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Study: Covid cases traced to December 2019 in US – ETHealthworld.com

Testing has found Covid-19 infections in the US in December 2019, according to a study, providing further evidence indicating the coronavirus was spreading globally weeks before the first cases were reported in China.

The study published on Monday identified 106 infections from 7,389 blood samples collected from donors in nine US states between December 13 and January 17. The samples, collected by the American Red Cross, were sent to the US Centers for Disease Control and Prevention for testing to detect if there were antibodies against the virus. The findings of this report suggest that SARS-CoV-2 infections may have been present in the US in December 2019, earlier than previously recognised, the paper said.

Reports of a mysterious pneumonia spreading in Wuhan, China, first emerged in late December 2019. The first US case was reported on January 19. The revelations in the paper by researchers from the CDC reinforce the growing understanding that the coronavirus was silently circulating worldwide earlier than known, and could re-ignite debate over the origins of the pandemic. Its not the first evidence showing the virus could have existed outside China before 2020. A patient in France was found to have contracted the virus at the end of December.

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Study: Covid cases traced to December 2019 in US - ETHealthworld.com

US Oncology Research Announces Schedule of Presentations at the Virtual 2020 American Society of Hematology Annual Meeting and Exposition – Business…

THE WOODLANDS, Texas--(BUSINESS WIRE)--During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, principal investigators from The US Oncology Network (The Network) and US Oncology Research will share detailed results from 30 studies covering topics that include Hodgkin lymphoma, multiple myeloma and the effects of cancers on older patient populations. The ASH Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will be taking place virtually from Dec. 5-8, 2020.

In this landscape impacted by COVID-19, real-world evidence shows that our collective fight against cancer must include advancing clinical research and empowering patients through timely health screenings, said Robert L. Coleman, MD, chief scientific officer, US Oncology Research. At this years ASH virtual meeting, we are looking forward to sharing the latest advances from investigators in The Network and to exploring ways we can continue working together to navigate the unprecedented challenges and risks that patients with cancer are facing today.

Christopher A. Yasenchak, MD, associate chair of hematology research for US Oncology Research and a hematologist with Willamette Valley Cancer Institute and Research Center, will present an oral abstract titled, Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients, on Sunday, Dec. 6, at 2:15 p.m. ET.

Older patients with Hodgkin lymphoma often have poorer outcomes than younger patients due to comorbidities and the toxicity of conventional first-line chemotherapy, said Dr. Yasenchak. Brentuximab vedotin, as monotherapy and in combination with other agents, shows high response rates and clinically meaningful improvements in progression-free survival and tolerability compared to conventional combination chemotherapy. The study, SGN35-015, presents compelling evidence underscoring the growing interest and urgency in research to advance cancer treatment and care for older populations.

In addition, Robert Rifkin, MD, FACP, medical director of biosimilars for McKesson, associate chair of hematology research and myeloma disease lead for US Oncology Research and a hematologist with Rocky Mountain Cancer Centers, a practice in The Network, co-authored The Phase 3 TOURMALINE-MM2 Trial: Oral Ixazomib, Lenalidomide, and Dexamethasone (IRd) Vs Placebo-Rd for Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma (NDMM). The oral presentation will take place on Monday, Dec. 7, at 7:45 a.m. ET.

Patients who are newly diagnosed with multiple myeloma and not eligible for autologous stem cell transplants need additional treatment options, said Dr. Rifkin. We believe the findings from TOURMALINE-MM2 emphasize the need for all-oral, proteasome inhibitor-based treatment options and will help pave the way for future innovation on behalf of the multiple myeloma community.

Dr. Rifkin will also present a trial-in-progress poster, DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) With Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM), on Monday, Dec. 7, from 7:00 a.m.3:30 p.m. ET.

Another oral abstract, Subgroup Analyses of Elderly Patients Aged 70 Years in MAGNIFY: A Phase IIIb Interim Analysis of Induction R2 Followed By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma, was co-authored by David Andorsky, MD, a hematologist with Rocky Mountain Cancer Centers. The presentation will take place on Sunday, Dec. 6, at 10:30 a.m. ET.

Results from MAGNIFY indicate an important option for older, high-risk patients with non-Hodgkin lymphoma who have relapsed or did not respond to previous treatment with chemotherapy, said Dr. Andorsky. In this patient population, lenalidomide combined with rituximabwith close attention to dose reductiondemonstrated encouraging efficacy and a tolerable safety profile.

Mitul Gandhi, MD, a medical oncologist with Virginia Cancer Specialists, a practice in The Network, co-authored the poster, Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma. The presentation will take place on Sunday, Dec. 6, from 7:00 a.m.3:30 p.m. ET.

Options are critically needed to improve outcomes for patients with diffuse large B-cell lymphoma who did not respond to previous therapy, are unsuitable for autologous stem cell transplantation or relapsed shortly after a transplantation, said Dr. Gandhi. I am looking forward to presenting findings that indicate the potential to meet the needs of more patients with this aggressive form of lymphoma.

Furthermore, Houston Holmes, MD, a medical oncologist and hematologist at Texas Oncology, a practice in The Network, co-authored the oral abstract Single-Agent Mosunetuzumab Is a Promising Safe and Efficacious Chemotherapy-Free Regimen for Elderly/Unfit Patients With Previously Untreated Diffuse Large BCell Lymphoma. The presentation will take place on Sunday, Dec. 6, at 12:15 p.m. ET.

Among patients with diffuse large B-cell lymphoma, approximately 30% over age 75 do not receive standard chemotherapy as a first-line treatment due to concerns about frailty and comorbidities, said Dr. Holmes. Based on early clinical data, single-agent mosunetuzumab could offer a promising chemotherapy-free regimen for these patients who otherwise have limited options.

Researchers with McKesson Data, Evidence and Insights also worked with US Oncology Research and The US Oncology Network physicians on studies advancing the applications of real-world evidence, which will be presented this year.

Dr. Yasenchak will present a real-world evidence study titled, Real-World Adherence to National Comprehensive Cancer Network (NCCN) Guidelines Regarding the Usage of PET/CT and Reported Deauville Scores in Advanced Stage Classical Hodgkin Lymphoma: A Community Oncology Practice Perspective. The poster presentation will take place on Sunday, Dec. 6, from 7:00 a.m.3:30 p.m. ET.

Providers may not always have the comprehensive information needed to optimize treatment modifications for patients with Hodgkin lymphoma, added Dr. Yasenchak. Based on our findings, there is an opportunity to educate oncologists and radiologists about the importance of consistently reporting PET/CT Deauville scores in the initial staging and assessment of treatment response for these patients.

An additional real-world evidence poster, NHL Patients and Nurses in the US Prefer Subcutaneous Rituximab Injection Versus Intravenous Rituximab Infusion: A Real-World Study, will be presented by Dr. Gandhi on Saturday, Dec. 5 from 7:00 a.m.3:30 p.m. ET.

As the COVID-19 pandemic adds new barriers to our health systems and the completion of clinical trials, real-world evidence is pivotal in providing insights into how we can improve outcomes, said Nicholas J. Robert, MD, medical director, McKesson Data, Evidence and Insights. By leveraging data from our electronic medical records, healthcare providers and researchers are making an impact and optimizing care for patients managing cancer.

The full schedule of affiliated data presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Claire Crye at 281.825.9927 or Claire.Crye@usoncology.com or Edie DeVine at 209.814.9564 or Edie.DeVine@gcihealth.com.

About US Oncology Research

US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves approximately 60 research sites and more than 165 locations, managing about 400 active trials at any given time. For the past 20 years, physicians in the research network have enrolled more than 82,000 patients in over 1,600 trials and have played a role in more than 100 FDA-approved cancer therapies. US Oncology Research is supported by McKesson Corporation.

About The US Oncology Network

Every day, The US Oncology Network (The Network) helps more than 1,380 independent physicians deliver value-based, integrated care to patients close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network provides practices with access to coordinated resources, best business practices, and the experience, infrastructure and support of McKesson Corporation. This collaboration allows the providers in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. The Network is committed to the success of independent practices, everywhere.

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US Oncology Research Announces Schedule of Presentations at the Virtual 2020 American Society of Hematology Annual Meeting and Exposition - Business...

Positron Emission Tomography (PET) Market To 2026: Growth Analysis By Manufacturers, Regions, Types And Applications – Murphy’s Hockey Law

A new research study has been presented by Industrygrowthinsights.com offering a comprehensive analysis on the Global Positron Emission Tomography (PET) Market where user can benefit from the complete market research report with all the required useful information about this market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. The report discusses all major market aspects with expert opinion on current market status along with historic data. This market report is a detailed study on the growth, investment opportunities, market statistics, growing competition analysis, major key players, industry facts, important figures, sales, prices, revenues, gross margins, market shares, business strategies, top regions, demand, and developments.

The Positron Emission Tomography (PET) Market report provides a detailed analysis of the global market size, regional and country-level market size, segment growth, market share, competitive landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunity analysis, strategic market growth analysis, product launches, and technological innovations.

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Major Players Covered in this Report are: GESiemens HealthcarePhilips HealthcareToshibaHitachiNeusoftTopgrade HealthCareUnited Imaging

Global Positron Emission Tomography (PET) Market SegmentationThis market has been divided into Types, Applications, and Regions. The growth of each segment provides an accurate calculation and forecast of sales by Types and Applications, in terms of volume and value for the period between 2020 and 2026. This analysis can help you expand your business by targeting qualified niche markets. Market share data is available on the global and regional level. Regions covered in the report are North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America. Research analysts understand the competitive strengths and provide competitive analysis for each competitor separately.

By Types:PET-CTPET-MROther

By Applications:OncologyCardiologyNeurologyOther

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Global Positron Emission Tomography (PET) Market Regions and Countries Level AnalysisRegional analysis is a highly comprehensive part of this report. This segmentation sheds light on the sales of the Positron Emission Tomography (PET) on 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.

The report offers an in-depth assessment of the growth and other aspects of the market in key countries including the US, Canada, Mexico, Germany, France, the UK, Russia, Italy, China, Japan, South Korea, India, Australia, Brazil, and Saudi Arabia. The competitive landscape chapter of the global market report provides key information about market players such as company overview, total revenue (financials), market potential, global presence, Positron Emission Tomography (PET) sales and revenue generated, market share, prices, production sites and facilities, products offered, and strategies adopted. This study provides Positron Emission Tomography (PET) sales, revenue, and market share for each player covered in this report for a period between 2016 and 2020.

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Table of Contents1. Executive Summary2. Assumptions and Acronyms Used3. Research Methodology4. Market Overview5. Global Market Analysis and Forecast, by Types6. Global Market Analysis and Forecast, by Applications7. Global Market Analysis and Forecast, by Regions8. North America Market Analysis and Forecast9. Latin America Market Analysis and Forecast10. Europe Market Analysis and Forecast11. Asia Pacific Market Analysis and Forecast12. Middle East & Africa Market Analysis and Forecast13. Competition Landscape

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Positron Emission Tomography (PET) Market To 2026: Growth Analysis By Manufacturers, Regions, Types And Applications - Murphy's Hockey Law

Animal Stem Cell Therapy Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By Industry Growth…

IndustryGrowthInsights (IGI), one of the worlds prominent market research firms has released a new report on Global Animal Stem Cell Therapy Market. The report contains crucial insights on the market which will support the clients to make the right business decisions. This research will help both existing and new aspirants for Animal Stem Cell Therapy market to figure out and study market needs, market size, and competition. The report talks about the supply and demand situation, the competitive scenario, and the challenges for market growth, market opportunities, and the threats faced by key players.

The report also includes the impact of ongoing global crisis i.e. COVID-19 on the Animal Stem Cell Therapy market and what the future holds for it. The published report is designed using a vigorous and thorough research methodology and IndustryGrowthInsights (IGI) is also known for its data accuracy and granular market reports.

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A complete analysis of the competitive scenario of the Animal Stem Cell Therapy market is depicted by the report. The report has a vast amount of data about the recent product and technological developments in the markets. It has a wide spectrum of analysis regarding the impact of these advancements on the markets future growth, wide-range of analysis of these extensions on the markets future growth.

Animal Stem Cell Therapy market report tracks the data since 2015 and is one of the most detailed reports. It also contains data varying according to region and country. The insights in the report are easy to understand and include pictorial representations. These insights are also applicable in real-time scenarios.

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Components such as market drivers, restraints, challenges, and opportunities for Animal Stem Cell Therapy are explained in detail. Since the research team is tracking the data for the market from 2015, therefore any additional data requirement can be easily fulfilled.

Some of the prominent companies that are covered in this report:

Medivet Biologics LLCVETSTEM BIOPHARMAJ-ARMU.S. Stem Cell, IncVetCell TherapeuticsCelavet Inc.Magellan Stem CellsKintaro Cells PowerAnimal Stem CareAnimal Cell TherapiesCell Therapy SciencesAnimacel

*Note: Additional companies can be included on request

The industry looks to be fairly competitive. To analyze any market with simplicity the market is fragmented into segments, such as its product type, application, technology, end-use industry, etc. Segmenting the market into smaller components helps in understanding the dynamics of the market with more clarity. Data is represented with the help of tables and figures that consist of a graphical representation of the numbers in the form of histograms, bar graphs, pie charts, etc. Another key component that is included in the report is the regional analysis to assess the global presence of the Animal Stem Cell Therapy market.

Following is the gist of segmentation:

By Application:

Veterinary HospitalsResearch Organizations

By Type:

DogsHorsesOthers

By Geographical Regions

Asia Pacific: China, Japan, India, and Rest of Asia PacificEurope: Germany, the UK, France, and Rest of EuropeNorth America: The US, Mexico, and CanadaLatin America: Brazil and Rest of Latin AmericaMiddle East & Africa: GCC Countries and Rest of Middle East & Africa

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Below is the TOC of the report:

Executive Summary

Assumptions and Acronyms Used

Research Methodology

Animal Stem Cell Therapy Market Overview

Animal Stem Cell Therapy Supply Chain Analysis

Animal Stem Cell Therapy Pricing Analysis

Global Animal Stem Cell Therapy Market Analysis and Forecast by Type

Global Animal Stem Cell Therapy Market Analysis and Forecast by Application

Global Animal Stem Cell Therapy Market Analysis and Forecast by Sales Channel

Global Animal Stem Cell Therapy Market Analysis and Forecast by Region

North America Animal Stem Cell Therapy Market Analysis and Forecast

Latin America Animal Stem Cell Therapy Market Analysis and Forecast

Europe Animal Stem Cell Therapy Market Analysis and Forecast

Asia Pacific Animal Stem Cell Therapy Market Analysis and Forecast

Middle East & Africa Animal Stem Cell Therapy Market Analysis and Forecast

Competition Landscape

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Contact Info: Name: Alex MathewsAddress: 500 East E Street, Ontario,CA 91764, United States.Phone No: USA: +1 909 545 6473Email: [emailprotected]Website: https://industrygrowthinsights.com

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Animal Stem Cell Therapy Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By Industry Growth...

G1 Therapeutics: Depressed Price Before Catalyst, No Apparent Reason – Seeking Alpha

We were discussing G1 Therapeutics (GTHX) in our TPT member chat yesterday. It has been a depressed stock for over a year now, and even today, despite having a PDUFA date in less than 3 months, the stock shows little sign of improvement. Lead drug candidate trilaciclib is a myelopreservation agent supporting chemo regimens that have shown enough data in phase 2 trials that the FDA has allowed GTHX to proceed to an NDA directly from there without requiring a phase 3 trial. Rintodestrant, their second asset, is in early stages of developing but targeting a larger opportunity in breast cancer and is going to announce a major update on December 9; and yet, the stock shows no sign of improvement.

Their current pipeline looks like this:

Source

I covered trilaciclib a year ago. There is not a lot to be added to that except that their NDA was accepted by the FDA on August 17 with a PDUFA date for February 15, 2021. The NDA was accepted under an accelerated review program, which is why PDUFA is occurring in 6 months instead of the regular 10. The Priority Review is based on positive data from three randomized clinical trials showing robust myelopreservation benefits for the drug.

There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur, said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.

Trilaciclib also has a Breakthrough Therapy Designation - meaning preliminary clinical evidence for trilaciclib shows a clear advantage over available therapy. In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for the drug.

While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations, said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, NC. Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.

Myelosuppression, caused by damage to bone marrow stem cells, occurs due to chemotherapy and can cause symptoms like anemia, neutropenia or thrombocytopenia. In clinical trials, trilaciclib has demonstrated strong reduction of chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Another important development is trilaciclibs expanded access program, which means the company is making the drug available to patients while it undergoes the approval process. The EAP usually means the drug is so beneficial that it is unethical to make patients wait even a few months to get it. This is an important development because it shows the value of trilaciclib.

In June, G1 Therapeutics entered into a 3-year US/Puerto Rico co-promotion agreement with Boehringer Engelheim, which has a lot of experience in oncology asset commercialization. GTHX will book revenue and retain full commercialization rights, and will pay Boehringer a promotional fee based on net sales. G1 will pay a promotion fee of a mid-twenties percentage of net sales in the first year of commercialization, which decreases to a low double-digit/high single-digit percentage in the second and third years of commercialization, respectively.

As for the total addressable market or TAM, over 25,000 people in the U.S. and Puerto Rico are diagnosed with SCLC every year. Approximately 90% of SCLC patients receive first-line chemotherapy treatment, and approximately 60% of those patients receive subsequent second-line chemotherapy treatment. That means, there are 22,500 patients in the 1st line setting who will benefit from trilaciclib, and another 13,500 patients in the 2nd line setting. That is a total of 36,000 patients. From research available last year, cost of chemotherapy treatment for SCLC patients was around $60,000. If we assume a 10% cost for trilaciclib, then we have $6000 per patient. So, every year, they are looking at a TAM of $216mn in this one indication in the US. With Boehringers involvement, we can safely assume a 10% penetration within the first two years of approval, especially given the breakthrough designation. So, that is $22mn from the US; similar figure for Europe, and another such figure from the RoW will give us $60mn in about 3 years, with increasing penetration of the market.

This is a conservative estimate. As I wrote in my earlier coverage:

According to a 2027 estimate by Decision Resources Group, trilaciclib has the potential to benefit a significant number of patients beyond SCLC. There were approximately 1 million chemo treated patients including adjuvant/1L CRC, 1L NSCLC, and adjuvant/1L BC in the U.S., Europe, and Japan in 2018. Chemotherapy treated patients include:

68,000 - ES-SCLC (1st Line - 3rd Line)

68,000 - 1st Line BC

126,000 - 1st Line NSCLC

356,000 - Adjuvant & 1st Line CRC

354,000 - Adjuvant BC

This vast cohort of patients can benefit from trilaciclib in combination with chemotherapy. The company estimates the target market to be at $3bn.

Trilaciclib is a first-in-class drug and doesn't have real competition. It could replace current rescue growth factor support treatments, "including Neulasta (pegfigrastim), Neupogen (filgrastim), Procrit (epoeitin alpha), and Aranesp (darbepoetin alfa)."

Trilaciclib is also being evaluated in other cancers. From their press release:

In a randomized trial of women with metastatic triple-negative breast cancer, preliminary data showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to present final overall survival data from this trial in the fourth quarter of 2020.

On November 18, the company announced that final overall survival data from the mTNBC trial was consistent with the above preliminary findings announced last year, and showed that trilaciclib significantly improved median OS for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin.

They will initiate a pivotal trial in mTNBC in 2021 with OS as the primary endpoint.

Trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL, and the company expects to initiate a Phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.

In the same press release quoted above, GTHX also announced that it will provide an update on Rintodestrant at the 2020 San Antonio Breast Cancer Symposium (SABCS) to be held virtually on December 9, 2020. Specifically, they said The company will also present updated monotherapy findings from the Phase 1 portion of its ongoing clinical trial of rintodestrant, a potential best-in-class oral selective estrogen receptor degrader (SERD) in development for treatment of ER+, HER2- breast cancer.

It seems they will provide pk/pd and mtd (maximum tolerated dose) data, with probable comments on early signs of efficacy. Primary outcomes are dose limiting toxicity and phase 2 dose determination. secondary outcomes are about efficacy, specifically tumor response with RECIST, and pk/pd. Before competitor fulvestrant went generic last year, it had $541mn annual sales. This indicates the potential for Rintodestrant.

I am providing below the entire abstract on Rintodestrant - there will be three of these but this is the critical one.

Background: Rintodestrant (G1T48) is a potent oral selective estrogen receptor degrader (SERD) that competitively binds to the estrogen receptor (ER) and blocks ER signaling in tumors resistant to other endocrine therapies. Preliminary results from Part 1 dose escalation showed robust target engagement on 18F-fluoroestradiol positron emission tomography (FES-PET), a favorable safety profile, and encouraging antitumor activity in patients with heavily pretreated ER+/HER2- advanced breast cancer (ABC), including those with ESR1 mutations (Dees et al., ESMO 2019 [abstract #3587]). Here, we present updated results from dose escalation and expansion (Parts 1 and 2). Methods: This Phase 1, first-in-human, open-label study evaluated rintodestrant monotherapy in women with ER+/HER2- ABC after progression on endocrine therapy. Part 1 was a 3+3 dose escalation (200- 1000 mg once daily [QD]); Part 2 expanded 600 and 1000 mg QD; and Part 3 was added to assess rintodestrant with palbociclib in patients in earlier lines in the advanced setting. Primary objectives included dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), safety, and recommended Phase 2 dose. Secondary objectives included pharmacokinetics and antitumor activity (RECIST v1.1). Exploratory objectives included pharmacodynamic inhibition of ER target engagement (FES-PET), mutation profiling (cell-free DNA [cfDNA]), and change in ER expression from baseline to on-treatment tumor biopsies. Results: As of May 13, 2020, 67 patients (Part 1: n = 26; Part 2: n = 41) were treated, with a median age of 61 years (range 34-83) and ECOG PS of 0 (49%) or 1 (51%). Median number of prior lines in the advanced setting was 2 (range 0-9), including prior fulvestrant (64%), CDK4/6 inhibitor (69%), mTOR inhibitor (22%), and/or chemotherapy (46%). Median number of prior lines of endocrine therapy in the advanced setting was 2 (range 0-5), with 61% of patients having received 2 lines. Treatment-related adverse events (TRAEs) were reported in 70% of patients. The most common TRAEs in 10% of patients included hot flush (24%), fatigue (21%), nausea (19%), diarrhea (18%), and vomiting (10%), mostly grade 1 or 2. No DLTs were reported and MTD was not reached. Dose reduction due to TRAEs occurred in 1 patient (1%), with elevated transaminases (grade 3 ALT and grade 2 AST) at 600 mg. Serious TRAEs occurred in 2 patients at 1000 mg (grade 5 cerebral hemorrhage in the setting of low molecular weight heparin and grade 2 upper abdominal pain). Two patients (3%) discontinued treatment due to TRAEs. Overall, the frequency of patients with TRAEs at 800 mg was comparable with that at 600 mg (57% vs 63%) and less than that at 1000 mg (81%). Of 67 patients, 16 were on study treatment for 24 weeks and 3 (n = 1 at 600 mg; n = 2 at 1000 mg, including 1 with ESR1 mutation) had a confirmed partial response (clinical benefit rate [CBR]: 28%). FES-PET standard uptake values decreased at week 4 with a mean reduction of 87% (8%) at doses 600 mg. Of 59 patients tested for baseline cfDNA, 41% harbored 1 ESR1 mutation, with a similar CBR in both groups (33% in ESR1 mutant and 29% in ESR1 wild-type). Seven of 9 patients had a decrease in ER immunohistochemistry H-score at both 600 and 1000 mg (median [range]: -27.8% [-33.8%, - 3.4%]), irrespective of ESR1 mutation status. Based on safety, efficacy, and ER degradation, 800 mg was selected as the optimal dose for further study. Conclusions: Rintodestrant continues to demonstrate an excellent safety/tolerability profile across all doses, with promising antitumor activity in patients with heavily pretreated ER+/HER2- ABC, including those with tumors harboring ESR1 mutations. Part 3 of this study, evaluating rintodestrant 800 mg QD with palbociclib in a more endocrine-sensitive population, is ongoing (NCT03455270).

There is not a lot to comment here. 800 mg seems to be the optimal dose, and that one patient with grade 5 cerebral hemorrhaging may be an outlier, especially with heparin in the mix, but that is something to keep an eye out for. Effect on an endocrine-sensitive population is preliminary but encouraging, and although a partial response, at this late stage in the game, that is not a bad deal. A larger trial developing the ESR1 scenario more fully is going to be interesting to watch.

According to latest reports, the company has $200-205mn in cash and cash equivalents as of the latest quarter. Burn was around $90mn last year, so with the Boehringer deal, that is not going to increase substantially, putting them in a comfortable position with a 2-year cash runway. The company recently changed CEOs, which seems to be in anticipation of approval, and nothing else.

For whatever reasons I cannot fathom, the stock remains depressed. They have a major catalyst 3 months down the line, and if past performance in trials is anything to go by, theres considerable chance of approval. Post approval scenario, both in terms of revenue stream and label expansions/other indications, looks good. I think this is a good candidate to accumulate at this time.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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G1 Therapeutics: Depressed Price Before Catalyst, No Apparent Reason - Seeking Alpha

Global Animal Stem Cell Therapy Market Research Report by Size, Data, Developments, Global Demand, In-Depth Analysis and Forecast 2020 to 2025 |…

Global Animal Stem Cell Therapy Market

Global Animal Stem Cell Therapy Market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to Global Animal Stem Cell Therapy market.

Global Animal Stem Cell Therapy Market is growing at a High CAGR during the forecast period 2020-2025. The increasing interest of the individuals in this industry is the major reason for the expansion of this market.

Key Market Players: MediVet Biologic, VETSTEM BIOPHARMA, J-ARM, Celavet, Magellan Stem Cells, U.S. Stem Cell, Cells Power Japan, ANIMAL CELL THERAPIES, Animal Care Stem, Cell Therapy Sciences, VetCell Therapeutics, Animacel, Aratana Therapeutics.

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Market Segmentation by Types:

Dogs

Horses

Others

Market Segmentation by Applications:

Veterinary Hospitals

Research Organizations

Additionally, the market report has a devoted segment covering the current market players from the Global Animal Stem Cell Therapy Market. A concise profile section similarly fuses the business system and capital-related information so that capital-related decisions can be recommended to the clients effectively.

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Important Facts about Global Animal Stem Cell Therapy Market Report:

This research report encompasses Global Animal Stem Cell Therapy Market overview, market share, demand and supply ratio, supply chain analysis, and import/export details.

The report has different approaches and procedures endorsed by Key Market players that enable efficient business decisions.

The report offers information such as production value, strategies adopted by market players and products/services they provide.

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Global Animal Stem Cell Therapy Market Research Report by Size, Data, Developments, Global Demand, In-Depth Analysis and Forecast 2020 to 2025 |...

Risk Factors for Early Relapse of DLBCL After CAR-T Therapy – Cancer Therapy Advisor

Disease burden and presence of at least 2 extranodal sites at either time of treatment (TT) or time of treatment decision (TD) was significantly associated with early disease progression among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, according to a study published in Blood Advances.1

CAR-T therapy is approved for patients with DLBCL who failed at least 2 prior lines of therapy, with clinical trial data suggesting complete response rates of approximately 30% to 40%. The purpose of this study was to determine if certain clinical, biological, or imaging characteristics at TT or TD were associated with relapse among patients with relapsed/refractory DLBCL after CAR T-cell therapy.

The multicenter, retrospective study included data from the medical charts of 116 consecutive patients with relapsed/refractory DLBCL between 2018 and 2020. The 2014 Cheson criteria was used to define relapse or progression of disease after CAR T-cell therapy, with biopsy of FDG-avid sites if feasible to ensure hypermetabolism on PET was not caused by inflammation due to the expansion of CAR T cells.

At TD, the median age was 60.7 years, with 36% of patients older than 65 years. The majority of patients had a good performance status (90%), 28% had at more than 2 extranodal sites, and 47% had elevated LDH. The International Prognostic Index (IPI) was low among 30.2% of patients, low-intermediate among 31%, high-intermediate among 24%, and high among 14%.

The majority of patients had DLBCL (80.2%), followed by transformed follicular lymphoma (14.7%), and primary B-cell lymphoma (5.2%). Treatment with >4 prior lines of therapy occurred in 30% of patients, with 26% who had undergone an autologous stem cell transplant.

Overall, the 6- and 12-month overall survival (OS) rates were 78.5% and 67%, respectively. The median progression-free survival was 7.4 months.

Relapse occurred among 47.4% of patients, with all but 1 relapse occurring within 4 months of CAR T cell infusion. Of the relapses, 49% occurred within the first month of treatment.

In multivariate analyses, relapse at any time was significantly associated with B symptoms (hazard ratio [HR], 1.85; 95% CI, 1.01-3.41; P =.0470) and elevated lactic dehydrogenase (LDH; HR, 2.04; 95% CI, 1.19-3.49; P =.0093) at TD. There was no association between relapse and age, lymphoma subtype, performance status, Ann Arbor stage, extranodal sites, or IPI status.

Early relapse after CAR-T therapy was significantly associated with performance status (HR, 2.95; 95% CI, 1.03-8.45; P =.044) and elevated LDH (HR, 9.61; 95% CI, 1.23-75.41; P =.031) at TD. Death after treatment was associated with having 2 or more extranodal sites at TD (HR, 4.17; 95% CI, 1.99-8.72; P =.00015).

At TT, relapse, early relapse, and death after CAR-T therapy were associated with having 2 or more extranodal sites, C-reactive protein, and total metabolic tumor volume.

The authors concluded that risk factors identified for early progression at TD and at TT were extranodal involvement and lymphoma burden.

Reference

Vercellino L, Di Blasi R, Kanoun S, et al. Predictive factors of early progression after CAR T-cell therapy in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. Published November 12, 2020.

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Risk Factors for Early Relapse of DLBCL After CAR-T Therapy - Cancer Therapy Advisor

Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Royal Caribbean, Mesoblast, Loop Industries, and…

NEW YORK, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Royal Caribbean Group (NYSE: RCL), Mesoblast Limited (NASDAQ: MESO), Loop Industries, Inc. (NASDAQ: LOOP), and Turquoise Hill Resources Ltd. (NYSE: TRQ). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link

Royal Caribbean Group (NYSE: RCL)

Class Period: February 4, 2020 to March 17, 2020

Lead Plaintiff Deadline: December 7, 2020

The complaint, filed on October 7, 2020, alleges that throughout the Class Period defendants failed to disclose material facts about the Companys decrease in bookings outside China, instead maintaining that it was only experiencing a slowdown in bookings from China. The Action further alleges that defendants failed to disclose material facts about the Companys inadequate policies and procedures to prevent the spread of COVID-19 on its ships. The truth about the scope of the impact that COVID-19 had on the Companys overall bookings and the inability of Royal Caribbean to prevent the virus spread on its ships was revealed through a series of disclosures.

First, on February 13, 2020, Royal Caribbean issued a press release stating that it had canceled 18 voyages in Southeast Asia due to recent travel restrictions and further warning that recent bookings had been softer for its broader business.

On this news, Royal Caribbean shares fell over 3 percent.

Second, on February 25, 2020, Royal Caribbean filed its 2019 Form 10-K, indicating that COVID-19 concerns were negatively impacting its overall business.

On this news, Royal Caribbean shares fell over 14 percent.

Third, on March 10, 2020, Royal Caribbean withdrew its 2020 financial guidance, increased its revolving credit facility by $550 million, and announced that it would take cost-cutting actions due to the proliferation of COVID-19, further revealing that COVID-19 was severely impacting Royal Caribbeans 2020 customer booking and that its safety measures were inadequate to prevent the spread of the virus on its ships.

On this news, Royal Caribbean shares fell over 14 percent.

Fourth, on March 11, 2020, Royal Caribbeans largest competitor, Carnival, announced a 60-day suspension of all operations, prompting concern that Royal Caribbean would follow suit. At the same time, Royal Caribbean also cancelled two cruises, beginning a series of cancellations and suspensions to follow.

On this news, Royal Caribbean shares fell almost 32 percent.

Fifth, on March 14, 2020, Royal Caribbean announced a suspension of all global cruises for 30 days.

On this news, Royal Caribbean stock fell over 7 percent.

Sixth, on March 16, 2020, the Company revealed that global operations could be suspended longer than anticipated, announcing the cancellations of two additional cruises throughout April and into May.

On this news, Royal Caribbean shares fell over 7 percent.

Finally, on March 18, 2020, analysts downgraded Royal Caribbeans stock and slashed their price targets.

On this news, Royal Caribbean shares fell more than 19 percent.

For more information on the Royal Caribbean class action go to: https://bespc.com/cases/RCL

Mesoblast Limited (NASDAQ: MESO)

Class Period: April 16, 2019 to October 1, 2020

Lead Plaintiff Deadline: December 7, 2020

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.

The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Mesoblast class action go to: https://bespc.com/cases/MESO

Loop Industries, Inc. (NASDAQ: LOOP)

Class Period: September 24, 2018 to October 12, 2020

Lead Plaintiff Deadline: December 14, 2020

On October 13, 2020, Hindenburg Research published a report alleging, among other things, that Loops scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the companys process internally. The report also stated that Loops previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were technically and industrially impossible, according to a former employee. Moreover, the report alleged that Executives from a division of key partner Thyssenkrupp, who Loop entered into a global alliance agreement with in December 2018, told us their partnership is on indefinite hold and that Loop underestimated both costs and complexities of its process.

On this news, the Companys share price fell $3.78, or over 32%, to close at $7.83 per share on October 13, 2020.

The complaint, filed on October 13, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Loop scientists were encouraged to misrepresent the results of Loops purportedly proprietary process; (2) that Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) that, as a result, the Company was unlikely to realize the purported benefits of Loops announced partnerships with Indorama and Thyssenkrupp; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Loop class action go to: https://bespc.com/cases/Loop

Turquoise Hill Resources Ltd. (NYSE: TRQ)

Class Period: July 17, 2018 to July 31, 2019

Lead Plaintiff Deadline: December 14, 2020

Turquoise Hill is an international mining company focused on the operation and development of the Oyu Tolgoi copper-gold mine in Southern Mongolia (Oyu Tolgoi), which is the Companys principal and only material resource property. Turquoise Hills subsidiary, Oyu Tolgoi LLC, holds a 66% interest in Oyu Tolgoi, and the remainder is held by the Government of Mongolia.

Rio Tinto plc and Rio Tinto Limited are operated and managed together as single economic unit and engage in mining and metals operations in approximately 35 countries. Through their subsidiaries, Rio Tinto owns 50.8% of Turquoise Hill. A Rio Tinto subsidiary, Rio Tinto International Holdings, Inc. (Rio Tinto International or RTIH; and collectively with Rio Tinto plc and Rio Tinto Limited, Rio Tinto), is also the manager of the Oyu Tolgoi project, including having responsibility for its development and construction.

On July 31, 2019, Turquoise Hill issued a press release and Management Discussion & Analysis (MD&A) making further disclosures about the status of the project, including that Turquoise Hill took a $600 million impairment charge and a substantial deferred income tax recognition adjustment tied to the Oyu Tolgoi project, and that it suffered a loss in the second quarter. The next day, before the market open, Rio Tinto issued a release concerning in part the project status, including that it had also taken an impairment charge related to the Oyu Tolgoi project, of $800 million.

Following this news, on August 1, 2019, Turquoise Hills common stock price closed at $0.53 per share, down 8.62% from the prior days closing price of $0.58 per share.

The complaint, filed on October 15, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements and omitted to disclose material facts regarding the Companys business and operations. Specifically, defendants made false and or misleading statements and/or failed to disclose that: (i) the progress of underground development of Oyu Tolgoi was not proceeding as planned; (ii) there were significant undisclosed underground stability issues that called into question the design of the mine, the projected cost and timing of production; (iii) the Companys publicly disclosed estimates of the cost, date of completion and dates for production from the underground mine were not achievable; (iv) the development capital required for the underground development of Oyu Tolgoi would cost substantially more than a billion dollars over what the Company had represented; and (v) Turquoise Hill would require additional financing and/or equity to complete the project.

For more information on the Turquoise Hill class action go to: https://bespc.com/cases/TRQ

About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq. Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com

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Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Royal Caribbean, Mesoblast, Loop Industries, and...

In a year of great loss, isolation and need, locals look to family, future this Thanksgiving – Florida Today

How many timeshave you been asked that age-oldholiday question:What are you thankful for this Thanksgiving?

Given a global pandemic thats taken so many from their loved onesand left so much sadness in its wake, but has also brought out incredible acts of sacrifice and kindness, how would you replythis year?

FLORIDA TODAY posed that question tofour locals: ateenager who's spent his senior year in isolation with his family. AGen X'er who helps feed the hungry. Ababy boomer who, at61, recently met his birth father. And anoctogenarian, whose pink-tinted hair reveals justa hint of her outgoing nature.

Their answers assure us that while our walk through this life may be very different from that of someone else,we're all walking toward some of the same goals taking care of each other. Good health. Food on the table. Enjoying"normal" moments, like a beach walk and hugging a pet. Treasuring family.

Meet Wesley Smith, Jeannette Harrell, Gabe Cenker and Larry Goodijohn.

And from all of us: Happy Thanksgiving.

Wesley Smith knows too wellthe daily struggle andeconomic nightmares thatso many people in his community are living.

He can see it on their faces, hear it in their voices, as the kitchen manager at the Central Brevard Sharing Center in Cocoa, which serves up to 150 meals sixdays a week out of a small, busy kitchen.

In a year that's left many people seeking aid for the first time, battered by job losses and other pandemic-fueled indignities, he thinks the least he can dois seethey get a meal and a smile.

So smile this 53-year-olddoes, the hint of it coming from behind the mask he wears as he and his colleagues turn out meal after meal. On Thanksgiving, he'll be part of the meal service at the center.

And hefeels blessed. Blessed to have his children and mom near. Tobe surrounded by co-workers who "never let you down." Blessed to be part of a mission, on Thanksgiving and every day, to get food and glimmers of hope to those who need a boost.

"For me, this is my everything," Smithsaid. "If you're having a bad day, I want you to be out there on the road and think, 'I can pick up something good at the Sharing Center.' And pick up your spirits, too."

Wesley Smith, the kitchen manager for the Central Brevard Sharing Center, says his faith has helped him get through hard times and is thankful for the opportunity to help others in need.(Photo: MALCOLM DENEMARK/FLORIDA TODAY)

A Philadelphia native who at one time was the chef at Wuesthoff Hospital, he's had his own struggles, personal and physical. Afew years ago, Smithwas walking with what's called a "spastic gait" like a robot, he said. The Navy veteran learned at the Veterans Administration that he had a tumor on his spinal cord and post-surgery, faced therapy to walk again. The scar from that surgery is covered by long dreads, which he grew when he thought he might have cancer.

"I said, 'I'll put a positive spin on it. I'll grow it long so maybe when I have chemo, I'll have something left.' The doctor told me it doesn't work like that," Smithsaid, laughing."I didn't have cancer, but I let it keep growing."

That kind of upbeat attitude endears Smith to his work family.

"When I think of Wesley, I think of a kind, loving person, who's a bright light in our organization," said David Brubaker, Sharing Center president and CEO. "He's been through so much, where he was literally learning to walk again, and to use his arms. And yet, you can always see that smile, even behind his mask. It shows in his eyes."

Wesley Smith, the kitchen manager for the Central Brevard Sharing Center, says his faith has helped him get through hard times and is thankful for the opportunity to help others in need.(Photo: MALCOLM DENEMARK/FLORIDA TODAY)

Smith'sfaith has onlygrown through hardtimes, pushinghim to continue serving othersand, in a tough year, maintain a positive attitude.

"Once I chose Jesus, God chose me," Smithsaid. "That allows me, through all the trials and tribulations I went through, to be more empatheticwiththe people who come here.

"I can leave my thing at the door. I try not to tell people what I wentthrough because it leaves their mouth on the ground, like, 'How are you sitting here in front of me?' It was through Jesus and God. You know, at one pointI couldn't lift a pan past my waist. I get goosebumps thinking about it.So for me to be able to giveto the people here ... a smile is the one thing that's free, and I give it to everybody."

At 83,Jeannette "Jan" Harrell isblunt about life and death.

The Sharpes residenthaspre-existing conditions that made the spread of COVID-19 over the past few months even scarier. It's been heartbreaking, she said, to read about deaths of people young and old.

Jeannette "Jan" Harrell, of Sharpes, with her dog, Max. When Jan had a bad fall this year, Max stayed with her for many hours until help arrived.(Photo: TIM SHORTT/ FLORIDA TODAY)

Then on Oct. 21, she had her own health scare, when, sick and weak, she sankto the bathroom floor around 5 a.m. With her Life Alert button and cell phone in the living room, she lay there for more than seven hours.

Her terrier, Max "my little love," she calls himsat near or beside her the entire time, barking off and on. Harrelllaughs nowabout looking at the toilet and thinking about how her daughter comes tohelp clean.

But she's serious about what she thought ofas she lay there, unable to gather the strength to stand: "I'm not scared to die ... but I want to live."

"I have three of the most beautiful children that I raised by myself without child support," she said. "I love them they're my best friends. I have a new great-grandchild, born in August. And then I have some of the best friends in the world, too. I love my little apartment ... I love my life."

A Florida native, Harrell's proud of her roots. Her great-grandfather was the first postmaster in Orlando. Harrell moved to Brevard County in 1960 from Daytona Beach to work for Pan Am and later, at Boeing, at Kennedy Space Center, retiring in January 2000. Her memories from the Space Center are strong and poignant, like seeing the Challenger explosion and thinking, "That's not right." She loved seeing the recent SpaceX night launch, a crewed mission that was "return to flight for me," she said. "It was wonderful."

Jeannette "Jan" Harrell, of Sharpes, with her dog, Max. When Jan had a bad fall this year, Max stayed with her for many hours until help arrived. Florida Today

Her lifeis as busy as she wants it to be. She gives rides to friends who no longer drive and runs her own errands. When life is "normal," as it's not in this far-from-normal year, she has lunch with friends with an occasional margarita.

But just a month before Thanksgiving, the life Harrellloves was, literally, on the line.

It happened so fast. After being sick in the night, falling and lying on the floor from 5 a.m. until around 1 p.m., Harrell was rescued after a neighbor came to check on her and calledEMT's, Her vitals were good, she said, once she was helped up, and she passed on going to the ER.

"Max even growled at the EMT's," she said. "That's how he is."

But aday later, she was sick again. This time, she went to the Rockledge Medical Center's ER, and was hospitalized for four days, with sepsis, low potassiumand COPD. The thought of COVID was not far from her mind, but she praised hospital staff for their care and concern.

Jeannette "Jan" Harrell, of Sharpes, with her dog, Max. When Jan had a bad fall this year, Max stayed with her for many hours until help arrived.(Photo: TIM SHORTT/ FLORIDA TODAY)

And back home on her couch, cuddling Max and surrounded by good neighbors, books, the TV that tunes her in to NASCAR, football and baseball... yes, she said. It's good to be alive. On Thanksgiving. On any day.

"I'm so grateful to the young couple next door, to the EMTs, to the hospital staff ...I didn't know I was that sick," Harrellsaid.

"I am not afraid of dying, but I am just not readyyet."

In 2017 and 2018, Gabe Cenkerhikedthe Appalachian Trail with his mother.

In 2019, the STEM-loving teentookcollege tours with his parents, visiting campuses including those at Yale and Princeton.

Then came COVID-19. Andmore isolation than most of uscould imagine, down to the prestigious summer programs hehad beenaccepted to going virtual. Even though the Rockledge teen isa veteran of homeschooling and Florida Virtual School,it's a sure bet this isnot the senior year Gabe was expecting or would have chosen.

Gabe Cenker, 17, is seen smiling just moments after opening a letter of acceptance from Penn State.(Photo: Jennifer Cenker for FLORIDA TODAY)

He's missed being part of the Rockledge Highrobotics team, which has just started online meetings to figureout the upcoming season: "I'm looking forward to that," he said. He can still do beach walks. Or play tennis. He and his dad, Dave, an engineer, recently took a socially distanced camping trip to Blue Springs State Park.

Gabe Cenker will graduate from high school in May 2021. A global pandemic changed his senior year, but it hasn't changed his focus on his future. Florida Today

But when quarantines and restrictions end,and he can roam aboutfreely, what's on the schedule for this bright and motivated teen?

You might just find him in the produce aisle.

"As much of anything at all possible. Not even with friends but just sort of stupid things, like being able to go to a grocery store," said Gable, wholl graduate from high school in May 2021.

"Just getting out and doing normal things again ... my family likesto go to Disney a lot. We'd go every month to try a different restaurant. Wereally enjoyed doing that. That's stopped, obviously, since COVID. I've been trying to come up withsome things to do throughout and it's like, 'No, can't do that because it's inside ...I'm not all that picky. I'll just beexcited to do really anything and everything that's normal."

Gabe Cenker, 17, pictured during a November 2020 camping trip with his father at Blue Springs State Park, has experienced a very different senior year than the one the teen might have expected.(Photo: Dave Cenker for FLORIDA TODAY)

Because of his deep thoughts and "old soul," Gabewas given the trail name "Deep Waters" bya fellow hiker on the Appalachian Trail, said his mother.

"He's so gifted, and he's always been involved in so many interesting subjects," said Jennifer Cenker, who taught for Brevard Public Schools before stepping backto homeschool her son.

"So he's missing his friends ...he's got a core group of five or six friends he's known all the way through in homeschooling. But he's come up with methods to be with them."

One of those ways: hitting the kitchen. Gabeand one of his best friends have cooked together online, fromchoosing recipes to shopping online and, via their laptops, comparing their culinary exploits as they cook for their families.

The forced isolation has given thisfamilya lot of time to talk about Gabe'sfuture and explore every career possibility: aerospace engineering? Meteorology? Geology?

And the always-studiousGabe is dual-enrolled at Eastern Florida State College, prepping, in virtual style, to head off to college however that turns out, online or in person.

He's modest about his accomplishments. He's thoughtful in his responses.He's grateful, this Thanksgiving, for all the possibilities ahead.

"I want to get into college and then figure out like exactly what I want," he said. "I know it's definitelyin the STEM area.

"It gets more interesting when you're at one of the schools. I got to see two of them, and we started looking at housing, where I'd live there if I were accepted, all that. Depending on how things are in the spring ... maybe another road trip."

Larry Goodijohn grew up in a loving home in Houlton, Maine,with his mother, two siblings and his adoptive father.

While he didn't knowhis birth father's identity, he had a good life. He graduated from the University of Florida, where he met his future wife, Laura, and is a recovery operations manager forJacobs Technology. AMerritt Island resident, he'sthe father of a son, Spencer, and a daughter, Kelly, and soon, he and Laura will be grandparents.

But life got even sweeter and the family bigger in 2019, when Spencer took a23andMe DNA test and learned he was 27% Jewish. Then, Goodijohndid his own test. He found some distant cousins. Then camethe call that changed his life, from a young man who turned out to be a nephew.

In short order, Larry was talking with that nephew's dad, one ofLarry's younger brothers by his birth father (that Jewish connection). Not long afterward, he was on the phone with that father, Gerald "Jerry" Kane who just happensto live in Florida, too.

Larry Goodijohn, 62, of Merritt Island is thankful that he has finally met his birth father, Geralrd "Jerry" King, 83. The two, who will celebrate their second Thanksgiving together this year, discovered each other through DNA testing, and had been living just a couple of hours apart for the past 14 years.(Photo: TIM SHORTT/ FLORIDA TODAY)

The two menmet in person for the first time in August 2019. The reunion? Going strong.

Father and son will marktheir second Thanksgiving together this year with COVID-19 precautions in a very small and safe familygathering. Their first Christmas together is up next. They had their first Father's Day together in June. In addition to the brother and sisterhe grew up with, Goodijohnhas three brothers and two sisters who are the children of Kane and Irene,his wife of 63 years. All the sibllingshavebeen "super-welcoming and loving," Goodijohn said, and he feels a strong biological connection.

Larry Goodijohn, 62, of Merritt Island, chats with his birth father, Jerry King, 83, on FaceTime. The two met for the first time in 2019.(Photo: TIM SHORTT/ FLORIDA TODAY)

So many firsts. So much joy. So manyjokes: Kane's a master at those, his son said.

"I didn't really expect to find my father," said Goodijohn, whose mother, Joyce, was happyfor his discovery.

"I figuredthere was a good chance he might not even be alive at this point, I thought maybe I could find a sibling that I didn't know. But it turns out he's been living in The Villages for 14 years.It's so wonderfulto find your dad and find out he's such a good person, thathe's really smart and funny and all those things you'd hoped for."

Jerry Kane, now 83, was 19 and in the Air Force when he dated Goodijohn's mother in Maine.Hemarried a few months after Larry would have been conceived in 1957, and had no idea that Goodijohn's mother had given birth to his child.

He and Irene were excited to welcomeGoodijohn's family into their already big brood.

"I think the best part of all of this was thatI mean, aside from the fact that I found that I have another son is that my other children took to him like he's been in their lives forever," Kane said.

"I didn't know how I was going to handle it at first. You know, one day you have five children and you wake up the next morning, you have six. Butwe were just so much at ease. And then, Larry and I discovered things about each other that were so similar ...what he did as a child, whatI didto make money. Wewere both business-minded, even when we were young. Plus the fact that it looks remarkably like my two youngest sons and myself."

Kane is proud of his oldest child, without a doubt.

"I give big kudos to his mom for handling things the way she did and and raising a really good son," he said.

Larry Goodijohn, 62, of Merritt Island is thankful that he has finally met his birthfather, Jerry Kane, 83. Florida Today

If people really do beam with happiness, Goodijohn isshootingsignals to faraway planets.

Laura Goodijohn teared up as her husband of 35 years chatted with his father on FaceTime recently, sharing that her "new" in-laws and Larry's siblings have been incredibly loving.

"Larry is happier than I can ever remember.I get really emotional when I talk about it," she said. "He's always wanted to know who his father was. Sofor him to find him and find that he is such a wonderful man, and he looks just like him ...I just want to say it's changed Larry's life."

The entire family is making up for lost time, Goodijohn said.

"I'm so thankfulfor being able to to get to know them," he said. "I couldn't imagine the story turning out better."

Contact Kennerly at 321-242-3692 or bkennerly@floridatoday.com. Twitter:@bybrittkennerlyFacebook: /bybrittkennerly

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Correlation of whole-bone marrow dual-time-point (18)F-FDG, as measured by a CT-based method of PET/CT quantification, with response to treatment in…

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Am J Nucl Med Mol Imaging. 2020 Oct 15;10(5):257-264. eCollection 2020.

ABSTRACT

The practical application of dual-time-point-imaging (DTPI) technique still remains controversial. One of the issues is that current parameters of DTPI quantification suffer from some deficiencies, mainly limited sampling of the diseased sites by confining measurements to specific locations. We aimed to examine the correlation between the percent change from early to delayed scans in whole-bone marrow (WBM) 18F-FDG uptake, as measured by a CT-based method of PET/CT quantification, and response to treatment in multiple myeloma (MM) patients. Pre-treatment 18F-FDG-PET/CT scans of 36 newly diagnosed MM patients were collected in a prospective study at 1 h and 3 h post tracer injection (NCT02187731). A threshold algorithm based on bone Hounsfield units on CT was applied to segment and quantify WBM 18F-FDG uptake. Patients were separated into two treatment groups: high-dose therapy with autologous stem cell transplant (HDT) and non-high dose therapy (non-HDT). The International Response Criteria for MM patients was used to determine each patients response to treatment. In the HDT group, WBM 18F-FDG uptake increased significantly in patients that had a poor response to treatment, from a median of 1.31 (IQR: 1.13-1.64) at 1 h to a median of 1.85 (1.45-2.10) at 3 h. The median percent change was 37.77% (IQR: 23.47-46.4), with a range of 6.10-50.73 (P = 0.003). However, no significant change in uptake was observed in patients with a complete response (P = 0.24). The same trend was observed for the non-HDT group. WBM uptake of 18F-FDG assessed with dual-time-point imaging may have a role in predicting treatment response in MM.

PMID:33224622 | PMC:PMC7675111

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Correlation of whole-bone marrow dual-time-point (18)F-FDG, as measured by a CT-based method of PET/CT quantification, with response to treatment in...

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