LOS ANGELES, June 8, 2017 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR) a biopharmaceutical research and
development company specializing in oncology, today announced an
update on the regulatory pathway for a New Drug Application (NDA)
submission for aldoxorubicin in soft tissue sarcomas (STS).
The Company plans to submit a rolling NDA under section
505(b)(2) to the FDA for aldoxorubicin as a treatment for
STS. The 505(b)(2) pathway is designed for a new drug that
contains the same active ingredient as a previously approved drug,
also known as a reference drug. For aldoxorubicin, doxorubicin
is the reference drug. The NDA submission is not reliant
solely on the recently completed Phase 3 clinical trial in STS or
overall survival results. Rather, CytRx's completed
pharmacokinetic clinical trial, Phase 2b and Phase 3 trials in STS,
along with preclinical safety and efficacy studies, will serve as
"scientific bridges" between aldoxorubicin and doxorubicin. These
studies, along with the published literature of doxorubicin's
effectiveness and safety, will form the basis of the NDA filing for
aldoxorubicin under the 505(b)(2) regulations.
"Having worked on aldoxorubicin's regulatory strategy and as a
participant in the March FDA meeting, the 505(b)(2) regulatory
pathway is the most appropriate for aldoxorubicin in STS," said
Scott Wieland, PhD, CytRx's Senior
Vice President of Drug Development. "As noted in the FDA meeting,
the aldoxorubicin preclinical and clinical studies will support a
505(b)(2) NDA submission, and no new clinical trials were requested
by the FDA at the meeting. Additionally, CytRx's previously
approved special protocol assessment is no longer applicable."
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. CytRx plans to
discuss with the European Medicines Agency (EMA) a path to filing a
Marketing Authorization Application (MAA).
The proposed product label would allow the treatment of soft
tissue sarcomas. New data could support future use of aldoxorubicin
in neoadjuvant (pre-surgery) settings, as well as a replacement for
doxorubicin in chemotherapy combinations. CytRx is also working on
a market expansion strategy which would include other indications
for aldoxorubicin including combinations with other
chemotherapeutics and immunotherapies.
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 the same active ingredient as a previously approved
drug. According to the publication Regulatory Focus (Reg
Focus, Apr. 2010, 8-13.), 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 its 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
effectiveness for the previously approved reference drug.
About the Phase 2b and Phase 3 Clinical Trials
The global 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 350 mg/m2 of
aldoxorubicin until disease progression 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 2017 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
ultra-high potency 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