Dr. Lisa McKerracher will participate on panel at Biotech Showcase 2013 entitled “Spinal Cord Injury: Investment Opportunities and challenges in an Area with Unmet Medical Needs”. The panel will be held Wednesday January 9, 2013 at 8 am during the BioTech Showcase 2013 in San Francisco. The panel of individuals from different aspects of the orphan disease continuum will discuss misconceptions about spinal cord injury and  the investment opportunities that exist for this indication with no effective treatment options.  This workshop is sponsored by the Rick Hansen Institute (RHI) and will be followed by corporate presentations.  The RHI invited BioAxone BioSciences to present at the corporate session, and BioAxone will highlight the profoundly encouraging clinical results showing efficacy of Cethrin to treat acute spinal cord injury. Cethrin is a therapeutic protein in Phase II clinical development to treat patients within the first week after injury.  BioAxone’s presentation will be held Jan 9, 2013 at 8:30 am. The RHI is a Canadian-based not-for-profit organization committed to accelerating commercialization of promising therapies.  The RHI was established in 2007 with a mission to foster greater collaboration across the SCI community and to accelerate progress towards a cure for paralysis after SCI.

News on Cethrin

In other news, one of the patients that received Cethrin during the Cethrin Phase 1/2a clinical trial was interviewed.  For a video on this story click here.

Drug helps reverse paralysis after spine injuries, by Joseph Hall

Just before they closed the incision after a six-hour operation to repair his shattered spine, surgeons at the Toronto Western Hospital asked John Picco’s parents if they could try something new.

The 17-year-old roofer had tumbled two days earlier through an opening on top of an Oshawa supermarket after removing his safety line to free himself from a snag.

He fell to the floor beneath, crushing the L1 vertebra in his lower back — a catastrophic injury that left him completely paralyzed from the waist down.

But with the new treatment along his wounded spine, the gel-like drug Cethrin was coating his injured nerves in a protective layer that was actually reversing the neurological damage.

“Oh jeez, yes I’m glad I got it,” says Picco, now 23, who has defied early predictions that he’d never move his legs again.

Picco can now shuffle almost 20 metres with the aid of braces and can leg press 45 kilograms in the gym.

And in a new study released this month, researchers at the Western’s Krembil Neuroscience Centre show the drug has likely produced significant movement regeneration in several of its 48 patients.

Most recent spine injury research has concentrated on drugs that attempt to block the inflammatory response caused by the original trauma, which continues to destroy nerve cells in the hours after an accident.

But Cethrin is the first drug tested on humans that actually appears to heal the damaged neurons, which carry electrical movement impulses from the brain to the rest of the body.

“There have been very few clinical trials done with reparative or regenerative therapies in humans, very few,” says Dr. Michael Fehlings, the Krembil centre’s director.

“And this is also one of the few that has really shown promise,” says Fehlings, the study’s lead author.

It did so, he says, despite the total paralysis suffered by all of the study’s subjects below their injury sites.

“There is no movement or feeling below the level of the injury, so someone is literally completely paralyzed,” Fehlings says.

“The prognosis for such patients is generally quite sobering in terms of neurological recovery,” he says.

As a small, early phase trial, the researcher’s key goals were to establish the drug’s safety and to determine the doses that might produce optimal results.

But it appeared to show the results produced by those optimal doses were profound, Fehlings says.

“In that group of patients we observed a rate of recovery which was astonishing,” he says.

Fehlings says 31 per cent of the optimally dosed patient group improved two to three grades on a standard paralysis scale, moving from complete paralysis to a place where they could both feel and move below the injury.

He says the study’s mobility improvement rates in those who responded best to the drug were more than three times greater than could be expected to occur normally.

Fehlings says the drug, which is slathered along the spinal cord at surgery’s end, likely blocks the actions of a protein known as Rho, which limits the ability of nerve cells, or axons, in the cord to regenerate and reconnect.

Fehlings cautions that the drug must be tested in much larger, more rigorous trials before it can be put into general clinical use. But he says it has excited the neurological community enough already that those new studies should be quick in coming.

The research, published this month in the Journal of Neurotrauma, comes hard on the heels of a study released last week that detailed the recovery of a paralyzed college baseball player through the use of electrical stimulation to the spine.

Fehlings says the Cethrin treatments would almost certainly work in conjunction with such electrical therapy, making patients’ spinal cords more receptive to the stimulation.

Picco himself credits a combination of Cethrin and relentless rehab work with his continuing recovery.

“I’d like to believe it’s both hard work and the drug,” he says.

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For a review of the clinical trial, see this link:

Christopher Reeve Foundation

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CAMBRIDGE, MA., Nov 28, 2012. BioAxone BioSciences celebrates official opening of clinical and research operations in Cambridge, Mass.

BioAxone’s lead drug, Cethrin, has been selected as one of the “Top Ten” partnering opportunities in the Neurosciences

For new reported by Mass High Tech  click here

 Press release November 28, 2012 BioAxone BioSciences, a privately held biotechnology company, today celebrated its opening of an its scientific and clinical headquarters in  Cambridge, Mass., as well as its selection this week by Windhover Conferences as one of the “Top Ten” Neuroscience Companies for Partnership. The company’s celebration was held today with local officials and industry leaders. Attending the event were BioAxone CEO, Dr. Lisa McKerracher; Massachusetts Life Sciences Center Vice President for Communications and Marketing, Angus McQuilken; MassBio Director of Economic Development and Global Affairs, Peter Abair; Founder of Massachusetts Walks Again,  Dr. Eric Ruby; and Boston Mayor Thomas Menino’s Commissioner for Persons with Disabilities, Kristen McCosh.

 BioAxone, headquartered in Florida, is developing a protein therapeutic drug called Cethrin to improve patient recovery from spinal cord injury. Its scientific and clinical headquarters will be located at the Cambridge Innovation Center in Cambridge, Mass., which was selected for its concentration of life sciences companies, availability of walk-in wet-lab incubator space and its skilled workforce. Dr. McKerracher will be starting operations in Cambridge, with plans to hire 12 employees by 2013.

 Dr. McKerracher, of BioAxone, said, “I am pleased that Cethrin and BioAxone’s leadership in the field of spinal cord injury have been recognized by Elsevier Business Intelligence and Windhover Conferences. Now that BioAxone has joined the Massachusetts life sciences community, we look forward to reporting progress on Cethrin and collaborating with members of the world’s leading life sciences cluster  to continue to develop novel drugs for unmet needs in the field of neurotrauma.”

 “Thanks to our growth strategy of investing in education, innovation and infrastructure, Massachusetts continues to lead the world in life sciences,” said Governor Deval Patrick. “We welcome BioAxone to Massachusetts and look forward to their contributions to our thriving life sciences community.”

 Traumatic spinal cord injury affects more than 12,000 Americans each year, mainly from motor vehicle accidents. Approximately 70 percent of patients suffer injuries to the cervical spinal cord, which leads to quadriplegia and dependence on care for daily living. There are no approved drugs to treat spinal cord injury. The only current treatment for SCI is surgery and rehabilitation.

 Cethrin’s mechanism of action is to facilitate plasticity and rewiring of pathways damaged by spinal cord injury. Studies on axon regeneration and recovery in rodents have revealed that “learning” can occur in spinal cord circuits and the spinal cord is not hard wired.  Cethrin facilitates axon regeneration and stimulates plasticity and is the only drug in development that targets multiple inhibitory signals to promote regenerative repair after spinal cord injury.

 “On behalf of the Center, we would like to warmly welcome BioAxone to Massachusetts,” said Susan Windham-Bannister, Ph.D., President & CEO of the Massachusetts Life Sciences Center, the agency charged with implementing Governor Patrick’s 10-year, $1 billion Life Sciences Initiative. “BioAxone’s drug development program is a source of hope for individuals suffering from traumatic spinal cord injuries, and the company is a welcome addition to our thriving life sciences community in Massachusetts. We are so pleased that that BioAxone selected Massachusetts as the best place for the company’s scientific and clinical headquarters!”

 “Massachusetts’ strength is in our density of life sciences companies, academic institutions, medical centers and organizations that support the cluster’s success,” said Abair, of MassBio. “We’re thrilled to welcome BioAxone to the Massachusetts supercluster, and celebrate the number of small, innovative research companies who are setting up shop in Kendall Square.”

 BioAxone’s clinical program to develop Cethrin has been selected by Windhover conferences as one of the “Top Ten” neuroscience partnership opportunities to watch. Cassak, Vice President, Content, Windhover Conferences explained that “to be selected as a winner, BioAxone has met  rigorous criteria, including unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability.”

 Also recognized at the event were other companies that have recently located offices in the Cambridge Innovation Center, including Alacrita, Arrayjet and Qserve Group.

 About BioAxone

BioAxone BioSciences Inc. is a new, privately owned company specializing in the development and commercialization of proprietary technologies for unmet medical needs and neurotrauma. The lead drug candidate, Cethrin targets Rho signaling, and has potential use in a number of  indications that include central nervous system injuries, degenerative diseases, and optic neuropathies. BioAxone BioSciences was formed by Dr. Lisa McKerracher and is currently privately financed. Early support of the Cethrin program was from grants and venture financing in Canada. Dr.  McKerracher acquired the patents that protect Cethrin and other assets from its former investors and formed BioAxone BioSciences, a USA based corporation. The scientific and clinical activities are now located  in Cambridge, Massachusetts.

 About Cethrin

Cethrin acts on a protein calledRhothat regulates the neuronal response to growth inhibitory molecules.  The activity of Cethrin is to facilitate the regeneration of injured axons, foster plasticity, limit tissue damage, and improve functional recovery after spinal cord injury. A Phase IIa study in acute spinal cord injured patients demonstrated safety and efficacy of Cethrin, which is delivered topically to the spinal cord during decompression surgery. Motor recovery was measured by American Spinal cord Injury Association (ASIA) motor scores. Patients who were quadriplegic after sustaining cervical (neck) spinal cord injury showed the most promising trends of recovery. In the open label clinical study, 31% of all cervical patients, and 66% in the most effective dose group, showed improvement from complete sensory and motor paralysis below the level of injury(ASIA A) to recovery of some motor function (ASIA C or D). The cervical patients treated with Cethrin recovered on average 2 neurological levels, restoring arm movements that are critical for normal daily activity, quality of life, and reducing long-term health care costs associated with paralysis. While further clinical study is required to demonstrate efficacy and to complete the approval process, the rates of recovery and the demonstrated safety in the first Clinical I/IIa study merit optimism.

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The key to healthy neurons and axon regeneration is a protein called Rho. Rho GTPase was discovered in non-neuronal cells as a protein that regulates cell motility. BioAxone and the McKerracher group showed that Rho is the mastermind that regulates the neuronal response to trauma in the central nervous system.  Using biochemical assays, they showed that  Rho is abnormally activated after  neurotrauma, including spinal cord injury (SCI), traumatic brain injury, and optic nerve injury. Others reports followed to show  activation of Rho in neurodegenerative disease, such as Alzheimer’s disease. BioAxone created Cethrin to  restore Rho to its inactive state in injured neurons. Treatment with Cethrin promotes axon regeneration and functional recovery in animals. It is now being tested in clinical trials as a promising drug therapy to improve recovery after spinal cord injury.

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At present, BioAxone BioSciences is not recruiting patients.

Information on other clinical trials can be found at the following web site:

http://clinicaltrials.gov/

Further information and patient resources for spinal cord injury can be found at the Christopher and Dana Reeve Foundation Web site:

http://www.christopherreeve.org/site/c.mtKZKgMWKwG/b.4451921/k.2951/Paralysis_Resource_Center_Home.htm

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