LOS ANGELES, April 19, 2017 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR) today announced the U.S. Food and Drug
Administration (FDA) has reached an agreement with CytRx on
preparations for a New Drug Application (NDA) submission for
aldoxorubicin in soft tissue sarcomas (STS). STS remains a high
unmet medical need.
"We are very pleased to have achieved clarity from the FDA
regarding CytRx's soft tissue sarcoma program," said Daniel Levitt, MD, PhD, Chief Operating Officer
and Chief Medical Officer. "The FDA agreed that CytRx could use the
application pathway for its filing that has been successfully used
previously by the oncology drugs Abraxane®, Doxil® and Onivyde®.
Our interaction with the FDA was part of a continued collaborative
and productive relationship with the Agency. We look forward to
providing the study reports and analysis that can lead to the
approval of aldoxorubicin for the treatment of patients with soft
tissue sarcomas."
The Company's goal is to submit a rolling NDA under section
505(b)(2) to the FDA for soft tissue sarcomas in the last quarter
of 2017. CytRx also plans to discuss with the European Medicines
Agency (EMA) a path to filing a Marketing Authorization Application
(MAA). The commercial launch of aldoxorubicin is still projected
for 2018 in the United States.
Aldoxorubicin has received Orphan Drug Designation by the FDA for
the treatment of STS. Orphan designation provides several benefits
including seven years of market exclusivity after approval, certain
R&D related tax credits and protocol assistance by the FDA.
European regulators granted aldoxorubicin Orphan Medicinal Product
Designation for STS which confers ten years of market exclusivity
among other benefits.
The proposed product label would include the treatment of soft
tissue sarcomas. New data could allow future use of aldoxorubicin
in neoadjuvant (pre-surgery) settings, as well as a replacement for
doxorubicin in combinations. CytRx is also working on a market
expansion strategy which could include other indications for
aldoxorubicin including combinations with other chemotherapeutics
and immunotherapies.
CytRx is under confidentiality agreements with a number of
companies for a commercial partnership for the marketing of
aldoxorubicin. The Company believes those active discussions may be
further advanced by this latest news.
Conference Call and Webcast
CytRx management will be hosting a conference call and
webcast today beginning at 8:30 a.m. Eastern
Time / 5:30 a.m. Pacific Time. To access the conference
call, dial 844-358-6753 and enter the passcode: 9364928. A
webcast will be available in the investor relations section of the
company's website, www.cytrx.com. A replay of the
call and webcast will begin approximately two hours after the live
call has ended. To access the replay, dial 855-859-2056 and
enter the passcode: 9364928.
About a 505(b)(2) New Drug Application
A new drug application (NDA) under the Food and Drug
Administration's (FDA) section 505(b)(2) is for a new drug
containing similar active ingredients as a previously approved
drug. According to the publication Regulatory Focus, a
drug reviewed under 505(b)(2) represents a modified version of a
previously approved product that requires additional clinical and
nonclinical studies, other than bioavailability/bioequivalence
studies, to demonstrate safety and efficacy. Such an application
differs from a typical NDA in that the sponsor can rely on, at
least in part, the FDA's findings of safety and/or effectiveness
for a previously approved reference drug.
About the Phase 2b and Phase 3 Clinical Trials
The Phase 2b trial involved 123 patients at 31 sites. Patients
with advanced soft tissue sarcomas were randomized 2:1 to receive
either 350 mg/m2 of aldoxorubicin (83 patients) or 75
mg/m2 of doxorubicin (40 patients) every 3 weeks for up
to 6 cycles. The trial was designed to compare aldoxorubicin
directly with doxorubicin.
The randomized, controlled Phase 3 trial enrolled a total of 433
patients at 79 clinical sites. Patients with metastatic,
locally advanced or unresectable soft tissue sarcomas who had
either not responded to, or who had progressed following treatment
with one or more systemic regimens of non-adjuvant chemotherapy
were randomized 1:1 to be treated with aldoxorubicin or the
investigator's choice of an approved chemotherapeutic regimen,
including doxorubicin, ifosfamide, dacarbazine, pazopanib
(Votrient®), or gemcitabine plus docetaxel.
About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood
vessels, tendons, fibrous tissues and connective tissue. It
can arise anywhere in the body at any age. STS remains a high
unmet medical need because of the difficulty in treating the more
than 50 types of this aggressive cancer. According to
the American Cancer Society, in 2016 more than 12,300 new
cases were diagnosed in the U.S. and approximately 5,000 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
Aldoxorubicin is a rationally engineered cytotoxic which
combines doxorubicin, a widely used chemotherapeutic agent, with a
novel linker molecule that binds directly and specifically to
circulating albumin, the most abundant protein in the
bloodstream. Protein-hungry tumors concentrate albumin, which
facilitates 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. Typically, 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.
Using this acid-sensitive linker technology, aldoxorubicin delivers
greater doses of doxorubicin (3 ½ to 4 times). To date, there has
been no evidence of clinically significant effects of aldoxorubicin
on heart muscle, even at cumulative doses of the drug well in
excess of 5,000 mg/m2. Aldoxorubicin is the first-ever
single agent to show superiority over doxorubicin in a randomized
clinical trial in first-line STS.
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, its improved version of the widely
used chemotherapeutic agent doxorubicin. CytRx is
also expanding 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. 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 timing of CytRx's preparation and
submission of an NDA for aldoxorubicin for the treatment of STS
and FDA acceptance and review of any NDA, the risk
that CytRx may be unsuccessful in
obtaining FDA approval or, if approval is obtained, in
commercializing aldoxorubicin in the United States or
elsewhere, risks related to CytRx's need for additional
capital or strategic partnerships to fund its ongoing working
capital needs and other 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.
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor
Relations
(310) 826-5648, ext. 304
dhaen@cytrx.com
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
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SOURCE CytRx Corporation