Avextra Unveils its Alliance for Evidence and Announces its Support of BELCANTO: A Clinical Trial for Oncology Patients

  • Avextra is launching its Alliance for Evidence-based Cannabis Medicine: a platform focused on collaborating with healthcare professionals and researchers to generate real-world patient data with the aim of designing robust clinical trials for proprietary Cannabis-based medicines that can achieve regulatory approval.
  • Avextra announces its support of BELCANTO; a Phase 2 double-blind clinical trial initiated by Prof. Dr. med. Thomas Herdegen of the Kiel University.

  • BELCANTO, will be held in multiple sites which include University Clinics in Kiel, Hamburg and Lübeck focused on treating early-stage palliative care patients with Avextra’s 10 THC/10 CBD standardised cannabis extract.

  • BELCANTO has received approval from The German Federal Institute for Drugs and Medical Devices (BfArM) and the responsible ethic committees with the first patient expected to be dosed in December 2023

BENSHEIM, Germany, Oct. 18, 2023 (GLOBE NEWSWIRE) -- Avextra AG (“Avextra” or the “Company”), a leading European vertically-integrated manufacturer of cannabis-based medicines (CBMs) located in Germany, is proud to unveil the Avextra Alliance for Evidence-based Cannabis Medicine. The alliance is a groundbreaking initiative aimed at advancing research and development in the field of cannabinoid-based therapies in European markets where federally regulated patient access schemes are in place. In these markets Avextra forges working 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 (“RWE”) studies and randomised controlled trials (“RCT”) with different galenic forms in targeted indications with significant unmet patient clinical needs. The ultimate objective is twofold: (1) increasing the evidence to support therapy with Avextra’s magistral products (2) after conducting RCTs that determine efficacy, safety and patient benefit, obtain full regulatory approval and reimbursement.

As the first project within this alliance, Avextra is delighted to announce its support of its first Phase 2 study – a randomised, double-blind, placebo-controlled clinical trial, under the name BELCANTO. The study is focused on treating early palliative care oncology patients with the Company’s own balanced 10 THC/10 CBD standardised cannabis extract currently available on the German, Italian, Switzerland and UK markets. BELCANTO was successfully approved by The Federal Institute for Drugs and Medical Devices (BfArM) over the Summer of 2023 marking a significant milestone for Avextra.

The primary objective of the study is to compare the change of overall symptom burden in oncology patients treated with a balanced cannabis extract with the placebo control group. The trial will be mainly conducted at Kiel University along with three other leading medical centres across Germany, enrolling approximately 170 oncology patients.

"BELCANTO is an ideal project to launch Avextra’s Alliance for Evidence-based Cannabis Medicine," said Dr. Bernhard Babel, CEO, at Avextra. "According to the WHO there are 56,8 million patients in need of palliative care. 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. Avextra is uniquely positioned with the necessary skills and capabilities to support, design and conduct such trials."

“We are delighted to be working with Avetra's standardised 10/10 cannabis extract and its exceptional dedicated and highly professional team. We expect to provide our palliative patients relevant symptom burden relief with simultaneous reduction of problematic poly-medication," added Prof. Dr. med. Thomas Herdegen, one of the initiators of BELCANTO and Professor at Institut für Experimentelle und Klinische Pharmakologie Kiel University.

About Avextra AG

Avextra is one of Europe’s leading vertically-integrated medical cannabis operators focused on the development and production of regulator-approved medicines. Founded in 2019 and based out of Germany, the company works in close collaboration with doctors and pharmacists to develop and produce precisely formulated cannabis-based medicines. Avextra controls the entire value chain – from cultivation in Portugal to EU-GMP certified extraction and manufacturing in Germany. Avextra operates across continental Europe through an expansive distribution network of multiple channels and strategically developed assets for these key markets.

Learn more at avextra.com and stay up to date at LinkedIn: LinkedIn.com/company/avextra-ag/

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Forward-Looking Statement:

This news release contains certain "forward-looking information" within the meaning of applicable securities law. A number of factors could cause actual results to differ materially from a conclusion, forecast or projection contained in the forward-looking information in this release including, but not limited to the risk that: synergies and expected collaboration from the event may not be fully realised or may take longer to realise than expected; consumer demand for cannabis products globally falls short of expectations; Avextra's subsidiaries and partners are able to obtain and maintain the necessary regulatory authorizations to conduct business; and general economic, financial market, legislative, regulatory, competitive and political conditions in which Avextra and its subsidiaries and partners operate will remain the same.

The forward-looking information in this release is based on information currently available and what management believes are reasonable assumptions. The forward-looking information contained in this release is expressly qualified by the foregoing cautionary statements and is made as of the date of this release.