Cytori Therapeutics (NASDAQ:CYTX) enrolled the first two patients
in a clinical trial using adipose-derived stem and regenerative cells
in the treatment of heart attack. In this trial, patients´ cells are
made available using Cytori´s Celution(TM) System, a real-time cell
processing device. One patient has been enrolled in each trial center,
Hospital Universitario Gregorio Maranon in Madrid, Spain, and
Thoraxcenter, Erasmus Medical Center in Rotterdam, The Netherlands.
Fat, known medically as adipose tissue, is one of the body´s
richest known sources of regenerative cells. Adipose-derived
regenerative cells include adult stem cells in addition to other
important cell types that have been shown to increase blood flow in
and around damaged and oxygen deprived tissues. As a result, these
cells hold exciting potential to revolutionize the treatment of heart
disease, which affects millions of patients worldwide each year.
"Time is of the essence in the treatment of patients with heart
attacks," said Prof. PW. Serruys, M.D., Ph.D., principal investigator
for the trial and Head of the Department of Interventional Cardiology
at the Thoraxcenter, Erasmus Medical Center. "The Celution(TM) System
makes adipose-derived regenerative cells available in real-time and
enables early treatment. For this reason, adipose-derived regenerative
cells processed by the Celution(TM) System could play a critical role
in limiting or reversing heart damage caused by a heart attack."
"A major challenge in cardiovascular cell therapy is having a
meaningful number of stem and regenerative cells," said Francisco J.
Fernandez-Aviles, Chief of Department of Cardiology at Hospital
Universitario Gregorio Maranon and an investigator for this APOLLO
trial. "To date, we have treated a number of patients with chronic
ischemia in Cytori´s PRECISE trial, and we are pleased that the
Celution(TM) device has enabled us to administer a meaningful dose of
their own cells in real-time."
The APOLLO trial is a 48-patient, randomized, placebo-controlled,
dose escalation, safety and feasibility multi-center study. A dose of
adipose-derived regenerative cells, or a placebo, will be delivered
through an intracoronary catheter within 36 hours following the onset
of a heart attack. The trial will involve four groups of 12 patients
each. In each group, nine patients will receive cells and three will
receive the placebo control. Cytori is the sole sponsor of the APOLLO
clinical trial.
"The Celution(TM) System is unique in its ability to potentially
address acute and chronic heart conditions using a patient´s own
cells," said Alex Milstein, M.D., Vice President, Clinical
Development, Cytori Therapeutics. "Cytori´s comprehensive clinical
development program for the Celution system addresses chronic ischemic
heart disease as well as in acute heart attack. The initiation of the
APOLLO trial is an important milestone that has a potential of
bringing innovative treatment options for patients with acute heart
attack."
Cytori Therapeutics
Cytori Therapeutics´ (NASDAQ:CYTX) goal is to be the global leader
in regenerative medicine. The company is dedicated to providing
patients with new options for reconstructive surgery, developing
treatments for cardiovascular disease, and banking patients´ adult
stem and regenerative cells. To reach its goal, Cytori is developing
its innovative Celution(TM) System to separate and concentrate a
patient´s own adult stem and regenerative cells from adipose (fat)
tissue for these cells to be delivered back to the patient during the
same surgical procedure. In 2008, the Celution(TM) System is being
introduced in Europe into the reconstructive surgery market and
launched in Japan for cryopreserving a patient´s own stem and
regenerative cells. Clinical trials are ongoing or planned in
cardiovascular disease, spinal disc degeneration, gastrointestinal
disorders, and other unmet medical needs. www.cytoritx.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding
events, trends and prospects of our business, which may affect our
future operating results and financial position. Such statements are
subject to risks and uncertainties that could cause our actual results
and financial position to differ materially. Some of these risks and
uncertainties include our history of operating losses, the need for
further financing, regulatory uncertainties, dependence on performance
of third parties, and other risks and uncertainties described (under
the heading "Risk Factors") in Cytori Therapeutics´ Form 10-K annual
report for the year ended December 31, 2006. We assume no
responsibility to update or revise any forward-looking statements to
reflect events, trends or circumstances after the date they are made.
