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The Hunt for Virus Treatments Continues Post Covid-19

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Investorideas.com has released a two-part series on virus treatment developments, featuring Aethlon Medical's (NASDAQ: AEMD) Hemopurifier®. The Hemopurifier® is a breakthrough device for cancer and viral disease treatment, recognized by the FDA. Recent updates include phase 1 clinical trials for cancer patients who are unresponsive to anti-PD-1 therapy. The device has shown potential in treating various viruses in vitro, including HIV, Ebola, and H5N1 bird flu. Zacks reported rising vaccine stocks due to growing bird flu threats. Other companies like ImmunityBio and Aligos Therapeutics are also advancing in viral treatments. This news follows WHO's alert on a new H5N2 bird flu strain causing a human death in Mexico.

Positive
  • Aethlon Hemopurifier® designated as a 'Breakthrough Device' by the FDA.
  • Phase 1 clinical trials planned for cancer patients using Hemopurifier®.
  • In vitro success of Hemopurifier® against multiple viruses, including HIV, Ebola, and H5N1.
  • Zacks reports rising vaccine stocks due to bird flu threats.
  • ImmunityBio's promising preclinical data for HIV treatment with N-803 and bNAbs.
  • Aligos Therapeutics reports positive antiviral and safety data at EASL Congress.
Negative
  • Uncertainty remains on the effectiveness of Hemopurifier® in large-scale human studies.
  • Potential competition from other companies like ImmunityBio and Aligos Therapeutics.
  • Risks associated with the adaptation of bird flu to spread among humans.
  • Continuous need for innovation due to evolving virus threats, leading to high R&D costs.

Insights

The ongoing research and development in viral disease treatments is crucial, especially in a post-COVID-19 world where the memory of the pandemic is still fresh. Aethlon Medical's Hemopurifier® represents a significant advance in therapeutic technology. The device is designed to remove cancer-promoting exosomes and circulating viruses rapidly. Designation as a 'Breakthrough Device' by the FDA underlines its potential, particularly for patients unresponsive to standard therapies. This designation often expedites the review process, which can benefit both patients and investors by possibly bringing the product to market sooner.

Additionally, the Hemopurifier®'s applications in viral diseases are noteworthy. It has been investigated for its efficacy against a wide array of viruses including HIV, hepatitis-C and Ebola. This broad-spectrum potential makes it a promising candidate in addressing future viral outbreaks, adding a layer of assurance for long-term investment in Aethlon.

While promising, investors should be aware that moving from clinical trials to commercial success can be lengthy and fraught with regulatory hurdles. The fact that these technologies are still in early feasibility stages means that considerable risk remains.

The market for treatments beyond vaccines is expanding, especially with the public's heightened awareness of viral threats. The mention of companies like Aethlon Medical and Aligos Therapeutics in the context of viral treatments provides a glimpse into the competitive landscape. Aethlon's approach with the Hemopurifier® indicates a strategic move towards broad-spectrum antiviral solutions that could become essential in public health responses to emerging viruses.

On the financial side, the breakthrough device designation may provide a competitive advantage, potentially increasing Aethlon's market share if the product proves successful. However, the competition from companies focusing on vaccines, as evidenced by the increased attention towards Moderna and Pfizer, illustrates the crowded and fast-evolving nature of this sector. The ability to capture significant market share will depend on clinical success and the speed at which these therapies can be brought to market.

Investors should monitor regulatory updates, partnership announcements and clinical trial results closely. The company's progress in these areas will be key indicators of future performance and market positioning.

From a financial perspective, the advancements and designations for Aethlon Medical indicate potential for substantial future revenue streams. The FDA's Breakthrough Device designation often translates into accelerated clinical development and review processes, which could shorten the time to market and thus, quicker returns on investment. This is particularly attractive for investors looking for high-growth opportunities in the biotech sector.

However, the financial landscape is not without risks. Clinical trials, especially those in early phases, are costly and bear a high degree of uncertainty. While the Hemopurifier®'s broad-spectrum efficacy against multiple viruses is promising, the company must secure substantial capital to sustain ongoing and future trials. The incremental costs tied to these developments must be balanced against expected future revenues.

Investors should also consider the broader market movements and trends influenced by the state of virus outbreaks and the global health landscape. The potential for future pandemics or significant viral outbreaks could drive demand for such treatments, impacting Aethlon’s financial performance positively. Still, these are speculative factors and should be weighed with caution.

Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - June 7, 2024) - Investorideas.com, a go-to investing platform, releases the second of a two-part series looking at news and developments for the treatment of viruses, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.

Read the full article on Investorideas.com
https://www.investorideas.com/News/2024/biotech/06070Virus-Treatments-Post-Covid-19.asp

The threat of viruses is back in the news with multiple news sources, including the Guardian reporting, "The World Health Organization (WHO) has said a man's death in Mexico was caused by a strain of bird flu called H5N2 that has never before been found in a human."

The WHO said Wednesday it wasn't clear how the person became infected. "Although the source of exposure to the virus in this case is currently unknown, A (H5N2) viruses have been reported in poultry in Mexico," it said in a statement.

Continued: "Scientists are on alert for changes in the virus that could signal that bird flu is adapting to spread more easily among humans.

Continued: "But the UN agency said Wednesday said the current risk of the bird flu virus to the general population in Mexico is low."

With global populations and economies still feeling the impact of Covid-19, any virus threat is going to make headlines.

As viruses make headlines, companies are seeking solutions and not all are focused on vaccine development.

Aethlon Medical, Inc. (NASDAQ: AEMD) just recently announced an update on its technology for cancer treatment on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.

The Aethlon Hemopurifier® technology is designed for the rapid depletion of cancer-promoting exosomes and circulating viruses. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® as a "Breakthrough Device" 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 exosomes have been shown to participate in the development or severity of the disease; and life-threatening viruses that are not addressed with approved therapies.

As reported previously, separate from its current focus on cancer treatment, Aethlon has investigated the potential for the use of the Hemopurifier® in viral diseases.

According to their SEC filing, "We also believe the Hemopurifier can be part of the broad-spectrum treatment of life-threatening highly glycosylated, or carbohydrate coated, viruses that are not addressed with an already approved treatment. In small-scale or early feasibility human studies, the Hemopurifier has been used in the past to treat individuals infected with human immunodeficiency virus, or HIV, hepatitis-C and Ebola."

"Additionally, in vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918. In several cases, these studies were conducted in collaboration with leading government or non-government research institutes."

Recently, Zacks reported that "Vaccine Stocks Rise on Growing Threat of Bird Flu Infections."

"Shares of several vaccine makers soared after reports suggest that the Biden administration is in discussions with Moderna and Pfizer to set up a possible vaccine program aimed at preventing the spread of the H5N1 virus, also known as bird flu, in humans."

Continued: "These reports came to light after the discovery of two cases of H5N1 virus in dairy farm workers in Texas and Michigan this year. Both these workers experienced symptoms in the eye after coming into contact with dairy cows infected with the H5N1 virus."

But the treatment of viral diseases has other options including immunotherapy.

ImmunityBio, a clinical-stage immunotherapy company, announced earlier this year the publication of preclinical data in the online issue of Science, First Release indicating that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without the need for antiretroviral treatment.

From the news: In the preclinical non-human primate study, researchers led by Dr. James Whitney, Ph.D. and funded by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases (NIAID) demonstrated that using N-803, in combination with broadly neutralizing antibodies (bNAbs), led to sustained viral control after discontinuation of antiretroviral therapy (ART) in ART-suppressed rhesus macaques infected with simian-human immunodeficiency virus AD8 (SHIV-AD8). Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir. Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs.

"The viral reservoir in people with HIV is established within the first few days of infection and cannot be eliminated by the body's immune system or currently available treatments, representing a significant obstacle in curing an established HIV infection," said James B. Whitney, M.D., Study Author and Researcher at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Harvard Medical School. "When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy."

Taking another approach to viral diseases, Aligos Therapeutics, Inc., is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos' strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses.

The Company just announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.

From the news: Reported for the first time were antiviral and safety data in HBeAg-negative CHB subjects who received a daily single dose of 300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%), complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA (<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels indicating inhibition of HBV replication, as well as inhibition of cccDNA establishment/replenishment. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough.

With bird flu cases on the rise, retail investors are once again on the hunt for stocks with potential solutions.

As Bloomberg reported recently "Mounting cases of bird flu in humans is luring the day trading crowd to snap up stock in vaccine developers. It's a familiar setup for industry veterans who have witnessed past trading frenzies at the first signs of an outbreak."

This won't be the last viral outbreak. There are more viruses than stars in the universe. And there are multiple solutions to treating viruses in addition to vaccines.

Read part one of the series at Investorideas.com
https://www.investorideas.com/news/2024/biotech/06031Blood-Purification-Medical-Devices.asp

Research biotech and medical device/ tech stocks at Investorideas.com
https://www.investorideas.com/BIS/Stock_List.asp

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FAQ

What recent updates did Aethlon Medical announce regarding their Hemopurifier®?

Aethlon Medical announced phase 1 clinical trials for their Hemopurifier® in cancer patients unresponsive to anti-PD-1 therapy.

How does Aethlon Medical's Hemopurifier® work in treating viruses?

The Hemopurifier® rapidly depletes cancer-promoting exosomes and circulating viruses, showing potential against viruses like HIV, Ebola, and H5N1 in vitro.

Why are vaccine stocks rising according to Zacks?

Vaccine stocks are rising due to the growing threat of bird flu infections, with discussions about a vaccine program involving Moderna and Pfizer.

What other companies are making advancements in viral treatments?

ImmunityBio and Aligos Therapeutics are also developing treatments for viral diseases, with ImmunityBio focusing on HIV and Aligos Therapeutics on hepatitis B and coronaviruses.

What did WHO report about a recent bird flu case?

The WHO reported a man's death in Mexico caused by a new H5N2 bird flu strain, though the current risk to the general population is low.

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