Advancing Medical R&D for Cannabinoid Medicinal Uses Identifying Growing Number of Health Benefits

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Jun 10, 2021, 08:30 ET

Palm Beach, Fla., June 10, 2021 /PRNewswire/ -- Cannabidiol (CBD) extract is a product that's derived from cannabis. It's a type of cannabinoid, which are the chemicals naturally found in marijuana plants. Even though it comes from marijuana plants, CBD doesn't create a "high" effect or any form of intoxication — that's caused by another cannabinoid, known as THC. CBD is extracted from marijuana plants as either an oil or powder. These can be mixed into creams or gels. They can be put into capsules and taken orally, inhaled or rubbed on your skin. The multiple sclerosis drug nabiximols is sprayed as a liquid into your mouth. How CBD should be used depends largely on what it's being used for. There's some controversy around cannabis products like CBD oil because of recreational marijuana use. But there's growing awareness about the possible health benefits of CBD oil. An article in Healthline.com published what you need to know about several potential medical uses of CBD and where the research stands. It highlighted Anxiety Relief, Anti-seizure, Neuroprotective, Pain relief and Cancer. CBD may be able to help manage anxiety. Studies have shown that CBD may help relieve anxiety by: reducing stress, decreasing physiological effects of anxiety, such as an increased heart rate; improving symptoms of post-traumatic stress disorder (PTSD); and inducing sleep in cases of insomnia. CBD has also been in the news before, as a possible treatment for epilepsy. Research is still in its early days. Researchers are testing how much CBD is able to reduce the number of seizures in people with epilepsy, as well as how safe it is. Active Companies active today in the cannabis related markets include: Tilray, Inc. (NASDAQ: TLRY) (TSX: TLRY), Rapid Therapeutic Science Laboratories, Inc. (OTCPK: RTSL), Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON), Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE), India Globalization Capital, Inc. (NYSE: IGC).

Researchers are also looking to learn about the ways that CBD could help people with neurodegenerative disorders, which are diseases that cause the brain and nerves to deteriorate over time. Researchers are studying the use of CBD oil for treating: Alzheimer's disease, multiple sclerosis, Parkin's disease and strokes. The effects of CBD oil on your brain's receptors may also help you manage pain. Studies have shown that cannabis can offer some benefits when taken after chemotherapy treatments. Other pre-clinical studies sponsored by the National Institutes of Health are also looking at the role of cannabis in relieving symptoms caused by: arthritis, chronic pain, MS pain, muscle pain and spinal cord injuries. Some studies have investigated the role of CBD in preventing cancer cell growth, but research is still in its early stages. The article concluded: "More human studies are needed to fully understand the range of risks and side effects that CBD oil may cause. Studies of CBD oil aren't common. This is partially because Schedule 1 substances like cannabis are highly regulated, causing some obstacles for researchers. With the legalization of marijuana products, more research is possible, and more answers will come."

Rapid Therapeutic Science Laboratories, Inc. (OTCPK: RTSL) Breaking News: Rapid Therapeutic Finalizes Lab Work on Pharmaceutical Formulas - Rapid Therapeutic Science Laboratories (the "Company" or "RTSL"), a SEC fully-reporting, growth-oriented aerosol manufacturing company focused on delivery of non-psychoactive cannabinoid compounds, announced today that it has concluded lab development on three (3) formulas related to manufacturing of pharmaceutical grade isolates used in both metered dose inhalers and other aerosol products.

RTSL has developed three (3) proprietary pharmaceutical formulas, two (2) for cannabidiol (CBD) and one (1) for cannabigerol (CBG), to initially be used in Metered Dose Inhalers (MDI). One CBD formula is expected to be used in testing of the MDI which the Company plans to submit to the U.S. Food and Drug Administration (FDA) in connection with an Investigational New Drug Application (IND), as previously announced. The other two are planned to be used in RTSL's other products.

RTSL's CEO, Donal R. Schmidt, Jr. stated, "We initially set out to find an ultra-pure, unadulterated pharmaceutical grade CBD isolate to use in our MDI. Early on we learned the purity level of an isolate is materially related to airway irritation and the level of cough reflex when using an MDI. We also learned CBD isolate is not chemically compatible with meter dose inhalers without significant modifications in the manufacturing process. In short, we were unsatisfied with any product we could source in the hemp space to meet our needs. As such, we set out to engineer a quality isolate to meet our needs."

"With the purchase of Razor Jacket and the addition of Dr. Drinkwine, each as previously announced, we learned how to manufacture pharmaceutical grade isolate in-house. We believe our process is unique and will result in one or more patents being granted to RTSL. Once the patent applications have been filed, which are planned to be filed in the next few weeks, we expect to release the details of our findings, which we believe will make a significant impact in the hemp space related to isolate manufacturing."

In conclusion, Mr. Schmidt stated, "At this point, as we head to market with other non-MDI products and while we are preparing to submit the IND, we believe we are well positioned as we have an ISO 6 certified aerosol filling lab, we are progressing well on our way to completion of our Good Manufacturing Process (GMP) certification, and we believe we have true pharmaceutical grade Active Pharmaceutical Ingredients (API)." CONTINUED… Read the full Press Release and more for RTSL at: https://www.financialnewsmedia.com/news-rtsl

In other active company news in the healthcare industry this week:

Tilray, Inc. (NASDAQ: TLRY) (TSX: TLRY), a leading global cannabis-lifestyle and consumer packaged goods company, recently announced the launch of Symbios, a complement to the Company's existing medical brand portfolio in Canada. This new brand was developed to provide a broader spectrum of formats and unique cannabinoid ratios at a better price point while offering medical patients a full comprehensive assortment of products, including flower, oils, and pre-rolls for their health and wellness regiment.

Irwin D. Simon, Tilray's Chief Executive Officer, said, "Medical cannabis innovation and patient care are core to the new Tilray's business and global growth strategy. As we look ahead, we remain focused on building momentum across our three medical brands – Symbios, Aphria, and Tilray -- while meeting the large and growing demand for new, high-quality cannabis products that promote health, wellness, and wellbeing."

Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) an innovative global cannabinoid company, and Ginkgo Bioworks, Inc. ("Ginkgo"), which is building the leading horizontal platform for cell programming, recently announced an amended collaboration and license agreement (the "Amended Agreement") that will enable the companies to accelerate the commercialization of cultured cannabinoids at scale.

The Amended Agreement with Ginkgo will enable Cronos Group to commercialize products using cultured cannabinoids ahead of reaching the originally stated productivity targets, while maintaining the incentives to continue to develop towards and achieve the previously agreed upon efficiency and cost goals. This approach is expected to facilitate Cronos Group's cultured cannabinoid products being first to market in Canada, which will drive significant market knowledge and consumer insights that are expected to help deliver future novel and innovative consumer-driven products. Cronos Group expects that the final productivity target for CBG will be achieved prior to September 2021, as previously announced.

Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, recently presented a poster at the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.

The poster titled, "ZYN002 Cannabidiol Transdermal Gel: Efficacy and Safety Findings in Children and Adolescents With Autism Spectrum Disorder (ASD) and Related Disorders," shows that Zygel™ may provide important clinical promise across a spectrum of endpoints, including, behavior, seizure reduction and sleep. The data are from two open-label Phase 2 trials and one double-blind placebo-controlled trial when added to standard of care in children and adolescents. Three groups of patients were evaluated: patients with autism spectrum disorder (ASD); patients with developmental epileptic encephalopathies (DEE) with comorbid ASD; and patients with fragile X syndrome (FXS) with comorbid ASD.

India Globalization Capital, Inc. (NYSE American: IGC) recently announced that it has completed Cohort 2 of its Phase 1 clinical trial on IGC's tetrahydrocannabinol ("THC")-based investigational new drug, IGC-AD1, intended to alleviate the symptoms of individuals suffering from Alzheimer's disease. As previously disclosed, IGC submitted IGC-AD1 to the U.S. Food and Drug Administration ("FDA") under Section 505(i) of the Federal Food, Drug, and Cosmetic Act. IGC received approval to proceed with the trial from the FDA on July 30, 2020.

As previously announced, for Cohort 1, we administered one dose of the investigational new drug IGC-AD1 per day to trial participants. We increased the dosage to two doses of IGC-AD1 per day in Cohort 2, which was conducted from early February 2021 through mid-May 2021. The Data and Safety Monitoring Committee ("DSMC") for IGC's clinical trial, having reviewed the data obtained through Cohort 1 and Cohort 2, recommended progressing to Cohort 3, which consists of administering three doses per day. Participants are monitored daily for safety and certain behavioral changes using, among others, the Neuropsychiatric Inventory (NPI) scale and the Columbia-Suicide Severity Rating Scale (C-SSRS). The Phase 1 clinical trial on Alzheimer's patients is currently anticipated to conclude during the July through September 2021 timeframe.

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