- Clinical Trials
Preliminary analysis of the interim data from the Phase II portion of our ONC-002 trial supported our belief that GPX-001 may provide medical benefit in several subpopulations of NSCLC patients for which there is an unmet medical need, and may provide pathways for accelerated approval by the U.S. Food and Drug Administration, or FDA. Data from our clinical trials, along with our preclinical data, provided the basis for our application for a Fast Track Designation, which was granted by FDA on January 14, 2020.
In granting our Fast Track Designation, the FDA found that GPX-001 may provide a benefit over existing therapies for patients whose tumors progress on osimertinib (AstraZeneca’s Tagrisso®). The FDA Fast Track Designation is for use of the combination of GPX-001 with osimertinib in patients whose tumors progressed on osimertinb. We believe that the Fast Track Designation provides a clearly defined pathway toward FDA approval of the combination of GPX-001 with osimertinib, and we plan to open a Phase I/II clinical trial of GPX-001 combined with osimertinib in early 2021. Based on the receipt of the Fast Track Designation of GPX-001 with osimertinib and the fact that osimertinib is now the standard of care for this patient population, we will no longer enroll patients in our ONC-002 trial in which we combined GPX-001 with erlotinib.
Tagrisso® is a registered trademark of AstraZeneca.