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:

Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:

Covid-19 Detection Kits Market - The growth of the global covid-19 detection kits market relies on the responsiveness of countries to contain the spread of the coronavirus. The pandemic has wreaked havoc across the healthcare industry, and has led medical researchers to redirect all their might towards developing test kits and antidotes for coronavirus. The World Health Organization (WHO) declared the coronavirus as a global health emergency, following an outbreak of cases in several parts of the world. Currently, more than 180 countries have reported cases of coronavirus in individuals of all age groups.

Stem Cell Therapy Market - All stem cells are beneficial for medical research; however, each of the different kinds of stem cells has both limitations and promise. Embryonic stem cells that can be obtained from a very initial stage in human development have the prospect to develop all of the cell types in the human body. Adult stem cells are found in definite tissues in fully developed humans.

Platelet Rich Plasma and Stem Cell Alopecia Treatment Market - The global platelet rich plasma & stem cell alopecia treatment market is expected to reach a value of approximately US$ 450.5 Mn by the end of 2026, expanding at a high single digit CAGR during the forecast period. Factors such as increase in demand for accurate and prompt treatment of alopecia and advancements in platelet rich plasma and stem cell therapies that have revolutionized the diagnostic science are likely to boost the market.

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

Uses and Abuses of Scientific Consensus – National Review

The New York Times Michelle Goldberg writes:

Conservative antipathy to science is nothing new; Republicans have long denied and denigrated the scientific consensus on issues from evolution to stem cell research to climate change. This hostility has several causes, including populist distrust of experts, religious rejection of information that undermines biblical literalism and efforts by giant corporations to evade regulation.

To say that there is a scientific consensus on stem cell research that conservatives deny is to misunderstand or deliberately misrepresent the conservative and religious objection to embryonic stem-cell research. There is no conservative with wh0m I am familiar who denies or denigrates the scientific consensus that stem cells are undifferentiated cells with the potential to transform into cells with more specialized functions. What they deny is that humanity has the right to create new human beings, destroy them, and harvest their cells for humanitys supposed medical or scientific advancement.

If Goldberg balks at that reasoning, fine but she is objecting to an ethical principle, not a matter of scientific fact that has been denied or denigrated. If scientists have a consensus view on the morality of embryonic stem-cell research, fine. Perhaps car mechanics have a corporate view on fuel-emissions standards. Neither consensus tells us much of anything about the underlying moral or political question involved.

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Uses and Abuses of Scientific Consensus - National Review

Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy – Business Wire

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were published online via the ARVOLearn platform as part of the 2020 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The presentation entitled, Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results (Abstract # 3363764), was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. Dr. Riemanns presentation is available on the Media page of the Lineage website. Lineage will also host a live call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineages website.

This update is significant as it builds on our earlier reports of gains in visual acuity and provides a more comprehensive picture of treatment with OpRegen for dry AMD, with meaningful improvements in the progression of geographic atrophy, visual acuity, and reading speed observed in our first Cohort 4 patient and first Orbit SDS with thaw-and-inject formulation dosed patient, stated Brian M. Culley, Lineage CEO. As dry AMD is a slow and progressive disease, it takes many months to observe changes to retinal anatomy or visual acuity. With the benefit of longer follow-up, we now can report that some OpRegen treated patients are able to see better, have less growth in their area of GA, and are able to read faster, all of which represent significant enhancements to vision and quality of life metrics. In addition to these individual results, the pooled data continues to suggest a treatment effect in both visual acuity and GA progression. Notably, we also are reporting additional evidence that OpRegen cells remain present for at least 4 years and hope that longer follow-up periods will reinforce a growing body of evidence that OpRegen is well-tolerated and can provide sustained and clinically meaningful benefits with a single dose of RPE cells. Our near-term objective is to treat and monitor the final four patients in Cohort 4 of the current study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market.

As a principal investigator on the OpRegen clinical study, I am excited to present this most recent update, where all Cohort 4 patients treated with OpRegen had improved Best Corrected Visual Acuity up to one year or at their last visit, demonstrating a substantial treatment response, stated Christopher D. Riemann, M.D. The pooled Cohort 4 data demonstrate a significant, greater than 10-letter sustained visual acuity improvement over the entire followup period. Reading center assessments of GA also suggest a reduction in GA progression in the OpRegen treated eye when compared to fellow eye in Cohort 4. I am encouraged by the results observed in patients treated to date with OpRegen and I look forward to dosing patients in this study at CEI.

KOL Call Information and Webcast

Lineage will host a conference call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineages website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the Lineage Cell Therapeutics Call. A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through May 19, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6597936.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineages objectives with respect to OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Excerpt from:
Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy - Business Wire

COVID-19 Impact on STEM CELL THERAPY MARKET 2020 TO 2027-EXPANDING WORLDWIDE WITH TOP PLAYERS FUTURE BUSINESS SCOPE AND INVESTMENT ANALYSIS REPORT -…

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Life science Industry, and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Stem Cell Therapy market globally. This report on Stem Cell Therapy market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

To get sample Copy of the report, along with the TOC, Statistics, and Tables please visit @https://www.theinsightpartners.com/sample/TIPHE100000991/

Stem cell therapy is a technique which uses stem cells for the treatment of various disorders. Stem cell therapy is capable of curing broad spectrum of disorders ranging from simple to life threatening. These stem cells are obtained from different sources, such as, adipose tissue, bone marrow, embryonic stem cell and cord blood among others. Stem cell therapy is enables to treat more than 70 disorders, including degenerative as well as neuromuscular disorders. The ability of a stem cell to renew itself helps in replacing the damaged areas in the human body.

MARKET DYNAMICSIncrease in the number of stem cell banking facilities and rising awareness on the benefits of stem cell for curing various disorders are expected to drive the market during the forecast period. Rise in number of regulations to promote stem cell therapy and increase in number of funds for research in developing countries are expected to offer growth opportunities to the market during the coming years.

Key Players

The research provides answers to the following key questions:

The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Stem Cell Therapy market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal according to different segments. The report also predicts the influence of different industry aspects on the Stem Cell Therapy market segments and regions.

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Our research and insights help our clients anticipate upcoming revenue compartments and growth ranges. This will help our clients invest or divest their assets.

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Stem Cell Therapy Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America

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COVID-19 Impact on STEM CELL THERAPY MARKET 2020 TO 2027-EXPANDING WORLDWIDE WITH TOP PLAYERS FUTURE BUSINESS SCOPE AND INVESTMENT ANALYSIS REPORT -...

Human Embryonic Stem Cells (HESC) Market 2020 | Growth Drivers, Challenges, Trends, Market Dynamics and Forecast to 2026 – Cole of Duty

Vitrolife

The scope of the Report:

The report analyzes the key opportunities, CAGR, and Y-o-Y growth rates to allow readers to understand all the qualitative and quantitative aspects of the Human Embryonic Stem Cells (HESC) market. A competition analysis is imperative in the Human Embryonic Stem Cells (HESC) market and the competition landscape serves this objective. A wide company overview, financials, recent developments, and long and short-term strategies adopted are par for the course. Various parameters have been taken into account while estimating market size. The revenue generated by the leading industry participants in the sales of Human Embryonic Stem Cells (HESC) across the world has been calculated through primary and secondary research. The Human Embryonic Stem Cells (HESC) Market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development 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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Highlights of the Human Embryonic Stem Cells (HESC) market study:

Speculations for sales:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Human Embryonic Stem Cells (HESC) market. Additionally, it includes a share of every segment of the Human Embryonic Stem Cells (HESC) market, giving methodical information about types and applications of the market.

Key point summary of the Human Embryonic Stem Cells (HESC) market report:

This report gives a forward-looking prospect of various factors driving or restraining market growth.

It presents an in-depth analysis of changing competition dynamics and puts you ahead of competitors.

It gives a six-year forecast evaluated on the basis of how the market is predicted to grow.

It assists in making informed business decisions by creating a pin-point analysis of market segments and by having complete insights of the Human Embryonic Stem Cells (HESC) market.

This report helps users in comprehending the key product segments and their future.

Strategic Points Covered in TOC:

Chapter 1: Introduction, market driving force product scope, market risk, market overview, and market opportunities of the global Human Embryonic Stem Cells (HESC) market

Chapter 2: Evaluating the leading manufacturers of the global Human Embryonic Stem Cells (HESC) market which consists of its revenue, sales, and price of the products

Chapter 3: Displaying the competitive nature among key manufacturers, with market share, revenue, and sales

Chapter 4: Presenting global Human Embryonic Stem Cells (HESC) market by regions, market share and with revenue and sales for the projected period

Chapter 5, 6, 7, 8 and 9: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions

Finally, the report global Human Embryonic Stem Cells (HESC) market describes Human Embryonic Stem Cells (HESC) industry expansion game plan, the Human Embryonic Stem Cells (HESC) industry knowledge supply, appendix, analysis findings and the conclusion. It includes a through explanation of the cutting-edging technologies and investments being made to upgrade the existing ones.

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Human Embryonic Stem Cells (HESC) Market 2020 | Growth Drivers, Challenges, Trends, Market Dynamics and Forecast to 2026 - Cole of Duty

Louis Bacon Is Having The Time Of His Life – Dealbreaker

When legendary hedge fund Louis Bacon returned his clients capital last year, possibly to avoid distraction from the destruction of his Bahamian neighbor and bte noire, he probably couldnt have known with certainty just how bad tings would get for Canadian discount fashion mogul Peter Nygard. Hed already seen their battle over tony Lyford Cay end in an arrest warrant for Nygard and the seizure of his impossibly garish and tasteless estate thereon. Since then, Bacons efforts to have Nygard exposed as a notorious sex criminal and human trafficker have exceeded beyond his wildest dreams: his company in bankruptcy and sold for parts; dozens of women alleging impossibly horrible assaults; and now a book to memorialize all of it and more.

Throughout the day, hed ask a particular girl if shed like to stay the night. If she said no? Ross alleged, Then theres always drugging. She even has alleged that Nygard went so far as to kill her family dog. The New York Times found that Nygard actually wired her $10,000 at one point, emailing Ross: I sent you money to buy a new dog..

I may be the only person in the world, he bragged, who has my own embryos growing in a petri dish.

One of his girlfriends, Suelyn Medeiros, wrote in her 2014 memoir about a trip she took with Nygard to Ukraine, where he was having stem cell research done.

He asked, Suelyn, do you know what the best stem cells are? she writes.

She did: Embryos.

Correct! she says Nygard responded. If you got pregnant and had an abortion, we could use those embryonic cells and have a lifes supply for all of us: you, your mother and me. A lot of people are doing it.

Well, if youre wondering just how much Bacon is enjoying all of this, why, take a look:

Billionaire investor Louis Bacons Moore Capital has gained 17 per cent so far this year, according to people familiar with the figures, which would rank it among the worlds best-performing hedge funds. Moores gains, which would rank among its biggest annual returns over the past decade, come as macro hedge funds enjoy a long-awaited revival.

Louis Bacons Moore Capital makes big gains after going it alone [FT]Fashion Mogul Peter Nygard Business Properties to Be Sold [WSJ]Canadian woman says fashion mogul Peter Nygard drugged and raped her in Bahamas [CBC]Inside the twisted world of rapist designer Peter Nygard: book [N.Y. Post]

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Louis Bacon Is Having The Time Of His Life - Dealbreaker

Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy – Yahoo Finance

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, today announced that updated results from a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium (RPE) cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were published online via the ARVOLearn platform as part of the 2020 Association for Research in Vision and Ophthalmology (ARVO) Meeting. The presentation entitled, "Phase I/IIa Clinical Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented Epithelium (RPE, OpRegen) Transplantation in Advanced Dry Form Age-Related Macular Degeneration (AMD): Interim Results" (Abstract # 3363764), was presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine. Dr. Riemanns presentation is available on the Media page of the Lineage website. Lineage will also host a live call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results of treatment with OpRegen. Interested parties can access the call on the Events and Presentations section of Lineages website.

"This update is significant as it builds on our earlier reports of gains in visual acuity and provides a more comprehensive picture of treatment with OpRegen for dry AMD, with meaningful improvements in the progression of geographic atrophy, visual acuity, and reading speed observed in our first Cohort 4 patient and first Orbit SDS with thaw-and-inject formulation dosed patient," stated Brian M. Culley, Lineage CEO. "As dry AMD is a slow and progressive disease, it takes many months to observe changes to retinal anatomy or visual acuity. With the benefit of longer follow-up, we now can report that some OpRegen treated patients are able to see better, have less growth in their area of GA, and are able to read faster, all of which represent significant enhancements to vision and quality of life metrics. In addition to these individual results, the pooled data continues to suggest a treatment effect in both visual acuity and GA progression. Notably, we also are reporting additional evidence that OpRegen cells remain present for at least 4 years and hope that longer follow-up periods will reinforce a growing body of evidence that OpRegen is well-tolerated and can provide sustained and clinically meaningful benefits with a single dose of RPE cells. Our near-term objective is to treat and monitor the final four patients in Cohort 4 of the current study and utilize these data to direct our clinical, regulatory, and partnership discussions. Our goal is to combine the best cell line, the best production process, and the best delivery system, to position OpRegen as the front-runner in the race to address the unmet need in the potential billion-dollar dry AMD market."

"As a principal investigator on the OpRegen clinical study, I am excited to present this most recent update, where all Cohort 4 patients treated with OpRegen had improved Best Corrected Visual Acuity up to one year or at their last visit, demonstrating a substantial treatment response," stated Christopher D. Riemann, M.D. "The pooled Cohort 4 data demonstrate a significant, greater than 10-letter sustained visual acuity improvement over the entire followup period. Reading center assessments of GA also suggest a reduction in GA progression in the OpRegen treated eye when compared to fellow eye in Cohort 4. I am encouraged by the results observed in patients treated to date with OpRegen and I look forward to dosing patients in this study at CEI."

KOL Call Information and Webcast

Lineage will host a conference call with Dr. Riemann, on Monday, May 11, 2020 at 5:00 p.m. ET/2:00 p.m. PT to further discuss the results following treatment with OpRegen. A live webcast of the conference call will be available online in the Events and Presentations section of Lineages website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A replay of the webcast will be available on Lineages website for 30 days and a telephone replay will be available through May 19, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 6597936.

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About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, a cancer immunotherapy of antigen-presenting dendritic cells in Phase 1 development for the treatment of non-small cell lung cancer. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineages objectives with respect to OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading "Risk Factors" in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200506005264/en/

Contacts

Lineage Cell Therapeutics, Inc. IR Ioana C. Hone(ir@lineagecell.com)(442) 287-8963

Solebury Trout IR Gitanjali Jain Ogawa(Gogawa@troutgroup.com)(646) 378-2949

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Lineage Cell Therapeutics Reports New Data With OpRegen for the Treatment of Dry AMD With Geographic Atrophy - Yahoo Finance

Human Embryonic Stem Cells, Germ Cells, and Cell-Derived …

NOTE: THIS GUIDANCE REPLACES OHRPS NOVEMBER 16, 2001, GUIDANCE ENTITLED, GUIDANCE FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS REGARDING RESEARCH INVOLVING HUMAN EMBRYONIC STEM CELLS, GERM CELLS, AND CELL-DERIVED TEST ARTICLES. CLICK HERE FOR THE NOVEMBER 16, 2001 GUIDANCE.

Office for Human Research Protections Department of Health and Human Services

Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-Derived Test Articles

Date:March 19, 2002

Scope: This document describes when research activities involving human embryonic stem cells (hESCs), human embryonic germ cells derived from fetal tissue, or hESC- or germ cell-derived test articles are considered human subjects research and what regulatory controls apply to that research.

Target Audience: Investigators who conduct research with these cells and test articles, sponsors of such research, institutions where the research is conducted, and Institutional Review Boards (IRBs) that review human subject research involving these cells or test articles.

APPLICABLE REGULATIONS AND LAWS

CONDITIONS REGARDING FEDERAL FUNDING OF RESEARCH ON HUMAN EMBRYONIC STEM CELLS

GUIDANCE

Under HHS regulations at 45 CFR Part 46, human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

HHS-conducted or supported research that involves neither interactions nor interventions with living individuals or obtaining identifiable private information is not considered human subjects research. Accordingly, in vitro research and research in animals using already derived and established human cell lines, from which the identity of the donor(s) cannot readily be ascertained by the investigator, are not considered human subject research and are not governed by the HHS or FDA human subject protection regulations appearing at 45 CFR Part 46 and 21 CFR Parts 50 and 56. IRB review is not required for such research.

Use of Identifiable Private Information

HHS-conducted or supported research that uses human cell lines where the donor(s) may be identified, including cells that retain links (such as a code) to identifying information is generally considered human subject research that is governed by 45 CFR Part 46 because the donors are human subjects. IRB review and approval is required for such research.

In vitro research or research in animals using a human cell line that retains a link to identifying information ordinarily would not be considered human subjects research if: (1) the investigator and research institution do not have access to identifiable private information related to the cell line; and (2) a written agreement is obtained from the holder of the identifiable private information related to the cell line providing that such information will not be released to the investigator under any circumstances. In this case, the research may be considered to not involve human subjects because the identity of the donor(s) could not be readily ascertained by the investigator or associated with the cell line. Under such circumstances, an institution or an IRB could determine that IRB review of the research using the cell line was not needed.

Intervention or Interactions with the Individual

All HHS-conducted or supported clinical research that involves interactions with living individuals, including the transplantation of human cells or test articles, such as differentiated cells derived from human embryos or human fetal tissue, into human recipients is human subjects research subject to HHS regulations at 45 CFR Part 46 because recipients are human subjects. IRB review and approval is required for such research.

Furthermore, all clinical research involving use of cells or test articles regulated by FDA as drugs, devices, and biological products is subject to regulation and oversight by FDA. This clinical research must be conducted in compliance with FDAs regulations governing INDs or IDEs regardless of source of funding. All human studies conducted under INDs and IDEs are subject to FDAs IRB and informed consent regulations.

Public Law 103-43, Research on Transplantation of Fetal Tissue, also applies to clinical research involving the transplantation of cells or test articles derived from human fetal tissue into human recipients.

In addition, other Federal, State or local laws may also apply to transplantation or other research involving these cells or test articles.

RELATED GUIDANCE

For further information regarding this guidance, please contact OHRP at ohrp@hhs.gov or 240-453-6900).

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Human Embryonic Stem Cells, Germ Cells, and Cell-Derived ...

Inside the twisted world of ‘rapist’ designer Peter Nygard: book – The Loppy

Peter Nygard, the flamboyant Canadian fashion mogul, built a nearly billion-dollar fortune hawking slacks and blouses at Sears, Walmart and his own store in Times Square. Known as a hard-partying Peter Pan, the man Forbes dubbed The Polyester Phenom was often surrounded by young women and threw legendary parties at his homes in the Bahamas and Los Angeles.

But it all came to a halt in February when the FBI raided Nygards Manhattan office. The bust came just a week after 10 unidentified women filed a federal lawsuit accusing the 78-year-old of a decades-long sex-trafficking scheme in which he recruited, lured, and enticed young, impressionable and often impoverished children and women, with cash payments and false promises of lucrative modeling opportunities only to, allegedly, sexually assault and rape them. On April 22, 36 more women joined a class-action complaint against Nygard.

The new book Predator King: Peter Nygards Dark Life of Rape, Drugs and Blackmail (Hot Books) by Melissa Cronin tells this dark story. (Nygards lawyer, who has sent a cease-and-desist letter to the books publisher, told The Post: Predator King recklessly presents a one-sided, unreliable, and wholly misleading portrayal of the allegations against Mr. Nygard.) Here, an adapted excerpt chronicles how Nygard allegedly used his power and privilege to take advantage of people.

Much of the alleged illegal activity is said to have taken place in and around Nygards 150,000-square-foot estate in Lyford Cay, Bahamas, which featured fake volcanos spouting dry ice, a gym on the beach, statues of nudes supposedly modeled on Nygards exes, a disco hut with cameras under the floors, an underground Mayan-themed cave housing 30 cars and an indoor swimming pool with glass through the middle, which allegedly had dolphins on one side and sharks on the other.

Massive cauldrons come to life, blazing with flames. The eyes of concrete Mayan-style gargoyles and snakes glow like embers. Angry organ chords in a minor key shoot out across the ocean, the beach and the surrounding properties: the foreboding first notes of the theme to Andrew Lloyd Webbers Phantom of the Opera.

When Peter Nygard was in residence at Nygard Cay, neighbors say, that was the nightly soundtrack. In the booming early 2000s, Nygard Cay was a playground for lingerie and bikini models flown in from Las Vegas and other major US cities.

According to Nygards [house manager], Richette Ross, his staffers used Facebook posts and messages to promote upcoming parties, which offered free dinners, massages, pedicures, and boat rides to guestsmainly females, said Ross. Mr. Nygard didnt like the competition.

Once the party began, though, Nygard would kick off a twisted competition of his own, she claimed. As guests arrived, they would be photographed and entered into Nygards personal database. He even rated them upon entry, Ross claimed: A, B, C or D, with A being the most beautiful. Ross claimed [those] women had to have what Nygard called a nice toilet a nice ass. It had to be big and round.

Ross claimed, Throughout the day, hed ask a particular girl if shed like to stay the night. If she said no? Ross alleged, Then theres always drugging.

Ross said that she personally witnessed one of Nygards bartenders drop a pill into a girls drink.

Around 10:00, we were almost ready to shut down, Ross claimed, when she spotted the girl again. She was crying naked in the office. Disorientated.

Tragically, according to Ross, this wasnt an unusual occurrence. She claimed, It happened often. She even said that at least once, she saw a girl escape from the property, only to be brought back by Bahamian police, apparently against her will.

When the New York Times covered the sexual assault accusations against Nygard earlier this year, it revealed that two accusers interviewed had then recanted and said they had been paid to lie by Ross. (Nygard has also claimed that his billionaire neighbor, Louis Bacon, with whom hes feuded for years, has paid people to make false statements about him.) However, Ross denied having paid anyone to lie and passed a polygraph test supporting her denial. In the book, Ross alleges that she herself even fell prey to her boss wicked scheme

Nygards girlfriend offered [Ross] a glass of wine. It seemed unusual, and she declined the offer to focus on her work. Still, Ross said, She stopped me and insisted I have that glass of wine. As I was going up the stairs I felt a warmness coming over my body. I turned to tell [Nygard] I wasnt feeling good. I remember going down.

When I came to, Ross alleged, he was penetrating me. I could see from the mirror (on the ceiling). I knew he was on top of me. I remember trying to ease my way to the edge of the bed He raped me.

Ross finally quit working for Nygard in 2014. She found support in a local nonprofit organization founded to help sexual violence victims. Ross even became a sort of leader in the community, introducing other alleged victims to the organization in the hopes of getting them therapy and the community support theyd never had.

She even has alleged that Nygard went so far as to kill her family dog. The New York Times found that Nygard actually wired her $10,000 at one point, emailing Ross: I sent you money to buy a new dog. (He blamed the dogs death on a political rival.)Before long, though, Ross had made herself a target. At one point, I was basically in hiding, she alleged, describing threats that were issued all the time.

According to the book, Nygard had almost unlimited power to do what he wanted in the Bahamas after bribing officials from the governments Progressive Liberal Party.

Former Nygard employee Richette Ross said she was personally tasked with putting together payoffs for high-ranking [Progressive Liberal Party] members.

[She claimed to have seen] stacks of $10,000 bundles from the bank stuffed into bags for delivery. For some, Ross said even that method of handoff was too risky. She claimed that Nygard got creative in his efforts to pay off politicos.

Mr. Nygard had required that I order some very large fish, she said. He had about $100,000 in $10,000 bundles. He told me he wanted me to break them up, roll them, and put them in this fish.

According to records obtained by the Bahamas Tribune, Shane Gibson [a member of the PLP] received $94,131.10 deposited into his Miami bank account from the Nygard Companies in 2012 and 2013. The donations were usually $5,000 or more, and were deposited on a semi-regular basis, marked services or travel.

When confronted with the records, Gibson, the Minister of Immigration and Labor at the time, told the Tribune that they were campaign donations, as well as financial contributions to community programs he was spearheading, like scholarships for local students. Gibson would later be photographed at one of Nygards pamper parties in 2014. (Gibson did not respond to The Posts requests for comment.) With Nygards support, the PLP rolled to victory in 2012 and the designer was quick to claim credit.

According to court documents obtained by the Tribune newspaper shortly [after the election] the government determined that appropriate acreage should be leased to Mr. Peter Nygard so he could develop a stem cell facility as a part of what was termed a touristic development.

Nygard admitted to having [met with government officials], but his attorneys later claimed that the minutes of that meeting had been fabricated, and that he had no desire to curry preferential treatment by the Bahamian government. The campaign to get his stem cell mecca built, though, would consume him for the next several years.

Nygard, obsessed with staying young, ended up establishing his stem cell research company in nearby St. Kitts. The alleged purpose: to use aborted fetuses from his pregnant girlfriends to provide him with fresh stem cells.

Nygard seemed to suggest that something like that could be afoot when he talked about the technology behind his treatments publicly. I may be the only person in the world, he bragged, who has my own embryos growing in a petri dish.

When I came to he was on top of me. I remember trying to ease my way to the edge of the bed.

Peter Nygards former house manager Richette Ross, claiming in Predator King that he drugged and raped her

One of his girlfriends, Suelyn Medeiros, wrote in her 2014 memoir about a trip she took with Nygard to Ukraine, where he was having stem cell research done.

He asked, Suelyn, do you know what the best stem cells are? she writes.

She did: Embryos.

Correct! she says Nygard responded. If you got pregnant and had an abortion, we could use those embryonic cells and have a lifes supply for all of us: you, your mother and me. A lot of people are doing it.

Medeiros says she was beyond stunned.

This was the sickest thing Id ever heard Peter say, she writes. I couldnt speak for a moment Finally, catching my breath, I said, Peter, I do not believe in abortion.

On Feb. 13, 2020, a class-action complaint on behalf of several Jane Does was filed in the US District Court for the Southern District of New York and revealed Nygards depravation.

On so many nights, it was alleged, the same story would unfold: Nygard lures the victims to his bedroom or has them ushered there by groomers, under the false pretense of discussing a potential modeling contract in private, where he uses physical force or coercion or knowing the victim has not attained the age of 18 years, to engage in commercial sex acts and coerce and force them to engage in unwanted sexual acts

The amounts of money provided to the victims is more than most of [them] have seen at one time in their entire lifetimes He promises many victims that he will contact them about future modeling contracts. However, in the vast majority of cases, Nygard never intends to follow through with the modeling contracts and tells his victims this for the sole purpose of maintaining control over them.

[He] also threatens the victims with implied or express threats of retribution if they tell anyone about what happened, often implying or expressly threatening to have his victims killed if they do not cooperate.

Today, Nygards Lyford Cay estate is quiet no more Phantom of the Opera melodies after it was seized by local authorities in 2018 because of illegal dredging, according to Canadas National Post. The moguls company filed for Chapter 15 bankruptcy in New York last week, and Nygard is reportedly in Winnipeg, Manitoba, awaiting the outcome of the FBI investigation.

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Inside the twisted world of 'rapist' designer Peter Nygard: book - The Loppy