MOUNTAIN VALLEY MD ANNOUNCES RESULTS FROM COLD CHAIN STORAGE EVALUATION OF NOVEL QUICKSOME TECHNOLOGY
Mountain Valley MD Holdings Inc. has released the results of its recent controlled cold chain evaluation of the company's Quicksome desiccated liposome technology.
The controlled cold chain evaluation was the company's first attempt at assessing the ability of a thin Quicksome desiccated liposome layer of trivalent inactivated poliovirus vaccine (tIPV), using a method of preservation in a vial for five days of exposure at 40 degrees Celsius and then reconstituted for injection at the point of administration.
Controlled cold chain testing results
The tIPV stability evaluation was conducted to assess the preservation application of the company's's Quicksome technology after five days exposure to 40 degrees Celsius. Trivalent IPV is composed of three serotypes of inactivated polioviruses.
IPV serotype two -- achieved 100 per cent preservation and stability.
IPV serotypes one and three achieved 50 per cent preservation and stability.
The 100-per-cent preservation and stability of IPV serotype two exceeds the World Health Organization's (WHO) guideline temperature requirements for all three defined vaccine management categories, including traditional cold chain between plus two degrees Celsius and plus eight degrees Celsius, extended controlled temperature conditions (ECTC) above plus eight degrees Celsius for a specified number of days to support vaccine distribution, and controlled temperature chain (CTC) where the vaccine must be able to tolerate ambient temperatures of at least plus 40 degrees Celsius for a minimum of three days.
IPV serotypes one and three will be the focus of the next phase of evaluation the company will conduct by focusing on lowering residual moisture content, achieving more robust liposomal protection, and faster drying of the mixture within the vial. The company's objective is to achieve full CTC compliance at 40 degrees Celsius for tIPV polio vaccines in a vial format that can be reconstituted at the point of administration for injection and is immediately commencing this work.
As announced in the company's news release dated June 24, 2021, the company has formally entered into a two-year collaborative research agreement with the Food and Drug Administration. The collaborative research agreement will support the continuation of research, development and evaluation of the company's Quicksome controlled cold chain technology.
"The validation of Mountain Valley MD's Quicksome technology supports our exploration around the ability to transport and store the polio vaccine outside of the traditional cold chain system," stated Mike Farber, director of life sciences for Mountain Valley MD. "While we will immediately pursue our goal of 100-per-cent preservation of trivalent IPV, our initial preservation achievement of IPV serotype two we believe is a proxy that we can apply to other vaccines in the future."
Cold chain is a temperature-controlled supply chain that prescribes necessary conditions during the transport, storage and handling of vaccines to preserve a temperature range between plus two degrees Celsius and plus eight degrees Celsius from the time the vaccine is produced until it is administered. Current estimates place cold chain biopharma logistics spending for 2020 at $17.2-billion (U.S.) annually, with costs due to failures in temperature-controlled logistics estimated at approximately $35-billion (U.S.) per year, and in most cases representing over half of a vaccine's cost. The WHO estimates that more than 50 per cent of vaccines are wasted globally every year due to temperature control, logistics and shipment-related issues.
"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," stated Dennis Hancock, president and chief executive officer of Mountain Valley MD. "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."
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.
Mountain Valley'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 toward helping people live their best life, Mountain Valley applies its Quicksome and Quicksol technologies to its groundbreaking 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). Mountain Valley'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 U.S. Food and Drug Administration, 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.