GB Sciences, Worldwide Clinical Trials partner on cannabis-based therapy trials
GB Sciences has signed a Consulting Services Agreement with Worldwide Clinical Trials to evaluate the company's intellectual property portfolio and to assist with pre-IND planning for its proprietary cannabis-based formulations. These pre-IND consulting services will be performed by the chief medical and scientific officer (CMSO) of Worldwide, Michael F. Murphy, M.D., Ph.D., as the representative of an extended Worldwide team. Dr. Murphy has participated in the IND application process for multiple small molecules and biologics with 19 therapeutic targets, across five divisions of the FDA. Dr. Murphy was also the Clinical Research and Excellence (CARE) Lifetime Achievement Award recipient for 2017. The award is presented annually to an extraordinary individual with exceptional contributions and a consistent history of service to the clinical research industry throughout their career.
According to Dr. Murphy, "Current research and development practices emphasize the importance of coordinated activity by industry, academia, and contract research organizations in the evaluation of innovative products, like those of GB Sciences. The process enhances program efficiency, facilitates the integration of the perspective of diverse stakeholders early in clinical development, and is a testament to GB Sciences' strategic vision for the development of their portfolio of products. Worldwide is very pleased to be a contributor to that process, and the state-of-the-art technology which it reflects."
Growblox Life Sciences, a wholly owned subsidiary of GB Sciences, Inc., has filed three provisional patent applications to protect complex mixtures derived from the cannabis plant, which address twenty-six different disease-specific formulations within the Company's intellectual property portfolio. On April 21, 2017, the company held a Drug Development Strategy Meeting in Las Vegas, co-chaired by Dr. Murphy, and GB Sciences' Chief Science Officer, Dr. Andrea Small-Howard. Reviewing the scientific validation and market factors related to the development of these twenty-six disease-specific formulations formed the basis of the criteria for selecting three disease-specific formulations from the portfolio for further development by Growblox Life Sciences.
The company will now focus its resources on the development of: a) two formulations that will be prepared for pilot human studies in the Nevada market and b) one formulation that will be put through pre-clinical studies prior to an IND-filing for official FDA-registered clinical trials.
"We are honored to be working with Dr. Michael Murphy and the industry experts at Worldwide Clinical Trials to evaluate our portfolio and to create the pre-IND plan for the development of our cardiovascular therapies and to design our pilot studies for evaluating the effectiveness of both our Parkinson's disease and chronic pain formulations," said Dr. Andrea Small-Howard, chief science officer of GB Sciences.