LOS ANGELES, May 17, 2017 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced the
presentation of two abstracts at the 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2017 in Chicago. The first is an
oral presentation featuring updated and more detailed results from
the Company's global Phase 3 clinical trial evaluating
aldoxorubicin versus investigator's choice in patients with
relapsed and refractory soft tissue sarcomas (STS). The other
is a poster presentation describing updated data from an ongoing
Phase 1/2 clinical trial combining aldoxorubicin with
ifosfamide/mesna (I-M) in first- and second-line STS.
"In addition to the significantly prolonged progression-free
survival achieved by both North American and L-sarcoma patients,
the data presented at ASCO this year demonstrate that, unlike any
other drugs in this class, aldoxorubicin can be dosed continuously
with minimal to no cardiotoxicity," commented Sant Chawla, M.D., F.R.A.C.P., Director of the
Sarcoma Oncology Center in Santa Monica,
California, and Principal Investigator for the Phase 3
trial. "Another distinct advantage is its ability to be
administered to patients who have already been treated with
doxorubicin. Taken together, these findings support
aldoxorubicin's potential as a superior anthracycline treatment for
patients suffering with these highly complex and difficult to treat
types of cancer."
Daniel Levitt, M.D., Ph.D., Chief
Operating Officer and Chief Medical Officer of CytRx, commented,
"The data from both of these important clinical trials evaluating
aldoxorubicin in sarcomas, along with our several other completed
clinical and preclinical studies, will form the basis of our
planned New Drug Application submission to the U.S. Food and Drug
Administration, and we are pleased to share these more mature and
detailed results in this peer-reviewed forum with the medical and
scientific communities."
Details for the presentations at ASCO 2017:
Oral Presentation
Title: Phase III study of aldoxorubicin vs investigators'
choice as treatment for relapsed/refractory soft tissue
sarcomas
Presenter: Sant Chawla, M.D.,
F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, and Principal Investigator
Abstract #: 11000
Session Title: Oral Abstract Session: Sarcoma
Location: S100bc
Date and Time: Friday, June 2, 2017; 3:00pm-6:00pm CT
Summary: This multicenter, randomized, open-label
Phase 3 trial enrolled 433 patients at 79 sites. The data
summarized here are as of August 2016. In patients with
leiomyosarcoma and liposarcoma (n=246), aldoxorubicin demonstrated
median progression-free survival (PFS) of 5.32 months, compared to
a median PFS of 2.96 months for investigator's choice therapy, a
statistically significant improvement of 2.36 months (p=0.007;
hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38%
reduction in the risk of tumor progression. In patients
treated in North America plus
Australia (n=312), aldoxorubicin
demonstrated a median PFS of 4.21 months, compared to a median PFS
of 2.96 months for investigator's choice therapy, a statistically
significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI
0.53-0.96). In the overall intent to treat (ITT) trial
population (n=433), aldoxorubicin performed better than
investigator's choice demonstrating a median PFS of 4.11 months,
compared to a median PFS of 2.96 months for investigator's choice
therapy, narrowly missing statistical significance (p=0.087;
HR=0.81, 95% CI 0.64-1.03). All responses in this study were
determined by an independent, blinded central lab assessment of
scans.
Key safety findings included that aldoxorubicin caused no
clinically significant cardiac, renal, or hepatic toxicities.
Aldoxorubicin administered at 350mg/m2 per cycle showed
no cardiotoxicity up to 40 cycles. Importantly, left
ventricular ejection fraction (LVEF) below 50% of expected values
were reported in 4.2% of patients treated with aldoxorubicin,
compared to 19.1% for patients receiving investigator's
choice. Additionally, ≥20% decreases in LVEF from baseline
were reported in 3.8% of patients treated with aldoxorubicin,
compared to 8.5% for patients receiving investigator's
choice. For the global trial population, the most commonly
reported (≥10%) Grade ≥3 adverse events were neutropenia, anemia,
febrile neutropenia, stomatitis and decreased white blood cell
count, and were manageable with standard supportive care. The
non-cardiac Grade ≥3 adverse events associated with aldoxorubicin
were similar to doxorubicin despite exposure up to 3-4 times the
standard doxorubicin dose.
Updated data relating to the trials other secondary endpoints,
including objective response rate (ORR), disease control rate
(DCR), overall survival, and other safety parameters were in line
with what has previously been reported by CytRx and will be
included in the oral presentation being given at ASCO 2017.
Following conclusion of Dr. Chawla's presentation, a PDF copy of
the oral presentation slides will be available at
http://cytrx.com/investors/presentations.
Poster Presentation
Title: Administration of aldoxorubicin and 14 days
continuous infusion of ifosfamide/Mesna in metastatic or locally
advanced sarcomas
Presenter: Frederick C.
Eilber, M.D., Director of the UCLA Sarcoma Translational
Research Program within the Jonsson Comprehensive Cancer Center
Abstract #: 11051
Session Title: Poster Session: Sarcoma
Location: Hall A
Poster board#: 374
Date and Time: Sunday, June 4, 2017; 8:00am-11:30am CT
Summary: This ongoing open-label Phase 1/2 clinical
trial is designed to assess the preliminary safety and activity of
aldoxorubicin plus I-M as a first- or second-line treatment in
patients with STS. Patients were administered 1 of 2 dose
levels of aldoxorubicin (170mg/m2 or 250mg/m2
[125mg/m2 or 185mg/m2 doxorubicin
equivalent]) on Day 1, then I-M (1g/m2 of each per day)
was administered for up to 14 days as a continuous infusion.
Chemotherapy cycles were repeated at 28 day intervals, but I-M was
limited to a maximum of 6 cycles to avoid cumulative bone marrow
toxicity. Aldoxorubicin was continued per investigator
decision in either responding or stable disease (SD)
patients. Patients were followed for tumor response by CT
scans and echocardiogram for cardiac toxicity every 8 weeks along
with standard labs.
Of the 44 evaluable patients as of May
10, 2017, 16 patients (36%) achieved a partial response
(PR), 25 patients (57%) achieved SD, with 20 patients (45%)
achieving SD for ≥4 months, for an overall disease control rate
(DCR) of 82% (PR+SD≥4). Twenty-two of 44 (50%) patients
received at least 6 cycles of aldoxorubicin (>1,300
mg/m2 cumulative doxorubicin equivalent). As of
the data cutoff date, the median PFS had not been reached.
The most commonly reported Grade ≥3 adverse event (AEs; >20%)
were neutropenia and anemia. Reported serious adverse events
(SAEs) included febrile neutropenia (14%, n=6), anemia (5%, n=2),
thrombocytopenia (2%, n=1), stomatitis (2%, n=1) and pyrexia (2%,
n=1). No clinically significant cardiotoxicity has been
observed and no patients had a clinically significant decrease
in LVEF or QTc prolongation, despite administration of median
cumulative doses of doxorubicin equivalents of
1364-1965mg/m2. No treatment related deaths
occurred. These results support the thesis that aldoxorubicin
can be administered safely and for prolonged periods with
continuous infusion I-M and achieves high response rates and SD,
with substantial tumor necrosis. Based on these results, the
decision was made to stop further aldoxorubicin dose escalation and
continue to enroll only in the 250mg/m2 cohort.
Following conclusion of the poster presentation, a PDF copy of
the poster will be available at
http://cytrx.com/investors/presentations.
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 drug well in excess of
6,500 mg/m2 of doxorubicin equivalents. 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 and
uncertainties relating to the 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, 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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