THE FULL PACKAGE INCLUDES AN UPDATED INVESTIGATOR BROCHURE, CMC (CHEMISTRY, MANUFACTURING AND CONTROLS), STABILITY AND STERILTY DATA
Toronto, Ontario–(July 15, 2024) – Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) (“Medicus” or the “Company”) is pleased to announce the submission of an updated and complete Phase 2 Investigational New Drug (IND) clinical protocol (SKNJCT-003) to the United States Food and Drug Administration (FDA) to non-invasively treat basal cell carcinoma (BCC) of the skin using micro-needle arrays containing doxorubicin (D-MNA), developed by its wholly owned portfolio company, Skinject, Inc.
The submission included updates to the clinical protocol, supporting Chemistry, Manufacturing, and Controls (CMC), stability and sterility information, as well as responses to the clinical non-hold comments received from the FDA on March 21st, 2024.
The company provided the safety data requested by the FDA from the Phase 1 safety and tolerability study completed in March 2021 (SKNJCT-001) to support the doses of 100μg and 200μg of D-MNA.
The company also provided an updated investigator brochure featuring safety information from the SKNJCT-001 and SKNJCT-002 clinical trials.
Earlier this year, the Company had submitted a Phase 2 IND clinical protocol (SKNJCT-003) to the FDA to non-invasively treat BCC of the skin using micro-array needles containing doxorubicin (D-MNA). The clinical study, SKNJCT-003, is designed to be a randomized, double-blinded, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with nodular type BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.
The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in Skinject’s Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.
SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAE). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC.
The updated Phase 2 clinical protocol (SKNJCT-003) includes the addition of artificial intelligence (AI) and confocal microscopy as supplementary endpoints at one of the clinical sites.
“This Phase 2 clinical protocol, in its final form, is a comprehensive design, well positioned to get the nod from the FDA to commence randomizing participants hopefully before the end of this quarter,” stated Dr. Raza Bokhari, Executive Chairman & CEO. “We are very excited to incorporate artificial intelligence (AI) powered software and confocal microscopy as supplemental endpoints in one of the clinical site to improve the assessment accuracy of the clinical program and hopefully also eliminate any invasive intervention even at the diagnostic stage, making our treatment regimen completely non-invasive from start to finish.”
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (TSXV: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells.
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