Good morning. I was really proud to send out a broad business update media release this morning that summarizes the progress our company has been making in an incredibly short amount of time.
I am hoping you can take the time to view the media release on our website at the link below, but I am pleased to summarize some of the amazing highlights of our progress:
Solubility Patent And Quicksol™ Trademark
The United States Patent Trademark Office has approved our patent filing related to our solubility technology. We made an acceleration request on this patent in just late December last year and I am very pleased to see the speed in which our legal and science team worked with the examiner to fast track this.
Additionally, our Quicksol™ trademark application has passed through the examination phase at the U.S. Trademark Office, and has been approved by the examining attorney. Quicksol™ is our governing trademark for the entire drug class we are applying our soluble technology to.
As I said in the media release, the awarding of this novel patent is a validation of the uniqueness of our solubilization technology and our proprietary approach to overcoming the number one limitation of the macrocyclic lactone drug class, solubility. This is a very important cornerstone patent that will now allow us to move forward in securing the global protections necessary across many human and animal health applications without competitive interference.
I am also very proud to announce that we have formally entered into a two-year collaborative research agreement with the Food and Drug Administration (“FDA”), which will govern the Company’s cold chain project going forward. I see this as a major validation of the league our science is playing in and the changemakers we are fortunate enough to work with.
Our work with the FDA is the first of its kind to assess the ability of a thin Quicksome™ layer of Inactivated Polio Vaccine (IPV) to be preserved in a vial under extreme temperatures. This is part of a critical exploration around the possibility of transporting and storing the polio vaccine outside of the traditional cold chain system.
Dose Sparing Adjuvant
As you may know, we have been working with Tulane University School of Medicine on many projects and more recently we have been coordinating our testing on a nano-particulate adjuvant for immunization. The goal is to achieve dose sparing advantages while driving an antibody response following vaccination.
Although there were some positives in this study, we unfortunately simply did not achieve what we were hoping to in the robustness of the immune response. Biotech requires fast failure and our collaboration session with key advisor, Dr. John Clements, and the lead project researcher from Tulane University, Dr. Elizabeth Norton, confirmed their support for the scientific rationale of what we are doing with some specific recalibration steps that we will continue to work on. Stay tuned for more on that.
Our work in husbandry animal trials with our injectable solubilized Ivermectin technology, Ivectosol™ 1%, is going very well and the poultry trials were the first to be completed of the broader husbandry group we are testing.
I was very pleased that we have received initial indication from the Quality Control Lead that the trials were successful, and we look forward to receiving the formal report for our review shortly.
Remember this is a massive market we are looking to change the game in (60 billion plus new injections in the smaller husbandry category alone that is not possible to inject today!) and our needleless application brings many advantages, including precision, humanity and overall efficacy.
We are conducting three separate pre-clinical trials for intratumoral injection in triple-negative breast cancer, metastatic melanoma and Lewis Lung Carcinoma. We have been advised that our research partner has successfully implanted melanoma tumor cells, with no toxicity of the initial treatment. The Lewis Lung implantation is scheduled for June 25, 2021 with treatment commencing seven days following, and the triple-negative breast cancer implantation is scheduled for July 16, 2021.
We look forward to progressing near term on this, reconfirming our plans to move directly into human phase trials if current pre-clinical trials are successful.
We are finalizing a study framework to apply our novel Selactosol™ 1.5% for preclinical evaluation trials targeting mycobacterium-based infections, namely Tuberculosis.
Tuberculosis affects roughly 25% of the world’s population and is the leading infectious disease killer in the world, claiming approximately 1.5 million lives each year. Tuberculosis also affects a large number of husbandry animals and will be targeted equally in the Company’s evaluation studies.
We currently working under through CBD and THC product formulations under NDA with a North American cannabis company, focused on initial products which include a THC recreational product, THC sleep product, and CBD pain relief cream.
This is a significant area to apply our technology to and we look forward to moving into a formal license agreement and commencing retail production.
So many important projects with such broad ranging benefits for human and animal health and we couldn’t be more honoured to drive forward this important work.
You can read the full media release and related trial status on our website at https://www.mountainvalleymd.com.
I thank our team members at MVMD for pushing new boundaries every single day, our extensive research partner network, our key science advisors and our shareholders for all of the ongoing support.
We continue to accelerate our focus and efforts on solving the most significant human and husbandry animal health problems facing our global population
Thanks for joining us on this journey to reimagine what is possible!
President & CEO, Mountain Valley MD