Newswise – A company founded by Scott Kachlany, a researcher at the Rutgers School of Dental Medicine, has received US Food and Drug Administration (FDA) approval to treat cancer patients with therapy based on Kachlany’s discovery according to which a protein produced by oral bacteria can kill leukemia and lymphoma cells.
The approval paves the way for Kachlany’s company, Actinobac Biomed, to launch a Phase I clinical trial in patients with relapsed or refractory leukemia or lymphoma. Their investigational drug, Leukothera, has further been shown to be effective in the treatment of autoimmune diseases in animals, and Actinobac is also developing its use for this purpose.
Unlike many cancer treatments, Leukothera quickly kills cancer cells but does not compromise the immune system. âDoctors and patients often have to trade efficacy for safety. However, we hope to provide patients with a treatment option that has both a robust safety profile and efficacy, âsaid Kachlany, professor in the department of oral biology at the dental school and chief scientist at Actinobac.
Clinical trials for Leukothera will begin with 24 patients but could be expanded to include an additional cohort of 20 or more patients if the response is positive, said Kachlany, who has been working on the treatment for nearly a decade. Since patients will be receiving Leukothera for a short period of once a week for four weeks, he expects to collect data quickly. If Leukothera is effective, with little or no negative side effects, patients can continue with “compassion” treatment, Kachlany said.
The first phase of testing, which will last around two years, will focus primarily on security. The trial will be conducted at three sites, including the Rutgers Cancer Institute in New Jersey. In the near future, Actionobac may also start testing Leukothera in patients with other diseases such as inflammatory bowel disease, Kachlany said.
Actinobac was funded by the NIH, the New Jersey Health Foundation, and Kairos Ventures.