LOS ANGELES, Sept. 12, 2016 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced that
results from its on-going Phase 1b/2 trial of aldoxorubicin in
combination with ifosfamide/mesna in patients with advanced
sarcomas will be presented at the European Society for Medical
Oncology (ESMO) 2016 Congress being held in Copenhagen, Denmark, from October 7-11, 2016.
"Presenting the results from this trial at the ESMO Congress
underscores the continued anti-tumor activity of aldoxorubicin
across a variety of treatment settings for patients with advanced
sarcomas," said Sant Chawla, M.D.,
F.R.A.C.P., the trial's principal investigator and Director of the
Sarcoma Oncology Center in Santa Monica,
California. "The data show that aldoxorubicin can
successfully be combined with ifosfamide and mesna, which are
regularly given with doxorubicin to patients with first-line soft
tissue sarcomas. Based on encouraging results, the trial was
expanded to 50 patients and continues to enroll."
The Phase 1b/2 clinical trial has enrolled 38 patients to date
with locally advanced, unresectable, and/or metastatic soft tissue
sarcoma, intermediate-grade or high-grade chondrosarcoma or
osteosarcoma. In the dose escalation phase, patients received
either 170mg/m2 or 250mg/m2 of aldoxorubicin
in combination with up to a 14-day continuous infusion of
ifosfamide (1g/m2/day) plus mesna over a 28-day cycle.
The expansion phase will enroll patients at the 250mg/m2
dose of aldoxorubicin and will allow for patients that had received
prior chemotherapy to be included. The primary endpoint of the
study is safety, and secondary endpoints include overall response
rates and progression-free survival.
About Aldoxorubicin
Aldoxorubicin is a rationally-engineered cytotoxic which
combines doxorubicin, a widely used chemotherapeutic agent, with a
novel linker molecule that binds directly and specifically to
circulating albumin, the most abundant protein in the
bloodstream. Protein-hungry tumors concentrate albumin, which
facilitates the delivery of the linker molecule with the attached
doxorubicin to tumor sites. In the acidic environment of the
tumor, but not the neutral environment of healthy tissues,
doxorubicin is released. Typically, doxorubicin is delivered
systemically and is highly toxic, which limits its dose to a level
below its maximum therapeutic benefit. Doxorubicin also is
associated with many side effects, especially the potential for
damage to heart muscle at cumulative doses greater than 450
mg/m2. Using this acid-sensitive linker technology,
aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4
times). To date, there has been no evidence of clinically
significant effects of aldoxorubicin on heart muscle, even at
cumulative doses of drug well in excess of 2,000 mg/m2.
Aldoxorubicin is the first-ever single agent to show superiority
over doxorubicin in a randomized clinical trial in first-line
STS.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and
development company specializing in oncology. CytRx currently is
focused on the clinical development of aldoxorubicin, its improved
version of the widely used chemotherapeutic agent doxorubicin, and
DK049, a novel drug conjugate which is expected to enter clinical
trials in 2016. CytRx is also expanding its pipeline of
oncology candidates at its laboratory facilities in Freiburg,
Germany, through its LADR™ (Linker
Activated Drug Release) technology platform, a discovery engine
designed to leverage CytRx's expertise in albumin biology and
linker technology for the development of a new class of anti-cancer
therapies.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended. Such statements involve risks and uncertainties that
could cause actual events or results to differ materially from the
events or results described in the forward-looking statements,
including risks relating to the outcome, timing and results of
CytRx's clinical testing of aldoxorubicin and preclinical testing
of its LADR™ linker technology platform, the outcome, timing or
results of CytRx's clinical testing of aldoxorubicin, the risk that
any future pre-clinical or human testing of compounds based on the
LADR™ technology platform might not show efficacy or reduced side
effects of those compounds, risks related to CytRx's need for
additional capital or strategic partnerships to fund its ongoing
working capital needs and development efforts, including the Phase
2 and Phase 3 clinical development of aldoxorubicin for SCLC and
STS, respectively, and the preclinical and clinical development of
compounds based on the LADR™ technology platform, and other risks
and uncertainties described in the most recent annual and quarterly
reports filed by CytRx with the Securities and Exchange Commission
and current reports filed since the date of CytRx's most recent
annual report. All forward-looking statements are based upon
information available to CytRx on the date the statements are first
published. CytRx undertakes no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext. 304
dhaen@cytrx.com
Investor Relations:
Alexander Capital, LP
(855) 288-ALEX (2539)
cytrx@alexandercapitallp.com
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SOURCE CytRx Corporation