CALGARY, AB / ACCESSWIRE / August 10, 2021 / Asia Green Biotechnology Corp. ("AGB" or the "Company") (CSE:ASIA) is pleased to announce that it has entered a new agreement with Pathway Rx Inc. ("Pathway Rx") and Swysh Inc. ("Swysh") pursuant to which AGB will expand its participation in the development and ultimate commercialization the Cannabis sativa varieties to which Pathway and Swysh own the rights for prevention and treatment of certain infectious diseases. Both Pathway and Swysh have previously entered agreements with the Company to participate in and to fund initial scientific trials activities on a general basis and in particular with respect to treatments for migraine and related health issues previously being developed by Pathway/Swysh. Under this new agreement, the Company will provide key elements of the financing required to undertake first and second stage human clinical trials of the specific migraine treatments being developed by Pathway/Swysh, and this participation will be rewarded with full licensing rights to such products in the Company's Asian territory as well as the grant of certain royalty provisions for sales of the products in North America.
Events to Date
(1) Pursuant to the agreement announced on December 8, 2020, the Company was granted an exclusive license to develop and commercialize in the region of Asia the Cannabis sativa varieties, and/or versions of the Cannabis sativa varieties owned by Pathway/Swysh for prevention and for treatment of, among other things, migraine head conditions and such other medical conditions, diseases, and ailments that the contemplated research activities may address.
(2) It was the understanding of the Parties at the time that further development of the various varieties and treatment options was limited by restrictions imposed by Health Canada which required the completion of a toxicity study under the direction of Pathway/Swysh. It was the intent of the Company to facilitate the completion of this study and it was prepared to fund that study on the basis provided in the December 8, 2020 agreement.
(3) That agreement further anticipated that future clinical developments activities would be required and the parties had agreed to evaluate and jointly undertake any such work as may be required to, in particular, bring the migraine program to a point of possible commercialization.
(4) After the submission by Pathway/Swysh of evidence of research programs already completed, Health Canada recently agreed to waive any further requirements for the completion of the toxicity study and invited Pathway/Swysh to proceed with the first stage of clinical human trials in respect of the migraine treatment.
Next Steps and Performance Milestones
(1) Based on the intent contained and expressed in the December 8, 2020 agreement, Pathway/Swysh has invited the Company to continue its direct participation in the conduct of these trials. AGB indicated its preparedness to finance and participate in the clinical trial to be undertaken and had confirmed that commitment with a local accredited academic institution.
(2) In order to proceed with the next stages of these clinical trials, the academic institution required evidence that a financing commitment is in place to satisfy the costs of the initial phase of that program.
(3) The initial phase of the trials is expected to have a budget of $275,000, and AGB is prepared to contribute a maximum of $150,000.00. If the results of the first phase of the clinical trials are positive and the various parties agree, a second and more detailed phase of clinical trial will be initiated. The Company is also prepared to and will finance the second phase and understands the expected cost of this will be approximately $400,000.00.
(4) AGB has secured the initial funding necessary to proceed with this first stage, and accordingly has entered the agreement with Pathway/Swysh to commence those clinical trials.
(5) The following is a detailed list of steps to be completed by the parties. Each step to be undertaken must meet with either the pre-approval or the final approval of Pathway/Swysh.
- Contract with local university as Contract Research Organization to conduct the Health Canada clinical trials.
- Submit applications to Health Canada for Phase II clinical trial for treatment of selected conditions.
- Engage a Director of Clinical Studies, pre-approved by Pathway/Swysh, to oversee and guide all clinical studies.
- Hire a formulator of medicines for the clinical studies who meets with the pre-approval of Pathway/Swysh.
This development is a significant part of a wider program to have these varieties, and possibly other versions of the strains, studied for their efficacy in humans and eventually approved and applied as new drugs and as over-the-counter health products. The particular focus of this study and further studies which may be derived from it is on the ability of an element of a proprietary strain to treat and minimize symptoms in those suffering from migraine headaches. In addition to the suffering of individuals, migraine also has an impact on society which can be measured in both direct costs (medical care etc.) and indirect costs (missed work and disability at work).
Dr. Igor Kovalchuk, a director of AGB, is also the chief executive, a director and a shareholder of Pathway Rx and Swysh. As such, he will maintain an active and direct role in the initiation and ongoing administration of the trials to be undertaken. In commenting on these developments, Dr. Kovalchuk stated: "This is a very significant development in the expansion of our relationship with AGB and in particular relative to our progress in testing products with potential to provide migraine headache treatments. Obtaining permission to proceed with clinical trials is an extremely material and positive step, and through this we are confident that we can expand our understanding of the important potential of these products to provide significant benefits to human health."
David Pinkman, CEO of AGB, added: "While we have recently experienced many positive developments in the expansion of our seed distribution and hemp crop promotional activities in SE Asia, to be a core partner in an undertaking such as the conduct of the migraine study clinical trials in Canada is a significant addition to the profile of our business. If successful, these trials may offer AGB sources of income from both the domestic and licensed international markets and, more importantly, will lay the groundwork for the introduction of significant treatments of multiple ailments which have afflicted people around the world."
AGB is an early-stage international bio-technology company focused on the development, evaluation, testing, application and, ultimately, supply to the market of proprietary organic hybridization technology and certain products derived from that technology. The core approach of the business is centred on the planting, growth and harvesting of new and valuable strains of hemp and related crops in commercial quantities under the terms of license agreements with InPlanta Biotechnology Inc., Swysh Inc. and Pathway Rx Inc.
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Chief Executive Officer
The Company is not making any express or implied claims that any product produced pursuant to the terms of its license agreements has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronovirus), migraine conditions or any other medical condition at this time.
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SOURCE: Asia Green Biotechnology Corp.