A breakthrough approach to basal cell carcinoma is putting one biotech growth company in the spotlight.
Medicus Pharma (TSX-V:MDCX) is spearheading new initiatives in cancer treatment. Led by CEO Dr Raza Bokhari, a physician turned serial entrepreneur, the company is making waves with its innovative approach to addressing the unmet medical needs of patients, particularly those diagnosed with basal cell carcinoma (BCC).
Basal Cell Carcinoma is the most common cancer in the world – and has a market size of over $20 billion annually.
The company recently announced a significant milestone—the submission of its Phase II Investigational New Drug (IND) clinical protocol to the United States Food and Drug Administration (FDA). The trial, named SKNJCT-003, aims to non-invasively treat BCC using micro-array needles containing doxorubicin, developed by Medicus Pharma (TSX-V:MDCX)'s portfolio company, SkinJect.
What is SkinJect?
SkinJect’s focus is on the commercialization of a unique treatment method employing a patented dissolvable microneedle patch, designed to deliver a chemotherapeutic agent transdermally, effectively targeting and eradicating tumor cells.
The proprietary technology behind SkinJect’s innovation stems from a relevant US Patent granted jointly to the University of Pittsburgh and Carnegie Mellon University in 2018. The company secured exclusive worldwide development and commercial rights to the patent in April 2016, a pivotal moment in its quest to provide a viable alternative to the invasive and often painful Mohs Surgery.
Why are microneedles important?
The incorporation of microneedles, measuring less than 1000 μm in length, represents a significant stride in transdermal drug delivery. This method offers advantages over traditional delivery systems by creating temporary microchannels through the skin, facilitating the targeted administration of therapeutic agents.
The potential impact of dissolvable microneedles on the medical landscape could be transformative.
What happened in the Phase I study?
Medicus completed a Phase I study in March 2021, focusing on participants with superficial or nodular BCC. Now, a randomized, controlled, double-blind, multicenter Phase Two clinical study is underway.
Designed to enroll up to 60 patients, the trial will evaluate the efficacy of two dose levels of D-MNA (Doxorubicin Micro-Array Needles) compared to a placebo. With the potential for accelerated new drug application and a waiver from a large Phase Three trial, Medicus Pharma (TSX-V:MDCX) aims to deliver a non-invasive and non-surgical treatment option for BCC.
CEO Raza Bokhari remarked recently that the company is delivering on the milestones it set out when Medicus started trading on the CSE in the fall of 2023.
“These findings have prompted us to consider the potential of our novel therapy, designed to offer a non-invasive and non-surgical treatment option currently unavailable in the market,” Bokhari said.
“With this in mind, we believe there's a strong likelihood that, with FDA alignment, we may qualify for an accelerated new drug application and potentially obtain a waiver from a large Phase Three trial.”
What’s in store for Medicus?
The trial design Medicus submitted to the FDA is strategically crafted to position itself as a pivotal Phase Two study, extending beyond proof of concept, Bokhari noted. As it progresses to the 90-day midpoint, the firm anticipates a comprehensive analysis of the data. Should the interim review indicate positive trends, Medicus plans to engage with the FDA, seeking further guidance on expanding the trial.
“Our ultimate goal is to fast-track towards accelerated approval, a prospect that holds great promise for both our company and the value creation for our shareholders,” Bokhari said.
The strategic addition of Dr Huma Qamar as Chief Scientific Officer reinforces Medicus Pharma (TSX-V:MDCX)'s commitment to advancing its research and development program. Dr Qamar, a biotech veteran, has a passion for oncology and the potential game-changing impact of SkinJect's microarray needles in treating basal cell carcinoma.
With a focus on scientific advancements and addressing unmet medical needs, Medicus Pharma (TSX-V:MDCX) aims to contribute significantly to the field of derma-oncology. As the company navigates the clinical landscape and garners attention from industry analysts, the future holds promising prospects for Medicus Pharma (TSX-V:MDCX) and its mission to redefine cancer treatment.
It’s a personal quest for CEO Bokhari and the team: "This is a thousand-mile journey, and we have taken some bold, important steps."