Initial Studies Show Harbor BioSciences' Triolex(R) for Parkinson's Disease Crosses the Blood-Brain Barrier in Mice
February 22 2011 - 7:30AM
Harbor BioSciences, Inc. (OTCBB:HRBR), which is investigating the
use the company's proprietary compound Triolex® as a treatment for
Parkinson's disease (PD) with funding from The Michael J. Fox
Foundation (MJFF), announced positive results in initial
preclinical studies. These studies in orally treated mice
demonstrate that Triolex crosses the blood-brain barrier in
significant quantities.
Harbor BioSciences designed these studies to determine if
Triolex, an anti-inflammatory, small-molecule compound believed to
reduce inflammation in the brain, was capable of crossing the
blood-brain barrier. The results described today show that more
than 50% of levels of Triolex measured in plasma were found in
mouse brains after oral administration. These positive findings
support rodent efficacy studies, which are expected to be completed
before the end of this year.
The terms of the collaboration call for MJFF to fund up to
approximately $150,000 toward pre-clinical development of Triolex
in rodents. If these studies are successful, additional funding may
be awarded by MJFF to continue the clinical development of Triolex
for the treatment of PD.
"Anti-inflammatory approaches to Parkinson's disease are of
increasing interest to Parkinson's researchers, but even the most
effective potential treatment must cross the blood-brain barrier in
order to be translated into practical treatments for PD patients,"
said Todd Sherer, Ph.D., Chief Program Officer, The Michael J. Fox
Foundation. "We are encouraged by the initial data showing that
Triolex may accomplish both of these goals, and look forward to
partnering with Harbor BioSciences to continue vetting this novel
compound in the hope of speeding its path to the clinic."
PD is a chronic neurodegenerative disorder of unknown cause.
While advancing age remains the greatest risk factor, PD can strike
people even under the age 30. The full spectrum of PD is not well
addressed by current treatments, which can only temporarily improve
some symptoms as the underlying disease continues to worsen. PD
affects one in 100 individuals over age 60. An estimated
500,000 people in the U.S. have PD and the numbers are expected to
grow as the population ages.
Harbor BioSciences believes Triolex may decrease chronic
inflammation in the brain, thereby protecting neurons whose loss
would otherwise lead to the damage associated with PD. This
belief is based on several factors: the company's previously
reported data regarding the anti-inflammatory effects of Triolex in
human clinical studies; attenuation of neuroinflammation in rodent
models; and the extensive literature describing the benefits of
related natural compounds in both humans and animal PD models. To
date, Triolex has been well tolerated when administered to more
than 180 people with type 2 diabetes and healthy volunteers.
"It is a privilege to be collaborating with MJFF to assess the
potential benefits of Triolex in patients suffering from PD,"
commented James M. Frincke, Harbor BioSciences' Chief Executive
Officer. "If Triolex demonstrates an effect on regulating key
inflammatory cytokines in PD patients similar to that observed in
animal models and in type 2 diabetes patients, it should provide an
entirely new approach to the treatment of this debilitating
disease. We are also hopeful that if Triolex is able to reduce
neuro-inflammation and protect neurons in PD, it may also be useful
in other inflammation-driven neurodegenerative disorders such as
Alzheimer's disease and multiple sclerosis."
"I'm very encouraged by this new data and pleased to be working
with MJFF," said Dominick L. Auci, Ph.D., lead investigator on the
project. "The consistent performance of Triolex in animal models of
neuro-inflammation, combined with published studies from other
groups, suggests a high likelihood of success. Milestones in the
first year include efficacy in various rodent
models. Non-human primate studies are planned for the
following years. If positive, these studies will enable
accelerated Phase I/II studies in PD patients since Triolex is
already in an advanced stage of clinical development for other
indications."
About The Michael J. Fox Foundation for Parkinson's
Research
The Michael J. Fox Foundation is dedicated to finding a cure for
Parkinson's disease through an aggressively funded research agenda
and ensuring the development of improved therapies for those living
with Parkinson's today. The Foundation has funded over $228 million
in research to date. For more information about PD and the
MJFF, go to www.michaeljfox.org.
About Harbor BioSciences, Inc.
Harbor BioSciences is a development-stage company with two
product candidates which recently completed Phase I/IIa clinical
trials: Apoptone® (HE3235) in patients with late-stage prostate
cancer, and Triolex® (HE3286) in obese type 2 diabetes mellitus
patients. Apoptone and Triolex represent two of the lead
candidates from Harbor BioSciences' small molecule platform based
on metabolites or synthetic analogs of endogenous human
steroids. For more information please visit
www.harborbiosciences.com.
This press release contains forward-looking statements within
the meaning of the federal securities laws including, Triolex
crossing the blood-brain barrier in significant quantities; that
rodent efficacy studies will be conducted; that rodent efficacy
studies are expected to be completed before the end of this year;
that additional funding may be awarded by MJFF; that Triolex may
decrease chronic inflammation in the brain; that if Triolex
decreases chronic inflammation in the brain, neurons whose loss
would otherwise lead to the damage associated with PD would be
protected; that if Triolex demonstrates an effect on regulating key
inflammatory cytokines in PD patients similar to that observed in
animal models and in type 2 diabetes patients, it should provide an
entirely new approach to the treatment of PD; that if Triolex is
able to reduce neuroinflammation and protect neurons in PD, it may
also be useful in other inflammation-driven neurodegenerative
disorders; the potential for success in using Triolex to treat PD;
that non-human primate Triolex studies are planned for the
following years; and that if positive, these studies will enable
accelerated Phase I/II studies in PD patients. Any statements
included in this press release that are not a description of
historical facts are forward-looking statements that involve risks,
uncertainties, assumptions and other factors which, if they do not
materialize or prove correct, could cause Harbor BioSciences'
actual results to differ materially from historical results or
those expressed or implied by such forward-looking
statements. Such statements are subject to certain risks and
uncertainties inherent in the Company's business, including, but
not limited to: the ability to complete preclinical and clinical
trials successfully and within specified timelines, if at all; the
Company's capital needs; MJFF's continued support; the Company's
ability to obtain additional funding; our ability to obtain
regulatory approval for Triolex; and other risks detailed from time
to time in the Company's filings with the Securities and Exchange
Commission. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. Except
as required by law, Harbor BioSciences undertakes no obligation to
update or revise the information contained in this press release as
a result of new information, future events or circumstances arising
after the date of this press release.
CONTACT: Robert Weber
Chief Financial Officer
Harbor BioSciences, Inc.
(858) 587-9333
rweber@harborbiosciences.com
Harbor Diversified (CE) (USOTC:HRBR)
Historical Stock Chart
From Jun 2024 to Jul 2024
Harbor Diversified (CE) (USOTC:HRBR)
Historical Stock Chart
From Jul 2023 to Jul 2024