As part of the consulting services agreement, Worldwide Clinical Trials will evaluate the cannabis company’s intellectual property portfolio and will assist with pre-IND planning.
Worldwide’s chief medical and scientific officer, Michael F. Murphy, MD, Ph.D., told us the companies held a meeting earlier this year to formulate a strategy for approaching clinical development considering the available nonclinical data, GB Sciences’ pipeline status, the competitive environment, and the potential unmet clinical need.
GB Sciences' wholly owned subsidiary, Growblox Life Sciences, has filed three provisional patent applications to protect complex mixtures derived from the cannabis plant, which the company said address twenty-six different disease-specific formulations within its intellectual property portfolio.
Following the meeting, three disease-specific formulations were selected for further development. Moving forward, the Morrisville, NC-based contract research organization (CRO) will focus on developing two formulations for pilot human studies in Nevada. It will also develop the third formulation for preclinical studies prior to an IND filing for an official FDA-registered clinical trial.
“Worldwide has never conducted a cannabis study,” Murphy said, noting that the field is relatively immature regarding good clinical practice (GCP) investigations in cannabis.
The company has, however, conducted GCP studies in all the clinical targets in which GB sciences has expressed interest and has provided consulting services for cannabis programs for two other companies in addition to GB Sciences. “We estimate there are approximately 30 companies active in the space,” Murphy added.
“These companies [in this space] have different approaches that either exploit unique devices (or other methods of delivery), or, they examine different active entities within the cannabis plant – the range of clinical targets is impressive and would span all of the therapeutic areas in which Worldwide has competency,” he explained.
According to Murphy, the opportunities and challenges associated with the GB portfolio will share many commonalities with other pharmaceutical companies. These similarities will provide some “predictability to the milestones and timelines likely to be encountered during clinical research, and enables Worldwide to participate in advancing solutions in advance of program initiation,” he added.
GB Sciences has established discovery and manufacturing capabilities within their organization, and as such, Murphy explained Worldwide will assist in providing access to clinical trial methods and operations as a part of the team required for clinical development.
“We will specifically help to inform the pre-IND plan for the development of cardiovascular therapies and to design pilot studies for evaluating the effectiveness of both Parkinson’s disease and chronic pain formulations,” he added.
Next steps for the CRO include introducing the therapeutic opportunities at GB Sciences to others within the organization and to acquaint its operational and regulatory staff with the GB Science rationale and potential clinical utility of the products under development – and, as Murphy said, to “help GB Sciences move toward clinical evaluation as expeditiously and efficiently as possible.”