Penetrium Bio: US Phase 2 trial is standard procedure

Penetrium Bio has clarified the rationale behind its new drug candidate, Penetrium, beginning its U.S. clinical trials at Phase 2 instead of Phase 1. The company addressed repeated concerns, stating that skipping Phase 1 is permissible and not a misunderstanding of drug development procedures.

“

This clinical plan was not decided by the company alone, but after reviewing it with several clinical CROs in the U.S., we concluded that starting from Phase 2 is appropriate.

The decision to proceed directly to Phase 2 was made in consultation with multiple U.S.-based Contract Research Organizations (CROs). The clinical trial design was reviewed by the local CRO responsible for FDA approvals, Penetrium Bio's U.S. Business Head, and Sandip Patel, a professor at the University of California, San Diego (UCSD), who has extensive experience in multi-cancer clinical trial design.

Phase 1 trials typically assess the safety of a drug when first administered to humans. However, for drug candidates with established safety profiles, initiating later-stage trials for different indications is permitted by the FDA. Penetrium's active ingredient has already undergone Phase 2/3 trials for COVID-19 and is currently being tested as a dengue fever treatment in Vietnam, providing the necessary human safety data.

“

We will prepare for the era of combination immunotherapy through Penetrium combination Phase 2 trials.

Penetrium Bio further emphasized that the dosage planned for the U.S. Phase 2 trial is lower than the doses already administered safely in previous COVID-19 and dengue fever trials. Animal studies have shown anti-cancer effects even at these lower doses. Chairman Cho Won-dong expressed his vision for Penetrium, stating, "We will prepare for the era of combination immunotherapy through Penetrium combination Phase 2 trials." He aims to usher in a new era of treatment that targets both cancer cells and their environment, realizing an anti-cancer principle proposed 137 years ago by British surgeon Stephen Paget, and alleviating patient suffering from treatment and metastasis through clinical outcomes.

“

We will usher in a new era of treatment that targets both cancer cells and their environment, realizing an anti-cancer principle proposed 137 years ago by British surgeon Stephen Paget, and alleviating patient suffering from treatment and metastasis through clinical outcomes.