MONTREAL, Dec. 12 /PRNewswire/ - BioAxone Therapeutic Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status to its drug candidate Cethrin(R), which is currently in a phase I/IIa clinical trial for patients with acute thoracic and cervical spinal cord injuries.
"The Orphan Drug Status, granted for rare diseases afflicting less than 200,000 patients per year in the U.S., provides BioAxone with considerable strategic advantages for accelerating the development of its lead drug candidate Cethrin(R) by extending its patent protection, reducing clinical development costs and facilitating regulatory filings in other countries" said Dr. Frank Bobe, President and Chief Executive Officer of BioAxone. "Recruitment for our phase I/IIa trial is on schedule and completion is expected by June of 2006".
There is currently no effective treatment for acute spinal cord injury, a condition that can lead to complete and permanent loss of sensory and motor functions and require life-long specialized care for the vast majority of patients. In addition to creating significant health care costs, spinal cord injury has a dramatic impact on the quality of life of patients and those who care for them. At BioAxone, in vitro as well as in vivo studies have demonstrated the neuro-protective and neuro-regenerative properties of Cethrin(R), underscoring the potential benefits of this treatment for patients with acute spinal cord injury.
BioAxone Therapeutic Inc. is a privately owned neuroscience company specializing in the development and commercialization of proprietary technologies that target Rho GTPase signaling.
BioAxone is a product-driven company, with one product currently in clinical development for the treatment of acute spinal cord injury and several candidate products in preclinical phase for the treatment of macular degeneration and glaucoma. The Company has proven expertise in recombinant protein drug development and has a focused small molecule program. BioAxone was established in April 2000 and is headquartered in Montreal, Canada.
BIOAXONE THERAPEUTIC INC.
CONTACT: Dr Frank Bobe, President and CEO, BioAxone Therapeutic Inc.,(514) 282-9990, firstname.lastname@example.org; www.bioaxone.com