CytRx Announces Agreement with FDA on Special Protocol Assessment for Global Pivotal Phase 3 Clinical Trial with Aldoxorubicin

  CytRx Announces Agreement with FDA on Special Protocol Assessment for Global
  Pivotal Phase 3 Clinical Trial with Aldoxorubicin for Soft Tissue Sarcoma

          SPA provides clear pathway through the regulatory process

                 Preparations underway to commence enrollment

Business Wire

LOS ANGELES -- April 23, 2013

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, announced today that it has reached an
agreement with the U.S. Food and Drug Administration (FDA) under a special
protocol assessment (SPA) for a global pivotal Phase 3 trial with
aldoxorubicin as a treatment for patients with soft tissue sarcomas who have
relapsed or were refractory following prior treatment with chemotherapy. The
SPA is a written agreement between the Company, as the trial’s sponsor, and
the FDA regarding the design, endpoints and planned statistical analysis
approach of the Phase 3 clinical trial to be used in support of a potential
New Drug Application (NDA) for aldoxorubicin. The Company is actively making
preparations for the pivotal Phase 3 trial.

“By reaching an agreement on an SPA, the FDA deems that results from this
single Phase 3 clinical trial will be acceptable to support the regulatory
approval of aldoxorubicin as a second-line treatment for patients with soft
tissue sarcoma, with final marketing approval dependent on the results of the
trial and other accomplishments,” said Steven A. Kriegsman, CytRx President
and CEO. “The ability to conduct the clinical trial under an SPA could save
significant time compared with a standard regulatory pathway. Our optimism
about aldoxorubicin’s prospects in this difficult-to-treat indication is
predicated on positive results from a Phase 1b/2 trial in which this novel
agent was associated with objective responses and prolonged progression-free
survival in several patients with advanced soft tissue sarcoma who had
relapsed or not responded to prior treatments, as well as on additional
clinical and preclinical data.”

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 80 clinical sites in the U.S., Europe, China,
Canada, Latin America and Australia. The primary endpoint of the study is
progression-free survival, and secondary endpoints include overall survival
and safety.

“There is a critical need for a second-line treatment for patients with soft
tissue sarcomas that improves clinical benefit with fewer side effects,” said
Daniel Levitt, M.D., Ph.D., CytRx Executive Vice President and Chief Medical
Officer. “Multiple chemotherapy regimens have been explored as palliative
therapy for these patients with several failures in Phase 3 trials.
Additionally, currently approved chemotherapeutic regimens are frequently
quite toxic with no significant impact on either progression-free survival or
overall survival.”

In the Phase 1b/2 clinical trial in patients with advanced soft tissue sarcoma
treated with aldoxorubicin in up to eight cycles at the maximum tolerated
dose, 77% (10 of 13) of the evaluable patients showed clinical benefit,
defined as partial response with tumor shrinkage in excess of 30% or stable
disease at four months following treatment. None of the patients in the Phase
1b/2 trial showed cardiotoxicity and there were no drug-related patient
deaths. Patients in this trial showed progression-free survival of
approximately 6.4 months, with a range of 1.0 months to more than 10.7 months.
This compares favorably with the median estimated progression-free survival
for advanced soft tissue sarcoma patients of approximately 3 months.

About Aldoxorubicin

Aldoxorubicin is an albumin-binding conjugate of the chemotherapeutic agent
doxorubicin, which is the current standard of care for advanced, metastatic
soft tissue sarcoma. It appears to accumulate in higher concentrations in
tumors than in normal tissues in the body. Doxorubicin has significant side
effects, including chronic cardiotoxicity, which limits the dosage to a level
below its maximum anti-tumor capabilities. Aldoxorubicin employs a unique,
proprietary linker that binds to albumin in the blood and allows doxorubicin
to accumulate preferentially at the tumor site, thereby reducing the toxic
side effects associated with systemic delivery of the unconjugated drug.
Multiple animal trials have demonstrated that aldoxorubicin may improve upon
the activity of doxorubicin without an increase in toxicity. Clinical trials
indicate that aldoxorubicin can deliver doxorubicin at 3.5 to 4 times the
standard dose of doxorubicin with higher levels of drug concentrating at the
tumor site. CytRx holds exclusive worldwide rights to aldoxorubicin, as well
as to the protein-binding platform technology that serves as the linker with
doxorubicin.

About Soft Tissue Sarcoma

Sarcoma is an umbrella term for more than 50 subtypes of cancer that occur in
the muscles, fat, blood vessels, tendons and other connective tissues in the
body. Last year an estimated 38,000 new cases of soft tissue sarcoma were
reported and more than 13,000 deaths were attributed to this cancer in the
U.S. and Europe. Patients with metastatic, locally advanced or unresectable
soft tissue sarcomas have a poor prognosis with progression-free survival of
around 2 months to 4.6 months and median overall survival of approximately 9
months to 12 months. CytRx has been granted orphan drug designation by the FDA
for the treatment of patients with soft tissue sarcomas.

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 plans to initiate 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 www.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 relating to the outcome, timing
and results of CytRx's clinical trials, the risk that any future human testing
of aldoxorubicin 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 otherwise.

Contact:

Investor Relations
Legend Securities, Inc.
Thomas Wagner
800-385-5790 x152
718-233-2600 x152
twagner@legendsecuritiesinc.com
or
CytRx Corporation
David Haen
Vice President, Business Development
(310) 826-5648 x304
dhaen@cytrx.com
 
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