Colorado’s MedPharm Clears Significant DEA Hurdle For Federal Cannabis Research License

COLORADO: MedPharm Research, the leader in cannabis research and formulation development, was notified by the Drug Enforcement Administration (DEA) that it had been selected to move forward as one of the first applicants to be granted a license to grow federally legal cannabis under the terms of a new policy statement issued today in the Federal Register.

“This is something we have been waiting for since we first sent in our application in September, 2016, as one of the first medical grow facilities to apply for a license,” Albert Gutierrez, CEO of MedPharm, said. “Now, finally, the DEA has seen the importance of allowing federally legal grows to get more active in medical cannabis research, and do the work that we really need to do for patients across the country. It is a real game-changer for the whole medical cannabis industry.”

In a letter to Gutierrez, the DEA stated that MedPharm will be issued a Notice of Proposed Rule-making, where the company will be asked to comment on regulations about growing cannabis for medical research. However, the DEA has not provided a timetable for when those regulations will be completed. “We at MedPharm stand ready to assist the DEA in any way we can to help expedite this process, and bring to patients the best quality, FDA-approved cannabis that they need for research and treatment as quickly as possible,” said Gutierrez.

According to the University of Mississippi News, in 1968, the Research Institute of Pharmaceutical Sciences at the University of Mississippi School of Pharmacy was awarded a competitive contract from the government to grow marijuana that could be standardized for research. For over 50 years, it has remained the only cultivation facility licensed by the DEA to provide federally legal cannabis for medical researchers, who have reported that cannabis from the university is of such poor quality that it is essentially useless in conducting the lab work and human trials necessary for a reliable FDA-approved medical research.

As more medical cannabis research ramped up, a growing group of medical cannabis researchers pressured the DEA to open up licensing to other facilities. Then, in August, 2016, the DEA stated that they would begin accepting applications for companies wanting licenses for legal grows, but nothing more happened until this June, when one of the applicants sued the DEA for unreasonable delays, prompting today’s response.

MedPharm is well-positioned to work with the DEA and be among the first providers of federally legal cannabis for medical research. The application for the license included outlining research objectives and creating areas where medical research cannabis is grown specifically for research purposes.

Tilray Announces Support Of Two New Clinical Research Studies In Australia And Canada

CANADA: Tilray, Inc., a global leader in cannabis research and production, today announced its support of two new clinical studies: a pilot study led by Murdoch Children’s Research Institute (MCRI) in Melbourne, to evaluate the feasibility and acceptability of a larger randomized placebo-controlled trial of cannabis extract as a form of treatment for reducing Severe Behavioral Problems (SBP) in pediatric patients with Intellectual Disabilities (ID); and a study with McGill University Health Centre’s Division of Infectious Diseases and Chronic Viral Illness, to examine the effectiveness of medical cannabis on immune activation in People Living with HIV.
 
Tilray_Logo“Tilray is at the forefront of clinical research in the medical cannabis field and we’re very proud to support two groundbreaking studies that have potential to identify more indications in which medical cannabis can benefit patients in-need,” says Philippe Lucas, VP of Global Patient Research and Access, Tilray. “We are committed to advancing cannabinoid-based science to further understand the potential benefits of medical cannabis as a treatment option among these critical patient populations. There is a serious need for more clinical data in our field, and we are proud to support research like this around the world.”
 
Murdoch Children’s Research Institute in Australia:  

Over 50,000 youth in Australia today have Intellectual Disability with Severe Behavioral Problems such as irritability, aggression, and self-injury. Anti-psychotic and other psychotropic medications are prescribed for half of these patients in Australia, despite limited evidence for their efficacy and a high risk of serious side-effects, including weight gain, metabolic syndrome and extrapyramidal movement disorders. Polypharmacy and off-label prescribing are common in these patients, and drugs are sometimes added to treat side effects. Novel interventions are urgently needed for this highly vulnerable patient group.
 
The American Academy of Pediatrics and the Royal Australasian College of Physicians have highlighted the need for further research into the therapeutic uses of cannabinoids in youth. There is intense interest from parents and physicians in medical cannabis as a treatment for SBP in youth with ID. Research to date suggests that CBD and other cannabis extracts, have had fewer reported side-effects than anti-psychotic medications; however, there is currently insufficient evidence to inform its use in treating SBP. MCRI is among the first institutions to conduct research specifically testing the effectiveness of CBD on patients with intellectual disabilities to reduce severe behavioral problems.  
 
“We are committed to increasing the scientific understanding of cannabinoid-based medicine as treatment for pediatric patients with intellectual disability and associated severe behavioral problems through this study.” says Associate Professor Daryl Efron, senior researcher at MCRI and pediatrician.
 
The single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants, compares CBD with a placebo in reducing Severe Behavioral Problems in pediatric patients aged eight to 16 years of age with Intellectual Disability. Participants are randomized 1:1 to receive either Tilray C100 oral solution or the placebo.
 
Tilray supplied the medical cannabis products used for this trial, which were successfully exported from Tilray’s Good Manufacturing Practices (GMP) certified facility in Nanaimo, British, Columbia, Canada to Australia in early 2019, with the trial commencing shortly thereafter.
 
The results from this trial are expected to be published by 2020.

OWC Pharmaceutical To Begin Testing On Cannabinoid-Infused Psoriasis Cream

ISRAEL: OWC Pharmaceutical Research Corp., an Israeli-based developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders, announced it has received Institutional Review Board (IRB) approval to conduct safety testing on its proprietary topical crème compound for the treatment of psoriasis and related skin conditions. The approval follows the Company’s February 1, 2017 8K filing announcing an extension to the size and scope of its efficacy study on the same compound, which began in November 2016.

The IRB approved study encompasses the cream itself, as a delivery mechanism, as well as the proprietary psoriasis formulation, and is the first to formally make such claims with the NIH Registry. The double-blind study, which will be conducted on healthy volunteers at one of Israel’s leading academic hospitals, is designed to demonstrate the safety of the formulation in treating psoriasis on human skin tissue. Administrators began soliciting for study participants as soon as approval was received.

Dr. Yehuda Baruch, the Company’s Director of Research and Regulatory Affairs, commented on the announcement, “This approval is a significant milestone for OWC, where our mission is to bring the same rigorous approach common to traditional pharmaceutical development to the medical cannabis field. As we reported earlier this year, the results of our efficacy studies were so encouraging that management decided it was in our interest to extend the size and scope of the study to check the biological markers that had been generated to date, among other things. “

Dr. Baruch went on to say, “With each study we conduct, the ability of our formulation to provide relief for psoriasis-related symptoms to patients suffering from the condition are substantiated. The study that was just approved was designed to assure patients and caregivers that it is safe to use outside of laboratory conditions.”

Ziv Turner, OWC’s Vice President of Business Development and Managing Director of One World Cannabis, Ltd., the Company’s wholly-owned subsidiary, went on to say, “As soon as we announced the formulation of our psoriasis treatment we began receiving requests for the product from patients suffering from the condition. After many years of research and development, this is the final study as we prepare to introduce it to the market. We expect to the program will be in full swing by the end of the month and hope to have it completed by during the second quarter of 2017, and in the hands of patients shortly thereafter.”

Psoriasis is an autoimmune disease that causes red, scaly patches to appear on the skin, and can be associated with other serious health conditions, including diabetes, heart disease and depression. Skin cells in patients with psoriasis grow at an abnormally fast rate, causing a buildup of lesions that tend to burn and itch. While the real cause of psoriasis is not known, genetics are believed to play a major role in its development. According to the National Psoriasis Foundation, psoriasis affects 7.5 million people in the United States.