CytRx Highlights Aldoxorubicin Data from its Global Phase 2b Clinical Trial in First-Line Soft Tissue Sarcoma

  CytRx Highlights Aldoxorubicin Data from its Global Phase 2b Clinical Trial
  in First-Line Soft Tissue Sarcoma

           Results to be Updated in Oral Presentation at ASCO 2014

Aldoxorubicin Demonstrated Highly Statistically Significant Increases in PFS,
               PFS at 6 Months and ORR, Compared to Doxorubicin

2014 ASCO Annual Meeting

Business Wire

LOS ANGELES -- May 28, 2014

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development
company specializing in oncology, today announced updated results from its
ongoing multicenter, randomized, open-label global Phase 2b clinical trial
investigating the efficacy and safety of aldoxorubicin compared with
doxorubicin as first-line therapy in subjects with metastatic, locally
advanced or unresectable soft tissue sarcomas (STS). The updated trial results
demonstrated that aldoxorubicin significantly increases progression-free
survival (PFS), PFS at 6 months, overall response rate (ORR) and tumor
shrinkage, compared to doxorubicin, the current standard-of-care, as a
first-line treatment in patients with STS. The data trended in favor of
aldoxorubicin for all of the major subtypes of soft tissue sarcomas. The
results will be presented by Sant P. Chawla, M.D., F.R.A.C.P., Director of the
Sarcoma Oncology Center, and principal investigator of the trial, in an oral
presentation at the 2014 American Society for Clinical Oncology (ASCO) Annual
Meeting, which is taking place May 30–June 3 in Chicago.

“These results indicate that aldoxorubicin is well tolerated and may improve
clinical outcomes in patients compared to doxorubicin therapy, the current
standard-of-care in this indication,” said Dr. Chawla. “This includes
promising improvements in progression-free survival, tumor shrinkage and
overall response rates in patients with a wide variety of soft tissue
sarcomas. We are hopeful that the next stage of development for aldoxorubicin,
a well-tolerated single agent that lacks the cardiotoxicity associated with
doxorubicin therapy, will demonstrate its potential to meaningfully extend
survival, and will lead to a new treatment option for patients fighting this
aggressive, life-threatening cancer.”

“We are delighted that these results were selected for oral presentation at
this year’s ASCO meeting,” said Steven A. Kriegsman, CytRx President and Chief
Executive Officer. “We look forward to discussing the data with the oncology
community and to reporting the full overall survival results from this trial
in the second half of 2014. In parallel, we continue to actively enroll
patients in our pivotal global Phase 3 trial in second-line STS. In that Phase
3 clinical trial, we are permitted to dose until progression, which could
substantially enhance the benefit for sarcoma patients.”

Results in Detail

In this 123-subject, 31-center Phase 2b trial, subjects with advanced soft
tissue sarcomas were randomized 2:1 to receive either 350 mg/m2 of
aldoxorubicin (83 subjects) or 75 mg/m2 of doxorubicin (40 subjects) every 3
weeks for up to 6 cycles. Subjects were then followed every 6 weeks with CT
scans to monitor tumor size. Two approaches were used to evaluate the efficacy
of aldoxorubicin compared to doxorubicin in patients with soft tissue
sarcomas: assessment by the study investigators, as well as assessment by a
blinded central laboratory review. The primary endpoint was PFS and secondary
endpoints included PFS at 6 months for each group, ORR (complete and partial)
and overall survival which will be reported when the clinical trial is


As determined by both the trial investigators and by blinded central radiology
review, subjects treated with aldoxorubicin demonstrated highly statistically
significant better clinical outcomes than subjects that received standard
doxorubicin therapy for their soft tissue sarcomas. Specifically, both
assessments showed an unambiguous 79-104% improvement in PFS among patients
treated with aldoxorubicin. Updated median PFS results are described in the
table below.

                                        All Subjects
                                                           P Value
Scans Read by Investigator                                 
Aldoxorubicin                      8.4 months                P=0.0004
Doxorubicin                        4.7 months              
Improvement over dox               3.7 months (79%)         
Hazard ratio                       0.419 (0.25 - 0.69)      P=0.0007
Scans Read by Blinded Central                              
Aldoxorubicin                      5.7 months                P=0.014
Doxorubicin                        2.8 months              
Improvement over dox               2.9 months (104%)        
Hazard ratio                       0.584 (0.37 - 0.93)      P=0.024

Updated median PFS at 6 months results are described here:

                                            All Subjects
                                                           P Value
Scans Read by Investigator                                 
Aldoxorubicin                          68.1%                 P=0.002
Doxorubicin                            36.6%               
Improvement over dox                   86.1%                
Scans Read by Blinded Central Lab                          
Aldoxorubicin                          45.7%                 P=0.02
Doxorubicin                            22.9%               
Improvement over dox                   99.6%                

Updated ORR results are described in the table below. Responses were evaluated
using the RECIST 1.1 criteria. Partial responses are defined as at least 30%
shrinkage in the target tumors with no increase in non-target tumors or
development of new tumors. Complete responses are defined as disappearance of
all target lesions.

                                     Aldoxorubicin      Doxorubicin
Scans Read by Investigator                              
Complete response                     2.4%               0.0%
Partial response                      19.3%              5.0%
ORR                                   21.7%              5.0%
Scans Read by Blinded Central                           
Complete response                     0.0%               0.0%
Partial response                      23.8%              0.0%
ORR                                   23.8%              0.0%

The percentage of patients having some shrinkage of their tumors as assessed
by RECIST 1.1 criteria is shown below. Regardless of whether the scans were
evaluated by investigators or by blinded reviewers, a higher percentage of
patients who received aldoxorubicin treatment demonstrated tumor shrinkage
compared with patients treated with doxorubicin.

                                    Aldoxorubicin      Doxorubicin
Scans Read by Investigator                             
Tumor Shrinkage (% of subjects)      64.5               41.2
Scans Read by Blinded Review                           
Tumor Shrinkage (% of subjects)      60.8               39.4


Adverse events were consistent with known doxorubicin toxicities. The majority
of adverse events resolved prior to the following cycle with no treatment
discontinuation. Aldoxorubicin-treated subjects experienced a higher
percentage of Grade 3 or 4 treatment emergent adverse events (TEAEs) of
neutropenia (40% vs. 20%), mucositis (11% vs. 3%) and nausea/vomiting (7% vs.
0%). All TEAEs resolved and were not treatment limiting. No clinically
significant cardiac toxicity was seen with aldoxorubicin while approximately
10% of doxorubicin patients had clinically significant cardiotoxicity. Most
importantly, there was no clinically significant reduction in cardiac function
in the aldoxorubicin patients despite receiving 3.5 times the standard dose of

ASCO 2014 Oral Presentation Details

Title: “Randomized phase 2b trial comparing first-line treatment with
aldoxorubicin versus doxorubicin in patients with advanced soft tissue
Presenter: Sant Chawla, M.D., F.R.A.C.P., Sarcoma Oncology Center
Abstract #: 10502
Date and Time: Sunday, June 1, 2014, 8:24 am – 8:36 am CDT
Session ID: Oral abstract session: Sarcoma

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels,
tendons, fibrous tissues and connective tissue, and can arise anywhere in the
body at any age. According to the American Cancer Society, there are
approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new
cases were diagnosed in the U.S. and approximately 4,400 Americans died from
this disease. In addition, approximately 40,000 new cases and 13,000 deaths in
the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent 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. Aldoxorubicin combines doxorubicin with a novel
single-molecule linker that binds directly and specifically to circulating
albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors
concentrate albumin, thus increasing 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. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be
administered while reducing its toxic side effects. In studies thus far there
has been no evidence of clinically significant effects of aldoxorubicin on
heart muscle, even at cumulative doses of drug well in excess of 2 g/m2.

Aldoxorubicin is currently being studied in a pivotal global Phase 3 clinical
trial evaluating the efficacy and safety of aldoxorubicin as a second-line
treatment for patients with STS under a Special Protocol Assessment with the
FDA. CytRx is also conducting two Phase 2 clinical trials evaluating
aldoxorubicin in patients with late-stage glioblastoma (GBM) and HIV-related
Kaposi’s sarcoma. Aldoxorubicin has been granted Orphan Drug Designation in
the U.S. and Europe for the treatment of soft tissue sarcoma.

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 (formerly known as INNO-206), its improved
version of the widely used chemotherapeutic agent doxorubicin. CytRx has
completed a global Phase 2b clinical trial with aldoxorubicin as a first-line
therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the
same indication, a Phase 1b study of aldoxorubicin in combination with
doxorubicin in patients with advanced solid tumors and a Phase 1b
pharmacokinetics clinical trial in patients with metastatic solid tumors.
CytRx recently initiated, under a special protocol assessment, a pivotal Phase
3 global trial with aldoxorubicin as a therapy for patients with soft tissue
sarcomas whose tumors have progressed following treatment with chemotherapy.
The Company also recently announced that it has received approval from the FDA
to continue dosing patients with aldoxorubicin until disease progression in
that clinical trial. CytRx has initiated a Phase 2 clinical trial with
aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and a
Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand
its pipeline of oncology candidates based on a linker platform technology that
can be utilized with multiple chemotherapeutic agents and may allow for
greater concentration of drug at tumor sites. CytRx also has rights to two
additional drug candidates, tamibarotene and bafetinib. CytRx completed its
evaluation of 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 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, risks related to lawsuits that have been brought
against the Company and its officers and/or directors for alleged violations
of the securities laws, 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.


Investor Relations:
Argot Partners
Michelle Carroll
Argot Partners
Eliza Schleifstein
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development
310-826-5648, x304
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