the therapy, both complete remission or partial responses. Other measures of the therapy’s effectiveness and safety parameters will also be evaluated. In a previous Phase 1 trial (NCT01618136) evalu
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