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REHOVOT, Israel, June 9, 2015 (GLOBE NEWSWIRE) -- NeuroDerm (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, announced the company will present its latest data of its lead products, ND0612L and ND0612H, at the International Parkinson and Movement Disorder Society's 19th International Congress of Parkinson's Disease and Movement Disorders meeting taking place on June 14 to 18, 2015 in San Diego, CA.
ND0612L and ND0612H are NeuroDerm's proprietary, first ever liquid levodopa/carbidopa (LD/CD) formulations, intended to maintain steady levodopa plasma levels through simple, continuous subcutaneous delivery. They are designed to significantly improve the treatment of moderate and severe Parkinson's patients and to replace the need for highly invasive current therapies requiring surgical intervention such as Deep Brain Stimulation (DBS) and Duopa/Duodopa.
Nir Giladi, MD, a Professor of the Sackler Faculty of Medicine at Tel Aviv University will present, "Pharmacokinetic Profile of ND0612L (LD/CD for subcutaneous infusion) in Patients with Moderate to Severe Parkinson's Disease," on Monday, June 15 from 12:30 to 2:00 PM PDT (Abstract number 226). Dr. Giladi is a recognized leader in the field of movement disorders. He is a chairman of the Department of Neurology at the Tel Aviv Sourasky Medical Center. He has served as an officer of the International Parkinson and Movement Disorders Society (MDS) since 2010. The abstract will be presented in a Guided Poster Tour Presentation during the MDS International Congress by Sheila Oren, MD, Vice President of Clinical and Regulatory Affairs at NeuroDerm Ltd., on June 18, 2015 at 12:00 - 1:30 PM PDT. The tour topic is titled "Parkinson's Disease: Neuropharmacology". The abstract will be available online on June 14.
The company will also present data of the high-dose version of its ND0612 product candidate, ND0612H, intended for severe Parkinson's disease patients. The late-breaking poster LBA 08, "Stable Levodopa Plasma Levels with ND0612 (LD/CD for subcutaneous infusion) in Parkinson's disease (PD) patients with motor fluctuations," will be presented by Dr. Nir Giladi as well on Wednesday, June 17 from 12:00 to 1:30 PM PDT. As a late–breaking poster it will be displayed for the entire duration of the Scientific Program (Monday, June 15 – Thursday, June 18).
In earlier studies, the company announced topline results for its Phase IIa pharmacokinetic study of ND6012H and ND0612L in December 2014. That study showed that continuous, subcutaneous delivery of its LC/DC product candidates led to clinically significant steady plasma levodopa levels, and that ND0612H reached plasma levodopa levels that should be sufficient to effectively treat the majority of patients considered as candidates for either DBS or DuoDopa.
Oral administration of LD/CD is regarded as the "gold standard" treatment for patients suffering from Parkinson's disease. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. Virtually all patients diagnosed with Parkinson's disease will require levodopa at some point over the course of their treatment for the disease, and 70% to 80% of patients receive the drug at any given point in time. However, levodopa is limited by its short half-life. Approximately three to four hours after a single dose, almost none of the drug remains in the plasma. In addition, levodopa suffers from low absorption when administered orally, with only about 30% of the levodopa entering the blood stream.
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD, maintaining steady, therapeutic levodopa plasma concentrations both day and night.
About Parkinson's Disease
Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient's motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also referred to as "off" time. In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the "off" time, some patients experience involuntary movements, or dyskinesia. The "off" time and dyskinesia affect the majority of Parkinson's disease patients and interfere with day-to-day functions, causing patients to become severely disabled. Continuous administration of levodopa has been shown to effectively treat motor fluctuations in Parkinson's disease patients, however, a convenient route of continuous administration has not been introduced to date.
NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. In Parkinson's disease, the company has four product candidates in different stages of development which offer a solution for almost every Parkinson's disease patient from the moderate to the very severe stage of the disease. The company has developed a line of LD/CD product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson's disease patients, respectively, and ND0680 for a subset of severe Parkinson's disease patients whose symptoms have advanced to a highly advanced stage, requiring even higher doses of LD/CD. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson's disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that involve risks and uncertainties. Such forward-looking statements may include projections regarding our future performance and may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the risks provided under "Risk Factors" in our annual report on Form 20-F for the year ended December 31, 2014 filed with the Securities and Exchange Commission. Any forward-looking statement made by us in this press release speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Oded S. Lieberman, PhD, MBA, CEO
Tel.: +972-8-946 2729
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Neurology - Central Nervous System (CNS)
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