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 (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
www.cytrx.com
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