Why Cynata is hopeful its COVID treatment trial will succeed where others have failed – Business News Australia

Cynata Therapeutics (ASX: CYP), founded by two clever stem cell researchers and one wise Australian techpreneur, is in the process of developing a treatment for COVID-19.

Using its in-house stem cell technology Cymerus, the ASX-listed biotech hopes to treat one of the deadliest complications of COVID-19 -acute respiratory distress syndrome (ARDS).

In doing so Cynata would achieve what competitor Mesoblast (ASX: MSB) couldn't with FDA approval.

By deploying an industrialised approach to stem cell therapeutics, Cynata CEO Ross Macdonald (pictured) is confident the clinical trial process won't leave the company hamstrung.

In 1981 scientists discovered a way to derive embryonic stem cells from early mouse embryos.

The discovery thrilled scientists, and eventually led to the development of a method to do the same in lab-grown human embryos by 1998.

While there have been plenty of discussions surrounding the ethics of using of embryonic stem cells, these major scientific movements have pushed researchers to discover new and inventive ways of treating a whole raft of diseases and infections.

One such researcher, Dr Ian Dixon, saw potential for the use of mesenschymal stem cells (MSCs) - a type of stem cell that can differentiate into a variety of cell types enabling the treatment of many diseases and infections.

However there was still an obstacle to overcome: how do you mass produce enough cells needed to commercialise a treatment?

Luckily, two researchers at the University of Wisconson, Professor Igor Slukvin and Dr Maksym Vodyanik, had invented a biotechnological breakthrough called Cymerus.

The technology was able to do exactly what Dixon needed: the consistent manufacture of MSCs on an ultra-large scale; basically what Henry Ford did to the industrialisation of the auto industry, but for stem cells.

So in 2003 Dixon partnered with the two researchers to start Cynata - now an ASX-listed biotechnology company trialing a number of different treatments for a wide variety of ailments.

Most recently, Cynata's focus has been on developing a treatment for a complication of COVID-19 called acute respiratory distress syndrome (ARDS).

The complication ravages COVID-19 infected patients, destroying their organs through what is known as a cytokine storm. The complication is estimated to kill up to half of COVID-19 patients that suffer from it.

Melbourne-based Cynata is currently in the very early stages of its investigation into whether its MSCs will be able to treat the coronavirus complication overwhelming hospitals globally.

If this all sounds familiar, you might be thinking of another ASX-listed biotech called Mesoblast (ASX: MSB).

In March last year Mesoblast, also based in Melbourne, saw its shares surge after announcing plans to evaluate its stem cell treatment solutions on COVID-19 patients.

The group commenced the arduous clinical trial process to see if its remestemcel-L therapy could treat ARDS by using bone marrow aspirate from healthy donors - a similar approach the company had already taken to treat a condition many suffer from after receiving bone marrow transplants.

Mesoblast was riding high on the ASX following positive announcements surrounding the clinical traila process, especially back in April 2020 when a trial at New York City's Mt Sinai hospital found its remestemcel-L therpay achieved "remarkable" results.

Serious attention gathered around Mesoblast, with the company even securing $138 in funds from investors to continue its important research.

The company went so far as to sign a commercialisation deal for the COVID-19 treatment with Novartis, and the US Food and Drugs Administration (FDA) fast tracked the approvals process for the potential game-changing treatment.

However, in December 2020, Mesoblast hit a stumbling block.

Mesoblast's COVID-19 treatment flunked the test - its remestemcel-L therapy failed to show a lower mortality rate for patients in the prescribed 30-day timeframe of treatment.

At that point Cynata had commenced research into its own ARDS treatment. But did Mesoblast's failure unnerve Cynata CEO Ross Macdonald? Not a chance.

"I'm more confident that our trial will be successful where theirs was a failure," Macdonald said.

"If you use a process like we have developed - we don't rely on multiple different [stem cell] donations. You start with exactly the same material every time."

To explain, Macdonald used the analogy of a local caf; you normally expect a coffee from one caf to taste more or less exactly the same every time you go there - the same beans are used every time.

Whereas Macdonald said Mesoblast's process is like going to the same caf every day, but each visit they use different beans from a different supplier which leads to inconsistency in taste and flavour.

Cynata's approach with its MSCs is in line with the first example - what you get the first time from them will be replicated in each and every dose of the drug - while MSB's is like the latter.

"Yes, you still got the coffee, but the experience of the taste is totally different than it was yesterday," he said.

"The FDA said to Mesoblast, well you've got a manufacturing problem that is reliant upon multiple donors prepared to donate bone marrow and that is flawed.

"So with that in mind it's perhaps not surprising that they had a pretty disappointing result in the clinical trials."

Additionally, Macdonald said the initial investor reactions to MSB's early COVID-19 trail results were overblown.

"The initial data from their trial that got everybody excited was, in my view, quite flawed, because they said "look at how many patients are dying in intensive care units with COVID compared the patients that we treated," he said.

"But the reality of the situation was quite different. The control group at that time - the death rate was way, way higher than you would typically see for ARDS, whether its COVID or anything else. And it was simply because of the chaos that existed in intensive care units in New York in the first wave.

"So we think that the initial enthusiasm was perhaps a little misguided."

When asked why Mesoblast is receiving so much attention compared to Cynata, especially considering the above, Macdonald said it was simply because MSB is bigger and has been around for longer. For context, MSB has a market capitalisation of $1.46 billion, whereas Cynata's is just $94.56 million.

"I'd love to know why there is less attention, and how we can get our market cap above a billion dollars," joked Macdonald.

"I think the answer though is that they've been around for a lot longer than we have, they have spent a hell of a lot more money than we've spent - their monthly spend is more than we've spent for pretty much our entire existence.

"But I think the fundamental reason why is that data drives value in biotech, so the more clinical data you generate that shows your product works, the more attention you attract from investors."

That's not to say Cynata is being totally ignored in favour of the larger Mesoblast.

The company secured a $15 million placement led by $10 million from healthcare investor BioScience Managers in December.

The funds will be used to expand Cynata's clinical development pipeline and scale their operations in Australia.

As such, the company is preparing to expand its clinical development pipeline to include idiopathic pulmonary fibrosis, renal transplantation, and diabetic foot ulcers.

"So we're starting to garner that attention now that says two things - one, cell therapies are definitely a medical revolution and two, Cynata is part of that new generation of companies," Macdonald said.

As for the company's pipeline, in addition to the COVID treatment trials, Cynata is planning on launching three new clinical candidates that will get under way this year.

There's also Cynata's osteoarthritis trial, which Macdonald describes as significant for the biotech company; with 2 million patients in Australia and 30 million in the United States the company is hoping to tap into an $11 billion plus addressable market.

"It will ultimately show whether MSCs are useful in that particularly devastating condition," he said.

"It doesn't just affect people who want to go and play golf or tennis, it affects, particularly manual labourers who can no longer work.

"So the cost to the economy of osteoarthritis is quite significant, which is of course one of the reasons why the Australian Government is funding this trial."

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Why Cynata is hopeful its COVID treatment trial will succeed where others have failed - Business News Australia

Missouri State Representative Indicted Over Alleged Stem Cell Therapy Scam – IFLScience

Tricia Derges, a member of the Missouri House of Representatives and doctor, has been indicted by a grand jury for among other things allegedly injecting people with amniotic fluid and telling them mesenchymal stem cells made it a miracle cure. Derges has pled not guilty, and IFLScience cannot assess the accuracy of the charges. However, the case brings attention to growing use of unproven and dangerous stem cell treatments.

The case against Derges is being taken by Tim Garrison, the U.S. Attorney for Missouri's Western District. Garrison alleges Derges acquired stem cell-free amniotic fluid and told patients it contained stem cells that would cure a variety of conditions, charging them four times what the fluid cost her to inject them with it. Garrison charged Derges with false statements over the use of the fluid, as well as illegal distribution of controlled substances and wire fraud in relation to other activities at the clinics she runs.

Among long posts on her Facebook page professing her innocence, Derges posted a picture of David and Goliath, writing, I actually thought that I was making a difference. What I didnt account for was how much satan would fight back.

Whatever the truth of the allegations in Derges' specific case, by charging astate representative, Garrison has highlighted what is definitely a growing problem: deceptive use of stem cell therapies.

Multipotent stem cells have the remarkable capacity to convert into the cells that make up many bodily tissues. The hematopoietic stem cells have been used for decades to treat leukemia with well-proven results. Hundreds of other applications are either under investigation in the laboratory, or currently in clinical trials, but a much smaller number have been approved by America's FDA and equivalent bodies worldwide.

Understandably, many people don't feel able to wait, making them vulnerable to quack doctors for whom stem cells are the 21st Century snake oil. Unlike embryonic stem cells, which often originate from abortions, amniotic stem cells are seen as an alternative acceptable to pro-life individuals. However, having been discovered more recently, research into them is less advanced, making any therapeutic value speculative.

Dirges' vocal opposition to abortionpresumably made amniotic cells attractive to her for this reason, but Garrison alleges the fluid Derges was using didn't even contain stem cells. Moreover, he claims the University of Utah where Derges bought the fluid told her that, so she would have known it couldn't possibly have been effective.

Derges gained a medical degree from the Caribbean Medical University in Curaao and ran a series of low-cost medical clinics, where volunteers saw patients and recommended to her what medication to prescribe. Although licensed as an assistant physician, Derges was not accepted into a post-graduate residency program and was not licensed as a physician. She fought to change licensing rules, and ran for Missouri state District 140, narrowly winning the Republican primary before being unopposed last November. Since being elected, Derges has made changing the law on physician licensing her first priority.

In a statement, Garrison allegedDerges used the fluid on patients with everything from Lyme disease to erectile dysfunction and kidney disease, despite the improbability a single fluid would cure such different ills. Although Derges' clinics are famous for charging just $5 for an ordinary visit, the costs of this treatment averaged $40,000 per patient.

The program came to Garrison's attention after she appeared on television claiming the same amniotic fluid should be used to treat COVID-19 and making similar claims on Facebook.

H/T Springfield News Leader

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Missouri State Representative Indicted Over Alleged Stem Cell Therapy Scam - IFLScience

Global Human Embryonic Stem Cells Market increasing demand with Industry Professionalist |know the Brand Players forecast 2027 Jumbo News – Jumbo…

Global Human Embryonic Stem Cells Market 2021IndustrialAnalysis, Regional Survey, and Forecast Report: Supply, Demand, Suppliers, Porters Five Forces Analysis, Segment-wise Trends, Statistical Survey, Pricing Analysis, Geographical Exploration, Revenues, Historical Data, and Projections to 2027

This research study evaluates the global Human Embryonic Stem Cellsmarket status, growth rate, player market shares, player positioning, projection trends, competition landscape, market drivers, challenges and opportunities, pricing analysis, deployment channels, and distributors.Syndicate Market Research AnalysesResearch Methodology overview consists ofSecondary Research,Primary Research,Company Share Analysis,Model ( including Demographic data, Macroeconomic indicators, andIndustry indicators i.e. Expenditure, infrastructure, sector growth, and facilities, etc),Research Limitations and Revenue Based Modeling.The establishment of the Human Embryonic Stem Cells showcase is additionally referenced in the report that can permit the customers in applying essential strategies to increase the upper hand. Such a sweeping and through and through research investigation gives the fundamental development with key proposals and impartial quantifiable examination. This can be utilized to upgrade the present position and structure future expansions in a particular zone in the Human Embryonic Stem Cells showcase. The report likewise gauges inclines in the market alongside mechanical headways in the business.It also has an In-depth analysis of the industrys competitive landscape, restraints, detailed information about different drivers, and global opportunities. Key competitors included in Global Human Embryonic Stem Cells Market areESI BIO, Thermo Fisher, BioTime, MilliporeSigma, BD Biosciences, Astellas Institute of Regenerative Medicine, Asterias Biotherapeutics, Cell Cure Neurosciences, PerkinElmer, Takara Bio, Cellular Dynamics International, Reliance Life Sciences, Research & Diagnostics Systems, SABiosciences, STEMCELL Technologies, Stemina Biomarker Discovery, Takara Bio, TATAA Biocenter, UK Stem Cell Bank, ViaCyte, Vitrolife

Our Research SpecialistAnalysesResearch Methodology overview includingPrimary Research, Secondary Research, Company Share Analysis,Model ( including Demographic data, Macro-economic indicators, andIndustry indicators: Expenditure, infrastructure, sector growth, and facilities ),Research Limitations and Revenue Based Modeling. Company share analysis is used to derive the size of the global market. As well as a study of revenues of companies for the last three to five years also provides the base for forecasting the market size (2021- 2027) and its growth rate.Porters Five Forces Analysis, impact analysis of covid-19 and SWOT Analysisare also mentioned tounderstand the factors impacting consumer and supplier behaviour.

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The point of this exploration report is to characterize, break down, portion, and estimate the size of the Human Embryonic Stem Cells showcase based on types, applications, end-clients, key districts, and key players. This report gives the worldwide market size of Human Embryonic Stem Cells in key topographies viz.Europe, North America, Asia Pacific, Central, and South America Middle East and Africa, with the prime spotlight on significant economies including Canada, U.S, Mexico, UK, Germany, Spain, France, Russia, Italy, India, China, South Korea, Japan, Southeast Asia, Indonesia, Australia, Argentina, Brazil, South Africa, GCC nations, Turkey and Egypt among other remarkable nations in rest of the world.The report centers around the offers of Human Embryonic Stem Cells in the previously mentioned districts/ nations. This exploration report arranges the worldwide Human Embryonic Stem Cells showcase by top brands/players/sellers, type, applications, end-users, regions, and Countries

Key Highlights of the TOC provided by Syndicate Market Research:

Major Product Type of Human Embryonic Stem Cells Covered in Market Research report:Totipotent Stem Cells, Pluripotent Stem Cells, Unipotent Stem Cells

Application Segments Covered in Market Research Report:Research, Clinical Trials

Global Human Embryonic Stem Cells Industry Market: By Region

North America

Europe

Asia Pacific

Latin America

The Middle East and Africa

Table of Content include Human Embryonic Stem Cells Market Worldwide are:

1 Study Coverage 1.1 Human Embryonic Stem Cells Product 1.2 Key Market Segments in This Study 1.3 Key Manufacturers Covered 1.4 Market by Type 1.4.1 GlobalMarket Size Growth Rate by Type (Totipotent Stem Cells, Pluripotent Stem Cells, Unipotent Stem Cells) 1.5 Market by Application 1.5.1 Global Market Size Growth Rate by Application (Research, Clinical Trials) 1.6 Study Objectives 1.7 Years Considered

2 Executive Summary 2.1 Global Human Embryonic Stem Cells Market Size 2.1.1 Global Human Embryonic Stem Cells Revenue 2013-2025 2.1.2 Global Human Embryonic Stem Cells Production 2013-2025 2.2 Human Embryonic Stem Cells Growth Rate (CAGR) 2021-2027 2.3 Analysis of Competitive Landscape 2.3.1 Manufacturers Market Concentration Ratio (CR5 and HHI) 2.3.2 Key Manufacturers 2.3.2.1 Manufacturing Base Distribution, Headquarters 2.3.2.2 Manufacturers Product Offered 2.3.2.3 Date of Manufacturers Enter into Market 2.4 Key Trends for Markets & Products

3 Human Embryonic Stem Cells Market Size by Manufacturers 3.1 Production by Manufacturers 3.1.1Production by Manufacturers 3.1.2 Production Market Share by Manufacturers 3.2 Revenue by Manufacturers 3.2.1 Revenue by Manufacturers (2013-2018) 3.2.2 Revenue Share by Manufacturers (2013-2018) 3.3 Price by Manufacturers 3.4 Mergers & Acquisitions, Expansion Plans

4 Human Embryonic Stem Cells Production by Regions 4.1 Global Production by Regions 4.1.1 Global Production Market Share by Regions 4.1.2 Global Revenue Market Share by Regions 4.2 United States 4.2.1 United States Production 4.2.2 United States Revenue 4.2.3 Key Players in United States 4.2.4 United States Import & Export 4.3 Europe 4.3.1 Europe Production 4.3.2 Europe Revenue 4.3.3 Key Players in Europe 4.3.4 Europe Import & Export 4.4 China 4.4.1 China Production 4.4.2 China Revenue 4.4.3 Key Players in China 4.4.4 China Import & Export 4.5 Japan 4.5.1 Japan Production 4.5.2 Japan Revenue 4.5.3 Key Players in Japan 4.5.4 Japan Import & Export 4.6 Other Regions 4.6.1 South Korea 4.6.2 India 4.6.3 Southeast Asia

5 Human Embryonic Stem Cells Consumption by Regions 5.1 Global Human Embryonic Stem Cells Consumption by Regions 5.1.1 Global Human Embryonic Stem Cells Consumption by Regions 5.1.2 Global Human Embryonic Stem Cells Consumption Market Share by Regions 5.2 North America 5.2.1 North America Human Embryonic Stem Cells Consumption by Application 5.2.2 North America Human Embryonic Stem Cells Consumption by Countries 5.2.3 United States 5.2.4 Canada 5.2.5 Mexico 5.3 Europe 5.3.1 Europe Human Embryonic Stem Cells Consumption by Application 5.3.2 Europe Human Embryonic Stem Cells Consumption by Countries 5.3.3 Germany 5.3.4 France 5.3.5 UK 5.3.6 Italy 5.3.7 Russia 5.4 Asia Pacific 5.4.1 Asia Pacific Human Embryonic Stem Cells Consumption by Application 5.4.2 Asia Pacific Human Embryonic Stem Cells Consumption by Countries 5.4.3 China 5.4.4 Japan 5.4.5 South Korea 5.4.6 India 5.4.7 Australia 5.4.8 Indonesia 5.4.9 Thailand 5.4.10 Malaysia 5.4.11 Philippines 5.4.12 Vietnam 5.5 Central & South America 5.5.1 Central & South America Human Embryonic Stem Cells Consumption by Application 5.5.2 Central & South America Human Embryonic Stem Cells Consumption by Country 5.5.3 Brazil 5.6 Middle East and Africa 5.6.1 Middle East and Africa Human Embryonic Stem Cells Consumption by Application 5.6.2 Middle East and Africa Human Embryonic Stem Cells Consumption by Countries 5.6.3 GCC Countries 5.6.4 Egypt 5.6.5 South Africa

6 Market Size by Type 6.1 Global Production by Type 6.2 Global Revenue by Type 6.3 Price by Type

7 Market Size by Application 7.1 Overview 7.2 Global Breakdown Dada by Application 7.2.1 Global Consumption by Application 7.2.2 Global Consumption Market Share by Application (2021-2027)

8 Manufacturers Profiles Overall Companies available in Human Embryonic Stem Cells Market 8.1.1 Company Details 8.1.2 Company Overview 8.1.3 Company Human Embryonic Stem Cells Production Revenue and Gross Margin (2014-2020) 8.1.4 Human Embryonic Stem Cells Product Description 8.1.5 Recent Development and others

9 Production Forecasts 9.1 Human Embryonic Stem Cells Production and Revenue Forecast 9.1.1 Global Human Embryonic Stem Cells Production Forecast 2021-2027 9.1.2 Global Human Embryonic Stem Cells Revenue Forecast 2021-2027 9.2 Human Embryonic Stem Cells Production and Revenue Forecast by Regions 9.2.1 Global Human Embryonic Stem Cells Revenue Forecast by Regions 9.2.2 Global Human Embryonic Stem Cells Production Forecast by Regions 9.3 Human Embryonic Stem Cells Key Producers Forecast 9.3.1 United States 9.3.2 Europe 9.3.3 China 9.3.4 Japan 9.4 Forecast by Type 9.4.1 Global Human Embryonic Stem Cells Production Forecast by Type 9.4.2 Global Human Embryonic Stem Cells Revenue Forecast by Type

10 Consumption Forecast 10.1 Human Embryonic Stem Cells Consumption Forecast by Application 10.2 Human Embryonic Stem Cells Consumption Forecast by Regions 10.3 North America Market Consumption Forecast 10.3.1 North America Human Embryonic Stem Cells Consumption Forecast by Regions 2021-2027 10.3.2 United States 10.3.3 Canada 10.3.4 Mexico 10.4 Europe Market Consumption Forecast 10.4.1 Europe Human Embryonic Stem Cells Consumption Forecast by Regions 2021-2027 10.4.2 Germany 10.4.3 France 10.4.4 UK 10.4.5 Italy 10.4.6 Russia 10.5 Asia Pacific Market Consumption Forecast 10.5.1 Asia Pacific Human Embryonic Stem Cells Consumption Forecast by Regions 2021-2027 10.5.2 China 10.5.3 Japan 10.5.4 South Korea 10.5.5 India 10.5.6 Australia 10.5.7 Indonesia 10.5.8 Thailand 10.5.9 Malaysia 10.5.10 Philippines 10.5.11 Vietnam 10.6 Central & South America Market Consumption Forecast 10.6.1 Central & South America Human Embryonic Stem Cells Consumption Forecast by Regions2021-2027 10.6.2 Brazil 10.7 Middle East and Africa Market Consumption Forecast 10.7.1 Middle East and Africa Human Embryonic Stem Cells Consumption Forecast by Regions 2021-2027 10.7.2 GCC Countries 10.7.3 Egypt 10.7.4 South Africa

11 Value Chain and Sales Channels Analysis 11.1 Value Chain Analysis 11.2 Sales Channels Analysis 11.2.1 Human Embryonic Stem Cells Sales Channels 11.2.2Distributors 11.3Customers

12 Market Opportunities & Challenges, Risks and Influences Factors Analysis 12.1 Market Opportunities and Drivers 12.2 Market Challenges 12.3 Market Risks/Restraints 12.4 Key World Economic Indicators

13 Key Findings in the Global Human Embryonic Stem Cells Study

14 Appendix 14.1 Research Methodology 14.1.1 Methodology/Research Approach 14.1.1.1 Research Programs/Design 14.1.1.2 Market Size Estimation 14.1.1.3 Market Breakdown and Data Triangulation 14.1.2 Data Source 14.1.2.1 Secondary Sources 14.1.2.2 Primary Sources 14.2 Author Details 14.3 Disclaimer

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