CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced the
appointment of Shanta Chawla, M.D. as Vice President, Clinical
Development. Dr. Chawla has more than 13 years of clinical research,
operations and development experience, with a focus on oncology
therapeutics.
“In this new position, Dr. Chawla will play a key role in the management
of our upcoming global Phase 3 clinical trial under a Special Protocol
Assessment with aldoxorubicin as a second-line treatment for soft tissue
sarcomas,” said CytRx Executive Vice President and Chief Medical Officer
Dr. Daniel Levitt. “She has designed and managed large clinical trials
in North America and Europe for a range of cancer types, and brings to
CytRx a proven ability to meet enrollment targets and work within budget
requirements. We are fortunate to have Dr. Chawla join our team as we
move into a very exciting and demanding phase of activity.”
“I am delighted to be joining CytRx at this critical point in the
company’s development, and in particular in light of the recently
announced highly positive results from the global Phase 2b trial with
aldoxorubicin in advanced soft tissue sarcomas,” said Dr. Chawla. “I
look forward to playing a significant role in the continued development
of this promising oncology therapeutic.”
From 2001 to 2013 Dr. Chawla was at Spectrum Pharmaceuticals, most
recently as Vice President, Clinical Research and Development, where her
expertise included selecting clinical trial sites and principal
investigators, establishing protocols with the FDA and key opinion
leaders, preparing FDA filings and project team management. Dr. Chawla
received her M.D. from Maulana Azad Medical College in New Delhi, and
performed her internship and residency in Philadelphia at Albert
Einstein Medical Center and Thomas Jefferson University Hospital,
respectively. She is board certified in Internal Medicine. Dr. Shanta
Chawla is not related to Dr. Sant Chawla, the principal investigator in
CytRx’s global Phase 3 clinical trial for soft tissue 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 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 (3½ 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.
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 plans to initiate 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. CytRx has initiated a
Phase 2 clinical trial with aldoxorubicin in patients with late-stage
glioblastoma (brain cancer), and plans to initiate 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 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 the results of any future human testing of aldoxorubicin
might not produce results similar to those described in this press
release, 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 2014