MASCC/ISOO Updates Its Guidelines on Preventing, Treating Mucositis Associated With Cancer Therapy – Oncology Nurse Advisor

Clinical setting-specific guidance was provided in a recently updated version of the Multinational Association for Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO) clinical practice guidelines on the management of cancer treatment-related mucositis, and published in the journal Cancer.

Mucositis is a common adverse effect of cancer treatments, including chemotherapy, radiotherapy (RT), and chemoradiotherapy (chemoRT), and intensive conditioning therapy administered in the setting of hematopoietic stem cell transplantation (HSCT). It is characterized by inflammation and ulceration of the mucosal lining of the gastrointestinal tract and can be associated with substantial morbidity, as well as early interruption of cancer therapy and a higher rate of opioid use in patients with cancer.

Following a recently conducted, rigorous, systematic review of the related medical literature, the MASCC/ISOO Mucositis Study Group issued the fourth version of its guidelines on the prevention and treatment of mucositis secondary to chemotherapy, RT, chemoRT, or HSCT. MASCC/ISOO guidelines were first published in 2004.

Of note, although mucositis has also been identified as a potential adverse effect of some targeted therapies and immunotherapies used in the treatment of cancer, these guidelines do not address management of mucositis in those settings.

Although the guidelines cover both prevention and treatment, the emphasis of these updates was on interventions for preventing mucositis and its potentially serious complications in patients undergoing cancer therapy.

Some of the key recommendations issued by the Study Group regarding mucositis secondary to chemotherapy, RT, chemoRT, and/or HSCT include:

Regarding professional oral care for the prevention of mucositis in patients with cancer undergoing treatment and the use of misoprostol mouthwash in patients with head and neck cancer treated with RT, the Study Group noted that only limited, high-quality evidence exists in these areas, hence no related guideline recommendations were issued on those topics.

However, recommendations were issued against prophylactic use of both topical granulocyte macrophage colony-stimulating factor (GM-CSF) in patients undergoing HSCT and chlorhexidine rinses in those with head and neck cancer undergoing RT.

Regarding treatment of mucositis, the guidelines suggested topical 0.2% morphine mouthwash for patients with pain related to oral mucositis secondary to the treatment of head and neck cancer with chemoRT (Level III Evidence). However, a recommendation was made against using combined topical and systemic sucralfate to treat oral mucositis-related pain in those with head and neck cancer receiving RT and those with solid tumors treated with chemotherapy.

The ultimate goal of these guidelines is to improve the supportive care for patients with cancer and provide direction for future trials. As new research is conducted, new evidence will become available, the guideline authors noted in their concluding remarks. To this end, the MASCC/ISOO Mucositis Study Group plans to continue periodically updating its guidelines.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Elad S, Cheng KKF, Lalla RV, et al; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. Published online July 28, 2020. doi:10.1002/cncr.33100

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MASCC/ISOO Updates Its Guidelines on Preventing, Treating Mucositis Associated With Cancer Therapy - Oncology Nurse Advisor

A systematic literature review of the effects of immunoglobulin replacement therapy on the burden of secondary immunodeficiency diseases associated…

This article was originally published here

Expert Rev Clin Immunol. 2020 Aug 12. doi: 10.1080/1744666X.2020.1807328. Online ahead of print.

ABSTRACT

INTRODUCTION: Secondary immunodeficiency diseases (SID) caused by hematological malignancies (HMs), stem cell transplant (SCT), and associated therapies are mainly characterized by the presence of hypogammaglobulinemia or antibody production deficits.

AREAS COVERED: The authors summarized the scientific literature on disease burden of SIDs in patients who had HMs or SCT. Systematic searches were conducted to identify English-language articles from 1994-2020, reporting on clinical, humanistic, and economic burdens of SID due to HMs or SCT. Definitions of SID and serum immunoglobulin G thresholds varied across the 24 studies that met eligibility criteria. In most (n=16) studies, patients received immunoglobulin replacement therapy (IGRT). Several studies found IGRT was associated with significant reductions in rates of infection and antimicrobial use. However, 1 study found no statistically significant difference in antibiotic use with IGRT. Only 3 studies reported on quality of life, and no economic studies were identified.

EXPERT OPINION: Overall, the findings show several beneficial effects of IGRT on clinical outcomes and quality of life; however, disparate definitions, infrequent reporting of statistical significance, and scarcity of clinical trial data after the 1990s present areas for further investigation. This paucity indicates an unmet need of current evidence to assess the benefits of IGRT in SID.

PMID:32783541 | DOI:10.1080/1744666X.2020.1807328

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A systematic literature review of the effects of immunoglobulin replacement therapy on the burden of secondary immunodeficiency diseases associated...

Global Stem Cell Therapy Market Future Growth Analysis, Business Demand And 2025 Opportunities – Bulletin Line

A research report on the global Stem Cell Therapy market offers an in-depth analysis of the market scope and objective of the target market. The report also gives complete information regarding the major market players and segments. This research report provides a precise market prediction for the global and the local market. The Stem Cell Therapy report also sheds light on the market share and market growth rate on the basis of different regions involved in this market.

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Global Stem Cell Therapy Market Future Growth Analysis, Business Demand And 2025 Opportunities - Bulletin Line

Experimental COVID treatment may have saved man’s life – 10News

SAN DIEGO A San Diego-based stem cell research institute believes its discovery may have saved the life of a COVID patient on death's doorstep.

GIOSTAR infused a 53-year-old man in a coma with Mesenchymal stem-cells taken from an umbilical cord. Prior to that, all other treatments were failing.

"He was having a stroke, he was under dialysis, liver function was declining," said Dr. Anand Srivastava, co-founder of GIOSTAR. "Nothing was working."

The patient, whose identity is not being released due to privacy laws, had been in a coma in a New Jersey hospital. GIOSTAR got special clearance from the Food and Drug Administration to try the stem-cell treatment.

Srivastava said the patient began to recover, gradually over three weeks.

"Slowly, his renal and liver function came closer to normal," he said. "He came out from the intubation, and now he is talking."

The family, in an interview with GIOSTAR, said they had lost all hope.

Srivastava said this treatment could be key as society awaits a vaccine.

GIOSTAR is planning to do a double-blind study to confirm its conclusions about its treatment. It says that study should take about three months.

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Experimental COVID treatment may have saved man's life - 10News

Stem Cell Therapy for Osteoarthritis Market Latest State Of Affairs On Innovation, Revolutionary Opportunities Customers 2026 – Science Examiner

The Stem Cell Therapy for Osteoarthritis market report [6 Years Forecast 2020-2026] focuses on the COVID19 Outbreak Impact analysis of key points influencing the growth of the market. Providing info like market competitive situation, product scope, market overview, opportunities, driving force and market risks. Profile the Top Key Players of Stem Cell Therapy for Osteoarthritis, with sales, revenue and global market share of Stem Cell Therapy for Osteoarthritis are analyzed emphatically by landscape contrast and speak to info. Upstream raw materials and instrumentation and downstream demand analysis is additionally administrated. The Stem Cell Therapy for Osteoarthritis market business development trends and selling channels square measure analyzed. From a global perspective, It also represents overall industry size by analyzing qualitative insights and historical data.

The study encompasses profiles of major companies operating in the global Stem Cell Therapy for Osteoarthritis market. Key players profiled in the report includes : Mesoblast, Regeneus, U.S. Stem Cell, Anterogen, Asterias Biotherapeutics, and among others.

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The global Stem Cell Therapy for Osteoarthritis market is valued at million US$ in 2019 and will reach million US$ by the end of 2026, growing at a CAGR of during 2020-2026. The objectives of this study are to define, segment, and project the size of the Stem Cell Therapy for Osteoarthritis market based on company, product type, application and key regions.

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Stem Cell Therapy for Osteoarthritis Market Latest State Of Affairs On Innovation, Revolutionary Opportunities Customers 2026 - Science Examiner

Jasper Therapeutics Strengthens Management Team with Appointment of Biopharma Industry Executive Kevin N. Heller, M.D., as Executive Vice President,…

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, today announced the appointment of Kevin N. Heller, M.D., as Executive Vice President, Research & Development. In this newly created role, Dr. Heller will lead the Companys clinical and research functions and oversee clinical development, clinical strategy and operations, medical affairs and early research and development activities.

As a physician-scientist with more than 20 years of experience in oncology research in academia and industry, Kevin will be an important addition to our growing executive team and will help us achieve our mission of developing more effective and safer therapies that will allow more patients to benefit from curative stem cell transplants and gene therapies, said Bill Lis, Executive Chairman and Chief Executive Officer of Jasper Therapeutics. With our lead investigational product, JSP191, in development for multiple indications, we look forward to Kevins contributions to growing our clinical function and helping us advance our pipeline.

Dr. Hellers biopharma industry experience spans all stages of oncology drug development from discovery (academia) and pre-IND through commercialization and business development. Before joining Jasper, Dr. Heller was Chief Medical Officer at NextCure, Inc. Prior to that, he was Vice President, Head of Antibody Clinical Development at Incyte, overseeing immunotherapy clinical development strategies for multiple antibody programs. He joined Incyte from AstraZeneca, where he was Senior Medical Director, overseeing global medicines development in oncology. Dr. Heller began working in the biopharma industry at Bristol Myers Squibb, where he held positions of increasing responsibility and leadership, most recently serving as Global Lead Oncology, Search, Evaluation and Diligence, where he was responsible for leading a team matrix across disciplines during due diligence and preparing recommendations for possible acquisitions. During his tenure at Bristol Myers Squibb, he led early development programs and was responsible for managing first-in-human clinical trials. Dr. Heller has been an Adjunct Professor at Yale University School of Medicine since October 2018.

Having dedicated my entire career to developing new medicines for children and adults with cancer, I am excited to join Jasper and contribute my knowledge and experience at this important time in the companys trajectory, as it continues to evaluate JSP191 in patients undergoing stem cell transplants and is developing new programs for gene therapy and stem cell transplants, said Dr. Heller. Jasper is one of the most exciting companies working in this space because of its uniquely targeted approach to improving conditioning agents. Im eager to help the team bring JSP191 to patients so we can cure far more people with stem cell transplants and gene therapy.

Dr. Heller earned a B.S. in molecular biophysics and biochemistry from Yale University and an M.D. from The George Washington University School of Medicine and Health Sciences before training in pediatrics and then pediatric hematology/oncology at Memorial Sloan Kettering Cancer Center. Following his fellowship, Dr. Heller joined the faculty of the Rockefeller University as Instructor and subsequently Chief Clinical Scholar of Clinical Investigation in the laboratory of immunologist Dr. Ralph Steinman. During that time, he served as principal investigator on clinical trials.

About JSP191

JSP191 (formerly AMG 191) is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow. JSP191 binds to human CD117, a receptor for stem cell factor (SCF) that is expressed on the surface of hematopoietic stem and progenitor cells. The interaction of SCF and CD117 is required for stem cells to survive. JSP191 blocks SCF from binding to CD117 and disrupts critical survival signals, causing the stem cells to undergo cell death and creating an empty space in the bone marrow for donor or gene-corrected transplanted stem cells to engraft.

Preclinical studies have shown that JSP191 as a single agent safely depletes normal and diseased hematopoietic stem cells, including in an animal model of myelodysplastic syndromes (MDS). This creates the space needed for transplanted normal donor or gene-corrected hematopoietic stem cells to successfully engraft in the host bone marrow. To date, JSP191 has been evaluated in more than 80 healthy volunteers and patients. It is currently being evaluated as a sole conditioning agent in a Phase 1/2 dose-escalation and expansion trial to achieve donor stem cell engraftment in patients undergoing hematopoietic cell transplant for severe combined immunodeficiency (SCID), which is curable only by this type of treatment. JSP191 is also being evaluated in a Phase 1 study in patients with MDS or acute myeloid leukemia (AML) who are receiving hematopoietic cell transplant. For more information about the design of these clinical trials, visit http://www.clinicaltrials.gov (NCT02963064 and NCT04429191). IND-enabling studies are planned to advance JSP191 as a conditioning agent for patients with other rare and ultra-rare monogenic disorders and autoimmune diseases.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on hematopoietic cell transplant therapies. The companys lead compound, JSP191, is in clinical development as a conditioning antibody that clears hematopoietic stem cells from bone marrow in patients undergoing a hematopoietic cell transplant. This first-in-class conditioning antibody is designed to enable safer and more effective curative hematopoietic cell transplants and gene therapies. For more information, please visit us at https://jaspertherapeutics.com.

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Jasper Therapeutics Strengthens Management Team with Appointment of Biopharma Industry Executive Kevin N. Heller, M.D., as Executive Vice President,...

Australian Therapeutic Goods Administration Approves the First Phase I Trial of ATG-017 for the Treatment of Patients with Advanced Solid Tumors and…

SHANGHAI and MELBOURNE, Australia, Aug.12, 2020 /PRNewswire/ -- Antengene Corporation, a leading innovative hematology and oncology-focused biopharmaceutical company, announced today the authorization of the first-in-human trial of ATG-017 (ERASER trial) by the Australian Therapeutic Goods Administration (TGA). ATG-017 is a potent and selective small molecule extracellular signalregulated kinases 1 and 2 (ERK1/2) inhibitor. The study will enroll patients with advanced solid tumors and hematological malignancies. Today's milestone marks the first TGA trial authorization for Antengene and is the first clinical trial for ATG-017 globally.

ATG-017 is an oral, potent and highly selective inhibitor of ERK1/2, which are related protein-serine/ threonine kinases that function as the terminal kinases in the RAS-RAF-MEK-ERK signal transduction cascade. This pathway participates in the control of numerous processes which include apoptosis, cell proliferation, and cellular immune response. In preclinical studies, ATG-017 has proven to regulate a large variety of cellular processes by targeting ERK1/2 and has shown to be effective in inhibiting the viability of tumor cell lines in vitro as well as the tumor growth in vivo.

"This first human trial for ATG-017 in Australia is a significant step for our company's global clinical strategy and we will initiate overseas trials continuously for a number of novel drugs in our pipeline in the near future," said Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of Antengene. "Our vision is to treat patients beyond borders. For Australian patients with life-threatening diseases and patients around the world, we are passionately working to continue to develop and commercialize more novel therapies to make a difference in patient lives."

"Aberrations in the MAPK pathway are amongst the most common in malignant cancer, so developing effective drugs targeting this pathway remains a high priority. We are excited to begin this trial with the ERK-targeting agent ATG-017, and bring together our group of highly experienced Australian investigators and sites to begin this collaboration with Antengene," said Associate Professor Jayesh Desai, Head of the Phase I/ Early Drug Development Program at the Peter MacCallum Cancer Centre.

"The RAS-MAPK pathway is a major player in a range of largely incurable hematological malignancies, so the potential to effectively target it with ATG-017 represents an exciting opportunity for Australian cancer patients. We very much look forward to collaborating with Antengene on this new trial," said Professor Andrew Spencer, Head of the Malignant Haematology and Stem Cell Transplantation Service at the Alfred Hospital, Melbourne.

In November 2019, Antengene entered into a licensing agreement with AstraZeneca (LSE/STO/NYSE: AZN) under which Antengene has been granted the exclusive global rights to further develop, manufacture and commercialize AZD0364 (ATG-017).ATG-017 is currently being studied in clinical trials for the treatment of various solid tumors and hematological malignancies.

About ATG-017

ATG-017 is a potent and selective small molecule extracellular signalregulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for the treatment of various solid tumors, non-Hodgkin's lymphoma, acute myeloid leukemia (AML) and multiple myeloma.

About Antengene

Antengene is a biopharmaceutical company with integrated drug discovery, clinical development, manufacturing and commercialization anchored in the Asia Pacific region and with a global layout, aiming to provide the most advanced first-in-class/best-in-class anti-cancer drugs and other treatments for patients in China, the rest of Asia and around the world. In April 2017, Celgene (now Bristol-Myers Squibb), a global leading innovative biopharmaceutical company became a founding partner and obtained an equity position as an investor in Antengene. Antengene has built a product pipeline of 12 clinical and pre-clinical stage programs, obtained 9 IND approvals with9 ongoing cross-regional clinical trials in the Asia Pacific region. The vision of Antengene, "Treating Patients Beyond Borders", is to meet the unmet medical needs of patients in the Asia Pacific region and around the world through our research & development and commercialization of first-in-class/best-in-class cancer medicines. For more information, please visit http://www.antengene.com.

Forward-looking Statement

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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Australian Therapeutic Goods Administration Approves the First Phase I Trial of ATG-017 for the Treatment of Patients with Advanced Solid Tumors and...

Cuban Pitcher Raymond Figueredo, I really admire Jacob deGrom – Call to the Pen

BUENOS AIRES, ARGENTINA - FEBRUARY 18: Cuban flag is seen during a demonstration by Venezuelans against foreign intervention under the slogan #VenezuelaQuierePaz (Venezuela Wants Peace) at United States Embassy on February 18, 2019 in Buenos Aires, Argentina. (Photo by Franco Fasuli/Getty Images)

2020 MLB Season: The extra-inning rule isnt so bad after all by Sean Basile

When Raymond Figueredo decided to leave Cuba he was one of the hardest throwers in the Serie Nacional, the 20-year olds heater hovered around 95 to 97 mph.

The righty was a rising star in the 2019 Sub 23 tournament for La Habana. During the season he posted an ERA of 1.13 and hitters hit a paltry .170 against him, Figueredo was even included in the list of 34 prospects handed over to MLB by the Cuban Federation. Yet for some reason he was left of Industriales roster, an elbow injury I suspect had something to do with the exclusion even though he was said to be recovered after having stem cell treatment.

Today the young hurler is training in the Dominican Republic in search of a contract with an MLB club and with his electric repertoire that might just be on the horizon.

You have a blazing fastball in your repertoire, what other pitches have you incorporated in your arsenal since leaving Cuba?

I left Cuba with only a fastball, but since coming to the DR Ive added a slider and changeup to diversify my pitches and keep the hitters off-balance.

How have you stayed in shape during the pandemic?

Basically doing exercises at home and a lot of running. Im also playing at a baseball field near my house every weekend so I dont get out of baseball shape.

Did the collapse of the accord between Cuba and MLB influence your decision to leave the island?

It influenced me a bit, but I really just wanted to play in the best baseball in the world. That without a doubt was the biggest reason why I decided to leave Cuba.

Have you had any private workouts for any big league ball clubs?

No, as of right now I have only done showcases for a multitude of teams and scouts as a collective.

Do you have any more showcases planned?

In the near future when everything settles down I have the most important showcases of my life planned. My performance in these showcases will make or break my future.

Will you be playing any winter ball this off-season?

As of right now no, but if I receive an offer I will definitely entertain the thought. Playing winter ball will definitely keep me in baseball shape.

What pitchers do you admire?

Well in Cuba Im an avid fan of Freddy Aisel lvarez of Villa Clara, but my favorite pitcher to watch is Jacob deGrom.

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Cuban Pitcher Raymond Figueredo, I really admire Jacob deGrom - Call to the Pen

Joliet cancer patient celebrated his 2nd birthday at home after all – The Herald-News

Owen Buell of Joliet spent his second birthday with his family after all.

In a Facebook message late Monday night, his great-grandmother Jackie Moore of Florida said Owens oncologist wound up giving Owen a day pass."'

Owen was supposed to be discharged from the Ann & Robert H. Lurie Childrens Hospital of Chicago on Monday but that was delayed due to the riots, Moore said.

He got his little party right before the storm blew through, Moore said. Better late than never.

Owen returned to the hospital on Tuesday morning where he was officially discharged. Moore said.

In February, Owen was diagnosed with a neuroblastoma, a type of cancer most commonly found in children age 5 or younger.

Before the cancer was diagnosed, Owen had stopped eating and drinking and began screaming and crying inconsolably.

His right eye looked bruised and was drooping; his abdomen had swollen to nearly double in size.

Since then, Owen's had chemotherapy and the first of two stem cell transplants.

He's also had a feeding tube, numerous ports, bone marrow tests, stem cell extractions, major abdominal surgery, according to The Help for Baby Owen Buell and his Family Facebook page, which Moore moderates.

"Throughout all of these frightening medical treatments, he has smiled and wanted to give loves to everyone," his GoFundMe page said.

Owen had spent the last week or so at a Ronald McDonald House in Chicago so he could be near the hospital, Moore said.

"I was so happy at how good they took care of him there," Moore said of Ronald McDonald House.

Although Moore was not able to fly to Illinois for Owen's birthday celebration, she did ship a 3-foot-tall stuffed llama to Owens home to because Owen really likes llamas, she said.

He had some really nice gifts, including the llama, but he was most interested in a bottle of bubbles from the dollar store, Moore wrote. Go figure.

In a few weeks, Owen will resume his cancer treatments in preparation for a second stem cell transplant, Moore said.

The goal of the transplant is to make his bones more receptive to the chemo and possibly have him go into remission, according to the Help for Baby Owen Buell and his Family Facebook page.

The medical bills for Owen's care are now over $1 million, according to the

"Help for baby Owen Buell and his Family"GoFundMe page at bit.ly/2S7sPN7.

Visit the "Help for Baby Owen Buell and His Family" Facebook page for updates and detailed instructions on other ways to help the family.

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Joliet cancer patient celebrated his 2nd birthday at home after all - The Herald-News

Drug development for severe respiratory diseases supported with $3.9 million grant – Washington University School of Medicine in St. Louis

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New drug candidate targets asthma, COPD, other progressive lung diseases

Shown is a section of mouse lung with progressive lung disease, similar to asthma or COPD. The red staining shows excess mucus production that is characteristic of progressive lung disease and can occur in the aftermath of viral infection or other injury to the lungs. Researchers at Washington University School of Medicine in St. Louis have received a grant to develop a drug to block this process, potentially leading to a new treatment for debilitating lung disorders.

Researchers at Washington University School of Medicine in St. Louis have received a $3.9 million development award supporting new technologies and therapeutics to advance a first-in-class drug to treat debilitating lung diseases, including asthma and chronic obstructive pulmonary disease (COPD).

The research, funded by the Department of Defense, is led by Michael J. Holtzman, MD, the Selma and Herman Seldin Professor of Medicine and director of the Division of Pulmonary & Critical Care Medicine at Washington University.

Holtzmans team has designed a new drug candidate that blocks two important signaling systems in the lungs. These systems cause cells of the respiratory tract to become mucus-producing cells. An overabundance of these cells creates too much mucus, which can block breathing. Evidence suggests that the drug could stop and perhaps even reverse progressive damage from overproduction of mucus that is triggered by aggravations to the lung, including from respiratory viruses, smoking and air pollution.

Obstructive lung diseases, such as asthma and COPD, are the third leading cause of death due to disease in the United States, Holtzman said. But we have no effective treatments that address the root causes of these illnesses or halt disease progression. We can only try to relieve symptoms. This grant will allow us to continue research into a new drug candidate that our group developed and that has shown evidence of stopping and correcting what goes wrong in the lungs when this type of disease process is triggered.

In past research, Holtzman and his colleagues identified specialized stem cells in the lungs that give rise to mucus cells. During development, such stem cells are responsible for growing the lung itself. Some of these stem cells remain in the lungs into adulthood and periodically make new cells to line the inner surfaces of lung tissue, including those cells that make mucus. These stem cells also respond to injury to the lung such as a burn injury from inhaling smoke or a severe viral infection and orchestrate the repair process.

Shown is a section of healthy mouse lung.

We need a certain level of mucus to protect the lungs from viruses or particles that can be inhaled, Holtzman said. The stem cell population is important in maintaining normal lung function and in injury situations, where they help with the healing process. But, unfortunately, in some people these cells can go off the rails. Under certain conditions, particularly a severe respiratory viral infection, these stem cells become reprogrammed so that theyre activated even after the injury or infection is resolved. This leads to overproduction of mucus and excessive inflammation that can interfere with lung function with airway obstruction and difficulty breathing.

The new drug candidate is being designed to be taken by mouth or inhalation and to specifically target two related but distinct signaling molecules known as MAP kinases to control both arms of the immune and inflammatory response. Studying human cells, as well as mouse and pig models of respiratory disease following respiratory viral infections, the researchers found that not only does the drug reduce mucus production, it also nudges the rogue stem cells back toward their quieter and healthier state of readiness. The new grant will support studies in human cells, mice and pigs to establish evidence for the safety and effectiveness of the lead drug candidate and to help determine proper doses for subsequent studies in people. The safety work also will be facilitated by a subcontract to the teams biotechnology company known as NuPeak Therapeutics, which is specially designed for this drug development activity. The goal is to gather data to support approval for a first-in-human clinical trial.

Holtzman said the drug does not treat the viral infection itself; rather, it stops what he calls post-viral disease and its progression, which includes asthma and COPD. Post-viral lung disease also could include COVID-19, as an example of another severe respiratory viral infection that causes progressive and in some cases long-term lung disease in some patients well after the infectious virus has been cleared.

SARS-CoV-2, the virus that causes COVID-19, is similar to the viruses Holtzman and colleagues are working with to study their new drug candidate. The group is gathering key information in patient and animal models to determine whether the same therapeutic strategy could prove useful in treating COVID-19 as it has been for lung disease due to other related respiratory viruses.

Were just beginning to learn how the body responds to SARS-CoV-2, but it is very common for any respiratory viral infection, especially severe infections, to trigger this progressive disease process in some percentage of the patients who contract the virus, Holtzman said. Whats interesting is that the infectious form of the virus is gone when this process ramps up. Patients arent fighting the virus any more, theyre fighting their own immune system. In future work, we will be interested in finding out whether our drug candidate can help shut this process down regardless of the trigger, viral or otherwise.

This work is supported by the Department of Defense, grant number PR190726. Holtzman founded the biotechnology company NuPeak Therapeutics, which is facilitating development of the drug candidate.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Drug development for severe respiratory diseases supported with $3.9 million grant - Washington University School of Medicine in St. Louis