Cardium Launches New AWARE Clinical Study Website
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June 11, 2008, San Diego --
Cardium Therapeutics (Amex: CXM) today announced the launch
of a new website at http://www.anginaresearchstudy.com to provide
patients, caregivers and physicians with information about
the Company's Phase 3 AWARE clinical study.
The AWARE study is evaluating the therapeutic
effects of Generx™ for the potential treatment of myocardial
ischemia (insufficient blood flow within the heart muscle)
and associated angina due to coronary heart disease. Generx
is designed to promote angiogenesis, a natural process of
blood vessel growth within the heart muscle, following a one-time
intracoronary infusion from a standard cardiac infusion catheter.
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The AWARE (Angiogenesis
in Women with Angina pectoris who are not candidates for
Revascularization) study, a Phase 3 randomized, placebo-controlled,
double-blind trial, is planned 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 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 can be found at http://www.clinicaltrials.gov/ct/show/NCT00438867
and at Cardium's website at http://www.cardiumthx.com/flash/aware.html.
Currently, there are 49 participating AWARE sites in 32 states across the nation,
including: Alabama (University of Alabama, Birmingham); Arizona (Banner Baywood
Heart Hospital and Medical Center, Mesa; Southwest Heart, Tucson); California
(Cardiovascular Medical Group of Southern CA, Beverly Hills; Cedars-Sinai Medical
Center, Los Angeles; LA Cardiology Associates, Los Angeles; Mission Internal
Medical Group, Mission Viejo; UCSD Medical Center, San Diego); Colorado (Aurora
Denver Cardiology Associates, Aurora; South Denver Cardiology Associates, Littleton);
District of Columbia (Cardiovascular Research Institute, Washington); Florida
(Florida Hospital, Orlando; University of Florida, Gainesville); Georgia (St.
Joseph's Research Institute, Atlanta); Idaho (St. Luke's Idaho Cardiology Associates,
Boise); Illinois (Fox Valley Cardiovascular Consultants, Aurora; Midwest Heart
Foundation, Lombard); Indiana (Northern Indiana Research Alliance, Fort Wayne;
The Care Group, LLC, Indianapolis); Kentucky (CardioVascular Associates, Louisville);
Massachusetts (Massachusetts General Hospital, Boston); Maine (Maine Medical
Center, Portland); Michigan (William Beaumont Hospital, Royal Oak); Minnesota
(Minneapolis Heart Institute, Minneapolis; St. Mary's Duluth Clinic, Duluth);
Missouri (St. Anthony's Medical Center, St. Louis; St. Lukes Hospital, Kansas
City); Nebraska (BryanLGH Heart Institute, Lincoln; The Cardiac Center of Creighton
University, Omaha); New Jersey (The Valley Hospital, Ridgewood); New York (Lenox
Hill Heart & Vascular Institute, New York; University of Rochester Medical Center, Rochester); North Carolina (Duke University Medical Center, Durham); Ohio (The Lindner Clinical Trial Center, Cincinnati; North Ohio Heart Center, Elria); Oklahoma (Oklahoma Cardiovascular Research Group, Inc., Oklahoma City); Oregon (Providence Heart & Vascular
Institute, Portland); Pennsylvania (Geisinger Clinic, Danville; Heritage Cardiology
Associates, Camp Hill); Rhode Island (The Miriam Hospital, Providence); Tennessee
(Meharry Medical College, Nashville; The Stern Cardiovascular Center, Germantown);
Texas (Baylor University Medical Center, Dallas; Baylor College of Medicine,
Houston; Cardiovascular Associates of East Texas, Tyler; South Texas Cardiovascular
Consultants, San Antonio); Vermont (Fletcher Allen Health Care, Burlington);
Washington (Swedish Heart and Vascular Clinic, Seattle); and Wisconsin (Care
Foundation, Wausau).
About Women and Heart Disease
An estimated 7.3 million American women are currently living with coronary heart
disease. Of these, approximately 4.6 million American women suffer from angina
and it is estimated that approximately 300,000 women will die annually from coronary
heart disease. 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 were aware that 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 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 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 designed to be a disease-modifying angiogenic therapeutic
to promote the heart's natural response to ischemia through the growth of new
blood vessels to increase blood flow within the heart muscle.
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 involved
663 patients at more than 100 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.
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 and its businesses, products
and therapeutic candidates, please visit http://www.cardiumthx.com or
view its
2007
Annual Report.
Cardium's InnerCool Therapies subsidiary is a San Diego-based medical technology
company in the emerging field of patient 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 patient temperature modulation,
including InnerCool's Celsius Control System™ and CoolBlue System™, please
visit http://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 http://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,
risks and uncertainties that are inherent in the development, testing and marketing
of complex biologics and therapeutic hypothermia devices and in the conduct of
human clinical trials, including the cost, timing and results of such trials,
our dependence upon proprietary technology, our ability to obtain necessary funding,
regulatory approvals and qualifications, 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.
Tissue Repair ™, Gene Activated Matrix™, GAM™ and Excellarate™
are
trademarks of Tissue Repair Company.
InnerCool Therapies®, InnerCool®,
Celsius Control system, CoolBlue™ and RapidBlue™ and Accutrol™
are trademarks of InnerCool Therapies, Inc.
Source: Cardium Therapeutics, Inc. |