Interim Results Report Drug’s Safety and Possible Recovery of Function After Debilitating Injury; FDA “Orphan Drug” Status Provides Important Strategic Advantages
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.
Other License Information
The BioAxone license agreement provides for an up-front license fee of $10 million payable in 2 installments ($2.5 million of which was paid on execution and $7.5 million due on or before March 31, 2007), possible performance milestones of up to $25 million, the majority of which are due and payable only after approval and achievement of certain specified sales goals, and on- going royalties based on sales of Cethrin after approval. To fund the initial $2.5 million of the license fee, the Company utilized borrowings available to it under the promissory notes from Robert and Thomas Gipson. The Company plans to secure additional debt or equity financing to fund the $7.5 million remainder of the license fee.
Conference Call Details
The company will host a conference call on January 5, 2007 at 10:00am EST to discuss the license agreement with BioAxone. To access the conference call, please dial (719) 457-2621 domestic and (800) 210-9006 internationally. The code for this conference call is 1940703. A replay of the call will be available on the IR section of our website, www.bostonlifesciences.com, until Friday, January 19, 2007.
Glossary of Terms:
ASIA Impairment Scale: The extent of injury is defined by the American Spinal Injury Association (ASIA) Impairment Scale (modified from the Frankel classification), using the following categories:
A – Complete: No sensory or motor function is preserved in Sacral
segments S4-S5.
B – Incomplete: Sensory, but not motor, function is preserved below the
neurologic level and extends through sacral segments S4-S5.
C – Incomplete: Motor function is preserved below the neurologic level,
and most key muscles below the neurologic level have muscle grade less
than 3.
D – Incomplete: Motor function is preserved below the neurologic level,
and most key muscles below the neurologic level have muscle grade
greater than or equal to 3.
E – Normal: Sensory and motor functions are normal.
Axon: A long fiber of a nerve cell (a Neuron) that acts somewhat like a fiber-optic cable carrying outgoing messages. The neuron sends electrical impulses from its cell body through the axon to target cells. Each nerve cell has one axon. An axon can be over 20 cm (a foot) in length.
Dura mater: Literally, hard mother (in Latin). The outermost, toughest, and most fibrous of the three membranes (meninges) covering the brain and the spinal cord.
Orphan Drug Designation: Orphan Drug designation is granted by the FDA’s Office of Orphan Products Development to a drug or biologic that is intended for use in a rare disease or condition. A rare disease is classified as effecting fewer than 200,000 in the United States. The Orphan Drug Act was enacted to encourage the development of treatments for these small patient populations by providing incentives: (1) seven year market exclusivity to sponsors on approved products, (2) a tax-credit of 50 percent of the cost of conducting clinical trials, (3) federal research grants for clinical testing of new therapies to treat and/or diagnose rare diseases, (4) exemption from PDUFA application fees.
About Boston Life Sciences, Inc.
Boston Life Sciences, Inc. (BLSI) is engaged in the research and clinical development of diagnostic and therapeutic products for central nervous system (CNS) disorders. ALTROPANE® molecular imaging agent is in Phase III clinical trials for the diagnosis of Parkinsonian Syndrome (PS) and Phase II clinical trials for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). The company’s research and pre-clinical CNS programs include Inosine for the treatment of stroke, a DAT blocker for the treatment of Parkinson’s disease, and a second generation technetium-based molecular imaging agent for PS and ADHD. BLSI’s current research collaborations include Harvard Medical School and Children’s Hospital Boston.
Safe Harbor
The foregoing release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward- looking statements include statements regarding Boston Life Sciences’ future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including the Company’s licensing arrangement with BioAxone, including the development and commercialization of Cethrin, the prospects of the Company’s CNS therapeutics program, the Company’s strategies to develop and commercialize axon regeneration technologies and the breadth of the Company’s technologies and intellectual property portfolio. Forward- looking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Such forward-looking statements involve known and unknown risks, uncertainties and other factors including those risks, uncertainties and factors referred to in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 filed with the Securities and Exchange Commission under the section “Risk Factors,” as well as other documents that may be filed by Boston Life Sciences from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. Boston Life Sciences is providing the information in this press release as of this date and assumes no obligations to update the information in this press release.
BLSI Contacts:
Meredith Patin – Investors
508-497-2360 ext. 239
Sharon Correia – Media
508-497-2360 ext. 224
Source: Boston Life Sciences, Inc.
