CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (FDA) to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas. The clinical trial is scheduled to begin this quarter. For purposes of the clinical trial, disease progression is defined as an increase in the size of measurable tumors by 20% or the development of a new tumor lesion. The following table sets forth the cumulative dose of doxorubicin in prior and planned CytRx clinical trials:
The study design under the trial's Special Protocol Assessment (SPA) originally called for dosing to be stopped after six treatment cycles. FDA acceptance of a protocol amendment to include a dose-to-progression regimen demonstrates the superior cardiac safety thus far of administrating a cumulative 2,080 mg/m2 dose of aldoxorubicin as seen in the Company's recently announced global, Phase 2b clinical trial results (which is equivalent to 1,560 mg/m2 of doxorubicin), which is 3.5 times the recognized maximum cumulative dose of doxorubicin (450 mg/m2) associated with cardiac toxicity (heart damage).
Sant Chawla, M.D., of the Sarcoma Oncology Center in Santa Monica, Calif., and principal investigator of the Phase 3 pivotal trial, commented, "In addition to observing no significant cardiotoxicity of aldoxorubicin to this point, the FDA's agreement to extend dosing beyond six cycles offers the potential to achieve even greater progression-free survival efficacy results than were demonstrated in CytRx's recent highly successful global Phase 2b trial for advanced soft tissue sarcomas. As the principal investigator for this trial, I can say that we are very pleased to have the opportunity to provide the maximum benefits of aldoxorubicin to the patients around the world."
"Current chemotherapy treatments for soft tissue sarcomas have demonstrated limited impact, and other potential treatments have provided no improved benefits in Phase 3 trials," said CytRx President and CEO Steven A. Kriegsman. "As such there is a significant need for a second-line treatment with greater efficacy and reduced or no measurable cardiac toxicity. This FDA acceptance of extended dosing represents a potential major breakthrough for CytRx and STS patients throughout the world."
The international, open-label pivotal Phase 3 clinical trial will enroll approximately 400 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to or have progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapies. Trial patients will be randomized 1:1 to be treated with aldoxorubicin or the investigator's choice of an approved chemotherapeutic regimen to include dacarbazine, pazopanib (Votrient®), gemcitabine plus docetaxel, doxorubicin or ifosfamide, with up to three comparator regimens to be selected by the investigator at each clinical site. The clinical trial will be conducted at approximately 100 clinical sites in the U.S., Europe, Canada, Latin America and Australia. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival and safety.
Review of Results for Phase 2b Trial with Aldoxorubicin as a First-line Treatment in Advanced Soft Tissue Sarcomas