Mountain Valley MD Proceeding With COVID-19 Clearance Trial in Level 4 Biohazard Facility

TORONTO, Jan. 27, 2021 /CNW/ - Mountain Valley MD Holdings Inc. (the "Company" or "MVMD") (CSE: MVMD) (FRA: 20MP) is pleased to announce it has executed an agreement to conduct its Bio Safety Level 4 ("BSL-4") lab study of COVID-19 viral clearance in transgenic mice designed to prove the superiority of the Company's solubilized Ivermectin technology versus commercially available oral form in speed and efficacy of viral clearance.  The agreement was signed January 26, 2021.

"This is a very significant project for MVMD and it will clearly demonstrate how our solubility technology applied to the Ivermectin drug can be applied as a broad therapeutic to immediately treat COVID-19, as well as its role in stopping the deadly spread of future pandemics that are certain to follow," stated Dennis Hancock, President and CEO of Mountain Valley MD.  "Quicksol™ allows us to imagine a world's first as an injectable Ivermectin format for emergency front line usage as well as a rapid dissolve tablet that is administered for prevention like vitamin C around the world."

There are less than thirty BSL-4 facilities in the world capable of performing this study and it is not unusual for projects to take up to three years to schedule.  The Company was able to demonstrate the significance of its patented solubilized Ivermectin technology through its presentation of the superior pharmacokinetic data documented from two previously completed pre-clinical trials and was granted approval by the BSL-4 facility to commence this trial in late February 2021.  The study results are anticipated in April 2021.

This study will be the first of its kind ever conducted with human grade solubilized Ivermectin anywhere in the world and its design was led by the Company's key scientific advisor, Dr. John Clements.  Dr. Clements is Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine and has over 35 years of experience in vaccine, immunology and infectious diseases research and development, with a distinguished scientific career focused on developing and evaluating vaccines for a wide range of infectious diseases globally.

"The transgenic mice model was selected to specifically enable preclinical evaluation of the potential therapeutics and monoclonal antibodies and molecular-based therapeutics as they apply to COVID-19 treatments," stated Dr. John Clements, MVMD scientific advisor and Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine.  "We designed the study with the goal of providing the first in vivo proof of enhanced COVID-19 viral clearance ability using both the oral sublingual product and the intramuscular injection product using MVMD's Quicksol™ technology."

The Company's previously completed pre-clinical trial work with a third-party Contract Research Organization tested the solubilized Ivermectin via both an intramuscular injection and applied to rapid dissolve oral strips with the Company's patented Quicksome™ desiccated liposome technology compared to existing oral and subcutaneous injection solutions.  The results demonstrated that the Company's patented Quicksol™ solubilized Ivermectin offered superior pharmacokinetic performance across every single measure conducted, with no adverse side effects using up to 1/8 less of the Ivermectin drug – a critical component that enables applications to use less of the Ivermectin drug while driving faster viral clearance.

"Given the recent pronouncements from both the World Health Organization* and National Institute of Health** on the acceptance of emerging Ivermectin data related to COVID-19 infection treatment, we believe it is essential to rapidly advance the clinical evidence of the effectiveness of MVMD's solubilized Ivermectin in viral clearance," stated Mike Farber, Director of Life Sciences at Mountain Valley MD.  "We see the supply of Ivermectin tightening globally with prices dramatically increasing so we believe it is more important than ever to enable viral clearance using a fraction of the drug with more certainty."

MVMD expects that the upcoming BSL-4 lab study will demonstrate meaningful dose sparing in two important ways; a reduction in the required Active Pharmaceutical Ingredient (API) Ivermectin due to the applications of the Company's technology, and the shorter course to complete viral clearance.

As previously communicated, MVMD's solubility technology applied to the Ivermectin drug is the only form in the world that uses strictly excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.

MVMD's patent application covers all highly solubilized macrocyclic lactones, including Ivermectin and Selamectin, which have also been shown to be effective in the treatment of tuberculosis even with limited solubility.  The Company believes its solubility technology can dramatically enhance the efficacy of both inhaled and injected Selamectin or Ivermectin providing a novel effective therapeutic for tuberculosis.

For more details on this release, please click on the following video interview:
https://youtu.be/DmWuKdIavI4

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

REFERENCES/SOURCES
* Covid-19: WHO-sponsored preliminary review indicates Ivermectin effectiveness
https://swprs.org/who-preliminary-review-confirms-ivermectin-effectiveness/

** Ivermectin is Now a Treatment Option for Health Care Providers https://covid19criticalcare.com/

ABOUT MOUNTAIN VALLEY MD HOLDINGS INC.

Mountain Valley MD is building a world-class biotech and life sciences company organization centred around the implementation of its patented Quicksome™ oral drug formulation and delivery technologies and its Quicksol™ solubilization technology for macrocyclic lactones, to innovate industry leading products that are sought out globally.

MVMD's proposition for delivering Quicksome™ formulations that have rapid onset, high bioavailability, low variability and precision dosing is core to the Company's success across key health and wellness categories. Consistent with its vision towards "Helping People Live Their Best Life", MVMD applies its Quicksome™ and Quicksol™ technologies to its ground-breaking work for advanced delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep, anxiety, and more.

The Company's patented Quicksome™ desiccation technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally.  The result is a new generation of product formulations that are capable of delivering vaccines, drugs and nutraceuticals into the body faster, with greater impact, efficiency and accuracy. 

The Company's patented Quicksol™ solubilization technology covers all highly solubilized macrocyclic lactones (including the drugs Ivermectin and Selamectin).  MVMD's solubility technology applied to the Ivermectin drug is the only form in the world that only uses excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity. 

For more Company information and contact details, visit www.mountainvalleymd.com.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified by the use of words such as "anticipate", "plan", "estimate", "expect", "may", "will", "intend", "should", and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information.

The Company's actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company.

The Company is making forward-looking statements, including but not limited to with respect to: the commencement, execution and completion of the BSL-4 lab study, including the timing thereof; the results and implications of the BSL-4 lab study, including the demonstration of dose sparing; the global supply of Ivermectin and the need for and effect of viral clearance; the application of Ivermectin as a broad therapeutic, including for the treatment of COVID-19.

The Company believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company's expectations as of the date hereof and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.

SOURCE Mountain Valley MD Holdings Inc.

Dennis Hancock, President and Chief Executive Officer, Mountain Valley MD Holdings Inc., Telephone: [phone], Email: [email protected], www.mountainvalleymd.com