Tahoe2468
6 months ago
New Human Cases of Avian Flu Anticipated
Allison Shelley
June 19, 2024
25
253
With avian influenza spreading quickly around the globe, the virus has more opportunities to mutate and cause problems for people. By some calculations, H5N1 bird flu is still at least two mutations away from widespread human infections, but experts warn that new flu symptoms in individuals at high risk are likely to start turning up in health systems this summer.
"There is a broad range of symptoms to be watching for," said Vivien Dugan, PhD, director of the influenza division at the US Centers for Disease Control and Prevention (CDC). "Some of this will not be obvious or at the forefront of our minds."
Dugan is leading the team of CDC scientists that is working with partners from the US Department of Agriculture, the US Food and Drug Administration (FDA), and state and local health departments to track and respond to the H5N1 bird flu outbreak currently sweeping through the US.
Since 2022, avian influenza A viruses have been detected in more than 9300 wild birds in 50 states and territories and in commercial and backyard flocks.
"It's a bad situation," said Florian Krammer, PhD, professor of vaccinology at the Icahn School of Medicine at Mount Sinai in New York. "Globally, we've seen tons of exposure in cities around the world and even in the birds here in New York City where I am."
Birds shed the virus in their saliva, mucous, and feces, so people or other animals with close, unprotected contact with infected birds or their contaminated environments can be infected.
And for the first time in March 2024, H5N1 bird flu was reported in dairy cows. The US Department of Agriculture said that at last count 101 dairy herds in 12 states had been infected, with several cases also found in dairy workers.
From Birds to Cattle and Farm Workers
The National Veterinary Services Laboratories confirmed the infections were highly pathogenic avian influenza H5N1 clade 2.3.4.4b of Eurasian lineage. Also known as the goose, Guangdong clade from China, phylogenetic analysis and epidemiology suggests a single introduction into cows followed by onward transmission.
"I was surprised when H5 was introduced to dairy cattle in this way," Dugan said during an interview. "Influenza viruses are always surprising us and it reminds me to stay humble and keep an open mind when dealing with them."
Tahoe2468
6 months ago
The Hunt for Virus Treatments Continues Post Covid-19
Newsfile - Fri Jun 7, 7:16AM CDT Contributor Content
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.
Tahoe2468
6 months ago
NEWSSSS!
June 18, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.
Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.
"The approval from the Human Research Ethics Committee at Central Adelaide Local Health Network marks a significant milestone for Aethlon, as they deemed that our clinical study meets the requirements of the Australia's National Statement on Ethical Conduct in Human Research," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations, NAMSA and ReSQ Clinical Research. The next steps include submission to the Therapeutic Goods Administration, the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit to facilitate patient enrollment. Following this Ethics Board approval, we plan to submit to the Ethics Committees at two additional sites in Australia and one in India."
The primary endpoint of the approximate 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.
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 exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes 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 exosomes 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.
Tahoe2468
6 months ago
https://www.meddeviceonline.com/doc/aethlon-medical-receives-fda-approval-to-0001
San Diego, CA /PRNewswire/ - Aethlon Medical, Inc. (OTC Bulletin Board: AEMD ), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Aethlon's request to export its Hemopurifier® medical device to India.
The FDA's approval was granted under Section 801 (e) of the Federal Food, Drug, and Cosmetic Act, as amended (the Act). Section 801 (e) of the Act covers class III medical devices, such as the Hemopurifier®, that have not yet received an approved Premarket Approval in the US by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA's Good Manufacturing Practices.
"The granting of our export license by FDA represents a critical step in our strategy to initiate future commercialization of our Hemopurifier® in India," stated Jim Joyce, Aethlon Chairman and CEO.
Aethlon is currently conducting a clinical study entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy" at the Medicity Institute (Medicity) near Delhi, India. The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier® in India.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com .
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Tahoe2468
6 months ago
Blood Purification Medical Devices Revolutionizing the Future of Health from Cancer to COVID
June 03, 2024 9:05 AM EDT | Source: Econ Corp Services DBA Investorideas.com
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - June 3, 2024) - Investorideas.com, a go-to investing platform, releases the first of a two-part series looking at medical device advancements for blood purification, 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/06030Blood-Purification-Medical-Devices.asp
According to Straits Research, "The global blood purification equipment market size was valued at USD 17,755.6 million in 2021. It is expected to reach USD 29242.21 million by 2030."
Aethlon Medical, Inc. (NASDAQ: AEMD), with a long history of development for its patented Hemopurifier® blood purification device, just released an update 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®.
"We continue to make progress preparing for our planned, safety, feasibility and "dose finding" oncology trials in Australia and India, and want to provide our shareholders and other constituents with an update," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "In early May, we announced new data showing the in vitro removal of exosomes from cancer patient plasma using a miniature version of our Hemopurifier®. This data has been quickly integrated into the required documentation for Ethics Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the Contract Research Organizations for these planned clinical trials. Subsequently, on May 24, 2024, one potential site submitted the documents to its Ethics Board. An additional site in Australia and another in India are currently assembling the packages for submission to their Ethics Committees."
"Once we receive the expected Ethics Committee approvals, we will finalize the Clinical Trial Agreements. After this, hospitals can begin recruiting patients for the trials."
As a reminder, the target patient population for these safety, feasibility, and dose finding trials is oncology patients with solid tumors who are failing their anti-PD-1 monotherapy treatment, such as Keytruda® or Opdivo®.
The Aethlon Hemopurifier® is a first-in-class technology 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.
Zach's Research recently commented on Aethlon following positive data from an in vitro binding study it had implemented of the potential for the Hemopurifier® to remove extracellular vesicles (EVs) directly from plasma of cancer patients.
"The data from this in vitro study is a critical element enabling the company to move the Hemopurifier forward in clinical oncology studies towards potential regulatory approval and commercialization. The company next intends to add this data to its Clinical Investigator Brochure, which will then be submitted to the Ethics Committees at clinical sites that are interested in participating in the planned phase 1 oncology trials in Australia and India. We expect AEMD to submit the Clinical Investigator Brochure this month."
"AEMD will then seek to obtain approval by the respective Ethics Boards of interested sites in India. The company has a strong clinical working relationship with Medanta Medicity Hospital in Delhi, India, which is currently participating in a study of the Hemopurifier in COVID patients and it would not surprise us if Medanta Medicity Hospital had interest in participating in the oncology study."
"Depending on how long it takes for the sites to review and potentially approve moving forward to participate in Aethlon's phase 1 trial, we believe clinical efforts could begin in 2H24. If Aethlon can demonstrate the ability of the Hemopurifier to improve outcomes of cancer patients suffering from a variety of different cancer types, we would anticipate strong commercial prospects for the Hemopurifier."
In early May, CytoSorbents Corporation, a pioneer in critical care and cardiac surgery blood purification technologies, announced unaudited financial and operating results for the quarter ended March 31, 2024. The Company reported a robust 14% increase in product sales year over year and a sequential quarterly increase of 22%.
From the news: Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "We are pleased to announce a strong start to 2024, driven by significant sales growth and operational efficiencies. First quarter 2024 product sales were $9.0 million, marking the highest quarter for core CytoSorb sales in nearly 3 years. We expanded our product gross margins to 76%, exclusive of a non-recurring inventory adjustment, up an absolute 8% from Q1 2023, which we believe highlights the scalability and efficiency of our state-of-the-art manufacturing facility and processes."
Furthermore, Principal Investigator Dr. Michael Mack presented the results of the U.S. and Canada pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized controlled trial at the Annual Meeting of the American Association for Thoracic Surgery (AATS) and at the KOL and Investor/Analyst Day we hosted earlier this week (replay available) that we believe support a favorable benefit-to-risk profile of the DrugSorb-ATR system* in the perioperative bleeding risk of patients undergoing isolated coronary artery bypass graft (CABG) surgery within 2 days of receiving Brilinta® (ticagrelor, AstraZeneca). We received positive and encouraging feedback on the importance of these data and the continued unmet medical need from cardiothoracic surgeons. Looking ahead, we expect to submit marketing applications for DrugSorb-ATR, which has an FDA Breakthrough Device Designation, to the FDA under the De Novo pathway, and Health Canada in the third quarter of 2024."
Also focused on blood purification, Cerus Corporation, dedicated solely to safeguarding the world's blood supply, announced financial results for the first quarter ended March 31, 2024.
Highlights included:
U.S. ReCePI Phase 3 clinical trial successfully met primary endpoint for INTERCEPT Blood System for Red Blood Cells in cardiovascular surgery patients.
Received FDA approval of extended shelf life for INTERCEPT Platelet Processing Sets to 12 months, doubling the previous shelf life.
Advanced the LED illuminator program towards the Company's target commercial launch in the EU in 2025.
The Company is reiterating its full-year 2024 annual product revenue guidance range of $172 million to $175 million. Included in this range is full-year 2024 guidance for INTERCEPT Fibrinogen Complex, which is expected to be between $8 million to $10 million.
"The Cerus team delivered against our plans for Q1, paving the way for the balance of 2024, with great progress on clinical milestones and a strong return to growth for our commercial business. The positive topline readout from ReCePI, the U.S. Phase 3 clinical trial for INTERCEPT Red Blood Cells, is a significant milestone for the program and for our efforts to potentially bring this product to the market globally," stated William "Obi" Greenman, Cerus' President and Chief executive Officer. "Red blood cells are the most commonly transfused blood components worldwide, and we are committed to providing the full INTERCEPT portfolio for all transfused blood components to our customers around the globe."
The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System of Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding associated with fibrinogen deficiency, including massive hemorrhage.
In mid- May, Spectral Medical Inc., a Phase 3 company seeking US FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ ("PMX"), announced its financial results for the first quarter ended March 31, 2024, and provided a corporate update.
PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
From the news:Spectral has continued its significant progress throughout the first quarter of 2024 both clinically and operationally and year-to-date enrolled 25 patients for a total of 106 patients out of the 150 total patient's target. The Company is focused on the final push to fully enroll and finish the Tigris trial and believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment and allow Spectral to rapidly reach the 150-patients target, bringing the Company closer to FDA submission and potential FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Baxter. In Q1 2024, Baxter exercised its right to maintain its exclusive distribution for PMX products in the U.S. and Canada and paid Spectral a non-dilutive milestone payment. Additionally, Spectral and Baxter mutually agreed to amend the initial term of their commercial partnership to ten years post-FDA approval of PMX. The Company believes this amendment provides a mutually beneficial runway for the parties to maximize PMX commercial economics, while providing motivation for continued support and allocation of resources to the PMX partnership.
Blood Purification technology made headlines during the pandemic when several companies including Baxter International Inc. received emergency use authorization (EUA) from the US FDA. Baxter's approval was for the company's Oxiris filter set to treat patients who have confirmed COVID-19 and have been admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT).
Separate from its current focus on cancer treatment, Aethlon (NASDAQ: AEMD) investigates the potential for the use of the Hemopurifier® in viral diseases under an open Investigational Device Exemption (IDE) and their FDA Breakthrough Designation for "…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy."
Based on our studies to date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Sars-CoV-2, and Ebola."
For the companies in this sector, the drive for innovation is 'in their blood', and with the global threats of viruses and future pandemics on the rise, it's a sector worth watching.
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