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June 19, 2020
Allied Corp. Begins Human Clinical PHASE I Research Trial for PTSD Pharmaceutical Product: ALID10
Kelowna, BC, Canada – June 19th, 2020 – Allied Corp. (“Allied” or the “Company”) (OTCQB: ALID), an international medical cannabis company focused on creating and providing targeted cannabinoid health solutions to address today’s medical issues is pleased to announce the initiation of a pharmaceutical human clinical PHASE I research trial with MGC Pharmaceuticals (“MGC”) (ASX: MXC).
Under the terms of this agreement, MGC Pharma will provide a comprehensive suite of pharmaceutical services to advance Allied’s pharmaceutical products into human clinical PHASE 1. This trial will test the efficacy and pharmacodynamics of Allied’s pipeline of proprietary cannabis derived drug candidates targeting Post Traumatic Stress Disorder (PTSD). The scope of MGC Pharma’s services will cover clinical research, IMP registration, manufacturing of lab volumes for the research project, drug stability testing, GMP manufacturing and regulatory assistance for obtaining an Investigational Medicinal Product (IMP) number that is needed in order to sell the pharmaceutical product.
Allied has also conducted an extensive prior art review on its previously submitted provisional patents for products AC001 and AC002 and has decided to abandon these. Along with creation of new formulations, representing the conception of new inventions, and its prior art review, Allied will submit patent submissions for products ALID-10 and ALID-11. ALID-10 and ALID-11 will be the products entering into the human clinical trials.
“This agreement with MGC Pharma is a significant milestone for Allied as we continue to make progress towards advancing our first cannabis derived pharmaceutical product into clinical trials for PTSD”, said Calum Hughes, CEO of Allied. “The drug candidates to be developed in our collaboration with MGC Pharma have been validated by Allied’s research through preliminary case study evidence conducted by our corporate physician and the Allied team. We are excited to be working with MGC Pharma, a company with a proven track record in developing cannabis-based drugs and bringing them to market. We look forward to leveraging their technical capabilities to accelerate the development, manufacturing and sales of our first pharmaceutical product for PTSD”.
For more information on Allied Corp., visit www.allied.health
About Allied Corp.
Allied Corp. is an international medical cannabis production company with a mission to address today’s medical issues by researching, creating and producing targeted cannabinoid health solutions. Allied Corp. uses an evidence-informed scientific approach to make this mission possible, through cutting-edge pharmaceutical research and development, innovative plant-based production and unique development of therapeutic products.
About MGC Pharma:
MGC Pharmaceuticals Ltd (ASX: MXC) is a European based bio-pharma company developing and supplying affordable, standardised, high quality phytocannabinoid derived medicines for the growing demand in the medical markets in Europe, North America and Australasia. The Company is initially targeting two widespread medical conditions – epilepsy and dementia – and has a number of products in the development pipeline.
Employing its ‘Nature to Medicine’ strategy, MGC Pharma has a number of research collaborations with world renowned institutions and academia to optimise the development of targeted phytocannabinoid derived medicine products prior to production in the Company’s EU-GMP Certified manufacturing facility. The Company has a growing patient base and through its global distribution footprint via an extensive network of commercial partners, has the ability to supply the global market.
This press release contains “forward-looking information” within the meaning of applicable securities laws in Canada or “forward-looking statements” made pursuant to the “safe harbour” provisions of the United States Private Securities Litigation Reform Act of 1995 (collectively, “forward-looking information”). Forward-looking information may relate to the Company’s future outlook and anticipated events, plans or results, and may include information regarding the Company’s objectives, goals, strategies, future revenue or performance and capital expenditures, and other information that is not historical information. Forward-looking information can often be identified by the use of terminology such as “believe,” “anticipate,” “plan,” “expect,” “pending,” “in process,” “intend,” “estimate,” “project,” “may,” “will,” “should,” “would,” “could,” “can,” the negatives thereof, variations thereon and similar expressions. The forward-looking information contained in this press release is based on the Company’s opinions, estimates and assumptions in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that management currently believes are appropriate and reasonable in the circumstances. Forward looking statements in this press release include the following: that Allied is leveraging the conditions in its Colombia grow operation and future Kelowna location to support its Research and Development efforts; that Allied is making important strides forward to position itself as a leader in the medical cannabis space, that Allied intends to make a series of proposed trademark and other intellectual property protection filings, as part of the Company’s Intellectual Property and Pharma Development (IP&PD) Strategy, statements respecting the joint development, manufacturing, and introduction of TACTICAL RELIEF™ branded products, and the use of proceeds from the offering of convertible notes.
There can be no assurance that the underlying opinions, estimates and assumptions will prove to be correct. Risk factors that could cause actual results to differ materially from forward-looking information in this release include: the Company’s exposure to legal and regulatory risk; the effect of the legalization of adult-use cannabis in Canada and Colombia on the medical cannabis industry is unknown and may significantly and negatively affect the Company’s medical cannabis business; that the medical benefits, viability, safety, efficacy, dosing and social acceptance of cannabis are not as currently expected; that adverse changes or developments affecting the Company’s main or planned facilities may have an adverse effect on the Company; that the medical cannabis industry and market may not continue to exist or develop as anticipated or the Company may not be able to succeed in this market; risks related to completion of the greenhouse construction in Colombia, risks related to market competition; risks related to the proposed adult-use cannabis industry and market in Canada and Colombia including the Company’s ability to enter into or compete in such markets; that the Company has a limited operating history and a history of net losses and that it may not achieve or maintain profitability in the future; risks related to the Company’s current or proposed international operations; risks related to future third party strategic alliances or the expansion of currently existing relationships with third parties; that the Company may not be able to successfully identify and execute future acquisitions or dispositions or successfully manage the impacts of such transactions on its operations; risks inherent to the operation of an agricultural business; that the Company may be unable to attract, develop and retain key personnel; risks resulting from significant interruptions to the Company’s access to certain key inputs such as raw materials, electricity, water and other utilities; that the Company may be unable to transport its cannabis products to patients in a safe and efficient manner; risks related to recalls of the Company’s cannabis products or product liability or regulatory claims or actions involving the Company’s cannabis products; risks related to the Company’s reliance on pharmaceutical distributors; that the Company, or the cannabis industry more generally, may receive unfavourable publicity or become subject to negative consumer or investor perception; that certain events or developments in the cannabis industry more generally may impact the Company’s reputation or its relationships with customers or suppliers; that the Company may not be able to obtain adequate insurance coverage in respect of the risks that it faces, that the premiums for such insurance may not continue to be commercially justifiable or that there may be coverage limitations and other exclusions which may result in such insurance not being sufficient; that the Company may become subject to liability arising from fraudulent or illegal activity by its employees, contractors, consultants and others; that the Company may experience breaches of security at its facilities or losses as a result of the theft of its products; risks related to the Company’s information technology systems; that the Company may be unable to sustain its revenue growth and development; that the Company may be unable to expand its operations quickly enough to meet demand or manage its operations beyond their current scale; that the Company may be unable to secure adequate or reliable sources of necessary funding; risks related to, or associated with, the Company’s exposure to reporting requirements; risks related to conflicts of interest; risks related to fluctuations in foreign currency exchange rates; risks related to the Company’s potential exposure to greater-than-anticipated tax liabilities; risks related to the protection and enforcement of the Company’s intellectual property rights, or the intellectual property that it licenses from others; that the Company may become subject to allegations that it or its licensors are in violation of the intellectual property rights of third parties; that the Company may not realize the full benefit of the clinical trials or studies that it participates in; that the Company may not realize the full benefit of its licenses if the licensed material has less market appeal than expected and the licenses may not be profitable; as well as any other risks that may be further described in and the risk factors discussed in the Company’s continuous disclosure including its Management’s Discussion and Analysis sections in its Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K and Current Reports on Form 8-K filed under the Company’s profile at www.sec.gov.
Although management has attempted to identify important risk factors that could cause actual results to differ materially from those contained in the forward-looking information in this presentation, there may be other risk factors not presently known to the Company or that the Company presently believes are not material that could also cause actual results or future events to differ materially from those expressed in such forward-looking information in this presentation. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers and viewers should not place undue reliance on forward-looking information, which speaks only as of the date made. The forward-looking information contained in this release represents the Company’s expectations as of the date of this release or the date indicated, regardless of the time of delivery of the presentation. The Company disclaims any intention, obligation or undertaking to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required under applicable securities laws.