As reported by Cannareporter.
Avextra will move forward with a double-blind Phase 2 clinical trial for the use of cannabis in the treatment of cancer patients in palliative care. It is called Belcanto and is being coordinated by Professor Thomas Herdegen, from the University of Kiel, but it will also include other university clinics, such as Hamburg and Lübeck, in Germany.
For this study, Avextra will use standardised 10 THC/10 CBD cannabis extract, having already received approval from the German Federal Institute for Medicines and Medical Devices (BfArM) and the responsible ethics committees. The medicine is expected to be administered to the first patient, out of a total of 170, in December 2023.
Avextra, which has a production unit in Azinheira dos Barros, near Grândola, in Alentejo, through its subsidiary CannEurox, announced the new clinical trial this week, in a press release, which will be developed within the scope of the Alliance for Cannabis Medicine Evidence-Based. It is a platform focused on collaborating with healthcare professionals and researchers to generate real patient data with the aim of designing robust clinical trials for cannabis-based medicines that can obtain regulatory approval.
According to the Avextra statement, the alliance is an initiative that aims to promote research and development in the field of cannabinoid-based therapies in European markets where federally regulated patient access systems exist. In these markets, Avextra establishes working relationships with a strong network of researchers and early adoption professionals to inform and enrich your clinical plan for pharmaceutical development.
The Alliance will combine real-world evidence studies and randomized clinical trials with different dosage forms in specific indications with significant unmet clinical patient needs. The ultimate goal is on the one hand to increase evidence to support therapy with Avextra’s masterful products and, on the other, after conducting randomized clinical trials that determine efficacy, safety and patient benefit, to obtain full regulatory approval and reimbursement.
As the first project of this alliance, Avextra is pleased to announce its support for its first Phase 2 study – a randomized, double-blind, placebo-controlled clinical trial under the name BELCANTO. The study focuses on treating oncology patients in early palliative care with the company’s own balanced 10 THC/10 CBD standardized cannabis extract, currently available in the German, Italian, Swiss and UK markets. BELCANTO was successfully approved by the Federal Institute for Medicines and Medical Devices (BfArM) during the summer of 2023, marking a significant milestone for Avextra.
Improving the symptoms of palliative patients and reducing polypharmacy
The main objective of this clinical trial is to compare the change in the general picture of symptoms in cancer patients treated with a balanced cannabis extract with the placebo control group. The trial will be conducted primarily at the University of Kiel, together with three other medical centers in Germany, following approximately 170 oncology patients.
Bernhard Babel, CEO of Avextra, said Belcanto is the ideal project to launch the Avextra Alliance for Evidence-Based Cannabis Medicine. “According to the WHO, there are 56,8 million patients who require palliative care. As with all pharmaceutical medicines, medical cannabis treatments will become an attractive therapeutic option for palliative care patients once regulatory agencies approve their efficacy and safety based on robust clinical trials. Avextra is uniquely positioned with the skills and capabilities required to support, design and conduct such trials,” he said.
For his part, Thomas Herdegen, one of the professors who started Belcanto, professor at the Institut für Experimentelle und Klinische Pharmakologie at the University of Kiel, said that the team was “very pleased to be working with Avextra’s 10/10 standardized cannabis extract and its exceptional, dedicated and highly professional team.” Herdegen further added that “we hope to provide our palliative care patients with relevant relief from symptom burden, with a simultaneous reduction in problematic polypharmacy.”
Founded in 2019 and headquartered in Germany, Avextra is one of Europe’s leading vertically integrated medical cannabis operators, focused on the development and production of regulatory-approved medicines. Avextra controls its entire value chain – from cannabis cultivation in Alentejo, Portugal, through the CannEurox subsidiary, to EU-GMP certified extraction and manufacturing in Germany.
Cannareporter spoke to Mike Kindratt, Avextra’s director for Southern Europe and responsible for the Portuguese cannabis cultivation unit, to find out more about the company’s operations in Portugal, and will publish this interview soon.