The designation applies to a Phase II trial with the University of Texas MD Anderson Cancer Center and a Phase III trial in patients whose disease has progressed after treatment with temozolomide and bevacizumab.
“The Fast Track designation marks an important milestone in the development of VAL-083 as a potential new therapy for cancer patients with limited or no treatment options,” interim CEO Saiid Zarrabian said in prepared remarks. “We appreciate the FDA’s recognition that the VAL-083 program addresses a significant unmet need in rGBM as we continue to evaluate this agent in patients with multiple tumor types.”
“Our ongoing VAL-083 clinical development program is supported by extensive preclinical research into the agent’s unique mechanism of action, as well as promising data from prior clinical trials sponsored by DelMar and the National Cancer Institute,” Zarrabian added. “We are enthusiastic about the potential of VAL-083 to offer a meaningful clinical benefit to patients with rGBM and for the opportunity to expedite the regulatory process through the FDA’s Fast Track program.”