NEW YORK, April 5 /PRNewswire-USNewswire/ -- The Michael J. Fox
Foundation today announced the launch of Biomarkers 2007, a two-year,
$2-million funding program dedicated to research toward the discovery of an
objective biomarker, or "biological fingerprint," of Parkinson's disease.
This is the third funding round under the Foundation's Biomarkers program
designed to drive discovery of this crucial resource, which the Parkinson's
field currently lacks.
"Discovering a definitive biomarker for Parkinson's disease is
critical," said Sarah Orsay, MJFF's chief executive officer. "By adding
this tool to the Parkinson's research 'toolbox,' we would gain the ability
to objectively diagnose PD and to more accurately measure its progression.
And we would remove a significant hurdle to effective clinical testing of
new therapies, particularly treatments with potential to slow or stop the
disease rather than just mask its symptoms."
The development of neuroprotective therapies is greatly hindered by the
lack of markers capable of serving as objective endpoints for clinical
trials testing these treatments. In recognition of this issue, Biomarkers
2007 will exclusively accept proposals with a focus on biomarkers that can
have significant impact on neuroprotective trials. Among the most
significant challenges currently facing Parkinson's clinicians:
-- To measure whether a treatment alters the course or progression of the
disease, researchers currently can only measure changes in patients'
clinical features, or the time it takes to reach the onset of specific
disease-associated disabilities. Unfortunately, these endpoints leave a
great deal to be desired. They may vary drastically between patients or
clinical raters; require long trial durations before significant
effects are seen; and not be accurate measures of disease progression.
-- Clinical measures, though the most important means for determining the
ability of a treatment to improve overall patient well-being, generally
do not allow researchers to draw a clear distinction between symptom-
masking versus disease-modifying (neuroprotective) effects of therapies
being tested.
-- Current trials must select patients largely based on clinical criteria
that may not adequately reflect the highly variant nature of the
underlying etiology and pathogenesis of PD. Participation of
inappropriate patient subtypes in a trial could result in a seeming
lack of effect and ultimately halt further development of an otherwise
promising treatment.
-- Only limited measures exist in many trials to determine whether a
treatment is reaching its hoped-for target site in the brain and
exerting its desired biological action. This can hinder ability to
determine appropriate therapeutic dosing and lead to trial results
(especially if results are negative) that are difficult to interpret.
"Identification of markers that can address the significant limitations
of neuroprotective trials, or act as surrogate endpoints for clinical
outcomes, would greatly improve our ability to develop and test new
disease-modifying therapeutics for PD," said Gene Johnson, PhD, MJFF's
chief scientific advisor. "For this reason, the Foundation has deliberately
focused the current RFA on markers with potential to improve the way
neuroprotective and disease- modifying clinical trials are carried out."
The Michael J. Fox Foundation has been a field leader in spearheading
the search for a PD biomarker, with approximately $5 million in biomarker
research funded to date.
Pre-proposals under Biomarkers 2007 are required and must be submitted
online by 6 p.m. Eastern Daylight Time on Thursday, May 17, 2007.
Information about submitting pre-proposals online can be found on the
Foundation's Web site (http://www.michaeljfox.org). Pre-proposals will be
reviewed by the Foundation's scientific staff and a panel of scientific
experts. Applicants whose pre-proposals are determined to meet the review
criteria will be invited to submit full application proposals. Funding is
anticipated by November 2007.
About The Michael J. Fox Foundation
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research
is dedicated to ensuring the development of a cure for Parkinson's disease
within this decade through an aggressively funded research agenda. The
Foundation has funded over $90 million in research to date, either directly
or through partnerships.