The clinical study will randomize up to 60 patients across 6 trial sites in the United States
Toronto, Ontario--(Newsfile Corp. - August 27, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") announces the enrollment of the first patient in its Phase 2 clinical trial SKNJCT-003 for the treatment of nodular basal cell carcinoma (nBCC).
Clinical Trial Design
The clinical study, SKNJCT-003, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with nBCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. 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.
"Randomizing the first participant is an important milestone for the company," stated Dr. Raza Bokhari, Exec. Chairman & CEO. "Our Artificial intelligence (AI) powered Phase 2 study protocol, supported by Confocal microscopy, is designed to position the company to gain regulatory alignment with the FDA and fast track the clinical development program. BCC is the most common cancer across the globe with estimated 5 million cases diagnosed in the US each year[1]. There is no effective non-invasive treatment regimen available to treat BCC; we aspire to deliver both first in class and best in class novel therapeutic alternative to fulfill this unmet medical need."
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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Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the submission and advancement of the phase 2 clinical protocol, including improvements thereto and the timing thereof, and approval from the FDA and the timing thereof. Forward-looking statements are often but not always, identified by the use of such terms as "hope" "may", "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions.
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[1] American Cancer Society, October 2023 - https://www.cancer.org/cancer/types/basal-and-squamous-cell-skin-cancer/about/key-statistics.html
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