Adamis Pharmaceuticals is seeking permission from federal regulators to begin testing APC-100, an experimental prostate cancer drug, on human patients for the first time, according to the San Diego Union-Tribune.
The Del Mar company’s Investigational New Drug application with the FDA seeks to recruit 30 men with castrate-resistant prostate cancer for a phase 1 trial. The testing will be conducted through the University of Wisconsin Carbone Cancer Center in Madison and Wayne State University’s Karmanos Cancer Institute in Detroit.
The oral drug, an organic molecule that was discovered by researchers at the Carbone center, is designed to block male hormones tied to prostate cancer in men who have become resistant to other hormone-blocking therapies.
In tests on mice with the disease, the drug worked 90% of the time in comparison to standard treatments that worked 55% of the time, the company said. The drug previously received a Rapid Access to Preventive Intervention Development grant from the National Cancer Institute.