Mountain Valley MD says it has filed a novel cancer adjuvant patent and is proceeding with pre-clinical trials

Mountain Valley MD Holdings Inc. (CSE:MVMD) (FRA:20MP) (OTCQB:MVMDF) announced that it 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.

Mountain Valley MD said the cancer patent has been filed for direct intratumoral injection, intravenously, infusions or instillations as adjuvants for broad chemotherapeutic to immunotherapeutic cancer regimens.

The company noted that it is proceeding with three separate pre-clinical trials with specialized third-party cancer CROs: (1) triple-negative breast cancer; (2) metastatic melanoma; and (3) Lewis Lung Carcinoma as a proxy for non-small cell lung carcinoma.

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

Mountain Valley MD said it believes the research will have near-immediate application to direct human trials based on safety and efficacy of ivermectin.

“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. 

“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.  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,” Farber added.

Extensive researching

Leading up to the implementation of pre-clinical trial cancer research, Mountain Valley MD said it has been extensively researching the drug ivermectin, including its impact on cancer, and has included numerous abstracts at the end of this media release.  

All of the research articles cited involve either existing oral ivermectin in a murine model or the in-vitro testing of ivermectin utilizing organic solvents for solubilization that would be prohibited in a human intravenous or intratumoral administration.

As cited by Pharmacological Research in January 2021, Ivermectin has powerful antitumor effects in a variety of cancer cells and promotes programmed cancer cell death, including apoptosis, autophagy, and necrosis.  The research also identifies how ivermectin has been shown to inhibit tumor stem cells and reverse multidrug resistance, Mountain Valley MD added.

Mountain Valley MD filed its cancer adjuvant patent, Novel Injectable, Infusable, Instillable Ivermectin Adjuvant for Cancer Therapies for its solubilized ivermectin (Ivectosol). The patent-pending adjuvant utilizes the company’s advances in macrocyclic lactone solubility to consider Ivectosol as a viable adjuvant for numerous cancer therapies.  

The company’s solubility technology applied to the ivermectin drug is the only form in the world that uses strictly excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection or intravenous infusion. 

“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 and our partners,” said Dennis Hancock, president and CEO of Mountain Valley MD. 

“Driving innovation in cancer research to support positive outcomes for increased survival rates, productivity, and improved quality of life for the global population is directly aligned with our mission of more life, less death.  We couldn’t be more honoured to drive forward this important work,” he added.

The three pre-clinical trials that are being conducted are designed to prove the utility of Ivectosol to synergize and improve various cancer regimens currently in use and as a potent enhancer of current immunotherapies and chemotherapies for difficult to treat cancers.

Study One:  Triple-negative breast cancer

• Study will test the effectiveness of Ivectosol combined with 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 – 2nd 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 flow cytometry and 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
• Complete readouts with flow cytometry and statistical evaluation estimated by end of July, 2021 with possible abstract submission in August, 2021

All three studies will assess tumor growth and metastases through bioluminescence imaging, a non-invasive optical imaging modality designed to visualize and quantify bioluminescent signal in tissues.  

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

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.

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