Mountain Valley MD files patent and begins pre-clinical trials to enter USD $100 billion cancer drug market

VANCOUVER, BC, May 4, 2021 /PRNewswire/ - Mountain Valley MD (CSE: MVMD) (FRA: 20MP) (OTCQB: MVMDF) announced it has filed a novel cancer adjuvant patent related to breast cancer, metastatic melanoma, and lung carcinoma.

Mountain Valley MD is a biotech and life sciences company implementing patented Quicksome oral drug formulation and delivery technologies and its Quicksol solubilization technology.

MVMD's core technology applied to the Ivermectin drug is unique in that it only uses excipients (substances formulated alongside the active ingredient) that are currently approved by the FDA.

Adjuvants modify the action of a principal ingredient.

Concurrent with its novel cancer adjuvant patent, MVMD is beginning pre-clinical trials with third-party cancer Contract Research Organizations (CROs).

A CRO is an outsourced company that manages pre-clinical and clinical trials to help bring drugs to market. CRO services typically include: clinical trial patient recruitment, disease coding, statistical analysis and reports.

"Because of its impact, safety and versatility, ivermectin has earned the title of "wonder drug" among public health specialists," states the Barcelona Institute of Global Health.

MVMD's cancer patent targets direct intratumoral injection, intravenously, infusions or instillations as adjuvants for broad chemotherapeutic to immunotherapeutic cancer regimens.

The cancer-specific CRO's will run three separate pre-clinical trials:

1. triple-negative breast cancer
2. metastatic melanoma
3. Lewis Lung Carcinoma as a proxy for non-small cell lung carcinoma.

"The extensive research supporting the drug ivermectin as effective in the inhibition of proliferation, metastasis, and angiogenic activity in a variety of cancers, and as an initiator of immunogenic cell death, is overwhelming," stated Mike Farber, Director of Life Sciences at Mountain Valley MD.

MVMD currently own patents on the only form of ivermectin that can be directly injected into a tumor or provided through more bio-available forms such as intravenously.

"We believe this will be ground breaking research with near-immediate application to be able to proceed directly to human trials based on the safety and efficacy of ivermectin," added Farber.

Ivermectin has exhibited powerful antitumor effects in a variety of cancer cells and promotes programmed cancer cell death, including apoptosis, autophagy, and necrosis. Ivermectin has also been shown to inhibit tumor stem cells and reverse multidrug resistance.

MVMD filed its cancer adjuvant patent, Novel Injectable, Infusable, Instillable Ivermectin Adjuvant for Cancer Therapies for its solubilized ivermectin (Ivectosol).

Study One: Triple-negative breast cancer

• Test the effectiveness of Ivectosol combined with checkpoint inhibitor
• Arms in the study will look at single checkpoint inhibitor, oral IVM + checkpoint inhibitor and intratumoral IVM + checkpoint inhibitor
• Estimated initial readouts/analysis – 2nd week of June, 2021

Study Two: Metastatic melanoma

• Test the effectiveness of Ivectosol™ intratumoral combined with checkpoint inhibitor for disease progression and complete response rate
• Arms in the study will look at single checkpoint inhibitor, oral IVM + checkpoint inhibitor and intratumoral IVM + checkpoint inhibitor
• Estimated initial readouts by end of June, 2021

Study Three: Lewis lung carcinoma as a proxy for non-small cell lung carcinoma

• Study will test the effectiveness of Ivectosol™ intratumorally combined with checkpoint inhibitor for disease progression and complete response rate
• Arms in the study will look at single checkpoint inhibitor, oral IVM + checkpoint inhibitor, intratumoral IVM + checkpoint inhibitor, navalbine + intratumoral IVM
• Estimated initial readouts by end of June, 2021

All three tests will use a non-invasive optical imaging technique to gauge the spread of cancer.

Complete readouts for the three tests anticipate flow cytometry and statistical evaluation by end of July, 2021 with possible abstract submission in August, 2021.

"A patent abstract is a 150-word summary that communicates the essence of your invention," writes the Canadian Intellectual Property Office.

"Ivermectin is a Nobel prize winning global blockbuster drug with unprecedented potential," stated Dennis Hancock, President and CEO of Mountain Valley MD, "Overcoming its number one limitation of solubility using FDA approved excipients has opened up significant applications."

The versality of ivermectin creates a wide platform of potential commercial uses for MVMD's patented technology.

Quicksome and Quicksol are potentially applicable to vaccines and pharmaceutical drugs as well as for pain management, weight loss, energy, focus, sleep, anxiety, and more.

On Jan 27, 2021 MVMD announced it has executed an agreement to conduct a Bio Safety Level 4 lab study of COVID-19 viral clearance in transgenic mice.=

On February 2, 2021 MVMD announced it has partnered with a School of Medicine in New Orleans to study its adjuvant Inactivated Polio Vaccine.

According to the World Health Organization, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020.

If MVMD's cancer adjuvant demonstrates a high degree of efficacy, it could create an opportunity to enter the USD $100 billion global oncology market.

The World Cancer Day foundation estimates the total annual economic cost of cancer at approximately USD $1.16 trillion.

MVMD is also pursuing a pre-clinical trial for bladder cancer and is currently assessing the best option to proceed through the evaluation of CRO proposals.

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