'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
Transitioning to Phase 2 Clinical Trial for Trichomylin 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
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.
'We are incredibly excited to work with
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.
About
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.
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.
Contact:
Email: media@zyus.com
Tel: 1-833-651-7723
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