April 14, 2005
Purdue licenses paralysis treatment to Indiana-based Andara Life Science Inc.
WEST LAFAYETTE, Ind. - An Indiana startup company will commercialize a Purdue University treatment for central nervous system injury and disease that has shown early promise in bringing quality-of-life improvements to patients with paralysis.
At a news conference at Riley Hospital Outpatient Center in Indianapolis today (Thursday, April 14), Purdue Research Foundation announced a license agreement with Andara Life Science Inc. (an DAR a). The agreement grants the company exclusive commercial rights to a platform of treatment alternatives, including a medical device, a combination medical device and drug, and a series of drugs, all targeting injury and diseases of the central nervous system. Purdue's patented oscillating field stimulator (OFS), which stimulates nerve regeneration and has shown initial results in human clinical trials, forms the foundation of the treatment.
"My first thought when I heard about the OFS human clinical trials results was that this just might be the first meaningful treatment opportunity for people with spinal cord injuries," said Mark Carney, a health-care entrepreneur, Purdue graduate and Andara's president and chief executive officer. "Based on its advanced state of development, the OFS device may take only three years to commercialize. In large part, the timing will be determined by the results of current and future clinical trials and by the Food and Drug Administration."
At any given time, more than 250,000 people live with a debilitating spinal cord injury in the United States. Each year, more than 11,000 additional Americans suffer from a spinal cord injury.
"It's not about getting up and walking for these patients," said Richard Borgens, Andara's chief scientific officer and the Mari Hulman George Professor of Applied Neuroscience who led a team of researchers to this discovery at the Center for Paralysis Research in Purdue's School of Veterinary Medicine. "It's about quality of life, and that includes being able to generate enough sensory recovery to determine whether or not they have a medical problem, such as a bladder infection, before it causes them serious damage. It's about being able to experience those minor, but extremely important, bodily sensations that act as our protective communication matrix."
In January, results from Phase I-A Food and Drug Administration regulated human clinical trials of OFS were published in the Journal of Neurosurgery - Spine. In the study, the physician who conducted the clinical trials at Indiana University School of Medicine said the drug-device combination has shown promising results.
"We have never seen this type of response before," said Dr. Scott Shapiro, the Robert L. Campbell Professor of Neurological Surgery at the IU School of Medicine, who is the chief of neurosurgery at Wishard Memorial Hospital as well as Andara's chief clinical investigator.
"In our study, the OFS was surgically removed at 15 weeks, and patients were followed for one year and tested to evaluate their sensory recovery. Some patients who had no sensation below the level of their injury prior to the implantation of the OFS found their sensation in certain areas almost back to normal following the clinical study regiment. In addition, some patients did regain sensation and motor function in their lower extremities but not enough to stand unassisted."
The initial study was supported by a special appropriation by the Indiana General Assembly and charitable gifts.
As a health-care executive, Carney said he recognizes the significance of the treatment from both a quality-of-life standpoint and health-care industry cost perspective.
"Its importance is twofold," Carney said. "Because most of these patients suffer these catastrophic injuries while in their 20s and require care for the rest of their lives, treatment costs can approach $650,000 in the first year and $120,000 every year thereafter. When you factor in lost wages, fringes and productivity, the overall expense can easily approach $3 million."
"Andara has the potential to be the largest Purdue Research Park startup to date," said Joseph B. Hornett, senior vice president and treasurer for the Purdue Research Foundation, which has provided Andara with business development services.
Andara executives are now in the process of hiring additional members of the management team and implementing the business plan that has been developed.
"A huge benefit to growing a life science company in Indiana is the tremendous support system provided by central Indiana firms who specialize in regulatory affairs expertise, reimbursement strategies, intellectual property and life science-based capital formation," Carney said.
Several locations in Indiana are under consideration by Andara for office and laboratory space.
Established in 1930, the Purdue Research Foundation is a nonprofit corporation that is legally constituted to accept gifts, administer trusts, acquire property, negotiate research contracts and perform other services helpful to Purdue. As part of its holdings, the foundation owns more than 130 properties including the Purdue Research Park, named best research park in the country in 2004. The park is home to the greatest number of technology companies in Indiana as well as the largest university-affiliated business incubator in the country.
More information about the OFS research is available online.
Jeanine Phipps, media relations, Purdue Research Foundation, (765) 494-0748 (office), (765) 409-2745 (mobile), firstname.lastname@example.org
A publication-quality photo is available at http://news.uns.purdue.edu/images/+2005/shapiro-borgens.jpg
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