CytRx Corp., a
biopharmaceutical research and development company specializing in oncology,
today announced it has received approval from the U.S. Food and Drug
Administration (FDA) to continue dosing patients with aldoxorubicin until
disease progression in a planned pivotal, global Phase 3 clinical trial with
aldoxorubicin as a second-line treatment for soft tissue sarcomas. The clinical
trial is scheduled to begin this quarter. This decision by the FDA reflects the
superior cardiac safety of aldoxorubicin, and the additional treatment cycles
create potential for substantially improved efficacy results
The study design under the
trial’s Special Protocol Assessment (SPA) originally called for dosing to be
stopped after six treatment cycles. FDA acceptance of a protocol amendment to
include a dose-to-progression regimen demonstrates the superior cardiac safety
thus far of administrating a cumulative 2,080 mg/m2 dose of aldoxorubicin as
seen in the Company’s recently announced global, Phase 2b clinical trial
results (which is equivalent to 1,560 mg/m2 of doxorubicin), which is 3.5 times
the recognized maximum cumulative dose of doxorubicin (450 mg/m2) associated
with cardiac toxicity (heart damage).
Sant Chawla, M.D., of the
Sarcoma Oncology Center in Santa Monica, Calif., and principal investigator of
the Phase 3 pivotal trial, commented, “In addition to observing no significant
cardiotoxicity of aldoxorubicin to this point, the FDA’s agreement to extend
dosing beyond six cycles offers the potential to achieve even greater
progression-free survival efficacy results than were demonstrated in CytRx’s
recent highly successful global Phase 2b trial for advanced soft tissue
sarcomas. As the principal investigator for this trial, I can say that we are
very pleased to have the opportunity to provide the maximum benefits of
aldoxorubicin to the patients around the world.”
“Current chemotherapy
treatments for soft tissue sarcomas have demonstrated limited impact, and other
potential treatments have provided no improved benefits in Phase 3 trials,”
stated CytRx President and CEO Steven A. Kriegsman. “As such there is a
significant need for a second-line treatment with greater efficacy and reduced
or no measurable cardiac toxicity. This FDA acceptance of extended dosing
represents a potential major breakthrough for CytRx and STS patients throughout
the world.”
The international,
open-label pivotal Phase 3 clinical trial will enroll approximately 400
patients with metastatic, locally advanced or unresectable soft tissue sarcomas
who have either not responded to or have progressed following treatment with one
or more systemic regimens of non-adjuvant chemotherapies. Trial patients will
be randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice
of an approved chemotherapeutic regimen to include dacarbazine, pazopanib
(Votrient®), gemcitabine plus docetaxel, doxorubicin or ifosfamide, with up to
three comparator regimens to be selected by the investigator at each clinical
site. The clinical trial will be conducted at approximately 100 clinical sites
in the U.S., Europe, Canada, Latin America and Australia. The primary endpoint
of the study is progression-free survival (PFS), and secondary endpoints
include overall survival and safety.
Review of Results for Phase
2b Trial with Aldoxorubicin as a First-line Treatment in Advanced Soft Tissue Sarcomas
As initially reported on
December 11, 2013, patients treated with aldoxorubicin demonstrated highly
statistically significant clinical outcomes compared to those receiving
standard doxorubicin therapy for soft tissue sarcomas in both an investigator
assessment and a central lab review. Specifically, both assessments showed an
unambiguous 80% to 100% improvement in PFS among patients treated with
aldoxorubicin.
In an intent-to-treat
analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin
patients versus 4.7 months for doxorubicin patients (p=0.0002), while the
blinded central lab review indicated that median PFS for aldoxorubicin patients
was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per
investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months,
compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded
central lab review, 46.8% of aldoxorubicin patients had not progressed at 6
months, compared with 23.7% of doxorubicin patients (p=0.038).
On January 8, 2014, CytRx
reported results of additional analyses that determined hazard ratios for the
primary endpoint of PFS by both investigators at study sites and by a blinded
radiology review performed at an independent central laboratory. The hazard
ratio for investigator-read scans was 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; and the hazard ratio for central lab scans was 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. Hazard ratios – the likelihood
that the study endpoint (in this case tumor progression) will be reached during
a given period – are an important measure of the reliability and uniformity of
the absolute data for PFS as presented above. Hazard ratios where the upper
limit is less than 1 indicate that there is a significant difference between
the two study groups.
CytRx also reported that a
Kaplan-Meier analysis of the trial results, which describes the time it takes
for tumors to progress in individual patients, showed significant improvement
in patients treated with aldoxorubicin versus patients treated with
doxorubicin.
For more information on
CytRx Corp. and Aldoxorubicin, visit www.cytrx.com
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