TORONTO , March 1, 2021 /CNW/ – Mountain Valley MD Holdings Inc. (the ” Company ” or ” MVMD “) (CSE: MVMD) (FRA: 20MP) (OTCQB: MVMDF) is pleased to announce it is commencing husbandry animal trials with a third-party preclinical contract research organization (“CRO”) to validate the superiority of the Company’s injectable solubilized Ivermectin technology, Ivectosol™ 1%, versus current commercially available forms to treat a broad category of animal parasites.
MVMD’s Ivectosol 1% will be tested in swine and poultry by way of advanced intra-muscular needleless injection to prove superior pharmacokinetics in terms of CMAX (peak serum concentration that a drug achieves) and AUC (area under the curve) with targeted drug withdrawal times within 10 days of administration. Additionally, the study is anticipated to demonstrate superior ease of administration with elimination of typically heavy restraint requirements, elimination of injection pain for the animal, while dramatically reducing the risk of potentially fatal clostridial infection common with traditional injection site penetration from large gauge needles.
“This is a very significant project that will move very quickly and will form the basis for our submissions in new animal drug applications to the Food and Drug Administration,” stated Dennis Hancock , President and CEO of Mountain Valley MD. “With our solubilized Ivectosol™1% solution, we will be able to pursue new injectable markets for Ivermectin such as game and poultry that doesn’t exist today, opening up tens-of-billions of animal applications globally per year.”
The Company’s Ivectosol 1% solution uses no harmful organic solvents and is the viscosity of water, which enables novel needleless injector applications. The Company believes the use of needle-free injection systems with a solubilized Ivermectin will deliver significant benefits to livestock and poultry producers, including increased efficacy and elimination of needles that transfer disease and risk of breaking into food supply, improved administration simplicity with reduced labour and safer handling protocols, minimized tissue damage that traditionally negatively impacts yields, and precision dosing that helps to eliminate human error.
Proceeding with the animal trial is part of the Company’s plan to pursue the broad husbandry and companion animal markets with its Ivectosol™ 1% technology, focused immediately on cattle, swine and poultry industries with a combined annual consumption market size of more than 67 billion animals.
Additionally, the Company is pleased to announce the introduction of Michel Rondeau , Doctor of Veterinary Medicine, as an advisor who will be overseeing the study and driving global pharmaceutical husbandry applications as part of the ongoing business commercialization of MVMD’s technology.
Dr. Rondeau has extensive experience in veterinary research having worked with numerous pharmaceutical companies in animal drug field trials and is credited with co-inventing a global award winning sprayable vaccination device that was acquired by Rhone Poulenc. Dr. Rondeau has completed an extensive range of research and development projects across a diverse range of husbandry animals including porcine industrial medicine across preventative and curative medicine, nutrition and animal health products and automated feed systems.
“I am honoured to be working with Mountain Valley MD in this advisory capacity and driving such transformational work that has the potential to broadly transform the animal health industry globally,” stated Michel Rondeau , Doctor of Veterinary Medicine and lead husbandry animal advisor for Mountain Valley MD.
These studies, which will be overlooked by Dr. Rondeau, are in line with MVMD’s belief that treating potential pandemic diseases in their zoonotic hosts can prevent further outbreaks in humans by eliminating their ability for transmission.
“We believe these pivotal studies in swine cattle and especially poultry will highlight the advantages of Ivectosol 1% over any existing competitive product today,” stated Mike Farber , Director of Life Sciences at Mountain Valley MD. “We anticipate Ivermectin’s antiviral qualities to prove extremely valuable to control outbreaks of influenza viruses such as H5N1 and H5N8 in poultry and the ability to use needleless applicators to inject Ivectosol 1% will be game changing for the livestock and poultry industries.”
As reported by Bloomberg** on February 22, 2021 , an avian flu variant that’s been spreading in wild birds and occasionally spilling over and killing poultry for years recently caused the first reported human infections in southern Russia . New strains capable of infecting people raise concern because of the potential for them to mutate and become better suited to human respiratory tracts, potentially sparking dangerous epidemics.
MVMD plans to evolve its testing after the current trials are completed to demonstrate the efficacy of its proprietary Ivectosol™ 1% solution in protecting fowl against Avian influenza viruses such as H5N8 and H5N1, opening the door for broad flock protection against these rapidly spreading viruses.
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 format 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.
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.
* Global Animal Statistics & Charts: 2020 Update
** The Bird Flu Virus That Has Infected People in Russia
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 husbandry animal trials for its proprietary Ivectosol 1% technology; the results and implications thereof; the engagement as advisor Dr. Rondeau and his involvement with the trials; and generally the impact of Ivectosol 1% technology on applicable industries and markets.
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.
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