Cytori Reports Bioequivalence Trial Results in Ovarian Cancer at AAPS
November 16 2017 - 8:00AM
Pharmacokinetic Bioequivalence Shown for Cytori’s
ATI-0918 Liposomal Formulation of Doxorubicin Hydrochloride,
Cytori Therapeutics (NASDAQ:CYTX) (“Cytori” or the “Company”) today
announced the results of its pharmacokinetic bioequivalence trial
of ATI-0918 (test product) and European sourced CAELYX® (reference
product). ATI-0918 is being developed by Cytori Therapeutics
as a generic formulation of Janssen’s CAELYX® and Sun Pharma’s
Lipodox®, liposomal formulations of doxorubicin hydrochloride
marketed internationally and in the U.S., respectively. The data
was presented this week at the American Association of
Pharmaceutical Scientists Annual Meeting held in San Diego and the
abstract is available online.
The pharmacokinetic bioequivalence trial was designed as a
single-blind, randomized, two-way, crossover bioequivalence study.
Ovarian cancer patients were randomized in a 1:1 ratio and received
one of two treatment sequences. Each sequence consists of two
treatment cycles, 28 days per cycle. In Sequence A, patients
received a single dose of 50 mg/m2 European sourced CAELYX® on Day
1 of Cycle 1 and a single dose of 50 mg/m2 ATI-0918 on Day 1 of
Cycle 2. In Sequence B, patients received a single dose of 50 mg/m2
ATI-0918 on Day 1 of Cycle 1 and a single dose of 50 mg/m2 European
sourced CAELYX® on Day 1 of Cycle 2. There was a 3-week wash-out
period between Cycle 1 and Cycle 2. The number of patients used in
the bioequivalence assessment was 44.
In summary, the pharmacokinetic bioequivalence
of ATI-0918 was confirmed as bioequivalent to European sourced
CAELYX®. The lower and higher 90% CI ratios for ln-Cmax, ln-AUC0-t
and ln-AUC0-inf of free doxorubicin, encapsulated doxorubicin and
the metabolite doxorubicinol following ATI-0918 were within 80.00%
to 125.00% of those ratios following European sourced CAELYX®.
ATI-0918 is a complex generic formulation of the
market-leading oncology drug, DOXIL®/CAELYX®, which is FDA approved
in the U.S. for ovarian cancer, multiple myeloma, and Kaposi’s
Sarcoma; and in the European Union for breast cancer, ovarian
cancer, multiple myeloma, and Kaposi’s Sarcoma. The current
approval pathway for ATI-0918 is to leverage existing
bioequivalence data to CAELYX® for approval in the EU and to
demonstrate bioequivalence to Lipodox® in the U.S. The global
market potential for liposomal doxorubicin is expected to grow to
$1.4B by 2024 and Cytori is actively seeking commercial partners
for its ATI-0918 asset.
About Cytori
Cytori is a therapeutics company developing
regenerative and oncologic therapies from its proprietary cell
therapy and nanoparticle platforms for a variety of medical
conditions. Data from preclinical studies and clinical trials
suggest that Cytori Cell Therapy™ acts principally by improving
blood flow, modulating the immune system, and facilitating wound
repair. As a result, Cytori Cell Therapy™ may provide benefits
across multiple disease states and can be made available to the
physician and patient at the point-of-care through Cytori’s
proprietary technologies and products. Cytori Nanomedicine™ is
developing encapsulated therapies for regenerative medicine and
oncologic indications using technology that allows Cytori to use
the benefits of its encapsulation platform to develop novel
therapeutic strategies and reformulate other drugs to optimize
their clinical properties. For more information, visit
www.cytori.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release includes forward-looking statements regarding
events, trends and business prospects, which may affect our future
operating results and financial position. Such statements,
including, without limitation, statements regarding the approval
pathway for ATI-0918, the expected growth in the global market
potential for liposomal doxorubicin and Cytori Cell Therapy’s
potential to provide benefits across multiple disease states, are
subject to risks and uncertainties that could cause our actual
results and financial position to differ materially. These risks
and uncertainties, which include inherent uncertainties in conduct
of clinical studies and trials and the results of such trials
(including risks that further studies may not support efficacy or
safety of Cytori Nanomedicine), risks associated with clinical use
of Cytori Cell Therapy in studies and trials not controlled by
Cytori, risks to Cytori’s intellectual property portfolio are
described under the heading "Risk Factors" in Cytori's Securities
and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori
assumes no responsibility to update or revise any forward-looking
statements to reflect events, trends or circumstances after the
date they are made.
CONTACTCYTORI THERAPEUTICS
Tiago Girao+1.858.458.0900 ir@cytori.com
Cytori Therapeutics (NASDAQ:CYTX)
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