New Haven-based Osmol Therapeutics has gotten approval from the U.S. Food and Drug Administration to begin its first human clinical trial of a drug aimed at preventing painful nerve damage in chemotherapy patients.
The drug, called OSM-0205, will be evaluated in healthy individuals for the prevention of a condition called Chemotherapy-induced Peripheral Neuropathy, or CIPN.
Osmol filed an Investigational New Drug application with the FDA for OSM-0205, which is based on the research of Yale School of Medicine professor Barbara Ehrlich, in August.
CIPN can involve symptoms such as numbness, tingling, pain and imbalance, with the latter increasing fall risk. Severe cases can result in trouble breathing, paralysis or organ failure, according to the American Cancer Society.
Chemotherapy treatments that destroy cancer cells based on microtubule disruption can produce an intracellular calcium surge that damages neurons, leading to CIPN, according to Osmol.
Dr. Arthur DeCillis, chief medical officer for Osmol, said OSM-0205 aims to prevent CIPN from happening. The drug is designed to be administered intravenously immediately before chemotherapy treatment starts.
“OSM-0205 has the potential to protect neurons in patients by preventing the surge in intracellular calcium associated with CIPN,” DeCillis said.
The Phase 1 human clinical trial will determine the drug’s safety, tolerability and impact on the body. Plans are to use the information gathered to select a dose to evaluate in Phase 2 clinical studies, which will involve breast cancer patients. Approximately 80% of breast cancer patients experience CIPN, according to the company.
