Mountain Valley MD files for accelerated review of its macrocyclic lactone solubilization patent with the United States Patent and Trademark Office

Mountain Valley MD Holdings Inc. (CSE:MVMD) (FRA:20MP) said it has filed for an accelerated review of its macrocyclic lactone solubilization patent with the United States Patent and Trademark Office (USPTO). To support the accelerated patent examination request, the company said it has provided the USPTO with new formulation analyses of different diluted concentrations of its Quicksol Ivermectin in solution, data that the company had fast-tracked for completion and validation by a third-party contract research organization (CRO). READ: Mountain Valley MD brings in over $4.3M in oversubscribed private placement to advance pre-clinical trials Mountain Valley MD previously confirmed its ability to make the anti-parasitic drug Ivermectin highly water-soluble without the use of organic solvents, improving its water solubility by nearly 5,000 times and that it had completed its initial safety and improved efficacy in pre-clinical validation with the leading third-party preclinical CRO.   The pre-clinical trials confirmed a significant improvement in the Ivermectin pharmacokinetics and efficacy when applied through the group's Quicksome and Quicksol technologies versus existing oral and subcutaneous forms. Mountain Valley MD'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. The company said it has been closely monitoring the global studies and reports that demonstrate the efficacy of the drug Ivermectin as a therapeutic for coronavirus (COVID-19), including the ongoing work from the Front Line COVID-19 Critical Care Alliance (FLCCC Alliance) and its recent publication outlining the evidence base supporting the efficacy of Ivermectin as a therapeutic to fight COVID-19, including data from 7,825 patients across 24 trials.   Additionally, according to a meta-analysis recently performed by an independent research consortium, it was calculated that the chances that Ivermectin is ineffective in COVID-19 to be 1 in 67 million. In a statement, Mike Farber, Director of Life Sciences at Mountain Valley MD commented: "Despite all of the media coverage of the COVID-19 vaccine rollout, we feel it is important that people understand that a large percentage of the world will not benefit from the current vaccination efforts due to extensive logistical and economic complexities. And then when you layer on the percentage of the global population that have known health challenges due to pre-existing conditions and allergic reactions to vaccines, MVMD believes that solubilized Ivermectin therapeutic will become a critical alternative." The company has also noted recent advancements in Belize, where the Ministry of Health and Wellness formally approved Ivermectin as a prescribed treatment option for persons with COVID-19. According to the Acting Director of Health Services, Dr Melissa Diaz-Musa, Belize's medical response team along with the Ministry of Health extensively reviewed supporting research on Ivermectin and its use in protocols in other countries and found significant evidence that Ivermectin has been beneficial in reducing viral replication and helping with prophylaxis against COVID-19. "Seeing the extensive collection of evidence of the role of Ivermectin as a broad therapeutic application to support COVID-19 suppression and beyond is a significant validation of our work in this area," said Dennis Hancock, President and CEO of Mountain Valley MD.   "Having a third party CRO confirm the exceptional water solubility of Mountain Valley MD's Ivermectin complex formulation and its dramatic improvement we have seen in the pharmacokinetics versus oral Ivermectin tablets and solvent-based subcutaneous injections supports the expedited opening of our patent and its global protection." Mountain Valley MD'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. The group said it 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. 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 to innovate industry-leading products that are sought out globally. The 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. Contact the author at jon.hopkins@proactiveinvestors.com