Canadian life sciences company Medicus Pharma has partnered with Japanese healthcare consultancy Swanielle to expand its Phase II clinical trial for treating basal cell carcinoma (BCC) into the Asia-Pacific region.
Under the agreement, Swanielle will assist in identifying potential partners for Medicus in Southeast Asia to facilitate the study’s expansion.
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The randomised, multi-centre trial will assess the efficacy of two dosage levels of D-MNA against a placebo control.
Subjects in the study are being randomised at a 1:1:1 ratio into either a placebo-controlled group receiving P-MNA, a low-dose group receiving D-MNA 100μg, or a high-dose group of D-MNA 200μg.
The ongoing SKNJCT-003 trial is currently being conducted across nine US clinical sites, with more than 25% of the anticipated 60 subjects randomised to date.
The partnership with Swanielle began on 1 December and has an initial one-year term.
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By GlobalDataSwanielle will receive a retainer fee of $22,500, along with a variable rate success fee of 1%-5% on the condition that it signs a definitive agreement with a qualifying partner.
Medicus Pharma CEO and executive chairman Dr Raza Bokhari said: “We are delighted with the progress we have made in advancing the clinical development programme of our novel, non-invasive treatment to cure the most common cancer in the world.
“The collaboration with Swanielle to explore the expansion of our clinical study to treat BCC in Southeast Asia will help us gather useful efficacy and safety data which will strengthen the analysis of the pivotal trial that we plan to commence in the not-so-distant future.”
Medicus aims to expedite the clinical development programme and transition the SKNJCT-003 exploratory clinical trial into a pivotal trial.
Over the next year, the company plans to carry out an interim data analysis and hold a ‘Type C’ meeting with the US Food and Drug Administration to discuss product development and the clinical pathway.
