LOS ANGELES, Oct. 10, 2016 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today presented
results from its on-going Phase 1b/2 trial of aldoxorubicin in
combination with ifosfamide/mesna in patients with advanced
sarcomas at the European Society for Medical Oncology (ESMO) 2016
Congress being held in Copenhagen,
Denmark.
Of the 36 evaluable patients receiving either
170mg/m2 or 250mg/m2 of aldoxorubicin plus
ifosfamide and mesna, 13 of 36 (36%) achieved a partial response of
the target lesion by RECIST 1.1 criteria, 22 of 36 (61%) had stable
disease, and one patient had progressive disease. Median
progression-free survival has not been reached, and dose-limiting
toxicities were not observed in either cohort. No clinically
significant cardiac toxicities were seen. The most common Grade 3
or 4 adverse events were neutropenia (71%), anemia (54%),
thrombocytopenia (17%) and febrile neutropenia (14%). There were
nine treatment-related serious adverse events, and no
treatment-related deaths. The trial has been expanded to allow
continued enrollment of additional sarcoma patients at the 250
mg/m2 dose of aldoxorubicin with ifosfamide and
mesna.
"The results to date demonstrate that aldoxorubicin combined
with ifosfamide provides significant clinical benefit for sarcoma
patients," 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. "More than one-third of sarcoma patients
achieved a partial response for the target lesion and 61% had
prolonged stable disease. Importantly, six patients with
unresectable tumors achieved greater than 50% tumor shrinkage
allowing some of them to become eligible for surgery. Further, we
did not see any signs of cardiotoxicity including in patients that
received approximately 10 times the cumulative maximum dose of
doxorubicin."
The Phase 1b/2 clinical study is a single-center trial that has
enrolled 40 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. Up to six cycles of
ifosfamide/mesna with aldoxorubicin can be administered, and
aldoxorubicin may be continued until tumor progression or
unacceptable toxicity occurs. 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 doxorubicin in excess of 5,000
mg/m2. Aldoxorubicin is the first-ever single agent to
show superiority over doxorubicin in a randomized global Phase 2b
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. 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 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/cytrx-presents-interim-results-from-on-going-aldoxorubicin-plus-ifosfamidemesna-combination-clinical-trial-at-esmo-2016-congress-300341510.html
SOURCE CytRx Corporation