CytRx Announces Positive Results from Animal Trial with Combination Aldoxorubicin and Doxorubicin Therapy

  CytRx Announces Positive Results from Animal Trial with Combination
  Aldoxorubicin and Doxorubicin Therapy

   Produces rationale for Company’s ongoing Phase 1b clinical trial of the
      combination therapy in cancer patients with advanced solid tumors

Results published in the peer-reviewed International Journal of Pharmaceutics

Business Wire

LOS ANGELES -- January 28, 2013

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, announced that an in vivo trial
investigating aldoxorubicin, its tumor-targeting conjugate of the widely used
chemotherapeutic agent doxorubicin, in combination with unconjugated
doxorubicin, demonstrated positive results and provided the basis for the
Company’s current evaluation of the combination therapy in cancer patients
with advanced solid tumors in a Phase 1b clinical trial.

The trial compared the antitumor efficacy and tolerability of weekly
intravenous treatments with saline or doxorubicin compared with three dosing
regimens of either aldoxorubicin alone or combination aldoxorubicin and
doxorubicin in a xenograft model of human pancreatic cancer. As single agents,
doxorubicin and aldoxorubicin were administered at their maximum tolerated
doses (MTD), while each agent was given at 50% of their MTD when combined.
Doxorubicin alone produced only modest tumor inhibition. Aldoxorubicin alone
and each combination therapy arm induced both complete and partial remissions,
with antitumor efficacy within all arms essentially identical. Importantly,
the trial data showed better tolerability for the combination therapy at these
low dose levels compared with single agent aldoxorubicin.

The study, “Evaluation of combination therapy schedules of doxorubicin and an
acid-sensitive albumin-binding prodrug of doxorubicin in the MIA PaCa-2
pancreatic xenograft model,” Kratz, F., et al., was published in the
peer-reviewed International Journal of Pharmaceutics, 441 (2013) pages
499-506.

“The data from this trial are particularly encouraging as pancreatic cancer
typically responds poorly to chemotherapy,” said CytRx Executive Vice
President and Chief Medical Officer Daniel Levitt, M.D., Ph.D. “The ability of
a combined therapy with aldoxorubicin and doxorubicin to demonstrate efficacy
in this cancer at doses that were well-tolerated indicates its potential for
the treatment of other chemotherapeutic-resistant tumors such as
chondrosarcoma and chordomas. The design and rationale behind this trial
produced valuable information and we are currently testing this combination in
a phase 1b clinical trial in patients with solid tumors. A study abstract has
been submitted for presentation at the American Society for Clinical Oncology
(ASCO) meeting later this year.”

About CytRx 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, 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 the
FDA to 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 is planning to submit 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 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 or uncertainties related to the
outcome, timing and results of CytRx's clinical trials with aldoxorubicin and
tamibarotene, including the planned Phase 3 clinical trial for aldoxorubicin
as a therapy for patients with soft tissue sarcomas whose tumors have
progressed following treatment with chemotherapy, the risk that any future
human testing of the Company’s drug candidates might not produce results
similar to those seen in earlier human or animal testing, uncertainties
regarding regulatory approvals for current and future clinical testing,
including the planned Phase 3 clinical trial for aldoxorubicin, and the scope
of the clinical testing that may eventually be required by regulatory
authorities, the significant time and expense that will be incurred in
developing any of the potential commercial applications for aldoxorubicin or
tamibarotene, risks related to CytRx's ability to manufacture its drug
candidates, including aldoxorubicin, 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 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
 
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