CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, has named Daniel Levitt,
M.D., Ph.D., to the newly created position of Executive Vice President.
Dr. Levitt will continue to serve as Chief Medical Officer.
“I am delighted to announce Dan’s well-deserved promotion and to express
our full confidence in his leadership of our clinical programs,
including preclinical research and manufacturing,” said CytRx President
and CEO Steven A. Kriegsman. “Since joining CytRx just over three years
ago, Dan has successfully implemented a strategy that has allowed us to
rapidly evaluate our drug candidates in various cancers, providing us
with a cost-effective pathway for entering into late-stage clinical
development. He has also enabled CytRx to standardize our manufacturing
processes, allowing us to rapidly advance our clinical trials. There is
no doubt that we are benefiting from his extensive senior management
experience, his prior success in piloting drug programs through the
clinical and regulatory processes, seven of which have received
marketing approval, and his credibility within the scientific community.
“We are currently making progress toward initiating our first Phase 3
pivotal clinical trial with aldoxorubicin. We also expect to report
clinical results from additional trials with aldoxorubicin and
tamibarotene this year. These are indeed major milestones in our quest
to bring new therapies to patients with cancer and enhance shareholder
value,” added Mr. Kriegsman. “Dan’s promotion to this senior executive
position reflects this significant progress in our clinical programs
that moves us closer to our ultimate goal of becoming a leading oncology
company.”
Dr. Levitt said, “I’m pleased to be appointed Executive Vice President
at this key juncture in the development of aldoxorubicin and
tamibarotene, both of which could have application in multiple cancers
and offer potential advantages over currently marketed oncology
therapies. I’m excited to be working with the CytRx team in what
promises to be an eventful future.”
CytRx is working with the FDA to develop a Phase 3 clinical trial
protocol with the doxorubicin tumor-targeting conjugate aldoxorubicin as
a therapy for patients with soft tissue sarcomas whose tumors have
progressed following treatment with chemotherapy. CytRx expects to
request the FDA’s agreement to conduct this trial under a special
protocol assessment (SPA). If granted, the SPA would indicate the
Agency’s agreement that the Phase 3 trial design, statistical analysis
and endpoints are acceptable to support regulatory approval, subject to
trial results.
In the second half of 2013, CytRx expects to announce clinical data from
an international Phase 2b clinical trial with aldoxorubicin as a
first-line therapy in patients with advanced soft tissue sarcoma who are
ineligible for surgery. The data from this trial will provide the first
direct clinical trial comparison of aldoxorubicin with native
doxorubicin, which is dose-limited due to toxicity. The trial is being
conducted under the direction of world-renowned expert in soft tissue
sarcoma treatment Sant P. Chawla, M.D., F.R.A.C.P., Director of the
Sarcoma Oncology Center in Santa Monica, California, and involves over
30 oncology centers throughout the world.
In the second half of 2013, CytRx also expects to report the results of
a Phase 2b clinical trial in patients with advanced non-small-cell lung
cancer (NSCLC) with its orally available, rationally designed, synthetic
retinoid compound tamibarotene. In this randomized clinical trial,
patients with advanced NSCLC are treated with paclitaxel plus
carboplatin and either tamibarotene or placebo. The trial’s objective is
to compare the objective response rates (complete and partial responses)
and progression-free survival, as well as evaluate overall survival and
quality-of-life between the two treatment regimens, among other measures.
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, and is in a Phase 2 clinical trial as a
treatment for acute promyelocytic leukemia (APL). 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.
