The Clinical Study Is Expected to Randomize Up to 60 Patients
Toronto, Ontario–(January 3, 2024) – Medicus Pharma Ltd. (TSXV: MDCX) (“Medicus” or the “Company”) is pleased to announce the submission to the United States Food and Drug Administration (FDA) 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), developed by its wholly-owned portfolio company, SkinJect, Inc. The company is seeking comments from the FDA to revise and amend the IND and finalize the protocol.
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 to be used in the trial, 200μg D-MNA, is the maximum tolerated dose that was established in SkinJect’s Phase 1 safety and tolerability trial completed in March 2021. This safety study, representing complete dissolution in six patients with BCC, also showed complete clinical response with no residual BCC and no relapse or recurrence across different dose levels and subject demographics.
“Our Phase 2 study is designed to position the company to gain regulatory alignment and fast track the clinical development program,” stated Dr. Raza Bokhari, Exec. Chairman & CEO. “BCC is perhaps the most common and fast-growing cancer across the globe with over 5 million cases diagnosed in the US each year. There is no effective non-invasive treatment regimen available to treat BCC; we aspire to deliver first in class, novel therapeutic alternative to treat this unmet medical need.”
For further information contact:
Carolyn Bonner, President
(610)636-0184
cbonner@medicuspharma.com
LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (TSXV: MDCX) is a clinical stage, multi-strategy holding company focused on investing in and accelerating novel life sciences and bio-technology companies through FDA approved clinical trials.
Through our diverse experience and extensive industry network, we are building Medicus into a leading pharmaceutical holding company, committed to delivering better treatment outcomes and alleviate pain and suffering. Utilizing a thesis driven collaborative process, we identify, acquire and advance relatively de-risked clinical stage assets through clinical development and commercialization.
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 and squamous cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The company currently has an FDA approved phase 2 trial actively recruiting patients.
Cautionary Notice on Forward-Looking Statements
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 future-oriented financial information with respect to prospective financial performance, financial position or cash flows that is presented as a forecast or a projection. 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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