Shares tumble at CytRx as lead oncology candidate fails to impress in Phase III
pharmafile | July 12, 2016 | News story | Manufacturing and Production, Research and Development | aldoxorubicin, cytrx
CytRx (NASDAQ: CYTR) has announced disappointing results from a Phase III trial for its lead drug candidate, aldoxorubicin, compared to investigator’s choice of therapy in patients with relapsed or refractory soft tissue sarcomas.
There was no statistical difference between aldoxorubicin and investigator’s choice therapy for progression free survival, the primary endpoint of the trial, with a median of 4.17 months and 4.04 months respectively.
The news was enough to send shares into freefall, with company stock down almost 70% in after-hours trading.
CytRx did attempt to point to mitigating circumstances explaining the poor quality of results. They indicate that enrolment was interrupted by a partial clinical hold in November 2014, and this meant that the current analysis of the data did not provide for sufficient follow-up for the nearly two-thirds of patients who entered the study after the hold was resolved and enrolment resumed.
The company also note encouraging signs in the objective response rate (ORR) and the rate of disease progression, with ORR doubling in the aldoxorubicin arm compared to the investigators’ choice of treatment. Nevertheless, as the data is announced in accordance with the FDA-granted special protocol assessment, and shares set to tank as a result, this trial is certainly not good news for CytRx.
Steven A. Kriegsman issued a statement attempting to mitigate the impact of the unwelcome results. He comments: “In over 550 patients to date, aldoxorubicin has demonstrated anti-tumour activity in multiple tumour types and has shown a manageable safety profile. With approximately $68.2 million in cash and equivalents as our last 10-Q filing, CytRx is funded through the next Phase III soft tissue sarcomas trial analysis and through a readout of our global Phase IIb trial for aldoxorubicin in small cell lung cancer.”
Sean Murray
Related Content
Weekly Movers: CytRx, Coherus BioSciences, Juno Therapeutics…
Shares in CytRx (Nasdaq: CYTR) lost nearly three-fourth in value after the company reported disappointing …
