Cleveland BioLabs is gearing up for the first trial of its Protectan anti-radiation sickness drug in advanced cancer patients at Roswell Park Cancer Institute, the Buffalo biotechnology company said Wednesday.
Roswell Park has approved a protocol for the trial, which will test the safety of Protectan and also examine how the drug moves into, through and out of the body, in tests with up to 48 patients with advanced cancer.
Cleveland BioLabs also has filed an investigational new drug application with the U.S. Food and Drug Administration to test Protectan on patients to determine how well they tolerate the drug and its maximum dosage in a long-term treatment plan.
Protectan was developed as a drug that could be used to reduce the harmful effects of radiation exposure, but it also has shown promise in cancer treatment.
Previous studies have shown positive signs that the drug could be helpful in treating cancerous tumors, especially in the liver, but also in the colon, as well as lung cancer and melanoma.
"This is a landmark event in our clinical program," said Andrei Gudkov, Cleveland BioLabs' chief scientific officer.
The trial is expected to yield information about how best to focus future trials, especially on patients taking multiple doses of the drug, said Dr. Michael Kurman, the company's chief medical officer.