MONTREAL, Jan. 4 /PRNewswire/ - BioAxone Therapeutic announced today that it has licensed its clinical phase II spinal cord injury drug Cethrin to Boston Life Sciences, Inc. . The worldwide, exclusive licensing agreement grants Boston Life Sciences the rights to develop and commercialize BioAxone's portfolio of proprietary recombinant fusion proteins, products, and associated patents to treat acute spinal cord injury (SCI) and other serious central nervous system disorders. The license provides for an up-front license fee of US$10 million payable in 2 installments (US$2.5 million paid on execution and US$7.5 million due on or before March 31, 2007), possible performance milestones of up to US$25 million and on-going royalties based on sales of Cethrin after approval. Detailed terms of the license were not disclosed.
In November 2006, interim results from Cethrin's open-label, clinical phase I/IIa North American dose escalation trial in SCI were published, indicating that a one-time application of Cethrin(R) onto the dura mater of the injured spinal cord is safe and well tolerated. The trial also has an efficacy component based on the American Spinal Injury Association's (ASIA) scale which is designed to assess sensory and motor function in patients. In this trial, 31% of patients, after six weeks, recovered some sensory and/or motor function below the level of their injury and converted from a complete injury to an incomplete injury. These functional benefits may be dose dependent.
"Boston Life Sciences' focus on axonal regeneration to restore sensory and motor function after severe nerve damage, along with their expertise in spinal cord injury, stroke and ocular injury, makes them an ideal licensing partner for BioAxone," said Dr. Frank Bobe, President and CEO of BioAxone. "Cethrin will be a core program for BLSI, thus assuring rapid clinical development and commercialization. Boston Life Sciences neuroregenerative programs are highly synergistic with BioAxone's technology. We are confident that we will see additional drug candidates evolve over time from this agreement."
"We are enthusiastic about having signed this licensing agreement with BioAxone," said Dr. Mark Pykett, President and COO of Boston Life Sciences. "The early clinical results from Cethrin's SCI trial are encouraging. They support pre-clinical studies in which the drug was found to be effective in facilitating axon regeneration following an acute injury to the CNS. If successfully developed, Cethrin could address a significant unmet medical need in acute spinal cord injury."
"During the next few months, BioAxone will work closely with Boston Life Sciences to ensure an efficient transfer of this technology," added Dr. Bobe. "We will jointly work with our stakeholders, in particular our clinical investigators who have been very committed and supportive through-out Cethrin's first clinical trial in acute spinal cord injury."
Cethrin is a recombinant protein which promotes neuroregeneration in the central nervous system (CNS). It was engineered by BioAxone to effectively penetrate into CNS tissue, where it has been clearly shown to elicit the rescue and repair of damaged neurons in preclinical animal models. Cethrin is delivered in a single dose directly onto the dura mater of the spinal cord during decompression/stabilization surgery. Cethrin was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) in December 2005.
About BioAxone Therapeutic
BioAxone is a privately owned neuroscience company specializing in the development and commercialization of proprietary technologies that target Rho signaling. Established in April 2000 and headquartered in Montreal, Canada, BioAxone has demonstrated expertise in recombinant protein product development and has a focused small-molecule program.
Desjardins Securities Inc. acted as financial and strategic advisor to Bioaxone in this licensing transaction.
BIOAXONE THERAPEUTIC INC.