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How Big Pharma Stands to Benefit from VSTA Human Clinical Trials in a Test Tube™ Platform
The U.S. Food and Drug Administration has a low tolerance for drug candidates with safety risks; countless potential new drugs candidates fail in preclinical or clinical trials due to safety concerns, costing pharmaceutical companies billions of dollars in research and development (R&D) costs. VistaGen Therapeutics, a biotech company applying stem cell technology for drug rescue and cell therapy, believes that the majority of pricey and unexpected heart and liver toxicity and metabolism issues is due to limitations of the major toxicological testing systems currently used in the pharmaceutical industry, such as animal testing and cellular assays based on transformed cell lines and human cadaver cells.
VistaGen has developed the Human Clinical Trials in a Test Tube™ to address this problem. The platform takes human pluripotent stem cells, cells that have the ability to be geared and developed into any other kind of cell in the human body, and differentiates them into useable human heart cells and human liver cells. The company’s goal is to pair its stem cell technology with modern medicinal chemistry to create a diverse drug pipeline consisting of new, proprietary, small molecule variants (drug rescue variants) of once-promising drug candidates.
Upon developmental success, each lead drug rescue variant has potential to be a new drug candidate through which VistaGen can have upfront and development milestone payments and royalties on commercial sales. For big pharma companies struggling to roll-out new drugs, VistaGen’s technology offers an incredible solution.
Take Pfizer, for example. The company cut its R&D costs by $800 million to $6.6 billion last year to offset lagging revenues. In a recent article published on FierceBiotech.com, author John Carroll writes that while Pfizer expects to spend between $6.4 billion – $6.9 million on this year’s R&D, there’s speculation the company is capable of developing new blockbuster products. In 2013, Pfizer received FDA approval for Duavee, for hot flashes caused by menopause. Carroll also notes while the company received numerous FDA approvals in 2012, revenues continued to disappoint.
In conclusion, Carroll writes of Pfizer, “… there’s no convincing sign that the pharma giant has figured out how to get more out of the multibillion-dollar research budget that remains.”
According to the Food and Drug Administration even only a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs, which for a company in Pfizer’s position would allow for maximum use of R&D funds before digging too deep into the budget. VistaGen’s 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.
For more information, visit http://www.VistaGen.com
VSTA Tackling Expensive Problem of Drug Failure with Human Clinical Trials in a Test Tube™
With diseases such as Alzheimer’s, type 2 diabetes, and rheumatoid arthritis on the rise, there is a growing need for new and more effective treatments. But as an editorial by the Washington Post on new drug development initiatives by the National Institutes of Health makes clear, the cost of drug development failure is staggering—and widespread. According to the editorial, “taking a drug candidate from early discovery through Food and Drug Administration approval takes a decade and has a 95?percent failure rate.” Plus, with the cost of drug development being known to be able to exceed $1 billion, it is clear that pharmaceutical companies face a very uphill challenge in bringing blockbuster, high-therapeutic-potential drugs to market in today’s “drug approval climate”.
VistaGen Therapeutics, a California-based biotechnology company, meets this problem head-on with its Human Clinical Trials in a Test Tube™, a human pluripotent stem cell technology that enables biotechnology and pharmaceutical companies to identify unexpected heart or liver safety concerns before a drug candidate has journeyed far into its development process. With this “drug rescue” capability, biotechnology and pharmaceutical companies also become able to renew their bring-to-approval efforts of once-promising-but-now-backshelved drug candidates that were discontinued due to heart or liver safety issues.
According to a Forbes article in 2012, the sunk cost of a failed drug candidate for a big pharmaceutical company can be huge. The article notes that the cost of an average drug developed by a major pharmaceutical company is at least $4 billion. That is where the drug rescue potential of VistaGen Therapeutics’ technology becomes clear. VistaGen Therapeutics believes that conventionally used toxicological testing systems, such as animal testing and other nonclinical methods, do not closely approximate human biology enough to account for initially undetected liver and heart toxicity and metabolism issues. Human Clinical Trials in a Test Tube™, in contrast, enables the differentiation of human pluripotent stem cells into mature human cells. With these resources in hand, therapeutic solution developers then become able to identify any emerging liver or heart safety issues before a drug candidate has generated huge sunk costs in research and development.
Mr. Shawn Singh, J.D., Chief Executive Officer of VistaGen Therapeutics, has described the disruptive potential of Human Clinical Trials in a Test Tube™ as “game-changing”. Having noted that he has not seen anything like the ways VistaGen Therapeutics is applying stem cell technology in his broad professional career, Mr. Singh has signified his confidence that the human pluripotent stem cell technology could change the face—and cost dynamics—of American drug development and approval.
For more information, visit: http://www.VistaGen.com
VSTA Highlights Drug Rescue Potential at Noble Financial Capital Markets’ 9th Annual Equity Conference
VistaGen Therapeutics is a California-based biotechnology company that specializes in the application of human pluripotent stem cell (hPSC) technology for drug rescue, including predictive toxicology and drug metabolism screening. The company’s hPSC technology platform, Human Clinical Trials in a Test Tube™, enables accessibility to the heart and liver safety profile of drug rescue variants and other new drug candidates with greater speed and precision than conventional nonclinical testing and technologies used in drug development. Harnessing this technology’s unique power, VistaGen Therapeutics enables “drug rescue” of once-promising-but-now-backshelved drug candidates that have been discontinued by biotechnology or pharmaceutical companies prior to market approval due to unexpected heart or liver safety concerns.
Recently, the company made an appearance at Noble Financial Capital Markets’ 9th Annual Equity Conference. The conference took place Wednesday, January 22, 2014 to Thursday, January 23, 2014 at the Seminole Hard Rock Hotel in Hollywood, Florida. There, some 100 publicly held companies’ corporate representatives showcased their companies’ profiles, business strategies, and outlooks. Investment portfolio managers and equity analysts were on hand to analyze the representatives’ presentations, ask questions, and get a good all-around sense of how each business offers growth potential.
At the event, Mr. Shawn K. Singh, J.D., Chief Executive Officer of VistaGen Therapeutics, said that VistaGen Therapeutics is “changing the game” in the area of stem cell technology. Noting his experience of 22 years in the biotech space, Mr. Singh noted that 2014 will be the “breakout year” for the company.
Having touched upon his executive experience, he then said that the company is “applying stem cell technology in ways [he] has not seen possible in the last couple of decades in this space.” According to a Forbes article from February 2012, the sunk cost of drug development is huge, as the “average drug developed by a major pharmaceutical company costs at least $4 billion.” Likewise, the failure of drug development was noted to be staggering and largely attributable to heart or liver toxicity, with over 50% of drug development efforts failing due to these medical concerns.
Mr. Singh touched upon the efficacy of Human Clinical Trials in a Test Tube in combating these sunk cost risks, as the hPSC technology platform identifies failure potential early in a drug’s development process before too many cost have been paid. In short, the technology lets pharmaceutical companies “bring human biology to the forefront of drug development”, thereby letting them “change the game early” in their drug development stages. He then went on to discuss other key company focuses and goals for 2014.
The entirety of Mr. Singh’s presentation at the Noble conference can be found at: http://noble.mediasite.com/mediasite/Play/7b2df397209e4accad8b01e55857bb431d?catalog=7196f4ed-1981-4e62-afb2-e3a1f13bc7fb
For more information about VistaGen Therapeutics and its technologies, visit: http://www.vistagen.com
VSTA Unlocking the Power of Stem Cells to Revive Shelved but Promising Drug Candidates
VistaGen Therapeutics has developed a unique stem cell technology platform called Human Clinical Trials in a Test Tube™ – it’s a fairly simple name representing a complex and innovative bioassay system with the ability to predict potential toxicity and metabolism issues of promising drug candidates before they are ever tested in human subjects.
What makes the platform unique is its capability for predictive toxicology early in the development cost curve, before millions of dollars and research hours are spent on the clinical development of a drug that may or may not pass safety and efficacy tests.
VistaGen believes that by utilizing the Human Clinical Trials in a Test Tube™, pharmaceutical companies can revisit substantial value for failed drug candidates. VistaGen’s goal is to use its stem cell technology to create a pipeline of new, proprietary drug rescue variants of once-promising candidates that were shelved due to liver or heart toxicity concerns.
So why stem cells? First and foremost, stem cells have the amazing capacity to self-renew and develop into mature, specialized cells that make up the various tissues and organs of the human body. Pluripotent stem cells take it even further. These cells can be grown indefinitely in vitro and developed into any of more than 200 specialized cell types in the human body. These capabilities are what make pluripotent stem cells so valuable to medical researchers and therapeutic applications.
Human embryonic stem cells (hES Cells) are pluripotent stem cells derived from the excess embryos that developed from eggs in an in vitro fertilization clinic and then donated. hES cells are not derived from eggs fertilized in a woman’s body.
However, over the years, developments in stem cell research have made it possible to obtain pluripotent stem cell lines from an individual without the use of embryos. Human induced pluripotent stem cells (hiPS Cells) are adult cells that have undergone genetic reprograming to behave like hES Cells – these cells express genes necessary for maintaining the pluripotent property of hES Cells.
VistaGen believes the pluripotent property of these cells is the key for creating its human cell-based bioassays to develop its drug rescue efforts.
For more information, visit http://www.VistaGen.com
VSTA Has Head Start in Race to Develop New Drug Rescue Variants
VistaGen is a biotech small-cap applying its stem cell technology to revive once-promising drug candidates that were shelved due to heart and liver safety concerns. Pharmaceutical companies spend millions of dollars and decades of time researching new drug candidates to advance them into clinical development. If the drug candidate fails to achieve a favorable safety profile in late-stage preclinical development, further development often grinds to a halt, and with it, the potential therapeutic and commercial benefits.
Approximately one-third of all potential new drug candidates fail in preclinical or clinical trials due to safety concerns, leaving a wake of lame-duck therapeutic possibilities that could save lives and advance science in leaps and bounds.
This is where VistaGen takes the baton. The company believes that valuable accuracy and application are lost in testing animal subjects, which only approximate human biology and can lead to unexpected safety issues. Conversely, VistaGen aims to provide predictive toxicology and metabolism screening systems that more closely approximate human biology in early development phases.
Leveraging its Human Clinical Trials in a Test Tube™ platform, VistaGen is positioned to have a “head start” in the identification and development of new, proprietary Drug Rescue Variants in a more rapid and less expensive manner than drug candidates discovered and developed using conventional and in vitro cell culture testing.
The technology allows for the controlled differentiation of human pluripotent stem cells into mature, functional human cells, which may allow researchers to identify human toxicity or metabolism issues early in the drug development process, saving money and freeing up resources to focus on drug candidates with the highest probability of success.
VistaGen believes that this capability has the potential to significantly reduce drug development costs, while producing effective and safer drugs.
For more information, visit http://www.VistaGen.com
VSTA Founded on a Joint-Vision to Revolutionize Global Drug Development
Approximately one-third of all potential new drug candidates are shelved in their late-stage development due to preclinical or clinical safety concerns. As a result, in the last decade the number of new drugs that are approved each year has dramatically dropped, as much as 50 percent according to some estimates, though in the same 10-year span there has been an increase in funding for the development of these drug candidates.
To those paying attention to the healthcare industry, the low yield of these investments was not and has not gone unnoticed. In 1998, Drs. Ralph Snodgrass and Gordon Keller, both renowned leaders in stem cell biology, found that they shared a common vision to develop stem cell technology that could revolutionize the way drugs are discovered and developed.
VistaGen Therapeutics was the result of this vision, a biotech company dedicated to transforming global drug development. The company’s core focus is on drug rescue using its proprietary stem cell technology platform to revive once-promising drugs that for one reason or another were discontinued in late stage preclinical development. VistaGen’s particular interest is on drug variants that were discontinued due to heart toxicity concerns.
Leveraging its Human Clinical Trials in a Test Tube™ technology, VistaGen’s strategy is to generate a pipeline of drug candidates and then partner with the right industry players to move these drug rescue variants into commercialization.
Human Clinical Trials in a Test Tube™ combines the company’s proprietary and exclusively licensed human pluripotent stem cell (hPSC) technologies to enable the controlled differentiation of hPSCs into mature, functional human cells that could lead to the identification of drug candidates with human toxicity or metabolism issues. The revolutionary characteristic of this process is that these safety issues can be detected early in the drug development process, drastically reducing development costs.
Thus far, VistaGen has utilized mature heart cells produced from stem cells to develop the CardioSafe 3D bioassay system, which can predict both toxic and non-toxic in vivo cardiac effects of a drug candidate before it is ever tested on a human being. The company’s LiverSafe 3D has the potential to assess potential liver toxicity and adverse drug-drug interactions among relative drug candidates.
The company also intends to advance pilot non-clinical development of regenerative cell therapy programs focused on blood, cartilage, heart, and liver and pancreas cells.
For more information, http://www.vistagen.com
VSTA Poised to Revolutionize Drug Development with ‘Human Clinical Trials in a Test Tube’
Biotechnology company VistaGen Therapeutics is on the cusp of revolutionizing drug development with its Human Clinical Trials in a Test Tube™, a versatile stem cell technology platform that brings human biology to the frontend of the drug development process.
VistaGen has developed Human Clinical Trials in a Test Tube to provide clinically relevant predictions of the potential toxicity of promising new drug candidates long before they are ever tested on humans. Animal testing and other nonclinical techniques and technologies currently used in drug development can only approximate human biology at best, but the company’s human pluripotent stem cell-based bioassay systems much more closely emulate human biology. This will mean greater success for pharmaceutical companies and their potentially lifesaving drug candidates that get stymied at the human trial level.
Currently, a major stumbling block in the drug development process is that pharmaceutical companies can spend years and tens of millions of dollars discovering, optimizing and validating the potential efficacy of a lead drug candidate, advancing it through preclinical development, only to see it fail in human trials and be discontinued due to unanticipated heart or liver toxicity or metabolism issues. When a drug that has shown great therapeutic and commercial potential in preclinical development hits a dead end, a pharmaceutical company’s substantial prior investment may be lost and the world loses a potentially lifesaving or revolutionary drug.
VistaGen is working to break down this fundamental barrier to more efficient new drug development by meeting the great need for predictive toxicology screening systems. By surpassing the limitations of current animal and in vitro cell culture testing and more closely approximating human biology early on in the drug development process, VistaGen hopes to help pharmaceutical companies recapture significant value from their prior investments in formerly promising drug candidates that have been shelved due to heart or liver toxicity or metabolism concerns in humans.
The company’s goal is to use its stem cell technology to create a diverse pipeline of new, proprietary small molecule variants (drug rescue variants) of once-promising small molecule drug candidates that have been discontinued by pharmaceutical companies, the NIH, or academic laboratories. VistaGen believes that focusing solely on these discontinued drug candidates with positive preclinical efficacy data will offer a valuable head start in the company’s efforts to identify and develop new, safe drug rescue variants more quickly and cheaply than drug candidates that are being discovered and developed using conventional animal studies and in vitro cell culture testing systems.
Human Clinical Trials in a Test Tube™ will enable VistaGen and its medicinal chemistry partner to focus drug rescue efforts on generating safer, proprietary drug rescue variants that retain the promising efficacy of discontinued drug candidates but with reduced toxicity.
For more information, visit http://www.vistagen.com
VSTA 8-K SEC Filing
We have an ongoing process of evaluating potential business opportunities that we expect will contribute to our future growth. Among our current opportunities, we have entered into a Securities Purchase Agreement, dated April 8, 2013 (as amended, the "Agreement"), with Autilion AG, a company organized and existing under the laws of Switzerland ("Autilion"). Pursuant to the Agreement, Autilion is contractually obligated to purchase a total of 72.0 million restricted shares of our Common Stock at a purchase price of $0.50 per share for aggregate cash proceeds to us of $36.0 million (the "Autilion Financing"). Through January 6, 2014, we have completed a nominal initial closing of the Autilion Financing. Although there can be no assurance that an additional closing of the Autilion Financing will occur, on January 6, 2014, Autilion informed us that it expects us to receive the full $36.0 million committed under the terms of the Agreement between mid-January and mid-February 2014.
http://vsta.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9698434&Type=HTML
VSTA 8-K SEC Filing
We have an ongoing process of evaluating potential business opportunities that we expect will contribute to our future growth. Among our current opportunities, we have entered into a Securities Purchase Agreement, dated April 8, 2013 (as amended, the "Agreement"), with Autilion AG, a company organized and existing under the laws of Switzerland ("Autilion"). Pursuant to the Agreement, Autilion is contractually obligated to purchase a total of 72.0 million restricted shares of our Common Stock at a purchase price of $0.50 per share for aggregate cash proceeds to us of $36.0 million (the "Autilion Financing"). Through January 6, 2014, we have completed a nominal initial closing of the Autilion Financing. Although there can be no assurance that an additional closing of the Autilion Financing will occur, on January 6, 2014, Autilion informed us that it expects us to receive the full $36.0 million committed under the terms of the Agreement between mid-January and mid-February 2014.
http://vsta.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9698434&Type=HTML
VSTA Utilizing Stem Cell Technology to Develop High Potential Drug Candidates
VistaGen is a biotech company applying its human pluripotent stem cell (hPSC) technology for drug rescue, including predictive toxicology and drug metabolism screening.
The company’s human pluripotent stem cell (hPSC) technology platform, Human Clinical Trials in a Test Tube™, is based upon a combination of the company’s proprietary and exclusively licensed hPSC technologies.
The platform assesses the toxicity and metabolism (drug-drug interaction) profile of new small molecule drug candidates applicable to a wide range of diseases and conditions. The platform is designed to work at an accelerated and more precise rate than non-clinical in vitro techniques and technologies currently used by biotechnology and pharmaceutical companies.
Among other products, AV-101 is VistaGen’s novel, orally available prodrug candidate for the treatment of neuropathic pain, depression, and potentially other neurological conditions.
In preclinical studies, AV-101 demonstrated positive levels of oral bioavailability, rapid and efficient transport across the blood-brain barrier, and preferential conversion into 7-CKYNA at the site of seizures and potential neural damage in the brain and spinal cord.
The candidate has undergone successful phase 1 development, funded by an $8.8 million grant from the U.S. National Institutes of Health, under an active Investigational New Drug (IND) application with the U.S. FDA.
For more information, visit http://www.VistaGen.com
VSTA Utilizing Stem Cell Technology to Develop High Potential Drug Candidates
VistaGen is a biotech company applying its human pluripotent stem cell (hPSC) technology for drug rescue, including predictive toxicology and drug metabolism screening.
The company’s human pluripotent stem cell (hPSC) technology platform, Human Clinical Trials in a Test Tube™, is based upon a combination of the company’s proprietary and exclusively licensed hPSC technologies.
The platform assesses the toxicity and metabolism (drug-drug interaction) profile of new small molecule drug candidates applicable to a wide range of diseases and conditions. The platform is designed to work at an accelerated and more precise rate than non-clinical in vitro techniques and technologies currently used by biotechnology and pharmaceutical companies.
Among other products, AV-101 is VistaGen’s novel, orally available prodrug candidate for the treatment of neuropathic pain, depression, and potentially other neurological conditions.
In preclinical studies, AV-101 demonstrated positive levels of oral bioavailability, rapid and efficient transport across the blood-brain barrier, and preferential conversion into 7-CKYNA at the site of seizures and potential neural damage in the brain and spinal cord.
The candidate has undergone successful phase 1 development, funded by an $8.8 million grant from the U.S. National Institutes of Health, under an active Investigational New Drug (IND) application with the U.S. FDA.
For more information, visit http://www.VistaGen.com
VSTA Developing Promising LiverSafe3D™ Bioassay System to Predict Liver Toxicity
In collaboration with Dr. Gordon Keller, one of the world’s leading stem cell researchers, biotech company VistaGen Therapeutics is developing a novel human liver cell-based bioassay system, LiverSafe3D™.
VistaGen believes it can use its technology to provide clinically relevant biological information about a new drug candidate early in the drug development process, before time and money are spent on clinical trials.
To do this, VistaGen focuses on applying proprietary human pluripotent stem cell technology for technology for drug rescue, predictive toxicology, and drug metabolism screening. The LiverSafe3D system is designed to predict liver toxicity and metabolism issues in connection with VistaGen’s drug rescue activities.
In a poster presentation entitled “Semi–quantitative assay of CYP3A4 allows the identification and selection of mature human stem cell derived hepatocytes,” Dr. Kristina Bonham, senior scientist, Hepatocyte Biology Project Leader, earlier this year presented data indicating that the LiverSafe 3D bioassay can monitor the induction of the key metabolic enzyme, CYP3A4, and its expression level.
This data suggests that VistaGen’s liver cells contain functional properties of mature adult liver cells, which would allow for multiple functional analyses and provides a system to evaluate the effects of drug candidates on CYP3A4 expression and liver function.
For additional information, visit http://www.VistaGen.com
VSTA Developing Promising LiverSafe3D™ Bioassay System to Predict Liver Toxicity
In collaboration with Dr. Gordon Keller, one of the world’s leading stem cell researchers, biotech company VistaGen Therapeutics is developing a novel human liver cell-based bioassay system, LiverSafe3D™.
VistaGen believes it can use its technology to provide clinically relevant biological information about a new drug candidate early in the drug development process, before time and money are spent on clinical trials.
To do this, VistaGen focuses on applying proprietary human pluripotent stem cell technology for technology for drug rescue, predictive toxicology, and drug metabolism screening. The LiverSafe3D system is designed to predict liver toxicity and metabolism issues in connection with VistaGen’s drug rescue activities.
In a poster presentation entitled “Semi–quantitative assay of CYP3A4 allows the identification and selection of mature human stem cell derived hepatocytes,” Dr. Kristina Bonham, senior scientist, Hepatocyte Biology Project Leader, earlier this year presented data indicating that the LiverSafe 3D bioassay can monitor the induction of the key metabolic enzyme, CYP3A4, and its expression level.
This data suggests that VistaGen’s liver cells contain functional properties of mature adult liver cells, which would allow for multiple functional analyses and provides a system to evaluate the effects of drug candidates on CYP3A4 expression and liver function.
For additional information, visit http://www.VistaGen.com
VSTA Turns Back Time to Give Once-Promising Drug Candidates a Second Chance
VistaGen Therapeutics, a biotechnology company, is blazing new trails by looking to the past. The company has developed a pioneering stem cell technology platform that can give a second chance to potentially lifesaving drugs that have been shelved during human trials – essentially turning back the clock for stymied drug candidates and giving them a new pathway to success.
Human Clinical Trials in a Test Tube is VistaGen’s revolutionary human pluripotent stem cell (hPSC) technology platform, offering the pharmaceutical world a gateway through which formerly discontinued drug development candidates can potentially make a comeback. The platform surpasses animal testing and other nonclinical techniques and technologies currently being used in drug development. These presently used methods can only approximate human biology in their attempts to predict the outcomes of a drug candidate, which has spelled disaster and a dead end for countless drug candidates when they reached human trials.
Pharmaceutical companies spend years and millions of dollars developing drugs that show great therapeutic and commercial potential in preclinical development, only to have them fail at the human trial stage because of unanticipated heart or liver toxicity or metabolism issues in human subjects. That fast, a massive investment goes down the drain and the world loses a potentially lifesaving and life-altering drug. But with Human Clinical Trials in a Test Tube, VistaGen can potentially change all that.
Human Clinic Trials in a Test Tube overleaps the limitations of animal and in vitro cell testing and offers a predictive toxicology screening system which much more closely emulates human biology early in the drug development process – long before real human subjects ever encounter the drug. Using this hPSC technology, VistaGen can not only help pharmaceutical companies experience greater success in their drug development efforts, but the company will be able to create its own diverse pipeline of new, proprietary drug rescue variants of discontinued small molecule candidates that were ultimately discontinued due to adverse reactions in human test subjects.
VistaGen intends to get a valuable head start in identifying and developing new, safe drug rescue variants by focusing on these once-promising discontinued drug candidates. The company will not only resurrect potentially revolutionary drug candidates – it will save a great deal of time and money on its journey to bring new drugs to market.
For more information, visit http://www.VistaGen.com
VSTA Turns Back Time to Give Once-Promising Drug Candidates a Second Chance
VistaGen Therapeutics, a biotechnology company, is blazing new trails by looking to the past. The company has developed a pioneering stem cell technology platform that can give a second chance to potentially lifesaving drugs that have been shelved during human trials – essentially turning back the clock for stymied drug candidates and giving them a new pathway to success.
Human Clinical Trials in a Test Tube is VistaGen’s revolutionary human pluripotent stem cell (hPSC) technology platform, offering the pharmaceutical world a gateway through which formerly discontinued drug development candidates can potentially make a comeback. The platform surpasses animal testing and other nonclinical techniques and technologies currently being used in drug development. These presently used methods can only approximate human biology in their attempts to predict the outcomes of a drug candidate, which has spelled disaster and a dead end for countless drug candidates when they reached human trials.
Pharmaceutical companies spend years and millions of dollars developing drugs that show great therapeutic and commercial potential in preclinical development, only to have them fail at the human trial stage because of unanticipated heart or liver toxicity or metabolism issues in human subjects. That fast, a massive investment goes down the drain and the world loses a potentially lifesaving and life-altering drug. But with Human Clinical Trials in a Test Tube, VistaGen can potentially change all that.
Human Clinic Trials in a Test Tube overleaps the limitations of animal and in vitro cell testing and offers a predictive toxicology screening system which much more closely emulates human biology early in the drug development process – long before real human subjects ever encounter the drug. Using this hPSC technology, VistaGen can not only help pharmaceutical companies experience greater success in their drug development efforts, but the company will be able to create its own diverse pipeline of new, proprietary drug rescue variants of discontinued small molecule candidates that were ultimately discontinued due to adverse reactions in human test subjects.
VistaGen intends to get a valuable head start in identifying and developing new, safe drug rescue variants by focusing on these once-promising discontinued drug candidates. The company will not only resurrect potentially revolutionary drug candidates – it will save a great deal of time and money on its journey to bring new drugs to market.
For more information, visit http://www.VistaGen.com
VSTA Duke Engineers Build Living Patch for Damaged Hearts
http://www.pratt.duke.edu/news/duke-engineers-build-living-patch-damaged-hearts
VSTA Addressing Costly, Far-Reach Neuropathic Pain Condition with Development of Lead Candidate AV-101
Neuropathic pain is a serious and chronic condition that affects millions of people around the world. This pain follows damage or disease of the peripheral or nervous system, resulting in a variety of abnormal sensations such as the feeling of electric shock, burning or coldness, numbness and itching, or “pins and needles.”
Recent market research estimates that more than 1.5 billion people worldwide are afflicted with neuropathic pain, costing the U.S. public health system alone between $560 billion – $635 billion annually, according to the American Academy of Pain Medicine.
Small-cap company VistaGen Therapeutics’ lead small molecule drug candidate, AV-101, is being developed in the United States for the treatment of neuropathic pain. AV-101 is also being developed for additional indications, such as depression and other neurological indications.
To-date, the company has been awarded more than $8.8 million from the National Institute of Health for the development of this treatment.
In preclinical studies, AV-101 demonstrated positive levels of oral bioavailability, rapid and efficient transport across the blood-brain barrier, and preferential conversion into 7-CKYNA at the site of the patient’s seizures and potential neural damage in the brain and spinal cord.
So far the drug candidate has completed phase 1 development in the United States under and active Investigational New Drug (IND) application with the U.S. Food and Drug Administration.
VistaGen Therapeutics believes that safety results from the completed phase 1 program has the potential to position the candidate for phase 2 development for both neuropathic pain and depression.
For more information, visit http://www.VistaGen.com
VSTA Duke Engineers Build Living Patch for Damaged Hearts
http://www.pratt.duke.edu/news/duke-engineers-build-living-patch-damaged-hearts
VSTA Addressing Costly, Far-Reach Neuropathic Pain Condition with Development of Lead Candidate AV-101
Neuropathic pain is a serious and chronic condition that affects millions of people around the world. This pain follows damage or disease of the peripheral or nervous system, resulting in a variety of abnormal sensations such as the feeling of electric shock, burning or coldness, numbness and itching, or “pins and needles.”
Recent market research estimates that more than 1.5 billion people worldwide are afflicted with neuropathic pain, costing the U.S. public health system alone between $560 billion – $635 billion annually, according to the American Academy of Pain Medicine.
Small-cap company VistaGen Therapeutics’ lead small molecule drug candidate, AV-101, is being developed in the United States for the treatment of neuropathic pain. AV-101 is also being developed for additional indications, such as depression and other neurological indications.
To-date, the company has been awarded more than $8.8 million from the National Institute of Health for the development of this treatment.
In preclinical studies, AV-101 demonstrated positive levels of oral bioavailability, rapid and efficient transport across the blood-brain barrier, and preferential conversion into 7-CKYNA at the site of the patient’s seizures and potential neural damage in the brain and spinal cord.
So far the drug candidate has completed phase 1 development in the United States under and active Investigational New Drug (IND) application with the U.S. Food and Drug Administration.
VistaGen Therapeutics believes that safety results from the completed phase 1 program has the potential to position the candidate for phase 2 development for both neuropathic pain and depression.
For more information, visit http://www.VistaGen.com
VSTA Brings Human Biology to the Forefront of Drug Development
Biotechnology company VistaGen Therapeutics is engaged in applying human pluripotent stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening. The company’s innovations are advancing drug development by predicting toxicity and other human response to new drug candidates long before they are ever tested in humans, thereby bringing human biology to the forefront of drug development.
VistaGen’s human pluripotent stem cell-based bioassay systems more closely emulate human biology than any of the conventional animal studies and other nonclinical techniques and technologies currently being used in drug development. The company believes its technology is the answer to the drug discovery and development crisis faced by U.S. pharmaceutical companies today.
Though billions of dollars are invested by the U.S. pharmaceutical industry each year for research and development, a relatively low number of novel drugs, known as new molecular entities (NMEs), are ultimately approved by the FDA. This is due in large part to unexpected heart and liver toxicity and metabolism issues. These unforeseen issues, the company believes, are often the result of the limitations of major toxicological testing systems currently being used in the pharmaceutical industry – namely animals and cellular assays that are based on transformed cell lines and human cadaver cells. VistaGen believes better cells make better bioassay systems – and VistaGen has better cells.
Human Clinical Trials in a Test Tube, VistaGen’s versatile stem cell technology platform, has been developed to give clinically relevant predictions of the potential toxicity of promising new drug candidates before the drugs ever reach human trials. Developed using pluripotent stem cell-derived human heart cells, the company’s CardioSafe 3D, a novel three-dimensional bioassay system, predicts the in vivo cardiac effects of new drug candidates prior to human testing. Also being developed is LiverSafe 3D, a novel predictive liver toxicology and drug metabolism screening system for drug rescue applications.
Using CardioSafe 3D and modern medicinal chemistry, VistaGen aims to build a pipeline of new, proprietary variants (drug rescue variants) of once-promising small molecule drug candidates that were discontinued by pharmaceutical companies, the NIH, and academic research institutions because of toxicity concerns – despite significant investment in the drugs and positive efficacy data signaling their potential therapeutic and commercial benefits.
For more information about VistaGen and its advancements, visit http://www.VistaGen.com
VSTA Brings Human Biology to the Forefront of Drug Development
Biotechnology company VistaGen Therapeutics is engaged in applying human pluripotent stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening. The company’s innovations are advancing drug development by predicting toxicity and other human response to new drug candidates long before they are ever tested in humans, thereby bringing human biology to the forefront of drug development.
VistaGen’s human pluripotent stem cell-based bioassay systems more closely emulate human biology than any of the conventional animal studies and other nonclinical techniques and technologies currently being used in drug development. The company believes its technology is the answer to the drug discovery and development crisis faced by U.S. pharmaceutical companies today.
Though billions of dollars are invested by the U.S. pharmaceutical industry each year for research and development, a relatively low number of novel drugs, known as new molecular entities (NMEs), are ultimately approved by the FDA. This is due in large part to unexpected heart and liver toxicity and metabolism issues. These unforeseen issues, the company believes, are often the result of the limitations of major toxicological testing systems currently being used in the pharmaceutical industry – namely animals and cellular assays that are based on transformed cell lines and human cadaver cells. VistaGen believes better cells make better bioassay systems – and VistaGen has better cells.
Human Clinical Trials in a Test Tube, VistaGen’s versatile stem cell technology platform, has been developed to give clinically relevant predictions of the potential toxicity of promising new drug candidates before the drugs ever reach human trials. Developed using pluripotent stem cell-derived human heart cells, the company’s CardioSafe 3D, a novel three-dimensional bioassay system, predicts the in vivo cardiac effects of new drug candidates prior to human testing. Also being developed is LiverSafe 3D, a novel predictive liver toxicology and drug metabolism screening system for drug rescue applications.
Using CardioSafe 3D and modern medicinal chemistry, VistaGen aims to build a pipeline of new, proprietary variants (drug rescue variants) of once-promising small molecule drug candidates that were discontinued by pharmaceutical companies, the NIH, and academic research institutions because of toxicity concerns – despite significant investment in the drugs and positive efficacy data signaling their potential therapeutic and commercial benefits.
For more information about VistaGen and its advancements, visit http://www.VistaGen.com
VSTA 8-K SEC Filing JAN.07 2014
We have an ongoing process of evaluating potential business opportunities that we expect will contribute to our future growth. Among our current opportunities, we have entered into a Securities Purchase Agreement, dated April 8, 2013 (as amended, the "Agreement"), with Autilion AG, a company organized and existing under the laws of Switzerland ("Autilion"). Pursuant to the Agreement, Autilion is contractually obligated to purchase a total of 72.0 million restricted shares of our Common Stock at a purchase price of $0.50 per share for aggregate cash proceeds to us of $36.0 million (the "Autilion Financing"). Through January 6, 2014, we have completed a nominal initial closing of the Autilion Financing. Although there can be no assurance that an additional closing of the Autilion Financing will occur, on January 6, 2014, Autilion informed us that it expects us to receive the full $36.0 million committed under the terms of the Agreement between mid-January and mid-February 2014.
http://vsta.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9698434&Type=HTML
VSTA Human Clinical Trials in a Test Tube Set to Rescue Once-Promising Drug Candidates
The limitations of current animal and in vitro cell culture testing have long been a stumbling block for pharmaceutical companies as they endeavor to develop new lifesaving drugs. A drug candidate that has shown great promise in preclinical development can come to a dead end in human trials due to unanticipated heart or liver toxicity or metabolism issues, costing pharmaceutical companies hundreds of millions of dollars they’ve invested in discovering, optimizing, and validating the potential efficacy of the drug candidate. However, one biotechnology company is working to remedy this problem by meeting the tremendous need for predictive toxicology screening systems with greater accuracy.
VistaGen Therapeutics is currently developing Human Clinical Trials in a Test Tube, a versatile new stem cell technology platform that will bring human biology to the forefront of drug development.
Human Clinical Trials in a Test Tube provides clinically relevant predictions of the potential toxicity of new drug candidates long before they ever reach human trials. Human biology can only be approximated by animal testing and other nonclinical techniques and technologies currently being used in drug development, but VistaGen’s human pluripotent stem cell-based bioassay systems are able to much more closely emulate human biology. Ultimately, the company’s revolutionary stem cell technology platform is expected to result in greater success for pharmaceutical companies and their drug candidates that have been stalled in human trials.
By overcoming the limitations of current testing methods, VistaGen hopes to enable pharmaceutical companies to recapture substantial value from their prior investments in drug candidates that were once promising. The company’s goal is to create, using its stem cell technology, a diverse pipeline of new proprietary small molecule variants (drug rescue variants) of small molecule drug candidates that once showed great potential but have been discontinued by pharmaceutical companies, the NIH, or academic laboratories due to heart or liver toxicity or metabolism concerns in humans. By focusing exclusively on these discontinued drug candidates that showed positive preclinical efficacy data, VistaGen believes it will capture a valuable advantage in its efforts to identify and develop new, safe drug rescue variants faster and more cost-effectively than companies that are discovering and developing drug candidates through conventional animal studies and in vitro cell culture testing systems.
Through Human Clinical Trials in a Test Tube, VistaGen and its medicinal chemistry partner will be able to focus drug rescue efforts on generating safer proprietary drug rescue variants and retaining the promising efficacy of discontinued drug candidates with reduced toxicity.
For more information about VistaGen and Human Clinical Trials in a Test Tube, visit http://www.vistagen.com
VSTA FDA Gives Nod to Stem Cell Clinical Trials for MS – Portends Opportunity for VistaGen Therapeutics, Inc.
The U.S. FDA in August announced its approval for clinical trials using autologous neural stem cells in the treatment of multiple sclerosis (MS), a chronic autoimmune disease affecting roughly 2.1 million people around the world. The disease damages the central nervous system, often leaving those afflicted with cognitive complications, severe mobility issues, and eventually death.
There is currently no cure for the disease, though this groundbreaking approval to study regenerative therapy for this indication is a lever of hope for MS patients and biotech industries sold on the power of stem cell technology. The aforementioned trial will be conducted by Tisch MS Center of New York research team and will utilize autologous stem cells, which are derived from the patient’s own body – or bone marrow, in this specific case.
If the clinical trial is successful in achieving its goals and endpoints, it is natural to anticipate further investigation into new FDA drug approvals focused on regenerative therapies, which would create a significant advance for biotechnology companies.
Narrowing in on the small-cap space, biotech company VistaGen for years has been working on advancing its stem cell technology platform, Human Clinical Trials in a Test Tube™ , that in a nutshell potentially will allow scientists to assess the toxicity and metabolism profile of new drug candidates before millions of dollars and countless hours are invested.
The application of human pluripotent stem cell technology provides more accuracy than conventional animal and in vitro cell culture testing, which only approximates human biology. VistaGen’s proprietary and licensed technologies supporting the Human Clinical Trials in a Test Tube™ platform will enable controlled differentiation of pluripotent stem cells into mature human cells specific to the company’s predictive toxicology, drug metabolism, drug rescue, and cell therapy programs.
The FDA’s investigational new drug approval potentially opens a treasure chest of opportunity for regenerative therapies and companies like VistaGen that are focused on advancing their stem cell technology, allowing for progressive research, powerful collaborations, wider acceptance, and possibly increased funding capabilities.
“As important a milestone as the FDA investigational new drug approval is,” Tisch researchers said in a statement announcing the trial, “it marks the true beginning and not the end of our clinical research of stem cell therapy.”
Indeed, the beginning for all players in the field of stem cell research.
For more information about VistaGen and its advancements, visit http://www.VistaGen.com
VSTA Drug Rescue Program Aligned with Needs in Drug Approval Process
In calendar year 2013, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 27 novel new medicines (NMEs) approved under New Drug Applications (NDAs) and Biologics License Applications (BLAs). This comes from a report from the FDA that also says submissions for novel new medicines in the last decade have been relatively flat, with the exception of 2012.
While all applications submitted in 2013 were not accepted for filing as of December 31, 2013, CDER forecasts that about 36 total applications were submitted for 2013, meaning nine were left on the table for one reason or another.
This information is of particular value to VistaGen Therapeutics, a small-cap biotech company focused on reviving once-promising drug candidates that were shelved due to toxicity issues. The expense of failure is staggering for the company and investors that have invested considerable time and money in their drug candidates. This high cost of failure associated with unexpected heart and liver toxicity and metabolism issues drives the cost to develop drug candidates higher and results in relatively low annual number of FDA-approved NMEs.
VistaGen believes that the majority of pricey and unexpected heart and liver toxicity and metabolism issues stem from limitations of the major toxicological testing systems currently used in the pharmaceutical industry, namely animal testing and cellular assays based on transformed cell lines and human cadaver cells.
The company’s solution is its Human Clinical Trials in a Test Tube™, which utilizes human pluripotent stem cells (hPSCs), cells that have the ability to be geared and developed into any other kind of cell in the human body, and differentiates them into useable human heart cells and human liver cells. VistaGen’s strategy is to apply this technology combined with medicinal chemistry to generate new, proprietary drug rescue variants of once-promising small molecule drug candidates that were discarded for safety concerns.
Using mature human heart cells produced from its stem cell technology, VistaGen has developed CardioSafe 3D™, a novel, three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects, both toxic and non-toxic, of drug rescue variants and other small molecule drug candidates before they are tested in animals and humans. The company is further expanding its drug rescue capabilities by developing LiverSafe 3D™, a novel bioassay system using hPSC-derived human liver cells to assess potential liver toxicity and adverse drug-drug interactions in drug rescue variants and other new drug candidates early in development, before animal and human testing. Identifying toxicity issues early in the development process can save considerable research, money and other resources.
Of the 27 drugs recently approved by CEDR, at least two pertained to cardiac disease. VistaGen is well-positioned to take advantage of unmet needs in this niche market of the healthcare industry.
For more information on VistaGen visit http://www.VistaGen.com
VSTA Stands to Benefit from Unprecedented, Long Overdue Shift in Pharmaceutical Industry
There’s a pivotal shift taking place the pharmaceutical industry, one that bridges the gap between the company with an $80 billion market cap and heavy cash flow and the one with an $8 million market cap scraping the bottom of the barrel. That bridge is called public market, and by connecting the landmass (market space, in this case) of both companies, there is considerable and growing symmetry in the balance of power between the pharmaceutical giants and the little guys.
In an interesting article entitled, “The Big Guys Have Lost Their Iron Grip, and It’s All Good,” author Luke Timmerman likens big pharma’s relationship with the small biotech players to his seventh grade physical education teacher, who used his size and a “patented ‘pinch’” to drag students to his office for disciplining.
Noting that big pharma companies for the last decade have taken the upper hand at the bargaining table against small companies with high-potential new therapies, Timmerman writes:
“That’s no longer true. The little guy with a promising new drug candidate can walk away from a low-ball bid and go public now. The rising tide of the stock market has roughly doubled the group of companies that have the cash to buy innovative new drugs. …What it means, essentially, is that the little guy in biotech that develops most of the innovative products suddenly has options. … More people will now be encouraged to start new biotech companies, to invest in them, and they will be fairly rewarded when successful. It’s the healthiest environment for innovation that I’ve seen in years.”
Here’s what used to happen. Biotech companies painstakingly and expensively worked for years to advance their innovations from idea through the development to validating results in clinical trials and setting out in search of licensing deals or acquisition. Then, a big pharma would flag the potential of this drug candidate and low-ball a measly bid to the biotech company who didn’t have the power to negotiate or ask for more.
“Then along came the great biotech bull market of 2013. It was the second-biggest year on record for biotech IPOs, with 52 companies going public by my count. The Nasdaq Biotech Index rose 66 percent last year, compared with the broader Nasdaq Composite Index, which saw a 39 percent gain,” writes Timmerman.
With the numbers comes leverage, and mid-cap pharmaceutical companies have grown into positions of opportunity to compete in acquisition bidding wars against bigger industry players. Now, small biotechs are in a better position to play the field of interested bidders and negotiate higher upfront payments, and more profitable milestones.
Take small-cap biotech company VistaGen, for example. VistaGen is focused on advancing its stem cell technology for drug rescue with the goal of generating a pipeline of drug rescue variants that it plans to license or sell them to larger biotech and pharmaceutical companies who have the resources to further develop and commercialize the product.
VistaGen is addressing major challenges in the drug development process based on the patented and clinically predictive drug development capabilities of its Human Clinical Trials in a Test Tube™ platform. In today’s market, VistaGen has an incredible change, buoyed by several variables, to sell its drug rescue variants to a larger company that will be willing to shell out a fair price.
“Part of what’s driving the higher prices, of course, is simple supply and demand. There’s always a scarcity of great new drugs in the pipeline … Pharma companies are as hungry as ever, and desperate in some cases, to fill up their meager R&D pipelines. … The big guys should be able to pick up a steady stream of innovations they can purchase, at still-reasonable prices. A few (not more than a handful) of venture capital firms will refill their coffers. They, along with a few good entrepreneurs, will be encouraged to invest in more groundbreaking, platform type technologies …,” states Timmerman.
Thanks to increasing equilibrium of power between pharmaceutical behemoths and innovative small-cap plays, companies like VistaGen find themselves in an unprecedented position of power and opportunity.
Read Timmerman’s full article here: http://www.xconomy.com/national/2014/01/20/the-big-guys-have-lost-their-iron-grip-and-its-all-good
VSTA Vision for Stem Cell Technology Aligned with Broader Hopes for Cardiotoxicity
The U.S. pharmaceutical industry is facing a “drug discovery and development crisis,” says small-cap biotech VistaGen Therapeutics, evidenced by the fact that while the pharmaceutical industry in 2012 invested nearly $49 billion in R&D, a total of only 39 novel drugs were approved by the FDA. The hang-up is on the costly price tag of drug development and non-approval due to safety concerns of the candidates.
In recognition of this crisis, a movement toward the use of stem cell technology to address these issues has begun. VistaGen is already on board, leveraging its human cells derived from its human pluripotent stem cell (hPSC) technology, which it considers superior to major toxicological testing systems that use animal cells and cellular assays based on transformed cell lines and human cadaver cells, which at best only approximate human biology. The company believes it can develop better medicine by using its technology to provide clinically relevant biological information about a new drug candidate early in the drug development process, before time and money are spent on clinical trials.
In July 2013, the U.S. Food and Drug Administration (FDA) led a meeting with the FDA-sponsored Cardiac Safety Research Consortium, and the Health and Environmental Sciences Institute (HESI) to plan and discuss an overhaul to incorporate various individual ion channel assays and electrophysiological tests of stem cell-derived cardiomycocytes to revolutionize cardiac safety.
“The key thing we’ve realized over the last few years working on stem cells is that they are very much a game changer, particularly in cardiotoxicity,” Nick Thomas, principal scientist in cell technologies at GE Healthcare in Cardiff, UK, told Kelly Rae Chi in a recent article in Nature Reviews.
As the FDA and its cohorts hammer out a schema to address toxicity concerns and the issues of the development of drug candidates, VistaGen continues to advance its technology portfolio. The company’s Human Clinical Trials in a Test Tube™, is based upon a combination of the company’s proprietary and exclusively licensed hPSC technologies. The platform assesses the toxicity and metabolism (drug-drug interaction) profile of new small molecule drug candidates applicable to a wide range of diseases and conditions. The platform is designed to work at an accelerated and more precise rate than non-clinical in vitro techniques and technologies currently used by biotechnology and pharmaceutical companies.
VistaGen’s CardioSafe 3D™ novel biological assay system uses mature human heart cells derived from hPSCs to screen for heart toxicity in connection with the company’s drug rescue activities. The company believes that CardioSafe 3D™ is stable, reproducible, and capable of generating data to allow more accurate in vitro prediction of the in vivo cardiac effects, both toxic and nontoxic, of promising new drug candidates long before they are tested in humans.
Furthermore, VistaGen believes the results of its internal validation studies indicate that CardioSafe 3D’s efficacy in identifying safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.
For more information visit http://www.VistaGen.com
VistaGen Therapeutics, Inc. JAN.07 2014 8-K SEC Filing
We have an ongoing process of evaluating potential business opportunities that we expect will contribute to our future growth. Among our current opportunities, we have entered into a Securities Purchase Agreement, dated April 8, 2013 (as amended, the "Agreement"), with Autilion AG, a company organized and existing under the laws of Switzerland ("Autilion"). Pursuant to the Agreement, Autilion is contractually obligated to purchase a total of 72.0 million restricted shares of our Common Stock at a purchase price of $0.50 per share for aggregate cash proceeds to us of $36.0 million (the "Autilion Financing"). Through January 6, 2014, we have completed a nominal initial closing of the Autilion Financing. Although there can be no assurance that an additional closing of the Autilion Financing will occur, on January 6, 2014, Autilion informed us that it expects us to receive the full $36.0 million committed under the terms of the Agreement between mid-January and mid-February 2014.
http://vsta.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9698434&Type=HTML
VistaGen plans to use proceeds of the financing to accelerate and expand its stem cell technology-based drug rescue programs. Using its innovative CardioSafe(TM) 3D and LiverSafe(TM) 3D bioassay systems and modern medicinal chemistry, the Company is focused on generating new, safer, proprietary variants (Drug Rescue Variants) of once-promising small molecule drug candidates discontinued in development by large pharmaceutical companies due to heart or liver safety issues. In collaboration with co-founder and renowned stem cell research scientist, Dr. Gordon Keller, as well as long-term strategic partner, the University Health Network in Toronto, and several other leading academic and corporate collaborators, VistaGen also plans to advance new pilot nonclinical regenerative cell therapy programs and certain other emerging commercial opportunities related to its Human Clinical Trials in a Test Tube(TM) platform.
VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism screening. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube(TM), with modern medicinal chemistry to generate novel, safer chemical variants (Drug Rescue Variants) of once-promising small molecule drug candidates. These are drug candidates discontinued by pharmaceutical companies, the U.S. National Institutes of Health (NIH) or university laboratories, after substantial investment in discovery and development, due to heart or liver toxicity or metabolism issues. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans, bringing human biology to the front end of the drug development process.
VistaGen's small molecule prodrug candidate, AV-101, has completed Phase 1 development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects millions of people worldwide.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.
VistaGen Appoints Industry Veteran Shawn Singh as Chief Executive Officer
Seasoned Biotech Executive to Lead VistaGen’s Stem Cell-based Clinical Trials in a Test TubeTM Platform Focused on Transforming the Way New Drugs Are Discovered and Developed
SOUTH SAN FRANCISCO, CA (August 20, 2009) — VistaGen Therapeutics has named Shawn K. Singh as Chief Executive Officer. Mr. Singh was Managing Principal of Cato BioVentures, one of VistaGen’s largest institutional investors, and the Company’s President (part-time). Mr. Singh also served as Chief Business Officer, President, CEO or Chairman of five different biopharmaceutical companies, as well as CBO and General Counsel of Cato Research Ltd., a global contract research and development organization. Ralph Snodgrass, PhD, VistaGen’s founder and former CEO, will continue to serve as President and Chief Scientific Officer. Both Dr. Snodgrass and Mr. Singh are members of VistaGen’s Board of Directors.
VistaGen is one of the leading companies worldwide focused on using the power of stem cell technologies to transform the way new medicines are discovered and developed. The Company’s internal programs are focused on discovery and development of next generation drugs to treat Alzheimer’s, cancer and diabetes.
“VistaGen is a dynamic company marked by visionary technology, a rich history of innovation and a remarkable ability to navigate through intense economic and political headwinds without veering off course,” said Shawn Singh. “We believe better human response information can lead to better medicine. By using our Clinical Trials in a Test TubeTM platform to focus on how new drugs work in the body and how they interact with people with specific genetic differences, we are confident that our founding vision can become a medical reality.” He added, “I am honored to have the opportunity to lead a team so passionately focused on commercializing science that will make a difference.”
“I have worked with Shawn for eight years, and I strongly support both his appointment as CEO and my new role as President and Chief Scientific Officer,” said Dr. Ralph Snodgrass. “Together, these changes significantly broaden and strengthen our management team, enabling us to accomplish more than ever before, both commercially and scientifically, and I look forward to this new phase in our corporate development.”
“VistaGen is moving rapidly on many business fronts,” said Jon Saxe, VistaGen’s Chairman. “We are fortunate to have available someone of Shawn’s leadership skills and extensive experience with a wide range of life science companies and technologies to lead VistaGen’s efforts to realize the full commercial potential of its stem cell technologies. At the same time, the continued service of our founder, Ralph Snodgrass, as President and CSO is invaluable. Shawn’s availability as CEO on a full- time basis will enable Ralph to devote more time to strategic vision and scientific development of the platform, including collaborations with commercial partners and our esteemed network of academic stem cell research centers.”
VistaGen’s stem cell-based Clinical Trials in a Test TubeTM platform is focused on creating in human cells a comprehensive picture of the intricate details of human biology and human disease in ways that conventional animal models and non-human cell culture systems can only approximate. This enables drug developers to test for drug toxicity and efficacy in the lab quickly and efficiently, before costly human clinical trials.
Mr. Singh began his career as a corporate finance attorney in the Silicon Valley offices of Morrison & Foerster. He later served as Chief Business Officer of SciClone Pharmaceuticals (NASDAQ: SCLN), Chief Business Officer and General Counsel of Cato Research Ltd., a global contract research and development organization, Chief Operating Officer and Managing Principal of Cato BioVentures, the venture capital affiliate of Cato Research Ltd, President of Echo Therapeutics (OTCBB: ECTE), Chairman of the Board and President of Durham Pharmaceuticals, President of Artemis Neuroscience, and Chief Executive Officer of Hemodynamic Therapeutics.
Mr. Singh received a B.A. from the University of California, Berkeley, and a J.D. from The University of Maryland School of Law. He currently serves on the Board of Directors of Echo Therapeutics and Hemodynamic Therapeutics and as a strategic advisor to Cato BioVentures and several other private biopharmaceutical companies.
VistaGen Therapeutics, Inc. is a South San Francisco-based biotechnology company that focuses on providing clinically relevant, commercially scalable, human stem cell biology-based screening systems capable of predicting the safety and efficacy of new drugs in ways never before possible. VistaGen’s Clinical Trials in a Test TubeTM platform is designed to generate predictive information that results in reduced probability of clinical trial drug failures, especially failures associated with heart and liver toxicity. VistaGen expects its new-generation stem cell-based human systems biology platform to enhance dramatically the pharmaceutical industry’s ability to deliver innovative drugs for some of the world’s most challenging diseases and conditions.
For more information, visit: http://www.VistaGen.com
Value of VSTA is Seen in Pharmaceutical Disasters
The importance of the work being done at VistaGen Therapeutics, developers of stem-cell based bioassay early-warning systems for determining possible toxicity of drug candidates, can be seen in the clinical disasters occasionally experienced by major players in the pharmaceutical industry. A recent article (http://dtg.fm/v3V4) by Valorie Sands in Minyanville, an Internet-based financial media and publishing company, gives an idea of the risks pharmacy companies face, and the need for better and earlier testing.
The article points to the 2010 withdrawal by Pfizer of Thelin (sitaxentan), a medication for treating pulmonary arterial hypertension that had been approved for marketing in Europe, Canada, and Australia, and was undergoing final clinical trials in the U.S., when liver toxicity claimed two lives. In 2008, Pfizer had paid roughly $195 million in a cash tender offer to acquire Encysive Pharmaceuticals to get the drug, which had generated sales of over $44 million for Pfizer in the 9 months prior to its withdrawal.
Another example referred to in the article was a class of highly effective anticancer drugs called anthracycines. In spite of their effectiveness in the treatment of lung cancer, breast cancer, lymphomas, leukemias, and other types of cancers, the use of these drugs is now considerably limited due to the later discovery of significant cardiotoxicity associated with anthracycines.
Overall, toxicity issues end up affecting many new drugs, often late in testing, or even when they have made it all the way to market. The risk is not only to the physical health of patients, but also to the fiscal health of the companies that have invested hundreds of millions in a drug’s development. VistaGen proposes a solution to the problem through its unique Human Clinical Trials in a Test Tube stem cell based platform designed to provide superior heart and liver toxicity testing right in the laboratory, well before clinical trials or market exposure.
For additional information, visit http://www.VistaGen.com
Bergamo Acquisition Corp. (BGMO) Enters Investment Agreement with National Wealth International
Bergamo Acquisition, a global investment holding company, announced that it has signed an investment agreement with National Wealth International Ltd., a privately held investment company.
Bergamo Acquisition’s wholly owned European subsidiary has been provided with cashed-backed securities consisting of three separate tranches of US $500 Million issued through HSBC Bank, one of the world’s largest banking and financial services organizations. These funds from National Wealth International will remain on deposit in accounts held by Bergamo Acquisition’s European subsidiary.
All profits spawned from the use of the funds will be deposited in full to the bank of Bergamo’s European subsidiary company. These profits will be divided 50/50 between National Wealth International Ltd. and the European subsidiary company of Bergamo Acquisition as mandated by the profit-sharing agreement.
Bergamo Acquisition also told investors that the parties have agreed that no less than US $88 million, or its equivalent value in Euros, shall remain on deposit in the account of Bergamo Acquisition’s European subsidiary for a period of one year. This amount represents the initial profit earned from the first US $500 million cash-backed securities investments entered into between the parties previously, as set forth in Bergamo’s most recent consolidated financial report compiled by L.L. Bradford & Company LLC, a public accounting firm based in Nevada.
For more information, visit http://bergamocorp.com
Bergamo Acquisition has entered into a financial understanding and partnership in an investment program with National Wealth International Ltd. The agreement, which was announced January 9, 2013, enables access to ultra-high-return investment opportunities available only to those with extraordinary funds. Bergamo’s portion of the proceeds and profits from the investments will be used to develop and expand the company’s activities within its target markets. Its investments will be principally focused in financial instruments, commercial banking, alternative energy, broker dealer operations, a company-owned hedge fund, projects that make clean water available, and unique opportunities in the biotechnology and healthcare industries.
Bergamo Acquisition is based in Henderson, Nevada, and has affiliated offices in Europe and Asia. BGMO relies on its deep network within the global institutional investment and banking industries to source opportunities. BGMO has taken a 60% interest in Bergamo Energy Inc. of Miami, FL, a provider of solar energy technologies to sovereign and corporate customers in the Asian markets. In order to enhance disclosure and investor interest, BGMO has engaged the accounting firm of L.L. Bradford, based in Las Vegas, Nevada, to audit its financial records.
Bergamo Acquisition is targeting a diversified portfolio of large corporate and middle-market companies for sole acquisition and co-investment alongside other sophisticated investors such as private equity funds, hedge funds, investment banks, and other institutions. As a source of funding, BGMO will also work alongside company management in effecting management buy-outs, friendly mergers, and value-accretive capital projects. From time to time, the company may provide debt financing as a proprietary investor in the form of bi-laterally negotiated private placements. Bergamo Acquisition has raised investable funds in order to pursue the investment activities listed above. BGMO has sole fiduciary discretion over these funds and will direct their disposition in such a way that it will increase shareholder value for BGMO and its portfolio companies in line with its acquisition strategy.
Bergamo Acquisition Corp.
August 16,2013
Bergamo Acquisition Corp. (OTC: BGMO) Board of Directors are currently in the process of updating the financial compliance's with OTC markets and various related authorities by also submitting the relevant documents attesting to the authenticity of all the previous announcements on the OTC markets.
The senior management of the company is presently visiting their subsidiaries abroad in order to make the final financial arrangements connected with its previous announcements.
Safe Harbor Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Actual results, events and performances could vary materially from those contemplated by these forward-looking statements. These statements involve known and unknown risks and uncertainties, which may cause the Company'S actual results, expressed or implied, to differ materially from expected results. These risks and uncertainties include, among other things, product demand and market competition. You should independently investigate and fully understand all risks before making an investment decision.
Bergamo Acquisition Corp.
Hillard Herzog, 702-269-4523
IR@BergamoCorp.com
www.BergamoCorp.com
or
Investor Relations:
The Eversull Group, Inc.
Jack Eversull, President, 972-571-1624
Fax: 214-469-2361
jack@theeversullgroup.com
http://ih.advfn.com/p.php?pid=nmona&article=58848559&symbol=BGMO
New York, NY -- (SBWIRE) -- 11/20/2013 -- Bergamo Acquisition Corp. (OTCMKTS:BGMO) a fully operating company, established in 1997. The company has engaged investments in financial instruments and companies worldwide. In May of 2012, BGMO purchased 100% interest in a European entity for its investing strategies using the Euro currency.
Bergamo Acquisition is targeting a diversified portfolio of large corporate and middle-market companies for sole acquisition and co-investment alongside other sophisticated investors such as private equity funds, hedge funds, investment banks, and other institutions. As a source of funding, BGMO will also work alongside company management in effecting management buy-outs, friendly mergers, and value-accretive capital projects. From time to time, the company may provide debt financing as a proprietary investor in the form of bi-laterally negotiated private placements. Bergamo Acquisition has raised investable funds in order to pursue the investment activities listed above. BGMO has sole fiduciary discretion over these funds and will direct their disposition in such a way that it will increase shareholder value for BGMO and its portfolio companies in line with its acquisition strategy.
Bergamo Acquisition is based in Henderson, Nevada, and has affiliated offices in Europe and Asia. BGMO relies on its deep network within the global institutional investment and banking industries to source opportunities. BGMO has taken a 60% interest in Bergamo Energy Inc. of Miami, FL, a provider of solar energy technologies to sovereign and corporate customers in the Asian markets. In order to enhance disclosure and investor interest, BGMO has engaged the accounting firm of L.L. Bradford, based in Las Vegas, Nevada, to audit its financial records.
Bergamo Acquisition has entered into a financial understanding and partnership in an investment program with National Wealth International Ltd. The agreement, which was announced January 9, 2013, enables access to ultra-high-return investment opportunities available only to those with extraordinary funds. Bergamo’s portion of the proceeds and profits from the investments will be used to develop and expand the company’s activities within its target markets. Its investments will be principally focused in financial instruments, commercial banking, alternative energy, broker dealer operations, a company-owned hedge fund, projects that make clean water available, and unique opportunities in the biotechnology and healthcare industries.
http://www.sbwire.com/press-releases/complete-description-of-otcmktsbgmo-390571.htm
Bergamo Acquisition Corp Announces Financial Compliance Update
Bergamo Acquisition Corp.
August 16,2013
Bergamo Acquisition Corp. Board of Directors are currently in the process of updating the financial compliance's with OTC markets and various related authorities by also submitting the relevant documents attesting to the authenticity of all the previous announcements on the OTC markets.
The senior management of the company is presently visiting their subsidiaries abroad in order to make the final financial arrangements connected with its previous announcements.
Bergamo Acquisition Corp.
Hillard Herzog, 702-269-4523
IR@BergamoCorp.com
www.BergamoCorp.com
or
Investor Relations:
The Eversull Group, Inc.
Jack Eversull, President, 972-571-1624
Fax: 214-469-2361
jack@theeversullgroup.com
http://ih.advfn.com/p.php?pid=nmona&article=58848559&symbol=BGMO
NOTES PREPARED BY THE INDEPENDENT ACCOUNTING FIRM OF L.L.BRADFORD
The Company is engaged in investing in financial instruments and companies worldwide. During May 2012, the
Company purchased 100% interest in a European entity for its investing strategies utilizing the EURO currency.
Note 1 – Investment in marketable securities
Investment in marketable securities consists of 2,132,157 shares of common stock in a publically traded company at a
cost of $1 million. During the period from January 1, 2012 through September 10, 2012, the Company recorded an
unrealized loss of $0.1 million. As of September 17, 2012, the estimated fair value of the shares was $0.9 million.
During August 2012, a Stock Purchase Agreement was entered into to purchase 60% of a Delaware corporation in
exchange for $7.5 million in order to effect the purchase of a majority control of the publically traded company noted in
the preceding paragraph. As of the date of these financials,
Note 2 – Commitments and Contingencies
During September 2012, the Company entered into a settlement agreement to satisfy outstanding debt and accrued
interest carried on the Company’s financials at approximately $1.0 million. The Company had previously defended
against the penalties and interest but agreed to a total settlement of approximately $2.9 million. Accordingly, the
Company recorded settlement expense of $1.9 million.
During August 2012, a subsidiary (“Subsidiary”) of the Company entered into an Investors’ General Agreement and
Investment Platform Provider Business Agreement (hereafter the “Investor Agreement”). The Investor Agreement
describes the profit sharing between the investors and the Subsidiary and provides for weekly payment of those profits.
The agreement will be ongoing for five years.
Note 3 – Nature of Business and Summary of Significant Accounting Policies
The Company is engaged in investing in financial instruments and companies worldwide. During May 2012, the
Company purchased 100% interest in a European entity for its investing strategies utilizing the EURO currency.
Summary of Significant Accounting Policies
Basis of Presentation
These financial statements and related notes are presented in accordance with accounting principles generally accepted in
the United States. The Company’s fiscal year-end is December 31.
The Company’s reporting currency is the United States dollar (USD) and functional currency is the EURO. Foreign
currency assets and liabilities are translated into their U.S. dollar equivalents based on year end exchange rates. Revenue
and expense accounts are translated at average exchange rates. Aggregate exchange gains and losses arising from the
translation of foreign assets and liabilities are included in shareholders' equity as a component of comprehensive income.
Accumulated gain on foreign currency translation adjustment was
Cash and Cash Equivalents
Cash equivalents include money market accounts which have maturities of three months or less. For the purpose of the
statements of cash flows, all highly liquid investments with an original maturity of three months or less are considered to
be cash equivalents. Cash equivalents are stated at cost plus accrued interest, which approximates market value.
Revenue Recognition
Investments in Financial Instruments – The Company earns commissions based on returns from investments in financial
instruments. Revenues are recorded upon receipt of actual returns.
Costs include commissions or revenue sharing arrangements with other parties.
Fair Value of Financial Instruments
The Company’s financial instruments include cash, receivables, available-for-sale securities and due to related parties.
Management believes the fair values of these financial instruments approximate their carrying values due to their shortterm nature.
For the period from January 1, 2012, through September 17, 2012, the company reported net income of $88,439,000, or $0.53 per share, on consolidated revenues of $283,952,000.
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