ZYUS Life Sciences Corporation, a Canadian-based life sciences company, has announced that it will proceed with a Phase 2 Clinical Trial in Canada to evaluate the effectiveness, safety, and tolerability of its Trichomylin softgel capsules in patients with advanced cancer and moderate to severe cancer-related pain. Chronic pain is a significant issue for cancer patients, affecting their quality of life and treatment adherence. By conducting this trial, ZYUS aims to redefine the standard of care for pain management and develop cannabinoid-based therapies.
Originally planned as a Phase 2a trial, ZYUS has decided to fast-track the process and move directly to a full Phase 2 trial. This decision was based on positive results from a Phase 1 clinical trial, which tested the safety and tolerability of Trichomylin softgel capsules. By progressing directly to the Phase 2 trial, ZYUS can save time and costs associated with obtaining regulatory approval and provide patients with this necessary therapeutic more quickly.
The Phase 2 trial will be conducted by a leading Canadian contract research organization and will enroll up to 126 patients with advanced cancer and moderate to severe cancer-related pain. The trial will be structured as a double-blinded, placebo-controlled, randomized study, with patients being recruited at six Canadian investigative sites. Dr. Julie Stakiw, a clinical professor in the Division of Oncology at the University of Saskatchewan, will serve as the medical lead for the trial, leveraging her expertise and commitment to advancing groundbreaking therapies for cancer patients.
Trichomylin softgels are a first-in-class drug product formulated with a proprietary combination of three cannabinoids, offering a unique approach to chronic pain management. ZYUS is dedicated to advancing the understanding of cannabinoids and developing evidence-based solutions to address unmet patient needs.