May 16, 2007 -- Cardium
Therapeutics (OTCBB:CDTP) announced the start of patient recruitment
for its Phase
3 clinical trial (AWARE) to evaluate the therapeutic effects of
Cardium's lead product candidate, Generx™ (alferminogene tadenovec,
Ad5FGF-4), in women for the potential treatment of myocardial
ischemia. Myocardial ischemia, insufficient blood flow within the
heart muscle, gives rise to angina associated with coronary heart
disease. Generx represents a new therapeutic class of biologics
designed to promote angiogenesis, a natural process of blood vessel
growth within the heart muscle, following a one-time intracoronary
administration from a standard cardiac infusion catheter.
The randomized, placebo-controlled, double-blind trial, which
is called AWARE (Angiogenesis in Women with Angina pectoris who
are not
candidates for Revascularization), is expected to enroll approximately
300 women with recurrent stable angina pectoris who are not candidates
for revascularization and who are receiving optimal drug therapy. The
primary endpoint is the improvement in time to onset of
electrocardiogram changes diagnostic of myocardial ischemia during
exercise treadmill testing at six months following administration. The
secondary endpoints are improvement in myocardial blood flow within
the affected heart muscle measured by adenosine SPECT (single photon
emission computed tomography) imaging, as well as improvements in
other measures of angina. The AWARE study is expected to include up to
50 U.S. clinical centers. Enrollment criteria, participating sites and
other information about the AWARE trial can be found here.
Cardium's therapeutic approach to the treatment of myocardial
ischemia associated with coronary heart disease has been the focus of
the most widely-conducted clinical studies for Angiogenic Gene Therapy
(AGENT-1 through AGENT-4), which to date have involved 663 patients at
more than one hundred U.S., European and other international medical
centers. Generx represents the first and only DNA-based cardiovascular
therapeutic to be advanced to Phase 3, and the Company believes it to
be the only current Phase 3 product candidate for the potential
treatment of patients with stable angina, a chronic medical condition
affecting millions of patients in the U.S. and worldwide.
"Our just-initiated AWARE trial is an important and timely
clinical study and represents a major milestone for Cardium. There is
a growing awareness that cardiovascular disease in men and women may
be somewhat different and while men have long been a focus with
respect to heart disease, it is well-documented that women have been
largely under-represented in cardiovascular clinical trials despite
the fact that heart disease is now the leading cause of death among
adult women in both the U.S. and Europe," stated Christopher J.
Reinhard, Cardium's Chairman and Chief Executive Officer. "We are
enthusiastic about our lead product candidate, Generx, which was
previously shown to be associated with substantial improvement in
myocardial blood flow, of a magnitude similar to that reported in the
literature for patients following bypass surgery or angioplasty."
About Women and Heart Disease
An estimated 7.4 million American women are
currently living with coronary heart disease and more than 4.6 million women
suffer from
angina. The American Heart Association reports that more women's lives
are claimed annually by cardiovascular disease than by the next five
leading causes of death combined (all cancers, chronic obstructive
pulmonary disease (COPD), Alzheimer's, diabetes and accidents).
Despite these stark statistics, surveys indicate that nearly half of
women are not aware that heart disease is the leading cause of death
among women, and only 20 percent identified heart disease as the
greatest health problem facing women today. Observed differences
between men and women with coronary heart disease are not fully
understood. Some researchers believe the differences may be the result
of microvascular disease, the narrowing or stiffening of the smaller
arteries and arterioles that nourish the heart. While microvascular
disease is believed to affect both men and women with coronary heart
disease, the prevalence is apparently somewhat higher in women and in
patients with diabetes.
About Generx
Generx™ (alferminogene tadenovec, Ad5FGF-4) is the lead product
candidate in a new class of cardiovascular biologics that is being
developed to leverage the body's natural healing processes in response
to repeated ischemic stress (insufficient blood flow and myocardial
oxygen supply due to coronary heart disease). The natural biologic
response to repeated transient ischemia is angiogenesis, the growth of
new collateral blood vessels, which is orchestrated by a complex and
incompletely understood cascade involving many myocardial-derived
growth factors. These newly-formed vessels can effectively augment
blood flow and oxygen delivery to parts of the patient's heart
downstream from a blockage in a coronary artery. In many patients
however, including those with recurrent angina, coronary collateral
vessel formation is insufficient to meet the heart's needs during
stress. Currently available anti-anginal drugs, which may provide
symptomatic relief, are generally designed to alter the oxygen demand
of the heart muscle or dilate vessels to temporarily relieve angina.
Generx is an angiogenic therapeutic that is designed to promote the
heart's natural response of collateral growth and to increase blood
flow in the microcirculation.
About Cardium
Cardium Therapeutics, Inc. and its subsidiaries, InnerCool
Therapies, Inc. and the Tissue Repair Company, are medical technology
companies primarily focused on the development, manufacture and sale
of innovative therapeutic products and devices for cardiovascular,
ischemic and related indications. Cardium's lead product candidate,
Generx (alferminogene tadenovec, Ad5FGF-4), is a DNA-based growth
factor therapeutic being developed for potential use by interventional
cardiologists as a one-time treatment to promote and stimulate the
growth of collateral circulation in the hearts of patients with
ischemic conditions such as recurrent angina. For more information
about Cardium Therapeutics and its businesses, products and
therapeutic candidates, please visit www.cardiumthx.com or view its
recent 2006 Annual Report at
www.cardiumthx.com/flash/pdf/2006CardiumAnnualReport.pdf.
Cardium's InnerCool Therapies subsidiary is a San Diego-based
medical technology company in the emerging field of temperature
modulation therapy to rapidly and controllably cool the body in order
to reduce cell death and damage following acute ischemic events such
as cardiac arrest or stroke, and to potentially lessen or prevent
associated injuries such as adverse neurological outcomes. For more
information about Cardium's InnerCool subsidiary and therapeutic
hypothermia, including InnerCool's Celsius Control System™, which
has received regulatory clearance in the U.S., Europe and Australia,
please visit www.innercool.com.
Cardium's Tissue Repair Company subsidiary (TRC) is a San
Diego-based biopharmaceutical company focused on the development of
growth factor therapeutics for the treatment of severe chronic
diabetic wounds. TRC's lead product candidate, Excellarate, is a
DNA-activated collagen gel for topical treatment formulated with an
adenovector delivery carrier encoding human platelet-derived growth
factor-BB (PDGF-BB). Excellarate is initially being developed to be
administered once or twice for the potential treatment of non-healing
diabetic foot ulcers. Other potential applications for TRC's Gene
Activated Matrix™ (GAM) technology include therapeutic angiogenesis
(cardiovascular ischemia, peripheral arterial disease) and orthopedic
products, including hard tissue (bone) and soft tissue (ligament,
tendon, cartilage) repair. For more information about Cardium's Tissue
Repair Company subsidiary, please visit www.t-r-co.com.
Forward-Looking Statements
Except for statements of historical fact, the
matters discussed in
this press release are forward looking and reflect numerous
assumptions and involve a variety of risks and uncertainties, many of
which are beyond our control and may cause actual results to differ
materially from stated expectations. For example, there can be no
assurance that results or trends observed in one clinical study will
be reproduced in subsequent studies, that our clinical trials can be
initiated and conducted in a timely and effective manner, that
clinical trials and other efforts to accelerate the development of our
Generx™ product candidate will be successful, that necessary
regulatory approvals will be obtained, that our actual or proposed
products and treatments will prove to be sufficiently safe and
effective, that competing products will not be safer, more effective
or less expensive, that third parties on whom we depend will perform
as anticipated, or that our products or product candidates will lead
to value enhancing or partnering opportunities. Actual results may
also differ substantially from those described in or contemplated by
this press release due to risks and uncertainties that exist in our
operations and business environment, including, without limitation,
our limited experience in the development, testing and marketing of
therapeutic product candidates, risks and uncertainties that are
inherent in the conduct of human clinical trials, including the cost,
timing and results of such trials, our dependence upon proprietary
technology, our history of operating losses and accumulated deficits,
our reliance on collaborative relationships and critical personnel,
and current and future competition, as well as other risks described
from time to time in filings we make with the Securities and Exchange
Commission. We undertake no obligation to release publicly the results
of any revisions to these forward-looking statements to reflect events
or circumstances arising after the date hereof.
Cardium Therapeutics™ and Generx™ are trademarks of Cardium
Therapeutics, Inc.
Gene Activated Matrix™ and GAM™ are trademarks of Tissue
Repair Company.
InnerCool Therapies®, InnerCool®, Celsius Control System™
and Accutrol™ are trademarks of InnerCool Therapies, Inc.