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,
Sentiment: Strong Buy
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 o
Sentiment: Strong Buy
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.
Sentiment: Strong Buy
VistaGen has developed a stem cell technology platform based on the controlled transformation of human pluripotent stem cells into mature human cells, which can then be used to create bioassay systems to provide clinically relevant predictions on the toxicity and metabolism issues of promising new drug candidates before they are ever tested in human subjects.
The company sees a huge disadvantage to the pharmaceutical industry in that conventional animal and in vitro cell culture testing only approximates human biology, generating risk for failed drug candidates and wasted resources.
VistaGen leverages its Human Clinical Trials in a Test Tube™ platform to mitigate such losses and to revive once-promising small drug molecule candidates that failed in the development process due to heart or liver toxicity or metabolism issues.
Human Clinical Trials in a Test Tube™ is based on a combination of proprietary and exclusively licensed stem cell technologies, some of which were developed over the past two decades by co-founders and renowned Canadian stem cell scientist Dr. Gordon Keller and company president and Chief Scientific Officer Dr. Ralph Snodgrass.
Backed with such expertise and technology, the company only focuses on discontinued drug candidates with positive preclinical efficacy data to identify and develop new, safe drug rescue variants in a faster and less expensive manner than drug candidates discovered and developed using animal studies, and in vitro cell culture testing systems.
Sentiment: Strong Buy
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 dr
Sentiment: Strong Buy
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
Sentiment: Strong Buy
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 h
Sentiment: Strong Buy
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
Sentiment: Strong Buy