FAIRFIELD, Conn., March 25, 2014 /PRNewswire/ -- The results
of a recently published, single-arm clinical study in the
Journal of Pain and Palliative Care Pharmacotherapy,
(December 2013) demonstrated how a
cohort of 39 chronic, chemotherapy- induced peripheral neuropathy
(CIPN) patients experienced an average pain score reduction of
31.8% in their level of chronic pain undergoing Calmare®
Pain Device therapy – Competitive Technologies, Inc.,
(OTCQX: CTTC) (CTI) flagship medical product.
Chemotherapy-induced peripheral neuropathy (CIPN) is damage done
to the peripheral nervous system. Typical symptoms include
numbness, tingling, or burning sensations that often begin in the
fingertips or toes, and often progresses. Patients may notice
things that were previously not painful, now cause pain, such as
touching hot or cold items, and develop various degrees of
weaknesses throughout their bodies. Several chemotherapeutics may
cause immediate reaction after the first dose while others have a
delayed onset of symptoms. From a pain score perspective, the U.S
Food & Drug Administration (FDA), requires a minimum
quality-of-life improvement of 20% in order to attain medical
device approval.
"The study's results are consistent with the typical Calmare
treatment protocol," commented Patrick J.
Coyne, MSN, ACHPN, ACNS-BC, FAAN, Clinical Director, Pain
and Palliative Care at the Thomas Palliative Care Services at
Virginia Commonwealth University.
"While the study was a single arm study, the results were
statistically significant and draws attention to the fact that
Calmare therapy may provide significant chronic pain relief and
marked improvement in a cancer patient's quality of life."
According to Competitive Technologies CEO Conrad Mir, "The pain relief obtained in this
study supports our effort to further develop and fully understand
the technology surrounding Calmare therapy. We are committed to
Calmare and its potential for addressing pain."
About the Study
Title: "A Trial of Scrambler Therapy in the Treatment of
Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral
Neuropathy.
Premise: Chronic chemotherapeutic-derived pain condition may be
treated with the Calmare® Pain Therapy Device, a
non-narcotic, non-invasive medical procedure for the treatment of
chronic pain. The study used Calmare, which is a patient-specific
electrocutaneous nerve stimulation device (Calmare MC5A device), to
treat 39 cancer patients with pain. The cohort was comprised of 16
men and 23 women with a mean age 56.5 years of age were
treated over an 18-month period for an average of 9.3 days
each.
Treatment: Patients in the single-arm trial received Calmare
therapy for 10 sessions (one daily) over a two-week period. The
primary outcome was a significant change in pain numerical rating
scale (NRS) at one month; secondary outcomes were changes in the
Brief Pain Inventory and European Organization for Treatment and
Cancer QLC-CIPN-20 (EORTC CIPN-20), over time.
Results: The study gauged the "now" pain scores which were
reduced from 6.6 before treatment to 4.5 or a 31.8% reduction at
14 days, 4.6, 4.8, and 4.6 at 1, 2, and 3 months, respectively
( p < 0.001). Clinically important and statistically
significant improvements were seen in average, least, and worst
pain; BPI interference with life scores; and motor and sensory
scales on the EORTC CIPN-20. No adverse effects were observed.
Conclusion: "Calmare therapy appeared to relieve
cancer-associated chronic neuropathic pain both acutely and
chronically, and provided sustained improvements in many indicators
of quality of life."
Authors: Patrick J. Coyne,
MSN, ACHPN, ACNS-BC, FAAN, Clinical Director, Pain and Palliative
Care, Thomas Palliative Care Services, Virginia Commonwealth University, Massey Cancer
Center, Richmond, VA, USA.,
Wen Wan, PhD – assistant professor
of the Department of Biostatistics at Virginia
Commonwealth University, Richmond,
VA, USA; Patricia Wagner Dodson, RN, MA – Research Nurse at
the Massey Cancer Center, Virginia
Commonwealth University, Richmond,
VA, USA; Craig Swainey, MD –
assistant professor of Hematology Oncology and Palliative Care at
the Virginia Commonwealth University,
Massey Cancer Center, and Richmond,
VA, USA; and Thomas J. Smith,
MD, FACP, FASCO, FAAHPM – director of Palliative Care for Johns
Hopkins Medical Institutions, Baltimore,
MD, USA.
About the Company
Competitive Technologies Inc., the
pain mitigation company, develops and commercializes innovative
pain management products and technologies. CTI is the licensed
distributor of the non-invasive, Calmare® pain therapy
medical device, which incorporates a novel biophysical approach
developed to treat neuropathic and cancer-derived pain.
Forward-Looking Statements
Certain statements
contained in this press release are forward-looking statements that
involve risks and uncertainties. The statements contained herein
that are not purely historical are forward looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements deal with the Company's current
plans, intentions, beliefs and expectations and statements of
future economic performance. Forward-looking statements
involve known and unknown risks and uncertainties that may cause
the Company's actual results in future periods to differ materially
from what is currently anticipated. Factors that could cause or
contribute to such differences include those discussed from time to
time in reports filed by the Company with the Securities and
Exchange Commission. The Company cannot guarantee its future
results, levels of activity, performance or achievements.
Contacts:
|
Competitive
Technologies,
Inc.
|
|
|
JV Public
Relations
|
Conrad
Mir
|
|
|
Janet
Vasquez
|
President and
CEO
|
|
|
Managing
Director
|
cmir@competitivetech.net
|
|
|
jvasquez@jvprny.com
|
973.798.8882
|
|
|
212.645.5498
|
Scrambler Therapy®:
www.scramblertherapy.org/english.htm
Calmare®: www.calmarett.com
Visit us: www.competitivetech.net | Follow us:
Facebook.com
Logo -
http://photos.prnewswire.com/prnh/20131015/NY97852LOGO
SOURCE Competitive Technologies, Inc.