SAN DIEGO -- (Business Wire)
Cytori Therapeutics, Inc. (NASDAQ: CYTX) has received notification from
the FDA that Cytori has provided additional information sufficient to
support continuation of enrollment in its ATHENA cardiovascular trials.
The FDA has agreed that the submitted data and protocol amendments
support the fact that there are no subject protection concerns that
preclude continuation of the trials.
The ATHENA trials have enrolled a total of 31 patients thus far but
enrollment was stopped last May by the company based on meeting the
trials’ internal stopping rules related to potential cerebrovascular
events affecting both cell and placebo treated patients.
Based on consultation with the FDA, Cytori initiated a thorough safety
review consisting of evaluating each adverse event in all of its
previous and ongoing cardiovascular trials and conducted additional
testing of its product and cellular output. In addition, Cytori
implemented several protocol changes to enhance the safety of the trial
procedures for patients. The FDA response to Cytori’s submission was
received on October 22, 2014.
“Cytori is first and foremost focused on patient safety in all its
endeavors, and we are pleased to have successfully navigated this issue.
Such issues are not uncommon in development programs involving novel
technology for a severely ill population,” said Dr. Marc Hedrick,
President and Chief Executive Officer of Cytori. “Currently, we are
assessing what this delay means for this particular trial and will
provide an updated plan on our forthcoming quarterly investor call.”
About Cytori Therapeutics, Inc.
Cytori Therapeutics, Inc. is developing cell therapies based on
autologous ADRCs to treat cardiovascular disease and repair soft tissue
defects. Our scientific data suggest ADRCs improve blood flow, moderate
the immune response and keep tissue at risk of dying alive. As a result,
we believe these cells can be applied across multiple “ischemic”
conditions. These therapies are made available to the physician and
patient at the point-of-care by Cytori’s proprietary technologies and
products, including the Celution® system product family. For more
information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events,
trends and business prospects, which may affect our future operating
results and financial position. Such statements, including, but not
limited to, those regarding our belief in the safety of the Celution®
System cell output, are forward looking statements. Such statements are
subject to risks and uncertainties that could cause our actual results
and financial position to differ materially. Some of these risks include
our pressing need to raise additional capital, clinical, pre-clinical
and regulatory uncertainties, the quality of data supporting execution
of ATHENA trials, including 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, and other risks and uncertainties described under the “Risk
Factors” in Cytori’s Securities and Exchange Commission Filings,
including in its most recent annual and quarterly reports. Cytori
assumes no responsibility to update or revise any forward-looking
statements contained in this press release to reflect events, trends or
circumstances after the date of this communication.
Contacts:
Cytori Therapeutics, Inc.
Tiago Girao, 1-858-458-0900
Chief
Financial Officer
ir@cytori.com
Source: Cytori Therapeutics, Inc.
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