SAN DIEGO, Nov. 11 /PRNewswire-FirstCall/ -- Cardium Therapeutics
(Amex: CXM) and its operating unit InnerCool Therapies, Inc., today announced
that it has developed a pelvic cooling catheter system called UroCool(TM),
which is designed to induce localized cooling during surgery for prostate
cancer (radical prostatectomy). The new technology is being applied in
collaboration with renowned prostate surgeon, Thomas E. Ahlering, M.D.,
Professor and Vice Chair of the Department of Urology at the University of
California, Irvine and is the subject of an exclusive licensing agreement with
the University of California. A regulatory application for FDA 510(k)
clearance of InnerCool's UroCool(TM) catheter is expected to be submitted in
the first quarter of 2009.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
Dr. Ahlering and his colleague Dr. David S. Finley are conducting clinical
studies designed to demonstrate safety and confirm the potential benefits of
localized cooling during robotic-assisted prostatectomy, which is now the most
common surgical technique for prostate cancer. The UroCool(TM) catheter is
designed to be placed within the rectal cavity adjacent to the prostate during
surgery. UroCool is used in conjunction with InnerCool's Celsius Control
Console which circulates cold saline in a closed loop within the catheter to
allow for localized cooling. Drs. Ahlering and Finley believe that
therapeutic cooling during prostate surgery (which includes both traditional
open surgical approaches and the newer robotic-assisted technique) can reduce
tissue damage and inflammation and thereby provide a faster return of bladder
control (continence) and possibly erectile function (potency). From a
practical viewpoint, they liken this concept to icing a severely sprained
ankle in order to minimize tissue injury and shorten the recovery process.
InnerCool's UroCool(TM) catheter is being incorporated into ongoing
clinical studies at the University of California, Irvine, which are designed
to provide additional information regarding the safety and usefulness of
cooling during robotic-assisted prostate surgery. Dr. Ahlering, who is
conducting the clinical studies, is an expert in the field of prostate
surgery, particularly in the rapidly expanding use of robotic-assisted
prostatectomy systems such as the da Vinci(R) system, which is a product of
Intuitive Surgical, Inc.
"Our findings using localized cooling techniques during robotic-assisted
radical prostatectomy surgery indicate that cooling resulted in a
statistically significant faster recovery of urinary continence following
surgery," noted Dr. Ahlering. "In addition, based on my surgical experience
with therapeutic cooling, I believe that our ongoing studies may offer the
potential to demonstrate improved post-operative erectile function for
patients as well." Drs. Ahlering and Finley's clinical data on hypothermic
radical prostatectomy was recently presented with an award at the European
Robotic Urologic Symposium in Prague and their findings are now being
published as a Rapid Review in the medical journal Urology (in press). Their
data will also be presented at a number of U.S. and international urological
meetings over the remainder of 2008 and early 2009.
"InnerCool has now developed a specialized tissue-specific cooling
catheter that is being developed to work with InnerCool's current Celsius
Control Console which has been marketed and sold since 2003," stated
Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium
Therapeutics and InnerCool Therapies. "The new UroCool system may provide an
important opportunity to potentially enhance patient recovery of urinary
control and erectile function following prostate surgery. These side effects
of prostate surgery are serious, profound and frequent, and all too often
patients defer proper surgical treatment because of these quality-of-life
issues, underscoring the importance of new therapeutic approaches."
"We are continuing to develop a portfolio of uniquely positioned medical
devices employing our platform technology and expertise in the growing field
of temperature modulation therapy," added Reinhard. "These new products, like
UroCool, are being developed for specific and defined vertical market
opportunities for companies having established sales and marketing
organizations, and we plan to structure these vertical market opportunities
through strategic alignments, financings and other transactions in keeping
with our ongoing strategy to leverage and monetize Cardium's InnerCool
investment."
Prostate Cancer
According to the American Cancer Society, prostate cancer is the most
common cancer in American men other than skin cancers. One in six men will
develop prostate cancer in their lifetime, and in 2007 over 200,000 men were
newly diagnosed with the disease. Fortunately, prostate cancer grows
relatively slowly and 7 out of 10 men are diagnosed in the early stages of the
disease before it has spread to other parts of their body, thus leading to
significantly increased survival with proper treatment. While the underlying
cause for the development of prostate cancer is still unknown, factors such as
age, race, and lifestyle affect the probability of developing the disease. Of
these, age is the strongest risk factor, and as life spans continue to
increase, more men are surviving to an age at which prostate cancer is more
prevalent. The chances of developing prostate cancer increases quickly after
reaching age 50, and about 2 out of every 3 prostate cancers are found in men
over the age of 65. The three treatment approaches to prostate cancer are
'watchful waiting,' radiation, or surgery, depending on patient age, and how
advanced the disease is.
Radical Prostatectomy
Radical prostatectomy is an effective means of eradicating prostate cancer
by surgically removing the entire prostate and surrounding tissue. It is a
complex procedure because the prostate gland is located deep inside the pelvis
and is intimately associated with delicate nerves that control erections and
bladder control. Historically, radical prostatectomy has been performed as an
open procedure requiring surgical precision to preserve these important
functions. Robot-assisted laparoscopic radical prostatectomy emerged with the
introduction of systems such as the da Vinci(R) Surgical System (a product of
Intuitive Surgical, Inc.), which is minimally invasive and enables a high
degree of precision. Since 2000, over 900 of such systems have been installed
in hospitals worldwide, of which more than 700 are located in North America.
Estimates show that more than 90,000 radical prostatectomies were performed in
2007 in the United States. Currently it is estimated that more than 70% of
radical prostatectomies are performed robotically.
Post-Operative Incontinence and Erectile Dysfunction
Urinary incontinence and erectile dysfunction are very common side effects
following open or robotic radical prostatectomy. Temporary loss of bladder
control occurs in most men. While most eventually regain full control, this
can take up to a year. This extended lack of urinary control is the most
bothersome patient-reported side effect of prostate surgery. In addition to
incontinence, many men experience some degree of erectile dysfunction
following radical prostatectomy, depending on a number of factors including
how potent the patient was prior to surgery, patient age, tumor stage, and how
the neurovascular bundles were preserved during surgery. This side-effect is
a frustrating and inconvenient experience. In many cases, the recovery of
sexual function can take up to 24 months.
Additional Targeted Tissue Cooling
In addition to use in radical prostatectomies, targeted tissue cooling as
developed for the UroCool catheter has a number of potential future clinical
applications for tissue cooling in the pelvic region. These include other
urological procedures such as radical cystectomy, a common procedure used to
treat bladder cancer that has spread into the bladder wall. There are also a
number of gynecological and colorectal cooling opportunities, including
radical hysterectomy, myomectomy for removing fibroids from the uterus, and
various types of transvaginal surgery.
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 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 patient temperature modulation, including InnerCool's new
RapidBlue(TM) System, which just received FDA clearance, and its CoolBlue(TM)
System, please visit http://www.innercool.com.
Cardium also has two biologic candidates in clinical development.
Cardium's Tissue Repair Company subsidiary (TRC) is focused on the development
of growth factor therapeutics for the treatment of severe chronic diabetic
wounds. TRC's lead product candidate, Excellarate(TM), 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(TM) 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.
Cardium's Generx product candidate (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 2007 Annual Report at
http://www.cardiumthx.com/flash/pdf/CardiumAR07_Book_FINAL.pdf.
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 observed in one study or using
one type of product or procedure will be replicated in subsequent studies or
in studies using newly-developed products or procedures, that planned product
development efforts and clinical studies can be performed in an efficient and
effective manner, that regulatory approvals can be obtained in a timely manner
or at all, that partnering, distribution or other commercialization efforts
can be achieved and if so that they will effectively accelerate InnerCool's
patient temperature modulation business or market, that product modifications
or launches will be successful or that the resulting products will be
favorably received in the marketplace, that our products or proposed products
will prove to be sufficiently safe and effective, that our products or product
candidates will not be unfavorably compared to competitive products that may
be regarded as safer, more effective, easier to use or less expensive, that
results or trends observed in one clinical study will be reproduced in
subsequent studies, that third parties on whom we depend will behave as
anticipated, or that necessary regulatory approvals will be obtained. 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
therapeutic hypothermia devices and the conduct of human clinical trials,
including the timing, costs and outcomes of such trials, whether our efforts
to launch new devices and systems and expand our markets will be successful or
completed within the time frames contemplated, 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.
Copyright 2008 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics(TM) and Generx(TM) are trademarks of Cardium
Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM) and Excellarate(TM)
are trademarks of Tissue Repair Company.
InnerCool Therapies(R), InnerCool(R), Celsius Control System(R),
RapidBlue(TM), CoolBlue(TM). Accutrol(R), Temperature Control Element(R) and
TCE(R) and UroCool(TM) are trademarks of InnerCool Therapies, Inc.
(other trademarks belong to their respective owners)
