CytRx Receives Recommendation from Data Safety Monitoring Committee to Complete International Phase 2b Trial with Aldoxorubicin as First-Line Treatment for Soft Tissue Sarcoma
Marks key milestone in late-stage trial that provides direct clinical comparison of aldoxorubicin and doxorubicin
No significant safety issues found with delivery of doxorubicin at 3.5 times its standard dose with aldoxorubicin, the first clinical-stage oncology candidate formed with CytRx's proprietary linker technology platform
LOS ANGELES--(BUSINESS WIRE)-- CytRx Corporation (NAS: CYTR) , a biopharmaceutical research and development company specializing in oncology, announced that the independent Data Safety Monitoring Committee (DSMC) overseeing the Company's international Phase 2b clinical trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion. This Phase 2b trial allows for a head-to-head clinical comparison of the commonly used chemotherapeutic agent doxorubicin with aldoxorubicin, CytRx's tumor-targeting doxorubicin conjugate. Doxorubicin is dose-limited at a level below its maximum anti-tumor capabilities due to toxicity, including cardiotoxicity. Data from the Phase 2b trial is expected in the second half of 2013.
"The recommendation to complete the Phase 2b trial indicates that the DSMC found no significant safety issues with aldoxorubicin, even though the dose of aldoxorubicin administered in this trial delivers doxorubicin at three-and-a-half times its standard dose," said CytRx CEO Steven A. Kriegsman. "The DSMC was not charged with evaluating efficacy at this point in the study. Aldoxorubicin combines doxorubicin with our proprietary linker technology. This platform technology includes a single molecule that, when attached to a chemotherapeutic agent, allows for concentration of the agent at the tumor site, thus allowing for greater drug infusion into the tumor. We believe that safely concentrating more drug at the tumor site could improve the drug's effectiveness.
"Aldoxorubicin is the first drug we are evaluating in the clinic based on the linker technology. Doxorubicin was selected for evaluation as it is well-known and has been used by the medical community for decades; however the linker has broad potential utility with proven affinity to couple with multiple chemotherapeutic agents including paclitaxel, docetaxel, cisplatin, irinotecan and methotrexate. Each of these agents may be incorporated into our future clinical development plans," he added.
The Phase 2b trial is enrolling a total of 105 patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy and are ineligible for surgery. Patients in the trial are randomized into two groups, with twice as many receiving aldoxorubicin as doxorubicin. The trial's primary objective is to compare progression-free survival between each group. Secondary endpoints include evaluating tumor response and overall patient survival, and assessing the safety of aldoxorubicin compared with doxorubicin in this patient population through a number of indicators, including the frequency and severity of adverse events. Patients are being enrolled in clinical sites in the U.S., Hungary, Romania, Russia, Ukraine, India and Australia.
CytRx holds exclusive worldwide rights to aldoxorubicin, as well as option rights to the protein-binding platform technology that serves as the linker with doxorubicin.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications: aldoxorubicin (formerly known as INNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, and has initiated a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors. The Company is in the process of 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. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer. The Company reached its enrollment target for that trial in February 2013. The Company completed its evaluation of a third drug candidate, 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. 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, the risk that any future human testing of CytRx's drug candidates or platform technology 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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