Cytori Files Pre-submission Request for New Drug Application
07 Marzo 2019 - 2:30PM
Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that
it officially filed a formal new drug application pre-submission
request to the European Medicine Agency (EMA) for Doxorubicin
Hydrochloride Cytori. This submission is the precursor to filing an
Article 58 Application for a Marketing Authorization Application
(MAA) via EMA’s centralized approval procedure. In June 2017, the
EMA Committee for Medicinal Products for Human Use (CHMP) confirmed
that Doxorubicin Hydrochloride Cytori was eligible for submission
of a MAA via the centralized procedure.
In addition, in late 2018, the EMA CHMP Name Review Group
validated Doxorubicin Hydrochloride Cytori as the official invented
name to replace ATI-0918. Doxorubicin Hydrochloride Cytori is
a liposomal nanoparticle medicinal product being developed for
cancer patients that contains the active substance doxorubicin, a
widely used chemotherapy drug. Doxorubicin Hydrochloride
Cytori is intended for the treatment of breast cancer, ovarian
cancer, multiple myeloma, and Kaposi’s sarcoma.
“Liposomal doxorubicin is a commonly prescribed chemotherapeutic
drug for patients with advanced breast and ovarian cancer as well
as other indications,” said Dr. Marc Hedrick MD, President/CEO of
Cytori Therapeutics. “Bringing Doxorubicin Hydrochloride
Cytori to market in Europe as an alternative to the branded drug is
an important near-term corporate goal.”
As a ‘hybrid medicine’, Doxorubicin Hydrochloride Cytori is
intended to be similar to a ‘reference medicine’, Adriamycin,
already authorized in the EU. Doxorubicin Hydrochloride
Cytori is different than Adriamycin in that the active substance is
encapsulated in tiny lipid nanospheres called liposomes that are
coated in polyethylene glycol or PEG. Cytori believes that it
has successfully completed all clinical development work for
Doxorubicin Hydrochloride Cytori and is currently manufacturing the
drug in its dedicated plant in San Antonio, Texas.
Cytori expects to receive assignment of a rapporteur and
co-rapporteur, who will work with the company through the MAA
submission and review process, by the end of April 2019. The
MAA submission is planned for later in 2019 or early 2020.
Cytori’s MAA will present data from the scientific literature
and from non-clinical studies, including comparisons with Janssen’s
Caelyx®, an authorized medicine containing doxorubicin in pegylated
liposomal form. The company will also present the results of
a completed clinical study intended to investigate whether
Doxorubicin Hydrochloride Cytori is ‘bioequivalent’ to Caelyx®,
meaning that they both produce the same levels of the active
substance in the body.
Janssen’s Caelyx® first received a marketing authorization for
the EU in 1996, is currently approved for the treatment of breast
cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, and
generated over €110M in sales across Europe in 2017. No
generic versions of Caelyx® are currently approved and available in
Europe.
About Cytori Therapeutics, Inc.
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 liposome encapsulated
therapies for regenerative medicine and oncologic indications. 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, conduct of clinical trials involving
our technology, clinical performance, and product approvals, are
all subject to risks and uncertainties that could cause our actual
results and financial position to differ materially. Some of these
risks and uncertainties include, but are not limited to, inherent
risk and uncertainty in the protection intellectual property
rights, regulatory uncertainties, risks in the conduct of clinical
trials, risks in the collection and results of clinical data, final
clinical outcomes, dependence on third party performance,
performance and acceptance of our products in the marketplace, as
well as other risks and uncertainties described under the heading
"Risk Factors" in Cytori's Securities and Exchange Commission
Filings on Form 10-K and Form 10-Q. We assume no responsibility to
update or revise any forward-looking statements to reflect events,
trends or circumstances after the date they are made.
Investor Contact:
Tiago GiraoCytori Therapeutics, Inc. 1-858-458-0900
ir@cytori.com
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