CytRx Receives Recommendation from Data Safety Monitoring Committee to Complete Global Phase 2b Clinical Trial with Tamibarotene

  CytRx Receives Recommendation from Data Safety Monitoring Committee to
  Complete Global Phase 2b Clinical Trial with Tamibarotene as First-Line
  Treatment for Non-Small-Cell Lung Cancer

  Represents Important Milestone in Clinical Development of Tamibarotene in
                     Potential Multibillion Dollar Market

            Enrollment Completion on Track for First Quarter 2013

Business Wire

LOS ANGELES -- January 31, 2013

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, announced that the Data Safety Monitoring
Committee overseeing the Company’s global Phase 2b clinical trial with
tamibarotene in combination with chemotherapeutical agents as a first-line
treatment for patients with advanced non-small-cell lung cancer (NSCLC) has
recommended conducting the clinical trial through completion. Enrollment of at
least 140 evaluable patients is expected in the first quarter of 2013.

“The Committee’s recommendation indicates that no significant safety issues
have been seen with tamibarotene in the international Phase 2b clinical trial
as we near enrollment completion with tamibarotene’s use in combination with
potent chemotherapy agents in patients with advanced NSCLC,” said CytRx CEO
Steven A. Kriegsman. “We are one step closer to completing this important
clinical trial and further assessing tamibarotene in a potential multibillion
dollar market, which is a major priority for our Company and our
shareholders.”

Subjects with stage IIIb or IV NSCLS who have not received prior non-adjuvant
chemotherapy are being enrolled in the blinded, randomized clinical trial at
sites in the U.S., Bulgaria, India, Mexico, Russia and Ukraine. Trial patients
are treated with paclitaxel plus carboplatin and either tamibarotene or
placebo. The primary objective of this trial is to determine the objective
response rate (complete and partial responses) and progression-free survival.
Secondarily, the trial will evaluate overall survival and quality-of-life in
this population, among other measures. The Data Safety Monitoring Committee is
an independent group of oncologists and biostatisticians who monitor the
safety and efficacy of the Phase 2b trial.

“Tamibarotene is an orally available, rationally designed, synthetic retinoid
compound that is 10-times more potent than all-trans retinoic acid (ATRA) and
was designed to avoid several side effects of ATRA,” said Daniel Levitt, MD,
Ph.D., CytRx’s Executive Vice President and Chief Medical Officer. “This event
is significant due to favorable results from a single-center clinical trial in
patients with advanced NSCLC that compared treatment with ATRA added to a
regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus cisplatin
alone. Patients who received the regimen with ATRA showed improved response
rates of 55.8% versus 25.4%, increased progression-free survival of 8.9 months
versus 6.0 months, and a 14-month median extension of life.”

CytRx holds the North American and European rights to certain tamibarotene
intellectual property for the treatment of NSCLC, and retains an option to
expand its licenses for the use of tamibarotene in other fields in oncology.

About Non-Small-Cell Lung Cancer

This year more than 228,000 new cases of lung cancer will occur in the U.S.
and more than 1.5 million worldwide. Deaths due to lung cancer account for the
majority of cancer-related deaths (approximately 160,000 in the U.S. and
approximately 1.4 million worldwide) and the five-year survival ranges between
8-15%. NSCLC accounts for 85-90% of all lung cancers, and claims more lives
than breast, prostate and ovarian cancer combined.

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
asINNO-206) and tamibarotene. With its tumor-targeted doxorubicin conjugate
aldoxorubicin,CytRxhas 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, a
Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas and
a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients
with advanced solid tumors. The Company has held a positive meeting with
theFDAto discuss a potential Phase 3 pivotal trial with aldoxorubicin as a
therapy for patients with soft tissue sarcomas whose tumors have progressed
following treatment with chemotherapy, and has submitted a special protocol
assessment related to this trial. 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 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 aboutCytRx
Corporation, visitwww.cytrx.com.

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 or uncertainties related to the
outcome, timing and results of CytRx's planned Phase 2b clinical trial for
tamibarotene as a treatment for NSCLC, uncertainties regarding regulatory
approvals for current and future clinical testing of tamibarotene and the
scope of the clinical testing that may eventually be required by regulatory
authorities for tamibarotene, the significant time and expense that will be
incurred in developing any of the potential commercial applications for
tamibarotene, including for NSCLC, the risk that any future human testing of
tamibarotene for NSCLC might not produce results similar to those seen with
ATRA, risks related to CytRx's ability to manufacture its drug candidates,
including tamibarotene, 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 any future
clinical development of tamibarotene, 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 otherwise.

Contact:

Investor Relations
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com
 
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