GB Sciences to test cannabis-based therapies in humans, taps Worldwide Clinical Trials

GB Sciences selected Worldwide Clinical Trials to assess its cannabis-based therapy portfolio and to help with pre-IND planning.

GB Sciences has decided to focus its drug development forces on three cannabinoid therapies in its pipeline, and it has tapped Worldwide Clinical Trials to assess its intellectual property portfolio and to help with pre-IND planning.

Through its subsidiary Growblox Life Sciences formed last July, the company is planning pilot human studies in Nevada for two formulations for Parkinson’s disease and chronic pain, respectively, with future IND-enabled clinical trials in other states; while another cardiovascular candidate will be directly put to FDA-registered IND after preclinical studies.

Sales of whole marijuana for nonmedical use have been legalized in Nevada since July 1 after state legislators passed a bill last November, while access to medicinal cannabis allowed among people with certain conditions within the state dates back to 2001.

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Instead of whole plants, the drug candidates that the life sciences arm of GB Sciences develops are actually extractions. The company touts that its chronic pain and Parkinson’s formulations do not contain delta-9 tetrahydrocannabinol (THC), the primary psychoactive ingredient in marijuana, and thus are less likely to be abused.

Previously known as Growblox Sciences until a name change last December, GB filed its first patent applications to the U.S. Patent and Trademark Office last October. The application covers cannabis-derived mixtures of formulations for neuroprotection, intended for treating neurodegenerative diseases like Parkinson’s, Alzheimer’s and Huntington’s. The company later filed two more patent applications: one in February, covering cannabinoid therapies for inflammatory disorders, and another one in May for myrcene-containing mixtures for chronic pain and heart diseases.

After scientific validation and market analysis, the cannabis specialist has decided to first pursue the development of three selected formulations out of all 26 it has. Worldwide will provide pre-IND consulting services, led by Michael Murphy, M.D. Ph.D., the CRO’s chief medical and scientific officer, who was instrumental in selecting the top formulations from GB Sciences’ growing portfolio.

That doesn’t mean GB Sciences intends to manage the studies on its own. Worldwide is bidding on the pilot trials and some of the preclinical work on cardiovascular indications, GB Sciences’ CSO Andrea Small-Howard, Ph.D., told FierceBiotech. She said that GB is also taking bids from other CROs over the next few months to try to find the perfect matches in different therapeutic areas, but added that Worldwide will likely be among the finalists given their close relationship.

“Worldwide has been instrumental in establishing our clinical trial designs across multiple disease categories,” said Small-Howard. “They have breadth of clinical expertise in their team that is unparalleled among CROs working with small companies.”