Presentation will provide a summary of data from the recent clinical study with BIO 300 in non-small cell lung cancer patients to mitigate radiotherapy toxicity


MINNEAPOLIS, MN — Humanetics Corporation (Humanetics) today announced that an abstract reporting the results of a clinical trial of BIO 300 in non-small cell lung cancer patients undergoing radiochemotherapy has been selected for oral presentation at the annual meeting of the American Society for Radiation Oncology, taking place virtually from October 25-28, 2020. More than 3,300 abstracts were submitted to the premier international radiation oncology annual meeting, and Humanetics’s abstract was one of only 280 selected for this highest level of oral presentation.

Dr. Charles B. Simone, II, MD, FACRO, Research Professor and Chief Medical Officer for the New York Proton Center, will be the presenting author of the multi-site phase 1b/2a study. The trial investigated the safety and efficacy of BIO 300, a novel drug candidate focused on mitigating toxicities to normal tissues commonly experienced by patients from radiotherapy.

Lung cancer is the most common cause of cancer-related deaths in the United States and affects nearly 230,000 individuals per year. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, comprising approximately 87% of all cases. A common treatment for NSCLC is radiotherapy, which is often accompanied by chemotherapy, particularly for stage II, III and limited-extent IV disease. However, radiation therapy can cause unwanted side effects to otherwise healthy tissue surrounding the tumor or in the path of the radiation beam. These effects include esophagitis, pulmonary pneumonitis and fibrosis, all of which limit patient quality of life, can contribute to lasting health problems, and, in severe cases, can be fatal.

“Drugs that can reduce or prevent the unwanted side effects of radiotherapy are a truly unmet need for patients,” said Dr. Simone. “Radiotherapy is an important standard of care, and its use is forecast to grow. Drugs like BIO 300 have the potential to significantly improve the quality of life and outcomes for our patients.” Dr. Simone served as one of the principal investigators for the BIO 300 clinical trial.

BIO 300 is an oral medication, taken once daily by patients prior to their radiation treatment. Its properties as a radioprotectant were discovered by researchers at the U.S. Department of Defense, where it was studied as a potential agent to be used by warfighters to prevent injury from radiation on the battlefield. Humanetics acquired the rights to the drug and has active development programs ongoing in both oncology and for biodefense.