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Angiogenesis Therapy
for Heart Disease Given Fast Track Designation by FDA
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July 25, 2007 -- San Diego, CA --
Cardium Therapeutics announced that the U.S. Food and Drug Administration
(FDA) has granted fast track designation to the Company's lead
product candidate,
Generx™ (alferminogene tadenovec, Ad5FGF-4) 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 fast track program is designed to facilitate the development and expedite
the review of new drug and biologic products that are intended
to treat serious or life-threatening conditions and that demonstrate
the potential to address unmet medical needs. Fast track designation
allows a company to submit portions of a biologic license application
(BLA) on a rolling basis, allowing the FDA to review sections of
the BLA prior to receiving the complete application. In addition,
fast track designation ordinarily allows the opportunity for increased
interactions with the FDA and the potential for priority review.
"We are pleased that the FDA has recognized the urgent and unmet medical need
for effective new therapies for the treatment of patients with recurrent angina
associated with heart disease," stated Christopher J. Reinhard, Chairman and
Chief Executive Officer of Cardium. "This represents a significant regulatory
milestone in the development of Generx, and further underscores its potential
to promote a disease-modifying improvement based on therapeutic angiogenesis
in patients with coronary heart disease."
The granting of fast track designation by the FDA follows the conclusion of four
clinical studies of Generx, which to date have involved more than 650 patients
with coronary heart disease. The Company recently initiated the Phase 3 AWARE
clinical study (Angiogenesis in Women with Angina pectoris who are not candidates
for Revascularization). The randomized, placebo-controlled, double-blind AWARE
trial 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. The secondary endpoints are improvement in myocardial blood flow
within the affected heart muscle measured by adenosine SPECT imaging (single
photon emission computed tomography), 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.
About Women and Heart Disease
An estimated 7.2 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 combined,
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 therapeutic 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. 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 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.
Source: Cardium Therapeutics,
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