CytRx Corporation (NASDAQ:CYTR) presented a poster with updated interim results from its on-going Phase 1b/2 trial of aldoxorubicin in combination with ifosfamide/mesna in patients with advanced sarcomas at the 2016 Annual Meeting of the Connective Tissue Oncology Society (CTOS) being held in Lisbon, Portugal.
Forty-two patients have been enrolled to date and 36 were evaluable as of the data cutoff. Of the 36 evaluable patients receiving either 170mg/m2 (n=7) or 250mg/m2 (n=29) of aldoxorubicin plus ifosfamide and mesna, 14 of 36 (39%) achieved a partial response of the target lesion by RECIST 1.1 criteria, 21 of 36 (58%) had stable disease, and one patient had progressive disease. As previously reported in October at the 2016 ESMO Congress, median progression-free survival has not yet been reached. Dose-limiting toxicities were not observed in either cohort, and no clinically significant cardiac toxicities were seen. The most common Grade 3 or 4 adverse events were neutropenia (71%), anemia (54%), thrombocytopenia (17%) and febrile neutropenia (14%). There were nine treatment-related serious adverse events, and no treatment-related deaths. The trial has been expanded to allow continued enrollment of additional sarcoma patients at the 250 mg/m2 dose of aldoxorubicin with ifosfamide and mesna.
“The CTOS annual meeting is the preeminent medical conference focused on sarcomas and provides an opportunity to update the international sarcoma community with the latest results for aldoxorubicin, said Sant Chawla, M.D., F.R.A.C.P., the trial’s principal investigator and Director of the Sarcoma Oncology Center in Santa Monica, California. “Our poster highlights that nearly 40% of the sarcoma patients receiving the combination of aldoxorubicin with ifosfamide and mesna achieved a partial response of the target lesion by RECIST criteria, and half of those had greater than 50% shrinkage of their tumors. This is important because it allowed some patients who initially could not have surgery to become eligible for surgery.”
The Phase 1b/2 clinical study is a single-center trial that has enrolled 42 patients to date with locally advanced, unresectable, and/or metastatic soft tissue sarcoma, intermediate-grade or high-grade chondrosarcoma or osteosarcoma. In the dose escalation phase, patients received either 170mg/m2 or 250mg/m2 of aldoxorubicin in combination with up to a 14-day continuous infusion of ifosfamide (1g/m2/day) plus mesna over a 28-day cycle. Up to six cycles of ifosfamide/mesna with aldoxorubicin can be administered, and aldoxorubicin may be continued until tumor progression or unacceptable toxicity occurs. The expansion phase is enrolling patients at the 250mg/m2 dose of aldoxorubicin and will allow for patients that had received prior chemotherapy to be included. The primary endpoint of the study is safety, and secondary endpoints include overall response rates and progression-free survival.(Original Source)
Shares of Cytrx are currently trading at $0.463, down $0.012 or -2.42%. CYTR has a 1-year high of $3.66 and a 1-year low of $0. The stock’s 50-day moving average is $0.54 and its 200-day moving average is $1.47.
On the ratings front, Cytrx has been the subject of a number of recent research reports. In a report issued on October 10, FBR analyst Christopher James reiterated a Buy rating on CYTR. Separately, on July 29, Jefferies’ Chris Howerton reiterated a Hold rating on the stock and has a price target of $0.75.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher James and Chris Howerton have a yearly average loss of 15.4% and 8.3% respectively. James has a success rate of 30% and is ranked #4053 out of 4200 analysts, while Howerton has a success rate of 30% and is ranked #3780.
CytRx Corp. operates as a biopharmaceutical research and development company specializing in oncology. It provides clinical development of aldoxorubicin oncology pipeline for the treatment of cancer.