CARLSBAD, CA--(Marketwire - Mar 19, 2013) - International Stem Cell Corporation ( OTCQB : ISCO ) (www.internationalstemcell.com) a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells announced today safety and encouraging efficacy of stem cell therapy in rodent and non-human primate models of Parkinson's disease. "This pilot study represents a first essential step in bringing cell-based therapies for Parkinson's disease to clinical trials," commented co-author of the study Evan Y. Snyder, MD, PhD, Director of Stem Cells and Regenerative Biology Program at Sanford Burnham Medical Research Institute. These placebo-controlled studies were designed to demonstrate the viability, fate and functional efficacy of the stem cell derived neural cells after implantation to the brain.Highly pure populations of neuronal cells were differentiated from human parthenogenetic stem cells (hpSC) according to the protocol developed by International Stem Cell Corporation and recently published in the Nature Publishing Group's Scientific Reports. The studies employ MPTP-lesioned African Green monkeys and 6-OHDA-lesioned rats, the principle models used to study Parkinson's disease.The duration of the primate study was four months and the rodent study six months.In the non-human primate model, behavioral endpoints were assessed with parkinsonian scores. These scores, based on a standardized rating … Continue reading →

One of the most promising new approaches to treating Parkinsons disease hit a snag after researchers found early evidence it may make people worse. The experimental technique involves reducing levels of alpha-synuclein, a protein found in clumps in the brains of people with Parkinsons that increases the risk of the disease. Research presented at the American Academy of Neurology meeting in San Diego shows the condition progresses more rapidly in patients with naturally low levels of the protein. Companies including Elan Corp., Alnylam Pharmaceuticals Inc. (ALNY), NeuroPhage Pharmaceuticals Inc. and Prana Biotechnology Ltd. (PBT) have early-stage efforts under way to develop drugs aimed at alpha-synuclein. The Michael J. Fox Foundation has put more than $47 million into research targeting the protein. The results suggest patients in clinical trials to lower alpha- synuclein may be at risk, said Demetrius Maraganore, a study author. There is a sense of urgency related to their safety, Maraganore, who is chairman of neurology at NorthShore University Health System in Evanston, Illinois, said in a telephone interview. If this work is reproducible and our interpretation of the findings is correct, this has immediate relevance to people with Parkinsons. The study released yesterday found patients with a … Continue reading →

ATLANTA, March 19, 2013 /PRNewswire/ --UCB today announced data from a non-interventional, observational study conducted in Germany that found that when Parkinson's disease (PD) patients were switched from an oral PD medication to Neupro (Rotigotine Transdermal System), they reported improvements in pre-existing gastrointestinal (GI) symptoms. The data were presented at the American Academy of Neurology's (AAN) 2013 Annual Scientific Meeting in San Diego, March 16-23, 2013. "GI symptoms are common non-motor symptoms in PD patients, and can significantly affect their daily life," said Dirk Woitalla, MD, lead study author, St. Josef-Hospital Universitatsklinik. "The findings presented at AAN show the potential improvement rotigotine may have on these symptoms for people living with PD. Controlled clinical studies are needed to confirm this finding." In the study conducted in a clinical practice setting in Germany, PD patients experiencing GI symptoms (e.g., heartburn, bloating, nausea, vomiting, abdominal pain or diarrhea) while receiving oral drug treatment were switched by their physician to rotigotine transdermal system.1 Primary efficacy outcomes included changes in GI symptoms (measured by a visual analogue scale [intensity; 0-100 mm]) and the sum score of GI complaints (six items each rated 0-12 for sum of 0-72), in addition to patient satisfaction in relation … Continue reading →

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and H. Lundbeck A/S announced today that a study of Azilect has met its primary endpoint in treating Parkinson's disease. The double-blind, placebo controlled, randomized, multicenter study, known as ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinsons disease), assessed the efficacy and tolerability of Azilect as add-on treatment to dopamine agonists compared to placebo. While the efficacy of Azilect as adjunct to levodopa has been established in previous studies (leading to its indication as adjunct therapy to levodopa), its efficacy in combination with dopamine agonist monotherapy has not previously been studied. Results from the study demonstrated that the addition of 1 mg of Azilect daily provided a statistically significant improvement in total Unified Parkinsons Disease Rating Scale from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo. Azilect was well-tolerated with no significant difference in adverse events compared to placebo. The positive outcome of this study is important news for the PD community, for patients and physicians, said University of South Florida, Director, Parkinsons Disease & Movement Disorders Center Dr. Robert A. Hauser and primary investigator of the study. In addition to rasagiline … Continue reading →

Grant to be used to help fund further human clinical testing of dipraglurant for the treatment of Parkinson`s disease levodopa-induced dyskinesia New York, NY and Geneva, Switzerland, 19 March 2013 - Addex Therapeutics (ADXN.SW), a leading company pioneering allosteric modulation-based drug discovery and development, and The Michael J. Fox Foundation for Parkinson`s Research announced today that the Foundation awarded a $1,000,000 grant to Addex to help fund continued human clinical testing of dipraglurant for the treatment of Parkinson`s disease levodopa-induced dyskinesia (PD-LID). One-third of people with PD develop dyskinesia within four to six years of beginning levodopa treatment; this increases to approximately 90 percent after nine or more years. Patients with Parkinson`s disease (PD) can live 10-20 years after diagnosis; however, PD-LID is a leading cause of disability in this growing patient population. "Dyskinesia is a top priority for our Foundation because of its significant negative impact on patients` quality of life," said Todd Sherer, Ph.D., Chief Executive Officer of The Michael J. Fox Foundation. "Candidates such as dipraglurant and other innovative therapies in development offer the possibility of improved quality of life through better symptomatic treatment of Parkinson`s. Dipraglurant targets a molecular mechanism that our Foundation has been investing … Continue reading →

CARLSBAD, CA--(Marketwire - Mar 20, 2013) - International Stem Cell Corporation (ISCC) ( OTCQB : ISCO ) (www.internationalstemcell.com), a California-based biotechnology company focused on the therapeutic applications of human parthenogenetic stem cells today announced positive results demonstrating the safety and efficacy of stem cell engraftment in a primate model of Parkinson's disease. The results were presented during the American Academy of Neurology (AAN) 65th Annual Meeting, Scientific Platform Session: Parkinson's Disease Therapeutics on Wednesday, March 20, 2013 in San Diego. "This pilot study represents a first essential step in bringing cell-based therapies for Parkinson's disease to clinical trials," commented co-author of the study Evan Y. Snyder, MD, PhD, Director of Stem Cells and Regenerative Biology Program at Sanford Burnham Medical Research Institute. These placebo-controlled studies were designed to demonstrate the viability, fate and functional efficacy of the stem cell derived neural cells after implantation to the brain. Highly pure populations of neuronal cells were differentiated from human parthenogenetic stem cells (hpSC) according to the protocol developed by International Stem Cell Corporation and recently published in the Nature Publishing Group's Scientific Reports. The studies employ MPTP-lesioned African Green monkeys and 6-OHDA-lesioned rats, the principle models used to study Parkinson's disease. The … Continue reading →

ESPOO, FINLAND--(Marketwire - Mar 21, 2013) - A new levodopa product (ODM-101) developed by Orion Corporation could improve the treatment of advanced Parkinson's disease patients. According to a Phase II study, presented yesterday at American Academy of Neurology's Annual Meeting in San Diego, ODM-101 significantly decreased daily OFF-time without increasing ON-time with troublesome dyskinesias compared to reference product Stalevo, which is an established standard medication for advanced Parkinson's patients experiencing so-called end-of-dose wearing off symptoms associated with levodopa therapy. Stalevo, also a product of Orion's own pharmaceutical R&D, contains three active substances in one tablet: levodopa and the enzyme inhibitors entacapone and carbidopa. ODM-101 has the same components as Stalevo but with higher and fixed amount of carbidopa (either 65 or 105 mg) regardless of levodopa dosage. For the clinical Phase II trial, 117 patients with Parkinson's disease and with response fluctuations were randomly given Stalevo, ODM-101/65 mg and ODM-101/105 mg in a cross-over study with three periods each lasting for 4 weeks. Daily OFF-time (time when patients do not have adequate response to their treatment) and ON-time (time when patients have a good treatment response) with and without troublesome dyskinesia (involuntary movements) were measured by patient diary. Both ODM-101/65 … Continue reading →