Scoring of the proposal was organized into six categories: significance, approach, broader impacts, environment, data analysis, and environment. Reviewers from the ICR review panel applauded the novelty of the project, the training needed for a scientific intern, and how well the proposal defines the metric of evaluation for each data analysis aim. They concluded that the likelihood of the project to succeed is high, adding that minor cannabinoids is an area where more research is needed.
According to the Center for Disease Control, Alzheimer’s disease and related dementias are projected to grow to 13.9 million, nearly 3.3 percent of the population in 2060. Brains of people with Alzheimer’s show neurodegeneration and high levels of oxidative stress and inflammation. “The study results will allow MedPharm to further develop innovative, bioavailable, and bioequivalent dosage forms. These are important elements in support of Investigational New Drugs (INDs) and New Drug Applications (NDAs) for future FDA-approved products,” says Scott Karolchyk, MS, RPh, Director of Formulation and Development. The phytocannabinoid cannabidiol (CBD) has neuroprotective, antioxidant and anti-inflammatory properties. Other studies have shown that CBD has been shown to be effective in vivo, making the phytocannabinoid an interesting candidate for novel therapeutic interventions in Alzheimer’s therapy, especially because there are no psychoactive or cognition-impairing properties, thus adding to the significance of the MedPharm study.
“It’s by pursuing this one-of-a-kind study in an area where research is really needed that sets MedPharm apart from other cannabis research and development companies,” Albert Gutierrez, President of MedPharm, says. “Alzheimer’s is a terrible brain disease. Any way we can provide therapies to help treat it, such as doing a pharmacological evaluation to find out what a certain compound can do, we know helps us close in on a better understanding of Alzheimer’s, and perhaps a pathway to greater and more helpful cannabis-based therapies down the road.” Anticipated start date of the project is October 1, 2022.
The announcement comes just as national Alzheimer’s researchers and health appropriations legislators seek significant sources of additional funding. In June, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations subcommittee proposed a $200 million increase in Alzheimer’s and dementia research funding at the National Institutes of Health (NIH), and $30 million to implement the bipartisan Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act at the CDC for fiscal year 2023.
“This is a big win for not only our team, but the entire cannabinoid research community,” says Director of Pharmacology & Experimental Therapeutics, Duncan Mackie, Ph.D. “The completion of this project will provide the first clear mechanistic and cellular evidence for the application of cannabis and cannabinoid-based natural products for the treatment of Alzheimer’s disease, Parkinson’s disease, and other neuroinflammatory diseases.” The selection by the ICR, according to Gutierrez, demonstrates once again that MedPharm can repeatedly tap into the cutting-edge work of its cannabis researchers and chemists to find out more about the “What, Why and How?” behind cannabis compounds and their medicinal effects on the human body. “Helping people live better, happier, and more productive lives has always been the focus of MedPharm,” says Gutierrez.
MedPharm has a 15,000-square-foot manufacturing, research and development laboratory and cannabis processing facility in Denver, Colorado. Since beginning operations in 2017, MedPharm has grown to a staff of 44 people. The company provides cannabis pharmaceutical-type products in a certified current Good Manufacturing Practices (cGMP) and Good Agricultural Practices (GAP) facility that includes cultivation, pre-formulation, formulation development, small scale commercial manufacturing, analytical method development and validation, routine quality control analysis and stability studies. MedPharm creates pharmaceutical-grade dosage forms and produces ingredients utilizing pharmaceutical technology to be used in the delivery of cannabis compounds. MedPharm specializes in neuropharmacology with a focus on Alzheimer’s disease and dementia. MedPharm received the first cannabis research license issued to the state of Colorado in October, 2018. MedPharm Research, a wholly owned subsidiary, also has pending federal application for a Bulk Manufacturing License and has been granted a Schedule I Research license to provide and use cannabis and cannabis dosage forms for research purposes. More information about MedPharm can be found at: www.medpharmholdings.com.