LOS ANGELES, April 29, 2019 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today highlighted
that arimoclomol licensee Orphazyme A/S (CPH: ORPHA) has completed
enrollment in its Phase 2/3 clinical trial evaluating arimoclomol
for the treatment of sporadic Inclusion Body Myositis (sIBM).
Orphazyme is currently developing arimoclomol in four different
indications, including amyotrophic lateral sclerosis (ALS),
Niemann-Pick disease Type C (NPC), Gaucher disease and sIBM.
"CytRx is proud to see the progress our partner Orphazyme is
making with arimoclomol's clinical development," said Eric Curtis, CytRx's President and Chief
Operating Officer. "The impressive rate of enrollment in this trial
is made possible by both the support and enthusiasm from the sIBM
patient community and Orphazyme's own sense of urgency in
developing and bringing to market arimoclomol. As Orphazyme makes
further progress with the drug, CytRx is eligible to receive future
royalty payments from our licensing agreement."
The Phase 2/3 trial of arimoclomol for the treatment of sIBM is
a 150-patient, 20-month, randomized, double-blind,
placebo-controlled trial in 11 centers in the United States and one in the United Kingdom. Orphazyme expects to conduct
an interim analysis in the first half of 2020 and to complete the
study by the end of 2020, with results anticipated to be announced
in the first half of 2021. Orphazyme has additionally initiated an
open-label extension trial to which patients from the Phase 2/3
trial may enroll.
About Sporadic Inclusion Body Myositis (sIBM)
Sporadic Inclusion Body Myositis (sIBM) is a progressively
debilitating muscle-wasting disease. sIBM is characterized by a
build-up of protein aggregates and atrophy of muscle cells, which
leads to weakness and over time severe disability. The estimated
prevalence of sIBM is 24.8-45.6 per million or 17,000-31,000
patients in the USA and
Europe. There are no approved
treatments for sIBM. Arimoclomol has been granted Orphan Drug
Designation (EU and USA) for the
treatment of sIBM.
About Arimoclomol
Arimoclomol is an investigational drug candidate that amplifies
the production of heat-shock proteins (HSPs). HSPs can rescue
defective misfolded proteins, clear protein aggregates, and improve
the function of lysosomes. Arimoclomol is administered orally,
crosses the blood brain barrier, and has been studied in seven
Phase 1 and three Phase 2 clinical trials. Arimoclomol is in
clinical development at Orphazyme for the treatment of Niemann-Pick
disease Type C, Gaucher disease, sporadic Inclusion Body Myositis,
and amyotrophic lateral sclerosis.
About CytRx Corporation
CytRx Corporation (NASDAQ: CYTR) is a biopharmaceutical company
with expertise in discovering and developing new therapeutics to
treat patients with cancer. CytRx's most advanced drug conjugate,
aldoxorubicin, is an improved version of the widely used
anti-cancer drug doxorubicin and has been out-licensed to NantCell,
Inc. In addition, CytRx's other drug candidate, arimoclomol
has been out-licensed to Orphazyme A/S (Nasdaq Copenhagen exchange:
ORPHA). Orphazyme is testing arimoclomol in four indications
including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease
Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis
(sIBM). CytRx Corporation's website is www.cytrx.com.
About Orphazyme A/S
Orphazyme is a biopharmaceutical company focused on bringing
novel treatments to patients living with life-threatening or
debilitating rare diseases. Our research focuses on developing
therapies for diseases caused by misfolding of proteins and
lysosomal dysfunction. Arimoclomol, the company's lead candidate,
is in clinical development for four orphan diseases: Niemann-Pick
disease Type C, Gaucher disease, sporadic Inclusion Body Myositis,
and Amyotrophic Lateral Sclerosis. The Denmark-based company is listed on Nasdaq
Copenhagen (ORPHA.CO). For more information, please visit
www.orphazyme.com.
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 Orphazyme A/S to obtain
regulatory approval for, manufacture and commercialize its products
and therapies that use arimoclomol; the results of future clinical
trials involving arimoclomol; the amount, if any, of future
milestone and royalty payments that we may receive from Orphazyme
A/S; 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/Maghan Meyers
(212) 600-1902
michelle@argotpartners.com
maghan@argotpartners.com
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SOURCE CytRx Corporation
