StemCell Therapy

Pacific University is proud to recognize its most dedicated employees with its annual faculty and staff awards.

The annual Faculty & Staff Honors & Awards Ceremony, scheduled for May 6, was canceled due to COVID-19 restrictions. The university, however, announced its awards to recognize employees virtually.

Today, we should be together, recognizing the exceptional work you have done at the Faculty & Staff Honors & Awards Ceremony, President Lesley Hallick said in an email to employees. But even though we are apart, I still want to take this opportunity to thank each of you and to especially call out the retirees and the exceptional individuals who have made notable impacts at Pacific this past year.

Pacific bestowed awards on 11 faculty and staff members, recognizing their contributions to teaching, student support, service and the university mission.

Among the awardees are Denise Goodwin of the College of Optometry, who was named Distinguished University Professor. The university also bestowed its Dedication to Students Award posthumously to Mike Charles, a College of Education professor who died earlier this year. See bios of all award winners here.

Additionally, the university recognized 16 long-time employees who retired, or are retiring, in 2019-2020 (meet the retirees) and honored those employees who have reached longevity milestones with Pacific (watch the award presentation).

The Boxer Spirit is, at its core, about people, Hallick said. You are what make the Pacific experience possible for our students, and you are what will carry us into the future.

Pacific University is the only comprehensive university in Washington County, Ore. Serving nearly 4,000 students in undergraduate, graduate and professional programs in the arts & sciences, business, education, health professions and optometry, Pacific is committed to discovery in a nurturing learning environment that pairs close, mentoring relationships with extraordinary educational experiences, research and service learning.

Pacific has moved more than 1,000 courses online this spring in response to the COVID-19 pandemic. As Oregon prepares to gradually reopen, the university is committed to offering its rigorous and personally meaningful academic programs this fall.

Read the rest here:
Pacific University Recognizes Faculty and Staff With Annual Awards and Honors - Pacific University

Ive been meaning to do this post for a while. It was originally planned for sometime in February, but I didnt get around to it before all the recruiting breakdowns I was doing. Then other things came up, and it kept getting pushed down the line. But here it is.

Its very rare a conference overturns half of its coaches in one single offseason. This was no ordinary offseason for the Mountain West, though. Some are familiar names, and others may be new. This post is giving each hire grades, broken up into different categories.

The first is the initial reaction, meaning perception when the coach was officially announced and had yet to do anything other than sign the contract, as some of the hires carried a bit more weight than others.

The next is their 2020 recruiting class. Yes, its a small sample size, and yes they all started at different times. But really, there isnt much else to go off of at this point.

Lastly, there will be a grade on longevity. Although it is a bit silly to think about how long these coaches will stay when they just got hired, ADs are certainly asking that question. Again, its hard to predict, will be subjective, and not the end-all, be-all when it comes to hiring a coach, but it does matter. Finding a coach who wont bolt after one winning season will help build or sustain the program.

Initial Reaction: A

Hiring Gonzales, the former Lobo player, and assistant coach was nothing short of a home run. The fact that they were able to hire him before the head coaching job at San Diego State opened up, and then he hired Rocky Long as his DC make stellar move continue to pay dividends.

Recruiting: B-

The fact that he is recruiting at all is a huge success, and one could argue this grade should be higher because of it. They turned in a pretty nice recruiting class all things considered, and it may be the first in a string of positively trending classes.

Longevity: A

Gonzales has strong ties to the New Mexico program and wouldnt figure to leave for just any job opening. He is as safe of a bet as any coach in the college football world.

Initial Reaction: A-

DeBoer was considered one of the top choices in the sudden Fresno State opening, having served as the offensive coordinator under Tedford before leaving for Indiana. Hes fairly young, is familiar with the program and players, and wanted the job. There is a lot to like here.

Recruiting: C-

DeBoer turned in a recruiting class similar to the ones Tedford produced. That is to say, average with some promise, but nothing that popped off the page. There will be some work to do in this area, or at least he will need to continue the emphasis on player development Tedford and his coaches were so good at.

Longevity: B

Its tough to say, but as a first-time coach, DeBoer will likely need to stay around to produce a few strong seasons before suitors begin to line up. Its unlikely he bolts before establishing himself.

Initial Reaction: A+

If Gonzales was a home run hire, then Arroyo was a grand slam. A top assistant at a top program, this was likely the best hire they could have made. It brought instant energy into the Rebel program, and they sorely needed it.

Recruiting: A

Arroryo got to work right away and landed one of the best recruiting classes in the entire conference. There is a lot of talent coming into the program, and its clear he is playing to his strength here.

Longevity: C+

Just a hunch, but it wouldnt be a surprise if this job is only a stepping stone for Arroyo. If he does well, he could easily cash in for a PAC12 job. However, its hard to be sure until the games are actually played, and the dominos begin to fall.

Initial Reaction: D+

This hire was puzzling when it was announced. The Rams were trading one .500 coach for another one? Addazio has head coaching experience, but he was just fired himself, and it appeared there were up and coming assistants with ties to the school available.

Recruiting: C+

Addazio went to work on the recruiting trail, going both local and nationwide for talent. He did alright with the time and challenges he had.

Longevity: B-

This one is actually a bit tougher to make a guess on. Does Addazio continue to be the coach he was before, and eventually Colorado State tries to upgrade again? Does he have success and try to get back into the P5? Or does he have success and settle in for the long haul, content with being a bigger fish in a smaller pond?

Initial Reaction: C+

Some may see this as a pretty good rehire, similar to Gary Andersen last year. Others may see these are a poor hire, since Hoke bolted after one good season the first time at SDSU and didnt do much at his other stops (which also sounds like Andersen). This grade splits the difference.

Recruiting: B-

San Diego State has turned in good but never great recruiting classes under Coach Long, and that basically seemed like what the Long/Hoke combo did this winter. Going forward, it seems like Hoke is focusing on recruiting earlier in the year, and it will be interesting to see if there is a shift in the type of players they recruit.

Longevity: C+

Similar to Addazio, maybe Hoke learns the grass isnt always greener, and its better to stay in a place where success is being had. Although, that success has been difficult to come by lately, so it seems like more of a toss-up.

Initial Reaction: C+

This hire was another one that was a bit questionable, but at least Graham has a pretty good track record as a coach and a very good track record as a person. He gets dinged a bit for not having ties to Hawaii, but he should be able to establish a culture there.

Recruiting: D+

Graham had next to no time to recruit and thus had to scrape things together in the last few weeks. I considered grading on a curve, but figured Id just tell it like it is, even if things were stacked against him. It will be interesting to see what happens in the class of 2021.

Longevity: B-

Who knows, really. Graham has made quite a few stops in his coaching career thus far. There are worse places to be at than the islands, but Hawaii doesnt pay much, and thats what caused local guy Rolovich to leave. Its probably safe to assume he stays a few seasons, which is a fairly long time in todays CFB landscape.

Again, its hard to honestly grade any of these hires until there are actual games being played. This is just going off of the perception of the hire and the small sample size of recruiting. Its guesswork, but there isnt much going on, so why not? Objectively, all of them have incomplete grades as it is too early to really judge. As for if these grades will hold up or be proven foolish, only time will tell.

These are one set of opinions. What do you think? Post in the comments below.

Read the original post:
Peak Perspective: Grading the New MWC Coaches - Mountain West Connection

When John Lynch and Kyle Shanahan took over the 49ers, one of their biggest offseason goals was to bring in a multi-talented running back fit for today's game.

They did so in signing Jerick McKinnon to a four-year deal in 2018. There's one problem, though: McKinnon has yet to play a regular-season down for San Francisco. An ACL injury and struggles with regaining comfort on the injured knee have kept the running back out of action for the last two seasons.

The former understudy to Adrian Peterson in Minnesota is turning to his old friend for a true test of where McKinnon stands at this point on his road to returning to football. He's heading to Houston to put himself through Peterson's legendary, marathon-like workouts.

"I feel like it's my last test to really see how it feels," McKinnon said, via The Athletic's Matt Barrows. "There's a lot of hard work going on down there. That's really where I'm going to amp it up as hard as I can and see where it goes."

Peterson's workouts are a significant source of his power, speed and longevity, with the latter prevailing most in recent years. It also set a standard for McKinnon, one he feels he must revisit now in order to fully grasp how prepared he is to return to football action.

"There were a lot of things back then that were tough," he said of his struggles with rehabilitation and a failed attempt to return to action in 2019. "I feel now that I'm getting back to where I was effortlessly."

McKinnon's absence has opened the door for other backs to shine. Matt Breida, Raheem Mostert and Jeff Wilson Jr. have all seen significant playing time in the last two seasons because the 49ers have had to find a way to replace what they lost with McKinnon's injury. Tevin Coleman would be the ideal complement to McKinnon (or vice versa) in a 2020 San Francisco backfield, which has been fine without McKinnon but could be even better with him.

The reason: McKinnon's lateral quickness and ability to change direction make him a very difficult target to cover in open space. Add that to an offense that's already masterful at times with Shanahan at the helm, and the reigning NFC champs only get stronger.

First, McKinnon will have to figure out how strong he is -- and he's going to get quite a test with the strong man nicknamed "All Day."

See the rest here:
McKinnon to test knee in workouts with AP - NFL.com

Ever since Apple announced the much-anticipated second coming of the iPhone SE, tech reviewers on both sides of the iOS vs. Android camp have been dumbfounded by just what a great value the smartphone seems to be. And while it is an impressive specimen in terms of fit, finish, and features, the hardware and appearance of the device are not what make it truly special. They're also not what makes the phone a legitimate threat not only to mid-range Android devices, but ostensibly to the entire Android ecosystem. No, that honor goes to something less obvious, less flashy, less sexy. The iPhone SE's real allure is all about the software/security updates and support. Period.

There had been rumors and speculation about the iPhone SE (2020) for years. Ever since the outsized popularity that the undersized 2016 handset generated, Apple faithful, as well as those still longing for quality, smaller phones with smaller price points, have been clamoring for a replacement to the original value iPhone.

It doesn't happen often in life, but in the iPhone SE (2020), fans basically got more of what they asked for.

Small iPhone fans were hopeful that any refresh to the 2016 SE would keep the original four-inch footprint, but bring a better processor, camera, and maybe some extras like wireless charging. This doesn't happen very often in life, but in the case of the SE, fans got most of (and in some cases, more of) what they wished for.

For a quick recap, the 2020 edition has a home button with Touch ID, a smaller and lighter form factor (though admittedly not as small as the original), the latest and greatest A13 processor, dual-SIM, portrait mode photos, IP67 water resistance, wireless charging, and the same affordable price from four years earlier.

For a thorough review of the iPhone SE (2020), head on over to iMore to read what my colleague Lory Gil had to say about the device.

Phone nerds (and not just Android fans) are quick to point out the iPhone SE's flaws and where it doesn't quite measure up to the mid-range Android devices it's positioned against from a price perspective. It's true, the design of the SE does look a little dated (if iconic) compared to something like the Pixel 3a, Nokia 7.2, or even Moto G Stylus. It has a much lower resolution screen than phones at that price point and cheaper, and it doesn't have a high megapixel camera, a 3.5mm headphone jack, a USB-C charging port, super-fast wired or wireless charging, or the large capacity batteries of many of its competitors.

The thing that got most tech folks excited about the iPhone SE was not the nostalgic form factor or stunningly fair price from Apple. Rather, it was the fact that Apple put its latest high-powered A13 processor into the device. The A13 is objectively better and more powerful at most tasks than anything that Qualcomm, Samsung, Huawei, or MediaTek have to offer the Android world, and it enables features and capabilities that most current mid-range Android phones can't match, (like enhanced image signal processing that makes the SE's iPhone 8-grade camera hardware perform on par with the iPhone 11 series).

The other thing that A13 enables is longevity. There's so much processing overhead in the chip that, at first glance, seems entirely unnecessary. Apple could have (and was expected to) easily gotten away with putting in an older A11 or A12 generation chip, and the SE still would have been a mid-range performance champ. But the secret is not about present-day performance it's about the long haul.

The A13 processor is overkill for now, but allows for long-term platform and security updates, among other improvements.

Apple's devices, and in particular, its iOS devices, are known to receive software and security updates for several years beyond what Android handsets get. iOS 13 is the current version of the software (iOS 13.4.1 at the time of writing, to be exact), and iPhones back to the 6S series and original SE, released in 2015 and 2016 respectively, are both capable of running it. And even though Apple forked iPadOS from iOS in 2019, iPads back to the Air 2 can run iPadOS based on iOS 13 (that's a 2012 device!).

This strategy helps Apple to not alienate fans who are slower to adapt to change, allows them to attract price-conscious smartphone shoppers and potential platform switchers, and allows them to follow their stated environmental focus by keeping phones in use and out of landfills for longer.

Older iOS devices can indeed run current software and get near-immediate, over the air (OTA) updates without waiting for carriers or other OEMs to make any changes, but that doesn't mean that they'll be able to take advantage of new platform features that rely on new hardware like advanced camera features and futuristic AR capabilities. But that's not the point. If flashy new hardware features are what you really want, then you're likely to fork over the additional cash for a more premium device like the Samsung Galaxy S20 series, OnePlus 8 Pro, or iPhone 11 Pro series.

Thanks to that beefy A13 and Apple's commitment and ability to push platform and security updates, by the time 2024 or 2025 rolls around and we're here reviewing what Moto G15 or Samsung A56 phone to get, the SE will probably still be ticking along just fine on iOS 17 or 18. Not too bad for $400 spread out over four or five years!

For a more thorough discussion of this topic, I encourage you to listen to the latest Android Central podcast with guest Lory Gil of iMore.

I know that most people reading Android Central would scoff at the idea of switching to iOS in general, or the iPhone SE in particular, and that's not what I'm advocating for here at all. I simply wish that more Android OEMs would dedicate themselves to supporting the platform and their devices for longer than they currently do.

It's rare to find even premium flagships that promise more than one major platform update (outside of Google and OnePlus), and even rarer still among the mid-range and low-end segments of the market. I realize the adage "you get what you pay for" applies in tech as elsewhere, but I still wish more could be done here.

I know that Apple has several advantages that allow it to produce an affordable mid-ranger with long-term software support. It designs and manufactures its processors, software, and hardware, and has the benefit of only dealing with a handful of suppliers and economies of scale to push its prices down (when it wants to). But there are way more Android manufacturers and customers, and only a couple of chip manufacturers that matter, so you would think that some of them could find a way to compete here with the SE where it matters - longevity. Hopefully, some of them (ahem, Samsung and Google), are getting their rears into gear for 2021 and beyond.

Right now, if you don't want to spend a lot on a good smartphone but you do want the guarantee of multi-year platform and security updates, your choices are between the Google Pixel 3a, and the iPhone SE. Right now, both are available for under $400, and we're eagerly looking forward to a similarly priced, but better specced, Pixel 4a any day now!

Lots to like, especially the camera

The Pixel 3a isn't the newest budget phone on the market, but it still holds up as one of the best. Its OLED display is a joy to look at, performance is really good, and there's no topping its camera quality. Add that together with a clean build of Android 10, USB-C charging, and a headphone jack, and you're getting a lot for your money.

Read the original:
The iPhone SE's major win over cheap Android phones isn't hardware it's software updates - Android Central

Pete Alonso and David Wright arent exactly similar to one another.

Sure, theyre both right-handed, but one is retired and the others career is (hopefully) just getting started, theyre from different areas of the country, and they play different positions on the diamond. Last, but most certainly not least, Alonso has flashed the kind of prodigious power we never saw from Wright.

Despite all that, they are actually pretty similar to one another.

Each have represented the New York Mets in the best possible light given the period of time theyve been associated with the organization and had much anticipated MLB debuts. Wright is the last player New York named as the teams captain, and if things continue going in the current direction, Alonso could end up being next. Last, but most certainly not least (again), Wright is unequivocally the Mets best third baseman in team history, while Alonso has given himself a terrific head start with regard to etching his name in New Yorks all-time record books.

When thinking about these two guys and how they could continue being connected to one another heading into the future, I got to thinking about one final similarity that one has achieved and one has a chance to achieve: continuity at their respective positions.

With regard to total games played at third base, Wright easily has the top spot on the leaderboard, suiting up to man the hot corner 1,586 times. The man in second place Howard Johnson would have to come out of retirement and more than double his current career games played at third (835) for the Mets to catch the Captain. Theres approximately as much space between Wright and Johnson as there is between Johnson and Joe Torre, who sits at 28th place with 87 games played.

As he typically did during the healthy portion of his playing career, Wright also brought the noise on a yearly basis. The Mets had a handful of good third basemen between 1962 and 2003, but there were only two occasions where someone led the team in games played at the position for more than three consecutive years: Hubie Brooks (1981-84) and Johnson (1987-91).

Then, of course, Wright took charge by leading in this category between 2004 and 2015, according to Ultimate Mets Database. That kind of longevity was something New York had obviously never had at this position before, and the top-tier production for the majority of that time was just icing on the cake.

Upon seeing this, I had to head over to first base in order to see whether Alonso could make a similar mark if he continued his current trajectory and was able to stick around in Flushing for the long haul. Hes got a ways to go before catching Ed Kranepool (1,302 career games at first base), but hes in good shape after just one year. There have been 164 different players to man first base as a Met, and Alonsos 153 games played from 2019 already has him at 19th all-time in franchise history.

Using the same parameters on a yearly basis, there have only been two Mets first basemen to lead the team in games played in more than three consecutive years: Kranepool (1964-69) and Keith Hernandez (1983-88). Kranepool does get some extra credit because he led the team in this category 10 times between 1964 and 1976.

Even though the 2020 season will feature a shortened schedule (if we get one), we can assume Alonso will reign supreme atop the games played leaderboard at first base for the second straight year, as long as hes healthy. That trend will almost undoubtedly continue through his pre-arbitration and arbitration years, which would already put him into the above exclusive club with Kranepool and Hernandez (again, assuming hes healthy). And if the Mets extend him beyond their initial team control, he could approach the territory Wright currently has on lock.

Alonsos National League Rookie of the Year campaign was certainly one to remember, and one the record books wont forget, either. He has a ways to go when it comes to having the kind of longevity thatll truly set him apart from the majority of players who have ever donned the orange and blue, but the future sure looks bright for the 25-year-old as he approaches his physical prime.

Continue reading here:
Another Potential Similarity Between Pete Alonso and David Wright - metsmerizedonline.com

DUBLIN--(BUSINESS WIRE)--The "COVID-19 Stem Cell Therapies Pipeline" report has been added to ResearchAndMarkets.com's offering.

Complementing the slew of vaccines in development are the upcoming stem cell therapies, aimed at boosting patients' immune systems and eliminating pathogens. The COVID-19 Stem Cell Therapies Pipeline report provides comprehensive data analysis of 22 organizations developing stem cell therapies for COVID-19 globally from the Americas, Europe, the Middle East and Africa (EMEA), and Asia-Pacific region (APAC).

Some report features include:

The report covers stem cell therapy market with detailed review of their cell therapy research and development including the stages of production (pre-clinical, clinical and commercial). In addition, it pulls together insights from interviews and surveys with key opinion leaders. It seeks to holistically inform the community on the current status of COVID-19 stem cell therapy development and discover future opportunities for collaboration, technology transfer and co-development.

Key Topics Covered

Section 1

Section 2: COVID-19 Stem Cell Therapies Pipeline in the Americas

Section 3: COVID-19 Stem Cell Therapies Pipeline in EMEA

Section 4: COVID-19 Stem Cell Therapies Pipeline in APAC

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/kpp6tj

Read the original here:
COVID-19 Stem Cell Therapies Pipeline, 2020 Report - ResearchAndMarkets.com - Business Wire

"global Stem Cell Therapy market"

A new market study, titled Covid-19 Impact on Global Stem Cell Therapy Market Size, Status and Forecast 2020-2026 has been featured on WiseGuyReports.

The global Stem Cell Therapy market research offers a comprehensive overall market analysis focused on the latest findings. The introduction portion includes a brief overview of the industry, along with the product and service descriptions. This also includes the main applications for all end-user industries. The report also presents market prospects along with the forecast, with the study covering the period 2020-2026. The report includes an in-depth analysis of the major factors that could decide the market's trajectory in the coming years.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use.

In the last several years, global stem cell therapy market developed fast at a average growth rate of 46.81%.

Competition Analysis

In the competitive analysis section of the report, leading as well as prominent players of the global Stem Cell Therapy market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.

The following players are covered in this report:

Osiris Therapeutics

NuVasive

Chiesi Pharmaceuticals

JCR Pharmaceutical

Pharmicell

Medi-post

Anterogen

Molmed

Takeda (TiGenix)

This report also analyses the impact of Coronavirus COVID-19 on the Stem Cell Therapy industry.

Regional and Country-level Analysis

The report offers an exhaustive geographical analysis of the global Stem Cell Therapy market, covering important regions, viz, North America, Europe, China, Japan, Southeast Asia, India and Central & South America. It also covers key countries (regions), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, UAE, etc.

The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by each application segment in terms of revenue for the period 2015-2026.

Stem Cell Therapy Breakdown Data by Type

Autologous

Allogeneic

Stem Cell Therapy Breakdown Data by Application

Musculoskeletal Disorder

Wounds & Injuries

Cornea

Cardiovascular Diseases

Others

Request Free Sample Report athttps://www.wiseguyreports.com/sample-request/5252275-covid-19-impact-on-global-stem-cell-therapy

Table of Contents

1 Report Overview

2 Global Growth Trends by Regions

3 Competition Landscape by Key Players

4 Breakdown Data by Type (2015-2026)

5 Stem Cell Therapy Breakdown Data by Application (2015-2026)

6 North America

7 Europe

8 China

9 Japan

10 Southeast Asia

11 India

12 Central & South America

13 Key Players Profiles

14 Analyst's Viewpoints/Conclusions

NOTE: Our team is studying Covid-19 and its impact on various industry verticals and wherever required we will be considering Covid-19 footprints for a better analysis of markets and industries. Cordially get in touch for more details.

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Wise Guy Reports is part of the Wise Guy Research Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe.

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Impact of Covid-19 Outbreak on Global Stem Cell Therapy Market Future Opportunities and Forecast Analysis 2020-2026 - Press Release - Digital Journal

GlobalStem Cell TherapyMarket Report 2020, Forecast to 2025presents a historical overview of market size, revenue, share, forecast, and market drivers. The report features detailed insights and deep research on the globalStem Cell Therapymarket. The report studies various segments, as well as key opportunities in the market and influencing factors which will help businesses increase their footprints in the industry. A comprehensive analysis of the product scope and market risks has been given for the participants. The report shows the company profile of the major vendors along with their winning strategies to give business owners, stakeholders, and field marketing personal a competitive edge over others operating in the market.

Get Free Sample Report:https://www.magnifierresearch.com/report-detail/36202/request-sample

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

The Market Report Addresses:

The report provides historical and forecasts market data including demand, application details, price trends, and company shares of the leading manufacturers by geography, and estimation of the globalStem Cell Therapymarket size by volume and value. The growth estimation of the market is offered on the basis of calculation by various segmentation and past and current data. This market has been divided into types, applications, and regions. The report also covers the growth aspects of the market along with the restraining factors which are expected to impact the overall growth of the market in the estimated forecast period from 2020 to 2025.

The top manufacturers/suppliers which are currently operating in the globalStem Cell Therapymarket industry includes:Mesoblast, Regeneus, U.S. Stem Cell

By the product type, the market is primarily split into:Monotherapy, Combination Therapy

By the end-users/application, this report covers the following segments:Osteoarthritis (unspecified), Knee Osteoarthritis, Shoulder Osteoarthritis, Hip Osteoarthritis

Market Regions and Countries Level Analysis:

Regional analysis is a highly comprehensive section of this report. This segmentation sheds light on the sales of theStem Cell Therapyon regional- and country-level. This data provides a detailed and accurate country-wise volume analysis and region-wise market size analysis of the global market. Market segmented by region/country:North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Access Full Report:https://www.magnifierresearch.com/report/global-stem-cell-therapy-market-report-2020-forecast-36202.html

Moreover, the report aims to deliver evaluation and essential information on the competitive landscape to meet the unique requirements of the companies and individuals operating in the market. The study recognizes the factors affecting the globalStem Cell Therapymarket growth such as drivers, restraints, opportunities, and trends. The report also recognizes emerging players with a potentially strong product portfolio and creates effective counter-strategies to gain competitive advantage. The report features reliable high-quality data and analysis which is suitable for supporting your internal and external presentations. The market research report will also help create regional and country strategies on the basis of local data and analysis.

Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team (sales@magnifierresearch.com), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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Global Stem Cell Therapy Market 2020 With COVID-19 Update by Development factors analysis, Competitive Strategies and Forecast to 2025 - Bandera...

In 2018, the market size of Animal Stem Cell Therapy Market is million US$ and it will reach million US$ in 2025, growing at a CAGR of from 2018; while in China, the market size is valued at xx million US$ and will increase to xx million US$ in 2025, with a CAGR of xx% during forecast period.

The report on the Animal Stem Cell Therapy market provides a birds eye view of the current proceeding within the Animal Stem Cell Therapy market. Further, the report also takes into account the impact of the novel COVID-19 pandemic on the Animal Stem Cell Therapy market and offers a clear assessment of the projected market fluctuations during the forecast period. The different factors that are likely to impact the overall dynamics of the Animal Stem Cell Therapy market over the forecast period (2019-2029) including the current trends, growth opportunities, restraining factors, and more are discussed in detail in the market study.

Get Free Sample PDF (including COVID19 Impact Analysis, full TOC, Tables and Figures) of Market Report @ https://www.researchmoz.com/enquiry.php?type=S&repid=2638488&source=atm

This study presents the Animal Stem Cell Therapy Market production, revenue, market share and growth rate for each key company, and also covers the breakdown data (production, consumption, revenue and market share) by regions, type and applications. Animal Stem Cell Therapy history breakdown data from 2014 to 2018, and forecast to 2025.

For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2014 to 2018.

In global Animal Stem Cell Therapy market, the following companies are covered:

Segment by Type, the Animal Stem Cell Therapy market is segmented intoDogsHorsesOthers

Segment by Application, the Animal Stem Cell Therapy market is segmented intoVeterinary HospitalsResearch Organizations

Regional and Country-level AnalysisThe Animal Stem Cell Therapy market is analysed and market size information is provided by regions (countries).The key regions covered in the Animal Stem Cell Therapy market report are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. It also covers key regions (countries), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, UAE, etc.The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of sales and revenue for the period 2015-2026.Competitive Landscape and Animal Stem Cell Therapy Market Share AnalysisAnimal Stem Cell Therapy market competitive landscape provides details and data information by players. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by players for the period 2015-2020. Details included are company description, major business, company total revenue and the sales, revenue generated in Animal Stem Cell Therapy business, the date to enter into the Animal Stem Cell Therapy market, Animal Stem Cell Therapy product introduction, recent developments, etc.The major vendors covered:Medivet Biologics LLCVETSTEM BIOPHARMAJ-ARMU.S. Stem Cell, IncVetCell TherapeuticsCelavet Inc.Magellan Stem CellsKintaro Cells PowerAnimal Stem CareAnimal Cell TherapiesCell Therapy SciencesAnimacel

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The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Animal Stem Cell Therapy product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Animal Stem Cell Therapy , with price, sales, revenue and global market share of Animal Stem Cell Therapy in 2017 and 2018.

Chapter 3, the Animal Stem Cell Therapy competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Animal Stem Cell Therapy breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2014 to 2018.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2014 to 2018.

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Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2014 to 2018.

Chapter 12, Animal Stem Cell Therapy market forecast, by regions, type and application, with sales and revenue, from 2018 to 2024.

Chapter 13, 14 and 15, to describe Animal Stem Cell Therapy sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Supply Chain Disruptions During Covid-19 Outbreak to Adversely Impact Animal Stem Cell Therapy Market - Jewish Life News

Members of the medical team from Beijing's China-Japan Friendship Hospital visit a novel coronavirus pneumonia patient in an ICU ward at Tongji Hospital in Wuhan, Central China's Hubei province, on March 25, 2020. [Photo by Zhu Xingxin/chinadaily.com.cn]

Experts exploring new, innovative approaches to tackle novel coronavirus

Science and technology have played, and will continue to play, a decisive role in mitigating the pandemic, whether it is by discovering new features about the novel coronavirus, looking for new treatment or vaccines or offering expertise in psychological services, experts said.

But science does not always proceed in an unambiguous straight line toward progress. These undertakings, especially those involve pushing boundaries deeper into the unknown, are time-consuming, complicated and unpredictable. So it is important for the public to understand the scientific process to fully respect and appreciate these efforts, they said.

As President Xi Jinping has said, the COVID-19 epidemic is the "fastest spreading, most infectious and most challenging public health emergency since the birth of New China". He has also stressed that epidemic control efforts require the support of science and technology and urged scientists who are working on treatment and a vaccine to accelerate their research while upholding rigorous scientific practices and ensuring their products are safe.

With the leadership of Xi and joint efforts by the whole of society, the epidemic is now under control in China, said Huai Jinpeng, executive vice-president of the China Association for Science and Technology.

"But the disease is still spreading across the globe, and there is a strong downward pressure for the world economy and a noticeable spike in instability and uncertainty," he said at a meeting with the nation's science officials on April 30.

During this critical juncture, Chinese scientists need to be even more hardworking and pragmatic, and make a greater contribution to the nation's post-epidemic socioeconomic recovery with science and innovation, Huai said.

At the same time, they also need to expand their network of cooperation at home and abroad. Science officials and workers should maintain high ethical and professional standards, and be a role model for society, he added.

Wan Gang, president of the China Association for Science and Technology, said the nation's science workers were immediately mobilized to tackle the epidemic when the outbreak began, and have provided crucial scientific support in controlling the disease and assisting the socioeconomic recovery.

Communication is also a key aspect of the overall disease prevention and control effort, he said, adding that the various COVID-19 related information platforms under the association have attracted over 7 billion views in the past few months.

When Chinese microbiologist Wang Jun volunteered to go to Wuhan, Hubei province, to help the city's hospitals research the novel coronavirus, he said he felt like he was heading into a "battlefield".

The motive behind his action was simple. "Our institute (the Institute of Microbiology of the Chinese Academy of Sciences) has been researching the virus since the outbreak began," Wang said on April 20.

"With Wuhan being the first place to have reported the disease, I had a gut feeling that there must have been many questions that our front-line medical staff didn't even know existed, so we had to go to the battlefront to learn about the situation and their needs," he said.

Since the outbreak began, the academy has sent dozens of researchers to Wuhan. Their work has played a major role in the overall epidemic control effort. Their five main objectives were viral research, creating new diagnostic tools, testing clinical treatments, health evaluation for recovered patients and psychological counseling.

Wang said his team had discovered that children, who were believed to be less susceptible to COVID-19, could still spread the disease even when their symptoms were mild, making them potential asymptomatic carriers that might float under the diagnostic radar.

The virus also has some very intricate immunological effects that would make case tracing via antibody tests more difficult, so "more research is definitely needed", he added.

Jin Qi, director of the Chinese Academy of Medical Sciences' Institute of Pathogen Biology, said that scientists' understanding of the novel coronavirus remains limited and is constantly expanding, and with new information unearthed, new questions would emerge.

For example, most researchers agreed that a 14-day quarantine is generally sufficient for a patient to show symptoms, but there are now rare cases in which patients experience the onset of symptoms well after the two-week period, Jin said.

Drugs and vaccines

Wang Guiqiang, head of Peking University First Hospital's department of infectious diseases, said at a seminar in late April that drugs and vaccines are crucial for stopping the pandemic for good, but this will require time and effort by scientists around the globe.

China has three vaccines, one vectorwhich uses just a gene from the coronavirusand two inactivated, currently in Phase II clinical trials. The vector vaccine is spearheaded by Chen Wei, a senior preventive medical expert, and the results for the Phase II trial are set to be published in May, according to official sources.

The two inactivated vaccines were developed respectively by the Wuhan Institute of Biological Products Co Ltd and Sinovac Research & Development Co Ltd.

Zhong Nanshan, a renowned respiratory expert, told People's Daily last month that although there has not been a wonder cure found for COVID-19, some drugs have proved to be effective to some extent.

"We're testing a variety of drugs, such as chloroquine, and experiment results have shown the drug is definitely effective," he said, adding that scientists are analyzing the data and would publish their findings soon.

Some traditional Chinese medicines, including Lianhua Qingwen Capsules, are also being studied. For the capsule, Zhong said although its anti-viral effect against COVID-19 isn't that pronounced, it does have a "remarkable anti-inflammatory effect" that can help patients recover quicker.

A major component of all scientific work is about testing available knowledge and methods, but not all tests can return positive results. Discovering what works, and, sometimes more importantly, what doesn't work and why, is crucial in expanding humanity's knowledge of the disease.

Cao Bin, vice-president of China-Japan Friendship Hospital, said at a seminar last month that they had found Lopinavir/Ritonavir, a combination of anti-HIV drugs that showed potential in treating COVID-19 in the early days of the outbreak, did not produce desirable results.

In late April, the Lancet medical journal published a study by Cao on his clinical trials on remdesivir in China. The study said the experimental drug from the United States did not significantly speed up the recovery of critically ill patients compared with the control group.

The authors warn that interpretation of their study is limited because it only recruited 237 adults, rather than the target of 453 patients, due to the rapid decline of COVID-19 cases in China. They concluded that more research is needed.

Pushing boundaries

Through strong government support and hard work, Chinese scientists are also exploring new and innovative ways to tackle the novel coronavirus.

Zhang Linqi, a professor at Tsinghua University School of Medicine in Beijing, said his team has been using antibodies to "drive a wedge" between the virus' spike proteinits "key" for entering cellsand the receptor that it binds to.

That would effectively block the virus from entry. It has been very effective in animal tests, and may serve to inspire new vaccine candidates, he said at an online seminar in late April.

Scientists have discovered that there is a small but potent section of the spike protein that does most of the work called the receptor-binding domain, or RBD.

Knowing that, Zhang's team, along with scientists from Shenzhen Third People's Hospital, found two antibodies that, together, can insert themselves at the junction of the RBD and the cell's receptor, blocking the virus from latching onto the cell.

Zhang said they are testing the blocking effect in possible vaccines, and early results are "really encouraging". But research is still in its early stages and more rigorous studies and tests are needed, he added.

Hu Baoyang, executive president of the Chinese Academy of Sciences' Institute of Stem Cell and Regenerative Medicine, said since arriving in Wuhan on March 1, his team had been busy testing stem cell therapy to calm the overreacting immune system and repair the lung tissue of severe and critically ill patients.

In the 46 days that followed, Hu and his team traveled to 13 hospitals and screened over 650 candidate patients for this innovative treatment. At a news briefing on April 16, Sun Yanrong, deputy director of the China National Center for Biotechnology Development, said over 200 patients in Wuhan had received stem cell therapy, and current results show the treatment can improve the recovery rate of severely ill patients and is generally safe.

However, stem cell therapy is far from perfect. Stem cells can differentiate into various types of cells, and some might turn cancerous, according to the University of Nebraska Medical Center. Some stem cells are also difficult to isolate and cultivate in large quantities, so more research and testing are also needed.

"Labs are our bastions, and our scientific research is the weapon against the epidemic," Hu said.

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Role of science highlighted in pandemic fight - Chinadaily.com.cn -

4 May 2020

A novel stem cell therapy may play a part in improving the survival rate of ventilator-dependent COVID-19 patients.

Twelve COVID-19 patients at Mount Sinai Hospital in New York were treated with a new type of stem cell therapy, resulting ina survival rate of 83 percent, significantly higher than the 12 percent survival rate for similar untreated patients.

Dr Keren Osman who led the team Mount Sinai Hospital, New Yorktold CBS News: 'What we saw in the very first patient was that within four hours of getting the cells, a lot of her parameters started to get better'.

Ryoncil (remestemcel-L) comprises culture-expanded mesenchymal stem cells (MSCs):rare cells that secrete factors that promote tissue repair and modulate an immune response.

The initial trial of Ryoncil with COVID-19 patients included two intravenous infusions of the drug over five days. Ten of the total 12 patients were able to come off ventilators after treatment. All patients had received other experimental therapies before receiving Ryoncil.

Dr Osman said 'we don't know if the ten people taken off ventilators would not have recovered if they had not been given the stem cell treatment and we would never dare to claim that it was related to the cells A randomised controlled trial would be the only way to make a true comparison.'

A300-person randomised, controlled clinical trial is now planned to determine the safety and efficacy of Ryoncil in the treatment of COVID-19 patients suffering from acute respiratory distress syndrome (ARDS), which results when the patient is unable to get enough oxygen and usually requires the use of a ventilator.

The overreaction of the immune system responsible for these effects is often termed a 'cytokine storm', where the systemic response to destroy the virus ends up damaging the infected lung tissue. Cytokines are small proteins released from certain cells in the immune system and play a role in cell signalling. Therapeutic use of Ryoncil is thought to down-regulate pro-inflammatory cytokine production and stimulate increased production of anti-inflammatory cytokines.

Ryoncil is currently under review by the US Food and Drug Administration (FDA) for the treatment of acute graft versus host diseaseand other rare diseases. The drug has been evaluated through several clinical trials, totalling over 1100 patients, including evidence of improved lung function in patients with similar biomarkers to COVID-19 patients with ARDS.

More here:
Investigational new drug may be beneficial in treating severe COVID-19 - BioNews

Adding the anti-CD20 monoclonal antibody rituximab (various brands) to induction chemotherapy in patients with B-precursor acute lymphoblastic leukaemia (B-ALL) does not improve outcomes, UK researchers have found in a primary analysis of phase 3 trial data.

However, a separate examination of findings from the same study may nevertheless point to an update to the genetic classification for the disease that could help in creating an overall combined clinical and genetic risk score.

The research was published as an abstract from the British Society for Haematology 60th Annual Scientific Meeting, which was cancelled due to the COVID-19 pandemic.

UKALL14 involved patients with B-ALL aged 2565 years, regardless of Philadelphia chromosome (Ph) status or CD20 expression, who were randomised to standard induction chemotherapy (SOC) with or without 4 doses of rituximab (SOC+R).

Focusing on patients recruited after an amendment to the SOC regimen in April 2012, the team conducted an intention-to-treat analysis in 288 SOC patients and 289 given SOC+R, of whom 95.5% received all 4 doses of the immunotherapy.

Adele Fielding, professor of haematology at University College London Cancer Institute, London, and colleagues report that complete remission rates, at 92.7% with SOC and 94.8% with SOC+R, were similar in the two treatment arms.

There was also no difference in minimal residual disease (MRD) rates, with 42.2% and 41.8%, respectively, negative for residual disease.

Adverse, including severe, event rates were similar between the two cohorts, and there was no difference in non-relapse mortality.

After a median follow-up of 50.5 months, the researchers calculate that the 3-year event-free survival (EFS) for patients given SOC was 41.9% versus 48.7% for those receiving SOC+R, at a hazard ratio of 0.88 (p=0.28).

This contrasts with the French GRAALL-2005/R study, in which adults aged 1859 years with CD20-positive, Phnegative ALL were randomised to chemotherapy with or without rituximab, with a total of 16 to 18 infusions given across all treatment phases.

Their results indicated that adding rituximab to the ALL chemotherapy protocol improved outcomes, increasing EFS by 33% versus chemotherapy alone (p=0.04).

Prof Fielding told Medscape News UK that, for UKALL14, they had "hypothesised that giving rituximab early would make the difference, namely in helping to eliminate MRD early on".

"We were anxious not to give too much in case of toxicity from infections. It turned out that it is not toxic and doesnt seem to work to eliminate MRD early on."

She added that, in fact, "the French data showed that too," which prompts her to wonder at the mechanism of action of rituximab in B-ALL.

"Maybe you need more doses at times when patients have functional neutrophils or macrophages, or natural killer cells."

Prof Fielding also pointed out that, in the French study, they focused on patients with Ph-negative disease and in those in whom more than 20% of blasts expressed CD20.

"An important finding from our workis that the level of CD20 expression does not correlate with response to rituximab."

Approached for comment, Rachel Kahn, research communications manager at Blood Cancer UK, said that, "the immunotherapy drug rituximab remains a vital treatment for many types of blood cancer".

She told Medscape News UK, however, that "this interesting research suggests that there may not be any additional benefit of taking this drug for people with ALL".

She highlighted that the results nevertheless suggested that patients who underwent myeloablative allogeneic stem cell transplant (MAallaSCT) appeared to derive a significant benefit from adding rituximab to SOC.

Three-year EFS was 50.7% among MAallaSCT patients given SOC alone versus 72.2% in those receiving SOC+R, at a hazard ratio of 0.47 (p=0.03), which was related to a reduction in relapse risk.

This effect was not seen in patients given reduced intensity allogeneic stem cell transplantation or in maintenance groups, prompting Rachel Kahn to call for further research to identify which patients with ALL "may benefit from taking rituximab".

Prof Fielding said that, as they "do not have any plausible biological explanation" for the finding, the team is "going to be cautious about interpreting" it.

Overall, she feels that, as rituximab is "safe, its probably better to give it to everyone", as "our ability to do that is greater than our ability to do proper flow cytometry in local centres to accurately quantify CD20".

In a separate analysis, Prof Fielding and colleagues looked at all 653 patients who started treatment both before and after the SOC regimen amendment, of whom 49% were found to have high-risk chromosomal abnormalities.

These included 31% with BCR-ABL1, 8% with KMT2A-AFF1, 9% with HoL and 5% with CK abnormalities.

CK and HoL patients had lower 3-year overall survival than the overall cohort, at 24% and 19%, respectively, versus 52%, while patients with KMT2A-AFF1 fusion had an overall survival of 44% and BCR-ABL1 patients had a similar survival to the overall group.

The team also identified a series of other chromosomal abnormalities, including 1.3% with ABL-class fusions and the same proportion with JAK-STAT abnormalities, the latter had reduced 3-year overall survival, at 35%.

In contrast, among the 3% of patients with ZNF384 fusions, only two relapsed and none died.

Having found that secondary copy number alterations affecting key genes had no impact on outcomes, the team proposed "an amendment to the genetic risk classification for adult ALL", consisting of:

very high risk: CK, HoL or JAK-STAT abnormalities

high risk: all KMT2A fusions

tyrosine kinase sensitive: BCR-ABL1 and ABL-class fusions

low-risk: ZNF384 fusions

standard risk: all other patients

The team writes: "The integration of these primary genetic risk factors with other risk factors such as age, white cell count and MRD into an overall risk score is a key goal of our current work."

Prof Fielding said that the "immediate goal" of the team is "evaluating an overall risk score in our next trial, UKALL15, which has been submitted to Cancer Research UK for funding".

Rachel Kahn commented that "this research is a key example of how important it is to continue developing risk scores based on the make-up of the cancer, which can help clinicians understand how likely someone is to respond to treatment".

"This study shows that further clues can be found based on changes to a patients chromosomes."

She continued: "The more we know about how abnormalities influence how risky a cancer is thought to be, the closer we get to being able to personalise treatment to each individual to give them the most effective treatments and the best possible chance of survival."

The study was funded by Cancer Research UK.

No conflicts of interest declared.

[However, Fielding declared to ASH : Amgen: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Incyte: Consultancy.

BSH 2020: Abstracts BSH2020-OR-001 & BSH2020-OR-004

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Rituximab Offers No Extra Benefit to Induction Chemo in ALL - Medscape

The first-in-human, universal chimeric receptor antigen (CAR) T-cell (CAR-T) therapy GC027 was tolerable and resulted in antileukemic responses among patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL), according to results from a phase 1 trial presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting I 2020.1

Theuniversal CAR T cells target CD7, which, according to Xinxin Wang, PhD, ofGracell Biotechnologies Co, Ltd, in China, and lead author and presenter of thestudy, is a good target for T-ALL because it is expressed by more than 95% ofT-ALL patients.

GC027 isallogeneic, which may prevent the development of graft-versus-host disease. Theproduct is introduced using lentivirus for rapid elimination of T-ALL cells. Preclinicalstudies showed efficacy in a T-ALL xenograft model, and this prospective studyevaluated the safety and efficacy in humans.

Thesingle-arm, open-label study treated 5 adult patients with relapsed/refractoryCD7-positive T-ALL with a single infusion of 1 of 3 different dose levels ofG027: 0.6 x 107/kg, 3 x 107/kg, and 1.5 x 107/kg.Lymphodepletion therapy was administered prior to the G027 infusion. Theprimary endpoint was safety and the secondary endpoints included objectiveresponse rate (ORR) within 3 months after G027 infusion.

Patientswith extramedullary or central nervous system disease were excluded. Atbaseline, the median age was 24 (range, 19-38). Patients were heavilypretreated, with 5 median number of prior therapies (range, 1-9). Two patientshad high-risk disease and the median bone marrow tumor burden was a median of38.2% of blasts. None of the patients had undergone a prior allogeneic hematopoieticstem cell transplant.

Allpatients developed cytokine release syndrome (CRS), 4 of which were grade 3 and1 was grade 4. All cases were manageable and resolved with treatment andsupportive care. None of the patients developed neurotoxicity.

The completeremission (CR)/CR with incomplete hematologic recovery was 100%. By day 28, 4patients achieved a CR with negative for minimal residual disease (MRD) and 3of these patients remained MRD negative up to day 161. One patient achieved CRbut was MRD positive, and relapsed by day 29.

Peak CART-cell expansion in peripheral blood occurred between week 1 and 2.

As the first-in-human, universal CAR T-cell therapy for adult relapsed/refractory T-ALL, Dr Wang said, GC027 has demonstrated superior clinical efficacy and induced deep response in patients with acceptable safety profile. She added that trial enrollment is ongoing.

Reference

Wang X, Li S, Gao L, et al. Clinical safety and efficacy study of TruUCAR GC027: The first-in-human, universal CAR-T therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). Presented at: American Association for Cancer Research (AACR) Virtual Annual Meeting I; April 27-28, 2020. Abstract CT052.

This article originally appeared on Cancer Therapy Advisor

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First-in-Human Universal CAR-T Therapy Found Active in Relapsed/Refractory T-ALL - Oncology Nurse Advisor

Alessandra de Oliveira Pinheiro,1 Valria M Lara,1 Aline F Souza,1 Juliana B Casals,2 Fabiana F Bressan,1 Paulo Fantinato Neto,1 Vanessa C Oliveira,1 Daniele S Martins,1 Carlos E Ambrosio1

1Department of Veterinary Medicine, Faculty of Animal Science and Food Engineering, University of So Paulo, Pirassununga, So Paulo, Brazil; 2Private Veterinary Practice, Pirassununga, So Paulo, Brazil

Correspondence: Carlos E AmbrosioDepartment of Veterinary Medicine, Faculty of Animal Science and Food Engineering, University of So Paulo, FZEA- Av. Duque de Caxias Norte, 225, ZMV, Pirassununga 13635-900, So Paulo, BrazilTel +55 19 3565-4113 Email ceambrosio@usp.br

Purpose: Amniotic membrane stem cells have a high capacity of proliferation, cell expansion, and plasticity, as well as immunomodulatory properties that contribute to maternal-fetal tolerance. Owing to the lack of research on human amniotic membrane at different gestational stages, the canine model is considered ideal because of its genetic and physiological similarities. We aimed to characterize the canine amniotic membrane (CAM) cell lineage in different gestational stages and evaluate the expression of immunomodulatory genes.Materials and Methods: Twenty CAMs from early (20 30 days) (n=7), mid- (31 45 days) (n=7), and late gestation (46 63 days) (n=6) stages were studied. The cell features were assessed by cell viability tests, growth curve, colony-forming units, in vitro differentiation, cell labeling for different immunophenotypes, and pluripotent potential markers. The cells were subjected to RT-PCR and qPCR analysis to determine the expression of IDO, HGF, EGF, PGE2, and IL-10 genes.Results: CAM cells exhibited a fibroblastoid morphology and adherence to plastic with an average cell viability of 78.5%. The growth curve indicated a growth peak in the second passage and we obtained an average of 138.2 colonies. Osteogenic, chondrogenic, and adipogenic lineages were confirmed by in vitro differentiation assays. Cellular immunophenotyping experiments confirmed the presence of positive mesenchymal markers (CD90 and CD105) and the low or negative expression of hematopoietic markers (CD45 and CD34). Qualitative analysis of the immunomodulatory functions indicated the expression of the IDO, HGF, EGF5, and PGE2 genes. When stimulated by interferon-gamma, CAM cells exhibited higher IDO levels throughout gestation.Conclusion: The CAMs from different gestational stages presented features consistent with mesenchymal stem cell lineage; better results were observed during the late gestation stage. Therefore, the gestational stage is a key factor that may influence the functionality of therapies when using fetal membrane tissues from different periods of pregnancy.

Keywords: canine stem cells, immunomodulation, fetal annexes

This work is published by Dove Medical Press Limited, and licensed under a Creative Commons Attribution License.The full terms of the License are available at http://creativecommons.org/licenses/by/4.0/.The license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Characterization and Immunomodulation of Canine Amniotic Membrane Stem | SCCAA - Dove Medical Press

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its oncology program will be presented at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program from May 29-31. More than 80 abstracts in nearly 20 types of solid tumors and blood cancers have been accepted across Mercks broad cancer portfolio and investigational pipeline, including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (in collaboration with Eisai); LYNPARZA (in collaboration with AstraZeneca); and MK-6482 (formerly PT2977), an investigational, oral hypoxia-inducible factor-2 alpha (HIF-2) inhibitor.

Despite the challenges we all face due to the COVID-19 pandemic, Merck remains fully committed to supporting the cancer community and to advancing important scientific research from our clinical program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The data to be presented at this years ASCO demonstrate how our deep and diverse oncology portfolio continues to show meaningful outcomes for patients in new tumor types and stages of disease, while long-term survival data for KEYTRUDA in non-small cell lung cancer, renal cell carcinoma and melanoma further support its important role in these types of cancer.

Key abstracts including late-breakers, oral sessions, and select poster discussions and posters to be presented at ASCO include:

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the ASCO20 Virtual Scientific Program on Tuesday, June 2 at 2 p.m. ET. Details will be provided at a date closer to the event at http://investors.merck.com/home/default.aspx.

Details on Abstracts Listed Above, Additional Presentations and Key Abstracts with Mercks Collaboration Partners

KEYTRUDA

Breast Cancer

Bladder Cancer

Classical Hodgkin Lymphoma

Colorectal Cancer

Lung Cancer

Renal Cell Carcinoma

Prostate Cancer

Melanoma

Ovarian Cancer

Head and Neck Cancer

KEYTRUDA plus LENVIMA (in collaboration with Eisai)

Hepatocellular Carcinoma

Renal Cell Carcinoma

Endometrial Cancer

LYNPARZA (in collaboration with AstraZeneca)

Ovarian Cancer

MK-6482

Renal Cell Carcinoma

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

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Merck to Present New Data from its Broad Oncology Portfolio and Pipeline at the ASCO20 Virtual Scientific Program - Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (Nasdaq: AVRO) and Magenta Therapeutics (Nasdaq: MGTA) today announced a research and clinical collaboration agreement to evaluate the potential utility of MGTA-117, Magentas novel targeted antibody-drug conjugate (ADC) for conditioning patients before they receive one of AVROBIOs investigational lentiviral gene therapies.

The collaboration will combine AVROBIOs leadership in lentiviral gene therapies with Magentas expertise in ADC-based conditioning and is expected to further the two companies shared mission to enable patients to live free from disease. Under the collaboration, AVROBIO and Magenta will jointly evaluate MGTA-117 in conjunction with one or more of AVROBIOs investigational gene therapies. Magenta will retain all commercial rights to MGTA-117. AVROBIO will retain all commercial rights to its gene therapies and will be responsible for the clinical trial costs related to the evaluation of MGTA-117 with AVROBIOs gene therapies.

This agreement with Magenta springs from our strategic focus on maintaining technology leadership in gene therapy, said Geoff MacKay, AVROBIOs president and CEO. AVROBIO has always led by investing early in technological innovations that further the field of lentiviral gene therapy, such as plato, our proprietary platform designed to optimize the safety, potency and durability of our investigational lentiviral gene therapies. Were continually assessing new technologies that could be complementary to our plato platform to sustain our cutting-edge advantage and continue to evolve platos capabilities.

We believe targeted ADCs represent the next generation of medicines to prepare patients for gene therapy or transplant in a targeted, precise way. AVROBIOs investigational gene therapies complement our platform as well as our focus and commitment to patients. This partnership will allow Magenta to validate our conditioning platform in lentiviral gene therapy applications, said Jason Gardner, D.Phil., president and chief executive officer, Magenta Therapeutics. Weve selected ADCs as the preferred modality for our conditioning programs, as we believe they offer the most promising option for more patients. We have optimized our ADCs for gene therapy and transplant settings and look forward to collaborating with AVROBIO to evaluate MGTA-117 in specific gene therapy settings. Magenta will continue to develop MGTA-117 in other diseases, including blood cancers and genetic diseases.

MGTA-117, Magentas most advanced conditioning program, is a CD117-targeted antibody engineered for the transplant setting and conjugated to amanitin, a toxin in-licensed from Heidelberg Pharma. It is designed to precisely deplete only hematopoietic stem and progenitor cells and has shown high selectivity, potent efficacy, wide safety margins and broad tolerability in non-human primate models, suggesting that it may be capable of clearing space in bone marrow to support long-term engraftment and rapid recovery in humans. Magenta plans to complete IND-enabling studies this year.

AVROBIO currently uses a personalized conditioning regimen with precision dosing of busulfan, an extensively validated conditioning agent generally considered to be the gold standard for ex vivo lentiviral gene therapy, based on decades of general use and administration to hundreds of patients treated with lentiviral gene therapy candidates. The treating clinician uses therapeutic drug monitoring (TDM) to evaluate how quickly the patient metabolizes busulfan and adjusts the dose regimen accordingly with the goal of achieving the optimum result. AVROBIO has reported early clinical data with this precision conditioning regimen with TDM in its own clinical trials, adding to a body of data that suggest busulfan can effectively clear space in the patients bone marrow, where stem cells engraft, produce generations of daughter cells carrying the therapeutic gene and make the functional protein the patient needs to maintain cellular health.

About AVROBIO

Our mission is to free people from a lifetime of genetic disease with a single dose of gene therapy. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease. AVROBIO is powered by the plato gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients. Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com. Follow Magenta on Twitter: @magentatx.

AVROBIO Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as aims, anticipates, believes, could, designed to, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, the expected benefits and results of our implementation of the plato platform in our clinical trials and gene therapy programs, the expected safety profile of our investigational gene therapies, and the potential and expected benefits of MGTA-117, Magentas investigational antibody-drug conjugate, including the ability of MGTA-117 to deplete hematopoietic stem and progenitor cells in order to clear space in bone marrow to support long-term engraftment in humans, as well as MGTA-117s potential application to AVROBIOs investigational gene therapies. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that AVROBIO may not realize the intended benefit of MGTA-117 with respect to AVROBIOs investigational gene therapies, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs most recent Annual or Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Magenta Therapeutics Forward Looking Statements

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including, without limitation, statements regarding the research and clinical collaboration agreement between Magenta and AVROBIO, including the timing, progress and success of the collaboration contemplated under the agreement, the successful evaluation MGTA-117 in conjunction with one or more of AVROBIOs investigational gene therapies under the agreement, the anticipated cost allocation and other commercial terms under the agreement, Magentas strategy and business plan, as well as the future development, manufacture and commercialization between AVROBIO and Magenta. The use of words such as may, will, could, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, seeks, endeavor, potential, continue or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation, risks set forth under the caption Risk Factors in Magentas most recent Annual Report on Form 10-K, as updated by Magentas most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission, as well as risks, uncertainties and assumptions regarding the impact of the COVID-19 pandemic to Magentas business, operations, strategy, goals and anticipated timelines, including, without limitation, Magentas ongoing and planned preclinical activities, ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, timelines for regulatory submissions and financial position. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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AVROBIO and Magenta Therapeutics Announce Collaboration to Evaluate Targeted Antibody-Drug Conjugate as a Potential Conditioning Regimen for...

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

VANCOUVER, Washington, May 04, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the Company is expecting enrollment completion for its 75 patient, Phase 2 double blinded, placebo controlled, randomized study by the end of this month.

CytoDyn has submitted a request to the FDA to grant expanded access, also known as compassionate use, to make leronlimab available for patients not eligible for participation in two ongoing clinical trials for coronavirus infections. Many severe and critically-ill patients, who have received off-label immunomodulatory treatments for COVID-19, are excluded from participation in the Companys Phase 2b/3 clinical trial and could potentially benefit from access to leronlimab under a compassionate use program.

There are 49 COVID-19 patients who have enrolled for treatment with leronlimab through eIND. Four out of 11 critically ill patients with a multitude of pre-existing conditions survived after treatment, and of the next 38 patients, many were extubated, improved, or were discharged.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We are very excited about the continuing positive responses from eIND patients following their treatment with leronlimab. We are equally excited about the prospects for patients should the FDA grant access to leronlimab under the compassionate use program. During this past Saturday, we had to overcome many obstacles for two patients who desperately wanted leronlimab. One patient was in the same hospital that enrolled the first 11 patients and the second was a VIP patient in Los Angeles. Under the compassionate use program, we could avoid and quickly overcome this type of stress and turmoil which was very difficult for the patients, their families, the physicians, and CytoDyn. The daughter of a patient who was on a machine used for severe heart and lung failure contacted us directly and expressed her immense gratitude believing leronlimab saved her mothers life. These are amazing times for us at CytoDyn; with the opportunity to wake up every day with the potential of saving somebodys life. For sure, I could never have imagined such an incredible honor.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. We would like to provide an update that the Biologics License Application (BLA) for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients will be considered completed after the clinical datasets are submitted on May 11, 2020. The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation and a rolling review previously assigned by the FDA and plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible...

Cheyenne Braganza has an entire floor to herself in her dorm building at the University of Vermont.

Her roommate is home in Massachusetts, gone with almost all 10,000-plus UVM undergraduates. The Burlington school told them in mid-March to stay away after spring break rather than return and risk spreading the COVID-19 virus.

Cheyenne Braganza, a sophomore at the University of Vermont, is a native of Kenya. She is among a handful of students remaining on the Burlington campus that stopped hosting in-person classes in mid-March.(Photo: COURTESY)

Braganza is among about 140 international students who, because of COVID-19-related travel complications, remain on campus. She has plenty of peace and quiet in her suite as she and students on-campus and at home continue their studies online in the last few days of final exams.

The solitude is great for doing school work, said the native of Nairobi, Kenya. The sophomore studying molecular genetics has a bathroom to herself, a glorious feeling for a college student. She can play music as loud as she wants.

But its isolating.

It gets lonely because I finished my work for the day and theres not much to do, said Braganza, who turns 21 in June. Her boyfriend, mother, father and brother are seven time zones away in Kenya. She talks with them on the phone during the day, but at night when her school work is done, her loved ones back home have gone to bed and the campus is forest-quiet Braganza feels forsaken.

Cheyenne Braganza of Nairobi, Kenya, says she gets a lot of work done but often feels lonely as one of only a few students remaining on campus at the University of Vermont.(Photo: COURTESY)

She finds comfort in socially-distant interactions with dining-hall workers and students she sees on meal runs. She takes solace in her work, which includes watching videos of scientists performing lab work before calculating data derived from that to write her own reports.

Braganzas career goals are timely. She dreams of doing medical research and running her own lab.

I dont want to treat patients. I want to do more-groundbreaking work, like research on vaccines, she said. Ive always had a passion for research.

More personal stories: How Vermonters are facing life in the coronavirus era

Contact Brent Hallenbeck at (802) 660-1844 or bhallenbeck@freepressmedia.com. Follow Brent on Twitter at http://www.twitter.com/BrentHallenbeck.

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A floor to herself: UVM international student remains on campus - Burlington Free Press

The Association for Molecular Pathology (AMP) today published consensus recommendations designed to support the design, validation, and interpretation of clinical genotyping tests for the prediction of warfarin response.

The new warfarin genotyping guideline offers a two-tier categorization of alleles that are recommended for inclusion in clinical PGx genotyping assays. Using criteria such as allele frequencies in different populations and ethnicities, the availability of reference materials and other technical considerations, the AMP PGx Working Group recommended a minimum set of alleles and their defining variants that should be included in all clinical warfarin sensitivity genotyping testswhat the guideline defines as Tier 1 PGx variant alleles.

The AMP PGx Working Groupdeveloped the guideline with organizational representation from the College of American Pathologists (CAP) and the Clinical Pharmacogenetics Implementation Consortium (CPIC). The team also defined a Tier 2 list of optional alleles that do not currently meet one or more of the criteria for inclusion in Tier 1. AMP said the recommendations were meant to be a reference guide and not a restrictive listand that it intends to update these recommendations as new data and/or reference materials become available.

Common benign variants in high linkage disequilibrium (LD) with established functional variant(s) are not currently being considered for inclusion as Tier 1 or Tier 2 variant alleles in routine clinical PGx genotyping panels, the Working Group added.

Guideline recommendations have been published in a manuscript, Recommendations for Clinical Warfarin Sensitivity Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists, that was released online ahead of publication inThe Journal of Molecular Diagnostics.

Clinical genotyping assays that help predict warfarin response and optimize a patients dosage requirements have enabled some of the earliest success stories of this precision medicine era, said Victoria M. Pratt, Ph.D., FACMG, Professor and Director of Pharmacogenetics and Molecular Genetics Laboratories, Indiana University School of Medicine, and AMP PGx Working Group Chair. Together, the AMP PGx Working Group defined a standard set of evidence-based recommendations that will help build on these past successes and improve phenotype prediction and test interpretation for all futurewarfarin sensitivity genotyping panels.

Earlier Recommendations

The AMP PGx Working Group previously developed recommendations for clinical CYP2C9 testing that were intended to be applied to CYP2C9-related medications including warfarin. Last year, the Working Group developed recommendations for clinical CYP2C9 testing that were intended to be applied to CYP2C9-related medications including warfarin.

Since then, the Working Group said, the discovery of additional well-characterized genes/alleles contributing to inter-individual variation in warfarin sensitivity created a need for a separate document addressing genes/alleles specifically related to warfarin sensitivity, including the CYP2C9 alleles.

CYP2C9 is a member of the CYP2C subfamily of the cytochrome P450 enzymes, and one of the most abundant and important drug metabolizing enzymes. It acts on approximately 15% of drugs in current clinical use, including ibuprofen and the blood thinner warfarin.As a result, it is currently included in the FDAs Table of Pharmacogenetic Biomarkers in Drug Labeling forseveral FDA-approved drugs.

According to the Working Group, clinicians have been able since 2010 to obtain CYP2C9 and VKORC1 genotypes and use either the FDA prescribing label or PGx dosing algorithms to define warfarin dose requirements for their patients. While experts have contributed to establishing high-quality genotype-based recommendations for warfarin14 and the accessibility of clinical PGx testing continues to increase, the diversity of available testing platforms and variants interrogated have led to inconsistencies in results among labs.

Although the initial CPIC guideline recommendations included variants that are more common among Caucasians and Asians, the updated 2017 guideline incorporated additional variants that are predictors of warfarin dose requirements in patients of African descent, the Working Group noted. In order to implement recommendations from the recent CPIC warfarin guideline, both the availability of self-reported ancestry and interrogation for specific alleles are therefore essential.

The Working Group recognizes that the benefit of genotype-guided dosing for warfarin to reduce under or over dosing episodes in patients from diverse ethnicities will not likely be realized unless testing panels account for appropriate clinical variants that are relevant for the ethnic groups to whom the test is offered, the Group added.

The new guideline on clinical warfarin sensitivity genotyping allele selection is the last in a series of three reports that are intended to facilitate testing and promote standardization for frequently usedpharmacogenetics (PGx)genotyping assays. The latest guideline builds on theearlier recommendations for clinicalCYP2C19andCYP2C9genotyping, according to AMP.

The recommendations should be implemented together with other clinical guidelines such as those issued by the CPIC, which focus primarily on the interpretation of PGx test results and therapeutic recommendations for specific drug-gene pairs.

AMP members are among the earliest adopters of pharmacogenetic testing in clinical settings, said AMP President Karen E. Weck, M.D., who is also a Professor of Pathology and Laboratory Medicine, Professor of Genetics and Director, Molecular Genetics and Pharmacogenomics at University of North Carolina Chapel Hill, and a PGx Working Group Member.This series of guidelines for common clinical PGx genotyping tests is another example of AMPs ongoing commitment to sharing our collective expertise with the broader laboratory community in order to improve professional practice and patient care.

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AMP Publishes Recommendations for Clinical Genotyping Tests to Predict Warfarin Response - Clinical OMICs News