CytRx (CYTR) Stock Falls On Unfavorable Aldoxorubicin Data

CytRx Corporation’s (NASDAQ:CYTR) shares plunged 59.8% after the company announced unfavorable initial results from a phase III study on its lead candidate, aldoxorubicin, in the treatment of patients with relapsed or refractory soft tissue sarcomas (STS).

The study is evaluating aldoxorubicin, in comparison with investigator's choice therapy, in patients with metastatic, locally advanced or unresectable soft tissue sarcomas, who had either not responded to, or who had progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapy. Investigator's choice therapy includes doxorubicin, Ifex (ifosfamide), dacarbazine, Votrient (pazopanib), or Gemzar (gemcitabine) plus docetaxel.

Data from the study failed to demonstrate a significant difference between aldoxorubicin and investigator's choice therapy for progression-free survival (PFS), thereby missing the primary endpoint. CytRx said that the analysis did not provide sufficient follow-up for nearly two-thirds of patients who entered the study after the partial clinical hold (instituted in Nov 2014) was lifted and enrollment was resumed. As a result, almost 50% of all study participants were excluded from the PFS evaluation.

Updated results from the study are expected to be presented at a future medical conference.

Meanwhile, the company expects to conduct a second analysis that will include longer follow-up data. Results from this analysis are expected in the fourth quarter of 2016. Moreover, the company intends to hold an end-of-phase III meeting with the FDA in the fourth quarter of this year.

Currently, aldoxorubicin is being developed for several indications including the second-line treatment of small cell lung cancer (phase IIb), HIV-related Kaposi's sarcoma (phase II) and late-stage glioblastoma (phase II). It is also being evaluated in two phase Ib studies, one in combination with Ifex for the treatment of sarcoma, and the other in combination with Gemzar for the treatment of metastatic solid tumors.

The recent unfavorable data from a study, which is being conducted under a Special Protocol Assessment (SPA) granted by the FDA, is a huge setback for CytRx, given that it is the only late-stage study on the candidate. Moreover, the company is highly dependent on aldoxorubicin for growth.

Going ahead, we expect investor focus to remain on further details pertaining to the second analysis of the study and the end-of-phase III meeting with the FDA. Investors focus should also be on the development of aldoxorubicin in the ongoing studies.

CytRx currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include GW Pharmaceuticals plc (NASDAQ:GWPH) , Innoviva, Inc. (NASDAQ:INVA) and Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) . Each of these stocks sports a Zacks Rank #1 (Strong Buy).

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