European vertically-integrated manufacturer of cannabis-based medicines Avextra AG unveiled the Avextra Alliance for Evidence-based Cannabis Medicine on Wednesday

The alliance is an initiative to advance research and development in cannabinoid-based therapies in European markets where federally regulated patient access schemes are in place, the German-based company said.

In these markets, Avextra is working on creating relationships with a strong network of early-adopting researchers and practitioners to inform and enrich its clinical plan for pharmaceutical development.

Avextra's alliance will combine Real-World Evidence studies and randomized controlled trials with different galenic forms in targeted indications with significant unmet patient clinical needs.

Why? The goal is to increase the evidence to support therapy with Avextra's magistral products and to obtain full regulatory approval and reimbursement after conducting RCTs that determine efficacy, safety and patient benefit.

See also: Children's Palliative Care & Medical Cannabis: Australian Researchers Conduct Pilot Study

BELCANTO Study To Examine Medical Cannabis Treatment For Early-Stage Palliative Care Patients

To mark its start, the alliance announced support of its first Phase 2 study – a randomized, double-blind, placebo-controlled clinical trial under the name BELCANTO, which was approved by the Federal Institute for Drugs and Medical Devices (BfArM) over the summer of 2023.

The study is focused on treating early palliative care oncology patients with Avextra's own balanced 10 THC/10 CBD standardized cannabis extract currently available on the German, Italian, Switzerland and UK markets.

Avextra's CEO Dr. Bernhard Babel praised the move.

"BELCANTO is an ideal project to launch Avextra's Alliance for Evidence-based Cannabis Medicine," Dr. Babel said. "As in the case of all pharmaceutical drugs, medicinal cannabis treatments will become a compelling therapeutic option for patients in palliative care once regulatory agencies have approved its efficacy and safety on the basis of robust clinical trials."

The trial will be mainly conducted at University Clinics in Kiel and clinical centers in Hamburg and Lübeck, enrolling approximately 170 cancer patients.

Researchers plan to compare the change in overall symptom burden in oncology patients treated with a balanced cannabis extract with the placebo control group.

Now read: Medical Marijuana In Hospice: How Cannabis Can Help With End-Of-Life Care

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Photo: Courtesy of Dominik Lange on Unsplash