CytRX Corp., a biopharmaceutical research and development company specializing in oncology, today released further clinical data from a multi-site global Phase 2b study comparing its aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas (STS) versus the widely used chemotherapeutic agent doxorubicin. The data will be presented today at the 18th Annual Connective Tissue Oncology Society Meeting at the Sheraton New York Times Square Hotel in New York City, NY. It will include additional information that was collected and recorded September 27 to October 16, 2013.
Still ongoing, the study had 47 remaining active patients in the clinical trial as of October 16, 2013 (36 on aldoxorubicin and 11 on doxorubicin). CYTR expects it will report top-line progression-free survival results for the trial sometime in December 2013.
“We are very pleased with the continued clinical findings from our global Phase 2b trial with aldoxorubicin as a first-line treatment in advanced soft tissue sarcomas, and the strength of the data presented today reinforces our belief that the linker technology platform can be applied to a broad range of cancer treatments,” said CYTR President and CEO Steven A. Kriegsman. “We look forward to advancing our aldoxorubicin second-line program into a Phase 3 pivotal trial in the first quarter of 2014 as well as evaluating aldoxorubicin as treatment for malignant glioblastoma (brain cancer) and HIV-related Kaposi’s sarcoma.”
In the trial 123 patients aged 18-80 years with histologically confirmed metastatic, locally advanced or unresectable soft tissue sarcomas were randomized 2:1 to receive 350 mg/m2 aldoxorubicin (260 mg/m2 doxorubicin equivalents) IV or 75 mg/m2 doxorubicin IV. They were slated to receive those dosages every three weeks for up to six cycles. The presented findings indicate ldoxorubicin can be administered at doses greater than 3 1/2 x the standard doxorubicin dose with similar or fewer systemic side effects. A significantly higher percentage of patients receiving aldoxorubicin are still active, have received at least 4 or 6 cycles of treatment, and have a greater number of tumor responses and stable disease. Patients in the trial treated with ldoxorubicin had a higher Overall Response Rate (ORR) (22%) compared with those treated with doxorubicin (0%) (p=0.004). In addition, a lower percentage of patients treated with aldoxorubicin (32%) showed progressive disease compared with patients treated with doxorubicin (50%) at the time of analysis.
The findings further showed 24 serious adverse effects associated with aldoxorubicin therapy patients as opposed to 6 serious adverse effects with doxorubicin-receiving patients. All of these effects were resolved and did not require treatment discontinuation. One treatment-related death in a patient treated with doxorubicin was reported.
A higher percentage of aldoxorubicin patients completed four cycles of treatment compared with doxorubicin patients (59 vs. 22, respectively) and six cycles of treatment (45 vs. 14, respectively). A similar percentage of aldoxorubicin patients (15%) and doxorubicin patients (16%) experienced neutropenic fever, and a higher percentage of doxorubicin patients (22%) had decreased cardiac output compared with aldoxorubicin patients (11%), as measured by a 15% decrease in left ventricular ejection fraction. No patient treated with aldoxorubicin had ejection fractions below 50% of their institutional norm versus 9.4% of patients that had received doxorubicin. Most importantly, there was no clinically significant reduction in cardiac function in the aldoxorubicin patients despite receiving 3 ½ times the standard dose of doxorubicin.
More information regarding CYTR, its initiatives, and the scientific background of its efforts can be found at: www.cytrx.com
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