Pico-Tesla Starts Phase III Clinical Trial of Its Proprietary Magnetic (Magneceutical) Therapy for Parkinson`s Disease

Mon Oct 5, 2009 2:43pm EDT
 
[-] Text [+]
Randomized, double-blind, sham-stimulation-controlled study of the application
of magnetic fields using the Company`s Resonator device has begun at Colorado
Neurological Institute
LITTLETON, Colo.--(Business Wire)--
Pico-Tesla, The Magneceutical Therapy Company, announced today that it has
commenced a Phase III clinical trial of its patented Resonator system that
facilitates the Company`s proprietary magnetic (Magneceutical) therapy for
treating Parkinson`s disease patients. In a Phase II clinical trial,
Magneceutical Therapy "demonstrated significant improvement over placebo after 8
weeks (endpoint) of therapy…improvement…persisted up to 2 months (week 16)
post-treatment…(and) no treatment-related adverse events were reported." 

The purpose of the Phase III clinical trial is to demonstrate the efficacy of
Magneceutical Therapy as an adjunctive therapy to improving aspects of health
and quality of life that are relevant to patients with Parkinson's Disease.
Pico-Tesla intends to submit the Phase III data and analysis via a 510(k) de
novo application to obtain FDA clearance to sell the device in the United
States. The Phase III clinical trial was designed by consulting neurologist
Rajeev Kumar, M.D., a movement disorder specialist and medical director of the
Colorado Neurological Institute Movement Disorder Center, Englewood, Colo. 

"The data from the Phase II clinical trial was extremely positive," said Dr.
Kumar. "It strongly suggested a wider study of magnetic therapy is warranted.
Given that we don`t know the mechanism of action of magnetic therapy, it`s
therefore hard to speculate about what we`ll see in the larger Phase III study.
Nevertheless I believe it`s realistic to expect some enhancement of motor and
non-motor Parkinson`s symptoms from magnetic therapy that are refractory to
conventional therapy," added Dr. Kumar. "Therefore I am looking forward to
further investigating the benefits of this unique, noninvasive and potentially
promising treatment for Parkinson`s disease." 

"There is no cure for Parkinson`s disease and currently marketed therapies have
risks or possible complications," said Allen Braswell, president and CEO of
Pico-Tesla. "For example, while drug therapies help alleviate some
motorsymptoms, their side effects can be significant-depression, hypotension,
abnormal movements and hallucinations. And only 15-20% of Parkinson`s patients
are candidates for surgical options that include implanting a probe into the
brain, deep brain stimulation (DBS), or ablative destruction of targeted brain
tissue. Such options are invasive and have potential for serious adverse side
effects. In contrast, our device is both non-invasive and non-significant risk.
Therefore we believe Pico-Tesla is well-positioned to uniquely address an
important unmet need among Parkinson`s patients: Quality of Life.PD patients
lead a significantly impaired quality of life because there are few options that
address this aspect of their disease." 

Magneceutical Therapy involves the use of an extremely low-level electromagnetic
field (EMF) applied by a specially designed device-the Resonator, invented by
Dr. Jerry I. Jacobson, along with proprietary therapeutic protocols-intended to
improve a number of the signs and symptoms of Parkinson`s and other
neurological-based diseases. Parkinson`s disease (also known as `PD`) affects
1.5 million people in the U.S., with 60,000 news cases diagnosed each year. PD
is a chronic and progressive degenerative disease of the brain that is
characterized by muscle rigidity, resting tremors and, in extreme cases, nearly
complete loss of movement. The popular actor Michael J. Fox, who has PD, has
raised awareness of the disease through the Michael J. Fox Foundation for
Parkinson's Research (MJFF). 

About Pico-Tesla Magnetic Therapies, Inc.

Privately held Pico-Tesla Magnetic Therapies is an emerging medical technology
company based in Littleton, Colo. Three pilot studies suggest its Magneceutical
Therapy-made possible by its proprietary Resonator device along with proprietary
treatment protocols-may give neurologists a whole new way of treating
Parkinson`s disease and other neurological-based disorders and diseases. 

CAUTION: The Resonator device is an Investigational Device limited by federal
(or United States) law to investigational use. The Resonator device is not for
sale, nor is the Magneceutical Therapy generally available outside of
Investigational Review Board (IRB)- approved clinical studies.

Ronald Trahan Associates Inc.
Ronald Trahan, 508-359-4005, x108
APR 

Copyright Business Wire 2009

 

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