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 (NCT03281681).
“The development of new treatments to overcome platinum resistance represents the largest unmet medical need in the treatment of ovarian cancer,” said Bradley J. Monk, MD, principal investigator of the trial and director of the Division of Gynecologic Oncology Research at Arizona Oncology. “Based on DelMar’s recent presentation of pre-clinical data demonstrating activity of VAL-083 against platinum-resistant ovarian cancer, we are enthusiastic about exploring the drug’s potential in this important clinical setting.”
The Phase 1 part of the trial is expected to include 24 participants with recurrent adenocarcinoma of the ovary, who have received at least two prior platinum-based chemotherapy regimens. All participants will receive intravenous VAL-083 once per week for up to 16 weeks or until disease progression.
The company expects to have interim results of the Phase 1 part within 18 to 24 months from treatment initiation. These results are expected to support expansion of the study into its planned Phase 2.
VAL-083’s effectiveness will be measured based on overall response rates, response duration, progression-free survival, and levels of the cancer biomarker CA-125.
“Based on our research, we believe that the REPROVe Trial has the potential to provide significantly improved outcomes for patients suffering from platinum-resistant ovarian cancer,” Bacha said.