Health & Fitness
Health and Fitness
Health and Fitness
Wed, February 18, 2009
Tue, February 17, 2009 Depomed Initiates Phase I Trial for DM-1992 Program in Parkinson?s Disease Following Positive Results of Preclinical Studies Sp
MENLO PARK, Calif.--([ BUSINESS WIRE ])--Depomed, Inc. (NASDAQ:DEPO) today announced that it has dosed the first patient in a Phase I trial for its DM-1992 program in Parkinson's disease based on positive results from preclinical studies sponsored by The Michael J. Fox Foundation for Parkinson's Research. DM-1992 is an investigative novel gastric retentive extended-release dosage form of Levodopa/Carbidopa, a marketed therapy used in the treatment of Parkinson's disease.
The Phase I trial has been designed to compare pharmacokinetics in Parkinson's patients of two formulations of DM-1992 and a generic version of Sinemet® CR, a commercially available sustained release Levodopa/Carbidopa formulation. Results of preclinical studies indicate that Depomed's formulations, developed using its proprietary AcuForm™ delivery technology, may optimize the absorption of Levodopa in the duodenum, the area of the upper gastrointestinal tract where Levodopa is preferentially absorbed. Improved drug delivery could result in more consistent efficacy while reducing the adverse events associated with fluctuating blood levels of Levodopa/Carbidopa, including dyskinesia (uncontrolled movement) when blood levels of levodopa are too high and akinesia (rigidity) when blood levels are too low.
"Based on the success of the preclinical studies, we are enthusiastic to begin the first clinical trial of our DM-1992 program in Parkinson's disease," said Carl A. Pelzel, president and chief executive officer of Depomed. "We believe our novel formulation of Levodopa/Carbidopa offers real clinical benefit and has the potential to positively impact the quality of life of Parkinson's patients. On behalf of Depomed, I'd like to thank The Michael J. Fox Foundation for its support of our preclinical studies in this area."
The Michael J. Fox Foundation awarded Depomed a modest preclinical grant in July 2008 under the foundation's Therapeutics Development Initiative. The grant amount supported Depomed in the development of DM-1992 under the hypothesis that Levodopa/Carbidopa's window of absorption in the upper gastrointestinal tract can be optimized using Depomed's AcuForm™ technology.
DM-1992 Phase I Trial Design
The Phase I trial is a randomized, open-label crossover study designed to enroll 18 patients with stable Parkinson's disease at two leading neurology centers in Russia. The objective of the study is to compare the pharmacokinetics of two distinct formulations of DM-1992 and a generic version of Sinemet CR sustained-release Levodopa/Carbidopa, as well as the safety and tolerability of the formulations. Patients in the trial will receive a single dose of each of the three treatments being studied. A dose of the first treatment will be administered at the beginning of the study, followed by a dose of a second treatment after 7 to 14 days, and a dose of the third treatment after another 7 to 14 days. Blood samples will be drawn during the 24 hour period following administration of each treatment. Patients will remain on any anti-Parkinson's therapy other than Levodopa/Carbidopa during the trial. Depomed Top-line results from the trial are expected to be reported in the 3rd quarter of 2009.
About DM-1992 Preclinical Studies
The preclinical pharmacokinetic studies of Depomed's DM-1992 program in Parkinson's disease found that all of its gastric retentive formulations extended the release and significantly increased the bioavailability of levodopa compared to Sinemet CR in Beagle dogs. The in vivo erosion studies indicate that Depomed's gastric retentive formulations could have a levodopa delivery time of approximately seven to ten hours in humans compared to approximately 1 hour for Sinemet CR. Depomed's pharmacokinetic modeling data has indicated that a release time of seven to ten hours may result in twice a day dosing in humans, with a relatively constant levodopa blood concentration.
About Parkinson's disease
Parkinson's disease is a chronic, degenerative neurological disorder that affects nearly one million Americans, with significant prevalence growth expected over the next 25 years due to aging population demographics. Six million worldwide are estimated to have Parkinson's. While the average age at onset is 60, disease onset starts by age 40 in an estimated five to 10 percent of patients, and people as young as 30 can also be affected. Current therapies are effective in addressing only the mild/moderate motor symptoms of the disease and have significant long-term side effects. There are no drugs available that target the numerous non-motor aspects of the disease as well as the underlying degenerative process.
About The Michael J. Fox Foundation for Parkinson's Research (MJFF)
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 the coming decade through an aggressively funded research agenda. The Foundation has funded over $135 million in research to date.
About MJFF's Therapeutics Development Initiative
In order to further advance its mission of finding improved treatment or a cure for Parkinson's disease, the Michael J. Fox Foundation has created the Therapeutics Development Initiative, recognizing the important role biotechnology and pharmaceutical industries play in the search for improved Parkinson's disease therapeutics. The Therapeutics Development Initiative is an industry-only initiative targeted at supporting and stimulating Parkinson's research within industry.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuFormTM drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. GLUMETZA® (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the United States. Proquin® XR (ciprofloxacin hydrochloride) is approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is being marketed in the United States within the urology, Ob/Gyn and long-term care specialties by Watson Pharmaceuticals. Product candidate DM-1796 is in clinical development for the treatment of neuropathic pain and has been licensed to Solvay Pharmaceuticals. Product candidate DM-5689 is in clinical development for menopausal hot flashes. Additional information about Depomed may be found on its website, [ www.depomedinc.com ].
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995.
The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our clinical development program for DM-1992; potential benefits of DM-1992; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
