(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announces further positive clinical data from a multi-site global Phase 2b study comparing the Company’s aldoxorubicin as a first-line treatment for advanced soft tissue sarcomas (STS) versus the widely used chemotherapeutic agent doxorubicin. The data is contained in a poster presented today at the 18
Annual Connective Tissue Oncology Society Meeting at the Sheraton New York Times Square Hotel and includes additional information captured between September 27 and October 16, 2013. The study is still ongoing, and as of October 16, 2013, 47 patients remained active in the clinical trial (36 on aldoxorubicin and 11 on doxorubicin). CytRx expects to report top-line progression-free survival results for the global Phase 2b clinical trial in December 2013.
In this trial 123 patients age 18-80 years with histologically confirmed metastatic, locally advanced or unresectable soft tissue sarcomas were randomized 2:1 to receive 350 mg/m
aldoxorubicin (260 mg/m
doxorubicin equivalents) IV or 75 mg/m
doxorubicin IV every three weeks for up to six cycles.
According to the findings presented in the poster, aldoxorubicin 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.
Among the findings presented today, patients in the trial treated with aldoxorubicin 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.
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.