CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced today that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a special protocol assessment (SPA) for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the Phase 3 clinical trial to be used in support of a potential New Drug Application (NDA) for aldoxorubicin. The Company is actively making preparations for the pivotal Phase 3 trial.
“Multiple chemotherapy regimens have been explored as palliative therapy for these patients with several failures in Phase 3 trials. Additionally, currently approved chemotherapeutic regimens are frequently quite toxic with no significant impact on either progression-free survival or overall survival.”
"By reaching an agreement on an SPA, the FDA deems that results from this single Phase 3 clinical trial will be acceptable to support the regulatory approval of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma, with final marketing approval dependent on the results of the trial and other accomplishments," said Steven A. Kriegsman, CytRx President and CEO. "The ability to conduct the clinical trial under an SPA could save significant time compared with a standard regulatory pathway. Our optimism about aldoxorubicin's prospects in this difficult-to-treat indication is predicated on positive results from a Phase 1b/2 trial in which this novel agent was associated with objective responses and prolonged progression-free survival in several patients with advanced soft tissue sarcoma who had relapsed or not responded to prior treatments, as well as on additional clinical and preclinical data."