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MGC Pharma (ASX:MXC) has received study approvals and an import permit from the South African authorities for its Phase IIb CimetrA dose finding study on patients diagnosed with COVID-19.
The trial is expected to provide additional data for claims on CimetrA as an Investigational Medical Product (IMP), which is critical towards its goal of being registered as a drug.
The South African study aims to determine the most effective dosage concentrations of the active ingredients, as well as collecting more data to further validate CimetrA’s anti-inflammatory and immune-modulatory effects.
CimetrA is the pharmaceutical version of MGC’s nutraceutical branded product, ArtemiC, which is already being sold by Swiss PharmaCan in Europe.
The drug has been proven through clinical trials to help reduce the hyper-inflammatory response seen in some patients with Long Covid.
Based on the recently released results, MGC Pharma is now planning to develop a clinical program for other inflammatory indications to determine the efficacy of CimetrA, which will include diseases such as IBD, RA, Influenza, and dermatological diseases among others.
Roby Zomer, co-founder and CEO of MGC Pharma, said:
“Clinical trials to date have demonstrated the efficacy of CimetrA against Covid-19, so it is crucial that we are able to complete the dosage trials in Israel and now South Africa as quickly as possible.
This is so we can move to the next stage of the clinical pipeline, and treat those suffering from the effects of the cytokine storm and Long Covid more effectively.”
Neurotech (ASX:NTI) rose 5% this morning after announcing breakthrough results from its Phase I/II study of NTI164, a cannabis strain that aims to treat children with Autism Spectrum Disorder (ASD).
The study demonstrated that 93% of patients showed improvement of symptoms and severity of illness after 28 days of daily treatment with NTI164.
NTI164 was also well-tolerated, with no serious adverse events were recorded across all doses (5, 10, 15 and 20 mg/kg).
Due to these positive outcomes, the study has been granted HREC (human research ethics committee) approval to continue for a further 54 weeks. The extension also came as parents and clinicians requested for no “washout” period.
NTI164 is one of Neurotech’s proprietary cannabis strains, exclusively licenced from Dolce Cann Global. It contains high levels of unique minor cannabinoids, and less than 0.3% THC.
“These exciting clinical results and the extensive pre-clinical data that we have available pave the way for an upcoming phase 2/3 trial in children with ASD, and potential trials in patients with many neuro-inflammatory disorders,” said Neurotech Director, Professor Allan Cripps.
Neurotech is currently in discussions with the US FDA regarding a pre-IND (Investigational New Drug) application scheduled for 2022.
Nova Eye Medical (ASX:EYE) expects to report total sales across the glaucoma surgical devices segment of approximately $13.1 million for the year ended 30 June, just 0.5% higher than the previous corresponding period.
The company says sales were materially impacted as a result of freight-delayed product bound for Wuhan, China, specifically, a $740k delivery was not freighted until 5 July, despite being scheduled for collection in June.
But sales in Germany sales were strong, up 24% on pcp.
The momentum in Germany was underpinned by the launch of the company’s new canaloplasty device, iTrack Advance.
“Early feedback from surgeons [on iTrack Advance] has been extremely positive, and I am confident that our team will roll out this world-leading technology to immense success,” said Nova’s CEO, Tom Spurling.
At Stockhead we tell it like it is. While MGC Pharmaceuticals and Nuerotech are Stockhead advertisers, they did not sponsor this article.