A Randomized, Open-Label Clinical Study on the Efficacy of Baloxavir Marboxil and Oseltamivir for Post-Exposure Prevention of Influenza in a Hospital Setting

This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.

Start Date05 Jan 2025

Sponsor / Collaborator

Capital University of Medical Sciences

[+2]

NCT06653569

/ RecruitingPhase 3IIT

A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza

The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
The main questions are:
1. When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover?
2. Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu?
3. Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu?
4. Can baloxavir reduce duration of contagiousness?
To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo.
Participants will:
* Take one single dose of baloxavir marboxil or placebo soon after hospitalization.
* Vital signs will be followed three times per day during hospital stay.
* Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation.
* Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Les Hôpitaux Universitaires de Genève

[+5]

CTR20243000

/ RecruitingPhase 3

一项在有流感症状的1至<12岁中国儿童患者中评估玛巴洛沙韦的安全性、药代动力学和有效性的III期、随机、开放性、活性对照研究

[Translation] A Phase III, randomized, open-label, active-controlled study to evaluate the safety, pharmacokinetics, and efficacy of mabaloxavir in Chinese pediatric patients aged 1 to <12 years with influenza symptoms

本研究将在有流感症状的1至<12岁中国儿童受试者中评价玛巴洛沙韦的安全性、药代动力学和有效性

[Translation]

This study will evaluate the safety, pharmacokinetics, and efficacy of mabaloxavir in Chinese pediatric subjects aged 1 to <12 years with influenza symptoms

Start Date27 Oct 2024

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+3]

100 Clinical Results associated with Baloxavir Marboxil

100 Translational Medicine associated with Baloxavir Marboxil

100 Patents (Medical) associated with Baloxavir Marboxil

240

Literatures (Medical) associated with Baloxavir Marboxil

01 Mar 2025·Journal of Infection and Chemotherapy

Incidence of severe illness in pediatric influenza outpatients treated with baloxavir or neuraminidase inhibitors

Article

Author: Miyazawa, Shogo ; Ogura, Eriko ; Takahashi, Yusaku ; Kojima, Satoshi ; Kitanishi, Yoshitake ; Miyairi, Isao

INTRODUCTIONA single oral dose of baloxavir marboxil, a cap-dependent endonuclease inhibitor, is approved for patients with influenza A or B infection; however, real-world evidence is limited. We evaluated the effectiveness of baloxavir vs neuraminidase inhibitors in reducing the incidence of severe illness in influenza outpatients aged 5-11 years.METHODSIn this retrospective cohort study, we analyzed individual-level data from patients treated with these antivirals, using a large, Japanese health insurance claims database (JMDC). Patients were included at the first date of diagnosis of the influenza virus infection (Day 1) in two influenza seasons. The primary outcome was the incidence of hospitalization from Day 2-14.RESULTSOf 196,749 included patients (Season 2018/2019, n = 103,709; Season 2019/2020, n = 93,040), 20.9 % received baloxavir, 38.8 % received oseltamivir, 28.7 % received laninamivir, and 11.6 % received zanamivir. In each treatment group, 61-70 % patients had influenza A. The incidence of hospitalization from Day 2-14 was significantly lower for baloxavir than for oseltamivir, laninamivir, and zanamivir. The adjusted risk ratio (95 % CI) for oseltamivir, laninamivir, and zanamivir were 1.86 (1.30-2.68), 2.11 (1.37-3.25), and 1.90 (1.31-2.77), respectively, compared with baloxavir. Comparative incidence of hospitalizations between agents were unaffected by season or virus type.CONCLUSIONUsing a large, Japanese health insurance claims database, a lower rate of hospitalization was demonstrated in children aged 5-11 years with an influenza virus infection when treated with baloxavir vs neuraminidase inhibitors. Thus, single dose, oral baloxavir may reduce the incidence of severe illness in these patients.

01 Feb 2025·Journal of Ethnopharmacology

Synergistic effects of Lianhuaqingwen in combination with Oseltamivir and Baloxavir against seasonal influenza virus: In vitro and in vivo assessment

Article

Author: Du, Han ; Li, Xuanxuan ; Qi, Hui ; Zhang, Cheng ; Duan, Xuefeng ; Li, Jianxiong ; Rong, Wenwan ; Yuan, Manhua ; Bi, Yuhai ; Dai, Bo ; Zhang, Ning ; Ji, Tiannan ; Ma, Zhenghai ; Yang, Jing

ETHNOPHARMACOLOGICAL RELEVANCELianhuaqingwen (LH), a traditional Chinese medicine, presents a broad-spectrum antiviral effect and has been widely used to treat influenza. Given the potential rise of drug-resistant influenza viruses, it is necessary to develop new antiviral drugs and explore combination therapies involving LH in tandem with existing antivirals such as Oseltamivir acid (Osel) or Baloxavir (Bal). These multidrug combinations could help effectively control the seasonal influenza epidemics and reduce the disease burden.AIM OF THE STUDYThis study aimed to evaluate the antiviral effects of LH, alone and in combination with Osel or Bal, against human seasonal influenza viruses in vitro and in vivo models.MATERIALS AND METHODSThe antiviral efficacy of LH alone and LH in combination with Osel/Bal against seasonal influenza A viruses (IAVs) (H1N1 and H3N2 subtypes) and influenza B viruses (IBVs) (BV- and BY-lineages) was assessed in vitro using MDCK cells. The median effective concentration (EC₅₀) was determined, and the drug synergies were analyzed. Additionally, the antiviral activity of LH monotherapy and LH + Osel/Bal combination therapy were evaluated in vivo using an H1N1-infected BABL/c mouse model by monitoring changes in body weight, survival rate, lung viral titer, pathological damage, and inflammatory reaction.RESULTSIn vitro, LH alone and in combination with Osel/Bal exhibited antiviral activity against both IAVs and IBVs. The addition of LH to Osel/Bal improved the therapeutic efficacy compared to Osel/Bal alone. In vivo, LH monotherapy reduced body weight loss and increased the survival rates of H1N1-infected mice. LH in combination with Osel/Bal resulted in lower virus titers, more effective relief of pathological damage, and comparable low expression of inflammatory factors in the lungs of H1N1-infected mice compared to the use of Osel/Bal alone. Transcriptomic analysis of the lungs revealed that LH + Osel/Bal significantly increased the expression of genes associated with antiviral and anti-inflammatory effects.CONCLUSIONSThis study evaluated the antiviral effects of LH monotherapy and combination therapy with Osel/Bal against human seasonal influenza viruses in vitro and in vivo models. The results suggest that combining LH with Osel or Bal could enhance the antiviral efficiency for influenza viruses compared to the monotherapy using any of these three drugs.

01 Jan 2025·FUKUSHIMA JOURNAL OF MEDICAL SCIENCE

Pharmacologic background and clinical issue of anti-influenza drugs

Article

Author: Sato, Masatoki

Since 2000, rapid antigen detection kits and anti-influenza drugs have been used for the early diagnosis and treatment of influenza in Japan, respectively.　The main drugs available in clinical practice are the neuraminidase inhibitors oseltamivir, zanamivir, laninamivir, and peramivir, as well as the cap-dependent endonuclease inhibitor baloxavir marboxil.　Antiviral therapy with neuraminidase inhibitors has been practiced for many years, especially in Japan; it can shorten the febrile period and reduce complications.　Despite having similar structures, the pharmacologic background of neuraminidase inhibitors differs significantly, as reflected in their varying clinical efficacy.　Due to its inhibitory mechanism, baloxavir marboxil can rapidly reduce the viral load than neuraminidase inhibitors.　However, the duration of symptoms was similar after the administration of baloxavir marboxil and oseltamivir, and variants with reduced drug susceptibility have been detected in 20%-30% of pediatric patients treated with baloxavir marboxil.　Clinical trials of several novel anti-influenza drugs are currently underway.　When these drugs are first marketed, the characteristics of the influenza virus and the pharmacologic background of the drugs must be clarified before their administration to patients in clinical practice.

News (Medical) associated with Baloxavir Marboxil

03 Jan 2025

·www.globenewswire.com

Cocrystal Pharma to Extend Phase 2a Influenza Challenge Study with Oral PB2 inhibitor CC-42344

Data support favorable safety and tolerability profile with no serious adverse events (SAEs) or study-related drug discontinuations Enrollment to be extended due to low influenza infection among challenged participants; virology results are uninterpretable Dec. 31, 2024 -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces plans to extend enrollment in the Phase 2a human challenge study with its investigational, broad-spectrum, oral influenza PB2 inhibitor CDI-42344 due to unexpectedly low influenza infection among study participants who were challenged with a H3N2 viral strain. This randomized, double-blind, placebo-controlled Phase 2a study is evaluating the safety, tolerability, pharmacokinetics (PK), antiviral activity and clinical measurements of CC-42344 at a single site in the United Kingdom. CC-42344 is a drug candidate in development as an oral treatment for pandemic avian and seasonal influenza A infections. In December 2023, Cocrystal Pharma announced enrollment of the first patient in this study and in May 2024, the Company announced full enrollment of 78 subjects. “While CC-42344 showed a favorable safety and tolerability profile, we’re disappointed by the low infectivity rate of the challenge influenza strain used in this study. The establishment of robust influenza infection in healthy, uninfected study subjects is critical to determine clinical endpoints for evaluating antiviral molecules. The low infectivity obtained in this study hindered antiviral data analysis,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We remain optimistic about CC-42344 due to its unique mechanism of action with a high barrier to developing resistance, which could render it a best-in-class antiviral treatment for pandemic and seasonal influenza infections. We are also encouraged by CC-42344’s favorable safety and tolerability profile from the Phase 2a study to date, with no SAEs and no drug-related discontinuations by study participants. “We are working with the clinical research organization to prepare a protocol amendment for approval by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) in order to extend enrollment in this study, and to ensure necessary infection rates among enrolled study subjects,” he added. CC-42344 is a new class of antiviral treatment designed to effectively block an essential step in the viral replication and transcription of pandemic and seasonal influenza A and was discovered using the Company’s proprietary structure-based drug discovery platform technology. CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In late 2022, Cocrystal reported favorable safety and tolerability results from a Phase 1 study in healthy subjects conducted in Australia. The Company initiated the Phase 2a human challenge study in December 2024 following authorization from the MHRA. In June 2024, the Company reported in vitro studies demonstrating that CC-42344 inhibited the activity of the PB2 protein in the new highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in humans. Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually. Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

23 Dec 2024

·www.accesswire.com

NanoViricides is in a Great Position to Fight Potential Bird Flu Pandemic with a Drug that the Mercurial H5N1 Influenza A Virus is Unlikely to Escape

SHELTON, CT / ACCESSWIRE / December 23, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), says that its broad-spectrum antiviral drug candidate NV-387 is the best weapon to fight a potential bird flu pandemic because the mercurial H5N1 Influenza A virus would not be able to escape the drug."Despite all changes, the H5N1 Influenza A virus should remain susceptible to NV-387 because NV-387 mimics the very essential host-side feature that H5N1 continues to use even as it changes," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding "This drug puts us in a great position to be able to fight a bird flu pandemic should it happen."WHO has stated "Available virus sequences from human cases [of H5 infection] have shown some genetic markers that may reduce susceptibility to neuraminidase inhibitors (antiviral medicines such as oseltamivir) [NAIs] or endonuclease inhibitors (such as baloxavir marboxil) [PBIs]" in their updated public health assessment of recent Influenza A H5 infections, dated December 20, 2024[1].NAIs and PBIs[2] are the only classes of drugs that currently exist for influenza treatment, and as the virus evolves, they are very likely to be rendered ineffective in the field, since already strains with reduced susceptibility are circulating.While the US Government has already sourced and stockpiled two different H5N1 vaccines, the Biden administration has currently no plans to authorize their use.Influenza viruses change far more rapidly than SARS-CoV-2 ever did in the COVID-19 pandemic[3]. At least one mutation in the H5 coat protein would be required for efficient infection of humans, and a few more changes that would still be required for rapid human-to-human transmission, in order for the H5N1 virus to turn into a pandemic virus; changes that have not happened yet.Nevertheless, any currently designed H5N1 vaccines are unlikely to be of much use, or possibly very limited use, from public health perspective to protect from a potential pandemic strain of H5N1 that has not appeared yet.In any case, vaccine against a rapidly changing virus is a game of chasing a rapidly moving target, as we have all learned from the experience during the COVID-19 pandemic[4].It is thus clear that a drug that the virus cannot escape is the only appropriate tool to fight a potential pandemic.We have already developed such a drug. NV-387 is a broad-spectrum antiviral that mimics the very host-side features that the virus continues to require no matter how much it changes in the field. It is highly unlikely that a susceptible virus would escape such a drug.The ultra-broad antiviral spectrum of NV-387, which encompasses a large number of diverse kinds of viruses including COVID, RSV, Influenza and even Orthopoxviruses (i.e. MPox, Smallpox), further substantiates that it is unlikely that a susceptible virus would escape this drug.What is more, NV-387 has demonstrated substantially superior activity to existing influenza drugs in a lethal lung infection animal study, as we have previously reported (reproduced below):Survival Lifespan of Lethally Infected Mice - Lung Infection with Influenza A H3N2TreatmentSurvival, DaysIncrease in Survival, DaysIncrease in Survival, %NV-387, Oral15788%Oseltamivir, Oral10225%Peramivir, I.V.11338%Baloxivir, Oral11338%Vehicle800%In this animal study, we also found that NV-387 treatment led to significant lung protection in the infected animals: lung destroying immune cell infiltration was substantially reduced, and the amount of mucus in the lungs was also substantially reduced, indicating that NV-387 protected the lungs and the animal from advancing into pneumonia.We believe that any H5N1 highly pathogenic virus is likely to be even more susceptible to NV-387 than the seasonal H3N2 influenza A virus. This is because all High-Path Avian Influenza A viruses are known to possess a poly-basic site that is much longer than the corresponding sequence in seasonal influenza viruses. The virus uses this poly-basic site to bind to sulfated proteoglycans prior to entry into cells. NV-387 displays a copious amount ligands that mimic this sulfated structure, which is how this drug (NV-387) entraps the virus. Thus a longer poly-basic site would be expected to cause a stronger interaction between the H5N1 High Path viruses and NV-387 in contrast to the interaction between NV-387 and seasonal influenza viruses.NV-387 has completed a Phase I human clinical trial with no reported adverse events and no drop-outs, indicating excellent safety and tolerability. We are now preparing for a Phase II clinical trial for the treatment of MPox which is currently an epidemic in Central Africa. We are also working on a Phase II clinical trial of NV-387 for the treatment of respiratory virus infections (including Influenza viruses, Coronaviruses, and RSV, among others).Thus we believe that we are in a strong position to combat a potential bird flu pandemic, being one of very few companies globally that is developing a broad-spectrum antiviral drug with the promise that viruses would be highly unlikely to escape the drug.[1] https://www-who-int.libproxy1.nus.edu.sg/publications/m/item/updated-joint-fao-who-woah-assessment-of-recent-influenza-a(h5n1)-virus-events-in-animals-and-people_dec2024[2] NAIs = Neuraminidase inhibitors. These include Oseltamivir (Tamiflu®), Peramivir (Rapivab®), Zanamivir (Relenza®). They inhibit the exit of the virus particle from cell after the virus has already replicated into copious quantities inside the cell. PBIs = Viral Polymerase (B) inhibitors. Currently only Baloxavir (Xofluza) is licensed. They inhibit the production of new copies of viral genomic RNA. However, resistant virus to baloxavir was created in patients treated with baloxavir in its clinical trial itself. Further, the toxicity of this drug limits its use to a single dose.[3] Influenza viruses change very rapidly because they have many more tools to change themselves compared to other viruses. Firstly, an influenza virus is made up of eight separate segments of RNA, that it can simply swap with other influenza viruses (called "Re-assortment"). Secondly, segments of RNA can hop from one RNA to another (Called "Recombination"), and thirdly, single point mutations occur all the time across the entire RNA, because the virus lacks "proof-reading" capability (i.e. ability to ensure that the RNA is copied correctly).[4] The COVID vaccines did not protect the vaccinated from getting sick, and they did not even stop the vaccinated from transmitting the virus to others. The benefit of vaccination is thought to be in persons with other morbidities who would have been likely to contract severe disease from infection with hospitalization and possible death. However, the vaccines always lagged behind in time, developed against a strain that was already overtaken by a different one in the field even before rollout of the vaccine.About NanoViricidesNanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.Contact:NanoViricides, Inc.[email protected]Public Relations Contact:[email protected]SOURCE: NanoViricides, Inc.

VaccineLicense out/inPhase 2Phase 1

20 Dec 2024

·www.prnewswire.com

Aethlon Medical Provides Update on the Ability of Its Hemopurifier® to Capture H5N1 Bird Flu

SAN DIEGO, Dec. 20, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today provided a statement of its investigational medical device with respect to H5N1 avian influenza "Bird Flu." Aethlon has recently received a number of inquiries regarding the potential utility of its Hemopurifier device in the treatment of Bird Flu. These inquiries come on the heels of the reporting of isolation of Bird Flu in dairy cows, 60 human cases in eight states including a case of severe infection in Louisiana, and yesterday's declaration of a state of emergency in California. The Aethlon Hemopurifier is an investigational extracorporeal medical device designed to remove enveloped viruses and extracellular vesicles from the bloodstream. The device incorporates plasma separation, size exclusion, and affinity binding to a proprietary resin containing the plant lectin Galanthus nivalis agglutinin (GNA) bound to a medical grade diatomaceous earth. Enveloped viruses and extracellular vesicles contain the sugar mannose on their surface, which is the therapeutic target of the GNA. Aethlon has previously contracted Battelle labs to examine the in vitro removal of influenza viruses including H5N1 by a scaled down version of the Aethlon Hemopurifier. In this experiment, cell culture media was spiked with the H5N1 virus and continuously circulated over the device. Samples were taken periodically to examine viral removal by the device. In this study, a miniature version of the device removed 99% of H5N1 following 6 hours of treatment. While the Aethlon Hemopurifier has not yet been used to treat patients with severe influenza, including those infected with H5N1, it has been used in 38 patients across 164 distinct treatment sessions, targeting diseases such as hepatitis C, HIV, and in patients critically ill due to COVID-19 and Ebola. The Hemopurifier has a "breakthrough device" designation with the FDA for life-threatening viruses for which there is no effective treatment. Current treatment guidelines from the Center for Disease Control and Prevention (), for hospitalized patients with suspected Bird Flu (H5N1), are to initiate antiviral therapy as soon as possible with Oseltamivir, with or without combination therapy with Baloxavir. Clinical failures during Oseltamavir therapy due to the development of antiviral resistance have been observed in hospitalized patients with H5N1. This phenomenon raises the possibility that novel treatment strategies may be required. Aethlon Medical will monitor this situation closely and interact with hospitals, the state of California, and the FDA as appropriate if cases mount and currently available treatments are not effective. About Aethlon and the Hemopurifier® Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful extracellular vesicles from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where extracellular vesicles may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which extracellular vesicles have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies. Additional information can be found at . Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such include, without limitation, the ability of the Hemopurifier to capture H5N1 Bird Flu; the possibility of novel treatment strategies; the efficacy of the Hemopurifier and virus removal after various treatment times; the use and efficacy of the Hemopurifier being utilized in treatment session for patients with hepatitis C, HIV, as well in patients with critical illness due to COVID-19 and Ebola; the occurrence and possible continuation of the state of emergency declaration in California and reported infections in other states; and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2023, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances. Company Contact: Jim Frakes Chief Executive Officer and Chief Financial Officer Aethlon Medical, Inc. [email protected] Investor Contact: Susan Noonan S.A. Noonan Communications, LLC [email protected] SOURCE Aethlon Medical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical StudyBreakthrough TherapyImmunotherapy

100 Deals associated with Baloxavir Marboxil

External Link

KEGG	Wiki	ATC	Drug Bank
D11021	Baloxavir Marboxil	J05AX25	DB13997

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	US	Genentech, Inc.	24 Oct 2018
Influenza A virus infection	JP	Shionogi & Co., Ltd.	23 Feb 2018
Influenza B virus infection	JP	Shionogi & Co., Ltd.	23 Feb 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Influenza A virus infection	Phase 3	IN	Hoffmann-La Roche, Inc.	10 Oct 2019
Influenza A virus infection	Phase 3	PR	Hoffmann-La Roche, Inc.	10 Oct 2019
Influenza-like symptoms	Phase 3	PL	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	CR	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	IL	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	ES	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	US	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Phase 3	RU	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza-like symptoms	Discovery	MX	Hoffmann-La Roche, Inc.	20 Nov 2018
Influenza, Human	Discovery	-	Shionogi, Inc.	08 Dec 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03969212 (CENTERSTONE, PipelineReview) Manual	Phase 3	Influenza, Human	-	Xofluza	(chgghznwqo) = demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus. evnzwzwplb (ikoyewdits ) Met View more	Positive	19 Sep 2024
NCT03653364 (CTgov)	Phase 3	Influenza-like symptoms \| Influenza, Human	49	Baloxavir Marboxil	(nllbxzxlwc) = jephjsifsb icckfnvtti (elgwguhngr, mzpximpioa - rgbhvcaysn) View more	-	17 May 2024
NCT03959332 (Pubmed \| Clin Transl Sci)	Phase 1	Influenza, Human	32	Baloxavir marboxil 40 mg	(ptkmxdairx) = ihbsebrveb onqmwpobhj (ovlkplewkw ) View more	Positive	17 Feb 2022
				Baloxavir marboxil 80 mg	(ptkmxdairx) = uupixstkoz onqmwpobhj (ovlkplewkw ) View more
NCT03684044 (Pubmed \| Lancet Infect Dis) Manual	Phase 3	Influenza, Human	366	Neuraminidase inhibitors+Baloxavir Marboxil	(doxcpuqfba) = fshuzqcgyx vlkzbvzxht (gbxmjfstmb, 75.9 - 117.2) View more	Negative	24 Jan 2022
				Neuraminidase inhibitors +Placebo	(doxcpuqfba) = htaiydaedt vlkzbvzxht (gbxmjfstmb, 75.9 - 144.4) View more
NCT03684044 (CTgov)	Phase 3	Influenza, Human	363	Baloxavir Marboxil (Baloxavir Marboxil)	(lvxllfusnl) = wtgepeiqxb xxnycpvxoz (ljktuufgpi, acaeykulsg - apaoeyilla) View more	-	30 Nov 2020
				Placebo (Placebo)	(lvxllfusnl) = gpnthygrfi xxnycpvxoz (ljktuufgpi, ykfsdkfgdg - elalointak) View more
NCT03969212 (Pubmed \| Clin Infect Dis)	Phase 3	Influenza, Human	-	Baloxavir marboxil	uqrubnaxdj(kdzddcmstn) = xxnvvctiyy vcdgpjosag (nrjoiekusa )	-	26 Oct 2020
				Neuraminidase inhibitors	uqrubnaxdj(kdzddcmstn) = ebbhxfdate vcdgpjosag (nrjoiekusa )
NCT03629184 (miniSTONE-2, Pubmed 1 \| Pubmed 2 \| Pediatr Infect Dis J) Manual	Phase 3	Influenza, Human	173	baloxavir	(faxmrxhwyn) = xqxasbfhbj lrbfgbdtjj (pumisfgixp ) View more	Positive	01 Aug 2020
				Oseltamivir	(faxmrxhwyn) = afagpptkcq lrbfgbdtjj (pumisfgixp ) View more
NCT03959332 (CTgov)	Not Applicable	-	32	Baloxavir Marboxil (Baloxavir Marboxil 40 mg)	mozubxzcik(slgfksjbnq) = umedtsvieu tkqytgysil (akpudhqoop, majqlllxso - tfzlojntxs) View more	-	22 Jun 2020
				Baloxavir Marboxil (Baloxavir Marboxil 80 mg)	vllhzinbkw(spunmqwxio) = hwahzwaiui csmakubctj (cpkxdakeqw, ohdxbtbccr - rccoijbzhe) View more
NCT03629184 (miniSTONE-2, CTgov)	Phase 3	Influenza-like symptoms \| Influenza, Human	173	Baloxavir Marboxil (Baloxavir Marboxil)	(redryozdth) = idifkwjtqm gvfaphqohz (unsodqlvlu, npzrxlpupf - fgyuynfjsi) View more	-	29 Apr 2020
				Oseltamivir (Oseltamivir)	(redryozdth) = cvztkyaecl gvfaphqohz (unsodqlvlu, cmubvxvnma - xuoacbbssg) View more
NCT02954354 (Pubmed \| J Infect Dis)	Phase 3	Influenza, Human	370	Baloxavir recipients with PA/I38X-substituted viruses	uajumadiug(doviutfmgi) = xzkcjqqfzo vykzzjzjei (gzfcqtvrxe )	-	14 Jan 2020
				Baloxavir recipients without PA/I38X-substituted viruses	uajumadiug(doviutfmgi) = julszrgqyc vykzzjzjei (gzfcqtvrxe )

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