Amarantus Bioscience Holdings Inc (AMBS)

[JPetroInc]

the TRUTH of AMBS and the CEO Blog content is not about who sponsored it

trying to diffuse, distract, distort and fabricate false narratives ain't going to work for you anymore Redspudder

we're on to you and your ilk brah...!

besides, if I were the twice failed hack wannabe "Financial Engineer" Stanford University grad AMBS CEO...

I too would want the AMBS CEO Blogs taken down permanently from the WWW internet

uh Ohhhh - well well well - lookie here Mr Redspudder - all distortions of reality and facts

and the false narrative and protection of a catastrophic failure CEO

with the help of YOU the infamous Back Office Promo Boy pumpers, shills and touts:



oh and here are some really good MANF CEO Blog pieces - for "entertainment purposes" only (of course)

read em and weep - cause this is what the TRUTH is about - and is absolutely NOTHING of what you say:

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01.) MANF: Arresting Cell Death in PD, TBI, Cardiac Ischemia & More
December 10th, 2012

Innovation is difficult and risky. In biotechnology, you can add long and expensive to the list of challenges. On the upside, with the right technology and strategy, biotechnology innovations have the power to improve and prolong the lives of millions of people who suffer from disease, while generating revenues and value for shareholders.
Here at Amarantus, we are innovators in the field of Programmed Cell Death, also known as Apoptosis. Our lead drug candidate (Mesencephalic-Astrocyte-derived Neurotrophic Factor) MANF is a first-in-class therapeutic protein that mitigates apoptosis by improving the protein-folding process inside the cell. MANF is currently in pre-clinical development for a range of indications. Our primary focus is on developing MANF as a new disease-modifying treatment for Parkinson’s disease. We also have programs in Traumatic Brain Injury and Cardiac Ischemia, and have initiated an effort to identify a suitable orphan drug indication to pursue MANF’s further development. Because MANF acts at such a fundamental cellular level, it is likely to have applications across a broad range of currently unaddressed disease indications.
Amarantus management has been following the evolution of the biopharmaceutical space and we’ve developed our business model around important themes that are reshaping the way innovative products get developed in this new economy. Below are what we believe to be the most important trends in the industry:
1. Technology is not enough; you must build a business. We are focused on building a business, not a science project. To that end, we are evaluating complementary therapeutic assets in mid-stage clinical development to add to our pipeline to reduce time to market as we prepare for a national exchange up-listing. MANF is the centerpiece of our business, and we believe we can attract strong assets around it because of MANF’s vast potential. To this end, the Company has attracted a world-class team of advisors to give us the expertise to guide our business direction and diversify our pipeline.

2. Intellectual property is what big companies are willing to pay for. Our patent portfolio around MANF is extensive and robust. We recently won a patent challenge to our key intellectual property in Europe where the courts asserted that our IP covered not only MANF, but also proteins that closely resemble MANF. We are in a very strong negotiating position with any company that wants access to MANF.

3. Targeted medicines are what regulators are looking for. Amarantus in-licensed a clinical-stage Parkinson’s diagnostic program called NuroPro that will gives us a competitive advantage as we seek to prove that MANF has a ‘disease-modifying’ effect in Parkinson’s. This approach separates Amarantus from competitors because we are focusing on both therapeutics and diagnostics to help manage the disease.

4. Today’s business model is about partnerships. We have developed a partnering business model that is based on the belief that we must maximize our internal strengths, while leveraging the strengths of partners to best achieve our objectives. In order to maximize potential returns, the Company is establishing its partnership criteria with our advisors as we look at near-term value inflexions to achieve further value-building milestones.
In closing, this is a very exciting time for Amarantus. We just completed our first institutional capital raise and have attracted Big Pharma talent to our Advisory Board. We have data coming shortly on our MANF Parkinson’s program and expect additional corporate milestones will be reached in the coming weeks. As we achieve these milestones, we believe we will be in a good position to up-list to a national exchange. Most importantly, we are looking to bring hope to millions of patients and their families who suffer from the debilitating diseases MANF has the potential to treat. We strongly believe this strategy will build long-term shareholder value.
I thank you for taking the time to read this letter and looking forward to communicating with you in the future.

Gerald E. Commissiong
President & Chief Executive

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07.) Ophthalmology: MANF’s Orphan Strategy Coming into Focus in Retinitis Pigmentosa
Posted on August 14th, 2013

MANF continues to perform on so many different levels for Amarantus. While the recent focus has been on the Company’s nearer-term product candidate LymPro, it is critically important to remember the vast potential of our MANF program. What I find most remarkable about the sheer breadth of the Company’s lead therapeutic program is that, in the end, all of its potential applications to treat diseases in various organs throughout the body, including the brain, heart, and most recently the eye, are based on the exact same fundamental biological mechanism: mitigating apoptosis.

Retinitis Pigmentosa (RP) is a chronic progressive degenerative disorder of the eye that is characterized by the death of photoreceptor cones and rods in the retinal pigment epithelium (RPE). It is a genetic disease that affects roughly 100,000 people in the United States, 100,000 people in Europe and 50,000 people in Japan. Due to its relatively small patient population, RP qualifies as an orphan indication which provides a number of financial incentives for development of MANF in this indication. Further, there is a very significant unmet medical need as few therapies effectively treat this population of patients, leaving most legally blind before they reach the age of 50. Moreover, delivery of MANF directly into the eye is far simpler than Convection Enhanced Delivery in Parkinson’s, or systemic delivery in Ischemic Heart Disease. Together, the components of a smaller patient population, a significant unmet medical and a local delivery need may provide an ideal opportunity for the rapid clinical development of MANF that could lead to commercialization years ahead of larger indications for MANF.

We believe RP is just the beginning of the MANF story in ophthalmology. Other neurotrophic factors have begun to show promise in many diseases in the area and the data announced earlier this week scientifically supports development in many therapeutic indications beyond RP in ophthalmology, including Dry Age-Related Macular Degeneration (Dry AMD). Dry AMD affects approximately 15 million people in the United States. 14%-24% of the U.S. population age 65-74 years and 35% of people aged 75 years or older have the disease[1]. Currently, there are no available disease-modifying treatments for Dry AMD, making the opportunity for MANF so attractive. MANF’s development in RP may accelerate the pathway for it to reach the significantly larger Dry AMD patient population by proving cone and rod protection in humans in the smaller RP population first.

Ophthalmology has taken on significantly greater interest as of late from major players in the biopharmaceutical industry: Pfizer Inc. (PFE), Allergan Inc. (AGN), Alcon Inc. (ACL), Novartis AG (NVS), Merck & co. Inc. (MRK) and Roche (RHHBY) cover approximately 70% of the $10 billion market. The primary reason why the ophthalmology market is currently so small is very simple: very few effective disease-modifying treatments exist. Interestingly, the FDA notes that only 21 new drugs were approved in the last 10 years, suggesting a significant lack of breakthrough biology in this space, as evidenced by these companies’ thin ophthalmology pipelines. What’s more, these companies have primarily added drug candidates to their pipelines through in-licensure and strategic transactions, making the opportunity even more appealing for Amarantus. There is no question that the medical outcome of new, truly disease-modifying treatments in the area will have a meaningful impact on patients’ lives; being able to see versus being blind is a massive improvement in quality of life that would undoubtedly be highly coveted by patients, caregivers and physicians.

As we continue our pursuit of identifying a variety of orphan indications for MANF, this first success is a major milestone. When data becomes available in the coming weeks on different applications, we will begin to spend some time reprioritizing our MANF pipeline to ensure that we are maximizing shareholder value, while simultaneously ensuring that we are expeditiously moving MANF forward in the various indications where MANF has shown benefit pre-clinically. We intend to rely heavily on not-for-profit funding for certain indications in order to minimize shareholder dilution while maximizing patient benefit as we move MANF forward. The economies of scale created by having a single therapeutic candidate treat multiple diseases cannot be overstated, as development milestones in one area support further development in the others. The Company’s orphan drug strategy outlined in November of 2012 is beginning to bear fruit and we intend to pursue orphan diseases aggressively as we see this as the most effective and expeditious route to getting MANF to patients.

A prime example of a successful orphan strategy is Genzyme, which was acquired by Sanofi Aventis (SNY) in 2011 for $20.1B. Another example of a successful orphan strategy is FerroKin Biosciences, which was acquired by Shire (SHPG) for $325M in early 2012 with only $27M in paid-in-capital and a virtual staff of 7 employees. In 2011, Alexion Pharmaceuticals (ALXN) reported $783M in revenue based on sales of its only product Soliris, a drug that treats a population of approximately 10,000 patients in the US and Western Europe.

We have taken a very important step forward in our MANF program and strategy and are looking forward to updating shareholders on further developments in the weeks and months ahead.

Thank you for taking the time to read this blog.

Gerald Commissiong
President & CEO

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18.) MANF Continues to Deliver Heading into 2H-14
June 30th, 2014

Looking back on the last two years, it is amazing to see how the MANF story has unfolded in conjunction with the other corporate initiatives the Company has undertaken including the addition of LymPro and Eltoprazine to our pipeline. The effort to diversify our pipeline was largely initiated to allow the Company’s scientific team to uncover MANF’s true value by identifying market opportunities with the highest net present value, which in biotechnology generally means fastest path to market in an orphan indication. That strategy bore fruit in the middle of 2013, when the Company identified in scientific literature a reference to MANF’s utility in Retinitis Pigmentosa (RP) from the University of Miami’s Bascom Palmer Eye Institute and later secured the intellectual property surrounding that finding. With an exclusive option agreement in hand, the Company has the necessary footing to make further investments in prosecuting MANF’s full potential in RP. Now midway through 2014, the Company is in the process of executing a methodical plan to deliver on the potential for MANF in RP, as well as continuing to expand with data the underlying scientific principles supporting MANF into new areas of research creating valuable intellectual property and know-how. Some of the key steps completed thus far include:

1. The Company has received interim data and is awaiting final results for functional assessments for MANF from a leading contract research lab with specialty in RP rodent models;
2. The Company has received interim data and is awaiting final results for toxicology safety assessments for MANF from a leading contract lab with specialty in rabbit ophthalmological models;
3. Researchers at the University of Miami have completed running additional experiments for MANF in functional models of RP, and expect their findings to be published in peer-reviewed journals in the near future;
4. The Company has received the final report from a leading contract research lab evaluating MANF’s activity in a tau hyperphosphorylation model of Alzheimer’s disease (AD). This study was conducted to confirm work previously published in a Chinese journal;
5. The Company has identified a number of significant independent peer-reviewed research papers published in Chinese journals confirming previously published Western data, as well as identifying new uses for MANF;
6. The Company has sourced contract manufacturing organizations capable of commercially manufacturing MANF, completed our due diligence and we expect to select a manufacturer in the third quarter.

All of the interim results we have seen to date in ophthalmology have been positive, which gives us a great deal of confidence heading into the second half of the year that RP will be the first of several INDs for MANF. All of the data being produced will be supportive of additional ophthalmological indications, including Wolfram’s-induced blindness which we are pursuing with Dr. Urano from the Washington University School of Medicine. Beyond these updates, the Company is establishing additional research collaborations with leading institutions in new and potentially groundbreaking areas, as well generating new IP surrounding the use of MANF in these various indications in the third quarter. We will be delivering the confirmatory AD results to the market very shortly, which in turn raises interesting prospects vis-a-vis our LymPro blood test for Alzheimer’s disease. When we first in-licensed LymPro, we had no idea that MANF could have an impact on aspects of the underlying pathophysiology of AD. However, with recently published data linking tau mis-folding to cell cycle dysregulation and amyloid aggregation, the prospect of MANF becoming the basis for new treatments in AD has become extremely interesting. Reproducibility is the hallmark of good science, and to date MANF has reproducibly demonstrated activity consistent with a breakthrough treatment across a highly valuable spectrum of indications. In addition, we are nearing the completion of the sourcing process necessary to retain our regulatory consulting group with expertise with a specialty in the area of ophthalmology to assist us in the filing of orphan drug designation with the FDA and EMA for MANF in RP. Based on the timelines and estimates we have received, we expect to submit to the FDA and receive a reply regarding our submission in the second half of this year, within the same time frame that we will be looking to up-list our common stock to a national exchange.

Last week we attended a successful BIO convention where we ended up participating in over 60 partnering meetings, and were extremely pleased with the reception we received from the community at large. It is clear that we have become highly visible to larger pharmaceutical companies, as well as promising early-stage companies seeking to partner their assets. The general theme was that each of our assets has tremendous promise within their own right, and most importantly that there is a strong scientific and business case to be made for each becoming a blockbuster asset. Taken together, the synergies created from a business perspective are able to insulate the Company from significant enterprise risk, and our ability to demonstrate progress with any of these assets will lend credibility to the rest of the portfolio. In light of these comments, we are now especially looking forward to the month of July which includes AAIC and our #C4CT Summit, as well as the rest of 2014. We believe the Company is growing stronger by the day and we are excited to share our enthusiasm with our fellow shareholders.

I thank you for taking the time to read this blog and look forward to updating you on additional progress for the Company as we achieve our true potential.

Warmest Regards,
Gerald E. Commissiong
President & CEO

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25.) Eltoprazine, LymPro and MANF: The Path Forward to Value Creation
Oct. 27th, 2014

The last several weeks have been a particularly exciting time for the team at Amarantus. Months of effort are beginning to bear fruit, as we’ve begun to reach milestones in all three of our key programs. As the company continues to make systematic progress in executing on our business plan, we are encouraged by the reception we are receiving from patients, physicians and shareholders who understand the importance of what we are doing. I’ve begun to receive many inquiries recently about our most advanced therapeutic program, Eltoprazine, following the announcement of our first interaction with the FDA. Given the imminent Phase 2b Parkinson’s disease clinical trial initiation, I’d like to take this opportunity to put some context to each of our programs so that there is a better understanding of their current status and what is before us in the weeks and months ahead, as many new prospective shareholders have been asking what our strategy is for each program going forward.

Eltoprazine is the company’s most classical asset from a pharmaceutical industry perspective. It is an orally administered, small molecule drug candidate, which selectively activates specific serotonin receptors in the brain. We are currently developing it for Parkinson’s disease Levadopa-induced dyskinesia (PD LID) and adult attention deficit hyperactivity disorder (Adult ADHD). Eltoprazine was originally developed by Solvay Pharmaceuticals for the treatment of aggression in multiple psychiatric conditions. Throughout its clinical development history, Eltoprazine has been administered to nearly 700 healthy subjects and patients, hence providing a sound body of safety data to support further development.
Amarantus holds all filed regulatory dossiers in the United States and Europe, and has an exclusive license to the key intellectual property covering Eltoprazine’s use in PD LID and Adult ADHD. Our license covers method of use patents issued for Eltoprazine in North America and Europe giving coverage for Eltoprazine through the middle of 2022, as well as method of use patent applications for PD LID filed in 2012 potentially giving coverage through 2027. Eltoprazine is eligible to receive post-approval marketing exclusivity of 5 years in the United States and 10 years in Europe under the New Chemical Entity (NCE) regulatory approval pathway.

Parkinson’s disease Levodopa-induced Dyskinesia (PD LID)

Initial proof-of-concept data for Eltoprazine in PD LID were obtained in a Phase 2a study supported by the Michael J Fox Foundation (MJFF). These data were presented at a MJFF meeting in 2012 and at the OneMedForum 2014 conference in January of this year and a manuscript of the study has been submitted for publication to a major a peer-reviewed Neurology journal. In the meantime, our therapeutics division clinical development team has been diligently preparing for the initiation of a Phase 2b study in PD LID in the United States and in Europe. We are looking forward to receiving pre-IND feedback from the FDA later in the fourth quarter and being able to open a new IND in the Neurology Division of FDA shortly thereafter. The Phase 2b trial is on schedule to start in early 2015. There is a big unmet medical need for PD LID drugs. So far, there are no products specifically approved for this indication. There is a strong desire among clinicians, patient advocacy groups and regulators to see drugs approved for the treatment of LID, which would markedly improve the quality of life for patients with PD.

Apart from its potential for treating PD LID, we see substantial opportunities for Eltoprazine in other aspects of PD that would enhance the product lifecycle management, increase its market share and therefore potentially substantially increase its value. Non-motor symptoms that include mood disorders, cognitive deficits and impulse control disorders, are an important part of advanced PD that are poorly addressed by current treatments. The clinical data we already have in more than 350 psychiatric patients support a potential utility of Eltoprazine in the treatment of non-motor symptoms of PD, thereby creating an exciting opportunity to expand the clinical development into additional indications in PD patients.
We have seen recent successes by other companies in the PD space provide tremendous value for shareholders when treating PD symptoms, and we believe Eltoprazine positions Amarantus to follow on a similar path.

Adult Attention Deficit and Hyperactivity Disorder (Adult ADHD)

Recent increased interest in the market’s need for new, non-scheduled ADHD drugs has highlighted the importance of Eltoprazine’s positive clinical data in the area of Adult ADHD, where the market seems to be growing rapidly in comparison to pediatric ADHD as many pediatric ADHD patients mature into adults. We previously outlined our intentions to initiate a Phase 2b trial for Eltoprazine in Adult ADHD following the initiation of the Phase 2b PD LID clinical trial, and we remain on track to achieve this as much of the groundwork for the Adult ADHD trial is being completed for the Phase 2b PD LID trial. Of note, the clinical data obtained in the Phase 2a Adult ADHD suggest that Eltoprazine has clinically significant activity across a broad spectrum of Adult ADHD patients including both the Primarily Inattentive (“PI”) subgroup, as well as the Hyperactive subgroup.
A copy of the summary of the clinical data for Adult ADHD data is available online at: http://www.sec.gov/Archives/edgar/data/1424812/000114420414005562/v367098_ex99-1.htm.We believe Eltoprazine could eventually be used to treat Pediatric ADHD in addition to Adult ADHD. With its novel mechanism of action in this area, and potential applicability to a variety of patient subtypes, we see an important market potential for Eltoprazine in ADHD. This condition affects over 58 million people worldwide, and the key unmet medical need in this indication is for non-scheduled, non-stimulant drugs, such as Eltoprazine.

We firmly believe Eltoprazine will generate significant value for the company as we continue its further development, especially given its extensive drug profiling while at Solvay. Combined with data emerging from our planned studies, we believe there will be significant interest from the pharmaceutical industry as our trials advance in 2015. The company intends to be active in business development for this asset.

LymPro is our most advanced program, given that it is set to be commercialized in the very near future. We are on track to bring LymPro to market for the Research Use Only market in the fourth quarter, primarily targeting pharmaceutical clinical trials, and will be submitting to CLIA shortly thereafter for widespread commercial use. LymPro demonstrated very high specificity and sensitivity for Alzheimer’s disease detection in severe and moderate patients in our recently announced LP-002 bridging study, and we are looking forward to additional data in early-stage Alzheimer’s this quarter from an extension of the LP-002 study to support additional intended-use statements under CLIA for LymPro. The company is currently preparing marketing materials to support the launch to both the pharmaceutical industry and the general practitioner community to ensure they understand the value that LymPro will bring to their diagnostic paradigms. In addition, the company is continuing the development of its reimbursement strategy to support commercial sales, in addition to putting in place its LymPro general marketing strategy. We believe putting all of the pieces in place for a successful launch of LymPro is crucial to its initial launch and establishment as the market leading blood diagnostic for Alzheimer’s disease. We intend to publish the LymPro data in a peer-reviewed journal following study completion.
As the launch of LymPro nears, the company is also looking to maximize the value of the investment we have made in the asset since acquiring it in late 2012. As a holding company, Amarantus is continuing to evaluate methods of returning value to shareholders, including a potential spinoff of the company’s diagnostic division. In addition to LymPro and our NuroPro Parkinson’s diagnostic, we are actively evaluating additional complementary late-stage neurology-focused diagnostic assets that would bolster our diagnostic division and make for a successful ‘spin-out’ while concurrently returning value to our shareholders. We believe we will be able to execute on this strategy in the near-term.

As a holding company, our strategy is to acquire undervalued assets, incubate them through critical de-risking milestones and thereafter seek to deliver value to our shareholders through strategic initiatives. We believe we are well positioned to deliver on that promise in the near-term with our diagnostic division, making for the first data point of success of the overall business model and positioning Amarantus to continue this model as we move forward. We believe wholeheartedly in LymPro, and want to ensure that it receives the necessary management focus and commercialization expertise for it to become the gold standard for Alzheimer’s diagnosis. We expect to have updates on this initiative in the near-term.

MANF continues to deliver. In the last year, we have strategically shifted the development focus of MANF towards ophthalmology, where we see significant opportunity to generate value in the near-term. MANF recently was shown to be efficacious in two additional Retinitis Pigmentosa models, as well as delivering positive data in a model of ocular ischemia which supports development in a number of indications, including Central Retinal Vein Occlusion (CRVO), Central Retinal Arterial Occlusion (CRAO) and Glaucoma. We also have experiments ongoing evaluating MANF’s efficacy in Wolfram’s Syndrome with Washington University in Saint Louis. We recently applied to the FDA for orphan drug designation for MANF in Retinitis Pigmentosa and expect additional orphan filings in the near future in the area of ophthalmology. We expect to initiate GMP manufacturing for MANF this quarter to support multiple IND filings for MANF in various indications. For those of you who are new to the MANF story, MANF has demonstrated efficacy in various animal models of human disease, including:

1. Retinitis Pigmentosa
2. Ocular Ischemia (CRVO, CRAO and Glaucoma)
3. Parkinson’s disease
4. Diabetes
5. Cardiovascular Ischemia (Myocardial Infarction)
6. Cerebral Ischemia (Stroke, Epilepsy)

A select list of peer-reviewed publications for MANF is available on our website at: http://ir.amarantus.com/scientific-publications
This is an impressive list of potential indications. We are currently focusing the majority of our efforts in the ophthalmological areas, however we see significant value in strategically advancing proof of concept animal work in these and other areas as MANF approaches first-in-man studies in orphan ocular indications. We continue to believe that MANF could be one of the big successes in biotechnology due to its unique mechanism and will diligently shepherd the MANF Program through de-risking milestones on its path to treating patients. We are very, very excited about MANF and what lies ahead.

In Closing we are continuing to evaluate new opportunities for the company that we believe will add significant value to our pipeline outside of our current areas of focus. As we expect to soon derive value from our diagnostics division, we believe it will be important to replenish our pipeline with strategically positioned programs that have the potential to deliver significant return on investment for the company, as LymPro has. We believe Eltoprazine is also well positioned to replicate that model, and believe the value created by both of these assets will further support MANF’s development. As a biotechnology holding company, we have the luxury of being strategically diversified in highly attractive areas of growth across our pipeline. With this strategy we are insulated from enterprise risk from any one program, thereby giving us leverage as we look for additional product opportunities and allowing us to return value to our long-term shareholders either through equity gains or dividends.
Alzheimer’s disease, Parkinson’s disease and blindness are devastating disorders that can leave families, caregivers and patients reeling from damage left in their path. Being able to impact each of these conditions delivers a sense of great pride to our employees that we hope you share as shareholders. I thank you for taking the time to read this blog, and look forward to communicating with you regarding our progress on many of the points discussed above later this quarter.

Warmest regards,
Gerald E. Commissiong,
President & CEO

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can't help it if you keep walking into the TRUTH....

but only wish to distort it - for personal reasons - from behind the veil you hide behind

hmmm - wonder why that is....???

here's to you - shill, tout and tool "Redspudder" - and your failed pumping endorsements of AMBS TOMDF VERB and many others:



"the truth will set you free" - you should try it some time "Redspudder"

SMH - sad but true

AJMHO