CytRx Corp. (NASDAQ: CYTR) absolutely crumbled in Tuesday’s session after the company released less than favorable late-stage results. The company announced the results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory soft tissue sarcomas (STS).
Because enrollment was interrupted by a partial clinical hold in November 2014, this analysis did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the Phase 3 study after the hold was resolved and enrollment resumed.
Unfortunately, this resulted in nearly half of all patients being censored (excluded) from the current progression free survival (PFS) evaluation. CytRx expects to conduct a second analysis, which will include longer patient follow-up and allow for greater maturation of all endpoints.
CytRx expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the Food and Drug Administration (FDA) in the fourth quarter of 2016. The partial clinical hold was related to a single patient enrolled in a compassionate use study, which was subsequently resolved successfully.
Also it is worth mentioning that with roughly $68.2 million in cash and equivalents as of the company’s last 10-Q filing, CytRx is funded through the next Phase 3 STS trial analysis and through a readout of its global Phase 2b trial of aldoxorubicin in small cell lung cancer.
Sant Chawla, M.D., FRACP, Principal Investigator and the Director of the Sarcoma Oncology Center in Santa Monica, California, commented:
While results from this current analysis are immature, a near doubling of response rates with aldoxorubicin suggests a highly active therapy which may benefit certain patients with soft tissue sarcoma. Because enrollment was interrupted by a clinical hold, both PFS and response data need to be analyzed at a future date to account for patients enrolled later in the trial. I look forward to this subsequent analysis providing a more complete understanding of aldoxorubicin’s potential in this very challenging disease.
Shares of CytRx were trading down over 60% at $0.94 on Tuesday, with a consensus analyst price target of $6.83 and a 52-week trading range of $0.74 to $4.20.