NCS1

Company plans to initiate clinical program in mid-2024, followed by a Phase 2 study for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancerNEW HAVEN, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that it has appointed Ron Weitzman, M.D., as interim Chief Medical Officer, replacing Arthur DeCillis, M.D., who is joining Osmol’s Scientific Advisory Board. “We are pleased to welcome Ron, with his significant oncology drug development expertise, to the Osmol team,” said Bob Linke, MBA, President and CEO of Osmol Therapeutics. “His medical leadership will be invaluable as we advance OSM-0205 into the clinic based on recent U.S. and German regulatory authority feedback on our development program, including clinical plans, nonclinical studies and manufacturing to support the Phase 2 studies.” “We would also like to express our sincere gratitude to Art for his many contributions during the early stages of development for OSM-0205 and look forward to continuing to work together as he joins Osmol’s Scientific Advisory Board,” concluded Linke. “I look forward to working with the Osmol team to guide the clinical development of OSM-0205 for the treatment of chemotherapy-induced peripheral neuropathy and chemotherapy-induced cognitive impairment, debilitating conditions with no approved treatment options,” said Dr. Weitzman. Ron Weitzman, M.D., has held leadership roles at various global biopharmaceutical companies, including Tango Therapeutics, Exelixis, Genentech and Novartis. Most recently he served as Chief Medical Officer at Tango Therapeutics, where he oversaw development of multiple oncology drugs, including three Investigational New Drug (IND) applications, while leading the clinical and clinical operations teams. Prior to Tango, Dr. Weitzman served as Vice President of Clinical Development at Exelixis, where he had overall responsibility for the strategy and execution of the clinical plan for cabozantinib, a drug therapy for prostate cancer. Dr Weitzman is board-certified by the American Board of Internal Medicine in Medical Oncology. About OSM-0205 Osmol’s lead therapeutic candidate, OSM-0205, is based on the research of Barbara Ehrlich, PhD, in neuronal calcium sensor-1 (NCS1) at Yale School of Medicine, which is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from non-clinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents the pathologic damage caused by these chemotherapy agents. About Osmol Therapeutics Osmol Therapeutics is a privately held, clinical stage biopharma company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy and chemotherapy-induced cognitive impairment based on the ground-breaking work of Barbara Ehrlich, PhD, Professor of Pharmacology, Yale School of Medicine, and Chief Scientific Officer, Osmol Therapeutics. The company’s lead indication will be for the prevention of CIPN related to taxane treatment. As an example of the extent of this condition, up to 80% of taxane-treated patients with breast cancer have been reported to experience CIPN. For more information, please visit https://osmoltherapeutics.com/. Contact: Gina Nugentgina@nugentcommunications.com

Up to 80% of taxane treated breast cancer patients are diagnosed with some degree of CIPN Currently there are no FDA-approved treatments for CIPN NEW HAVEN, Conn.--(BUSINESS WIRE)-- Osmol Therapeutics, a privately held biopharmaceutical company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy (CIPN), today announced that the U.S. Food and Drug Administration (FDA) notified the company that the first-in-human clinical trial of OSM-0205 in healthy subjects for the prevention of CIPN may proceed. Osmol filed the Investigational New Drug application (IND) with the FDA for OSM-0205 in August 2023. Microtubule-based chemotherapy treatments, which destroy cancer cells based on microtubule disruption, produces an intracellular calcium surge that damages neurons, leading to CIPN. Each year, approximately 360,000 cancer patients in the U.S. and E.U. are treated with taxanes most commonly for the treatment of breast cancer but also for prostate cancer as well as other malignant solid tumors. Approximately 80% of breast cancer patients experience some degree of CIPN. Currently there are no FDA-approved treatments for CIPN, and the only way to mitigate the effect of this painful and often debilitating condition is by interrupting treatment or reducing the dosage of chemotherapy, which can adversely impact patient outcomes. “Preventing CIPN would address a major women’s health issue for which there are currently no FDA-approved disease modifying treatment options,” said Arthur DeCillis, MD, Chief Medical Officer, Osmol Therapeutics. “OSM-0205 is administered intravenously immediately prior to chemotherapy treatment and has the potential to protect neurons in patients by preventing the surge in intracellular calcium associated with CIPN. This first-in-human Phase 1 clinical trial in healthy subjects will determine the safety, tolerability, and pharmacokinetics of single ascending doses of OSM-0205 intravenous infusion to select a dose to evaluate in Phase 2 clinical studies in breast cancer patients.” About OSM-0205 Osmol’s lead drug, OSM-0205, is based on Dr. Barbara Ehrlich’s research in neuronal calcium sensor-1 (NCS1) at Yale School of Medicine and is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from preclinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents the pathologic damage caused by these chemotherapy agents. About Osmol Therapeutics Osmol Therapeutics is a privately held, clinical stage biopharma company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy (CIPN) based on the ground-breaking work of Dr. Barbara Ehrlich. The company’s lead indication will be for the prevention of CIPN related to taxane treatment. As an example of the extent of this condition, up to 80% of taxane-treated patients with breast cancer have been reported to experience CIPN. For more information, please go to .