Important clinical drug trials begin

As the Blanchette Rockefeller Neurosciences Institute prepares for the opening of a new state of the art research facility in Morgantown, clinical drug trials are already in the preparation stage for a groundbreaking BRNI discovery.

Earlier this year scientists at the Blanchette Rockefeller Neurosciences Institute discovered that a drug called Bryostatin administered up to 24 hours after a stroke can rescue and repair brain tissue in laboratory animals. These findings are markedly advanced when compared to current stroke treatments that must be administered within three hours of a stroke, and are unable to repair damaged brain tissue.

The discovery was led by BRNI Scientific Director Dr. Daniel Alkon who says it has applications for not just stroke victims, but for those with Alzheimer’s disease and traumatic brain injury.

“In each case we’ve been able to show that by using relatively mild chronic treatment for 5-6 weeks, we can virtually reverse the loss of synapses, we can reduce and then reverse the loss of these connections and make new ones and actually restore the function to these animals, says Alkon. “This is what I mean when I say this is going to introduce a whole new era of treating brain disease.”

Bryostatin must now go through the rigors of a clinical drug trial.

Dr. James Stevenson is chair of the Department of Behavioral Medicine and Psychiatry at the WVU School of Medicine. He’s also an administrator at Chestnut Ridge Center, a treatment center for psychiatric illness and substance addiction. Stevenson will oversee the clinical trials of Bryostatin, and future drugs developed at BRNI.

Stevenson says unless you have the opportunity to try those medications out in a safe environment on humans that have these illnesses than you really haven’t accomplished what you would like which is have an impact on humanity. “So we’re positioned because we (Chestnut Ridge Center) have the patients. We have a large population of dementia patients that we have followed for years,” says Stevenson.

Chestnut Ridge Center has had a clinical trials unit for several years and has conducted drug trials on depression, anxiety, ADHA, and diabetes.

Stevenson says running clinical trials is a very structured process with strict guidelines, regulations and on-going checks, to safeguard patients health, all of whom are volunteers.

“These are very elaborate very tightly written protocols, there’s multiple oversights of those protocols including the involvement of the FDA, plus what we call the Institutional Review Board, you know it’s the maxim: first do no harm,” says Stevenson.

Stevenson says it may take until next year to start those clinical trials on Bryostatin. The opening of the new BRNI research facility is scheduled for Friday, October 17.