Philux, Recruiting Patients for Phase 2 Clinical Trial of Immuno-Oncology Drug... Smooth Progress in Development Process

[Asia Economy Reporter Hyungsoo Park] Viral Gene, Inc., a U.S. subsidiary of Philux, announced on the 25th that it is actively recruiting patients for the Phase 2 clinical trial of the immuno-oncology drug (Ad5.F35-hGCC-PADRE).

They submitted supplementary data including immuno-oncology drug-related data produced by Baylor College of Medicine and additional QC analysis data to the U.S. Food and Drug Administration (FDA). The FDA is currently reviewing these materials and patient recruitment is underway.

Although the clinical trial progress could have been delayed due to the COVID-19 pandemic, Philux was able to continue advancing the immuno-oncology drug development trial through active collaboration with Dr. Scott Arthur Waldman’s team.

According to Dr. Scott’s team, patient recruitment for the clinical study began on the 10th. Only the administrative procedures at Thomas Jefferson University, where the clinical study is being conducted, remain. Once these procedures are completed, the clinical trial will officially commence with the first patient receiving the treatment.

The clinical trial aims to determine the appropriate dosage of the treatment. Patients enrolled in the trial will be divided into three groups, and on the first day of weeks 1, 5, and 9, different doses of the treatment will be administered via intramuscular injection. For safety, three patients in each group will be dosed first, and if deemed safe, the treatment will be administered to the remaining patients. The trial targets patients with stomach cancer, pancreatic cancer, esophageal cancer, and colorectal cancer. The company emphasized that clinical trial details can also be found on the U.S. National Library of Medicine website and the FDA website.

Philux plans to actively pursue joint research with leading domestic universities and research institutions, as well as investments in bio companies, coinciding with the start of the Phase 2 clinical trial.