Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing
in oncology, today announced the recommendation by the Data Safety
Monitoring Board (DSMB) to continue with the global Phase 2b clinical
trial with tamibarotene in combination with chemotherapeutical agents as
a first-line treatment for patients with advanced non-small-cell lung
cancer (NSCLC). The DSMB's pre-scheduled review of Phase 2b trial data
collected as of May 31, 2012 showed no significant difference in
drug-related severe or serious adverse events reported by trial patients
between those treated with tamibarotene and those treated with placebo.
The DSMB is an independent group of oncologists and biostatisticians who
monitor the safety and efficacy of the Phase 2b trial.
"We've achieved a key milestone in advancing the late-stage clinical
development of tamibarotene in a significant oncology indication that
claims more lives than breast, prostate and ovarian cancer combined,"
said CytRx CEO Steven A. Kriegsman. "We expect to report data from the
global Phase 2b clinical trial in 2013. There is no question that
effective treatment of metastatic NSCLC is a major unmet medical need
and that tamibarotene in this indication could represent an important
market opportunity for CytRx and our shareholders."
One hundred forty (140) evaluable patients with advanced NSCLC are being
enrolled at 25 clinical sites in the U.S., Mexico, Europe and India in
the double-blind, placebo-controlled Phase 2b trial. Trial patients are
treated with paclitaxel plus carboplatin and either tamibarotene or
placebo. The primary objective of this trial is to determine the
objective response rate (complete and partial responses) and
progression-free survival. Secondarily, the trial will evaluate overall
survival, quality-of-life and examine the pharmacokinetics of
tamibarotene in this population, among other measures.
"We are optimistic about tamibarotene's prospects in advanced NSCLC
based on clinical data indicating a statistically significant
improvement in these patients when all-trans retinoic acid (ATRA) was
combined with paclitaxel and cisplatin," said Daniel Levitt, MD, Ph.D.,
CytRx's Chief Medical Officer. "Tamibarotene appears to be 10-times more
potent than ATRA and was designed to avoid several of the toxic side
effects of ATRA by selectively binding to specific molecular receptors.
The DSMB's recommendation to move forward with Phase 2b testing
indicates that there are no significant safety issues seen thus far when
tamibarotene is used with potent chemotherapy agents, even in patients
with advanced disease."
A clinical trial conducted by Arrieta (the principal investigator for
CytRx's clinical trial) et al. and published in the peer-reviewed Journal
of Clinical Oncology (June 17, 2010) compared ATRA added to a
regimen of paclitaxel plus cisplatin to a regimen of paclitaxel plus
cisplatin alone as a treatment for patients with advanced NSCLC. The
group administered ATRA plus the chemotherapeutic agents showed improved
response rates of 55.8% versus 25.4%, and increased progression-free
survival of 8.9 months versus 6.0 months. Median overall survival was
increased from 9.5 months to 23.5 months when ATRA was added to the
above chemotherapy regimen, representing a 14-month median extension of
Non-Small-Cell Lung Cancer
This year more than 226,000 new cases of lung cancer will occur in the
U.S. and more than 1.5 million worldwide. Deaths due to lung cancer
account for the majority of cancer-related deaths (160,000 in the U.S.,
1.4 million worldwide) and the five-year survival ranges between 8-15%.
NSCLC accounts for 85-90% of all lung cancers.
Tamibarotene is an orally available, rationally designed, synthetic
retinoid compound. CytRx also is conducting a Phase 2 clinical trial
with tamibarotene as a treatment for acute promyelocytic leukemia (APL).
CytRx holds the North American and European rights to certain
tamibarotene intellectual property for the treatment of NSCLC and APL,
and retains an option to expand its licenses for the use of tamibarotene
in other fields in oncology.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development
company specializing in oncology. The CytRx oncology pipeline includes
three programs in clinical development for cancer indications: aldoxorubicin
(formerly known as INNO-206), 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, recently initiated a Phase 2 trial for
patients with advanced pancreatic ductual adenocarcinomas, and plans to
meet with the FDA to discuss a potential Phase 3 pivotal trial as a
third-line therapy for soft tissue sarcomas in the second half of 2012.
CytRx's pipeline also includes tamibarotene, which it is testing in a
double-blind, placebo-controlled, international Phase 2b clinical trial
in patients with non-small-cell lung cancer, and which is in a Phase 2
clinical trial as a treatment for acute promyelocytic leukemia (APL).
The Company 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 the Company, visit www.cytrx.com.
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
planned Phase 2b clinical trial for tamibarotene as a treatment for
NSCLC, uncertainties regarding regulatory approvals for current and
future clinical testing of tamibarotene and the scope of the clinical
testing that may eventually be required by regulatory authorities for
tamibarotene, the significant time and expense that will be incurred in
developing any of the potential commercial applications for
tamibarotene, including for NSCLC, the risk that any future human
testing of tamibarotene for NSCLC might not produce results similar to
those seen with ATRA, risks related to CytRx's ability to manufacture
its drug candidates, including tamibarotene, 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 tamibarotene, 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.
Legend Securities, Inc.