Ethics approval for new Medlab trials

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Medlab Clinical (ASX:MDC) has received Human Research Ethics Committee (HREC) approvals to begin human trials of two different cannabis based medicines. 

The company said the medicines, which are being developed at the company's laboratory in Sydney, have two different applications and will be clinically tested at different locations.

The two medicines are NanaBis and NanaBidial.

NanaBis will be clinically tested in advanced stage cancer patients with intractable pain. The trial, which will test safety, efficacy, tolerability and exploratory, will be conducted at the Royal North Shore Hospital’s Northern Sydney Cancer Centre.

NanaBis combines the two most active ingredients in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC). It will be administered by NanoCelle, Medlab’s nano-particle spray to the inside of the cheek that quickens absorption of the medicine into the bloodstream.

NanaBidial comprises cannabidiol (CBD) derived from marijuana. The trial will test its safety in healthy individuals.

According to Medlab CEO, Sean Hall, commencement of these clinical trials is a significant breakthrough for Australian medicine.

“NanaBis would meet a need globally for better pain management, with research having shown cancer pain was an increasingly widespread condition and generally undertreated,” he said.

“With the recent US crackdown on opioid abuse, there is a significant need for better, efficacious treatment.

“NanaBidial is intended to be made available to GPs so it would give many Australians access to a drug which governments around the country have been keen to see introduced.

“While time lines can’t be predicted with accuracy, it is possible Medlab may have these medicines on the market later in 2018 should SAS applications be successful.

“Our research with cannabis also indicates potential for other related conditions, creating a distinctive positioning for the research from a medical and market perspective,” added Mr Hall.

Medlab’s director of medical research, Professor Luis Vitetta, said the company's research direction with molecules from the cannabis plant had been developed to address unmet patient needs in the areas of oncology and neurology.

“These clinical studies will establish Medlab’s cannabis based intellectual property as a medicine, distinct from `medicinal’ cannabis, which will help with Medlab’s path toward special access scheme approvals from the TGA, a pre-requisite for medical practitioners being able to prescribe with confidence,” said Professor Vitetta.