FDA Agrees with the Study Design of Randomizing Up To 60 Participants with Nodular Type of Basal Cell Carcinoma
Toronto, Ontario--(Newsfile Corp. - March 21, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) (the "Company") is pleased to announce the receipt of comments from the U.S Food and Drug Administration (FDA).
The clinical non-hold comments from the FDA consider the results of the study exploratory and request the Company to provide data from clinical studies (SKNJCT-001) to support the dose of 100μg and 200μg of micro-array needles containing doxorubicin (D-MNA). FDA has also requested the Company to provide an updated investigator brochure that include information from the clinical studies SKNJCT-001 and SKNJCT-002; specifically, include data regarding any adverse events/dose limiting toxicities at each dose level.
Earlier this year, the Company had submitted to the FDA for comments a Phase 2 Investigational New Drug (IND) clinical protocol (SKNJCT-003) to non-invasively treat basal cell Carcinoma (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 placebo in patients with nodular BCC. 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 found to be safe and well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or adverse events (AE). 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.
"We are immensely encouraged by the feedback from the FDA," stated Dr. Raza Bokhari, Executive Chairman and CEO. "The clinical non-hold comments by the FDA bring us one step closer to delivering a game changing novel, non-invasive alternative to treat basal cell carcinoma (BCC) of the skin."
The Company intends to make a full submission to the FDA in Q2 2024 and shall provide the information requested by the FDA as well as include CMC (Chemistry, manufacturing, and Controls) stability data.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
[email protected]
LHA Investor Relations
Tirth T. Patel
212-201-6614
[email protected]
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 statements regarding the Company's expectations regarding making a full FDA submission and the timing thereof, the outcomes of any protocols, eventual approval of the Company' treatment methodology and its ability to deliver a game changing novel, non-invasive alternative to treat basal cell carcinoma (BCC) of the skin. Forward-looking statements are often but not always, identified by the use of such terms as "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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