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  • CytRx Corp. (CYTR) Data Confirm Top-Line Efficacy Results Of Phase 2b Clinical Trial For Cancer Drug 0 comments
    Jan 8, 2014 2:38 PM | about stocks: CYTR

    CytRx today reports that additional statistical analyses further support the company's previously announced highly positive top-line efficacy results of a phase 2b clinical trial designed to determine the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy for unresectable soft tissue sarcomas (STS).

    Hazard ratios are a measurement of the likelihood that the study endpoint (in this case tumor progression) will be reached during a given period. These ratios reflect the reliability and uniformity of the absolute data for PFS - hazard ratios with an upper limit of less than 1 indicate that there is a significant difference between the two study groups.

    The recent additional analysis, conducted by investigators at study sites and by a blinded radiology review performed at an independent central lab, determined the following hazard ratios for the primary endpoint of progression-free survival (PFS):

    •Investigator-read scans: 0.37 (95% confidence interval, range of 0.212 to 0.643) (p=0.0004) , reflecting a 63% reduction in the risk of disease progression

    •Central lab scans: 0.59 (95% confidence interval, range of 0.36 to 0.96) (p=0.034), reflecting a 41% reduction in the risk of disease progression

    CytRx also reported that a Kaplan-Meier analysis of the trial results, which indicates the time it takes for tumors to progress in individual patients, greatly improved in subjects treated with aldoxorubicin vs. subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology (OTC:ASCO) Meeting in June, 2014 in Chicago, Illinois.

    "Because of the tremendous potential for aldoxorubicin to treat soft tissue sarcomas and other common cancers, it is important that we present the initial trial analyses in a timely manner. We are very pleased that additional statistical analyses strongly support the earlier top-line results, which reinforces our confidence in the ability of our linker technology to target the release of doxorubicin directly at the site of cancer," CytRx president and CEO Steven A. Kriegsman stated in the news release.

    As initially reported in December, 2013, both the investigator assessment and central lab review, aldoxorubicin demonstrated highly statistically significant superiority over doxorubicin therapy for STS. Specifically, both assessments showed an unambiguous 80% to 100% improvement in PFS among patients treated with aldoxorubicin.

    For more information, visit cytrx.com

    MissionIR provides investor relations services to publicly traded companies in exchange for compensation. This article may be part of our efforts to widen a client's exposure. To read our full disclaimer, visit http://disclaimer.missionir.com

    Stocks: CYTR
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