LOS ANGELES, Jan. 14, 2019 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today
highlighted that aldoxorubicin licensee NantCell, Inc., a
private subsidiary of NantWorks, LLC, has dosed the first patient
in the Phase 1b portion of a Phase
1b/2 clinical trial for patients with
relapsed or refractory colorectal cancer (CRC) who have been
previously treated with standard of care (SOC)
therapy. This is the fourth trial conducted by NantCell
which will investigate high-affinity natural killer (haNK) cell
therapy in combination with anti-cancer agents, including
aldoxorubicin, in certain high unmet need cancer indications.
"Among the most compelling recent medical advances has been the
significant improvement in efficacy seen when immunotherapy is
combined with chemotherapy, especially in high unmet medical need
cancers such as non-small cell lung, pancreatic cancer and triple
negative breast cancers," said Eric
Curtis, CytRx's President and Chief Operating Officer.
"NantCell is leveraging this important emerging combination trend
and to date has initiated four Phase 1b/2 clinical trials investigating their haNK
cell therapy in combination with several anti-cancer agents,
including aldoxorubicin. Aldoxorubicin targets and binds to serum
albumin to concentrate drug inside solid tumors,
maximizing efficacy and minimizing systemic
toxicity. This newest clinical trial in relapsed or
refractory CRC speaks to NantCell's continued commitment to
maximizing the clinical and commercial potential of targeting solid
tumors with albumin binding aldoxorubicin for these patients with
difficult to treat malignancies."
The trial titled "QUILT-3.071: NANT Colorectal Cancer (CRC)
Vaccine: A Phase 1b/2 Trial of the
NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who
Have Been Previously Treated With Standard-of-Care Therapy,"
(NCT03563157) is a single-center, open-label, Phase 1b/2 clinical trial designed to evaluate the
safety and efficacy of several combination therapies, including
combinations with aldoxorubicin, in subjects with CRC who have
progressed on or after SOC therapy. The primary endpoint
for the Phase 1b portion of the trial
is safety and if the study proceeds to phase 2, the primary
endpoint for the Phase 2 portion of the trial is progression-free
survival (PFS) and objective response rate (ORR), both by
RECIST.
About Colorectal Cancer
Colorectal cancer (CRC), also
known as bowel cancer, colon cancer, or rectal cancer, is any
cancer that affects the colon and the rectum. According to the
Colorectal Cancer Alliance, CRC is the third most common type of
cancer in the U.S., and the second leading cause of cancer
death. The American Cancer Society estimates that
approximately 140,000 new cases of CRC are expected to be diagnosed
in the U.S. in 2018 and it will cause over 50,000 deaths in the
same timeframe. CRC affects men and women of all racial
and ethnic groups, and is most often found in people 50 years or
older, however, incidence in those younger than 50 is on the
rise.
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). 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 Centurion BioPharma Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma
Corporation, is focused on the development of personalized medicine
that will transform solid tumor treatment. This transformational
strategy combines a portfolio of novel, anti-cancer drug candidates
that employ LADR™ (Linker Activated Drug Release) technology, a
discovery engine designed to leverage Centurion's expertise in
albumin biology and linker technology for the development of a new
class of breakthrough anti-cancer therapies with a unique albumin
companion diagnostic (ACDx) that can help identify patients who are
most likely to benefit from treatment with the LADR™-derived
therapies. A critical element of the LADR™ platform is its ability
to bind anti-cancer molecules to circulating albumin, the most
ubiquitous protein in human blood plasma, and then to release the
highly potent cytotoxic payload at the tumor site. This technology
allows for the delivery of higher doses of drug directly to the
tumor, while avoiding much of the off-target toxicity observed with
the parent molecules. Centurion BioPharma Corporation's
website is www.centurionbiopharma.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 NantCell to obtain
regulatory approval, manufacture and commercialize its products and
therapies that use aldoxorubicin; the ability of NantCell to enroll
additional patients in the clinical trials discussed in this press
release; the amount, if any, of future milestone and royalty
payments that we may receive from NantCell; the ability of
Centurion BioPharma to enter into strategic transactions or
partnerships involving the LADR™ drug candidates LADR‑7, LADR-8,
LADR-9 and LADR-10, and the companion diagnostic ACDx, and to enter
clinical trials or obtain regulatory approvals for any such
products; the efficacy and safety of such products; the ability of
Centurion BioPharma to develop new ultra-high potency drug
candidates based on its LADR™ technology platform; 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, Inc.; risks and uncertainties relating
to the ability of Orphazyme A/S to obtain regulatory approval for
its products that use arimoclomol; the ability of Orphazyme A/S to
manufacture and commercialize products or therapies that use
arimoclomol; the amount, if any, of future milestone and royalty
payments that we may receive from Orphazyme A/S; Centurion
BioPharma Corporation's ability to develop new ultra-high potency
drug candidates based on its LADR™ technology platform; or the
ability of CytRx and Centurion BioPharma to attract potential
licensees; 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