ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
FDA Grants Fast Track Designation To Cardium's Phase 3 Angiogenic Gene Therapy For Heart Disease
Cardium Therapeutics (OTCBB:CDTP)
announced that the U.S. Food and Drug Administration (FDA) has granted
fast track designation to the Company's lead product candidate,
Generx(TM) (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(TM) (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 http://www.cardiumthx.com or view its
recent 2006 Annual Report
here.
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(TM), which
has received regulatory clearance in the U.S., Europe and Australia,
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(TM) (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
conducted in a timely and effective manner, that clinical trials and
other efforts to accelerate the development of our Generx(TM) 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.
http://www.cardiumthx.com
FDA Granturi Urmãrire rapidã de a Cardium Desemnarea lui Gene de fazã 3 Angiogenic terapie pentru boalã de inimã - FDA Grants Fast Track Designation To Cardium's Phase 3 Angiogenic Gene Therapy For Heart Disease - articole medicale engleza - startsanatate