FoxFeed Blog
September 01, 2015
The Michael J. Fox Foundation’s largest grant to a single investigator thus far awarded $5.6M in 2008 to Michael Schwarzschild, PhD, of Massachusetts General Hospital for a Phase II trial of inosine, a precursor to the antioxidant of urate. Observational studies had shown people with higher levels of urate had lower risk of Parkinson’s disease (PD) and, if diagnosed with PD, slower disease progression.
Today
Dr. Schwarzschild and his Parkinson Study Group colleagues announced funding
from the National Institutes of Health (NIH) to conduct an inosine Phase III
trial at 60 U.S. clinical sites with 270 people with early-stage Parkinson’s.
Enrollment is expected to begin early next year.
One
quick, very important note: Inosine is available commercially as a dietary
supplement, but patients should act with caution. Inosine has not been proven
as a therapy for Parkinson’s, and, in the absence of medical supervision, it
can cause serious side effects such as gout, kidney stones and possibly high
blood pressure. It is critical to discuss any medications or natural
supplements with your physician before taking them.
MJFF
Support Advances Potential Disease-Modifying Drug
"The
Foundation's early and step-wise investment has not only helped us reach this
advanced stage of testing for disease modification. The knowledge gained with
its support also greatly enhances the prospects for success of the Phase III
trial,” said Dr. Schwarzschild. "In addition to granting dollars to
advance inosine's therapeutic candidacy, the Foundation has also provided
valuable scientific, recruitment and regulatory guidance."
The MJFF-funded
Phase II study showed that inosine is safe, tolerable and does
raise urate levels in people with early-stage PD.
The
Foundation also funded early pre-clinical work investigating the mechanism of
urate in neuroprotection. And MJFF will continue to support this project by
funding two small studies — one clinical, one pre-clinical — to assess
interactions between inosine and common foods and other medications taken by
people with Parkinson’s.
“Patients’
greatest unmet need is a therapy to stop or slow Parkinson’s disease,” said
Todd Sherer, PhD, MJFF CEO. “There is a large body of evidence to show that
using inosine to raise urate levels could impact Parkinson’s progression. We’re
glad that The Michael J. Fox Foundation could support this important work at a
critical stage and that the NIH is funding this trial to move inosine closer to
patient relevance.”
Because
inosine is already commercially available, Foundation and government funding is
essential for testing its efficacy as a Parkinson’s treatment. Pharmaceutical
companies are not incentivized to invest in testing of a compound already on
the market.
Scientists
Uncover Potential Mechanism of Neuroprotection
Researchers
have studied antioxidants, such as Vitamin E, for their effect on Parkinson’s
disease before without success. A new paper from
Dr. Schwarzschild’s team (from non-MJFF funded research),
however, points to a urate-specific role in neuroprotection. This finding grows
the evidence for likely disease modification with inosine.
The
investigators report that urate stimulates brain cells called astrocytes, the
first step in a chain reaction releasing another antioxidant and activating a
protein pathway. Both may protect brain cells from degeneration.
“This
new evidence of a more nuanced molecular mechanism for urate-induced
neuroprotection boosts our enthusiasm that this will be a truly novel strategy
and not ‘just another direct antioxidant’ that will fail to protect the brain
cells that degenerate in Parkinson’s,” said Dr. Schwarzschild.
Listen to Dr. Schwarzschild explain
his inosine research in an MJFF podcast.
https://www.michaeljfox.org/foundation/news-detail.php?inosine-trial-secures-phase-iii-funding-to-study-effect-on-slowing-parkinson&os_cid=fb-a30U00000004hgl&s_src=MJFFfb&s_subsrc=inosine_trial_news#prclt-eHo1kjBl
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