PenetriumBio announced on the 4th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical trial of 'Penetrium' in patients with relapsed or refractory progressive solid tumors.

According to the disclosure, the trial is an open-label, randomized, multicenter Phase 2a study designed to evaluate the efficacy and safety of Penetrium in combination with standard of care (SoC) for each tumor type. The trial will be conducted at three sites in the United States, with a target enrollment of 18 patients. The company stated that the primary objective of the trial is to evaluate the anti-tumor activity of Penetrium when administered in combination with standard of care. The clinical trial period will be within 24 months from the date of FDA IND approval and may vary depending on the pace of patient enrollment.

The company explained that the date of this disclosure's occurrence is 'the date on which confirmation of the clinical trial protocol submission was received from the FDA.' If the clinical trial protocol receives final approval in the future, the company plans to submit additional disclosures accordingly.

Meanwhile, through its investment cautionary notice, the company noted that the statistical probability of a clinical-stage drug receiving final marketing approval is approximately 10%. It added that clinical trials and the drug approval process may yield results that fall short of expectations, which could lead to changes in or abandonment of commercialization plans. The company urged investors to carefully consider the investment risks disclosed through periodic disclosures and business reports before making investment decisions.