German Pain Association (DGS) and Pharmaceutical Company Avextra Join Forces to Launch Their New Study OCEAN

• Avextra, the German pharmaceutical company focused on Cannabis-Based Medicines (CBM) and the German Pain Association (DGS), the leading physicians’ society dedicated to chronic pain therapy, jointly announces their collaboration to support patients suffering from Chemotherapy-induced neuropathic pain (CINP).
  
  
• CINP causes persistent pain and numbness symptoms in 60-80% of oncology patients undergoing cancer treatments, significantly impacting their quality of life.
  
  
• For the next 18 months the two organisations aim to investigate the efficacy and safety of Avextra’s THC/CBD full-spectrum extract in approximately 400 CINP patients in over 20 DGS centres throughout Germany in a real-world environment.
  
  
• OCEAN marks the next project in Avextra’s Alliance for Evidence-based Cannabis Medicine dedicated to conducting studies within the framework of exclusive partnerships using diverse galenic forms to address indications with significant unmet patient need.  
  

BENSHEIM, Germany, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Avextra AG (“Avextra” or the “Company”), a leading European vertically-integrated manufacturer and developer of pharmaceutical cannabis-based medicines (CBMs) located in Germany, is proud to announce a joint study with the German Pain Association (DGS) focused on Chemotherapy-induced neuropathic pain (CINP). The study which is being conducted under the name of OCEAN is the next initiative as part of Avextra’s Alliance for Evidence-based Cannabis Medicine. Initial studies indicate that cannabis-based medicine (CBMs) could be a promising indication for neuropathic pain conditions, including CINP. However, as is often the case in the field of cannabis medicine, reliable evidence is lacking for this vulnerable patient population. Avextra is proud to collaborate with the German Pain Association (DGS) on their OCEAN study and address the research gap.

CINP is an independent pain disorder resulting from the toxic peripheral nerve damage caused by chemotherapy agents in the course of the treatment. The real-world study aims to investigate whether a full-spectrum cannabinoid extract could be a suitable therapeutic addition to alleviate the symptom burden of chemotherapy patients.

OCEAN is a prospective 12-week parallel group observational study utilising Avextra’s own balanced 10:10 (THC:CBD) Cannabis extract conducted under real-world conditions with 400 adults suffering from CINP. OCEAN will evaluate a number of factors including pain intensity, pain-related impairments, sleep quality and the phenotypes of neuropathic pain. Upon completion, the study results will contribute to a more precise understanding of the treatment requirements for the patients affected, offering valuable insights to inform the design of a future Phase III clinical trial.

"OCEAN is a unique and promising opportunity to gain valuable patient data aimed to improve the quality of life for CINP patients. We are delighted to partner with the DGS to collect real-world evidence in Germany throughout this study. This initiative is an important part of our Alliance for Evidence-Based Cannabis Medicine, with a significant goal of developing cannabis-based medicines tailored to address specific indications, ultimately providing symptom relief to a broader patient population," explains Dr. Bernhard Babel, CEO of Avextra.

The OCEAN study is now underway. "Our association has gathered valuable experience in treating chronic pain patients with cannabis-based medicines. Together with Avextra, we aim to investigate the efficacy and safety of a THC/CBD full-spectrum extract 10mg/10mg in comparison to a non-cannabis-based comparative therapy amongst the large patient population suffering from neuropathy as a result of chemotherapy. This prospective, 12-week parallel group study is designed as a non-interventional approach," states DGS President, Dr. med. Dipl. Lic. Psych. Johannes Horlemann. "There is a large unmet need for neuropathic pain therapy amongst patients after undergoing chemotherapy. Because success of the chemotherapy is often the main focus, patients often do not address their pain symptoms in subsequent physician consultations. Standard medications for neuropathic pain provide little or no relief. A study is therefore essential to determine how pain and the accompanying symptoms can be improved by a THC-CBD full-spectrum extract. We are looking forward to the results," summarises Dr. med. Dipl. Lic. Psych. Johannes Horlemann.

Avextra is focused on creating cannabis-based medicines “CBMs” that will gather the necessary evidence to support the use of unregistered CBMs and expedite the development of Registered Cannabis-based Medicines. The Company is committed to transparency, and as such, the trials and study results will be shared with the scientific community and regulatory authorities, contributing to the collective knowledge of cannabinoid-based therapies. The company is dedicated to working in collaboration with the medical community, regulators, and other stakeholders to drive evidence-based innovation forward.

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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About DGS

With around 4,000 members and 120 pain centres, the German Pain Association (DGS) is the leading specialist society for the treatment of people with chronic pain. Collaborating closely with the German Pain League, its primary goal is to improve the quality of life of these patients – through better diagnostics and treatment that is aligned with the patient's everyday life. To this end, DGS members work together on an interdisciplinary basis every day in medical practices, clinics, pain centres, pharmacies, physiotherapeutic and psychotherapeutic facilities. Since 1989, the DGS's annual German Pain and Palliative Care Day established itself as one of the most important specialist events and forums for international dialogue. There are currently around 1,321 ambulant pain specialists treating the increasing number of patients. At least 10,000 trained pain doctors would be needed to provide comprehensive care for the approximately 3.9 million people suffering from severe pain. In order to achieve better care for people with chronic pain, the DGS is calling for holistic and needs-oriented structures - both outpatient and inpatient - as well as a fundamental reorientation of demand planning.

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 authorisations 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.