CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced that
additional preliminary data from its Phase 2b clinical trial
demonstrating aldoxorubicin’s potential advantage over doxorubicin in
the treatment of soft tissue sarcoma (STS) will be presented at the 18th
Annual Connective Tissue Oncology Society (CTOS) Meeting on Thursday,
October 31 at 4:30 p.m. Eastern time at the Sheraton New York Times
Square Hotel.
The Company previously reported that patients in the trial treated with
aldoxorubicin had an Overall Response Rate (ORR) of 22%, whereas those
administered the widely used chemotherapeutic agent doxorubicin had an
ORR of 0%. The Company expects to report top-line data for the global
Phase 2b clinical trial in December 2013.
“Because CTOS draws thought leaders in the treatment of sarcoma from
around the world, it provides an ideal forum to gain awareness of this
compelling data and to acquaint the oncologists with our phase 3 study
in patients with relapsed or refractory soft tissue sarcomas,” said
CytRx President and CEO Steven A. Kriegsman. "Discoveries of new sarcoma
treatments have been relatively few, particularly when compared with
treatments for breast or prostate cancer, but the preliminary clinical
results thus far drive our optimism that aldoxorubicin can fill an
important medical need in patients with advanced soft tissue sarcoma. ”
STS 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. There are more than 30 types of STS, and according to
the American Cancer Society more than 10,500 new cases are diagnosed
each year in the U.S.
In addition to the Phase 2b trial for STS, the Company has received
acceptance from the U.S. Food and Drug Administration (FDA) for a
protocol to conduct a Phase 2 clinical trial with aldoxorubicin in
glioblastoma, a difficult-to-treat and deadly brain cancer, and also
plans to conduct a Phase 2 clinical trial in HIV-related Kaposi’s
sarcoma.
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 500 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 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.
About the Connective Tissue Oncology Society
Formed in 1995 and incorporated in 1997, the Connective Tissue Oncology
Society (CTOS) is an international group comprised of physicians and
scientists with a primary interest in the tumors of connective tissues.
The goal of the society is to advance the care of patients with
connective tissue tumors and to increase knowledge of all aspects of the
biology of these tumors, including basic and clinical research.
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 is conducting a global Phase 2b clinical trial with aldoxorubicin
as a treatment for soft tissue sarcomas, has completed its Phase 1b/2
clinical trial primarily in the same indication and a Phase 1b study of
aldoxorubicin in combination with doxorubicin in patients with advanced
solid tumors, and has completed a Phase 1b pharmacokinetics clinical
trial in patients with metastatic solid tumors. CytRx plans to initiate
under a special protocol assessment a potential pivotal Phase 3 global
trial with aldoxorubicin as a therapy for patients with soft tissue
sarcomas whose tumors have progressed following treatment with
chemotherapy. CytRx also is initiating Phase 2 clinical trials with
aldoxorubicin in patients with late-stage glioblastoma (brain cancer)
and AIDS-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 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, including the
conclusion of the Phase 2b clinical testing of aldoxorubicin as a
first-line treatment in patients with metastatic, locally advanced or
unresectable soft tissue sarcomas who have not been previously treated
with any chemotherapy, might not produce objective response results
similar to the preliminary data described in this press release, or
might not correlate with the trial’s primary endpoint of
progression-free survival, 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.
Copyright Business Wire 2013