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Dr. Bob is Robert Hsiung, MD,
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Posted by Phillipa on December 31, 2011, at 17:55:14
Neuralstem, Inc. (NYSE Amex: CUR) announced that it has been approved by the Food and Drug Administration to advance to Phase Ib in its ongoing clinical trial to test its novel neuroregenerative compound, NSI-189, for the treatment of major depressive disorder (MDD). Phase Ib will test the safety and tolerability of the drug in depressed patients. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in MDD as well as other diseases and conditions, such as Alzheimers disease and post-traumatic stress disorder (PTSD).
We are pleased to be approved to begin testing NSI-189 in patients who suffer from depression, said Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstems Board of Directors. Loss of hippocampal volume is a known characteristic in depressed patients. NSI-189 stimulates neurogenesis and increases hippocampal volume in healthy adult mice, at the same time reversing behavioral symptoms in mouse depression models, so it could address depression at the source.
It is exciting to see a new class of drugs that potentially offers a novel and different approach to this disease moving into patients, said Maurizio Fava, MD, Slater Family Professor of Psychiatry at Harvard Medical School and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital. Dr. Fava, one of the worlds leading researchers in MDD, helped design the Neuralstem trial.
About NSI-189
Neuralstems technology enabled the creation of neural stem cell lines from many areas of the human CNS, including the hippocampus. The hippocampus is a part of the brain involved in memory and the generation of new neurons. It is also implicated in several major neurological and psychiatric diseases. From its hippocampal neural stem cell lines, Neuralstem has created virtually unlimited amounts of mature human neurons and glia in laboratory dishes. These can be used to mimic the natural brain environment in order to test drug effects.
Neuralstem has been engaged in its own drug discovery program with these human hippocampal stem cell lines since 2000. In 2009, Neuralstem was granted U.S. patents on four first-in-class chemical entities that boost the generation of new neurons. NSI-189, the first of these to be in a clinical trial, significantly stimulates the generation of new hippocampal neurons (neurogenesis) in vitro and in animal models, above and beyond the neural stem cells innate differentiation.
NSI-189 is the lead compound in Neuralstems neuroregenerative small molecule drug platform, which the company plans to develop into orally administered drugs for MDD and other psychiatric disorders, such as Alzheimers disease, anxiety, bipolar disorder and post traumatic stress disorder.
NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in-vitro. In healthy normal adult mice, NSI-189 stimulated neurogenesis in the hippocampus and significantly increased its volume, apparently by increasing its synaptic network after 28 days of daily oral administration. In mouse models of depression, NSI-189 significantly improved behavioral responses associated with depression. In humans, NSI-189 may reverse the human hippocampal atrophy seen in MDD and other disorders and reverse their symptoms. This program has received significant support from both the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).
About the Trial
The NSI-189/MDD trial is a randomized, double-blind, placebo-controlled, multiple-dose escalating trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effect of NSI-189 in the treatment of MDD. Phase Ia tested escalating doses of single administration of NSI-189 in healthy patients. Phase Ib will test the safety of escalating doses of NSI-189 for 28 daily administrations in 24 depressed patients. The Phase Ib portion of the trial is expected to take approximately six months to complete.
Found this no idea what it means and is about? Phillipa
Posted by Twinleaf on December 31, 2011, at 18:31:57
In reply to New ad About to begin trials, posted by Phillipa on December 31, 2011, at 17:55:14
This sound very exciting and promising. All the things that have been really helpful to me - TMS, lithium and tianeptine - are all known to cause neurogenesis in the hippocampus. Hope it proves safe to take!
I would love to see development of medications which damp down the HPA axis. It's the excessive cortisol from that that is supposed to damage the hippocampus by stopping neurogenesis, I think.
Posted by Phillipa on December 31, 2011, at 21:25:33
In reply to Re: New ad About to begin trials, posted by Twinleaf on December 31, 2011, at 18:31:57
Twinleaf does the cortisol your body manufactures affect the brain? Just had cortisol testing done for Cushings which I knew didn't have. The 24 hour fasting dexamethasone test is the last of three I took and was normal? Thanks Phillipa
Posted by SLS on January 1, 2012, at 5:26:23
In reply to Re: New ad About to begin trials, posted by Twinleaf on December 31, 2011, at 18:31:57
> It's the excessive cortisol from that that is supposed to damage the hippocampus by stopping neurogenesis, I think.
I believe this is correct. Stress in general can't be good. It pays to reduce psychosocial stress and anxiety.
- Scott
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