MGC Pharma’s cannabinoid medical spray passes pre-clinical FDA tests
Health & Biotech
Health & Biotech
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Second-stage safety and toxicity tests for MGC Pharmaceuticals’ (ASX:MXC) anti-inflammatory cannabinoid medical spray have revealed the product has no adverse effects.
The results complete US Food & Drug Administration toxicology test requirements for new drug development and support the safety profile of the medical spray in human patients, including those with COVID-19.
“The histology results provide the company with important insights into the potential effects of the medical spray on major organs,” said co-founder and managing director, Roby Zomer.
“Pleasingly, no adverse impacts were recorded on major organs which provides critical information in relation to planning for future clinical studies,” he added.
The medical spray is designed to target inflammatory complications known as a cytokine storm immune response in some patients arising from COVID-19, which can cause organ damage and lung complications.
The product is currently under evaluation in a phase two human clinical trial in Israel that covers efficacy end points and dosage finding elements and will use data from the toxicology tests.
The anti-inflammatory spray is formulated from MGC Pharma’s patented nano delivery MyCell technology, a unique drug delivery platform for the cellular level.
The FDA requires new medicines to be tested on two types of rodents in pre-clinical trials.
MGC Pharma completed an in vivo safety and toxicity pre-clinical study, including histology testing (microscopic study), on 24 rats in four groups with three different dosages of its anti-inflammatory spray.
The pathology study was carried out at the Science in Action Laboratory in Ness Ziona, Israel, and included pathological examination of the test rodents’ organs.
Each rats’ heart, liver, brain, spleen, spinal cord, kidneys and lungs and tongue were tested and revealed no pathological changes in all tested animal samples.
Results from the study support the safety profile of the anti-inflammatory spray in humans and follow a phase two medical study on 10 patients released in August.
“These positive results demonstrating no pathological impact on the major organs of the animals in the study is significant as this completes the FDA requirements for toxicology tests for new drug development,” said the company.
In an earlier pre-clinical study reported in July, MGC Pharma carried out the first round of toxicity and safety tests for its cannabinoid medical spray on mice in three study groups for different dosages.
MGC Pharma has meanwhile added to its intellectual property with the launch of its CannEpil App for patients who are prescribed its CannEpil medicinal cannabis treatment.