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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 Human Clinical Trials in a Test Tube™ Aims to Revive Failed Small Drug Molecule Candidates
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.
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 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
Two questions all BGMO shareholders want answered.
1) How much money has BGMO made since September 17th
2) When will they have access to the money to close the VSTA and other acquisitions.
When we get the answer to question 2, BGMO will run like the proverbial scalded ape.
Timing is everything !!!!
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.
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
It's not a matter of if BGMO will acquire approximately 70% of VSTA it just a matter of when.
We know the hold period of the of the initial profit of $88 million earned from the first tranche of investment funds of US $500 million will be up in a couple of months, but obviously BGMO and VSTA management believe the acquisition of VSTA will happen before then.
Quote:
In addition, 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
Timing is everything
FACTS !!!
The strategy of VistaGen Therapeutics, a California based stem-cell technology company, is primed to drive rapid growth because of its unique structure. VistaGen is a developer of stem-cell based bioassay early-warning systems for determining possible toxicity of drug candidates. It provides a distinctive way of determining potential drug toxicity well before the time and expense involved in performing animal or human trials.
The history of the pharmaceutical industry is one littered with drug candidates that were developed, and sometimes even released to the public, only to discover later that there were heart or liver toxicity issues. These drugs were then often shelved, resulting in a massive loss of invested time and money for the pharmaceutical company involved. For drug companies around the world it’s a major problem. However, for VistaGen it represents a major opportunity.
VistaGen’s plan is to use their proprietary Human Clinical Trials in a Test Tube stem cell based platform, a novel bioassay system that provides toxicity testing right in the laboratory, to build a portfolio of drug rescue variants from once-promising but discontinued drug candidates. Considering the fact that development costs for a new drug can easily exceed $1 billion, VistaGen sees these shelved drugs as a veritable diamond mine which it now has the means to tap. It’s like having someone run a 20-mile marathon for you, and then letting you step in near the end to cross the finish line.
Specifically, VistaGen believes each lead drug rescue variant will have the potential to be a viable new drug candidate in which VistaGen can have significant economic participation rights, such as up-front and development milestone payments and royalties on commercial sales. Its valuable technology also sets the company up as a potential takeover target.
For additional information, visit http://www.VistaGen.com
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, the
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.
http://www.otcmarkets.com/financialReportViewer?symbol=BGMO&id=92172
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.
http://ih.advfn.com/p.php?pid=nmona&article=58848559&symbol=BGMO
NO PR. RETRACTION FROM VISTAGEN FULLY REPORTING COMPANY
Knowing the TRUTH about Vistagen/Bergamo. Why it's Undervalued?
Be very proud:
Mr. Singh began his career as a corporate finance attorney in the Silicon Valley offices of Morrison & Foerster LLP, an international law firm.
What Mr. Singh, a former investment banker knows and sees in Bergamo Acquistion:
Learning Finance Value in BGMO.
Be Humble, Spread the wealth to Investors.
One POINT Five Billion dollar reason I follow BGMO is to learn the latest trends in penny stocks’ securing greatest % gains in a real investment. BGMO is magnet for these sort of things, since amateur investors do not understand investment banking how its Cash is King clients and its Banks utilize cash instruments (backed by CASH Only) enter into an irrevocable investment agreement are leveraged many times into trading platforms by only top banks of the world. The board is being run by B/S and smear campaign who seem frustrated 24/7 for years they can’t milk it below 0.01 as easily as others before. This stock signals Great Buying Opportunity for the sophisticated investor.
How to identify and pick a real stock Winner with potential to increase > 15, 535% over the course of 2013-2014:
1. Announcement PR Jan 9th, 2013, "National Wealth International Ltd. has provided Bergamo Acquisition's wholly owned European subsidiary cashed-backed securities consisting of three separate tranches of 500 Million US Dollars issued through HSBC Bank, one of the world's largest banking and financial services organizations."
2. National Wealth International Ltd has a 1.5 Billion Dollars on Deposit at HSBC.
*National Wealth and BGMO`S European subsidiary signed various investment agreements,
*National Wealth then made an investment and instructed HSBC to issue Cash Backed Securities and is sharing 50 percent of the profit with BGMO`S European subsidiary.
*ie, The account holder National Wealth approached its bank HSBC and asked them to issue CASHED BACK SECURITIES to BGMO`S European Subsidiary Bank against the Deposit.
Companies or Corporation are not Bank's they do not issue Cash Back Securities, it is Banks who do that.
*Only Bank's can issue Cashed Back Security instruments, Wire transfers, Bank Drafts etc etc.
*In this transaction the instrument was issued by HSBC on behalf of the client who has deposit of funds at HSBC.
3. Understanding Cash Backed Security at HSBC
(Backed By the Deposited Funds at HSBC by National Wealth)
*National Wealth is a Client of HSBC
*National Wealth has Bank A/C at HSBC with Cash Funds on Deposit
*HSBC on the instructions provided by client issued Cash Backed Security Bank to Bank to BGMO European Subsidiary
*What is Cashed Backed Security or Cash Backed Wire Transfer?
Answer: National Wealth has Cash Deposit at HSBC Bank A/C @ 1.5 Billion. That's why security issued to BGMO Europe Subsidiary is Backed by the CASH DEPOSIT of National Wealth in HSBC.
SECURITY ISSUED TO BGMO EUROPE IS CALLED CASH BACKED in another words Yoda refers to CASH IS KING!
4. Transaction between parties is based on CASH ONLY!
TRANSACTION IS BACKED WITH CASH FUNDS
In Order to:
*Banking Swift has multiple different types of messaging systems
*MT 760 is one of those options
*This message is sent at the request of the Bank account holder, from one bank to other bank. Bank to Bank.
*The account holder wants to show the other bank there are funds available in his bank account to cover a particular transaction
*In order to make this message happen this is the process for account holder irrevocably agrees that their bank will hold the same amount of funds as security for the transaction. Cash Backed Security is a Cash Backed Financial Instrument sent via Swift MT 760 which is called Cash Backed Security
http://financetraining.com/mt760-explained-the-mt760-explained-in-terms-you-can-understand/
“In order to transfer messages, SWIFT developed nine different types of messages. The MT760 is one of those messaging options. Usually, it is a message sent at the request of the account holder, from one bank to another. The account holder wants to show the other bank there are funds available to cover a particular transaction. In order to make this message happen, the account holder agrees that their bank will hold the same amount of funds as security for the transaction. This security feature makes the MT760 a cash-backed financial instrument.”
Sift out how for 7 years now BGMO is still up and running. Reality is the sophisticated investors who have already been accumulating realize the company is fundamentally stronger than ever. As of Sep 17, 2012, Secured by hard cash investment program ongoing for 5 years.
Loyal Vistagen shareholders,
In Trust be proud of your CEO and its board of directors in bringing enormous value into your company, Mr. Singh has great perception of the funding at hand with its Partner Bergamo Acquisition.
Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "I met with Autilion's team earlier this week, and we have been working closely with them since signing our agreement in April. We are confident and excited about completing this transformative financing. Building on the positive developments in our labs presented during the Annual Meetings of the Society of Toxicology and International Society of Stem Cell Research in March and this month, respectively, we look forward to accelerating our lead programs towards valuable outcomes for our shareholders."
always IMO humbly seeking the genuine truth in gold, assets, bonds MT760's and cash.
GLTA
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
Shawn K. Singh, VistaGen's Chief Executive Officer, stated, "I met with Autilion's team earlier this week, and we have been working closely with them since signing our agreement in April. We are confident and excited about completing this transformative financing. Building on the positive developments in our labs presented during the Annual Meetings of the Society of Toxicology and International Society of Stem Cell Research in March and this month, respectively, we look forward to accelerating our lead programs towards valuable outcomes for our shareholders."
CPA L.L. BRADFORD WOULD NOT SIGN OFF ON FRAUDULENT HSBC BANK STATEMENT
http://bergamocorp.com/cpa-letter-1-13/#/2
VISTAGEN THERAPEUTICS ON CANADAS LARGEST NEWS BROADCASTER
Key information in the notes prepared by L.L.Bradford and recent PRs
1) 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 year
2) All profits generated 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 equally between National Wealth International Ltd. and the European subsidiary company of Bergamo Acquisition pursuant to the profit-sharing agreement between the parties.
3) Hillard Herzog, President and CEO of Bergamo, stated, “By contractual agreements, the funds deposited into our European subsidiary’s bank account are exclusively authorized for the investment program in place with National Wealth International. We requested examination by our corporate certified public accounting firm to erase any doubt that Bergamo Acquisition is able to move directly ahead with its investment program.”
4) L.L. Bradford has reviewed and verified all the original documents and the original bank deposit statement from HSBC. These original documents provided the location, account number and dollar value of deposits, and were signed & sealed by two bank officers for authenticity. L.L. Bradford finally confirmed Bergamo Acquisition’s current financial agreements. For further information on the recently announced investment agreement, review the press release issued by Bergamo Acquisition on January 10, 2013 (http://finance.yahoo.com/news/bergamo-acquisition-corp-signs-investment-165821767.html).
The letter of confirmation written by L.L. Bradford, together with redacted versions of all original documents reviewed by the CPA firm, has been posted on the OTC Markets website (www.otcmarkets.com/stock/BGMO/filings) as well as the website of Bergamo Acquisition ( http://bergamocorp.com ). Bergamo Acquisition has posted redacted versions in conformity to nondisclosure and non-circumvent agreements with its partners.
For 72 million shares of restricted common stock
VistaGen signed a strategic financing agreement with the European subsidiary of Bergamo Acquisition Corp., a global diversified investment holding company.
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, VSTA 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. VSTA 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
FDA Gives Nod to Stem Cell Clinical Trials for MS – Portends Opportunity for VistaGen Therapeutics, Inc. (VSTA)
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
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
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
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.
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 Offers Innovative Technological Solution to Ongoing Drug Discovery and Development Crisis
California based VistaGen Therapeutics, a biotech company focused on using their proprietary pluripotent stem cell technology for superior predictive toxicology and drug metabolism screening, is aggressively pursuing an innovative drug development path with unusually high profit potential. The company intends to identify once-promising small molecule drug candidates on which large amounts of research and development money has already been spent, but which have been discontinued and “shelved” due to unexpected safety concerns relating to heart or liver toxicity. The company’s one-of-a-kind bioassay platform, called Human Clinical Trials in a Test Tube, allows highly cost effective toxicity testing for heart and liver cells right in the laboratory, offering a unique way to quickly test and modify drug candidates, maintaining drug efficacy while eliminating toxicity.
VistaGen’s strategy leverages their developing stem cell technology based bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, as well as their network of strategic relationships, and substantial prior third-party investment in drug discovery and development
The company’s approach is buoyed by the ongoing drug discovery and development crisis being experienced by the U.S. pharmaceutical industry. Last year, in spite of a $49 billion R&D investment by the pharmaceutical industry, the FDA’s Center for Drug Evaluation and Research approved only 39 novel NME (New Molecular Entity) drugs. Since 2003, the FDA has approved an average of only 26 NME’s annually. The high cost of drug development, coupled with this very low approval rate, means that such drug failures are a serious economic drain on the industry, and a potential economic catastrophe for the developing company.
A big part of the problem comes from known limitations of the industry’s current toxicological testing methodology, which relies primarily on animal models, transformed cell lines, or human cadaver cells. It’s an approach that can only approximate live human biology, and can lead to unpleasant surprises after millions or billions of dollars have already been spent on drug development.
VistaGen’s system offers mature human cells for more accurate and timely testing. It’s a technology of huge potential value to the industry, but also of value to VistaGen as a base for developing their own line of drug rescue variants.
For additional information, visit http://www.VistaGen.com
VSTA Uses Proprietary Stem Cell Technology to Address Two Separate Medical Needs
VistaGen Therapeutics is applying its innovative stem cell technologies in two separate but related fields. On the one hand, the company has developed one of the most important new approaches to the field of drug testing in decades, the use of stem cells to create their proprietary Human Clinical Trials in a Test Tube bioassay platform, which is designed to avoid the extensive time and expense involved in animal or other traditional tests. But VistaGen is also exploring a number of opportunities in the field of regenerative cell therapy, focused on blood, cartilage, heart, liver, and pancreas cells, each based on the proprietary stem cell differentiation and production capabilities of the company’s testing platform.
VistaGen’s stem cell based drug testing technology has resulted in CardioSafe 3D, a three-dimensional in vitro bioassay system for accurately assessing toxic (as well as non-toxic) effects of small-molecule drug candidates on human heart tissue. They are also finalizing the development of LiverSafe 3D, offering early and cost effective drug effect testing for the liver. VistaGen’s primary near-term goal for their testing technology is to use CardioSafe 3D, and eventually LiverSafe 3D, for drug rescue, to recapture substantial potential value associated with the pharmaceutical industry’s prior investment in drug discovery and development, involving once-promising small molecule drug candidates that were discontinued due to safety issues related to unexpected heart or liver toxicity or drug metabolism issues.
On the regenerative cell therapy side of things, VistaGen has developed AV-101, an orally available small molecule prodrug candidate, aimed at the needs of the multi-billion dollar neurological disease and disorders market. AV-101 has successfully completed Phase I development in the U.S. for treatment of neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system. Neuropathic pain affects approximately 1.8 million people in the U.S. alone. The company has already been awarded over $8.3 million of grant funding by the National Institutes of Health to support preclinical and Phase I clinical development of AV-101. The company believes that AV-101 may also be a candidate for development as a therapeutic alternative for depression, epilepsy, and Parkinson’s disease.
For additional 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 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 Human Clinical Trials in a Test Tube™ Aims to Revive Failed Small Drug Molecule Candidates
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.
For more information, visit 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 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
Two questions all BGMO shareholders want answered.
1) How much money has BGMO made since September 17th
2) When will they have access to the money to close the VSTA and other acquisitions.
When we get the answer to question 2, BGMO will run like the proverbial scalded ape.
Timing is everything !!!!
The strategy of VistaGen Therapeutics, a California based stem-cell technology company, is primed to drive rapid growth because of its unique structure. VistaGen is a developer of stem-cell based bioassay early-warning systems for determining possible toxicity of drug candidates. It provides a distinctive way of determining potential drug toxicity well before the time and expense involved in performing animal or human trials.
The history of the pharmaceutical industry is one littered with drug candidates that were developed, and sometimes even released to the public, only to discover later that there were heart or liver toxicity issues. These drugs were then often shelved, resulting in a massive loss of invested time and money for the pharmaceutical company involved. For drug companies around the world it’s a major problem. However, for VistaGen it represents a major opportunity.
VistaGen’s plan is to use their proprietary Human Clinical Trials in a Test Tube stem cell based platform, a novel bioassay system that provides toxicity testing right in the laboratory, to build a portfolio of drug rescue variants from once-promising but discontinued drug candidates. Considering the fact that development costs for a new drug can easily exceed $1 billion, VistaGen sees these shelved drugs as a veritable diamond mine which it now has the means to tap. It’s like having someone run a 20-mile marathon for you, and then letting you step in near the end to cross the finish line.
Specifically, VistaGen believes each lead drug rescue variant will have the potential to be a viable new drug candidate in which VistaGen can have significant economic participation rights, such as up-front and development milestone payments and royalties on commercial sales. Its valuable technology also sets the company up as a potential takeover target.
For additional information, visit http://www.VistaGen.com
It's not a matter of if BGMO will acquire approximately 70% of VSTA it just a matter of when.
We know the hold period of the of the initial profit of $88 million earned from the first tranche of investment funds of US $500 million will be up in a couple of months, but obviously BGMO and VSTA management believe the acquisition of VSTA will happen before then.
Quote:
In addition, 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
Timing is everything
FACTS !!!!
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.
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
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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 2 – 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, the
Note 3 – 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 1 – 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.
http://www.otcmarkets.com/financialReportViewer?symbol=BGMO&id=92172
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.
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NO PR. RETRACTION FROM VISTAGEN FULLY REPORTING COMPANY