First US Clinical Study Assessing Hemp-Derived Cannabinoid Supplementation In Recovery From Traumatic Brain Injury Begins In Colorado

COLORADO:  The Flowering HOPE Foundation and Clover Leaf University have just announced sponsorship and collaboration on the first US clinical study to be approved to investigate plant-derived cannabinoid supplements in recovery from brain injury. 

The study will analyze quantitative EEG brain activity and a cannabinoid-sensitive salivary biomarker in 40 subjects with mild traumatic brain injury and controls who currently take hemp-derived botanical supplements on a regular basis (i.e. phytocannabinoids). The study is recruiting adults age 18 to 55 to participate in the year-long trial. 

Jason Cranford, Founder of the Flowering HOPE Foundation, a Colorado registered 501(c)(3) nonprofit organization that supports the medicinal use of plant-derived cannabinoids, called phytocannabinoids, described the motivation for sponsoring the study: “We hope to provide scientific support for the benefits of the natural plant-based compounds contained in hemp and move a step closer towards the unrestricted availability of non synthetic cannabinoid therapeutics.”

Cranford is a pioneer in the emerging cannabis industry with more than 25 years experience in cultivation, extraction and formulations. His know-how allowed him to breed a unique hemp strain selected for a blend of phytoterpenes and phytocannabinoids designed to alleviate treatment-resistant epilepsy in children without psychoactive side effects. The resulting strain, called Haleigh’s Hope, was formulated into a supplement offered by the FHF (2013). 

The FHF has partnered with Clover Leaf University to study brain injury. The President and Founder, Chloe Villano, received accredited approval for CLU in 2013 by the Colorado Department of Higher Education’s Private Occupational School Board. Villano is a pioneer in the cannabis and hemp industry and prioritized brain injury for the study.

“This historic study is the first of its kind and it is a privilege to work with the Flowering HOPE Foundation to address the problem of brain injury and collaborate with a neuroscientist who understands the brain endocannabinoid system, such as Dr. Cooper. There are currently no effective treatments for traumatic brain injury or chronic traumatic encephalopathy, but phytocannabinoids may be a good candidate, based on the established science of anti-inflammatory and neuroprotective mechanisms. Clover Leaf University is excited to take the lead in clinical studies that will improve and save lives,” said Villano.

The lead neuroscientist responsible for the study,  Don Cooper, Ph.D, is President of Real-Time Diagnostics Ventures Inc. He has published 45 peer reviewed papers on neuronal memory formation/plasticity and has studied brain cannabinoids since 2000, when he received his first NIH grant. 

“I never thought it would take almost 20 years from when I started working on the brain cannabinoid system to have the first approved clinical study on phytocannabinoids and brain injury. We have convincing preclinical data showing that phytocannabinoids are neuroprotective and may be critically important for restoring neuronal function after brain injury,” stated Cooper.

For more information contact the study Clinical Coordinator at TBIstudy@protonmail.com.

Librede Inc. Awarded Highly Competitive Phase II SBIR Grant From NIH

CALIFORNIA: Librede, an early stage biotechnology company, has been awarded a $1,490,000 Phase II Small Business Innovative Research Grant (SBIR) from the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), to further develop and scale their proprietary yeast-based cannabinoid production platform.

The NIH SBIR program is a highly competitive program aimed at translating cutting edge research with large societal, health, and economic benefits into commercial products. This new grant follows the successful completion of a previous Phase I SBIR award granted to Librede by NIH, covering development of complete biosynthesis of cannabidiol (CBD) in yeast. This platform technology has been patented by Librede (Patent # 9,822,384) and will serve as the basis of an industrial scale pharmaceutical cannabinoid production system.

In the new Phase II award, Librede will improve titers and scale the technology in large bioreactors. Dr. Anthony Farina, Librede’s Chief Scientific Officer (CSO) and Principal Investigator of the new Phase II award, explains Librede’s technology and current focus, “By harnessing the power of genetic, metabolic and protein engineering, we have developed a highly robust system to produce the valuable therapeutics found in the cannabis plant. We have successfully demonstrated the production of CBD in yeast from low cost feedstocks such as sugar. The CBD produced in our system is identical to agriculturally produced CBD, but our system is more efficient and better controlled. Now we will begin to scale our technology. This is the last technical step that must be addressed before we can move into production and provide high quality, pharmaceutical grade cannabinoids.”

Cannabidiol (CBD) is one of many cannabinoids that are currently being explored as therapeutic agents for a wide range of diseases. As new uses for these compounds are discovered, the market for cannabinoids will continue to rise globally, with many estimates placing the market size in excess of $50B in 2020, with that of CBD alone being $2.1B. As the market rapidly expands, this industry will require innovation that can increase volume, reduce costs, and improve the quality of these therapeutic compounds. Librede’s fermentation platform has the ability to meet this demand.

Dr. Jason Poulos, Chief Executive Officer (CEO) of Librede explains, “Other industries have turned to biotechnology to source high value ingredients in an environmentally and economically sustainable way. Here at Librede we are taking a similar approach to the large scale production of cannabinoids. Agricultural production is high in cost and not environmentally sustainable requiring large amounts of land, water, labor, pesticides, fertilizers, and energy. By utilizing a different manufacturing approach, production is faster, lower in cost, and uses less water, less land, and less electricity, while requiring no fertilizers or pesticides. Although our initial focus is CBD production, development of this technology is also applicable to production of other cannabinoids.”

Librede Awarded NIH Funding to Optimize Cannabinoid Production in Yeast

CALIFORNIA: Librede, a San Diego-based synthetic biology company, has received a Phase I Small Business Innovative Research (SBIR) Grant from the National Institute of General Medical Sciences (NIGMS), part of the National Institutes of Health (NIH), to improve Cannabidiol production in genetically engineered yeast.

Cannabidiol (CBD) is one of several pharmacologically active chemicals (cannabinoids) found in the cannabis plant and has been shown to be useful in treating a wide range of diseases including childhood epilepsy. Librede recently completed another NIH Phase I SBIR to engineer production of CBD from sugar; Librede’s new award will improve the yield of CBD production in preparation for commercial launch. Dr. Anthony Farina, Librede’s Chief Scientific Officer, explains, “Our pioneering work producing cannabinoids in yeast has given us a number of insights into the redirection of yeast metabolism for CBD production. During this NIH award, our team will implement these insights to improve production efficiency of our current CBD-yeast system. High throughput techniques and new gene editing tools allow us to make a large number of modifications and screen them for performance rapidly and inexpensively.”

Although the therapeutic value of many cannabinoids is well recognized, their primary source is the cannabis plant, which produces most of the 70+ cannabinoids in very low amounts, requiring problematic large scale agricultural production. Dr. Jason Poulos, Chief Executive Officer of Librede, explains: “As demand for cannabinoids increases we must find an environmentally and economically sustainable way for their production. Large scale agricultural production is environmentally destructive, requiring huge amounts of land, water, fertilizers, pesticide and energy. Our yeast-based system is superior to agricultural production with respect to all of these areas.”

Although the focus of this award is on CBD, Librede’s platform is capable of making many different cannabinoids. “It is straightforward to modify the engineered yeast to produce a number of different cannabinoids,” said Dr. Farina. “Many of these cannabinoids are produced in plants at such low levels that it is infeasible to produce them agriculturally. We are very excited to expand the range of cannabinoids produced for use in pharmaceutical studies.”

 

 

CBD and THC: What’s the Difference?

CBD and THC: What’s the Difference?

What is the difference between CBD and THC? Why is CBD preferred over THC in the medical community? We explore each compound and its effects on the body.

Medical marijuana patients have a wide range of marijuana strains available to them. While most people are familiar with the strains that contain high levels of THC (the compound that gets you high), there are also strains with higher levels of CBD (non-psychoactive).

What’s the difference between CBD and THC?

THC is Psychoactive – CBD is Not

THC is probably best known for its psychoactive effects. CBD, on the other hand, is actually non-psychoactive – meaning it can’t get you “high”.

Because of its non-psychoactive properties, CBD is usually preferred by the medical community and has even been used to treat some younger patients for a variety of ailments. CBD can also act as a very effective anti-psychotic for patients who suffer with schizophrenia.

THC is preferred by recreational users because of its psychoactive effects. Pure THC oil can amplify this effect – especially for inexperienced users.

CBD is Calming – THC Can Cause Paranoia

CBD is believed to have a calming effect, whereas large amounts of THC can cause some people to feel paranoid or anxious.

One very small study, which was published in the Journal of Pharmacology, found that CBD helped patients suffering with Social Anxiety Disorder. More research is needed to measure the true effects of CBD on anxiety, but there’s plenty of anecdotal evidence that backs up this claim.

THC Promotes Sleep – CBD Wakes You Up

Many people use marijuana as a sleep aid, and it’s the THC that’s responsible for its sleep-inducing effects.

CBD has the complete opposite effect. Studies have shown that CBD actually makes you feel more awake and alert.

The differences between THC and CBD make it abundantly clear why the medical community prefers CBD. It’s calming, gives you a boost of energy and won’t get you high. Some studies have also found that CBD can reduce some types of inflammation as well as nausea.

Marijuana that has a mix of both THC and CBD tends to offer the best results. In cases where THC causes anxiety and confusion, CBD appears to counteract or prevent it. Different strains have different levels of each compound; with one being more prevalent than the other. That’s why it’s important to choose the right strain for the symptoms you want to treat.

There are numerous strains of marijuana out there, and each one has a different effect on the body. Sites like Weedy.com simplify the process of finding the right strain by allowing users to explore strains based on type, symptoms and effects.

 

Medicine Has Yet To Find Something Wrong With Marijuana

The conservative National Review magazine recently opined in an editorial: “Compared to binge drinking or alcohol addiction, marijuana use is a minor public health concern.”

There is no record of anyone dying from the direct toxic effect of using marijuana. It doesn’t cause cancer. We know from scientific study that it kills or stalls the spread of cancer cells in a petri dish. The big problem is that the government won’t allow clinical double-blind studies on people because marijuana is classified as a Schedule 1 drug with no accepted medical use. Those are the kind of studies where you figure out effective therapeutic dosages.

As far as public policy is concerned, activists have been pushing that envelope the past couple of decades through state initiatives and federal suits. Now that polls are showing that the majority of Americans believe marijuana should be legalized, there will be more movement — a CNN/ORC poll released last week found that 55 percent of Americans favor marijuana legalization. (If a president is elected with 55 percent of the vote it’s considered a landslide.)