CAMBRIDGE, Mass., Sept. 25, 2013 /PRNewswire/ -- BioAxone BioSciences Inc. announced today publication of clinical data showing motor recovery scores in spinal cord injury patients treated with Cethrin. Cethrin is an innovative biologic drug with a regenerative mechanism of action designed specifically to treat spinal cord injury, a devastating condition with no current effective treatment. In addition, Lisa McKerracher, Ph.D., CEO of BioAxone, presented the new data at the at the National Neurotrauma Meeting held in Nashville, TN in July, and at BioPharm America in Boston, MA last week.
TheJournal of Neurotrauma article reveals the potential of Cethrin to promote recovery of upper body movement in quadriplegic patients through analysis of neurological recovery of treated patients compared to standard recovery noted in current spinal cord registries and historical data.
The Cethrin clinical trial was an open-label Phase I/IIa trial undertaken to assess the safety, tolerability, and neurological status of acute spinal cord injury patients treated with escalating doses of Cethrin.
Dr. McKerracher stated, "To date, no other therapy has shown such promising increases in upper extremity motor score. In the United States, 75% of spinal cord injury is cervical, meaning patients are paralyzed from the neck down. Even small amounts of neurological improvements for these patients is tremendously important because recovery of arm movement allows patients to be independent in basic functions such as eating and getting dressed."
Cethrin differs from other drugs tested in neurotrauma because it is a regenerative therapeutic protein designed specifically to promote reconnection of damaged circuitry by promoting axon regeneration. Axons are the fibers of communication that transmit electrical signals. "A neuron is like a TV and its axon like the electrical cord," explained Dr. McKerracher. "If the electrical cord is damaged, making sure that the TV is intact will not restore the program. The damaged cord must be repaired to restore electrical signals." Cethrin works by blocking signals that inhibit regeneration by targeting a key regulatory protein called Rho. In addition to regeneration, targeting Rho is neuroprotective and reduces inflammatory damage.
The next step in development is the completion of the next round of financing (estimated to as low as $15M) to complete the placebo-controlled pivotal clinical trial. Dr. McKerracher is a past co-recipient of the Christopher Reeve Medal for her work on axon regeneration. The relatively small patient population masks the incredible need for effective drugs. Once pivotal trials for Cethrin are underway, BioAxone plans to test Cethrin alone and in combination with the company's other products in development to provide treatment for other types of spinal injury. With the new changes occurring as a result of the JOBS Act (Jump Start Our Business Startups), BioAxone is optimistic that the pace of development to translate cures for spinal cord injury will accelerate. In the U.S., there are 30 new spinal cord injuries each day, and no treatments available except surgery and rehabilitation. The majority of people affected by spinal cord injury are young people in car accidents, who go on to lead an entire life of disability. BioAxone plans to change that, and the company expects top-line results by 2015.
About BioAxone BioSciences, Inc.
BioAxone is a privately held biotechnology company developing proprietary technologies to treat spinal cord injury and other types of neurotrauma. Cethrin, the company's lead drug candidate, targets Rho signaling and has potential use in multiple indications that include central nervous system injuries, degenerative diseases, and optic neuropathies. BioAxone was founded in 2011 by Dr. Lisa McKerracher.
Tiberend Strategic Advisors, Inc.
SOURCE BioAxone BioSciences Inc.