- Dr. Robert Hauser to Present Late Breaking Poster Highlighting Efficacy of Northera in Patients with Neurogenic Orthostatic Hypotension associated with Parkinson's Disease on June 8th 2011
- Dr. Gregor Wenning to Present Poster on Safety and Efficacy of Northera in Multiple System Atrophy on June 8th 2011
- Chelsea to Sponsor Symposium Reviewing Results from Northera Clinical Program in Neurogenic Orthostatic Hypotension on June 9th 2011
CHARLOTTE, N.C., May 2, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that two posters describing the clinical benefit of NORTHERA™ (droxidopa) have been accepted for presentation at the Movement Disorder Society's 15th International Congress of Parkinson's Disease and Movement Disorders June 5-9, 2011 at The Metro Toronto Convention Centre, Toronto, Ontario, Canada. In addition to the two posters presentations, Chelsea will sponsor a symposium detailing the clinical results of Northera for the treatment of neurogenic orthostatic hypotension (NOH) at 12:00 pm on June 9, 2011.
The following poster detailing results from Northera Study 306A has been accepted as a late breaking submission and will be presented by the study's principal investigator, Dr. Robert A. Hauser, on June 8, 2011 from 1:30 pm – 3:00 pm ET:
"Efficacy of Northera (droxidopa) in Patients with Neurogenic Orthostatic Hypotension associated with Parkinson's disease (PD)," Robert A. Hauser(1) MD, Ramon Gil(2) MD and Stuart Isaacson(3) MD. Tampa(1), Port Charlotte(2), Boca Raton(3) Florida, USA. Abstract Number: LB21
In addition, the following poster will be presented during Poster Session III, June 8, 2011, from 9:00 am - 6:00 pm ET:
"Safety and efficacy of Northera (droxidopa) in Multiple System Atrophy," Gregor K Wenning, MD, PhD MSc1, Horacio Kaufmann, MD2, Christopher J Mathias, D.Phil, DSc, F.R.C.P3 and Pietro Cortelli, MD4. 1Division of Clinical Neurobiology, Innsbruck Medical University; 2NYU Medical Center; 3Division of NeuroScience and Psychological Medicine, Imperial College of Science, Technology, and Medicine at St Mary's London and 4Department of Neurosciences, University of Bologna. Abstract Number: 778
Chelsea will also be sponsoring a symposium, featuring a panel of academic thought leaders and experts in the field of movement disorders, to review the role of norepinephrine in primary autonomic failure, clinical findings and therapeutic opportunities for Northera in neurogenic orthostatic hypotension. The session being held on Thursday, June 9, 2011 at 12:00 pm ET will be moderated by Joseph Jankovic, MD, Baylor College of Medicine, Houston, TX, and will include the following presentations:
The Role of Norepinephrine in Primary Autonomic Failure associated with PD, MSA and PAF
Peter LeWitt, Southfield, MI, USA
- Focus on NOH and Autonomic Failure in PD
Northera (droxidopa) Phase III Clinical Data
Gregor Wenning, Innsbruck, Austria
- Clinical Trial Considerations for Neurogenic Orthostatic Hypotension (NOH)
- Study 301 Results
- Orthostatic Hypotension Questionnaire (OHQ)
- Symptoms; Activities of Daily Living
- Preliminary patient falls data
Northera (droxidopa) 306A Clinical Data
Robert Hauser, Tampa, FL, USA
- OHQ and Falls
- Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scores
- Hoehn & Yahr scores
- Prospective study in 306B
About Neurogenic Orthostatic Hypotension
NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in lightheadedness, dizziness, blurred vision and fainting episodes when a person assumes a standing position. Symptoms of chronic NOH can be incapacitating, not only putting patients at high risk for falls and associated injuries, but also severely affecting the quality of life of patients and their loved ones. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.
About Northera
NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing Phase II trial and completed a Phase II trial in intradialytic hypotension (IDH) study with positive results.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, NORTHERA™ (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risk of regulatory approvals, including our planned NDA for Northera; risks and costs of drug development, including the uncertainty of cost, timing and outcome of clinical trials like Study 306; our reliance on our lead drug candidates Droxidopa and CH-4051; our need to raise operating capital; our history of losses; reliance on collaborations and licenses; intellectual property risks; competition; market acceptance for our products, if any are approved for marketing; and reliance on key personnel including specifically Dr. Pedder.