VistaGen Therapeutics, Inc. (VSTA)

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VistaGen Therapeutics, Inc. (VSTA)

Postby QualityStocks » Wed Oct 03, 2012 8:24 am

VistaGen Therapeutics is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants ("drug rescue variants") of once-promising drug candidates that have been discontinued during late-stage preclinical development due to heart or liver safety concerns. VistaGen also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs.

VistaGen's versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant predictions of potential heart and liver toxicity of promising new drug candidates long before they are ever tested on humans.

By more closely approximating human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development, VistaGen's human stem cell-based bioassay systems can improve the predictability of the drug development cycle and lower the cost of new drug research and development by identifying product failures earlier in the cost curve. According to the Food and Drug Administration even only a ten percent improvement in predicting failure before clinical trials could save $100 million in development costs, which savings ultimately could be passed on to patients.

Using mature human heart cells produced from stem cells, VistaGen has developed and internally validated CardioSafe 3D™, a novel three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. VistaGen is now focused on using CardioSafe 3D™ to generate up to two new, safer small molecule drug rescue variants every twelve to eighteen months. VistaGen anticipates that these drug rescue variants will be modified versions of once-promising new drug candidates that have been discontinued by pharmaceutical companies and academic research institutions because of heart toxicity concerns, despite substantial prior investment and positive efficacy data demonstrating their potential therapeutic and commercial benefits. In most cases, VistaGen plans to license or sell its new, safer drug rescue variants in strategic partnering arrangements with global pharmaceutical companies, arrangements providing VistaGen with both near term and downstream milestone payments and economic participation rights but without future development cost obligations.

VistaGen's lead drug candidate, AV-101, is in Phase Ib development in the U.S. for treatment of neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system.

Neuropathic pain affects approximately 1.8 million people in the U.S. alone. Although the current active AV-101 IND is for the treatment of neuropathic pain, VistaGen's development plan and regulatory strategy for AV-101 has been designed to allow its Phase 1 safety studies to support Phase 2 development for depression, epilepsy, Huntington's Disease and Parkinson's disease, indications for which there is now supporting preclinical efficacy data. To date, VistaGen has been awarded over $8.5 million from the U.S. National Institutes of Health (NIH) for development of AV-101.

VistaGen is also developing LiverSafe 3D™, a novel predictive liver toxicity and drug metabolism bioassay system for drug rescue applications. In parallel with drug rescue activities, the Company is funding early-stage nonclinical studies focused on potential cell therapy applications of its Human Clinical Trials in a Test Tube™ platform.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby mwest » Wed Oct 03, 2012 11:38 pm

Wow that process is very interesting so they use heart cell's made from Stem Cells?
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Thu Oct 04, 2012 7:17 am

The beauty of it is that, using these lab-generated human heart cells, pharmaceutical companies can get an accurate idea, very early in the drug development process, as to whether their drug candidate is safe or not. This can save such companies many millions of dollars, letting them avoid going to all the expense of developing and marketing a new drug only to find out later that it's toxic to the heart or liver.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby armedical » Thu Oct 04, 2012 7:38 am

This new technology will reduce the liability that many of these pharmaceutical companies have wfile testing a product. They will be willing to psych big bucks for this
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby stockseeker30 » Thu Oct 04, 2012 10:41 pm

Also huge in preventing lawsuits as well
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Fri Oct 05, 2012 7:02 am

Right. There's huge money involved in this.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby armedical » Fri Oct 05, 2012 5:35 pm

That is why it is so important to protect their assets.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Mon Oct 08, 2012 7:26 am

Once perfected and adopted by the marketplace, it could save the industry billions of dollars every year.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby mwest » Mon Oct 08, 2012 9:23 pm

And save many lives they ultimately hope for
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby stockseeker30 » Mon Oct 08, 2012 9:51 pm

What a unique way they are finding to do so as well
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Tue Oct 09, 2012 7:32 am

As they say, it's like having Human Clinical Trials in a Test Tube.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby QualityStocks » Tue Oct 09, 2012 8:45 am

VistaGen Therapeutics, Inc. (VSTA) and Neuropathic Pain

VistaGen Therapeutics is best known for having developed a versatile stem cell technology platform which can be used to produce superior testing options for new drug candidates, with the potential of saving the drug industry millions or even billions of dollars. But the company also has entered the high-dollar world of neuropathic pain management with the clinical development of AV-101, its small molecule drug candidate for the treatment of pain, and possibly depression and other neurological disorders.

Although the sensation of pain is an important protective mechanism for the body, warning of injuries and disease, it can sometimes persist long after an injury has healed, due to errant nerve impulses. Such chronic neuropathic pain can go on for months, and, in some cases, can itself be detrimental, causing organ damage or leading to a persistent pain state.

The global neuropathic pain market, though competitive, is huge, estimated at $4.8 billion in 2010 and expected by some to grow to $10 billion by 2018, representing an annual growth rate of over 9%. The increasing number of people facing diseases related to neuropathic pain will continue to fuel market growth. Today, the market is dominated by Pfizer’s Lyrica and Eli Lilly’s Cymbalta, with relatively few drugs in total currently approved for the treatment of neuropathic pain.

VistaGen’s AV-101 is a novel, orally available prodrug that is unique in its ability for rapid and efficient transport across the blood-brain barrier, where it converts in form to an effective pain blocker. Specifically, AV-101 is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), which is an antagonist of the N-methyl-D-aspartate (NMDA) receptors. 7-Cl-KYNA is a synthetic analogue of kynurenic acid, a naturally occurring CNS regulatory compound, and is one of the most potent and selective blockers of the regulatory GlyB-site of the NMDA receptor.

AV-101 is completing Phase 1 clinical development in the U.S., under an active Investigational New Drug (IND) application on file at the U.S. FDA.

For additional information, visit the company’s website at www.VistaGen.com
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby mwest » Tue Oct 09, 2012 11:08 pm

Very interesting to see how the pain management side of it will go
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Wed Oct 10, 2012 7:17 am

And that's just one of the therapeutic applications they are working on.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby mwest » Wed Oct 10, 2012 9:44 pm

Anyone dealing with pain will find this statement to be so true; "Although the sensation of pain is an important protective mechanism for the body, warning of injuries and disease, it can sometimes persist long after an injury has healed, due to errant nerve impulses. Such chronic neuropathic pain can go on for months, and, in some cases, can itself be detrimental, causing organ damage or leading to a persistent pain state."
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby stockseeker30 » Wed Oct 10, 2012 9:47 pm

I know I can assest to that and VSTA is welcomed for that reason alone
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Thu Oct 11, 2012 4:26 am

Persistent pain is more than just unpleasant. It can itself cause physical and emotional damage, and is a serious medical condition.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby mwest » Thu Oct 11, 2012 6:23 pm

The body is so fragile in this way and so good to have the technology to give relief
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby protostars » Fri Oct 12, 2012 7:04 am

A huge market if it works out for them.
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Re: VistaGen Therapeutics, Inc. (VSTA)

Postby stockseeker30 » Fri Oct 12, 2012 5:44 pm

Glad they pointed out the fact that there is a big difference between pain that alerts you and pain that persists way too long
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