- Quicksome uses advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats
- Developing products for pain management, weight loss, energy, focus, sleep and anxiety
- Also looking at the fight against coronavirus (COVID-19)
What Mountain Valley MD does:
Mountain Valley MD Holdings Inc (CSE:MVMD) (OTCMKTS:MVMD) is building a world-class biotech and life sciences company centered around the implementation of its patented Quicksome oral drug formulation and delivery technologies.
The Vancouver, British Columbia-based company applies its Quicksome desiccation technology towards the oral delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep and anxiety. It is also looking at the fight against the coronavirus (COVID-19).
The patented Quicksome technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally.
Quicksome enables unprecedented delivery impact through sublingual and buccal formats that provide direct absorption into the bloodstream, dramatically improving drug efficacy, dosing and end-user experience. 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.
Activating molecules and formulas with Quicksome also vastly improves their economic viability, opening up markets and applications that were previously not feasible for our partners. By way of example, the group is working on applications where it can eliminate the need for subcutaneous injection with needles. Such applications can vastly improve access and the economics for life-saving drugs globally.
The Quicksome technology has been in development since 2010, and initially incorporated into several commercial dietary supplement products. To date, the company has 14 patents in its portfolio, 12 extensions and has filed over a dozen provisional patents with respect to its Quicksome technology.
Led by president and CEO, Dennis Hancock, the group’s management team brings together world-class leadership across mucosal delivery sciences, molecular research, IP and legal management, marketing, distribution and financial services
How is it doing:
Mountain Valley MD has had a busy 2021 on several fronts, including in the battle against the ubiquitous coronavirus (COVID-19).
Recently, the company also revealed it had hired experienced pharma executive D. Azhar Rana as its chief medical officer (CMO).
Dr Rana has nearly two decades of life sciences experience in clinical development, pre and post launch medical affairs, regulatory and commercial strategy, including ten years of pharmaceutical leadership at Bristol Myers-Squibb, Novo Nordisk (NYSE:NVO) and AstraZeneca.
In May, the firm revealed it aimed to progress to Phase One human trials after a lab study of its Ivectosol technology showed positive antiviral effects on three coronavirus variants.
The BSL-4 study was the first of its kind ever conducted with human grade solubilized Ivermectin in the world, noted Mountain Valley, and was tested on the original B.1.1.7 variant, the South African B.1.351 variant and the P.1 Brazil variant.
Transgenic mice were modified with human ACE2 receptors and then dosed by aerosolization with COVID-19. Then, after five says, the mice were dosed with ascending therapeutic doses of Ivectosol as intramuscular injection.
"This is the validation of our Ivectosol technology that we were looking for in its direct application to stop the replication of the targeted COVID-19 variants," the company had said.
The same month, the company updated investors on other news highlights from its trial portfolio, listing the following:
- It has filed the Porous Aluminum Nano-Structured Adjuvant patent to support its advanced vaccine dose sparing work, with results from the associated study expected in late May or early June
- Husbandry animal trials have started in Canada and Bangladesh to validate the superiority of its injectable solubilized Ivermectin technology, Ivectosol 1%, versus current commercially available forms to treat a broad category of animal parasites, with results from both studies expected in June
- It has filed the cancer patent for direct intratumoral injection, intravenously, infusions or instillations as adjuvants for broad chemotherapeutic to immunotherapeutic cancer regimens
- Separate pre-clinical trials for triple-negative breast cancer, metastatic melanoma and Lewis Lung Carcinoma are being conducted..
In July this year, the company presented more positive findings from tests using its Quicksome technology, namely, to store a polio vaccine, outside of the traditional cold chain system.
As reported in June, MVMD struck a two-year collaborative research agreement with the US Food and Drug Administration (FDA) to support the continuation of research, development, and evaluation of its Quicksome controlled cold chain technology.
The current system dictates that the vaccines, during transport and storage, must be preserved at a temperature range between plus 2°C and plus 8°C from the time the vaccine is produced until it is administered.
The tests used Quicksome with the Trivalent Inactivated Poliovirus Vaccine (tIPV). It was left in a vial for five days exposed to 40°C and then reconstituted for injection at the point of administration.
The Trivalent IPV is composed of three serotypes of inactivated polioviruses and IPV serotypes one and three achieved 50% preservation and stability, while IPV serotype two achieved 100% preservation and stability, said the company.
Notably, the 100% preservation and stability of IPV serotype two exceeds the WHO's guideline temperature requirements for all three defined vaccine management categories, noted the company.
On March 16, 2021, the company revealed it was starting husbandry animal trials in Bangladesh for the company’s injectable solubilized Ivermectin technology, Ivectosol 1%. Mountain Valley MD will be working under the supervision of Bangladesh’s Ministry of Fisheries & Livestock on the trials.
Ivectosol 1%, a fully solubilized form of the anti-parasitic drug Ivermectin, will be tested in cattle, goat and poultry under the supervision of the Bangladesh government's approved and authorized laboratories and research institutes, Mountain Valley told investors.
The company is working with local partner R&G Group of Bangladesh to quickly advance research, development and manufacturing capabilities inside the country.
In March, Mountain Valley MD announced that it had achieved a water solubilized selamectin product using its patent-pending Quicksol technology.
To date, the company noted, selamectin was considered a virtually water-insoluble molecule with tremendous potential in treating parasitic infestations in husbandry and companion animals, as well as mycobacterium-based infections, including buruli ulcer, leprosy, and tuberculosis.
Mountain Valley MD said its scientists have successfully solubilized selamectin at 15mg/ml into a water solution without any organic solvents, which it believes is a critical achievement to allow formulation into topical application creams, oral rapid dissolve sublingual tablets, and injectable applications.
The company has filed for trademark protection under the brand name Selactosol to support its continuing work within the Quicksol line of water solubilized macro-cyclic lactones.
The company has focused its initial efforts on already-approved macro-cyclic lactones because they will yield the broadest commercialization opportunities in the shortest period of time. Having successfully applied the Quicksol solubilization technique to the selamectin drug, Mountain Valley MD said it will now proceed to formulate Selactosol 1.5% for preclinical evaluation trials of mycobacterium-based infections such as buruli ulcer, leprosy, and tuberculosis.
In February, the company said it had struck an agreement with Circadian Wellness Corp to apply Quicksome technology to mushroom neutraceutical products.
The agreement includes ongoing product royalties and an initial payment of C$250,000 to Mountain Valley MD – the company’s first revenue. The $250,000 - which is comprised of $200,000 cash and $50,000 in Circadian shares - will go towards formulation, product development and sample development work, the company said.
Mountain Valley MD said it was working closely with Circadian on proprietary formulations for mushroom-infused products that achieved a significant increase in overall molecule efficacy with Quicksome desiccated liposome technology applied across a variety of rapid dissolve oral products. Circadian is finalizing its product plans and go-to-market strategy for a broad line of naturally derived mushroom products that will first be distributed in North America.
On the patent front, in January, Mountain Valley MD said it had filed a patent to protect its Porous Aluminum Nano-Structured Adjuvant (PANA) process for vaccine dose sparing, which allows a vaccine to be delivered at a fraction of its normal dose without losing potency.
The PANA patent includes a novel adjuvant that was created to be fully compatible with current vaccine manufacturing methods.
Adjuvants are pharmacological or immunological agents that improve the immune response of a vaccine, the company said, enabling vaccines to produce more antibodies and achieve longer-lasting immunity, thus allowing for lower dosage.
Inflection points:
- Phase I trial for Investosol for coronavirus
- More news on Husbandry animal Ivectosol 1% trials
- Cold chain development news
What the boss says:
In the July statement on the results of cold chain storage evaluation of Quicksome, Dennis Hancock, CEO of Mountain Valley, said: "MVMD’s Quicksome technology has taken an important step forward in our pursuit to change the global vaccination landscape and provide more certainty of vaccine distribution to the most disadvantaged communities in the world. With the planned work in the coming months on our tIPV project, we feel our Quicksome technology is progressing positively towards our vision of reducing the complexity, wastage and significant costs associated with cold chain distribution."
Conatct the author at giles@proactiveinvestors.com