(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the three months and nine months ended September 30, 2012. The Company also announced that it has held a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 pivotal trial with aldoxorubicin (formerly INNO-206) as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy.
“We are planning to submit a special protocol assessment (SPA) for the Phase 3 trial in patients with advanced soft tissue sarcomas,” said President and Chief Executive Officer Steven A. Kriegsman. “An agreement with the FDA with regards to an SPA would provide a clear regulatory pathway through the approval process. The initiation of a Phase 3 program for our lead drug candidate aldoxorubicin would represent a significant milestone in CytRx’s efforts to bring value to our stockholders and for those patients suffering from soft tissue sarcoma.”
The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a New Drug Application (NDA). Final marketing approval by the FDA depends on the results of the trial.
CytRx had previously announced its intention to pursue a Phase 3 pivotal trial with its tumor-targeting doxorubicin conjugate aldoxorubicin in patients with advanced soft tissue sarcomas, supported in part by positive data from a Phase 1b/2 clinical trial. Clinical results from the Phase 1b/2 trial were featured in presentations at the prominent American Society of Clinical Oncology (ASCO) and the European Society of Medical Oncology (ESMO) conferences within the past five months and will soon be presented at the Connective Tissue Oncology Society (CTOS) conference in Prague, Czech Republic.