CytRx Receives Recommendation from Data Safety Monitoring Committee to Complete International Phase 2b Trial with Aldoxorubicin

  CytRx Receives Recommendation from Data Safety Monitoring Committee to
  Complete International Phase 2b Trial with Aldoxorubicin as First-Line
  Treatment for Soft Tissue Sarcoma

    Marks key milestone in late-stage trial that provides direct clinical
                 comparison of aldoxorubicin and doxorubicin

 No significant safety issues found with delivery of doxorubicin at 3.5 times
   its standard dose with aldoxorubicin, the first clinical-stage oncology
     candidate formed with CytRx’s proprietary linker technology platform

Business Wire

LOS ANGELES -- May 6, 2013

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development
company specializing in oncology, announced that the independent Data Safety
Monitoring Committee (DSMC) overseeing the Company’s international Phase 2b
clinical trial with aldoxorubicin as a first-line treatment for patients with
late-stage metastatic soft tissue sarcoma has recommended conducting the
clinical trial through completion. This Phase 2b trial allows for a
head-to-head clinical comparison of the commonly used chemotherapeutic agent
doxorubicin with aldoxorubicin, CytRx’s tumor-targeting doxorubicin conjugate.
Doxorubicin is dose-limited at a level below its maximum anti-tumor
capabilities due to toxicity, including cardiotoxicity. Data from the Phase 2b
trial is expected in the second half of 2013.

“The recommendation to complete the Phase 2b trial indicates that the DSMC
found no significant safety issues with aldoxorubicin, even though the dose of
aldoxorubicin administered in this trial delivers doxorubicin at
three-and-a-half times its standard dose,” said CytRx CEO Steven A. Kriegsman.
“The DSMC was not charged with evaluating efficacy at this point in the study.
Aldoxorubicin combines doxorubicin with our proprietary linker technology.
This platform technology includes a single molecule that, when attached to a
chemotherapeutic agent, allows for concentration of the agent at the tumor
site, thus allowing for greater drug infusion into the tumor. We believe that
safely concentrating more drug at the tumor site could improve the drug’s

“Aldoxorubicin is the first drug we are evaluating in the clinic based on the
linker technology. Doxorubicin was selected for evaluation as it is well-known
and has been used by the medical community for decades; however the linker has
broad potential utility with proven affinity to couple with multiple
chemotherapeutic agents including paclitaxel, docetaxel, cisplatin, irinotecan
and methotrexate. Each of these agents may be incorporated into our future
clinical development plans,” he added.

The Phase 2b trial is enrolling a total of 105 patients with metastatic,
locally advanced or unresectable soft tissue sarcomas who have not been
previously treated with any chemotherapy and are ineligible for surgery.
Patients in the trial are randomized into two groups, with twice as many
receiving aldoxorubicin as doxorubicin. The trial’s primary objective is to
compare progression-free survival between each group. Secondary endpoints
include evaluating tumor response and overall patient survival, and assessing
the safety of aldoxorubicin compared with doxorubicin in this patient
population through a number of indicators, including the frequency and
severity of adverse events. Patients are being enrolled in clinical sites in
the U.S., Hungary, Romania, Russia, Ukraine, India and Australia.

CytRx holds exclusive worldwide rights to aldoxorubicin, as well as option
rights to the protein-binding platform technology that serves as the linker
with doxorubicin.

AboutCytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company
specializing in oncology. The CytRx oncology pipeline includes two programs in
clinical development for cancer indications: aldoxorubicin (formerly known as
INNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate
aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as
a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical
trial primarily in the same indication, and has initiated a Phase 1b
pharmacokinetics clinical trial in patients with metastatic solid tumors and a
Phase 1b study of aldoxorubicin in combination with doxorubicin in patients
with advanced solid tumors. The Company is in the process of initiating a
Phase 3 pivotal trial under a special protocol assessment (SPA) with
aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors
have progressed following treatment with chemotherapy. Tamibarotene is being
tested in a double-blind, placebo-controlled, international Phase 2b clinical
trial in patients with non-small-cell lung cancer. The Company reached its
enrollment target for that trial in February 2013. The Company completed its
evaluation of a third drug candidate, bafetinib, in the ENABLE Phase 2
clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and
plans to seek a partner for further development of bafetinib. For more
information about CytRx Corporation, visit

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 trials, the risk that any future human testing
of CytRx’s drug candidates or platform technology might not produce results
similar to those seen in past human or animal testing, risks related to
CytRx's ability to manufacture its drug candidates in a timely fashion,
cost-effectively or in commercial quantities in compliance with stringent
regulatory requirements, 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 3 clinical development of
aldoxorubicin, and the 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


Investor Relations
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
CytRx Corporation
David Haen
Vice President, Business Development
310-826-5648 x304
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