CytRx Corporation Soars on Positive Phase 2b Sarcoma Data
On Wednesday morning, shares of CytRx Corporation (NASDAQ:CYTR) soared by as much as 80 percent after the company announced positive data from its Phase 2b clinical trial in soft tissue sarcoma. The trial was evaluating the efficacy and safety of aldoxorubicin compared with doxorubicin in patients with first-line metastatic, locally advanced or unresectable soft tissue sarcomas.
Aldoxorubicin is a tumor-targeted doxorubicin conjugate. It essentially combines doxorubicin (current standard of care in cancer treatment) with a novel-linker molecule that binds to albumin in the blood. This molecule allows for a higher delivery of doxorubicin (3.5 to 4 times as much) without the associated toxicity. The principal investigator of the study, Dr. Sant Chawla, stated that, “Aldoxorubicin is the first and only single agent to surpass doxorubicin as a first-line treatment for soft tissue sarcomas.”
The trial evaluated 123 patients who received either aldoxorubicin or doxorubicin in a 2:1 randomization (83 patients received aldoxorubicin while 40 patients received doxorubicin). In order to properly analyze the results, CytRx used two approaches to evaluate the efficacy; an investor assessment and a central lab review. The major takeaways from the data include the following:
- The median progression-free survival for patients treated with aldoxorubicin was 8.4 months versus just 4.7 months for doxorubicin patients in the investigator assessment.
- In the central lab review, the median progression-free survival for aldoxorubicin patients was 5.7 months versus just 2.8 months for doxorubicin patients.
- Investigators determined that the overall response rate for aldoxorubicin patients was 25.4 percent (2.7 percent complete response and 22.7 percent partial response) versus just 5.4 percent doxorubicin patients. Of that 5.4 percent, none elicited a complete response.
- In the central lab review, the overall response rate for those on aldoxorubicin was shown to be 23 percent compared to 0 percent for those on doxorubicin.