Quell® Demonstrates Encouraging Clinical Trial Results in Chemotherapy Induced Peripheral Neuropathy (CIPN)
31 Mai 2023 - 3:00PM
NeuroMetrix, Inc. (Nasdaq: NURO) noted publication of an abstract
describing partial results from a NIH-funded, multi-site randomized
controlled trial of Quell titled "Wireless transcutaneous electric
nerve stimulation (TENS) for chemotherapy-induced peripheral
neuropathy (CIPN): A proof-of-concept, placebo-controlled,
randomized clinical trial (RCT)." The abstract will be published at
the 2023 American Society of Clinical Oncology (ASCO) annual
meeting to take place June 2-6 in Chicago, IL. The principal
investigator is Dr. Jennifer Gewandter of the University of
Rochester School of Medicine and Dentistry. The trial leveraged the
National Cancer Institute (NCI) Community Oncology Research Program
(NCORP).
The study was a phase II, multi-site, double
blinded, randomized, sham-controlled trial. A total of 142 subjects
with CIPN were randomized to an active or sham Quell device for
6-weeks. Subjects in both arms were instructed to wear their device
for 5 hours each day. As reported in the abstract, patients with
moderate to severe CIPN symptoms of hot/burning pain,
sharp/shooting pain or muscle cramping experienced about a 50%
reduction in symptoms for active treatment compared to about 30%
for sham treatment. The study authors concluded "A RCT of an
app-controlled, wireless TENS device for chronic CIPN with
excellent adherence and retention rates is feasible in NCORP.
Preliminary efficacy evidence suggests that TENS [Quell] is
promising for pain and cramping from CIPN ... A confirmatory RCT of
TENS for painful CIPN is highly warranted." The abstract is
available at link and the study details are available at
NCT04367480.
"These efficacy results from a sham-controlled
RCT of Quell in CIPN are exciting and consistent with an earlier
published open-label study. CIPN is very difficult to manage, with
no FDA approved treatments. As evidenced by its designation from
the FDA as a breakthrough device for chronic CIPN, Quell offers the
potential for a safe and effective treatment that can be
administered at home," said Shai N. Gozani, M.D., Ph.D., President
and CEO of NeuroMetrix. "We look forward to obtaining further
details on the trial results over the coming months and will
correspondingly finalize our regulatory strategy, potentially to
include a near term regulatory submission for a Quell CIPN
indication. We are also enthusiastic about continuing to support
Dr. Gewandter and her colleagues at NCORP as they pursue a
confirmatory trial that further investigates the clinical benefits
of Quell in CIPN."
The use of Quell for chemotherapy
induced peripheral neuropathy is investigational and has not been
cleared or approved by the FDA. The safety and effectiveness for
this purpose have not been reviewed by the FDA.
About Chemotherapy Induced Peripheral
Neuropathy
About 650,000 cancer patients receive
chemotherapy annually in the United States. CIPN is a disabling
complication that occurs in many patients treated with common
chemotherapeutic drugs such as vincristine, paclitaxel and
cisplatin. A recently published systematic analysis reported that
CIPN prevalence was 68% the first month after chemotherapy and 30%
six-months after chemotherapy. CIPN symptoms include
burning/shooting pain, tingling, cramping, and numbness in the
hands and feet. CIPN is also associated with impaired balance,
walking, and sleep, decreased quality of life, and increased risk
of falls. CIPN is difficult to treat with few treatment options,
and those that are used have limited effectiveness and may cause
serious side effects.
About Quell Technology
Quell is an advanced, non-invasive,
neuromodulation technology that is covered by 26 issued or granted
U.S. utility patents. It is the only wearable neuromodulator that
is enabled by a proprietary microchip to provide precise,
high-power nerve stimulation in a form factor the size of a credit
card. Quell utilizes position and motion sensing to automatically
adjust stimulation for an optimal user experience both day and
night. The device supports Bluetooth® low energy (BLE) to
communicate with mobile apps for multiple smartphone platforms.
Quell is currently indicated to reduce fibromyalgia symptoms in
patients with high pain sensitivity and to reduce lower extremity
chronic pain.
About NeuroMetrix
NeuroMetrix is an innovation-driven company with
a mission to improve individual and population health through novel
medical devices and technology solutions for neurological disorders
and pain syndromes. The Company has three commercial products.
Quell® is a prescription wearable neuromodulator that is the only
FDA-authorized medical device to help reduce the symptoms of
fibromyalgia. DPNCheck® is a diagnostic device that provides rapid,
point-of-care detection of peripheral neuropathies. ADVANCE® is a
legacy diagnostic device that provides automated, in-office nerve
conduction studies for the evaluation of focal neuropathies. For
more information, visit www.neurometrix.com.
Source: NeuroMetrix, Inc.
Thomas T. HigginsSVP and Chief Financial
Officerneurometrix.ir@neurometrix.com
NeuroMetrix (NASDAQ:NURO)
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