Evaluating Efficacy, Safety, and Tolerability in Patients with Moderate to Severe Cancer-Related Pain
ZYUS Life Sciences Corporation ("ZYUS" or the “Company”) (TSX-V: ZYUS), a Canadian-based life sciences company leading scientific research and global development of innovative cannabinoid-based pharmaceutical drug products, announced today it has made the strategic decision to proceed with a Phase 2 Clinical Trial in Canada to assess the preliminary efficacy, safety and tolerability of Trichomylin® softgel capsules in patients with advanced cancer and moderate to severe cancer-related pain.
“Chronic pain is a major unmet medical need for cancer patients and has been linked with an impaired quality of life, lower adherence to treatment and higher healthcare costs,” said Brent Zettl, President and CEO of ZYUS. “This Phase 2 Clinical Trial is a landmark moment in ZYUS’ mission to reimagine the treatment of pain by redefining the standard of care with the development of cannabinoid-based therapies for pain management in pursuit of transformational impact on patients’ lives.”
Transitioning to Phase 2 Clinical Trial forTrichomylin Softgels
Initially planned as a Phase 2a Clinical Trial, ZYUS has made the strategic decision to fast-track and progress directly to a full Phase 2 Clinical Trial following receipt of positive results from its Phase 1, first-in-human clinical trial testing the safety and tolerability of Trichomylin softgel capsules. While a Phase 2a Clinical Trial could have provided preliminary efficacy data for Trichomylin softgels, it would not have generated the data required by regulatory agencies in Canada and the U.S. to formally commence the regulatory drug approval process and, therefore, completion of a Phase 2b clinical trial would have been necessary. In addition to efficiently building shareholder value, ZYUS believes advancing directly to a full Phase 2 Clinical Trial will also reduce the time and cost associated with obtaining regulatory approval of Trichomylin softgel capsules and delivering this important therapeutic to patients in need.
Phase 2 Clinical Trial Structure
ZYUS has selected a leading, full-service Canadian contract research organization with extensive clinical trial management experience to conduct its Phase 2 Clinical Trial. ZYUS anticipates the trial will be structured as a double-blinded, placebo-controlled, randomized, multiple dose escalation study that will enroll a total of up to 126 patients with advanced cancer and moderate to severe cancer-related pain. The company plans to recruit patients at six Canadian investigative sites, with patients being randomized at a 1:1 ratio with approximately 63 patients in each arm.
Clinical Trial Investigation
Dr. Julie Stakiw, a clinical professor in the Division of Oncology at the University of Saskatchewan and a malignant hematology and stem cell transplant physician with the Saskatchewan Cancer Agency, has agreed to serve as medical lead for the Phase 2 Clinical Trial. In this capacity, Dr. Stakiw will provide medical oversight for the clinical trial, leveraging her wealth of expertise and commitment to advancing groundbreaking therapies for patients with cancer. As a cancer specialist, Dr. Stakiw has extensive clinical trial experience and has served as primary investigator of numerous clinical trials. Dr. Stakiw’s extensive background in Oncology coupled with her considerable cancer-related clinical trial experience, align with ZYUS’ commitment to the development of evidence-based solutions to address unmet patient needs.
“We are incredibly excited to work with Dr. Stakiw to advance our clinical program and provide patients with a cannabiniod-based pain management therapy,” said Mr. Zettl. “Dr. Stakiw’s deep experience and commitment to research is reflective of ZYUS’ own commitment to addressing critical gaps in therapeutic strategies and will assist ZYUS in advancing its mission to deliver a first-in-class drug to patients with moderate to severe cancer-related pain.”
About Trichomylin Softgels
Trichomylin softgels, a first-in-class drug product candidate formulated with a proprietary fixed-dose combination, has been specifically designed for the management of chronic pain. Its unique mechanism of action targets the endocannabinoid system distinguishing it from current pain management therapies, offering a novel approach in addressing chronic pain by delivering a balanced ratio of three cannabinoids – cannabidiol (“CBD”), cannabichromene (“CBC”) and delta-9-tetrahydrocannabinol (“THC”).
About ZYUS Life Sciences Corporation
ZYUS is a publicly traded Canadian-based life sciences company focused on the global development and commercialization of regulated cannabinoid-based pharmaceutical drug product candidates. Through clinical research, ZYUS is committed to furthering the understanding of cannabinoids with the clinical development of its pharmaceutical drug product candidates and intellectual property activities to protect its novel formulations. Additionally, ZYUS is dedicated to delivering high quality, cGMP/EU GMP-compliant cannabinoid products to patients through the exempt global medical market. The ZYUS vision is to reimagine the potential of pain therapeutics by pursuing regulatory approval of cannabinoid formulations and elevating cannabinoids as a standard of care in pursuit of transformational impact on patients’ lives. ZYUS: Advancing the Science of Well-Being. For additional information, visit www.zyus.com or follow us on X (formerly known as Twitter) @ZYUSCorp.
Cautionary Note Regarding Forward-Looking Statements
This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the Company’s business, the Company’s ability to advance clinical research activities , realize on its objectives and obtain regulatory approval of cannabinoid-based pharmaceutical drug product candidates such as Trichomylin softgel capsules, introduce products that act as alternatives to current pain management therapies, advance Phase 2 clinical development of Trichomylin softgel capsules, reduce time and costs associated with regulatory approval and build shareholder value. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. Statements about, among other things, the Company’s business, the Company’s ability to advance clinical research activities, realize on its objectives and obtain regulatory approval of cannabinoid-based pharmaceutical drug product candidates such as Trichomylin softgel capsules, introduce products that act as alternatives to current pain management therapies, advance Phase 2 clinical development of Trichomylin softgels, reduce time and costs associated with regulatory approval and build shareholder value are all forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that the Company will be able to advance its clinical research activities and further operations, realize its objectives and obtain regulatory approval of cannabinoid-based pharmaceutical drug product candidates, introduce products that act as alternatives to current pain management therapies or advance Phase 2 clinical development of Trichomylin softgels. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231205569650/en/