July 12th, 2011
The National Parkinson Foundation (NPF) has awarded more than $1 million dollars in clinical research projects in 2011 for three key areas of Parkinson’s disease research, including an advanced biomarker study, a clinical trial to treat memory impairment, and a study of the effectiveness of a treatment for sleep apnea in PD.
Under the direction of the Clinical and Scientific Advisory Board (CSAB), NPF supports research conducted by the top neurological experts at its 43 Centers of Excellence worldwide. These research awards will support three novel clinical investigations at Centers of Excellence in the United States and Canada.
NPF funded the following two-year clinical research grants:
MRI Biomarkers for Motor and Non-Motor Manifestations of Parkinson’s Disease. To examine Parkinson’s disease patients to measure the shapes of deep structures in the brain in an effort to develop a biomarker for Parkinson’s. This new technique combines advances in computing power with established (and inexpensive) imaging techniques to provide greater insight.
Sleep Disordered Breathing and its Impact on Cognitive Performance and Quality of Life in Parkinson’s Disease. Poor sleep affects the quality of life for people with PD, and it is also possible that it may contribute to decreased cognition. This study will evaluate the prevalence of sleep-disordered breathing (SDB) and test the effectiveness of a common SDB treatment in people with Parkinson’s.
Sleep and Learn with Transcranial Magnetic Stimulation (TMS) in Parkinson’s Disease.
Motor learning involves practicing a task followed by forming a habit—a short-cut in the brain to do a complex motion. This study will investigate this process and how it is affected by PD in people with PD and then attempt to improve motor learning by stimulating neurons using TMS. TMS therapy has been shown to activate neurons in the brain and can be targeted to those associated with motor learning.
For additional information:
http://www.prnewswire.com/news-releases/national-parkinson-foundation-awards-more-than-1-million-for-research-124772678.html
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July 7th, 2011
Stephen J. Ubl, CEO of Advanced Medical Technology Association (AdvaMed), recently said that America’s role as world leader in medical technology is being challenged and that the certain public policies need to be put in place to “to provide a level playing field between the U.S. and foreign competitors.”
There is growing concern that other nations are catching up to the U.S. in this medical technology arena, and a recent PwC Innovation Scorecard showed that other developed nations are closing the gap with the U.S. On a scale of 1 to 9 the U.S. scores 7.1. while the UK, Germany, Japan and France are moving up, and fall within the 4.8 to 5.4 range. Of those nations in the study, Germany and the UK demonstrate the strongest support for innovation.
“The medical technology field in the U.S. has long benefited from a confluence of social, technical, political and economic forces that came together to create an ecosystem which fosters medical technology innovation,” said Michael Swanick, U.S. Pharmaceuticals, Medical Device and Life Sciences industry leader, PwC.
Swanick said that the balance is beginning to shift with changes in global economic dynamics, governmental policies and the actions of individual companies and entrepreneurs. Those who are positioned to adapt to new modes of innovation will find opportunities in this space.
AdvaMed released a “Competitiveness Agenda” with specific policy recommendations:
- Innovation in the life sciences must be a government priority, including requiring an innovation impact statement for significant new regulations that affect the health sector.
- The FDA review process must be reformed to reduce total review times. American patients should have as prompt access to new treatments as do European patients.
- Payment policies of Medicare, Medicaid and private insurers must support medical innovation and not penalize early adopters of new treatments and cures.
- A vigorous trade policy must support export growth and provide a level playing field for U.S.-based manufacturing.
- Strategic tax policies to level the playing field must be implemented, including improvements to the R&D tax credit to keep it competitive with other countries.
- The American research and development infrastructure must be sustained and improved. Special emphasis should be placed on creating research structures that support commercialization of the R&D.
For additional information: http://www.industryweek.com/articles/can_the_u-s-_hold_onto_its_lead_in_medical_technology_innovation_24868.aspx
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June 27th, 2011
Treatment of type 1 or type 2 diabetes patients with the investigational ultra rapid acting mealtime insulin AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events according to the results of two different recent studies.
The results of the studies also show that inhaled AFREZZA did not produce clinically significant effects on heart rate, PR and QRS interval duration, or cardiac morphology.
Two phase 3, clinical trials are currently underway AFREZZA(R), a novel, ultra rapid-acting mealtime insulin therapy in late stage clinical investigation for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia. Trials are seeking to evaluate the efficacy and safety of AFREZZA using MannKind Corporation’s next generation inhalation device.
Researchers reviewed cardiovascular adverse events from nine phase 2/3 clinical trials (of 4,467 patients treated for periods from three months to two years) to determine if excess cardiovascular events occurred in patients treated with AFREZZA versus current antidiabetic therapies.
In controlled trials, the incidence of cardiovascular events did not show increased risk with AFREZZA use in type 1 (31 vs. 35, 0.85 relative risk), type 2 (167 vs. 136, 1.02 relative risk) or the combined type 1 plus type 2 (198 vs. 171, 1.01 relative risk) diabetes populations. The number of patients with ischemic events was low and similar between treatment groups. Cerebrovascular events and other cardiovascular events, such as coronary artery disease, and arrhythmic events were also similar between treatment groups.
For further detail: http://www.marketwatch.com/story/studies-show-no-increased-risk-of-cardiac-events-in-diabetes-patients-treated-with-afrezzar-2011-06-24?reflink=MW_news_stmp
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June 23rd, 2011
A new safety study showed that injecting a diagnostic echo-contrast agent in patients undergoing right heart catheterization did not alter baseline pulmonary pressures.
Thirty patients, including 19 with pulmonary hypertension, participated in the crossover, placebo-controlled study. Study results show that the administration of perflutren protein-type A microspheres injectable suspension did not lead to a rise in pulmonary arterial systolic pressure (PASP) or pulmonary vascular resistance (PVR).
The study, which was jointly designed by the United States Food and Drug Administration and GE Healthcare, indicated that there is no significant safety issue related to the general physical blockage of pulmonary vasculature.
For additional reading: http://www.theheart.org/article/1238593.do
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June 7th, 2011
According to new studies, more researchers are focusing on the use of genetic information to match drugs to the drivers of tumors in specific patients, creating personalized treatments with increased effectiveness that can be delivered more quickly to market.
The studies, which were released recently at the American Society of Clinical Oncology’s annual meeting, indicate that personalized medicine is becoming an increasingly important tool in the battle against cancer.
Researchers are matching genetic information about a tumor to new treatments to improve results, and they believe that by targeting mutations fewer patients will be needed to prove the efficacy of new drugs. This could increase the speed with which those treatments can be delivered to other patients.
The researchers are using “biomarkers,” or specific genetic traits in tumors, in the development of treatments. However, many tumors are fueled by multiple pathways that can help the tumors to develop resistance when a single pathway is disrupted. Researchers and drug companies are already testing combinations of targeted treatments, which both complicates the risks of treatment and the process necessary to achieving approval.
Targeted drugs are also expensive and do not necessarily offer a cure, but the increased response by patients is remarkable.
http://online.wsj.com/article/SB10001424052702304432304576367802580935000.html?KEYWORDS=cancer
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May 31st, 2011
Taking aspirin or simvastatin does not appear to benefit those with pulmonary arterial hypertension (PAH), according to recently published research.
Researchers from the University of Pennsylvania School of Medicine conducted a study with 65 patients with PAH who had been randomized into four groups: those taking aspirin, simvastatin, aspirin plus simvastatin, or neither.
The investigators used a six-minute walk distance (6MWD) as the key outcome measure in the study, and found that the 6MWD tended to be lower among those taking simvastatin at six months.
The investigators also found no significant difference in the 6MWD between those who received aspirin and those who received placebo. The results of this study do not support the routine treatment of PAH with aspirin or simvastatin.
The research was published in Circulation, coinciding with a presentation at the American Thoracic Society’s 2011 International Conference in Denver.
For more information: http://www.doctorslounge.com/index.php/news/pb/20258
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May 18th, 2011
Northwest Biotherapeutics and Fraunhofer have announced that they are partnering to produce DCVax®-L for brain cancer for both clinical trials and compassionate use cases in Europe.
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis.
Fraunhofer — a highly respected leader in many areas of technology, including cell and immune therapies — is the largest applied research foundation in Europe. The company has a staff of more than 18,000 scientists, engineers, and business personnel dedicated to practical applications and commercialization of research results.
The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in Leipzig, Germany, has dedicated a substantial portion of its state-of-the-art manufacturing facilities to the production of DCVax®, and is assisting NWBT with the applicable regulatory requirements for both clinical trials and compassionate use cases.
The partnership will enable NWBT to advance clinical trials in Europe, and to provide compassionate use treatments of patients along with clinical trials.
For additional information: http://www.4-traders.com/NORTHWEST-BIOTHERAPEUTICS-277398/news/NORTHWEST-BIOTHERAPEUTICS-INC-Northwest-Biotherapeutics-and-the-Fraunhofer-Institute-for-Cell-Therap-13630366/
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May 16th, 2011
Neuronetics, Inc. has announced that it has completed its Series E financing totaling $30 million, with two new investors — Polaris Venture Partners and Pfizer Venture Investments — leading the round.
Neuronetics, Inc. is the maker of the NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy® System for the treatment of major depression. Investor Growth Capital, New Leaf Venture Partners, Interwest Partners, Three Arch Partners, Quaker BioVentures, and Onset Ventures are previous investors who participated in the round.
Neuronetics has marketed the NeuroStar TMS system for the treatment of major depression for patients who have not adequately benefitted from prior antidepressant medication. The therapy system was cleared by the United States Food and Drug Administration in October 2008.
“This financing is a tremendous vote of confidence in the potential of NeuroStar TMS Therapy by two premier life science investors,” said Bruce J. Shook, President and CEO of Neuronetics, Inc. “The financial resources, experience and knowledge that Polaris and Pfizer bring to our company will allow us to build on our success and accelerate our efforts to bring NeuroStar to the millions of people suffering from depression.”
“The market opportunity for a novel, non-invasive and non-systemic treatment for major depression like Neuronetics’ NeuroStar TMS Therapy is extremely attractive,” said Kevin Bitterman, Ph.D., Principal at Polaris Venture Partners. “The NeuroStar TMS system gives psychiatrists an entirely new tool in their effort to treat those patients who are struggling with depression and do not get relief from existing therapies. The team at Neuronetics has done an impressive job of bringing this technology into mainstream medical practice, and we look forward to helping advance this important effort.”
“Pfizer has had a longstanding interest in treating depression,” said Elaine Jones of Pfizer Venture Investments. “We look at Neuronetics’ progress as the beginning of a potentially important advance in how we treat this often debilitating, chronic and costly disease. We are excited about supporting Neuronetics’ effort to bring a new and innovative solution to psychiatry.”
Neuronetics, Inc. is a privately held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic-field pulses. Based in Malvern, Penn., Neuronetics is the leader in the development of NeuroStar TMS Therapy, a non-invasive and non-systemic form of neuromodulation. Neuronetics, Inc. was represented in the Series E financing by Pepper Hamilton, LLP.
For additional information: http://www.sys-con.com/node/1834573
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May 12th, 2011
Researchers from the Cardiac Center at The Children’s Hospital of Philadelphia have found that children with congenital heart defects (CHD) who receive heart surgery in infancy experience better neurodevelopmental outcomes at age four when born closer to term. Better outcomes were found in infants born after 39 weeks versus infants born at 36 to 38 weeks.
Concerns over maternal and fetal health often prompt early delivery of children with CHD. When health concerns are not present, this research suggests that elective or spontaneous delivery at 39-40 weeks is preferable as it is associated with better neurodevelopmental outcomes.
The researchers analyzed a total of 351 infants born at 36 weeks gestation or later that were enrolled in a study for apolipoprotein-E (APOE) polymorphisms and neurodevelopmental outcome after infant cardiac surgery. Formal neurodevelopmental testing was performed at four years of age, including tests for attention, impulsivity, memory, cognition, language skills, executive function, social competence and visual-motor and fine-motor skills.
The median gestational age was 39 weeks with 125 patients born at 40 weeks or older. Older gestational age predicted better performance for short and long-term outcomes including cognition, visual-motor and fine-motor skills.
For further information: http://www.prnewswire.com/news-releases/neurodevelopmental-outcomes-for-babies-with-congenital-heart-defects-are-better-with-delivery-at-39-weeks-or-more-121647128.html
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May 12th, 2011
Medtronic, based in Minneapolis, recently announced that its cardiac catheter system, Arctic Front, the first cryoballon-based technology treatment for a common type of irregular heartbeat, was approved by Health Canada.
Cryoballon technology uses a coolant delivered through a catheter to block atrial fibrillation, a common arrhythmia. The minimally-invasive procedure creates circumferential lesions around the pulmonary vein, which can cause an irregular heartbeat through erratic electrical signals. The cooling technology allows the catheter to adhere to the tissue, and this leads to increased stability.
Health Canada approved the treatment based on a study demonstrating that 69.9% of patients treated with the system were free from atrial fibrillation at one year, compared to only 7.3% of patients who were free from atrial fibrillation at one year after treatment with drug therapy.
Half of all diagnosed atrial fibrillation patients fail drug therapy, according to recent research. If atrial fibrillation is left untreated, patients have up to a five times higher risk of stroke and an increased chance of developing heart failure.
More info: http://www.proactiveinvestors.com/companies/news/14487/medtronic-receives-health-canada-approval-for-common-heart-rhythm-disorder-14487.html
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