HOPKINTON, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Boston Life Sciences, Inc. (Nasdaq: BLSI - News), a biotechnology company focused on diagnostic and therapeutic products for central nervous system disorders, announced today that it has entered into an exclusive, worldwide license with BioAxone Therapeutic Inc. of Montreal, Canada, to develop and commercialize Cethrin as well as other specified compounds subject to the license to treat acute spinal cord injury (SCI) and other serious central nervous system disorders. The license provides for an up-front license fee, possible performance milestones, and on-going royalties based on sales of Cethrin after approval.
Cethrin was designed to specifically target the cellular response to an acute SCI, promote the re-growth of injured axons, and restore sensory and motor function. Research in animal models has shown that re-growth of injured axons after an SCI restores motor and sensory function. In November 2006, BioAxone reported interim results from a Phase I/IIa clinical trial of Cethrin in acute spinal cord injury patients indicating drug safety, tolerability and the potential to promote recovery of motor function and sensation.
"The licensing of Cethrin enables us to continue toward our goal of transforming BLSI into a CNS-focused therapeutics company. We believe Cethrin, if approved, could also be great news for the thousands of people who suffer devastating spinal cord injuries every year," said BLSI Chairman and Chief Executive Officer, Peter Savas. "Our primary technology focus is on stimulating the growth of nerve axons to help restore sensory and motor function after severe nerve damage such as that which occurs in spinal cord injury, stroke or ocular injury. This license represents another successful step in our strategy to assemble, develop and commercialize compelling axon regeneration technologies. In May 2006, we announced that we had extended our portfolio of intellectual property related to axon-regeneration through an agreement with Children's Hospital Boston for technologies under development in the labs of Drs. Larry Benowitz and Zhigang He. We believe that the license for Cethrin and the licenses with Children's Hospital Boston position BLSI as a potential leader in the pursuit of effective therapies to reverse the effects of traumatic central nervous system injuries and provide us with what we believe is one of the broadest sets of technologies in the industry for achieving this aim."
"After conducting an exhaustive worldwide search of CNS candidates, we are very enthusiastic about the licensing of Cethrin because we believe it adds considerable tactical and strategic value to our new product pipeline and intellectual property estate," commented Mark Pykett, President and Chief Operating Officer. "Cethrin is a clinical stage compound supported by what we believe are compelling pre-clinical data, encouraging early clinical trial results and Orphan Drug designation. If successfully developed and approved, Cethrin could address a significant unmet medical need in acute spinal cord injury."
Cethrin is a recombinant protein drug intended to facilitate the re-growth of axons during the critical period immediately after a major injury to the spinal cord. Following an SCI, about two-thirds of patients undergo decompression/stabilization surgery. In this surgery, Cethrin is delivered in a single dose directly onto the dura mater of the injured region of the spinal cord without the need for further invasive procedures. Positive interim results from a Phase I/IIa clinical trial with Cethrin were recently reported. The primary endpoint of the open-label trial was to demonstrate the safety and tolerability of Cethrin in patients who have suffered a complete cervical or thoracic spinal cord injury. A total of 37 patients was enrolled at nine centers in the US and Canada at Cethrin doses between 0.3 mg and 6.0 mg. Results from a six-week follow up indicated the treatment was safe and well tolerated.
The study also had an efficacy component based on the American Spinal Injury Association's (ASIA) scale for assessment of sensory and motor function in patients. According to BLSI Chief Medical Officer, Mark Hurtt, "We believe the early efficacy findings are promising. The reported interim data indicate that, after six weeks, 31 percent of patients recovered some sensory and/or motor function below the level of their injury and improved from a complete ASIA A injury to a less severe injury on the ASIA scale. Further, the study indicates that improvement in function may be dose dependent. We plan to continue the existing trial protocol to explore this effect in increasingly higher doses."
The U.S. Food and Drug Administration (FDA) has designated Cethrin as an "Orphan Drug". The Company believes that this designation could provide BLSI considerable strategic advantages. Orphan Drug designation gives the Company seven-year market exclusivity after FDA approval, waives select fees and streamlines the requirements for clinical development, potentially helping to accelerate the approval process and reduce costs. Orphan Drug designation also provides certain tax advantages.
There are approximately 11,000 new cases of SCI each year in the US. The average age of injury is 38. The estimated health care and living costs that are directly attributable to SCI vary greatly according to severity of the injury. The National Spinal Cord Injury Statistical Center estimates that the direct lifetime care costs for a patient with the most-severe injury and complete loss of function below the injury site is $2.9 million. That figure is dramatically reduced for people who have partial function, with current estimates in the $650,000 range. Restoring even limited function to those who otherwise would have complete loss of function could reduce total medical costs by millions of dollars each year and dramatically improve the quality of life for patients and their families. |
