WEILL CORNELL Medical College opens FDA Approved Clinical Trial to test treatment for chemotherapy-related hair loss
| Source:Dignitana AB
DigniCap® Scalp Cooling System Now Available at Leading U.S. Medical Centers
NEW YORK – AUGUST 23, 2013 — Dignitana, a world leader in medical scalp-cooling
technology, announced today that Weill Cornell Medical College in New York will
be part of its multi-center pivotal trial of the patented DigniCap® System for
the prevention of chemotherapy-related hair loss. The trial, which was recently
approved by the FDA, is part of the second and final phase of study in the
United States and paves the way for FDA market approval of the scalp-cooling
device, which is already widely used overseas.
Weill Cornell joins other prestigious medical centers initiating the trial,
including University of California San Francisco and Wake Forest Baptist Medical
Center. The study will be conducted with 110 patients. Additional sites in New
York and California will be announced in the near future.
"Our partnership with Weill Cornell is a testament to the eagerness of leading
medical professionals to provide their patients with an alternative to
potentially devastating hair loss associated with treatment,” said Martin
Waleij, Chief Executive Officer for Dignitana “Clinical evaluation by such
trusted medical centers is a primary reason that the DigniCap® System is fast
becoming the preferred treatment option for cancer patients throughout the
world. We are excited to get the study underway at Weill Cornell.”
To participate in the trial, patients must be at least 18 years old and have a
documented diagnosis of Stage I or Stage II breast cancer, and must plan to
complete chemotherapy within six months of using standard chemotherapy regimens
stipulated in the trial protocol.
“Going through a cancer diagnosis is painful enough without dealing with the
emotional trauma and stress of losing your hair to chemotherapy. Some women even
avoid recommended therapies because of the risk of losing their hair,” said Dr.
Anne Moore, medical director of the Weill Cornell Breast Center and principal
investigator for the Center’s trial. “This clinical study could help lead us to
remove that barrier and make patients more relaxed and open to the best possible
course of cancer treatment.”
UCSF and Wake Forest previously conducted a pilot study using the DigniCap®
System in 20 women with early stage breast cancer. The treatment was successful
in the majority of women and well tolerated, laying the groundwork for this
pivotal and larger trial.
The state-of-the-art DigniCap® System being tested in this study features a
tight-fitting silicone cap that is placed directly on the head, and an outer
neoprene cap that insulates and secures the inner one. Both are connected to a
cooling and control unit with touch screen controls. A patented coolant
circulates throughout the inner silicone layer, and the cap is designed to
deliver consistent cooling to all areas of the scalp. DigniCap is the only
system to offer scalp-cooling above freezing with patented, built-in temperature
sensors and a precision cooling mechanism that allows for gradual and highly
tolerable scalp temperature fluctuations.
When a cap is applied to the head, the temperature of the scalp is lowered and
blood vessels surrounding the hair roots contract, resulting in a significant
reduction of cytotoxins to the follicle. Reduced blood flow leaves a smaller
amount of chemotherapy available for uptake in the cells and the decreased
temperature results in less absorption of and reduced effects from chemotherapy.
These factors together reduce the risk of hair loss.
Clinical trials done in Europe and Asia show eight out of 10 women who used the
DigniCap® System during chemotherapy retained their hair. Additional trials at
leading medical centers around the world have proven the system to be a viable
alternative for both women and men of diverse ethnicities.
“The DigniCap® System has been extremely well received in clinical trials at
leading medical centers around the world,” Waleij says. “We are pleased to be
able to work now with the U.S. regulatory system and these prestigious medical
centers to provide this highly tolerable, safe and effective therapy for cancer
patients in the United States.”
Historically, cooling systems and cold caps have not been used in the United
States because of concerns that the scalp cooling could allow cancer cells to
hide in the scalp. Hope S. Rugo, principal investigator for the study in San
Francisco and Director of Breast Oncology and Clinical Trials
Education at the UCSF Helen Diller Family Comprehensive Cancer Center, reports
that “the incidence of scalp metastases in breast cancer is extremely low and in
a large review of published data on scalp cooling systems, scalp metastases were
not increased. We are carefully following patients using these systems in
several clinical trials.”
For more information about participating in one of The DigniCap® System clinical
trials, please visit www.Dignitana.com.
About Weill Cornell Medical College
Weill Cornell Medical College, Cornell University's medical school located in
New York City, is committed to excellence in research, teaching, patient care
and the advancement of the art and science of medicine, locally, nationally and
globally. Physicians and scientists of Weill Cornell Medical College are engaged
in cutting-edge research from bench to bedside, aimed at unlocking mysteries of
the human body in health and sickness and toward developing new treatments and
prevention strategies. In its commitment to global health and education, Weill
Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil,
Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar,
the Medical College is the first in the U.S. to offer its M.D. degree overseas.
Weill Cornell is the birthplace of many medical advances — including the
development of the Pap test for cervical cancer, the synthesis of penicillin,
the first successful embryo-biopsy pregnancy and birth in the U.S., the first
clinical trial of gene therapy for Parkinson's disease, and most recently, the
world's first successful use of deep brain stimulation to treat a minimally
conscious brain-injured patient. Weill Cornell Medical College is affiliated
with NewYork-Presbyterian Hospital, where its faculty provides comprehensive
patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The
Medical College is also affiliated with the Methodist Hospital in Houston. For
more information, visit weill.cornell.edu.
Dignitana AB (publ) is a Swedish medical device company listed on the OMX NASDAQ
First North Stockholm is a world leader in technologies within the area of
medical cooling. For more information about Dignitana and the DigniCap® System,
please visit http://www.dignitana.com.
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