five (1 votes)

Scientists have uncovered a change within the H5N1 bird flu virus which makes it resistant towards the anti-viral drug Tamiflu. The mutation in the N1 component was discovered in human cases of the illness and suggests that a single drug approach is most likely to be ineffective in case of a bird flu pandemic in humans. The findings by a team at the Medical Study Council’s National Institute for Medical Investigation are published in Nature.

The investigation looked in the structure of the flu neuraminidase (N1) which is the target for each Tamiflu and Relenza, the two existing flu drugs. Each drugs aim to inhibit the N1 that is responsible for the release of the virus from infected human cells and therefore enables the disease to spread.

Using a method called X-ray crystallography the scientists looked at a mutation in the structure of N1 neuraminidase that has been observed in human instances of H5N1 and in seasonal flu. They identified that when this mutation occurred, the virus became resistant to Tamiflu, even though still remaining susceptible to Relenza.

Viruses have a high rate of mutation typically adapting to the remedies devised to tackle them. It had previously been thought that this mutation in N1 made it less virulent, but recent study from the United States has shown that the mutation does not reduce the infectiousness of the virus.

The team led by Dr Steven Gamblin also looked at samples from the seasonal flu H1N1 and discovered that samples showing this mutation were also resistant to Tamiflu. While the proportion of seasonal flu samples showing this resistance varies widely across Europe and is fairly low in the UK, there is no telling how the seasonal virus will evolve next year.

Dr Steve Gamblin said: “What this analysis shows is the fact that stockpiling any one drug to prepare for a potential H5N1 pandemic is unlikely to offer sufficient cover. In order not to be outflanked by the virus, it’s going to be necessary to have stocks of both existing drugs. We realize this is something the Government is already exploring. There’s also a huge imperative to create further drugs that could assist disable this protein on the virus surface. It really is likely a future pandemic will have to be tackled making use of a three- or four-pronged approach, significantly as we tackle HIV right now.”

References:

Crystal structures of oseltamivir-resistant influenza virus neuraminidase mutants
Collins et. al. is published online at http://www.nature.com

1. Yen et al Neuraminidase inhibitor-resistant recombinant A/Vietnam/1203/04 (H5N1) influenza viruses retain their replication efficiency and pathogenicity in vitro and in vivo. J Virol 81, 12418-12426 (2007).

Medical Research Council

View drug details on Relenza; Tamiflu capsule.

three.five (2 votes)

It’s the case of the missing flu virus. When the flu is not generating individuals sick, it seems to just vanish. However, every year, everywhere on Earth, it reappears in the appropriate season and begins its attack. So exactly where does it go when it disappears? Does it hibernate, lying dormant in several men and women and preparing for its next onslaught? Does it bounce around from the Northern hemisphere to the Southern hemisphere and back, following the seasons?

Neither, it turns out. The virus’s breeding grounds are in Asia, a crew of virus-hunters has discovered, and it then teems out to take over the world anew every year. New varieties nearly usually evolve in Asia after which hitch a ride with travelers, spreading to Europe, Australia and North America and lastly to South America, where they die away.

The work might make the flu vaccine even far better than it already is. Because the flu virus is constantly evolving, scientists meet at the Globe Well being Organization twice a year to decide whether to update the vaccine. Their job is made harder since they’ve to determine on a formulation a year in advance of when the flu will truly hit, to let time for the vaccine to be manufactured and administered. So they have to predict which of the strains of flu virus are going to be causing essentially the most disease a year down the line.

“In order to make an effort to predict how flu viruses may possibly evolve, we need to recognize how they are moving around the globe and where they are evolving,” says Derek Smith, now of the University of Cambridge and formerly of the Santa Fe Institute, corresponding author of the investigation. Asia, the study suggests, will be the greatest location to appear for up-and-coming strains.

The team published its findings April 18 in Science (http://www.sciencemag.org/cgi/content/full/320/5874/340).

The team traced the virus’s steps by studying 13,000 flu samples from worldwide. The World Well being Organization Global Influenza Surveillance Network collected this information between 2002 and 2007, keeping track of when and where diverse strains of the virus popped up. They analyzed the shape differences between the proteins every single virus uses to bind to human cells, along with the genetic makeup of every single virus.

The team utilised this information to generate an “antigenic map” which visually shows the relationships between all of the various viruses. This map allowed them to determine the migration patterns of the virus all over the world.

The work was funded by an NIH Director’s Pioneer Award (http://nihroadmap.nih.gov/pioneer) to Smith given for extremely innovative investigation that has the possible for large impacts.

The roots of the project extend all the way back to when Smith was a graduate fellow at the Santa Fe Institute performing a PhD with Stephanie Forrest and Alan Perelson. He later began collaborating with Alan Lapedes, Robert Farber, and Terry Jones, all of whom had been also affiliated using the Santa Fe Institute, to create the methods and software program to develop antigenic maps.

“This work is very multidisciplinary, with epidemiologists, laptop or computer scientists, computational biologists, mathematicians, virologists, immunologists, geneticists, veterinarians, and MDs,” Smith says. “It was created possible by collaborations with folks from all of these disciplines. The Santa Fe Institute is one of the couple of areas that could have gestated such function and I’m immensely grateful for the five years I spent at SFI.”

###

A profile of Smith accompanies the study article in Science, giving an account of Smith’s journey from studying the mathematics of speech recognition to being among the foremost international authorities in influenza virus evolution (http://www.sciencemag.org/cgi/content/full/320/5874/310).

The Santa Fe Institute (SFI) is an acknowledged leader in multidisciplinary scientific analysis. Its objectives are to discover and recognize the typical basic principles in physical, computational, biological, and social complex systems that underlie several of the most profound troubles facing science and society nowadays. By transcending disciplines, breaking academic molds, and drawing together an international network of unorthodox creative thinkers, SFI is an independent non-profit research and education center supported by grants, charitable giving, and corporate relationships.

Source: Derek Smith
Santa Fe Institute

Emergent BioSolutions Inc. (NYSE:EBS) and Protein Sciences Corporation (PSC), based in Meriden, Connecticut, announced that the two companies have entered into an asset purchase agreement under which Emergent will acquire PSC’s ongoing operations, such as FluBlok, a Phase III recombinant influenza vaccine candidate, and certain other assets. This agreement achieves a important component of Emergent’s stated technique for growth via acquisition of late-stage product candidates.

Under the terms of the agreement, Emergent will acquire substantially all assets of PSC, such as:

-FluBlok? (trivalent recombinant hemagglutinin vaccine). FluBlok is a Phase III influenza vaccine candidate that, if approved, could be the first recombinant cell culture influenza vaccine. FluBlok has potential for use in each seasonal and pandemic settings. The clinical program for FluBlok, which consists of four trials and much more than 6,000 participants, has demonstrated promising immunogenicity, including within the elderly. FluBlok has been granted each fast track status and priority review by FDA.

-Baculovirus Expression Vector Method (BEVS) technology. BEVS is a cell culture-based manufacturing platform utilized to manufacture FluBlok. The BEVS technology can be applied to develop vaccines and therapeutic candidates to avoid or treat a wide range of illnesses.

-Other product candidates. PSC’s other product candidates are according to the BEVS platform and include a SARS vaccine in preclinical development.

-A vaccine manufacturing facility. This facility is located in Meriden, Connecticut and consists of a 600-liter bioreactor and associated upstream and downstream capabilities.

Emergent intends to retain all of the approximately 50 PSC employees and anticipates continuing production of FluBlok in the Meriden, Connecticut facility. Emergent expects to launch out of this location. In parallel, Emergent is evaluating plans for future large-scale manufacturing of FluBlok and is considering Meriden as a web site for the facility.

In April 2008, PSC submitted to FDA a Biologics License Application (BLA) for FluBlok, including information from the Phase III clinical program. The next steps within the BLA method include readiness preparations for the upcoming FDA pre-approval inspection. Furthermore, late last year, PSC applied for a study and development grant in response to a Biomedical Advanced Investigation and Development Authority (BARDA) RFP, “Advanced Development of Recombinant Influenza Virus Vaccines.” BARDA has indicated its intention to issue one or much more awards under this RFP in late 2008.

“We are delighted concerning the opportunity to commercialize the first recombinant cell culture influenza vaccine. We believe that FluBlok will turn into a strong competitive product within the sizeable and growing seasonal influenza market and that BEVS will offer a distinctive platform for the development of a novel pandemic influenza candidate. We congratulate the management of PSC in building a manufacturing operation and for bringing FluBlok through a Phase III clinical trial to the point of a BLA submission. Emergent, using the combined resources of PSC, is properly positioned to bring this exciting product to the market successfully, according to our product development, regulatory and manufacturing experience,” stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “The acquisition of FluBlok is consistent with Emergent’s technique of expanding its product portfolio with a vaccine candidate focused on a significant infectious illness.”

Daniel D. Adams, president and chief executive officer of Protein Sciences Corporation, said, “We are grateful that Emergent recognized the value of our lead product, FluBlok, and our proprietary BEVS technology and is supplying financial and operational assistance to assist us in bringing FluBlok by way of regulatory approval. Combining our expertises should help to make sure the continued success of FluBlok and our other strategic assets.”

William H. Narwold, chairman of the board of directors of Protein Sciences Corporation, commented, “Emergent enhances our regulatory, manufacturing and approach development capabilities and brings a confirmed track record of operating using the United States Government to deliver critical infectious illness products. It truly is for these reasons that the Board of Directors of Protein Sciences has approved this transaction and believes that our shareholders will have the opportunity to benefit from the continued growth and success of Emergent BioSolutions.”

Terms of Acquisition

Under the terms of the asset purchase agreement, the consideration paid by Emergent will incorporate:

-Up to $28 million in cash as well as the assumption of PSC liabilities, which includes trade payables associated with the Phase III clinical trials of FluBlok;

-A $20 million, 4.75%, 5-year note, convertible into Emergent common stock at a conversion cost of $12.50 per share;

-Up to $30 million in future payments according to the achievement of FluBlok commercialization milestones and net sales of FluBlok;

-A percentage of net sales of FluBlok.

The closing of this transaction, anticipated by the end of the second quarter of this year, is subject to the approval of the stockholders of PSC, the receipt of regulatory approvals as well as the satisfaction of certain conditions of closing. Emergent BioSolutions’ financial advisor on this transaction was Jefferies & Company, with Thelen Reid Brown Raysman & Steiner LLP as primary legal counsel. PSC’s financial advisor on this transaction was BMO Capital Markets, with Brenner, Saltzman & Wallman, LLP as legal counsel.

Update on Emergent BioSolutions 2008 Financial Guidance

As Emergent evaluates the impact of this acquisition on current year financial guidance, management expects revenue for 2008 to remain unchanged, between $180 and $195 million. With respect to net income, management is still evaluating present forecasts associated to PSC’s anticipated operating fees as well as the appropriate accounting treatment for the acquisition. Management expects to be in a position to update guidance for 2008 net income when the company reports financial outcomes for the second quarter of 2008, anticipated during early August.

About the Influenza Market

According to industry reports, you will find 1 billion cases of influenza every year, resulting in 250,000 to 500,000 deaths, world-wide. Within the US alone, you will find an estimated 15 million to 60 million cases and 30,000 to 40,000 deaths annually, making influenza a key public wellness concern. Young kids as well as the elderly are at a particularly high risk of infection and complications.

About FluBlok?

FluBlok is a novel recombinant subunit influenza vaccine manufactured in a cell culture medium, which represents the next-generation in flu vaccine technology. The currently licensed flu vaccines are manufactured via egg-based technologies, which presents numerous operational and market challenges. FluBlok consists of 3 recombinant hemagglutinin (rHA) proteins derived from the flu strains selected by the World Health Organization as well as the U.S. Centers for Disease Control and Prevention for every year’s seasonal flu vaccine. These proteins are produced in a proprietary cell culture and formulated without preservatives, adjuvants, or antibiotics. FluBlok has been developed as a single-dose vaccine to be administered intramuscularly. In clinical trials, FluBlok has demonstrated promising immunogenicity in both healthy adults as well as the elderly, with a positive safety profile. Preliminary evidence of protection against influenza illness has been observed in adults, as published in the April 2007 concern of JAMA? (The Journal of the American Medical Association).

About BEVS

The Baculovirus Expression Vector Technique (BEVS) is recognized as a robust and versatile tool for producing a variety of functional recombinant proteins. The BEVS manufacturing method begins by cloning the gene for the desired target protein into a virus capable of infecting insect cells (baculovirus). When these genetically engineered baculoviruses are utilised to infect insect cell cultures, these cells are “programmed” to manufacture the desired proteins.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a profitable biopharmaceutical company dedicated to 1 simple mission-to defend life. We develop, manufacture and commercialize vaccines and therapeutics that assist the body’s immune technique to stop or treat illness. Our products target infectious illnesses along with other medical conditions that have resulted in important unmet or underserved public well being needs. Our marketed product, BioThrax? (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.

Emergent BioSolutions Inc.

5 (1 votes)4 (2 votes)

Bioject Medical Technologies Inc. (Nasdaq:BJCT), a leading developer of needle-free injection therapy (“NFIT”) systems, announced that the Biojector?2000 (“B2000″) needle-free program has advanced to Phase II in a clinical study sponsored by the Centers for Illness Control and Prevention (“CDC”). The trial performed in the Dominican Republic, evaluates influenza vaccine using a reduced dose delivered into the skin via an intradermal (“ID”) route, compared to similar and normal larger doses delivered intramuscularly (“IM”) by conventional needle and syringe.

The study is a prospective, phased, randomized, investigator and parent-blinded controlled comparison of therapeutic activity (immunogenicity) and safety/side effects (reactogenicity) in infants and toddlers from 6 to 23 months of age.

The ID route of vaccination is of interest for influenza as well as other illnesses for which vaccines might be in short supply in a pandemic or otherwise unaffordable in developing countries. Prior studies found that reduced doses within the skin often function just as well as full doses injected into fat or muscle. Such “dose-sparing” might extend protection to more individuals than otherwise could be doable. The influenza pandemic preparedness plans of each the U.S. Government and the World Well being Organization have identified such analysis as a priority.

ID injection by conventional needle method, however, is hard and requires extra training and encounter by well being workers to perform correctly. An intradermal spacer on the B2000 injector provides a quick and simple method to deliver such doses. A needle-free system also eliminates other drawbacks of needle-syringes, such as needlestick injuries, and in several countries, improper unsterile reuse and unsafe disposal of needle waste.

The CDC decided to use the B2000 simply because its ID spacer had one of the most clinical use in adult studies to justify its investigational use in kids. Phase I of the still-blinded trial is now complete and its safety outcomes had been presented in poster presentation P25 in the 11th Annual Conference on Vaccine Study, in Baltimore, MD, May 2008 (http://www.nfid.org/pdf/conferences/vaccine08abstracts.pdf). An independent Information Safety Monitoring Board reviewed unblinded outcomes from Phase I and deemed the study safe and ethical to proceed to its larger Phase II, which began in April 2008.

“We are hopeful this study will determine whether intradermal vaccination by needle-free jet-injector will be of practical use in young children, who are particularly vulnerable to influenza,” stated Dr. Bruce G. Weniger of CDC, U.S. principal investigator and sponsor of the study. “If it works, developing country health officials would have additional options to better safeguard their populations against this severe disease,” Dr. Weniger added.

“This study is very properly designed to carefully evaluate the safety and effectiveness of our needle-free injection device for the intradermal delivery of reduced-dose influenza vaccine,” said Dr. Richard Stout, MD, Executive Vice President and Chief Medical Officer of Bioject. “We are delighted that the B2000 was selected to be included in this crucial CDC study which aims to benefit patients inside the developing world, and appear forward to results from the trial’s ongoing Phase II,” he continued.

The influenza vaccine studied is Vaxigrip?, manufactured by the Sanofi Pasteur in France. Participant children who receive reduced doses will afterwards get a full dose to guarantee protection. All children will get a bonus dose six months later for the next influenza season.

Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy (NFIT) systems. Needle-free injection works by forcing medication at high speed by means of a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication inside the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties as well as other factors that could cause the actual outcomes, performance or achievements of the Company, or industry outcomes, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such risks consist of that the results of clinical studies may possibly not produce the anticipated results and that intradermal injection device may possibly not be commercialized. Readers of this press release are referred towards the Company’s filings using the Securities and Exchange Commission, including the Company’s reports on Form 10-K and Forms 10-Q for further discussions of factors that could affect the Company’s business and its future results. Forward-looking statements are according to the estimates and opinions of management on the date the statements are created. The Company assumes no obligation to update forward-looking statements if conditions or management’s estimates or opinions really should change.

Bioject Medical Technologies Inc.

GPs aren’t an integral component of Australian influenza planning, despite the important role they will play in limiting deaths in the event of a pandemic hitting the country, according to research from The Australian National University.

Researchers from the University’s National Centre for Epidemiology and Population Well being and ANU Medical School examined 89 Australian and international pandemic response plans and found general practice involvement was restricted, and sometimes not considered.

Research lead Associate Professor Mahomed Patel says international evidence from the SARS outbreaks and influenza epidemics illustrates GPs and allied health professionals have an critical role to identify and treat cases, take on hospital workload and continue to assistance the chronically ill inside the event of an outbreak.

“Studies in other countries show that in the course of public well being emergencies, most people prefer to see their GPs whom they trust and have a good relationship with. Yet most plans focused on the responses by well being departments with small reference to collaborations with GPs,” he stated.

Despite wellness specialists around the world saying a pandemic was a ‘when not if’ scenario, pandemic preparing is still not seen as an activity to be jointly prepared by wellness departments, general practitioners and hospitals, Dr Patel added.

“With over 97 million visits annually, general practice is Australia’s single largest health sector. If we do not prepare it well, our responses will fail in critical points in the course of an influenza pandemic,” he said.

The researchers have devised a framework to guide preparing to incorporate general practice covering clinical care for influenza along with other conditions, public well being responsibilities, the internal environment of general practice and interactions within the broader health method.

General practice coordination was identified as an location of need to have throughout Exercise Cumpston 2006, which tested systems for an influenza outbreak, and national guidelines for main care providers are being developed, the researchers stated. The researchers also emphasise the must move beyond a paper exercise in planning, to drills, simulations and continuing collaboration among individuals who will should pull together in a crisis situation.

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Source: Martyn Pearce
Research Australia

5 (1 votes)

Juvaris BioTherapeutics, Inc., a biotechnology company developing therapeutics and adjuvanted vaccines for infectious illnesses and cancer, announced the initiation of a Phase 1 clinical trial of its lead compound, JVRS-100. The trial will compare the safety, tolerability and immunogenicity of the JVRS-100 adjuvant co-administered with a commercial influenza vaccine compared to vaccine alone.

“JVRS-100 has demonstrated the capacity to significantly enhance immune responses of existing vaccines in preclinical studies, delivering a possible chance to improve influenza vaccine efficacy,” stated Grant E. Pickering, President and CEO of Juvaris. “This double blind trial will evaluate varying dose amounts of JVRS-100 and is designed to supply safety data, dose determination along with the primary immunological response information employed to figure out efficacy for adjuvanted vaccines. Whilst 1 influenza vaccine will likely be used within the study, we believe the results will inform concerning the broad applicability of JVRS-100 for use with a lot of available vaccines.”

Seasonal influenza affects roughly 1 billion individuals worldwide every year and outcomes in 5 million severe illnesses and 500,000 deaths. Roughly 90 percent of the deaths occur within the elderly. Seasonal influenza vaccines, which are widely used inside the U.S. and developed countries, have modest effectiveness in kids and young adults, but are efficient in only 30 percent of the elderly population. Manufacturers of influenza vaccines are actively pursuing adjuvanted vaccines in order to improve efficacy and reduce vaccine dosage needs due to supply constraints.

“There is a great should improve upon the efficacy of influenza vaccines, particularly given their ineffectiveness inside the elderly, who stand to benefit one of the most from vaccination but, unfortunately, receive the least amount of protection,” said Eric A. Sheldon, M.D., Medical Director and Director of Vaccine Development at Miami Research Associates and an investigator for the Juvaris trial. “The JVRS-100 adjuvant has demonstrated promising preclinical activity, and we look forward to evaluating this candidate in a randomized Phase 1 trial.”

The randomized, double blind, controlled Phase 1 trial is expected to enroll 128 healthy subjects in four therapy cohorts. The study will evaluate a licensed trivalent, inactivated, split influenza vaccine with ascending dose levels of JVRS-100 compared towards the vaccine alone. JVRS-100 will also be studied with reduced doses of the influenza vaccine to assess its effectiveness and vaccine dose-sparing effects. Primary objectives of the study are to assess the safety and tolerability of the JVRS-100 adjuvant and its capability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine.

About JVRS-100

JVRS-100 is a toll-like receptor-directed cationic lipid-DNA complex that is being developed as a therapeutic and an adjuvant to treat multiple illnesses. JVRS-100 has been shown to be a minimum of 50 instances more potent at triggering innate immune activation and interferon release than current immune stimulants, indicating its prospective to treat multiple infectious diseases and cancers. When combined with disease-specific antigens, JVRS-100 is capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes (CTL). Immunological responses elicited by the lipid-DNA complexes have already been successfully demonstrated in each prophylactic and therapeutic vaccine settings in multiple species. This platform provides the chance to develop numerous disease-specific immunotherapy products for which you can find considerable unmet medical needs.

About Adjuvants

Adjuvants are utilized to enhance the effects of a vaccine by stimulating the immune technique to respond to the vaccine a lot more robustly, offering improved immunity to illness by stimulating antigen presenting cells such as dendritic cells (DCs), lymphocytes and macrophages.

About Juvaris

Juvaris BioTherapeutics is a clinical-stage company developing a platform of toll-like receptor-directed therapeutics and adjuvanted vaccines to treat infectious diseases and cancer. The Company’s lead product candidate, JVRS-100, is currently being evaluated as an adjuvant to improve the efficacy of seasonal influenza vaccines. The Company plans to initiate further clinical studies with JVRS-100 in hepatitis C and acute myelogenous leukemia. Juvaris completed a $12.3M Series A financing led by Kleiner Perkins Caufield & Byers and has been awarded multiple NIH grants, such as a recent award for roughly $9M to develop adjuvants for influenza vaccines. The Company also recently announced a significant worldwide licensing agreement for Juvaris technology’s use within the animal health field with Bayer Healthcare AG.

Juvaris BioTherapeutics, Inc.

2.67 (three votes)

Article Opinions:1 posts
Banner Pharmacaps Inc., a leader inside the pharmaceutical industry for the development of soft gelatin dosage form technology, announces that the US Food & Drug Administration granted approval for the Company’s Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride USP 100 mg soft gelatin capsules on May 29, 2008.

Amantadine is indicated for the prophylaxis and remedy of signs and symptoms of infection inside the respiratory tract caused by various strains of influenza A virus. Amantadine is also utilized in the therapy of Parkinson’s Illness and drug-induced extrapyramidal reactions.

About Banner Pharmacaps Inc.

Banner Pharmacaps Inc. is a global drug delivery and specialty pharmaceutical company which is developing a proprietary portfolio of exclusive products and oral dosage forms that incorporate the enhanced technologies of enteric and controlled release softgels, along with Soflet? Gelcaps. Headquartered in High Point, North Carolina, Banner is committed to the investigation, development, and manufacture of high quality healthcare products to serve our global community. Additional data about Banner is available at http://www.banpharm.com.

The parent company of Banner is VION N.V., an international food group that produces high-quality foodstuffs and ingredients for humans and animals. VION has annual sales of a??.1 Billion, with 15,150 employees worldwide. The head workplace of VION is in Son en Breugel, The Netherlands.

Banner Pharmacaps Inc.

three.5 (6 votes)three (1 votes)

Aethlon Medical, Inc. (OTCBB:AEMD) announced that the Aethlon Hemopurifier? has confirmed successful in capturing the reconstructed Spanish Flu of 1918 virus (1918rv). Through in vitro testing, high concentrations of 1918rv were rapidly depleted from cell culture fluid when circulated through the Hemopurifier?. The study documented that 76 percent of 1918rv was removed from circulation in the course of the first two hours, and by the end of the sixth hour, 93 percent of 1918rv was cleared from circulation. The study information was quantified by reverse transcription polymerase chain reaction (PCR). The Spanish Flu of 1918 is believed to have caused 40-50 million deaths throughout a two-year time span. The Hemopurifier? has also demonstrated effectiveness in capturing H5N1 avian influenza (bird flu). As previously disclosed, the Hemopurifier? removed up to 99.four percent of infectious H5N1 virus from cell culture fluids through a six-hour testing period. Scientists are increasingly worried that H5N1 avian flu could mutate into a strain that triggers a global pandemic that rivals the Spanish Flu of 1918.

“Data against history’s most lethal form of influenza along with the looming H5N1 threat validates the Hemopurifier? as an innovative technique to address existing and future pandemic flu threats,” stated Aethlon chairman and CEO, James A. Joyce. “The data is especially timely, as scientists have discovered that H5N1 virus has emerged to be resistant to the globally stockpiled drug Tamiflu,” concluded Joyce.

The Could 15, 2008 problem of the science journal Nature reported that researchers have confirmed that H5N1 avian influenza virus has mutated to become resistant to Tamiflu. As per the recommendation of the World Well being Organization (WHO), Tamiflu is an antiviral drug agent that has been stockpiled by governments around the world as a prospective remedy against pandemic influenza. Researchers now believe that viral mutation will necessitate a multi-pronged therapy strategy against future flu pandemics, as antiviral drugs are unlikely to give clinical benefit as stand-alone therapies. The Hemopurifier? holds promise to enhance the benefit of stockpiled drugs and future candidate therapies by clearing the viral strains from circulation that cause drug and vaccine resistance.

The Hemopurifier? is a broad-spectrum therapeutic device able to separate and then capture circulating viruses by glycoproteins that reside on their surface. Inside the case of pandemic influenza, the Hemopurifier? is able to separate and then capture circulating influenza virus by hemagglutinin (HA) and neuraminidase (NA) glycoproteins that reside on the virus surface regardless of mutation. Consequently, the potential applications of the Hemopurifier? against pandemic influenza contain:

-The Hemopurifier? is a first-line countermeasure against highly virulent strains of pandemic influenza which are untreatable with drug and vaccine therapies.

-The Hemopurifier? is an adjunct therapy that captures mutant strains of circulating influenza virus to strengthen the clinical benefit of candidate therapies, such as stockpiled countermeasures that are unable to demonstrate therapy effectiveness in advance of a pandemic outbreak.

-The Hemopurifier? assists within the initial identification of emerging influenza strains through the concentration and capture of pandemic influenza viruses from the entire circulatory method of infected patients, thus directing the development of candidate drug and vaccine therapies towards the strain of influenza virus that sparks widespread infection.

-The Hemopurifier? may possibly also address the needs of immunocompromised and at-risk populations, such as young children, pregnant women, and senior citizens for whom the administration of drugs or vaccines developed against pandemic influenza might be medically contraindicated.

The reconstructed 1918 influenza virus tested in Hemopurifier? in vitro studies, and depicted as 1918rv in this disclosure, was a recombinant virus with two genes (the HA and NA) from the 1918 strain of influenza along with six genes from the Texas 91 influenza strain. The resulting analysis virus is known as 1918 HA/NA:TX/36/91 in scientific literature. It’s anticipated that the use of the Hemopurifier? is going to be directed only towards pandemic strains of influenza whose virulence is attributed by survival and spread in the circulatory method of infected patients. This does not preclude the use of the Hemopurifier? as a broad-spectrum countermeasure against other infectious disease and cancer therapy targets.

About Aethlon Medical

Aethlon Medical is the developer of the Hemopurifier?, a first-in-class medical device designed to treat infectious illness. The Hemopurifier? provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and is positioned to address the remedy of drug and vaccine resistant viruses. Additionally, the device holds promise in cancer care, as research studies have verified the Hemopurifier? is able to capture immunosuppressive particles secreted by tumors. The Hemopurifier? is designed to act both as a stand-alone therapeutic, and as an adjunct therapy to enhance clinical benefit of established therapies. Pre-clinical studies conducted by researchers representing leading government and non-government well being organizations each inside the United States and abroad have documented the effectiveness of the Hemopurifier? in capturing from circulation the viruses that constitute pandemic threats, which includes H5N1 Avian Influenza (bird flu), and Dengue Hemorrhagic Fever (DHF) from circulation. The company is conducting studies to assistance the use of the Hemopurifier? as a broad-spectrum therapy countermeasure against bioterror threats, such as Smallpox, and Ebola, Marburg, and Lassa hemorrhagic fever. Regulatory and commercialization initiatives in the United States are presently focused on bioterror threats, whilst international initiatives are directed toward naturally evolving pandemic threats, and chronic infectious illness conditions including the Human Immunodeficiency Virus (HIV) and Hepatitis-C (HCV). Aethlon demonstrated the safety of the Hemopurifier? in a 24-treatment human study in the Apollo Hospital in Delhi, India, and is currently conducting further human studies in the Fortis Hospital, also located in Delhi. The company has submitted an investigational device exemption (IDE) to the U.S. Food and Drug Administration (FDA) to advance the Hemopurifier? as a broad-spectrum remedy countermeasure against category “A” bioterror threats. Extra information relating to Aethlon Medical and its Hemopurifier? technologies is accessible on-line at http://www.aethlonmedical.com.

Certain of the statements herein could be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which might cause the actual outcomes, 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 incorporate, without limitation, the Company’s capacity to raise capital when needed, the Company’s ability to complete the development of its planned products, the capability of the Company to obtain FDA as well as other regulatory approvals permitting the sale of its products, the Company’s capability to manufacture its products and give its services, the impact of government regulations, patent protection on the Company’s proprietary technologies, product liability exposure, uncertainty of market acceptance, competition, technological change, as well as other risk factors. In such instances, actual outcomes could differ materially as a result of a variety of factors, which includes the risks associated using the effect of changing economic conditions as well as other risk factors detailed inside the Company’s Securities and Exchange Commission filings.

Aethlon Medical

View drug data on Tamiflu capsule.

Influenza outbreaks were shorter and resulted in fewer cases and fewer deaths at long-term care facilities that started residents on preventive antiviral medicines within five days of the first case, compared to those that started later, according to a new study inside the July 1 concern of Clinical Infectious Diseases, currently offered online.

Long-term care facilities housing elderly men and women are vulnerable to influenza outbreaks. Once an outbreak has occurred at a facility, antiviral medications are generally given to the residents to stop more folks from acquiring sick. This preventive administration of medication is known as chemoprophylaxis.

Common sense suggests that the sooner antiviral medications are given to long-term care residents who were potentially exposed to influenza, the more likely it would be that influenza infection could be prevented and facility outbreaks controlled. The new study confirms this by showing important differences in outcomes when administering chemoprophylaxis within five days of detecting an influenza outbreak versus initiating medications a lot more than 5 days after influenza outbreaks were identified.

“Prompt initiation of chemoprophylaxis after identification of influenza A in a long-term care facility can decrease the severity of influenza outbreaks in those settings,” stated Marcie Rubin, MPH, MPA, of the Columbia University Mailman School of Public Well being.

Ms. Rubin and personnel from the New York City Department of Well being and Mental Hygiene’s Bureau of Communicable Illnesses looked at data from 52 outbreaks of influenza A in New York City long-term care facilities more than the course of 3 influenza seasons. An outbreak was defined as either a single laboratory-confirmed case or a cluster of two or much more cases of influenza-like illness.

Facilities that began prophylaxis within 5 days of the influenza outbreak’s detection had outbreaks that lasted only about a third as long as those institutions that took longer to begin treating people (6.7 vs. 18.3 days). Early intervention also led to far fewer cases (6.2 cases/100 residents vs. 10.5 cases/100 residents) and deaths (0.45 deaths/100 ill residents vs. three.three deaths/100 ill residents).

Given the striking benefits of a quick response, the authors recommend the development of strategies that might hasten an intervention. They suggest that facility staff increase their vigilance for diagnosing influenza cases. They also recommend that the method for collecting respiratory specimens for influenza detection be streamlined, with rapid testing and efficient communication of outcomes from the laboratory to the staff.

The outbreaks the researchers studied occurred between 2001-2004, at which time amantadine was the frontline therapy for treatment and prophylaxis of influenza A. Since 2004, there has been growing influenza resistance to amantadine and neuraminidase inhibitors have turn into the newest antivirals of choice. Further study is needed to determine whether rapid initiation of chemoprophylaxis with this class of antiviral drugs will result in similar positive impacts.

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Founded in 1979, Clinical Infectious Diseases publishes clinical articles twice monthly in a variety of locations of infectious illness, and is one of probably the most highly regarded journals in this specialty. It really is published below the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Virginia, IDSA is a expert society representing a lot more than 8,000 physicians and scientists who specialize in infectious illnesses. For much more details, visit http://www.idsociety.org/.

Source: Steve Baragona
Infectious Diseases Society of America