French biotech company MedinCell, tracked prior by TrialSite for its research into ivermectin, recently reported on the results of a comprehensive safety test evidencing that the drug ivermectin is safe. Based on the analysis, the company declared there are no safety concerns anticipated that would preclude health authority review as a new indication for COVID-19. Authorized by a prominent toxicologist, the study included an extensive analysis of over 350 articles and reports from various medical and scientific journals. The company will submit the analysis for peer review to an internally acknowledged journal.
The study was conducted by Pr. Jacques Descotes, MD, PharmD, PhD, Professor Emeritus, Claude Bernard University of Lyon, a world-renowned toxicologist with a 40-year track record working both with pharmaceutical companies as well as with regulatory bodies around the world.
Administered to ‘Hundreds of Millions of People’
Dr. Descotes recently went on the record for the MedinCell press release: “Ivermectin has been administered orally to hundreds so millions of people throughout the world in the past three decades. The assessment of reported adverse events temporally associated with ivermectin exposure shows that ivermectin-induced adverse effects have so far been infrequent and usually mild to moderate.”
The expert continued, “It is noteworthy that no deaths have seemingly ever been reported after an accidental or suicidal overdose of ivermectin. No greater toxicity of ivermectin has been substantiated in elderly people despite repeated assertions that an ageing blood-brain barrier might lead to increased ivermectin toxicity level. The positive clinical experience accumulated with ivermectin administration led many medical experts to break away from early adamant contra-indications in pregnant women. Finally, several national pharmacovigilance networks around the world released information and opinions to ascertain ivermectin safety in human subjects. So far, there are no critical safety limitations to ivermectin prescription in current indications.”
No Adverse Events in Dozens of Studies
Dr. Descotes also declared, “I also want to point out that no severe adverse event has been reported in dozens of completed or ongoing studies involving thousands of participants worldwide to evaluate the efficacy of ivermectin against COVID-19.”
Conflict of Interest?
Note that Dr. Descotes does disclose that he holds shares to MedinCell but has no other relevant affiliations or financial involvement. TrialSite has reported that the French company, which has previously received money from the Gates Foundation for other malaria research, has been on a pathway to commercialize an ivermectin-based COVID-19 treatment.
Of course, MedinCell is reacting to the industry circling the ivermectin wagons now. With up to a couple hundred billion in revenue to be generated over the next five years, a prescribed program of vaccine and advanced monoclonal antibodies and biopharma therapies will be the favored horse in the COVID-19 vaccine and treatment race.
About the Company
France-based MedinCell wants to revolutionize the pharmaceutical industry. By combining purposeful innovation with breakthrough business models, both are needed, and core to their success is technology, affording the ability to offer more efficient and importantly, affordable treatments. The MedinCell technology value proposition centers on what they refer to as “game changing delivery system for long-acting injectables.” Known as BEPO, this simple yet flexible technology approach is based on custom proprietary copolymers and a biocompatible solvent (where the API is solubilized or suspended), hence this approach represents a fully bioresorbable depot once injected.
This means that BEPO technology manages to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable BEPO can be administered subcutaneously for systematic exposure of APIs or locally for targeted treatments.
Traded as MEDCL on the EURONEXT Paris, the clinical stage pharmaceutical company develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 130 people representing 25 different nationalities.
The company was founded by Dr. Anh Nguyen, an American who was involved with Life Technologies as well as MedinCell SA and Syntro Corp.
A TrialSite Reminder
For all those in the TrialSite Network in America, the FDA has issued a cautionary statement about ivermectin. While TrialSite seeks the underlying source of the data the agency used to issue this recent commentary, those in America must read and understand this message.
Call to Action: If you are interested in the report, request from MedinCell here.