Penetrium Bioscience is set to submit an Investigational New Drug (IND) application for its groundbreaking drug candidate, Penetrium, to initiate Phase 2 clinical trials in the U.S.
The company announced on Tuesday that it plans to conduct Phase 2 trials in the U.S. to assess the anticancer efficacy of Penetrium, leveraging existing human safety data for the same formulation.
Penetrium is a promising candidate drug designed to modulate the tumor microenvironment surrounding cancer cells. The identical formulation has previously undergone global clinical trials as a potential COVID-19 treatment, generating valuable human safety data. Currently, Phase 2 and 3 trials for dengue fever are underway in Vietnam, further accumulating safety and pharmacokinetic (PK) data.
Building on this safety profile, the company aims to conduct trials in the U.S. focused on confirming Penetrium’s anticancer efficacy. Concurrently, ongoing Phase 1 trials in South Korea will determine the appropriate dosage for anticancer indications. Both U.S. and domestic clinical trials will proceed in parallel, tailored to each region’s specific development objectives and regulatory landscape.
The U.S. clinical trial design has been meticulously reviewed by a local contract research organization (CRO) and the company’s U.S. business management team. Professor Sandeep Patel from UC San Diego, an expert in basket trials for solid tumors, is leading the study as the principal investigator. He is spearheading the design of criteria for cancer types, patient selection, and methods for evaluating safety and efficacy.
Jo Won-dong, Chief Executive Officer (CEO) of Penetrium Bioscience, emphasized that the approach to advancing the U.S. Phase 2 trial is not about bypassing clinical procedures. Rather, it’s a strategic development plan that capitalizes on our existing human safety data. The final go-ahead for the clinical trial will be subject to the U.S. Food and Drug Administration’s (FDA) official review. It’s committed to maintaining transparency throughout this process and will openly share key developments, including the IND submission and subsequent review outcomes.