Stem Cell Clinic

Millions of Human Cells Have Been Grown Inside Mice Embryos – Newsweek

Scientists have created millions of human cells in mouse embryos, in a technique which they hope could one day be used in a variety of ways, from growing organs for life-saving transplants to finding treatments for diseases including COVID-19.

The study centred around what are known as stem cells, which can grow into many different types of cells. Researchers at the State University of New York at Buffalo and Roswell Park Cancer Institute injected 10 to 12 human stem cells into 3.5-day-old mouse embryos.

After 17 days, millions of human cells formed in 10 mouse embryos. They included eye, liver, and red blood cells, which each represent one of the three types of cells we are made up of. The human cells accounted for between 0.1 to 4 percent of the cells in 14 of the mouse embryos, creating a chimera.

Professor Jian Feng of the Jacobs School of Medicine and Biomedical Sciences at State University of New York at Buffalo who co-authored the study published in Science Advances, told Newsweek: "This will enable the generation of human cells, tissues or even organs in animals."

Feng said he was most surprised that his team were able to produce lots of human red blood cells for reasons that are unclear. This shows that the human stem cells developed faster in the mouse embryos, as such cells would not be found in a human embryo until after about seven to eight weeks, he explained.

The study also showed how the team were able to turn stem cells from a primed to nave state in order to grow the different cells. While nave cells aren't on track to become a specific type of cell, primed stem cells are on the path to developing into a specific type of cell.

They did this by inhibiting an enzyme in primed human stem cells for three hours. This enabled the newly nave human stem cells to grow with nave mouse cells in the embryos. The technique previously used to create nave human stem cells wasn't able to create human cells of different types in mouse embryos.

Feng said the technique could be used to produce mice which are better models of human diseases, "particularly infectious diseases that specifically or preferentially impact human, e.g., COVID-19.

"It is possible to make human immune cells or cells of the respiratory system in a mouse with this technology. Such chimeric mice would be very useful for studying COVID-19, which gravely impacts humans, not barely affects mice."

The method could also be used to generate organs in large farm animals, like pigs, for organ transplants in humans. But the approach would need to be significantly developed to translate what the team found in mice to large animals such as pigs, according to Feng.

"There are lots of hurdles to go through before it can be done. The human organs need to be free of pig cells. This would be very hard. One potential pathway is to understand how it works in a chimeric pig and try to develop an artificial system to grow human organs. If this can be realized, many patients who are waiting for organ transplant will be saved."

However, Feng acknowledged: "There are lots of things that we do not understand. More research is needed to understand how exactly human stem cells develop in a mouse embryo, whether it is possible to make even more human cells of a particular kind, for example, so the chimera can be used to study diseases or provide cells for transplantation. It is still at the early stage of this field."

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Deborah Gumucio, Professor Emerita of the Department of Cell and Developmental Biology and Department of Internal Medicine at University of Michigan Medical School, who did not work on the project, told Newsweek: "This study's major advance is the establishment of culture conditions that permit the relatively (compared to previous studies) robust contribution of human embryonic stem cells to multiple organs/tissues in intact mouse embryos.

"This could eventually permit the study of human cells in the context of fully functioning organs, thereby offering real potential for new and exciting scientific exploration.

"A very surprising aspect to me was the amazing speed with which the human red cells and photoreceptors developed in the context of the mouse embryo. Of course, the functional properties of these human cells have yet to be examined.

"It makes one wonder, if we were to increase the amount of chimerism (maximally 4 percent in this study), would the developmental properties of the cells resemble those seen in mouse or human?" said Gumucio.

Although the work is an important proof of concept, Gumucio said: "In any groundbreaking study like this, tremendous potential sits side-by-side with limitations and questions that must be answered with further research.

"Here, the authors were able to achieve 0.14 to 4 percent chimerism. This might be enough to study the properties/behavior of the human cells in their new murine [mouse] homes, but, since we know that much of cell behavior is directed by cell to cell communication, will these cells behave like human cells or mouse cells?

"Certainly, the speed-up in development mentioned above suggests that the mouse environment does in fact affect human cellular development. Whether it also affects cell function will need to be further explored in each tissue/organ context."

Noa Novershtern of the Department of Molecular Genetics at the Weizmann Institute of Science, Israel, who didn't work on the study, told Newsweek: "As always, such exciting findings need to be repeated and confirmed by other labs. In addition, there is still a need to test carefully whether the human cells gained the function of the mouse tissue they reside in, as there is a possibility that they populate the embryo but do not function correctly."

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Millions of Human Cells Have Been Grown Inside Mice Embryos - Newsweek

AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update – Business Wire

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics , Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the first quarter ended March 31, 2020.

The human tragedy of this pandemic has long tentacles that effect numerous businesses including AgeX, said Greg Bailey M.D., Chairman. Given the current global economic landscape, and the changes that businesses will need to make to accommodate to a post pandemic world, we feel that new business model aligns well to be able to function in this new environment. We see enormous opportunity to license and joint venture PureStem and HLA-G while implementing a definitive plan to begin preclinical trials on tissue regeneration under the leadership of Michael West and Michael May. We will update you in the future as these plans progress.

AgeX has completed a company restructuring to help set it up for success in the future. The combination of company priorities, cash position and the COVID-19 pandemic led to employee lay-offs designed to support the evolution of AgeX's current team to execute on strategic business goals going forward and to ensure cash is directed at near-term priorities to deliver maximum shareholder value. AgeX has a dual business strategy to diversify risk and maximize opportunities. It plans to continue to pursue its licensing and collaboration strategy for its two primary technology platforms, UniverCyte immunotolerance technology for the generation of universal cells, and PureStem cell derivation and manufacturing technology for the production of therapeutic cells with potential advantages, including industrial scalability and lower manufacturing costs. Since the launch of its licensing and collaboration strategy in January 2020, AgeX has delivered a research collaboration in Japan focused on developing universally transplantable cells for therapeutic use based on UniverCyte, entered into a neural stem cell therapy research collaboration for neurological disorders utilizing PureStem at a California University, and AgeX licensee ImStem Biotechnology received the first-ever clearance of a cell therapy derived from AgeXs embryonic stem cells by the FDA to enter human studies.

In addition, AgeX remains committed to pursuing in-house cell therapy product development and plans to raise money to build the optimal team to deliver on its products, AGEX-BAT1 for metabolic diseases such as type II diabetes and AGEX-VASC1 for tissue ischaemia. AgeXs budgetary and personnel adjustments will result in the deferral of in-house product development and may also lead to AgeX seeking arrangements with other companies in the cell therapy or biopharma industry for the development of its product candidates and technology, or outsourcing of some of that work to service providers until further funding can be obtained to rebuild in-house research and development staff for one or more of those programs. Development of AgeXs iTR technology may be done at AgeXs subsidiary Reverse Bioengineering, Inc. subject to successful financing of the subsidiary.

Upwards of 80% of healthcare expenditures in the United States relates to chronic degenerative disease and aging is a principle underlying cause of such conditions, said Michael D. West, Ph.D., AgeXs Chief Executive Officer. Therefore, the ability to manufacture to scale young clinical-grade cells capable of regenerating functionality in diverse tissues of the body has the potential to transform healthcare as we know it today. Perhaps even more noteworthy is the potential of reversing developmental aging in the body itself through AgeXs iTR technology. Our goal in the coming year is to advance the development of our intellectual property with the goal of bringing value to our shareholders.

Q1 Highlights

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. On April 1, 2020 AgeX drew the initial $500,000, and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on March 30, 2020 and May 14, 2020, respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan will bear interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the PPP to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX intends to use the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

During April 2020, AgeX initiated staff layoffs that affected 12 employees, primarily research and development personnel. AgeX has paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which are expected to be settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, and considering that loans from Juvenescence in excess of an initial $500,000 advance under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the $500,000 loan under the New Loan Agreement, the PPP Loan and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three months ended March 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

First Quarter 2020 Operating Results

Revenues: Total Revenues for the first quarter of 2020 were $515,000 as compared with $388,000 for the first quarter of 2019. AgeX revenue is primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $86,000 of allowable expenses under its research grant from the NIH as compared with $15,000 in the same period in 2019.

Operating expenses: Operating expenses reported for the three months ended March 31, 2020 were $3.7 million as compared to $3.4 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended March 31, 2020 were $3.2 million as compared to $2.8 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses increased by $0.3 million to $1.6 million during the three months ended March 31, 2020 from $1.3 million during the same period in 2019. The increase was primarily attributable to an increase of $0.2 million in scientific consultants, $0.2 million in laboratory facilities and equipment related expenses and maintenance, $0.1 million in personnel related expenses allocable to research and development, and $0.1 million in depreciation and amortization of laboratory equipment and improvements. These increases were offset to some extent by a decrease of $0.3 million in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of the Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses for the three months ended March 31, 2020 remained consistent with the same period in 2019 of $2.1 million despite bearing the full lease and facilities related costs since April 2019, and an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

March 31,

2020

December 31,

2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

468

$

2,352

Accounts and grants receivable, net

366

363

Prepaid expenses and other current assets

1,238

1,339

Total current assets

2,072

4,054

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AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update - Business Wire

Human Embryonic Stem Cells (HESC) Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 – Cole of Duty

Vitrolife

Moreover, the Human Embryonic Stem Cells (HESC) report offers a detailed analysis of the competitive landscape in terms of regions and the major service providers are also highlighted along with attributes of the market overview, business strategies, financials, developments pertaining as well as the product portfolio of the Human Embryonic Stem Cells (HESC) market. Likewise, this report comprises significant data about market segmentation on the basis of type, application, and regional landscape. The Human Embryonic Stem Cells (HESC) market report also provides a brief analysis of the market opportunities and challenges faced by the leading service provides. This report is specially designed to know accurate market insights and market status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Table of Content

1 Introduction of Human Embryonic Stem Cells (HESC) Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Human Embryonic Stem Cells (HESC) Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Human Embryonic Stem Cells (HESC) Market, By Deployment Model

5.1 Overview

6 Human Embryonic Stem Cells (HESC) Market, By Solution

6.1 Overview

7 Human Embryonic Stem Cells (HESC) Market, By Vertical

7.1 Overview

8 Human Embryonic Stem Cells (HESC) Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Human Embryonic Stem Cells (HESC) Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Human Embryonic Stem Cells (HESC) Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 - Cole of Duty

The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -…

DUBLIN--(BUSINESS WIRE)--The "Cell Therapy - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The cell-based markets was analyzed for 2018, and projected to 2028. The markets are analyzed according to therapeutic categories, technologies and geographical areas. The largest expansion will be in diseases of the central nervous system, cancer and cardiovascular disorders. Skin and soft tissue repair as well as diabetes mellitus will be other major markets.

The number of companies involved in cell therapy has increased remarkably during the past few years. More than 500 companies have been identified to be involved in cell therapy and 309 of these are profiled in part II of the report along with tabulation of 302 alliances. Of these companies, 170 are involved in stem cells.

Profiles of 72 academic institutions in the US involved in cell therapy are also included in part II along with their commercial collaborations. The text is supplemented with 67 Tables and 25 Figures. The bibliography contains 1,200 selected references, which are cited in the text.

This report contains information on the following:

The report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice.

Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation.

Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices.

Cell therapy has applications in a large number of disorders. The most important are diseases of the nervous system and cancer which are the topics for separate chapters. Other applications include cardiac disorders (myocardial infarction and heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders, and wounds of the skin and soft tissues.

Regulatory and ethical issues involving cell therapy are important and are discussed. Current political debate on the use of stem cells from embryonic sources (hESCs) is also presented. Safety is an essential consideration of any new therapy and regulations for cell therapy are those for biological preparations.

Key Topics Covered

Part I: Technologies, Ethics & Regulations

Executive Summary

1. Introduction to Cell Therapy

2. Cell Therapy Technologies

3. Stem Cells

4. Clinical Applications of Cell Therapy

5. Cell Therapy for Cardiovascular Disorders

6. Cell Therapy for Cancer

7. Cell Therapy for Neurological Disorders

8. Ethical, Legal and Political Aspects of Cell therapy

9. Safety and Regulatory Aspects of Cell Therapy

Part II: Markets, Companies & Academic Institutions

10. Markets and Future Prospects for Cell Therapy

11. Companies Involved in Cell Therapy

12. Academic Institutions

13. References

For more information about this report visit https://www.researchandmarkets.com/r/7h12ne

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The Cell Therapy Industry to 2028: Global Market & Technology Analysis, Company Profiles of 309 Players (170 Involved in Stem Cells) -...

2025 Projections: Cell Freezing Media for Cell Therapy Market Report by Type, Application and Regional Outlook – AlgosOnline

The ' Cell Freezing Media for Cell Therapy market' report Added by Market Study Report, LLC, enumerates information about the industry in terms of market share, market size, revenue forecasts, and regional outlook. The report further illustrates competitive insights of key players in the business vertical followed by an overview of their diverse portfolios and growth strategies.

The new research report on the Cell Freezing Media for Cell Therapy market provides a comprehensive analysis of the business vertical and comprises of crucial information pertaining to the industry such as profits estimation, periodic deliverables, market size, market share, current revenue, and market tendencies.

Request a sample Report of Cell Freezing Media for Cell Therapy Market at:https://www.marketstudyreport.com/request-a-sample/2547285?utm_source=algosonline.com&utm_medium=TS

A brief summary of the performance analysis of the Cell Freezing Media for Cell Therapy market has been given in the report. Moreover, the report includes pivotal insights such as growth rate expected during the forecast period and key aspects affecting the market size. The Cell Freezing Media for Cell Therapy market report also elaborates on growth opportunities along with hindering factors associated with the industry vertical.

Main pointers highlighted in the Cell Freezing Media for Cell Therapy market report:

Unveiling the geographical landscape of the Cell Freezing Media for Cell Therapy market:

Cell Freezing Media for Cell Therapy Market Segmentation:

A gist of the details presented in the Cell Freezing Media for Cell Therapy market report:

A complete summary of the Cell Freezing Media for Cell Therapy market with regards to the product and application spectrum:

Product landscape:

Product types: With FBS and Without FBS

Key insights presented in the report:

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Application landscape:

Application segmentation: Human Embryonic Stem Cells, CAR-T Cell Therapy, Neural Stem Cell Therapy, Mesenchymal Stem Cell Therapy, Hematopoietic Stem Cell Transplantation and Other

Specifics provided in the report:

Other major pointers included in the report:

Some details about the competitive landscape of the Cell Freezing Media for Cell Therapy market include:

Vendor base of the industry: BioLife Solutions, Thermo Fisher Scientific, GE Healthcare, Zenoaq, Merck, Akron Biotechnology, WAK-Chemie Medical and Biological Industries

Competitive landscape parameters mentioned in the report include:

For More Details On this Report: https://www.marketstudyreport.com/reports/global-cell-freezing-media-for-cell-therapy-market-growth-2020-2025

Some of the Major Highlights of TOC covers:

Development Trend of Analysis of Cell Freezing Media for Cell Therapy Market

Marketing Channel

Market Dynamics

Methodology/Research Approach

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2025 Projections: Cell Freezing Media for Cell Therapy Market Report by Type, Application and Regional Outlook - AlgosOnline

Tolero Pharmaceuticals Announces Expansion of the Zella 102 Study in Patients with Intermediate and High-Risk Myelodysplastic Syndromes (MDS) – The…

SALT LAKE CITY, Utah, May 14, 2020 /PRNewswire/ --Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced that the first patient has been dosed with a one-hour dosing schedule for investigational agent alvocidib, a potent CDK9 inhibitor, administered in sequence after azacitidine, in the expansion of the Phase 1b/2 Zella 102 study in patients with myelodysplastic syndromes (MDS).

The Zella 102 study is being conducted in patients with previously untreated MDS and patients with MDS who have received fewer than six cycles of treatment with a hypomethylating agent. The initial study design was to evaluate the safety and efficacy of alvocidib using a 30-minute bolus followed by a four-hour intravenous infusion (IVI), in combination with decitabine. An amendment was made to the study design to include treatment with azacitidine, in sequence before a one-hour infusion of alvocidib.

"We are pleased that this study now includes both standard of care hypomethylating agents for patients with myelodysplastic syndromes. In addition, the expansion of this study offers an alternative alvocidib dosing schedule, which reduces the amount of time patients spend in infusion," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "Preclinical research suggests that treatment with hypomethylating agents may sensitize MDS blast cells to suppression of MCL-1 through alvocidib. We look forward to building our understanding of the potential role of alvocidib in this patient population."

MDS is a form of cancer that can occur when cells in the bone marrow are abnormal and create defective blood cells, which often die earlier than normal cells. In one of three patients, MDS can progress into AML, a rapidly growing cancer of bone marrow cells.1

About the Zella 102 Study

The Zella 102 study is an open-label, dose-escalation Phase 1b/2 study evaluating the safety and efficacy of alvocidib, when administered in sequence after eitherdecitabine or azacitidine, in patients with previously untreated MDS and patients with MDS who have received fewer than six cycles of treatment with hypomethylating agents. The primary objective of the Phase 1b portion of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of alvocidib, when administered in these regimens. Secondary objectives are to determinethe complete response rate and if treatment with alvocidib, administered in sequence after decitabine or azacitidine,results in improvements in transfusion dependence and/or hemoglobin level.

The primary objective of the Phase 2 portion of the study will be to determine the objective response rate of alvocidib, when administered to untreated patients with de novo or secondary MDS in sequence after a hypomethylating agent, using revised International Working Group (IWG) criteria.

The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at http://www.ClinicalTrials.gov (NCT03593915).

About Alvocidib

Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in the Phase 2 studies Zella 202, in patients with acute myeloid leukemia (AML) who have either relapsed from or are refractory to venetoclax in combination with decitabineor azacitidine(NCT03969420)and Zella 201, in patients with relapsed or refractory MCL-1 dependent AML, in combination with cytarabine and mitoxantrone(NCT02520011). Alvocidib is also being evaluated in Zella 101, a Phase 1 clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with cytarabine and daunorubicin (7+3) in newly diagnosed patients with AML(NCT03298984), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with decitabine or azacitidine(NCT03593915). In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax(NCT03441555).

About CDK9 Inhibition and MCL-1

MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.2 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.3 MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.2,4 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).5,6 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.5 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.2

About Tolero Pharmaceuticals, Inc.

Tolero Pharmaceuticals is a clinical-stage biopharmaceutical company researching and developing treatments to improve and extend the lives of patients with hematological and oncological diseases. Tolero has a diverse pipeline that targets important biological drivers of blood disorders to treat leukemias, anemia, and solid tumors, as well as targets of drug resistance and transcriptional control.

Tolero Pharmaceuticals is based in the United States and is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan. Tolero works closely with its parent company, Sumitomo Dainippon Pharma, and Boston Biomedical, Inc., also a wholly owned subsidiary, to advance a pipeline of innovative oncology treatments. The organizations apply their expertise and collaborate to achieve a common objective - expediting the discovery, development and commercialization of novel treatment options.

Additional information about the company and its product pipeline can be found atwww.toleropharma.com.

Tolero Pharmaceuticals Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available, and involve both known and unknown risks and uncertainties, which could cause actual outcomes to differ materially from current expectations. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

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Tolero Pharmaceuticals Announces Expansion of the Zella 102 Study in Patients with Intermediate and High-Risk Myelodysplastic Syndromes (MDS) - The...

Strides in Medical Tourism Market Key Driver of Low-cost Patient Care in Globalized Healthcare Systems, Notes TMR – Stockhouse

ALBANY, New York, May 13, 2020 /PRNewswire/ -- The globalization of healthcare has been a key driver for consistently rising opportunities for all stakeholders in the global medical tourism market. Developing economies have been at the forefront of constantly expanding their clinical expertise and advanced technologies in medical services, notes Transparency Market Research. Their constant emphasis on offering patient care options that are comparable to those in developed nations is attracting revenues to the global medical tourism market.

The popularity of medical tourism is, to a large part, propelled by aggressive promotion and advertisement initiatives by healthcare institutions in medical tourism destinations.

Advances in National Health Care Systems of Developing Countries Play Crucial Role

Advances in protocols that expand the continuity of care for people who move outside their native countries have helped drive new technology developments in healthcare. The avenues have also emerged from people coming from less developed economies to a developing economy to access better health care. Clinicians, particularly doctors, from positive developments in national health care systems, imparting momentum to the expansion of the global medical tourism market.

The global medical tourism market stood at US$ 61.3 bn in 2018 and is projected to clock a CAGR of more than 10.5% from 2019 to 2027.

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Hospitals and specialty clinics have aimed at achieving compliance to global patient care standards, thus cementing the prospects in medical tourism. Healthcare institutions in recent years have been leaning to get certified by numerous non-profit organizations, such as Joint Commission International (JCI).

Countries with well-established infrastructures in North American and European countries, such as France, Italy and Germany, have been key contributors to the rapidly medical tourism in developing regions. Particularly the residents in the U.S. and the U.K. in recent years have been generating demand for healthcare services in emerging economies, thus propelling strides in medical tourism market. The trend has been observed due to several factors. One of the key factors is the high cost of patient care and more waiting times in developed countries of the world. The easing of regulations by governments in developing economies has facilitated their access to equally robust clinical expertise, albeit at much less cost.

On the other hand, Europe will also continue to contribute significant revenues, due to the presence of advanced medical treatments in the region.

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Constant upgrades in clinical expertise have enabled prominent markets to contribute substantial avenues in global medical tourism market. Post-procedure care and recuperation are also being constantly improved by deploying the state-of-the-art healthcare IT and patient-centered platforms in these markets.

Asia Pacific Key Regional Market; Presence of Healthcare Institutions Drive Demand

On the global front, Asia Pacific has emerged as the dominant market in 2019. It will gain more shares in relation to North America and Europe. Strides made in health care infrastructure of the region are helping the regional market gain shares. Further, the cost of surgery has come down substantially in the region. In Asia Pacific countries, the presence of doctors certified by regulatory agencies of the developed nations is increasing, thereby creating new demand in medical tourism market. The region has also benefitted from the rapidly growing array of studies in cancer patient care.

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On the other hand, the U.S., India, Israel, and Singapore have been hotbed of opportunities from the substantial demand for medical care for people suffering from cardiovascular disease (CVD). Rise in orthopedic surgeries in developing and developed regions from population residing in less developed countries will expand the horizon of opportunities in the medical tourism market.

Some of the well-entrenched players in the medical tourism market are Bahrain Specialist Hospital, Zulekha Healthcare Group, Hamad Medical Corporation, Dr. Soliman Fakeeh Hospital, Bumrungrad International Hospital, Apollo Hospitals Enterprise Limited, and Asklepios Kliniken GmbH.

The study presented here is based on a report by Transparency Market Research (TMR) titled "Medical Tourism Market (Medical Treatment - Cosmetology, Dentistry, Cardiology, Orthopedic surgery, Neurology, and Oncology) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 - 2027".

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The global medical tourism market is segmented based on:

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Strides in Medical Tourism Market Key Driver of Low-cost Patient Care in Globalized Healthcare Systems, Notes TMR - Stockhouse