SAN DIEGO, Feb. 22, 2011 (GLOBE NEWSWIRE) -- 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 firstname.lastname@example.org
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