US biotech firm CytRx Corp (Nasdaq: CYTR) says that it will now focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase IIb clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer.
The recommendation was based on an interim analysis indicating that patients treated with tamibarotene were unlikely to show improved progression-free survival over treatment with approved chemotherapeutic agents. No safety concerns were raised.
“This is an eventful time as we expect to announce data from three clinical trials with aldoxorubicin this year and are making preparations to begin our first pivotal Phase III clinical trial with aldoxorubicin,” said Steven Kriegsman, CytRx president and chief executive, adding: “We see significant opportunities ahead with potential from multiple drug candidates addressing numerous oncology indications. Aldoxorubicin is its own pipeline with demonstrated efficacy in human tumor models of breast, ovarian, lung and pancreatic cancers and renal cell carcinoma (kidney cancer). We are disappointed by the outcome of the tamibarotene trial for our company, but more importantly for patients. The trial was well-conducted but the DSMC judged that it would not be able to successfully meet its primary endpoint.”
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