Mountain Valley MD proceeds with pre-clinical cancer trials and files a related cancer patent

Mountain Valley MD Holdings Inc (CSE:MVMD) (FRA:20MP) (OTCQB:MVMDF) announced that the company has filed a novel cancer adjuvant patent and is proceeding with pre-clinical trials with third-party cancer Contract Research Organizations (CROs) in triple-negative breast cancer, metastatic melanoma, and lung carcinoma.

The Toronto-based biotech and life sciences company said it has filed its cancer patent, “Novel Injectable, Infusable, Instillable Ivermectin Adjuvant for Cancer Therapies for its Solubilized Ivermectin.”

The patent-pending adjuvant utilizes the firm’s advances in macrocyclic lactone solubility to consider ivectosol as a viable drug for numerous cancer therapies. Mountain Valley said its “solubility technology” applied to the ivermectin drug is the only form in the world that uses “excipients that are approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection or intravenous infusion.”

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Meanwhile, the firm is proceeding with three separate pre-clinical trials with specialized third-party cancer CROs in: triple-negative breast cancer; metastatic melanoma; and 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,” said Mike Farber, the director of Life Sciences at Mountain Valley MD.

“Imagine what is possible when you have the world’s only human injectable form of ivermectin that can be directly injected into a tumor or provided through more bio-available forms such as intravenously.”

The pre-clinical trials are designed to prove the utility of Ivectosol to improve various cancer regimens and as a potent enhancer of immunotherapies and chemotherapies for difficult to treat cancers.

“We believe this will be groundbreaking research with near-immediate application to be able to proceed directly to human trials based on the safety and efficacy of ivermectin,” said Faber.

Study One: Triple-negative breast cancer

• Study will test the effectiveness of Ivectosol combined with a checkpoint inhibitor that would be equivalent to either OPDIVO or Keytruda 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/analysis – second week of June 2021;
• Complete readout with flow cytometry and statistical evaluation estimated mid-July 2021 with possible abstract submission in August, 2021;

Study Two: Metastatic melanoma

• Study will 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;
• Complete readout with statistical evaluations estimated end of July 2021 with possible abstract submission in August 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 studies will assess tumor growth and metastases through bioluminescence imaging. The company is also pursuing a pre-clinical trial for bladder cancer.

“Ivermectin is a Nobel prize winning global blockbuster drug with unprecedented potential. Overcoming its number one limitation of solubility using FDA approved excipients has opened up significant applications across multiple human and animal health lanes for Mountain Valley MD,” said Mountain Valley MD CEO Dennis Hancock.

“Driving innovation in cancer research to support positive outcomes for increased survival rates, productivity, and improved quality of life for the population is directly aligned with our mission of more life, less death.”

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

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

Story by ProactiveInvestors