MMJ BioScience, an affiliate of medical cannabis research company MMJ International Holdings, has hired a principal investigator to lead clinical trials exploring potential therapeutic applications of cannabinoids in progressive multiple sclerosis (MS).
Dr. Bianca Weinstock-Guttman, a neurology professor at the State University of New York at Buffalo, is executive director of the New York State Multiple Sclerosis Consortium. She will lead Phase 2 clinical trials, which have already been cleared by the U.S. Food and Drug Administration (FDA), with the guidance of Parexel, a clinical research organization.
“There is a considerable body of evidence to suggest that cannabis may have a number of positive medicinal uses, including the relief of pain and spasm in multiple sclerosis,” company spokesman Michael Sharpe said in a press release. “We are now well on the way to being able to demonstrate this in a controlled clinical research environment.”
He added: “Entering Phase 2 trials is a highly significant point in the development of our cannabis-based medicines. These trials will allow us to demonstrate efficacy in a limited number of subjects and to establish the necessary dosage regimen and delivery mechanisms to provide the most effective relief to sufferers from the acute pain and spasticity associated with MS.
This is MMJ’s first study of cannabis-based medicines involving patients with MS and related forms of severe pain and spasticity. Patients will receive proprietary formulations of cannabis-based medicine via an oral gel cap.
The trial will be conducted at several locations in New York and should begin by early 2018. It will likely involve several hundred patients over the next 18 to 24 months. Its goal is to prepare data for FDA approval of a cannabis-based medicinal product.
MMJ, based in Reston, Virginia, hopes to bring to market prescription medicines by 2020. These would let MS patients and others access the medical benefits of cannabis without the unwanted psychoactive side effects, or the health dangers linked to smoking.
“Our aim is to test some of the claims which have been made for the medicinal qualities of cannabis in a structured clinical research program,” said Sharpe. “This is an exciting moment, and we expect that our findings will lead to significant improvements in the pain relief available for sufferers of MS.”
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