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TO HEALTH, MEDICAL, AND NATIONAL EDITORS:
Potential Parkinson's Therapy Secures $23 Million for Testing from NIH
after Foundation Funding
NEW YORK, March 31, 2014 /PRNewswire-USNewswire/ -- Results out of a
study funded by The Michael J. Fox Foundation for Parkinson's Research
(MJFF) have enabled researchers to secure a $23 million grant from the
National Institutes of Health (NIH), continuing a repurposed drug
approved for hypertension to Phase III testing for slowing Parkinson's
progression. The trial investigating the compound isradipine will be
the most advanced, current study into a disease-modifying therapy for
Parkinson's, an unmet need.
Isradipine is a calcium channel blocker prescribed to treat high blood
pressure. Epidemiological data from population-scale studies note a
lower incidence of Parkinson's disease (PD) among people who take this
drug. Furthering PD researchers' interest, laboratory tests have shown
that blocking calcium channels protects dopamine neurons, degeneration
of which is one of the hallmarks of Parkinson's disease.
"What the millions living with Parkinson's disease need is a drug that
will halt or slow the progression of their disease," said Todd Sherer,
PhD, CEO of MJFF. "We've invested in isradipine, and we're glad to see
it moving forward with NIH support, because it has shown such
potential to do just that."
Early Investment Secures Follow-on Funding
The NIH funding will move the Safety, Tolerability and Efficacy
Assessment of Dynacirc@ for PD (STEADY-PD) study into Phase III
efficacy testing. Dynacirc@ is the commercial name of the isradipine
hypertension drug. Principal investigator Tanya Simuni, MD, director
of the Parkinson's and Movement Disorders Program at Northwestern
University, and the Parkinson Study Group hope to enroll more than 300
participants at 56 clinical sites throughout North America.
MJFF began funding isradipine research in 2007 with support for a
project from D. James Surmeier, PhD, also of Northwestern University,
looking at the compound's neuroprotective effects in PD models. The
NIH also funded Surmeier's pre-clinical work into this compound.
In 2008, the Foundation granted STEADY-PD $2.1 million for the Phase
II clinical trial, and researchers published results in September 2013
in the Movement Disorders journal showing that isradipine is safe and
tolerable in Parkinson's patients. They also determined the maximal,
tolerable dosage (10 mg daily).
Millions Have Critical Need for Better Therapy
Drug repurposing - studying a small molecule or compound approved to
treat one disease for its effect on another - speeds a drug into
clinical trials and hastens approval from the U.S. Food and Drug
Administration because detailed information on its pharmacology,
formulation and safety is already available and has been reviewed.
This urgency is of particular importance for the one million Americans
living with Parkinson's and, with a growing U.S. population of older
adults, the many more who may age into the disease in the near future.
Parkinson's disease is a progressive, neurological disorder that leads
to motor symptoms such as tremor and rigidity and non-motor symptoms,
including depression and cognitive decline.
Current PD therapies treat the symptoms of the disease, but do not
slow its progression. Furthermore, their timeframe of efficacy is
limited and PD medications can elicit their own serious side effects.
"We're all after the same goals - a cure for Parkinson's and better
quality of life for those living with this disease," said Story
Landis, PhD, director of the National Institute of Neurological
Disorders and Stroke, which granted STEADY-PD the Phase III funding.
"We can work together to move promising research forward and make a
difference in patients' lives."
About The Michael J. Fox Foundation for Parkinson's Research As the
world's largest nonprofit funder of Parkinson's research, The Michael
J. Fox Foundation is dedicated to accelerating a cure for Parkinson's
disease and improved therapies for those living with the condition
today. The Foundation pursues its goals through an aggressively
funded, highly targeted research program coupled with active global
engagement of scientists, Parkinson's patients, business leaders,
clinical trial participants, donors and volunteers. In addition to
funding more than $450 million in research to date, the Foundation has
fundamentally altered the trajectory of progress toward a cure.
Operating at the hub of worldwide Parkinson's research, the Foundation
forges groundbreaking collaborations with industry leaders, academic
scientists and government research funders; increases the flow of
participants into Parkinson's disease clinical trials with its online
tool, Fox Trial Finder; promotes Parkinson's awareness through
high-profile advocacy, events and outreach; and coordinates the
grassroots involvement of thousands of Team Fox members around the
world.
For more information, visit us on Facebook, Twitter, Web and LinkedIn.
SOURCE The Michael J. Fox Foundation for Parkinson's Research
-0- 03/31/2014
/CONTACT: Maggie McGuire, 212-509-0995 ext. 295, mmcguire@michaeljfox.org
CO: The Michael J. Fox Foundation for Parkinson's Research
ST: New York
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