Boston Life Sciences Gets Spinal Cord Candidate Via Licensing Deal
This article was originally published in The Pink Sheet Daily
Executive Summary
Cethrin represents “a new generation of drugs” to treat central nervous system injuries, exec says.
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Boston Life Sciences will continue a Phase I/IIa trial of novel spinal cord injury candidate Cethrin in the first half of the year, Chief Medical Officer Mark Hurtt said Jan. 5. "We see evidence of a dose-response relationship that warrants further investigation at higher doses," he said. FDA has already granted Cethrin orphan drug status. During a same-day conference call, Hopkinton, Mass.-based Boston Life Sciences announced that it had received an exclusive, global license to the drug from Montreal-based BioAxone Therapeutic for future development and commercialization. Under the terms of the deal, BLS will pay BioAxone $10 million up front, and up to $25 million in milestones. According to CEO Peter Savas, the BioAxone license will help position BLS "as a leader in the field of axon regeneration for functional recovery following traumatic central nervous system injuries." Chief Operating Officer Mark Pykett said that while spinal cord injuries impact about 11,000 people annually in the United States, he estimated that the market opportunity worldwide "could approach half a billion dollars annually." "Cethrin is the first clinical candidate in a new generation of drugs designed to specifically target the cellular response to an acute spinal cord injury, promote the regrowth of axons, and restore sensory and motor functions," the exec added. Cethrin would be delivered in a single dose during surgery directly on the affected region, eliminating the need for additional invasive procedures, Pykett said. Interim results of the Phase I/IIa dose escalation study showed Cethrin was safe and well tolerated with no adverse events, according to Hurtt. Cethrin was administered to 37 patients at four dose levels ranging from 0.3 mg to 6 mg. "Interim results at 6-week follow-up indicated 31 percent of patients recovered sensory and motor function below the site of the injury," Hurtt said. BLS has one other axon regeneration candidate, Inosine , which is close to entering Phase I. Pykett said the licensing of Cethrin would not impact further development of Inosine. "We will continue to press forward with our efforts to move Inosine into the clinic, and to advance the entire portfolio of capabilities we have in functional recovery as we focus more and more on our therapeutic efforts." BLS' lead candidate is the molecular imaging agent Altropane , which is in Phase III for Parkinson's disease and Phase II for attention deficit/hyperactivity disorder. - Jonathan M. Block ([email protected]) |