Problems for competitor likely to benefit CytRx' aldoxorubicin

The failure of Ziopharm’s palifosfamide in metastatic soft tissue sarcoma (STS; The Pharma Letter March 26) is viewed as incrementally positive for US biopharma firm CytRx’ (Nasdaq: CYTR) aldoxorubicin by analysts at Edison Investment Research.

It eliminates a potential competitor in the first-line setting and, critically, confirms doxorubicin as the “gold standard” comparator for its ongoing Phase IIb study in front-line STS. The analysts’ CytRx valuation of $120 million ($4.0/share) remains unchanged following the palifosfamide news as they currently value aldoxorubucin in second-line STS only. However, this could change if front-line Phase IIb data are positive in H213.

There are now two products in mid-to-late stage development for first-line STS – Threshold’s TH-302 (Phase III) and CytRx’ aldoxorubicin (Phase IIb). Further clarity on the competitive landscape in first-line STS could emerge mid-2013, when Threshold conducts an interim PFS futility analysis for TH-302. Assuming TH-302 is not futile, the next datapoint will be an interim overall survival (OS) analysis around end-2013. For aldoxorubicin, headline PFS data from the head-to-head study versus doxorubicin is expected in the first half of 2013.