DelMar Receives IND Allowance from FDA to Initiate Clinical Trials of VAL-083

DelMar Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has allowed an additional Investigational New Drug Application (IND) to study its lead drug candidate VAL-083 as a potential treatment for ovarian cancer.

"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," said Jeffrey Bacha, DelMar's president and chief executive officer.

VAL-083 is a first-in-class, DNA targeting agent that demonstrated clinical activity against a range of tumor-types in prior clinical trials sponsored by the U. S. National Cancer Institute (NCI). Published results from NCI studies include recommendations for further study of VAL-083 in advanced clinical trials for ovarian cancer and other gynecologic malignancies.

DelMar's clinical trial will be a multi-center, Phase 1/2 Study of VAL-083 in patients with Recurrent Platinum Resistant Ovarian Cancer (VAL-083 REPROVe Trial). DelMar's research demonstrates that VAL-083's unique mechanism of action has the potential to overcome chemo-resistance to platinum-based chemotherapy in ovarian, lung and other solid tumors.

Ovarian cancer remains the leading cause of death among women with gynecological cancers and the fifth most frequent cause of cancer deaths in women overall. The American Cancer Society estimates that in 2017, approximately 22,440 women in the US will be diagnosed with ovarian cancer and approximately 14,080 will die from their disease. The majority of these deaths were patients whose tumors had become resistant to platinum-based chemotherapy regimens. Currently, there are no high-efficacy therapeutic options for platinum-resistant ovarian cancer, leaving these cancer patients with very poor prognosis. According to published literature, the overall response rate ("ORR") to second line therapy is in the 10-15% range and overall survival is approximately 12-months.

The VAL-083 REPROVe Trial is an open label, multi-center, Phase 1/2 clinical trial to evaluate the safety and efficacy of VAL-083 in patients with recurrent adenocarcinoma of the ovary, who have been previously treated with a minimum of two courses of platinum-based chemotherapy, and whose cancer has recurred within six months of the most recent platinum-based chemotherapy. Patients enrolled in the trial will receive VAL-083 intravenously once per week for 16 weeks or until disease progression.

VAL-083 activity against platinum-resistant ovarian cancer will be measured based on ORR using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria as well as response duration, progression free survival, and a measurement of CA-125 biomarker levels in the blood. The study's primary endpoint is to demonstrate an ORR benefit compared to historical control of 12-15%.

Twenty-four patients will be enrolled under the first phase of the VAL-083 REPROVe Trial with top line results expected within 18-24 months from trial initiation of patient treatment. DelMar plans to request a meeting with the FDA following the completion of Phase 1. If successful, DelMar expects that data from Phase 1 will lead to a Phase 2 expansion study.  If Phase 2 is successful, and subject to FDA feedback, DelMar may be positioned to file an application for accelerated approval or, alternatively, to advance VAL-083 to a pivotal Phase 3 trial.