CytRx Reaches Enrollment Target in International Phase 2b Clinical Trial with Aldoxorubicin as First
CytRx Reaches Enrollment Target in International Phase 2b Clinical Trial with Aldoxorubicin as First-Line Treatment for Soft Tissue Sarcoma
Late-stage clinical trial directly compares efficacy and safety of aldoxorubicin with doxorubicin
Progression-free survival data expected in the second half of 2013
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NAS: CYTR) , a biopharmaceutical research and development company specializing in oncology, announced that it has reached the targeted enrollment of 105 evaluable patients in its international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma. This trial allows for a head-to-head clinical comparison of the efficacy and safety of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx's improved version of doxorubicin.
"Achieving this key milestone puts us on track to report highly anticipated progression-free survival data from the Phase 2b clinical trial in the second half of 2013," said Steven A. Kriegsman, CytRx President and CEO. "Doxorubicin is a well-known chemotherapy drug, having been used by the medical community for decades, and it is the current standard of care for advanced, metastatic soft tissue sarcoma as well as numerous other cancers. Doxorubicin, however, has many side effects, including potential damage to the heart muscle. These side effects limit the dosage of doxorubicin to a level below its maximum anti-tumor capabilities.
"Aldoxorubicin is formulated using a novel linker technology designed to safely deliver higher concentrations of doxorubicin directly to tumors, which could improve effectiveness while reducing toxicity. In fact, the Phase 2b clinical trial is comparing a dose of aldoxorubicin that delivers doxorubicin at 3.5 times the dose of doxorubicin in the comparator arm of the trial," he added. "Last month, the independent Data Safety Monitoring Committee overseeing the Phase 2b trial recommended conducting the trial to completion, indicating that the Committee had found no significant safety issues with aldoxorubicin, even at this high dose."
In the Phase 2b clinical trial, patients with metastatic locally advanced or unresectable soft tissue sarcoma who have not been previously treated with any chemotherapy are randomized into two groups with twice as many receiving aldoxorubicin as doxorubicin. In addition to the primary objective of measuring median progression-free survival, the Phase 2b trial will evaluate tumor response and overall patient survival. The trial is being conducted at clinical sites in the U.S., Hungary, Romania, Russia, Ukraine, India and Australia.
CytRx expects to evaluate aldoxorubicin in additional indications, and the linker molecule has broad utility with the ability to attach to multiple widely used chemotherapeutic agents. One or more of these agents may be incorporated in CytRx's future development plans. CytRx holds exclusive worldwide rights to aldoxorubicin, as well as option rights to the linker platform technology.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx reached targeted enrollment in an international Phase 2b clinical trial with aldoxorubicin as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and is conducting a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. The Company is initiating a Phase 3 pivotal trial under a special protocol assessment (SPA) with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx is expanding its pipeline of oncology candidates based on a novel linker platform technology that can be utilized with multiple chemotherapeutic agents and could allow for greater concentration of drug at tumor sites. The Company also has rights to two additional drug candidates, tamibarotene and bafetinib. The Company completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib, and is evaluating further development of tamibarotene. For more information about CytRx Corporation, visit www.cytrx.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx's clinical trials, including its Phase 2b clinical trial with aldoxorubicin as a first-line treatment for soft tissue sarcoma, the risk that any future human testing of aldoxorubicin might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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