Mountain Valley MD Holdings Inc (CSE:MVMD) (OTCMKTS:MVMD) is applying its innovative Quicksome desiccation technology to a whole host of applications.
The company is focused on 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 involved in the fight against the coronavirus (COVID-19) and against cancer.
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.
Proactive sat down with Mountain Valley MD CEO Dennis Hancock to find out more about the company’s exciting developments.
Mountain Valley MD is making great progress across a variety of its technologies but I am particularly interested in understanding where you are at with your Quicksol technology?
So, we have had a lot of progress across our Cold Chain, and our Quicksome, and our Dose Sparing Adjuvant, which are all coming along, but you're right, Quicksol is one that we've been getting a lot of press on and doing a lot of work on right now.
For those that don't understand Quicksol was essentially a patent we filed late last year, and it applies to the macrocyclic-like lactone drug class. Essentially, in that class is a drug called Ivermectin which has some pretty broad implications globally, right now for coronavirus (COVID-19) as a therapeutic, while as an anti-parasitic it also has lots of other applications. So we've had a lot of traction with that across a lot of projects.
One of the notable things we did late last year was put our solubilized Ivermectin via our Quicksome patent, through some preclinical trials, and we've achieved a pretty impressive leap forward. In one example, we did an oral to oral comparison where our rapid dissolve sublingual wafer was compared to head-to-head against an existing oral Ivermectin application. Essentially, we used one-fifth of the API - the Ivermectin - and we were able to achieve a one-hour onset versus six hours, so a fairly dramatic increase in bioavailability. And the variability dropped from 40% to 5%. And so these are pretty magical things when you start dosing and looking at broad production.
And then we also did a solubilized Ivermectin that we applied in its pure form, which is essentially the viscosity of water now versus molasses. And what we're able to achieve with that is a 15-minute onset with 0% variability versus a comparable subcutaneous injection of 36 hours. So a really dramatic ability to administer that drug in a way that, candidly, isn't available on earth today. And so when you start to look at its treatments for COVID-19, and some of those applications, it opens up a lot of avenues.
The final comment I'd make on Quicksol relates to another drug in that class, Selamectin, which has really strong literature about its ability to treat tuberculosis. So, we've been able to solubilize Selamectin, and are starting to look at applications in that area as well, which is really exciting.
I know you have been pursuing both human and animal husbandry uses across a broad spectrum of applications. Can you tell us more about your progress there?
There is so much that we've been doing. Perhaps one of the biggest things we announced was the start of some testing in a BSL Four lab - and there are less than 30 of these facilities globally - which has a very strict control for viral outbreaks. Importantly, in this trial we're testing the original COVID-19 variant and then we're also testing the South African variant and Brazil variants. We are expecting news on that trial any day now, for its speed and efficacy for clearing COVID-19 and it will inform dosing and toxicity applications in human trials, which are pending, so really cool progress.
And then, while that's all been happening in the background, we've forged ahead on a couple of animal husbandry trials - one in Canada, that's going down poultry, swine, and cattle. And then we started another parallel trial in Bangladesh with our partners there, doing poultry, goat and cattle. And the significance of these trials is sort of two-fold. One is, again, it informs the efficacy of Ivermectin in our solubilized state into animals, but we're also using a very novel needleless injector application which essentially opens up an airpath the size of a hair follicle and injects the Ivermectin into the animal. Today that's not possible. As I said earlier, there is a very thick molasses-type structure of Ivermectin which is only administered in heavy swine and cattle under restraint and, in many cases, even with a painkiller because it's such a thick, straw-like application.
In Bangladesh, in particular, we're working directly with the government and senior husbandry officials in the application, because we're looking at some immediate commercialization opportunities inside the country. And then, at the same time, setting up global production hubs that would facilitate our Quicksol, which is the brand name we've applied to that application to facilitate the production of that for global export. So really, really cool. progress there.
The final comment I’d make about worlds we're advancing, is that in North America we've also applied for our 505 B2 pathway with the FDA (US Food & Drug Administration) and with that we would expect, in early 2022, to have our Ivectosol considered for human applications there, which is very significant. And that's predicated on the mass safety data that we've seen.
People don't realize that Ivermectin has been around since the 1980s. It’s administered annually and has been used more than 3.8 billion times in humans with an adverse reaction on average of just 168 events a year, which is safer than most vitamins. So the 505 (b) 2 pathway takes the safety data that's been previously documented, and is a proxy for a fast track with the FDA. So we're working fast and furiously on that and quite excited about what that would bring for our business.
I also noted that in a recent interview, you mentioned some work you were doing in oncology to fight cancers. Can you tell us more about what you are doing there?
Yeah, that's also an amazing area. I've hinted at that being on our whiteboard for quite some time and there's an overwhelming mountain of evidence around Ivermectin in its effectiveness in cancer, but again, the number one limitation has been solubility. So now that we've got a form that could be injected, which only uses two excipients that are already approved by the FDA, we are exploring aggressively an application of injecting solubilized Ivermectin directly inside a tumor.
We will be pronouncing on the specific trials and cancer types., but broadly - based on the supporting literature - we're going after breast cancer, melanoma and bladder cancer as strong candidates for what we believe we can achieve in that. Most people on earth have been affected in their family or degrees of separation by someone that's been impacted by cancer and so it would be really amazing to be able to progress in that area. One of our company’s founding mission statements is ‘More life, less death’, and I can't think of a better topic than cancer to make good global impact in.
Absolutely. So what do you consider is your main strength as Mountain Valley MD CEO?
So our principal scientist is a very brilliant guy. We acquired him and some of his patents previously, and he's invented some really novel applications here. So probably my biggest strength is marshaling the team around him to achieve a lot of science very fast. That essentially involves building third-party networks and in-house infrastructure around our formulation lab.
We’re a hockey country here in Canada, with Wayne Gretzky one of the greatest-ever players, so my job is like making sure Wayne Gretzky gets the right ice-time and is set up to score and impact the team. I consider myself very fortunate to be leading this team, so my role in inspiring them and making sure they have the right resources to achieve a lot very quickly is my number one strength.
And what should investors expect from the company over the current year?
The idea of getting vaccines more efficiently to the people globally and to the countries that need them the most is very inspiring work for us. So I think the way I would translate that to our investors is that this is a massive foundational year for the company. All of our breakthroughs are right on the precipice and we expect some very significant things.
Looking at valuations of similar biotechs, even just ones that are pursuing cancer, there’s one company we've been watching, for example, with something we believe will be a fraction of what we're about to demonstrate in cancer, that alone has a $5 billion valuation for a partner.
And so we're working on the types of applications to bring significant shareholder value. And I think shareholders that understand the rocket ship that we're building and where we're headed, will be excited about our ability to bring technology into commercialization status this year.
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