|Positive Results in Abbott's Treatment for Parkinson's Disease; PROLOR Announces Positive Results of Its Obesity/Diabetes Drug|
|By Staff and Wire Reports|
|Tuesday, 17 April 2012 20:03|
Abbott (NYSE: ABT) announced the results from a Phase 3 trial evaluating the company's investigational compound for advanced Parkinson's disease, levodopa-carbidopa intestinal gel (LCIG). The study showed that patients treated with LCIG for 12 weeks reported clinically meaningful and statistically significant improvements in "off" time compared to levodopa-carbidopa immediate release (IR) tablets, without increasing troublesome dyskinesia. "Off" time refers to the periods of poor mobility, slowness and stiffness experienced by patients with Parkinson's disease. The results from the study will be presented as part of the Emerging Science program (formerly known as Late-Breaking) at the American Academy of Neurology's 64th Annual Meeting in New Orleans on April 25.
This study was conducted to determine the efficacy, safety and tolerability of continuous LCIG infusion in patients with advanced Parkinson's disease compared to standard levodopa-carbidopa IR tablets. LCIG contains the same active medication as levodopa-carbidopa IR tablets but in gel form and is administered directly into the small intestine via a procedurally-implanted tube connected to a portable pump. At baseline, patients enrolled in the study had Parkinson's disease for an average of 10.9 years and experienced an average of 6.6 hours of "off" time a day.
Key Findings: The primary efficacy endpoint was change from baseline in daily "off" time (16 waking hours) at 12 weeks.
Mean "off" time at 12 weeks decreased by 4.0 hours per day with LCIG, an average of 1.91 fewer hours of "off" time compared to levodopa-carbidopa IR tablets.
The secondary efficacy endpoint was change from baseline in daily "on" time without troublesome dyskinesias. "On" time refers to periods of good motor symptom control.
Mean "on" time improved by 4.1 hours with LCIG, an average of 1.86 more hours compared to levodopa-carbidopa IR tablets.
Treatment-emergent adverse events (AE) occurred in 35 patients on LCIG (95 percent) and in 34 patients on levodopa-carbidopa IR tablets (100 percent) and were similar between the two treatment groups. The most common adverse events were complication of device insertion (51 percent), abdominal pain (42 percent), procedural pain (32 percent), nausea (25 percent), constipation (21 percent), orthostatic hypotension (18 percent), post-operative wound infection (17 percent), and incision site erythema (16 percent). Treatment-related serious adverse events (SAE) were reported in five patients (14 percent) in the LCIG arm and in seven patients (21 percent) in the levodopa-carbidopa IR tablets arm. All patients that experienced an SAE recovered. Premature discontinuation because of AEs was low (4.2 percent), and similar between treatment groups.
"These results demonstrate that continuous delivery of levodopa-carbidopa intestinal gel produces statistically meaningful improvements in advanced PD patients by decreasing 'off' time and increasing 'on' time without troublesome dyskinetic symptoms," said Dr. C.W. Olanow, M.D., Professor of Neurology and Neuroscience at the Mount Sinai School of Medicine in New York City. "These benefits in a patient group that cannot be satisfactorily controlled with standard levodopa, represent an important step forward in our efforts to treat advanced PD patients."
Parkinson's disease is a movement disorder resulting from progressive loss of brain cells that produce the chemical dopamine. Dopamine helps control movement of the body. Early on in the disease, patients usually respond well to medications that increase dopamine levels. As the disease progresses, the effect of oral medications may not last as long and can cause increasing side effects.
Patients with advanced Parkinson's disease may experience fluctuations between periods of poor mobility or slowness and periods when disease symptoms are well controlled. The loss in mobility or slowness/stiffness and periods of good symptom control are referred to as "off" time and "on" time, respectively. When "off" time increases, a patient's "on" time progressively shortens. Additionally, many patients experience dyskinesias, which are involuntary movements associated with treatments used to manage Parkinson's disease. Some of these involuntary movements can bother patients and make it difficult to perform activities. These are referred to as "troublesome dyskinesias."
"Parkinson's disease is a devastating condition that gets increasingly more difficult to treat as it progresses. In the later stages, patients have a disease burden that negatively impacts their quality of life and can impact normal activities of daily living," said Robert Lenz, M.D., divisional vice president, Global Pharmaceutical Research and Development, Abbott. "Many patients at this stage are in need of additional treatment options, and we hope that LCIG may soon be a viable option for some of these patients."
LCIG is an investigational therapy that is currently being evaluated in patients with advanced-stage Parkinson's disease in additional Phase 3 clinical trials in the U.S. It is approved in 40 countries outside the U.S.
PROLOR Biotech, Inc. (NYSE: PBTH) reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels. The study results will be presented at GTC's 5th Diabetes Drug Discovery and Development Conference on April 19, 2012 in Boston, MA.
In the study, MOD-6030 administered to diet-induced obese (DIO) mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat.
"We believe there is great demand among obese patients and their physicians for therapies that will help patients lose weight and reduce elevated glucose levels resulting from obesity with minimal side effects and a favorable administration profile," said Dr. Abraham Havron, CEO of PROLOR. "In this study in animals, our MOD-6030 therapy demonstrated a unique combination of achieving substantial weight loss and improved glycemic profiles while also significantly lowering cholesterol levels."
Dr. Havron continued, "MOD-6030 is a long-acting version of a native peptide that acts as a natural satiety signal to reduce food intake, and we believe it has the potential be a major new treatment for obesity and Type II diabetes that is both effective and safe. We are currently on track to initiate the first human clinical trial of MOD-6030 in 2013."
MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide, is a long-acting version of oxyntomodulin, a naturally occurring hormone that acts as a natural satiety signal to reduce food intake and increase energy expenditure following food ingestion. Previous third-party studies in humans showed that the native oxyntomodulin can reduce appetite and food intake, leading to significant weight loss without apparent side effects. However, as a result of its very short half-life, oxyntomodulin has to be administered via three daily injections. PROLOR developed MOD-6030, its longer-acting version, by combining the naturally occurring hormone with the company's proprietary Reversible PEGylation technology designed to increase the half-life of therapeutic peptides and small molecules.
Affymetrix, Inc. (NASDAQ: AFFX) today announced that its first quarter 2012 operating results will be reported after market close on Thursday May 3, 2012.
BioClinica®, Inc., (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, will release its financial results for the first quarter ended March 31, 2012 on Wednesday, May 9, 2012.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the BioCentury Future Leaders in the Biotech Industry Conference in New York on April 20, 2012 at 11:00 am EDT.
Celgene Corporation (NASDAQ: CELG) senior management will host a conference call and live audio webcast on Thursday, April 26, 2012 at 9 a.m. ET to discuss the company’s first quarter 2012 financial and operational results.
In conjunction with the Charing Cross International Symposium (CX34), which concludes today in London, Minneapolis-based Medtronic, Inc. (NYSE: MDT) announced its plans for the imminent start of the IN.PACT Global SFA clinical study, an international research program to evaluate the treatment of peripheral artery disease using the company’s IN.PACT Admiral™ drug-eluting balloon.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that a Phase 4 study of ENTEREG® (alvimopan) in patients undergoing radical cystectomy met its primary endpoint of time to achieve recovery of both upper and lower gastrointestinal (GI) function.
Derma Sciences, Inc. (Nasdaq: DSCI) (“Derma Sciences”), a medical device and pharmaceutical company focused on advanced wound care, has completed its previously announced acquisition of MedEfficiency, Inc. (“MedEfficiency”), manufacturer of the TCC-EZ™ Total Contact Cast system.
Dyax Corp. (NASDAQ:DYAX) and Eclipse Therapeutics, Inc., a privately held oncology company, announced today that Dyax has granted Eclipse an exclusive worldwide license for the development and commercialization of preclinical fully-human antibodies discovered using Dyax’s gold-standard phage display technology for use in oncology indications.
Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that reported earnings per share equaled $0.72 in the fourth quarter of fiscal 2012.
Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, today announced that it will host a meeting on Wednesday, June 20, 2012 to review its late-stage product development pipeline and commercialization strategy.
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced the appointment of Linda Rosenstock, M.D., M.P.H. to its Board of Directors.
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) today announced the treatment of the first patient in a Phase 2 clinical trial of IMO-3100, the Company’s lead Toll-like receptor (TLR) inhibitor for the treatment of autoimmune diseases, in patients with moderate to severe plaque psoriasis.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced the start of clinical testing with its IMGN529 product candidate.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced that the Investigational New Drug (IND) application for its IMGN853 product candidate is now active.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of cloud-based clinical development solutions, today announced that it will release its first quarter 2012 financial results before the open of the market on Tuesday, May 1, 2012.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase IIb multi-center, 100-patient clinical trial.
Mentor Capital, Inc. (Pink Sheets:MNTR) reports that its proprietary Cancer Immunotherapy Index has appreciated 47.3% during the first quarter of 2012.
NeuroMetrix, Inc. (Nasdaq: NURO) today said it plans to issue its 2012 first quarter financial results before the opening of the market on April 24, 2012.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that its board of directors has declared its next ongoing quarterly cash dividend of $0.05 per share to its shareholders will be distributed on Tuesday, May 8, 2012, for shareholders of record as of Friday, April 27, 2012.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the first quarter 2012 financial results, provide an update on the Company’s business, and discuss expectations for the future.
Value Plastics, a Nordson Company (Nasdaq: NDSN), announces the PharmaLok™ Series – a new line of ergonomic, single-use sanitary clamps for securing fittings to bag ports and filters in the biopharmaceutical market.
Walgreens (NYSE: WAG)(NASDAQ: WAG) Executive Vice President and Chief Financial Officer Wade Miquelon will present during the Barclays Capital 2012 Retail & Restaurants Conference in New York City at approximately 3:30 p.m. Eastern time Tuesday, April 24.