San Francisco Business Times - by Steven E.F. Brown
Impax Laboratories Inc. said a drug it’s testing for use against Parkinson’s Disease did well in a mid-stage clinical trial.
The Hayward business (NASDAQ: IPXL), led by CEO Larry Hsu, makes generic drugs. It also has its own drug-making division, Impax Pharmaceuticals, led by President Michael Nestor, which is working on this drug.
This formulation of carbidopa-levdopa, IPX066, was tested against an existing carbidopa-levdopa drug called Sinemet, made by Merck & Co. (NYSE: MRK) and sold by Bristol-Myers Squibb Co. (NYSE: BMY). It performed better than Sinemet in this test, with the comparison being a measurement of “off” time reported by Parkinson’s patients during waking hours. IPX066 improved those symptoms for two hours longer in the test than Sinemet.
This Phase II trial enrolled 27 people with advanced Parkinson’s Disease. Impax is signing people up now for a Phase III test of the drug and plans another one early next year.
For more information go to www.parkinsonresearchfoundation.org
Tuesday, September 22, 2009
Monday, September 14, 2009
Transgenomic and Power3 publish Parkinson's paper
Transgenomic and Power3 Medical Products have announced the advance online publication of a clinical research paper in the Biochemical and Biophysical Research Communications scientific journal.
The study, entitled 'Abnormal Serum Concentrations of Proteins in Parkinson's Disease', demonstrates the usefulness of a protein biomarker panel to distinguish Parkinson's Disease (PD) patients from age-matched normal controls, independent of the severity of symptoms, using clinical blood serum samples.
The analytic technology forms the basis for the NuroproPD test for PD being commercialised by Transgenomic as per a licensing/collaboration agreement with Power3Medical signed in early 2009.
The publication of the peer-reviewed article is described as a validation milestone in the clinical development of the NuroproPD diagnostic assay.
The article describes the use of analytically validated quantitative 2D gel electrophoresis to identify protein biomarkers for diagnosing PD using serum from routinely collected blood samples.
Some 57 protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls.
A multi-variate statistical method, stepwise linear discriminant analysis, selected a combination of 21 of the biomarkers as optimal to distinguish PD patients from controls.
When applied to the PD samples, the 21-protein set had sensitivity of 93.3 per cent (52 of 56 PD correctly classified) and specificity of 92.9 per cent (28 of 30 controls correctly classified); 15 of 15 patients with mild and 28 of 30 with moderate-to-severe symptoms were correctly classified, as were all six PD samples from an independent site.
Craig Tuttle, chief executive officer of Transgenomic, said: 'We are enthusiastic about the acceptance of our paper in this established peer-reviewed scientific journal.
'It represents independent external validation of the clinical data and so increases the confidence that we have in NuroproPD to be a meaningful tool for the diagnosis of Parkinson's Disease, especially early in its course.
'We are completing the clinical validation of the assay in our CLIA-certified molecular testing laboratory and will be launching the assay in the very near future,' he added.
Dr Ira Goldknopf, president and chief scientific officer of Power3 Medical and lead author on the paper, said: 'In the US, there are an estimated 1.5 million individuals with Parkinson's Disease.
'Unfortunately, by the time patients are given a probable diagnosis, many have already suffered substantial and irreparable brain damage, rendering treatment less effective.
'The fact that these results were obtained using fresh blood serum, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for their robustness and their commercial value.' Clinical investigators in the study were Dr Katerina Markopoulou of Thessaly University in Greece, Dr Marwan Sabbagh and Dr Holly Shill of Banner Sun Health Research Institute in Sun City, Arizona, and Dr Stanley Appel of the Texas Methodist Health System in Houston.
For more information go to www.parkinsonresearchfoundation.org
The study, entitled 'Abnormal Serum Concentrations of Proteins in Parkinson's Disease', demonstrates the usefulness of a protein biomarker panel to distinguish Parkinson's Disease (PD) patients from age-matched normal controls, independent of the severity of symptoms, using clinical blood serum samples.
The analytic technology forms the basis for the NuroproPD test for PD being commercialised by Transgenomic as per a licensing/collaboration agreement with Power3Medical signed in early 2009.
The publication of the peer-reviewed article is described as a validation milestone in the clinical development of the NuroproPD diagnostic assay.
The article describes the use of analytically validated quantitative 2D gel electrophoresis to identify protein biomarkers for diagnosing PD using serum from routinely collected blood samples.
Some 57 protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls.
A multi-variate statistical method, stepwise linear discriminant analysis, selected a combination of 21 of the biomarkers as optimal to distinguish PD patients from controls.
When applied to the PD samples, the 21-protein set had sensitivity of 93.3 per cent (52 of 56 PD correctly classified) and specificity of 92.9 per cent (28 of 30 controls correctly classified); 15 of 15 patients with mild and 28 of 30 with moderate-to-severe symptoms were correctly classified, as were all six PD samples from an independent site.
Craig Tuttle, chief executive officer of Transgenomic, said: 'We are enthusiastic about the acceptance of our paper in this established peer-reviewed scientific journal.
'It represents independent external validation of the clinical data and so increases the confidence that we have in NuroproPD to be a meaningful tool for the diagnosis of Parkinson's Disease, especially early in its course.
'We are completing the clinical validation of the assay in our CLIA-certified molecular testing laboratory and will be launching the assay in the very near future,' he added.
Dr Ira Goldknopf, president and chief scientific officer of Power3 Medical and lead author on the paper, said: 'In the US, there are an estimated 1.5 million individuals with Parkinson's Disease.
'Unfortunately, by the time patients are given a probable diagnosis, many have already suffered substantial and irreparable brain damage, rendering treatment less effective.
'The fact that these results were obtained using fresh blood serum, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for their robustness and their commercial value.' Clinical investigators in the study were Dr Katerina Markopoulou of Thessaly University in Greece, Dr Marwan Sabbagh and Dr Holly Shill of Banner Sun Health Research Institute in Sun City, Arizona, and Dr Stanley Appel of the Texas Methodist Health System in Houston.
For more information go to www.parkinsonresearchfoundation.org
Sunday, September 6, 2009
Parkinson’s disease affects more than just motor control
Although Parkinson’s disease is most commonly viewed as a “movement brouhaha,” scientists give birth to establish that the disease also causes widespread abnormalities in touch and idea - effects that give birth to second been verified using useful winning resonance imaging (fMRI) of the brain.
The new findings, by scientists at Emory University School of Medicine and Zhejiang University Medical School in Hangzhou China, were presented on Oct. 17 at the Society for Neuroscience meeting in Atlanta.
Scientists studying Parkinson’s disease (PD) previously have focused on the brain’s motor and premotor cortex, but not the somatosensory or the visual cortex. But Emory neurologist Krish Sathian, MD, PhD, and colleagues had earlier discovered, through tests of tactile ability, that PD patients have sensory problems with touch. They designed a study using fMRI to investigate the brain changes underlying these sensory abnormalities.
Dr. Sathian’s research group studied six patients with moderately advanced PD and six age-matched healthy controls. After documenting the typical movement problems of PD and ruling out dementia and nerve problems in the PD patients, they administered a common test of tactile ability to both groups, asking the participants to use their fingers to distinguish the orientation of ridges and grooves on plastic gratings. At the same time, they conducted a brain-scanning study using fMRI. This technology measures activations of neurons in different areas of the brain by means of variations in blood flow as an individual does a particular task.
The fMRI scans showed that the PD patients had much less activation of the somatosensory areas in the brain’s cortex than did the healthy controls. The scientists also were surprised to find similar widespread differences in the visual cortex, although the task involved touch, not vision.
“Our finding that the visual cortex is affected in Parkinson’s disease, while surprising, makes sense given that our laboratory and many others have shown previously that areas of the brain’s visual cortex are intimately involved in the sense of touch,” Dr. Sathian notes. “Although the reasons for this are uncertain, they may involve a process of mental visualization of the tactile stimuli and may also reflect a multisensory capability of the visual cortex.”
Dr. Sathian believes the study shows that the traditional boundaries between brain systems involved in touch and vision, and between those involved in sensation and movement, are artificial constructs that break down with more in-depth study. From a practical standpoint, it shows that patients with PD and other movement disorders have considerable problems in addition to movement control.
“These problems need to be appreciated in caring for these patients and in designing newer strategies for treatment and rehabilitation,” Dr. Sathian emphasizes.
For more information go to: www.parkinsonresearchfoundation.org
The new findings, by scientists at Emory University School of Medicine and Zhejiang University Medical School in Hangzhou China, were presented on Oct. 17 at the Society for Neuroscience meeting in Atlanta.
Scientists studying Parkinson’s disease (PD) previously have focused on the brain’s motor and premotor cortex, but not the somatosensory or the visual cortex. But Emory neurologist Krish Sathian, MD, PhD, and colleagues had earlier discovered, through tests of tactile ability, that PD patients have sensory problems with touch. They designed a study using fMRI to investigate the brain changes underlying these sensory abnormalities.
Dr. Sathian’s research group studied six patients with moderately advanced PD and six age-matched healthy controls. After documenting the typical movement problems of PD and ruling out dementia and nerve problems in the PD patients, they administered a common test of tactile ability to both groups, asking the participants to use their fingers to distinguish the orientation of ridges and grooves on plastic gratings. At the same time, they conducted a brain-scanning study using fMRI. This technology measures activations of neurons in different areas of the brain by means of variations in blood flow as an individual does a particular task.
The fMRI scans showed that the PD patients had much less activation of the somatosensory areas in the brain’s cortex than did the healthy controls. The scientists also were surprised to find similar widespread differences in the visual cortex, although the task involved touch, not vision.
“Our finding that the visual cortex is affected in Parkinson’s disease, while surprising, makes sense given that our laboratory and many others have shown previously that areas of the brain’s visual cortex are intimately involved in the sense of touch,” Dr. Sathian notes. “Although the reasons for this are uncertain, they may involve a process of mental visualization of the tactile stimuli and may also reflect a multisensory capability of the visual cortex.”
Dr. Sathian believes the study shows that the traditional boundaries between brain systems involved in touch and vision, and between those involved in sensation and movement, are artificial constructs that break down with more in-depth study. From a practical standpoint, it shows that patients with PD and other movement disorders have considerable problems in addition to movement control.
“These problems need to be appreciated in caring for these patients and in designing newer strategies for treatment and rehabilitation,” Dr. Sathian emphasizes.
For more information go to: www.parkinsonresearchfoundation.org
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