Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV

The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.

开始日期2025-06-01

申办/合作机构

Pulmotect, Inc.

[+1]

NCT03097796

/ Withdrawn临床1期

An Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of PUL-042 Inhalation Solution in Subjects With Hematologic Malignancies and Recipients of Stem Cell Transplantation

Subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant, without any evidence or respiratory infection, will receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4 dose levels tested

开始日期2024-12-01

申办/合作机构

Pulmotect, Inc.

[+2]

NCT04312997

/ Completed临床2期

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Adults who have tested positive for SARS-CoV-2 infection and who may require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome

开始日期2020-06-16

申办/合作机构

Pulmotect, Inc.

[+1]

100 项与 ODN/Pam2 相关的临床结果

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100 项与 ODN/Pam2 相关的转化医学

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100 项与 ODN/Pam2 相关的专利（医药）

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项与 ODN/Pam2 相关的文献（医药）

2025-05-14·mBio

Immunotherapy with nebulized pattern recognition receptor agonists restores severe immune paralysis and improves outcomes in mice with influenza-associated pulmonary aspergillosis

Article

作者: Burch-Eapen, Madeleine ; Wang, Yongxing ; Moghaddam, Seyed J. ; Bharadwaj, Uddalak ; Ntita, Mbaya ; Kulkarni, Vikram K. ; Foncerrada Lizaola, Jania ; Covarrubias López, Daniela ; Wurster, Sebastian ; Evans, Scott E. ; Bhoda, Keerthi ; Kontoyiannis, Dimitrios P. ; Matula, Lauren M. ; Larsen, Katherine E. ; Rodríguez Carstens, Paris ; Albert, Nathaniel D. ; Pantaleón García, Jezreel

ABSTRACT:

Influenza-associated pulmonary aspergillosis (IAPA) is a potentially deadly superinfection in patients with influenza pneumonia, especially those with severe disease, underlying immunosuppression, corticosteroid therapy, or requiring intensive care support. Given the high mortality of IAPA, adjunct immunomodulatory strategies remain a critical unmet need. Previously, the desensitization of pattern recognition pathways has been described as a hallmark of IAPA pathogenesis and a predictor of mortality in IAPA patients. Therefore, we studied the impact of nebulized Toll-like receptor 2/6/9 agonists Pam2 CSK4 (Pam2) and CpG oligodeoxynucleotides (ODNs) on infection outcomes and pulmonary immunopathology in a corticosteroid-immunosuppressed murine IAPA model. Mice with IAPA receiving mock therapy showed rapidly progressing disease and a paralyzed immune response to secondary Aspergillus fumigatus infection. Nebulized Pam2ODN was well tolerated and significantly prolonged event-free survival. Specifically, dual-dose Pam2ODN therapy before and after A. fumigatus infection led to 81% survival and full recovery of all survivors. Additionally, transcriptional analysis of lung tissue homogenates revealed induction of pattern recognition receptor signaling and several key effector cytokine pathways after Pam2ODN therapy. Moreover, transcriptional and flow cytometric analyses suggested increased frequencies of macrophages, natural killer cells, and T cells in the lungs of Pam2ODN-treated mice. Collectively, immunomodulatory treatment with nebulized Pam2ODN strongly improved morbidity and mortality outcomes and alleviated paralyzed antifungal immunity in an otherwise lethal IAPA model. These findings suggest that Pam2ODN might be a promising candidate for locally delivered immunomodulatory therapy to improve outcomes of virus-associated mold infections such as IAPA.

IMPORTANCE:

The COVID-19 pandemic has highlighted the significant healthcare burden, morbidity, and mortality caused by secondary fungal pneumonias. Given the heightened prevalence of severe viral pneumonias, such as influenza, and poor outcomes of secondary mold pneumonias, adjunct immunotherapies are needed to prevent and treat secondary infections. We herein demonstrate severely paralyzed immunity to secondary Aspergillus fumigatus infection in a corticosteroid-immunosuppressed mouse model of influenza-associated pulmonary aspergillosis (IAPA), partially due to dysregulated pathogen-sensing pathways. To overcome immune paralysis and IAPA progression, we used a dyad of nebulized immunomodulators (Toll-like receptor agonists). Nebulized immunotherapy significantly improved morbidity and mortality compared to mock therapy, increased frequencies of mature mononuclear phagocytes and natural killer cells in the lung, and stimulated antimicrobial signaling. Collectively, this proof-of-concept study demonstrates the feasibility and efficacy of locally delivered immunomodulatory therapy to alleviate virus-induced immune dysregulation in the lung and improve outcomes of post-viral mold pneumonias such as IAPA.

2023-06-01·American journal of respiratory cell and molecular biology

Redox-Dependent Activation of Lung Epithelial STAT3 Is Required for Inducible Protection against Bacterial Pneumonia

Article

作者: Evans, Scott E. ; Pantaleon Garcia, Jezreel ; Wang, Yongxing ; Kulkarni, Vikram V.

The lung epithelium is dynamic, capable of considerable structural and functional plasticity in response to pathogen challenges. Our laboratory has demonstrated that an inhaled combination of a Toll-like receptor (TLR) 2/6 agonist and a TLR9 agonist (Pam2ODN) results in robust protection against otherwise lethal pneumonias. We have previously shown that intact epithelial TLR signaling and generation of multisource epithelial reactive oxygen species (ROS) are required for inducible protection. Further investigating the mechanisms underlying this phenomenon of inducible resistance, reverse-phase protein array analysis demonstrated robust STAT3 (signal transducer and activator of transcription 3) phosphorylation following treatment of lung epithelial cells. We show here that Pam2ODN-induced STAT3 phosphorylation is IL-6-independent. We further found that therapeutic epithelial STAT3 activation is required for inducible protection against Pseudomonas aeruginosa pneumonia. Additional studies showed that inhibiting epithelial dual oxidases or scavenging ROS significantly reduced the Pam2ODN induction of STAT3 phosphorylation, suggesting a proximal role for ROS in inducible STAT3 activation. Dissecting these mechanisms, we analyzed the contributions of redox-sensitive kinases and found that Pam2ODN activated epithelial growth factor receptor in an ROS-dependent manner that is required for therapeutically inducible STAT3 activation. Taken together, we demonstrate that epithelial STAT3 is imperative for Pam2ODN's function and describe a novel redox-based mechanism for its activation. These key mechanistic insights may facilitate strategies to leverage inducible epithelial resistance to protect susceptible patients during periods of peak vulnerability.

2020-12-01·American journal of respiratory cell and molecular biology

CD8⁺ T Cells: Exacting a Toll in Viral Pneumonia

Communications

作者: Ballinger, Megan N. ; Davis, Ian C.

Acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread across the globe, resulting in more than 170,000 deaths in the United States alone.Severely ill SARS-CoV-2-infected patients can develop a form of acute respiratory distress syndrome (ARDS) termed coronavirus disease (COVID-19).In the current study, Pam2-ODN pretreatment did not alter either the kinetics or the magnitude of the macrophage response to infection,indicating that their role may not be essential.Nevertheless, the link between early TLR stimulation and modulation of antiviral T-cell responses is an intriguing, and somewhat counterintuitive, finding, which will have implications for both our understanding of the pathogenesis of viral lung injury and its treatment.

项与 ODN/Pam2 相关的新闻（医药）

2022-11-08

·PRNewswire

Extremely Robust COVID-19 Clinical Trial Pipeline With 420+ Key Companies Expected to Change the Pace of the COVID-19 Treatment

COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. Common Cold Market Common Cold Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Pipeline Common Cold Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight Related Healthcare Blogs Increasing COPD Prevalence ARDS Market Outlook Emerging ARDS Therapies About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

疫苗基因疗法抗体生物类似药细胞疗法

2021-10-28

·BioSpace

Texas A&M Drug Shows Promise Against Multiple Respiratory Infections

Texas A&M University Science Center, MD Anderson Cancer Center, and Pulmotect report that the drug PUL-042 appears to work against COVID-19 and other respiratory infections. The drug stimulates the innate immune system in the lungs. They believe it might work against all existing and future variants of SARS-CoV-2, the virus that causes COVID-19, in addition to future pandemics. “We have not found a virus PUL-042 cannot work against in the lungs, in animal studies,” said Dr. Colin Broom, chief executive officer of Pulmotect. “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants. It also has potential utility for other patient populations which we plan to explore, including immunosuppressed cancer patients.” On September 21, Pulmotect announced positive topline data from the first of two Phase II trials of PUL-042 against COVID-19. The U.S. Department of Defense (DOD) supported the trial. The study demonstrated that patients receiving inhaled PUL-042 had a statistically significant decrease in the time to improvement of combined respiratory symptoms of cough and shortness of breath. Patients tolerated the drug well when given as a single dose on day 1, day 3, and day 6 of the trial with patient follow-up for 28 days. In total, three patients were hospitalized when their COVID-19 progressed, two in the placebo arm who both required intensive care for five days and nine days, and one patient in the PUL-042 cohort was hospitalized for four days after receiving a single dose of the drug. The patient, however, did not require intensive care. The drug is a first-in-class, synergistic combination of two toll-like receptor agonists that activate the lung’s surface innate immune system. In addition to COVID-19, in animal models, it has shown protection against the coronaviruses that cause MERS and SARS. “I am excited about the topline results with PUL-042 and the shortening of time to symptoms improvement for patients with early COVID-19, which could have significant health and economic benefits as the global pandemic continues to unfold,” Broom said. “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants and has potential utility for other patient populations which we plan to explore including immunosuppressed cancer patients.” The drug was discovered by Magnus Höök, Ph.D., Regents and Distinguished Professor at the Texas A&M Health Institute of Biosciences and Technology, and Burton Dickey, M.D., chair of the pulmonary department at MD Anderson Cancer Center and instructional professor in the Texas A&M Engineering Medicine program. “The lungs are the point of entry for many viruses and bacteria,” Höök said. “By activating the innate immune defense of the lungs, PUL-042 can provide effective protection against a wide range of deadly pathogens. We believe that if we had this therapy available in December of 2019, we could have prevented the COVID-19 pandemic and avoided the 6 million lives lost.” The protection the drug offers only seems to last three to five days but can be re-administered once every few days.

First in Class

2021-09-29

·BioSpace

Pulmotect's Positive Topline Results for Inhaled PUL-042 against COVID-19 Delivered by PARI Nebulizer

MIDLOTHIAN, Va., Sept. 29, 2021 /PRNewswire/ -- Pulmotect reported positive topline results from their randomized, placebo-controlled Phase-2 trial of PUL-042 against COVID-19. Patients treated with inhaled PUL-042 had a statistically significant reduction in the time to improvement of the combined respiratory symptoms of cough and shortness of breath. Pulmotect's PUL-042, an inhaled immunomodulatory agent to prevent and treat coronavirus infections was delivered by PARI's LC Sprint Reusable Nebulizer. PARI Nebulizers and systems are the most widely used nebulizers by pharmaceutical companies developing new nebulized medications for delivery to the lungs. "We have demonstrated PUL-042's unique ability to stimulate the immune system in the lungs to protect against a wide range of pathogens in multiple animal models," said Colin Broom, MD, Chief Executive Officer of Pulmotect. "We are delighted to follow up with evidence of clinical activity from our double blind, randomized, placebo-controlled Phase 2 clinical trial in patients with early COVID-19. PUL-042 was administered by nebulization on Day 1, Day 3, and Day 6 of the trial with patient follow up to Day 29. "PARI's LC Sprint Nebulizer equipped with a PARI Filter Valve Set to reduce potential fugitive aerosol emission and the Vios PRO compressor (now PRONEB Max) exclusively delivered PUL-042 to subjects in the Phase 2 study. We want to congratulate the Pulmotect team on the positive topline results of the PUL-042 program which could provide a significant benefit to those with COVID-19.", said Lisa Cambridge, MSHS, RRT, Director of Medical Science at PRE Holding, Inc. "It is another great example of PARI's nebulizers being used successfully in new clinical trials for respiratory indications, including COVID-19". About PARI Respiratory Equipment, Inc. PARI is a leading worldwide developer and manufacturer of fast and efficient aerosol delivery systems for patients with asthma, COPD, cystic fibrosis, and NTM. PARI's mission is to improve the lives of those affected by respiratory diseases and those who provide care for them. This is reflected in our comprehensive portfolio of innovative products and services. PARI's North American headquarters is in Midlothian, VA with worldwide headquarters in Starnberg, Germany. Online at About Pulmotect, Inc. Pulmotect is developing PUL-042, a clinical stage, first-in-class, inhaled, immunomodulatory agent. A synergistic agonist that amplifies the innate immune defenses of the lung epithelial mucosa to provide broad-spectrum, pathogen-agnostic protection against respiratory infections. Invented at UT MD Anderson Cancer Center/Texas A&M University, PUL-042 has patents issued in 27 countries, both as a stand-alone composition of matter product and in combination with antivirals. PUL-042 R&D has been supported by the National Institutes of Health (NIAID, NIGMS), the Cancer Prevention and Research Institute of Texas (CPRIT), other funding agencies, and the Fannin Innovation Studio. For more information, visit .

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100 项与 ODN/Pam2 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
造血干细胞移植	临床2期	美国	Pulmotect, Inc.	2025-06-01
白血病	临床2期	美国	Pulmotect, Inc.	2025-06-01
下呼吸道感染	临床2期	美国	Pulmotect, Inc.	2025-06-01
新型冠状病毒感染	临床2期	美国	Pulmotect, Inc.	2020-06-09
慢性阻塞性肺疾病	临床2期	英国	Pulmotect, Inc.	2019-01-21
鼻病毒感染	临床2期	英国	Pulmotect, Inc.	2019-01-21
呼吸系统疾病	临床2期	-	Pulmotect, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ATS2025	N/A	呼吸道感染	-	Pam2ODN	餘齋窪繭夢壓鏇衊網選(繭網觸範鑰簾膚繭淵淵) = 艱齋簾構窪夢夢醖醖鏇壓齋窪衊鹹構遞齋選築 (膚鏇繭醖鏇遞膚壓選淵 ) 更多	-	2025-05-16
NCT04313023 (CTgov)	临床2期	新型冠状病毒感染	217	PUL-042 Inhalation Solution (PUL-042 Inhalation Solution)	襯積淵夢鬱醖鏇鹽製襯(糧糧襯製製觸鹽窪窪選) = 積鏇選齋遞壓積壓製醖廠鏇顧齋艱築淵構糧淵 (醖鹹積壓憲獵願鏇構壓, 衊蓋憲鏇製築築鹽醖艱 ~ 餘艱選範艱遞鏇遞範獵) 更多	-	2023-05-17
				Placebo (Sterile Saline for Inhalation)	襯積淵夢鬱醖鏇鹽製襯(糧糧襯製製觸鹽窪窪選) = 鹽衊衊壓膚醖範顧網鹹廠鏇顧齋艱築淵構糧淵 (醖鹹積壓憲獵願鏇構壓, 鬱襯網憲範廠淵繭鬱製 ~ 鏇餘積壓襯窪鏇獵構築) 更多
NCT04312997 (CTgov)	临床2期	新型冠状病毒感染	101	PUL-042 Inhalation Solution (PUL-042 Inhalation Solution)	餘壓廠積顧觸範艱獵鬱 = 醖繭範繭夢餘壓築構獵範簾憲製繭觸網積蓋艱 (願築艱觸蓋願獵構醖簾, 憲餘齋繭鹹窪夢簾鏇憲 ~ 鬱繭構築鑰製窪選範獵) 更多	-	2023-04-18
				Placebo (Sterile Saline for Inhalation)	餘壓廠積顧觸範艱獵鬱 = 餘遞鹽製鏇繭鏇選繭餘範簾憲製繭觸網積蓋艱 (願築艱觸蓋願獵構醖簾, 鑰觸餘醖築膚鏇糧鬱網 ~ 積選鹽鹽網鹽醖鏇廠壓) 更多
NCT04313023 (BusinessWire) 人工标引	临床2期	新型冠状病毒感染	217	PUL-042	構願齋製構鏇餘鏇構顧(範簾獵廠積選衊獵鑰衊) = no statistically significant difference 衊淵憲顧願繭醖壓鏇壓 (憲鏇願積範鹹衊襯壓餘 )	不佳	2021-12-01
				Placebo
NCT04312997 (BusinessWire) 人工标引	临床2期	新型冠状病毒感染	101	PUL-042	簾簾衊範衊獵壓襯遞齋(範觸構簾鹹鏇鬱齋繭餘) = PUL-042 was well tolerated with a low incidence of adverse effects with no drug related serious adverse events reported in the trial and no deaths in this patient population. 壓鬱選衊淵網醖糧範鬱 (遞餘鏇壓選簾構醖艱齋 ) 更多	积极	2021-09-24
				Placebo