VANCOUVER, Nov. 5, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) today announced its unaudited operating results for the three and nine-month periods ended September 30, 2012. Allon also reported that it is on track to advance toward commercialization of its lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease.
Gordon McCauley, President and CEO of Allon Therapeutics, said the quarter's progress has kept the company on track to meet its schedule of completing patient treatment as well as analysis and release of top-line data before the end of 2012 for the multinational phase 2/3 pivotal clinical trial that is evaluating davunetide in more than 300 PSP patients.
"Our shareholders stand with thousands of patients, caregivers, families, and health professionals in search of a treatment for this debilitating and fatal disease," McCauley said.
Allon estimates the market potential for the first approved treatment for PSP will exceed $700 million in the U.S. and Europe. PSP affects approximately 25,000 people in the United States and 40,000 people in the European Union. Patients are typically diagnosed when they are between 45 and 65 years of age.Allon's pivotal trial is proceeding under a Special Protocol Assessment with the U.S. Food and Drug Administration. This multi-national study is being conducted in the United States, Canada, the United Kingdom, France, Germany and Australia. The trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data. PSP is considered a tauopathy, involving the tau protein in brain cells. Allon has previously demonstrated, in both preclinical and clinical studies, that davunetide has an impact on the tau pathology. The current evaluation of davunetide in a pivotal clinical trial as a potential treatment for PSP makes it the most advanced tau therapy in the world.