MMJ International Holding’s, the premier medical cannabis research company that is advancing the science of medical marijuana through patient clinical research and operation of medical cannabis healthcare businesses, today announced that its affiliate MMJ Bioscience has engaged QuintilesIMS has their Contract Research Organization. QuintilesIMS has been recognized as the Best Full-service Provider Contract Research Organization (CRO).
With a global team of 50,000 QuintilesIMS will assist MMJ BioScience in providing a new level of understanding around what clinical outcomes lead to commercial success in the development process of MMJ Bioscience’s first pharmaceutical formulation of cannabinoid (CBD) derived from certain extracts of the cannabis plant.
Working alongside the principal investigator Bianca Weinstock-Guttman,MD, a Professor of Neurology at the State University of New York at Buffalo who also serves as the Executive Director of the New York State Multiple Sclerosis Consortium, MMJ BioScience will access vast amounts of patient healthcare data from the progressive Multiple Sclerosis study. The MMJ BioScience team is focused on transforming medical cannabis clinical development by connecting healthcare data, new technologies, advanced methodologies and scientific expertise – these capabilities will distinguish the company as a leader in the medical cannabis business and significantly improve clinical trial results.
MMJ BioScience’s phase 2 studies will explore the potential therapeutic applications of cannabinoids across a broad range of multiple sclerosis disease areas for an orphan indication with a particular focus on neurological conditions. Dr. Weinstock-Guttman has been involved in multiple pivotal therapeutic clinical trials in MS and currently is involved in multiple phase III studies as well as in investigator-initiated phase I and IV studies. She has published more than 150 peer-reviewed articles in Neurology and Immunology medical journals. Her current special research interests are focused on genetic and environmental interactions and influences on MS disease phenotype, response to therapy and influences on physical and neurological cognitive status.
Tom Ryan, MMJ’s COO stated that “MMJ BioScience’s discovery of novel cannabinoid pharmacology through our network of world leading scientists, our intellectual property portfolio, proprietary formulations, contract processing, and regulatory expertise all uniquely position us to develop and manufacture plant-derived cannabinoid formulations at sufficient quality and uniformity which will meet the FDA regulatory requirements for pharmaceutical development.”
A large percentage of Multiple Sclerosis patients are resistant to currently available treatments and experience multiple symptoms including spasticity and pain. These conditions are difficult to manage and treatment options are currently limited. The day-to-day impact of these devastating conditions are significant and have high rates of mortality. Subsequently there is considerable unmet patient need and justification for MMJ BioScience’s novel new drug therapies.
While a growing number of states have legalized marijuana for medical use, medical marijuana differs from pharmaceutical treatments in that even legal forms are not FDA regulated. For this reason, there is no way to ensure consistency between batches or even that there is accurate product labeling.In addition, there is no standardization in terms of how these products are prescribed or dosed for specific conditions.The MMJ BioScience team will be, carefully conducting these controlled studies to determine the benefits and risks of its cannabis pharmaceutical products for safe patient use.
MMJ BioScience’s formulation IS NOT MEDICAL MARIJUANA, it is a pharmaceutical formulation of purified cannabinoids that is derived from the cannabis plant. Medical marijuana is the use of the marijuana or cannabis plant or its basic extracts to attempt to treat symptoms of illness and other conditions. It can come in different forms which may contain all or various components of the cannabis plant such as THC, CBD and other cannabinoids.The FDA has not yet recognized or approved the marijuana plant or any natural extract from it as a pharmaceutical medicine.
While a growing number of states have legalized marijuana for medical use, medical marijuana differs from pharmaceutical treatments in that even legal forms are not regulated. For this reason, there is no way to ensure consistency between batches or that there is accurate labeling.
Once MMJ BioScience has succeeded with its FDA-approved medicine this will allow patients access to purchase the medicine with a doctor’s prescription.