LOS ANGELES, Oct. 2, 2017 /PRNewswire/ -- CytRx Corporation
(NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, today provided a business update
and highlighted the Company's future plans.
Aldoxorubicin for the Treatment of Soft Tissue Sarcomas
and Other Oncology Indications
During 2017, CytRx has made significant strides in advancing its
lead oncology asset aldoxorubicin from a late-stage clinical asset
to a partnered, pre-New Drug Application (NDA) candidate in the
U.S. In July 2017, CytRx
announced a strategic licensing transaction with NantCell, Inc.,
for the global rights to aldoxorubicin. Dr. Patrick Soon-Shiong, the CEO and founder of
NantCell, developed, obtained regulatory approval for, and
commercialized Abraxane®, another albumin-mediated cytotoxic agent
which currently generates approximately $1B in annual sales. CytRx believes that
Dr. Soon-Shiong's track record and expertise with albumin-mediated
agents will prove invaluable as NantCell works to obtain regulatory
approval for aldoxorubicin, with the goal of commercialization
thereafter.
"In addition to the initial indication of soft tissue sarcomas,
NantCell is planning to develop aldoxorubicin in combination with
immuno-oncology agents and cutting edge natural killer (NK)
cell-based therapies in multiple tumor types, including breast and
brain cancers," said David Haen,
CytRx's Vice President of Business Development and Investor
Relations. "NantCell is a true innovator in the field of
oncology and brings a deep appreciation for the clinical benefit
that aldoxorubicin can offer patients. We are confident that
placing the asset in their hands will maximize both its future
clinical and commercial potential."
CytRx has been actively working with the NantCell team to
transition the aldoxorubicin program, including both completed and
ongoing studies. Both teams are diligently working toward the
preparation of the NDA for aldoxorubicin as a new treatment for
soft tissue sarcomas, as well as getting additional clinical trials
underway. CytRx looks forward to seeing aldoxorubicin enter
NantCell-initiated clinical trials in the near future.
LADR™ Technology Platform and CytRx's Future Oncology
Pipeline
CytRx's internal R&D activities at its expanded laboratory
in Freiberg, Germany, are now
focused on developing new drug candidates generated from its
proprietary LADR™ (Linker Activated Drug Release)
discovery platform.
Ongoing preclinical data is being generated for several
LADR™-derived ultra-high potency compounds, and CytRx
researchers have obtained partial and complete responses in a
variety of solid tumor animal models to date. Additional
in vivo efficacy and toxicology testing is underway, and
CytRx's goal is to file one or more new patent applications during
the fourth quarter of 2017. The Company also hopes to
nominate the next LADR™ candidate for clinical development by the
end of 2017 and to submit these important preclinical data for
presentation at an upcoming scientific meeting in 2018. CytRx
is extremely eager to move these programs forward and is taking
great care to select the correct clinical candidates in order to
optimally position these molecules for success once they enter
clinical trials.
CytRx's strategy is to pursue a two-pronged approach to
advancing its ultra-high potency LADR™ conjugates.
Once a candidate is selected for clinical testing, the Company will
conduct the necessary preclinical studies to enable an
Investigational New Drug (IND) application filing, with the goal of
taking the first LADR™-discovered, ultra-high potency conjugate
into clinical trials during 2018. If the selected conjugate
is successful in early-stage clinical studies although there can be
no guarantee, CytRx hopes to seek Breakthrough Designation from the
FDA. In parallel with internally advancing its
LADR™-discovered conjugates, the Company also plans to explore
pre-clinical strategic alliances with large pharmaceutical partners
where a collaboration could demonstrate the utility of the LADR™
platform.
Corporate and Financial
For a non-revenue-generating, development-stage life science
company, a strong balance sheet will always be a key concern.
CytRx ended the second quarter of 2017 with $55 million in cash. Subsequent to the
close of the second quarter, the NantCell transaction brought in an
additional $13 million through their
purchase of CytRx common shares at $1.10 per share, an approximately 92% premium to
the Company's stock price at that time. The Company also
restructured and paid down $10
million of its existing debt during the third quarter.
Mr. Haen concluded, "The grim reality is that 5-year survival
rates for many cancers are still well below 50%. As a result,
the Company's long-term goals have not changed, and that is to
develop breakthrough oncology drugs to help provide new therapies
for patients with cancer."
About CytRx Corporation
CytRx Corporation is a biopharmaceutical company specializing in
research and clinical development of novel anti-cancer drug
candidates that employ linker technologies to enhance the
accumulation and release of drug at the tumor. Aldoxorubicin,
CytRx's most advanced drug conjugate, is an improved version of the
widely used chemotherapeutic agent doxorubicin and has been
out-licensed to NantCell, Inc. CytRx is also rapidly
expanding its pipeline of ultra-high potency 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 potential breakthrough
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 and
uncertainties relating to: the ability of NantCell, Inc., to obtain
regulatory approval for its products that use aldoxorubicin; the
ability of NantCell Inc. to manufacture and commercialize products
or therapies that use aldoxorubicin; the amount, if any, of future
milestone and royalty payments that we may receive from NantCell;
our ability to develop new ultra-high potency drug candidates based
on our LADRTM technology platform; 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.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
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SOURCE CytRx Corporation