Dr. Raza Bokhari reports

MEDICUS PHARMA LTD. SUBMITS TO THE FDA PHASE 2 IND CLINICAL PROTOCOL TO NON-INVASIVELY TREAT BASAL CELL CARCINOMA OF THE SKIN

Medicus Pharma Ltd. has submitted to the U.S. 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 microarray 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-blind, placebo-controlled (P-MNA), multicentre 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 with 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 100 micrograms of D-MNA and a high-dose group receiving 200 micrograms of D-MNA.

The high dose to be used in the trial, 200 micrograms 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, executive chairman and chief executive officer. "BCC is perhaps the most common and fast-growing cancer across the globe, with over five million cases diagnosed in the U.S. 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."

About Medicus Pharma Ltd.

Medicus Pharma is a clinical-stage, multistrategy holding company focused on investing in and accelerating novel life sciences and biotechnology companies through FDA-approved clinical trials.

Through its diverse experience and extensive industry network, the company is building Medicus into a leading pharmaceutical holding company, committed to delivering better treatment outcomes and alleviating pain and suffering. Utilizing a thesis-driven collaborative process, Medicus Pharma identifies, acquires and advances relatively derisked clinical-stage assets through clinical development and commercialization.

SkinJect, a wholly owned subsidiary of Medicus Pharma, 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 tumour cells. The company currently has an FDA-approved phase 2 trial actively recruiting patients.

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