The World Health Organization has listed Psoriasis as a serious public health concern, with at least 100 million individuals affected worldwide. Psoriasis is a chronic autoimmune skin disease meaning that part of the body’s own immune system becomes overactive and attacks normal tissues in the body. Psoriasis causes patches of thick red skin and silvery scales. Patches are typically found on the elbows, knees, scalp, lower back, face, palms, and soles of feet, but can affect other places (fingernails, toe nails, and mouth). Psoriasis is caused by environmental and genetic factors, as well as unhealthy lifestyles. Increased alcohol consumption and smoking, unhealthy diet and sedentary living makes people more prone to this condition.
An International Federation of Psoriasis Association report indicates roughly 5.0% of people are afflicted with one or more forms of Psoriasis worldwide. Nearly 7.5 million people are affected by this condition in the U.S. alone. Moreover, at least 100,000 new cases are registered and reported every year. A GrandViewResearch Report estimates that in 2016, the market for drugs that treat Psoriasis was valued at $11.3 billion. A recent report by Transparency Market Research on the global Psoriasis treatment market estimates that the market for drugs that treat Psoriasis will reach $12.1 billion by 2024. Increasing awareness regarding treatment and rising demand for improved healthcare infrastructure are among the primary growth stimulants for the market. This rising incidence of Psoriasis is fueling demand globally for innovative viable treatments.
There is no permanent cure for Psoriasis and current treatments only relieve the symptoms of these diseases. Treatments aim to reduce inflammation and scales, slow the growth of skin cells, and remove plaques. Topical ointments (creams) and drugs applied to the affected areas are the common forms of treatment. The high cost of Psoriasis treatments, extensive costs of drug development, and long extensive approval processes are hindering the growth of the global Psoriasis drugs market.
This Company Could Be The Answer
OWC PharmaceuticalResearch Corp, through its wholly-owned Israeli subsidiary, One World Cannabis Ltd.,conducts medical research and clinical trials to develop cannabis based products, specifically designed for smoking substitute and for the treatment of several illnesses/medical conditions including Psoriasis, multiple myeloma, PTSD and fibromyalgia.
OWCP’s goal is to improve patients’ quality of life by developing novel therapeutic methods for the treatment of serious medical conditions using cannabis-based therapies. OWCP is conducting pre-clinical studies and randomized, placebo-controlled clinical trials to evaluate the safety of new cannabis-based compositions and the develop of unique,condition-specific products.
OWCP has made progress using specific dosages of its Cannabinoid-based products administered through soluble pills taken orally, with its initial focus on smoking substitute and chronic pain syndromes. OWCP developed a topical ointment for topical treatment of Psoriasis and other inflammatory skin diseases. The company has also developed a way of delivery for high concentration of cannabinoids in order to treat Multiple Myeloma where they have showed probable efficacy in pre-clinical studies. OWCP’s business model includes collaborative ventures with academic medical centers and highly regarded researchers in Israel. They are licensed by the Medical Cannabis Unit of the Israeli Health Ministry.
There have been numerous studies demonstrating cannabis’s therapeutic value, including a comprehensive research review from the National Academies of Sciences, Engineering and Medicine (NASEM). The 395-page report found conclusive evidence that cannabis and its cannabinoids are beneficial for treating symptoms like chronic pain, nausea and vomiting, and spasticity.
OWCP maintains a competitive edge being based in Israel. Israel is one of the few countries globally which approves Cannabis clinical studies. Scientists in Israel are in a unique position thanks to its expertise in advanced agricultural technologies, in research on the effect of cannabis on the human body, and in drug delivery.
One of the products being developed by OWCP is a topical ointment which is indicated for different skin diseases, but the initial indication is showing promise towards Psoriasis. The ointment could be sold and purchased in countries and U.S. states that have legalized the use of Marijuana for medical purposes.
Results From Clinical Trial
OWCP reported initial results from a pre-clinical trial evaluating the safety of cannabinoid-based topical ointment for the treatment of Psoriasis. According to pre-clinical results, the ointment led to up to 70 percent reduction in Psoriasis-related inflammation parameters. Based on the results from this study, OWCP expanded the size and scope of its pre-clinical trial. OWCP will complete the safety study for a cannabis-based topical ointment containing approximately 3% THC in Sheba Tel Hashomer academic hospital.
- Preclinical studies showed reduction of Psoriasis biomarkers and reduction in keratinocytes.
- Phase I safety study is expected to be completed at Sheba Hospital, Tel Hashomer soon.
- Phase II (efficacy study) initiation planned for Q1-Q2/2019.
- TLR Phase II estimated Q3/2020.
OWCP files patent applications in several countries for its active cannabinoid-based topical ointment. The patent applications, if approved, should accelerate the ongoing discussions and negotiations regarding scientific and medical collaborations. The filing of the patents allows OWCP to engage in serious discussion with potential customers and partners regarding the requirements needed for manufacturing and distributing the ointment.
OWCP has also been issued a patent in Australia for the treatment of skin disorders using its proprietary ointment. The approval marks yet another important milestone as OWCP continues to strengthen its IP portfolio.
New Delivery System
OWCP announced it completed the development of a proprietary, cannabinoid-enriched sublingual tablet to easily deliver medical cannabis, with fast and effective absorption. They have been working on a new delivery system that would make medical marijuana easier for doctors to administer. OWCP has developed a cannabis tablet (ODT – Orally Disintegrating Tablet) which allows doctors to closely monitor dosage, unlike current methods such as smoking and ingesting edibles. This tablet will be a substitute for patients being treated with medical cannabis by smoking. Key indications will include chronic pain syndromes and other conditions associated with pain.
The technology behind the Oral Disintegrating Tablet is protected and provides for the ingestion of virtually any dosage of medical cannabis with a sublingual delivery mechanism, whereby the compounds are absorbed directly into the patient’s blood through oral epithelial tissue.
OWCP has completed the following milestones:
- First generation formulation is fully developed
- Second generation formulation development was completed
- Submission of provisional patent application
- Phase I safety study and PK study completion expected Q1/2019 at Tel Aviv Sourasky Medical Center for smoking/inhalation substitute
In December 2017, OWCP announced they received a new permit from the Israeli Medical Cannabis Agency (IMCA) to proceed with safety studies for their proprietary cannabis soluble tablet delivery system. They concurrently received Institutional Review Board (IRB) approval from the Sourasky Medical Center in Tel Aviv and from the central Israeli Review Board to conduct these studies.
OWCP is also making progress on a Nasal Spray which could potentially treat Fibromyalgia and PTSD. It was already tested in pre-clinical studies and the maximum feasible dose was established. A PK study is ongoing.
OWC Pharmaceutical Research Corp Successfully Tests Unique, Innovative Delivery Formulation Aimed at Multiple Myeloma Therapy
Multiple myeloma is a cancer of plasma cells in bone marrow and its sufferers make up 1 percent of cancer patients around the world. The disease is responsible for 2 percent of the world’s cancer-related deaths.
OWCP developed a cannabinoid-based drug therapy aimed at multiple myeloma therapy. They have shown that a combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) was able to decrease the survival of cancerous cells, and had a synergistic effect with known anti-MM drugs.
SUBJECT TO ACHIEVING RESEARCH MILESTONES, THE COMPANY WILL SUBMIT AN APPLICATION TO THE FDA FOR AN ORPHAN DISEASE DESIGNATION
OWCP’s Intellectual Property Portfolio comprises the following:
- 9 patent families
- 31 patent filings in selected domains at various stages from PCT filings, National Phase filings and Continuations in Part (CIPs)
- 2 of the patent families are in the field of Multiple Myeloma
- 7 patent families are in the fields of pharmaceutical emulsions, Fibromyalgia, Migraine, Sexual Function and Skin Disorders
The Bottom Line
OWCP trades at market cap of just over $24MM.
In their most recently filed quarterly report on Form 10-Q, OWCP reported that it has over $4.2MM in cash and cash equivalents.
OWCP has a number of things going for them. As an innovative developer of Cannabis-based medical and pharmaceutical products, they are centered in Israel – the world leading center for Cannabis research and clinical trial capability. OWCP’s growing intellectual property portfolio protects them from competitors trying to steal their research and apply it for themselves.
Most importantly, OWCP has defined development pathways including medicinal and pharmaceutical products, some of which could be ready for market soon. All of these products in the pipeline provide for growth opportunity as the company continues to successfully implement its vision and plan.
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