Purdue Research Foundation has signed a license agreement with Andara Life Science Inc. 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.
Andara’s president and chief executive officer says, “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.
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.
He added, “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.”