US FDA allows Ph II for Sound's hearing loss drug

Sound Pharmaceuticals has received US Food and Drug Administration notification that it may proceed with its Phase II study to prevent chemotherapy-induced hearing loss. The trial will enroll 80 patients with advanced head and neck, and non-small cell lung cancer at the National Center for Rehabilitative Auditory Research at the Veterans Administration Hospital and the Oregon Health and Science University in Portland, Oregon.

Hearing loss due to ototoxic medications such as chemotherapy, antibiotics or loop diuretics often results in permanent and progressive disability. Furthermore, the combined use of these ototoxic agents is contraindicated, often limiting their clinical utility.

In several preclinical studies, Sound has shown that its novel chemoprotectant drug, a small-molecule that mimics and induces Glutathione peroxidase activity, was critical in preventing ototoxicity while not interfering with the chemotherapy treatment. In one rodent model of cancer, the chemoprotectant enhanced the tumoricidal activity of cisplatin.