LOS ANGELES, Sept. 3, 2015 /PRNewswire/ -- CytRx
Corporation (Nasdaq: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced that
the Phase 2b clinical trial design of its clinical trial in
small-cell lung cancer (SCLC) will be presented in the P3.07 Poster
Session on SCLC at the 16th World Conference on Lung
Cancer in Denver, Colorado,
September 6 - 9, 2015. Entitled
"Phase 2 Study of Aldoxorubicin versus Topotecan for
Relapsed/Refractory Small Cell Lung Cancer" (Poster # 1736), the
poster will be available starting at 9:30 AM
MDT, on September 9,
2015. Additionally, aldoxorubicin will be discussed in the
Novel SCLC Therapies Mini Symposium (MS 16) on September, 8,
2015.
"We are pleased to present the aldoxorubicin Phase 2b clinical
trial design in SCLC at the World Conference on Lung Cancer," said
Steven A. Kriegsman, Chairman and
Chief Executive Officer. "We believe this will raise
awareness of aldoxorubicin's potential to treat patients with
relapsed or refractory SCLC, a devastating disease with a large
unmet need. In prior Phase 1 trials, we have seen encouraging
evidence of SCLC patients with tumor shrinkage and prolonged stable
disease. Our previous data in relapsed or refractory solid tumor
patients indicates that the dose of aldoxorubicin being
administered to these patients is well tolerated and without any
treatment-limiting side effects. Up to 21 cycles (4.8
grams/m2) have been given to one patient with small cell
lung cancer with minimal side effects and good anti-tumor
activity."
The Phase 2b trial is currently enrolling 132 patients at 37
sites in the USA, Hungary and Spain. Patients with
metastatic small cell lung cancer who have either relapsed or were
refractory to prior chemotherapy will receive either aldoxorubicin
or topotecan in a 1:1 randomization. The primary endpoint for the
trial is progression-free survival. Overall survival and
safety are secondary endpoints.
About Small Cell Lung Cancer
An estimated 1.6 million new cases of lung cancer are diagnosed
worldwide each year. In the Western world, approximately 13-15% of
cases are SCLC, a deadly form of lung cancer associated with
tobacco use. The five year survival rate is less than 7%, in part
because an estimated 70% of patients have extensive disease at
diagnosis. According to the National Cancer Institute, more than
30,000 new cases were diagnosed in the USA in 2014. The estimated 2014 SCLC
incidences for Europe and
Asia are over 58,000 and 136,000,
respectively.
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 2,000 mg/m2.
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 also seeking to
expand its pipeline of oncology candidates at its laboratory
facilities in Freiburg, Germany,
through its LADR™ (Linker Activated Drug Release) technology
platform, a discovery engine designed to leverage CytRx's expertise
in albumin biology and linker technology for the development of a
new class of anti-cancer therapies.
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 testing of aldoxorubicin, 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 clinical development of aldoxorubicin for SCLC, 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:
The Trout Group LLC
Matt Beck
(646) 378-2933
mbeck@troutgroup.com
Alexander Capital, LP
John Columbia
(855) 288-ALEX (2539)
jcolumbia@alexandercapitallp.com
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext 304
dhaen@cytrx.com
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SOURCE CytRx Corporation