MedPharm to hold the first licence for R&D Study for marijuana effects on Alzheimer's Disease.
The Denver-based company, MedPharm Holdings became the first company in Colorado to apply for a research and development (R&D) study in hopes to investigate the effects of cannabis on Alzheimer's disease.
Under the R&D licence, MedPharm Holdings aims to test the effects of Tetrahydrocannabinol (THC), Cannabidiol (CBD) and other cannabinoids on Alzheimer's and Dementia patients. According to the Marijuana Enforcement Division, MedPharm has been the only company to apply for an R&D licence.
Alzheimer's disease affects 5.8 million Americans and is the sixth leading cause of death in the U.S. while dementia is the second leading cause of death in Australia. Alzheimer's is a neuro-cognitive disorder that affects memory and cognitive processing. Although there are medications to assist with cognitive function is there no medication to treat the progress of the disease and it continues to have no known cure.
MedPharm CEO, Albert Gutierrez, is eager to research the effects of the cannabis plant, saying that Alzheimer's "is one of the biggest things that's plaguing our country now and in the future."
"We haven't yet tapped into what this plant can really do to help alleviate the symptoms," says Gutierrez. "We hear a lot of anecdotal evidence as far as helping with epilepsy or… .arthritic pain…now it's time to put the cannabinoids to the test and really understand what cannabinoids and what doses and. . . delivery methods really help deliver that relief."
While the anecdotal evidence supporting the medicinal use of cannabis to help ease the symptoms of chronic pain, insomnia, and chemotherapy-induced side-effects, clinical research remains scarce. This is due to cannabis still being categorised as a Schedule One drug under U.S. federal law, regardless of the legalisation of the medicinal use of the plant in thirty-three states across the U.S.
What Can Cannabis do?
Although to date there has been no conclusive evidence that proves that cannabinoids can stop the progression and onset of Alzheimer's, a few studies have found that the plant can help alleviate its behavioural and agitation side-effects.
One study found that the use of cannabis can remove the build-up of the protein amyloid from the nerve cells, a trademark of the disease. Other studies found that giving cannabinoids to mice presenting with Alzheimer's symptoms reduced the amount of amyloid protein in their body and increased cognitive function.
According to Jim Herlihy, senior director of marketing and communications for the Colorado chapter, the Alzheimer's Association has also funded several studies to research how cannabis assist with brain inflammation in 2016 and 2017.
"The Association has been exploring all legitimate avenues of research. . . and investigating chemical components of marijuana and other plants because we understand that traditionally plants are an important source for many life-saving medicines," says Herlihy.
The MedPharm Trial
In 2018, when MedPharm acquired its licence while waiting for city-level applications to open, their scientists started growing cannabis plants in their Denver-based lab, producing a range of drug formulas. MedPharm will then use these unique formulas to produce drugs and placebos in clinical trials If the application is successful under the R&D licence.
The trials aim to understand how cannabinoids network with neurological receptors through brain mapping, measuring cognitive abilities and progressive patterns in patient behaviour.
Trials are expected to start in the first phase (to investigate how cannabinoids are absorbed into the body and to test any potential side-effects) of double-blind testing (when neither the researcher nor the patient knows who is receiving the drug) in the second quarter of 2020 and will likely run for about six to nine months, according to Gutierrez.
The future of Cannabis research
Colorado is also the home of the Institute of Cannabis, located on the campus of Colorado-State University (CSU) Pueblo where research is being aimed at investigating the effects of cannabis on cancer and Parkinson's Disease.
According to the director of the Institute of Cannabis CSU Pueblo, Jeff Kinney, research has tended to be limited to campus-based labs because the pre-existing technology and infrastructure allow for research to be carried out. However, it's a different story for companies performing in-house research with its own funding.
Gutierrez stated that the start-up costs for MedPharm were upwards of US$12 million to ensure that the facility was equipped and ready for research. However, while restrictive federal laws still are in place, federal funding to run these facilities is at risk if pharmaceutical companies want to research the effects of the plant, says Gutierrez.
While it is the hope that under the R&D licence, MedPharms application will allow for other companies to also undergo research that will allow for further research into the plant's medicinal benefits.
Who else is getting in the game?
While Colorado appears to be making headway into the research and production of medicinal cannabis, bio-pharma company MGC Pharma (ASX: MXC), is also making strides well on the way of becoming an industry-leading source of cannabis-derived medicines. According to our recent research report, MGC Pharma is on its way to being able to produce Active Pharmaceutical Ingredients of Phytocannabinoids (APIs), creating a more cost-effective option to produce medicinal cannabis products through the company's facility in Slovenia, and a second being constructed in Malta.
MGC Pharma's patient growth has doubled within the past twelve months, breaking into new markets across the EU and increasing its production capacity. It's also currently targeting conditions such as Epilepsy, Glioblastoma and using a specific CBD:THC ratio to target symptoms of Alzheimer's and dementia.
MGC Pharma received the go-ahead to start Phase IIb trials for a product, CogniCann for Alzheimer's and dementia patients in January 2019.
"[CogniCann] has the potential to seriously alleviate the symptoms of patients living with Alzheimer's disease and dementia," says Roby Zomer, Co-Founder and Managing Director of MGC Pharma.
The randomised double-blind cross-over study (when patients will cross-over different treatments during different time-periods) will be conducted by the University of Notre Dame in Western Australia (WA) over sixteen weeks. The trial will perform qualitative research via focus groups and surveys to determine the perception of the treatment by staff and members of the patient's family.
The trials are expected to conclude in the second quarter of 2021.
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