ZYUS Life Sciences Corporation announced that 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. 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 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.