DelMar Announces VAL-083 Clinical Trials Will Soon Start for Recurrent Ovarian Cancer

DelMar Announces VAL-083 Clinical Trials Will Soon Start for Recurrent Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has approved DelMar Pharmaceuticals’ investigational new drug (IND) application for VAL-083 for the treatment of ovarian cancer. The IND approval allows the company to start clinical development of its lead drug candidate. A Phase 1/2 trial is set to begin patient enrollment in early 2018, depending on the availability of funding. "The opening of this new IND to study VAL-083 in ovarian cancer marks a major milestone for our company as we continue to investigate this agent as an important potential therapy for the treatment of multiple cancers," Jeffrey Bacha, DelMar's president and CEO, said in a press release. VAL-083, also known as dianhydrogalactitol, is a small-molecule chemotherapeutic agent that targets the DNA of cancer cells, promoting their death. VAL-083's unique mechanism of action has the potential to overcome treatment resistance, representing a possible new treatment option for cancer patients. Its anti-tumor activity was demonstrated in 42 Phase 1 and Phase 2 clinical trials sponsored by the U.S. National Cancer Institute. Clinical data collected from these studies have supported further evaluation of VAL-083 as a treatment for ovarian cancer and other gynecologic malignancies. DelMar now will evaluate the effectiveness, safety, and tolerability of its drug candidate in the multicenter, VAL-083 REPROVe Trial (
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