Special Report: Biopharma and medicinal cannabis experts MGC Pharmaceuticals have updated investors on a wave of key business milestones, including the Therapeutic Goods Administration’s go-ahead to take its Alzheimer’s treatment into clinical trials.

The company has received formal approval from the Therapeutic Goods Administration (TGA) to initiate its Phase IIb clinical trial testing CogniCann in dementia and Alzheimer’s patients with the University of Notre Dame in Western Australia. It follows approval from the Human Research Ethics Committee.

In the update, MGC Pharma (ASX:MXC) also detailed other regulatory approvals which will support its progress towards commercialisation across Europe.

MGC shares rose eight per cent on the news to an intraday high of 4.3c.

CogniCann treating Alzheimer’s

CogniCann™ is one of MGC’s Good Manufacturing Practice certified, pharmaceutical-grade medicinal cannabis formulations.

The company can now start recruiting patients, and the trial is due to start before July.

The 16-week trial will focus on the effects of the medicinal cannabis treatment on the symptoms of mild dementia and Alzheimer’s and the improvement of patient’s quality of life, on a total of 50 patients aged 65 and over, alongside a series of pre and post-treatment surveys and focus groups that will be used to assess the effects of the product.

More regulatory approvals

MGC also detailed the receipt of a permit from the Slovenian Ministry of Health granting it with permission to operate its extraction facility to develop phytocannabinoids.

It is one of the first EU facilities to develop its own natural phytocannabinoids, giving the company a significant edge as it delivers a further step in full vertical integration for production of is own biopharma products.

“This is very significant for MXC because the company can now produce in-house and cost-effective active pharmaceutical ingredients (API) for its own phytomedicine production at a very cost-effective rate,” Roby Zomer, MGC chief and co-founder, told investors.

It has also become the first Australian medicinal cannabis company to receive SME qualification from the European Medicines Agency (EMA), the European equivalent of the TGA and the US’ Food and Drug Administration (FDA).

It allows the company to apply for official advice, drug evaluation and registration of its products such as CogniCann and CannEpil.

“The achievement of these milestones demonstrates material progress on MXC’s pathway to commercialisation and is testament to the Executive Management’s commitment to building a strong company under its seed-to-pharma strategy,” chairman Brett Mitchell said.

“The progress within our pharma business is evidence of the tireless work behind the scenes from the entire MXC team and we expect 2019 to deliver significantly more growth and development.”




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