CytRx Gets FDA Approval To Extend Aldoxorubicin Dosing Until Disease Progression

(RTTNews) - CytRx Corp. (CYTR) announced Tuesday that it has received approval from the U.S. Food and Drug Administration or 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 study design under the trial's Special Protocol Assessment or 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).

The company stated that 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.

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas.