May 26, 2021 -- The U.S. Food and Drug Administration (FDA) has given a Rutgers School of Dental Medicine researcher the green light to treat cancer patients with a new kind of therapy based on a protein produced by an oral bacterium.
Scott Kachlany, PhD, an associate professor of oral biology, discovered that a protein produced by an oral bacterium can kill leukemia and lymphoma cells. Specifically, the drug is a protein toxin that is secreted from Aggregatibacter actinomycetemcomitans. His company, Actinobac Biomed, can now initiate a phase I clinical trial in patients who have relapsed or refractory leukemia or lymphoma, Rutgers University said.
The experimental drug, Leukothera, rapidly kills cancer cells but does not compromise the immune system, according to Kachlany. Leukothera is also effective in treating autoimmune diseases in animals, which Actinobac is concurrently developing for that purpose.
Clinical trials will start with 24 patients but could be expanded to include an additional cohort of 20 or more if the response is positive, Kachlany said. The trial will take approximately two years to complete, and patients will receive Leukothera once a week for four weeks. Rutgers is one of three sites participating in the trial.