Pharmacokinetic Bioequivalence Shown for Cytori’s ATI-0918 Liposomal Formulation of Doxorubicin Hydrochloride,
Results Presented at the 2017 American Association of Pharmaceutical Scientists Annual Meeting
SAN DIEGO, Nov. 16, 2017 (GLOBE NEWSWIRE) -- 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.
CONTACT
CYTORI THERAPEUTICS
Tiago Girao
+1.858.458.0900
ir@cytori.com