Latest news with #Smallpox
Miami Herald
14-07-2025
- Business
- Miami Herald
Adaptive Clinical Protocol Design for Phase II MPox Clade I Treatment with a Novel Broad-Spectrum Drug NV-387 is Almost Complete, Reports NanoViricides
SHELTON, CT / ACCESS Newswire / July 14, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announces that the design of the adaptive clinical trial protocol for the treatment of MPox Virus Clade Ia and Ib infections and disease is nearly complete. The adaptive clinical trial is designed to provide information on three important aspects in a single, compact clinical trial: safe and effective dosing regimen in patients,safety and tolerability of the drug in patients, andantiviral effectiveness of the drug in patients. The overall clinical trial will enroll approximately 80 patients. "This is an important milestone towards filing of the clinical trial application and starting the clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "Our CRO and the Principal Investigator have created a marvelous design that is both frugal and efficient while providing all of the information necessary for understanding the safety and effectiveness of NV-387 for treating MPox disease." Currently there is no drug approved for the treatment of MPox disease that is actually effective for treating the disease. NV-387, if it shows effectiveness, will be the very first drug that has shown effectiveness in human clinical trial of an orthopoxvirus. If NV-387 is found to be effective in this Phase II clinical trial, the Company intends to continue further development of NV-387 for treatment of orthopoxvirus infections under a US FDA IND towards studies as needed for regulatory approval of NV-387 for the treatment of MPox as well as Smallpox indications. The Company intends to obtain regulatory approval in the African Region as well, which is likely to arrive before a US approval, and also seek approvals in the European Union and other countries and regions. MPox is an Orphan disease in the USA and treatment of MPox by NV-387 is eligible for Orphan Drug Designation by the US FDA with attendant benefits. Smallpox is a bioterrorism agent of concern in the USA as well as across the world and is an important revenue opportunity for the Company. Tecovirimat sales to the US Government alone have netted SIGA, the drug holder, over $600 million through December 31, 2024, according to SIGA's annual report to the SEC [1] . The adaptive, randomized, SOC controlled clinical trial will proceed in two parts: In Phase IIa part, an oral dose of the drug NV-387 given twice daily initially for six days will be compared with the standard of care (SOC) at the hospital for treatment of MPox disease. Patients will be sequestered in the hospital and will be evaluated daily for clinical drug safety and tolerability parameters, and clinical MPox disease evaluation parameters. Additionally, lab evaluations including clinical blood chemistry, CBC, cytokines, urinalysis, ECG, X-rays when necessary, and virological assays will be conducted every 3 days. Based on the results, the Principal Investigator will determine whether additional days of drug dosing can be well tolerated and can improve on effectiveness. If so, the patients will continue to receive same dosing for six more days with same evaluations. The patients will be followed until full resolution of the MPox disease. There will be two arms in this Phase IIa: The New Treatment Arm of 10 patients with NV-387 dosing plus SOC and the control SOC Arm of 10 patients. The dosing regimen for Phase IIb will be determined on the basis of Phase IIa results. In the Phase IIb part, the clinical trial will be in a 2:1 randomized patients base with approximately 40 subjects in the New Treatment Arm and 20 patients in the SOC Arm. Evaluations will be similar to those in Phase IIa, with more emphasis given to specific points that may have come up in Phase IIa regarding safety, tolerability, as well as efficacy. The Phase IIa will be conducted at a single site in Democratic Republic of Congo (DRC). Phase IIb may be expanded to include additional sites within DRC as well as other countries experiencing severe MPox outbreak in the African Region. The "NV-387 Oral Gummies" drug product formulation will be employed in the Phase II. This is a soft solid formulation that is designed to stick in the oral cavity and dissolve naturally over time, with no solid object (pill or capsule) swallowing necessary. This is important for MPox because MPox causes lesions on mucosal surfaces that make swallowing painful and difficult. MPox is primarily known for the explicit characteristic painful rash on the external skin, but it is a significantly more severe disease than just a skin rash. Two drugs, Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox and MPox on the basis of the US FDA "Animal Rule," i.e. based on animal infection and treatment studies only to demonstrate efficacy, and a safety/tolerability human clinical trial. Tecovirimat failed in clinical trials for the treatment of MPox with no improvement over the standard of care. Brincidofovir was abandoned in a clinical trial of MPox due to first three patients coming down with drug induced liver injury. Despite this, brincidofovir was recently resurrected under an international coalition led by US CDC and first patient was dosed around January 2025 in the "MOSA" clinical trial [2] . The topline results were expected to be announced as early as CY Q1 (March 2025) and efficacy topline data were expected no later than CY Q2 (June, 2025). No press releases post initiation of the MOSA clinical trial could be found. The MPox virus circulating in DRC and neighboring regions is of Clade 1a and Clade 1b subtypes, with the latter predominant. Clade 1b is more transmissible of the two, which is why it has resulted in a sustained epidemic. The MPox Clade 1a case fatality rate (CFR) is about 3%-11% whereas the CFR for Clade 1b is about 1%. The MPox Clade 2b is the virus causing continuing cases in the Western world, which causes a much less severe disease than Clade 1a/1b and has a very low CFR, according to CDC. Sporadic cases of Clade 1 in the Western world continue to occur. Four separate travel-related MPox Clade 1 cases reported in the USA that did not result in any further spread, since November 2024, according to the CDC [3] . Clearly, the threat of MPox Clade 1 causing a potential epidemic in the USA cannot be ignored, and readiness with a drug that works against the same is important to achieve. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( is a publicly traded (NYSE-American, stock symbol NNVC) 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. 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, Public Relations Contact:ir@
Yahoo
17-05-2025
- Health
- Yahoo
Mysterious package received at North Canaan facility tests negative for Plague, Anthrax
NORTH CANAAN, Conn. (WTNH) — The town of North Canaan has released an update about the hazmat incident that occurred Thursday at Becton-Dickinson. Over 300 people 'decontaminated' due to suspicious package incident in North Canaan Over 300 people had to be decontaminated after a mysterious package arrived at the facility. The Connecticut Department of Public Health confirmed that the mysterious package received negative test results for Anthrax, Burkholderia Species, Plague, Tularemia and Smallpox. Additionally, a negative Ricin test was confirmed. Officials continue to ensure that there is no risk to the public and no symptoms or illnesses reported by employees who had to be decontaminated. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Independent
15-04-2025
- Health
- The Independent
WHO tests the world's pandemic response with fictional ‘mammothpox' outbreak
The World Health Organisation has tested 15 countries on their response to a hypothetical new pandemic, simulating the deadly outbreak of a fictional disease. More than 350 health emergency experts took part in a two-day simulation looking at how they would deal with 'mammothpox', an invented virus similar to smallpox and mpox that was described as 'lethal and fast-moving'. In the scenario, called Exercise Polaris, the outbreak occurred when a team of scientists discovered the remains of a woolly mammoth in the frozen Arctic tundra. Representatives from the countries looked at how they would deal with the first few weeks of the outbreak, according to exercise documents seen by The Independent. 'Mammothpox disease is severe, with a mortality intermediate between Mpox and Smallpox,' according to the papers. 'With modest transmissibility and minimal asymptomatic spread it is controllable', they added, but only with 'effective coordinated responses – similar to SARS or Mpox'. Participants included Canada, Colombia, Costa Rica, Denmark, Ethiopia, Germany, Iraq, Kingdom of Saudi Arabia, Mozambique, Nepal, Pakistan, Qatar, Somalia Uganda and Ukraine, with additional countries as observers. Each country was given a 'small piece of the puzzle' to test how they would share information and co-operate in order to contain the spread of the virus, according to The Telegraph. The newspaper reported that one country was told that an Arctic researcher 'presenting with symptoms of a pox-like illness' had boarded a cruise ship carrying 2,450 passengers and 980 crew. By the second day of the exercise, participants were told plans to prevent the spread of the virus were being hampered by politics and differing strategies. While some countries implemented 'strict border controls, banned all international arrivals and restricted internal movement,' the newspaper reported, others maintained 'open borders with minimal restrictions,' relying instead on 'contact tracing, isolation, and quarantine measures'. Within weeks, ICUs were 'overwhelmed' and health systems struggled to cope across the globe. The intent of the programme was to see how countries would deal in the event of another worldwide outbreak, following the real-world experience of Covid five years ago. Exercise Polaris tested the WHO's Global health Emergency Corps, a framework designed to strengthen countries' emergency workforce, coordinate the deployment of surge teams and experts and enhance collaboration between countries. Dr Tedros Adhanom Ghebreyesus, WHO Director-General said: 'This exercise proves that when countries lead and partners connect, the world is better prepared. 'No country can face the next pandemic alone. Exercise Polaris shows that global cooperation is not only possible – it is essential.'
Yahoo
15-04-2025
- Health
- Yahoo
WHO tests pandemic response with Arctic ‘mammothpox' outbreak
The outbreak began when a team of scientists and documentary film-makers excavated the remains of a woolly mammoth in the frozen Arctic tundra. Within weeks, ICUs were 'overwhelmed' and health systems were struggling to cope. Some countries introduced contact tracing and 'enforced quarantines,' while others took a more laissez-faire approach – and saw the 'uncontrolled spread' of a dangerous new disease. This is the all-too-familiar scenario that ministers from 15 countries around the world were faced with last week when they gathered to test their readiness for the next pandemic. The desktop exercise, led from the World Health Organisation's (WHO) headquarters in Geneva, was overseen by Dr Mike Ryan, the no-nonsense director of the agency's Health Emergencies Programme. It simulated an outbreak of 'Mammothpox,' a deadly but fictional virus from the orthopox family, similar to smallpox (which killed an estimated half a billion people in the century before it was eradicated in 1980) and mpox, a dangerous variant of which is currently surging across central Africa. The exercise documents, obtained by The Telegraph, give a rare insight into how the WHO and its member states might react and coordinate in the event of a new pandemic. While the disease depicted was fictitious, the exercise was based on real science and imagines a paleontological dig for mammoths, sabretooth tigers, and other extinct creatures held in the permafrost going horribly wrong. 'Scientific research has demonstrated that ancient viruses can remain viable in permafrost for thousands of years,' says the WHO briefing document. 'The thawing of permafrost due to climate change has raised concerns about the potential release of pathogens previously unknown to modern medicine.' The virus was potentially lethal and fast-moving, participating health officials were told. 'Mammothpox disease is severe, with a mortality intermediate between Mpox and Smallpox,' say the papers. Smallpox killed about 30 per cent of those it infected before its eradication. Mpox is much less lethal but is currently exacting a terrible toll, especially on young children in Africa. 'With modest transmissibility and minimal asymptomatic spread it is controllable', they added, but only with 'effective coordinated responses – similar to SARS or Mpox'. The assembled officials were all told that a 'multinational team of scientists' and a 'film crew' were behind the outbreak. They had travelled into the Arctic to find Mammoth remains being exposed by the retreating permafrost. In a scene reminiscent of the opening of the film Jurassic Park, the team discovered a 'remarkably well-preserved' specimen and proceeded to thaw and analyse samples of its tissues on site. They then returned to their respective countries, only to fall ill shortly after, 'presenting with symptoms of a pox-like illness'. Among the participants in the two-day simulation were representatives from Denmark, Somalia, Qatar, Germany, Saudi Arabia, and Ukraine. The United States and China did not take part. Each country was given a 'small piece of the puzzle' to test how well they would share information and collaborate to contain the spread of the virus. In an echo of the Covid pandemic, one country was told that a symptomatic Arctic researcher had boarded a cruise ship carrying 2,450 passengers and 980 crew. The vessel effectively became a petri dish for scientists, who gathered data as the virus moved from cabin to cabin, allowing them to calculate the virus's reproduction or R number at between 1.6 and 2.3. Qatar was told the virus was being spread through large social gatherings and in workplaces, while in Uganda all of its 22 cases were put down to 'household transmission'. The desktop exercise was held over two days but simulated the first three weeks of the outbreak. On the second day of the exercise, participants were told that progress in holding back the virus was being hampered by politics and divergent contaminants strategies between states. Some countries implemented 'strict border controls, banned all international arrivals and restricted internal movement,' the document says. Others maintained 'open borders with minimal restrictions,' relying instead on 'contact tracing, isolation,and quarantine measures'. During the Covid-19 pandemic, countries like Singapore, South Korea, New Zealand and Taiwan turned their ports and airports into a first-line of defence and tried to stop the virus from getting in altogether. But others, including Britain, were criticised for keeping their borders largely open. Throughout the simulation, health officials from each of the participating countries joined Zoom calls to share details of how the outbreak was unfolding in their respective towns and cities and debate how to respond. 'Some of the countries were being very strict about border controls and in some cases very close neighbouring countries were being very loose, so on the calls we could have discussions around how we could harmonise those approaches,' said Dr Scott Dowell, a senior adviser at the WHO. Dr Nedret Emiroglu, a director in the WHO's Health Emergencies Programme, said the mammothpox scenario was designed to be 'realistic with the ability to spread around the world'. But the disease was also designed to be 'controllable if countries worked together,' she told The Telegraph. While Exercise Polaris was playing out, negotiations on a new 'pandemic treaty' were continuing at the WHO. After three years of arduous negotiations, including disagreements over plans for the distribution of drugs and vaccines, an agreement on the treaty could be reached as early as Tuesday, sources told The Telegraph. While the countries involved in the mammothpox exercise were, ultimately, able to band together to contain the virus, a real outbreak would prove much more complicated, the WHO acknowledged. The question of how to implement a vaccine strategy was not dealt with in the fictional dry run, for example, and the US – the WHO's biggest single funder – is about to leave the body. Meanwhile, real digs continue in the Siberian permafrost, where the receding ice has sparked a gold rush for scientists and ivory hunters alike. In 2023, Nasa researchers unfroze a 48,500-year-old 'zombie virus' found alongside frozen mammoth and wolf remains that would be lethal to humans. And last month, the New York Times revealed that Siberian ivory hunters were scavenging for mammoth remains without concern or precaution for the ancient pathogens they might stumble across. In total, there are thought to be over 10 million mammoths buried in the arctic permafrost. Protect yourself and your family by learning more about Global Health Security Broaden your horizons with award-winning British journalism. Try The Telegraph free for 1 month with unlimited access to our award-winning website, exclusive app, money-saving offers and more.
Telegraph
15-04-2025
- Health
- Telegraph
WHO tests pandemic response with Arctic ‘mammothpox' outbreak
The outbreak began when a team of scientists and documentary film-makers excavated the remains of a woolly mammoth in the frozen Arctic tundra. Within weeks, ICUs were 'overwhelmed' and health systems were struggling to cope. Some countries introduced contact tracing and 'enforced quarantines,' while others took a more laissez-faire approach – and saw the 'uncontrolled spread' of a dangerous new disease. This is the all-too-familiar scenario that ministers from 15 countries around the world were faced with last week when they gathered to test their readiness for the next pandemic. The desktop exercise, led from the World Health Organisation's (WHO) headquarters in Geneva, was overseen by Dr Mike Ryan, the no-nonsense director of the agency's Health Emergencies Programme. It simulated an outbreak of 'Mammothpox,' a deadly but fictional virus from the orthopox family, similar to smallpox (which killed an estimated half a billion people in the century before it was eradicated in 1980) and mpox, a dangerous variant of which is currently surging across central Africa. The exercise documents, obtained by The Telegraph, give a rare insight into how the WHO and its member states might react and coordinate in the event of a new pandemic. While the disease depicted was fictitious, the exercise was based on real science and imagines a paleontological dig for mammoths, sabretooth tigers, and other extinct creatures held in the permafrost going horribly wrong. 'Scientific research has demonstrated that ancient viruses can remain viable in permafrost for thousands of years,' says the WHO briefing document. 'The thawing of permafrost due to climate change has raised concerns about the potential release of pathogens previously unknown to modern medicine.' The virus was potentially lethal and fast-moving, participating health officials were told. 'Mammothpox disease is severe, with a mortality intermediate between Mpox and Smallpox,' say the papers. Smallpox killed about 30 per cent of those it infected before its eradication. Mpox is much less lethal but is currently exacting a terrible toll, especially on young children in Africa. 'With modest transmissibility and minimal asymptomatic spread it is controllable', they added, but only with 'effective coordinated responses – similar to SARS or Mpox'. The assembled officials were all told that a 'multinational team of scientists' and a 'film crew' were behind the outbreak. They had travelled into the Arctic to find Mammoth remains being exposed by the retreating permafrost. In a scene reminiscent of the opening of the film Jurassic Park, the team discovered a 'remarkably well-preserved' specimen and proceeded to thaw and analyse samples of its tissues on site. They then returned to their respective countries, only to fall ill shortly after, 'presenting with symptoms of a pox-like illness'. Among the participants in the two-day simulation were representatives from Denmark, Somalia, Qatar, Germany, Saudi Arabia, and Ukraine. The United States and China did not take part. Each country was given a 'small piece of the puzzle' to test how well they would share information and collaborate to contain the spread of the virus. In an echo of the Covid pandemic, one country was told that a symptomatic Arctic researcher had boarded a cruise ship carrying 2,450 passengers and 980 crew. The vessel effectively became a petri dish for scientists, who gathered data as the virus moved from cabin to cabin, allowing them to calculate the virus's reproduction or R number at between 1.6 and 2.3. Qatar was told the virus was being spread through large social gatherings and in workplaces, while in Uganda all of its 22 cases were put down to 'household transmission'. The desktop exercise was held over two days but simulated the first three weeks of the outbreak. On the second day of the exercise, participants were told that progress in holding back the virus was being hampered by politics and divergent contaminants strategies between states. Some countries implemented 'strict border controls, banned all international arrivals and restricted internal movement,' the document says. Others maintained 'open borders with minimal restrictions,' relying instead on 'contact tracing, isolation,and quarantine measures'. During the Covid-19 pandemic, countries like Singapore, South Korea, New Zealand and Taiwan turned their ports and airports into a first-line of defence and tried to stop the virus from getting in altogether. But others, including Britain, were criticised for keeping their borders largely open. Throughout the simulation, health officials from each of the participating countries joined Zoom calls to share details of how the outbreak was unfolding in their respective towns and cities and debate how to respond. 'Some of the countries were being very strict about border controls and in some cases very close neighbouring countries were being very loose, so on the calls we could have discussions around how we could harmonise those approaches,' said Dr Scott Dowell, a senior adviser at the WHO. Dr Nedret Emiroglu, a director in the WHO's Health Emergencies Programme, said the mammothpox scenario was designed to be 'realistic with the ability to spread around the world'. But the disease was also designed to be 'controllable if countries worked together,' she told The Telegraph. While Exercise Polaris was playing out, negotiations on a new 'pandemic treaty' were continuing at the WHO. After three years of arduous negotiations, including disagreements over plans for the distribution of drugs and vaccines, an agreement on the treaty could be reached as early as Tuesday, sources told The Telegraph. While the countries involved in the mammothpox exercise were, ultimately, able to band together to contain the virus, a real outbreak would prove much more complicated, the WHO acknowledged. The question of how to implement a vaccine strategy was not dealt with in the fictional dry run, for example, and the US – the WHO's biggest single funder – is about to leave the body. Meanwhile, real digs continue in the Siberian permafrost, where the receding ice has sparked a gold rush for scientists and ivory hunters alike. In 2023, Nasa researchers unfroze a 48,500-year-old 'zombie virus' found alongside frozen mammoth and wolf remains that would be lethal to humans. And last month, the New York Times revealed that Siberian ivory hunters were scavenging for mammoth remains without concern or precaution for the ancient pathogens they might stumble across. In total, there are thought to be over 10 million mammoths buried in the arctic permafrost.
