Laesie onderzoeken
Neotropfin(AIT-082) lijkt heel veel op Inosine alleen dit passeert de "bloed/hersen grens" wel bij orale opname.Ze zijn het nu op ratten met SCI aan het testen en als het werkt zal het heel snel op mensen getest gaan worden omdat het waarschijnlijk oraal ingenomen kan worden en ze dus makkelijker toestemming van de FDA krijgen.
December 18, 2000
Company Press Release
NeoTherapeutics' Neotrofin(TM) Improves Brain Function in Alzheimer's Disease Patients, Clinical Study Shows
IRVINE, Calif., Dec. 18 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today clinical data from a study of its nerve regeneration drug, Neotrofin(TM), showed that the novel compound facilitates brain activity in Alzheimer's disease patients, leading to statistically significant improvement in memory, attention and judgement. Clinical data were presented at the 39th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in San Juan, Puerto Rico.
The double-blind, dose-escalating Phase 2 pilot study, conducted by Steven Potkin, M.D., professor of psychiatry and director of the Brain Imaging Center at the University of California, Irvine, evaluated 19 patients diagnosed with Alzheimer's disease who were treated with Neotrofin(TM).
Dr. Potkin reported that patients treated with Neotrofin(TM) experienced statistically significant improvement in three areas: memory, attention and judgement ( "executive function''). The improvement was dose related, with 500 mg and 1000 mg doses producing statistically more benefit than the 150 mg dose. These functional improvements were demonstrated by a multi-faceted battery of neurocognitive tests. Positron Emission Tomography (PET) scanning, which measures the metabolic activity of the brain, and electroencephalography (EEG), which measures brain waves, on the same patients, were consistent with improvement following Neotrofin(TM). The findings of this study support NeoTherapeutics' recently announced decision to initiate early next year a one-year clinical study at doses of 500 mg and 1000 mg in patients with moderate Alzheimer's disease.
"The clinical symptoms that were affected positively by Neotrofin(TM) -- memory, attention and judgement - are hallmarks of Alzheimer's disease,'' said Dr. Steven Potkin. "The positive changes in these symptoms were associated with increased metabolism in specific brain areas on PET scans. In addition, there were no serious side-effects reported by the patients.''
"The results of Dr. Potkin's clinical study validate our contention that Neotrofin(TM) is perhaps the first Alzheimer's disease therapy that stimulates nerve cell regeneration in the brain leading to disease course modification,'' said Rajesh Shrotriya, M.D., president of NeoTherapeutics. "The findings of Dr. Potkin's study show us that Neotrofin(TM) works, and together with the important results from our Phase 2b U.S. and Global clinical trials, provides us with the information we needed to properly design a large, long-term clinical study to demonstrate the drug's effectiveness for regulatory purposes. That trial is presently being designed, and after we reach agreement with the FDA on the protocol early next year, we will begin enrolling patients. With evidence such as this, it is easy to see why moving forward with clinical studies for Neotrofin(TM) in patients with Alzheimer's disease, Parkinson's disease and spinal cord injury remains our highest priority.''
"Especially gratifying is that the results of Dr. Potkin's study were presented at the ACNP meeting, an exclusive gathering of the preeminent experts in the field of neurology, psychiatry and neurodegenerative diseases, where attendance is limited to selected members and invitees,'' added Dr. Shrotriya.
NeoTherapeutics is a biopharmaceutical company focused on the development of small molecule drugs for unmet medical needs for the treatment of important diseases. The Company's most advanced drug, Neotrofin(TM), is currently being developed for Alzheimer's disease and other neurodegenerative diseases, such as Parkinson's disease and Spinal Cord Injury. In animal models of cognitive decline, aging and spinal cord injury, Neotrofin(TM) has been shown to restore neurological function. NeoGene Technologies, Inc., a subsidiary of NeoTherapeutics, is engaged in functional genomics research. NeoOncoRx, Inc., a subsidiary of NeoTherapeutics, is engaged in the development of anticancer drugs. For additional Company information, visit NeoTherapeutics' web site at www.neotherapeutics.com.
Gepost door Jan de Boer 19:06
Nog een onderzoek
Ze hebben nu een manier ontdekt om embryostamcellen zo te manipuleren dat ze geen tumoren meer ontwikkelen waardoor ze weer een hindernis hebben overwonnen om deze cellen bij dwarslaesiepatienten te gaan gebruiken.Het interessante van het artikel is de volgende passage "The next step, Gearhart pointed out, is to place the cells in animals to see whether they can treat disease or heal spinal cord injuries. Official results will not be available for several months, but preliminary findings look promising, he said".Binnen enkele maanden weten we dus meer.En dat Geron inc. (een biotechnologiebedrijf) er zich ook mee bemoeit waardoor er dus geld beschikbaar is voor evt. human trials later.
Wednesday January 3 10:09 AM ET
Scientists Clear One Hurdle for Using Stem Cells
By Merritt McKinney
NEW YORK (Reuters Health) - Scientists may have found a way to overcome some of the obstacles preventing the use of embryo-derived stem cells, a type of immature cell thought to hold great promise in the treatment of illnesses such as Parkinson's disease and diabetes.
While the cells can be grown in the laboratory after they are collected from embryos, the characteristics of stem cells make it difficult to move them from the laboratory to the clinic.
``We can't take the embryonic (stem) cells that we have and transplant them into anything,'' said Dr. John D. Gearhart, of Johns Hopkins University in Baltimore, Maryland. They will ''just as likely form a tumor as they will differentiate into some sort of tissue,'' he said.
Stem cells never stop dividing, so if the cells were to be transplanted before they had begun to form more specialized cells, they might form a tumor instead of normal tissue, Gearhart explained.
The key to overcoming this problem is to transplant cells that have already specialized somewhat, a process known as differentiation, according to the Johns Hopkins researcher. Differentiated cells are no longer immortal, so they do not run the risk of becoming cancerous, Gearhart noted. ``Once a cell commits, it won't become a tumor,'' he said.
In a report in the January 2nd issue of the Proceedings of the National Academy of Sciences, Gearhart and his colleagues detail their successful efforts to produce cells that can still form many different types of cells, but do not carry a risk of forming tumors.
The researchers started by coaxing embryonic stem cells to form clusters of cells known as embryoid bodies. From these small masses, the scientists then isolated cells called embryoid body-derived cells, which they grew in culture dishes to form different types of cells.
When they analyzed the embryoid body-derived cells, the researchers detected genes for several different cell types, including neurons and blood cells, Gearhart stated.
The fact that the embryoid body-derived cells contain the genes and other markers for several different cell types is intriguing, according to Gearhart. It suggests that the cells ''share a cluster of genes,'' he said. If this proves to be the case, it may mean that the cells, although more differentiated than the earliest of stem cells, may have the capability to form different types of tissue depending on where in the body they are transplanted, Gearhart added.
The researchers also found that, unlike the most immature stem cells, embryoid-derived cells are not immortal. They will divide 70 to 80 times and then die, Gearhart said, which is enough to grow tissue but not to form tumors.
The next step, Gearhart pointed out, is to place the cells in animals to see whether they can treat disease or heal spinal cord injuries. Official results will not be available for several months, but preliminary findings look promising, he said.
Gearhart and his colleagues also note that growing embryoid body-derived cells is much easier and faster than growing early stem cells. The ease in growing the cells, as well as the ability to have a uniform population of the cells and the ability to freeze and thaw them--which is important for storage--may reduce the number of cells that need to be collected from embryos, according to Gearhart.
The research was funded by Geron, Inc. Gearhart and one of his colleagues, as well as Johns Hopkins, have a financial interest in the company.
SOURCE: Proceedings of the National Academy of Sciences 2001;98:113-118.
Gepost door Jan de Boer 21:36
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