LOS ANGELES, Jan. 4, 2017 /PRNewswire/ -- CytRx
Corporation (NASDAQ: CYTR), a clinical-stage biopharmaceutical
company focused on discovering, developing and commercializing new
therapeutics to treat patients with cancer, today announced that,
in response to a request from the company, the U.S. Food and Drug
Administration (FDA) has agreed to a Type B pre-NDA meeting at
which the company will seek input on its planned New Drug
Application (NDA) for aldoxorubicin as a new second-line treatment
for patients with soft tissue sarcomas (STS). Assuming a
positive outcome from this pre-NDA meeting, CytRx expects to submit
an NDA for aldoxorubicin to the FDA in the last quarter of 2017,
and, subject to FDA approval, bring aldoxorubicin to market next
year.
"Based on positive, statistically significant results from
our pivotal Phase 3 trial evaluating aldoxorubicin compared to
investigator's choice in patients with previously treated relapsed
or refractory sarcomas, we requested, and were recently granted, a
Type B meeting with the FDA," said Daniel
Levitt, M.D., Ph.D., Chief Operating Officer and Chief
Medical Officer of CytRx. "The purpose of this meeting is to
share the Phase 3 data with the Agency and discuss the regulatory
path forward for aldoxorubicin. In our view, this meeting is
an important next step toward our goal of bringing aldoxorubicin to
the thousands of patients in need of a new treatment for relapsed
soft tissue sarcoma."
Overview of the Updated Phase 3 Trial and Results
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 aldoxorubicin or the
investigator's choice of an approved chemotherapeutic regimen,
including doxorubicin, ifosfamide, dacarbazine, pazopanib
(Votrient®), or gemcitabine plus docetaxel. The primary
endpoint of the study is PFS. Secondary endpoints include
overall survival, response rates, disease control rates and
safety.
In November 2016, CytRx reported
positive results which demonstrated a statistically significant
improvement in progression-free survival (PFS) between
aldoxorubicin and investigator's choice therapy in 246 patients
with leiomyosarcoma and liposarcoma, (p=0.007). The hazard
ratio (HR) was 0.62 (95% CI 0.44-0.88), representing a 38%
reduction in the risk of tumor progression for patients receiving
aldoxorubicin versus investigator's choice. Leiomyosarcoma
and liposarcoma are the two most common types of STS and accounted
for 57% of the patients enrolled in the trial. Aldoxorubicin
also demonstrated a statistically significant improvement in PFS
over investigator's choice in 312 patients treated in North America (p=0.028; HR=0.71, 95% CI
0.53-0.97). Notably, aldoxorubicin performed better than
investigator's choice for the entire study population and narrowly
missed statistical significance (p=0.12; HR=0.81, 95% CI
0.64-1.06). All responses were determined by an independent,
blinded central lab assessment of scans.
Aldoxorubicin did not cause clinically significant cardiac,
renal, or hepatic toxicities. For the global trial
population, the most commonly reported adverse events were
neutropenia and anemia consistent with prior clinical trials with
aldoxorubicin. Grade 3 or higher adverse events were manageable
with supportive care and occurred at a rate of 61% for patients
receiving aldoxorubicin and 46% in patients treated with
investigator's choice. Importantly, treatment-emergent
adverse events leading to discontinuation occurred in 4.2% of
patients treated with aldoxorubicin, compared to 6.3% for patients
receiving investigator's choice.
Patients continue to be followed for overall survival (OS), a
secondary endpoint, and CytRx expects the OS data to be available
in 2017.
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 within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended. 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 and final results of CytRx's
clinical testing of aldoxorubicin, the prospects for a path forward
to regulatory approval of aldoxorubicin, 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
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/cytrx-granted-type-b-pre-nda-meeting-with-us-fda-for-registration-pathway-with-aldoxorubicin-as-a-treatment-for-patients-with-relapsed-soft-tissue-sarcomas-300385274.html
SOURCE CytRx Corporation