The week in medical cannabis: ethics approval granted, new JV formed

Tuesday, 20 June, 2017

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It’s been a big week for Australia’s growing medical cannabis industry, with ethics approval granted for two human trials as well as the formation of a new joint venture.

Life science company Medlab Clinical Limited has received Human Research Ethics Committee (HREC) approvals to begin human trials of two different cannabis-based medicines. Developed at Medlab’s Sydney laboratory, the patent-pending medicines have two different applications and will be clinically tested at different locations.

The first of the two medicines, NanaBis, is a potent medicine combining the two most active ingredients in cannabis, cannabidiol (CBD) and tetrahydrocannabinol (THC). Set to be clinically tested in advanced stage cancer patients with intractable pain, the medicine will be administered by NanoCelle, Medlab’s patented nanoparticle spray to the inside of the cheek that quickens absorption of the medicine into the bloodstream.

The clinical trial will be supervised by Professor Stephen Clarke OAM, a medical oncologist, palliative medicine specialist and professor of medicine at the University of Sydney. It will be a safety, efficacy, tolerability and exploratory study which will form the basis for a TGA Special Access Scheme (SAS) application to enable prescription by specialist doctors.

The second medicine, NanaBidial, comprises cannabidiol (CBD) derived from marijuana. It is indicated for chemotherapy-induced nausea and vomiting, with a secondary endpoint in patients suffering seizures. NanaBidial will also be administered by the NanoCelle delivery platform.

Medlab will manage conduct of the NanaBidial Phase 0 safety trial on healthy individuals, with completion expected hopefully within six months. This would form the basis for a TGA Special Access Scheme (SAS) application to enable prescription by general practitioners (GPs).

Medlab believe these two drugs will provide a significant increase in market potential by ultimately allowing a prescriptive therapeutic agent for both GPs and oncology/pain specialists. And with the trials expected to commence shortly, it is possible that both medicines could be on the market in late 2018 should the SAS applications be successful.

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

“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.

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

It was separately announced that iCAN: Israel-Cannabis (iCAN), an Israeli developer of medical cannabis formulations, clinical trials and cannabis testing, has formed a joint venture with LeafCann Research and Advisory, a Melbourne-based leader in the development of cannabis medications, clinical research and education. The new venture, iCAN: Australia, will collaborate on a range of initiatives including medicinal cannabis research, education, acceleration and innovation.

This joint venture combines Israel’s role as a medical cannabis R&D powerhouse with Australia’s newly eased access regulations for patients in need. According to iCAN: Israel-Cannabis CEO Saul Kaye, the collaboration will “bring world-class cannabis products to the Australian market as well as accelerate our collaborative research and development of new products for a range of indications”.

“This agreement paves the way for significant investment in clinical research to support the development of evidence-based cannabis medicines for patients most in need,” added LeafCann Group CEO Dr Jaroslav Boublik. “In addition, iCAN: Australia will develop global clinical education initiatives to bridge the gap between public demand and practitioner education. We are also excited to be part of iCAN’s global acceleration program to develop a professional, ethical and sustainable medicinal cannabis sector worldwide.”

LeafCann’s practitioner education program will be incorporated into iCAN’s product offerings and distributed via iCAN’s global reach. In addition, iCAN: Australia will take a significant interest in CannaTech Australia, the country’s first major medical cannabis summit modelled after the highly successful CannaTech Israel Summits. The first CannaTech Australia conference will take place in Sydney in 2018.

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