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[zocku]

Vitex Reports Parasite Inactivation Results at ISBT 2002
-Presentations Highlight Safety and Utility of INACTINE(TM) Technology as Promising Approach to Improve Safety of Red Blood Cell Transfusions -
Monday August 26, 6:45 pm ET

VANCOUVER, B.C., Aug. 26 /PRNewswire/ -- Transfusion experts gathered from around the world in Vancouver for the 27th Congress of the International Society of Blood Transfusion (ISBT) Meeting will hear Vitex present further efficacy and safety data on its INACTINE(TM) red blood cell technology. V.I. Technologies, Inc. (Vitex) (Nasdaq: VITX - News), a biotechnology company dedicated to developing products that improve the safety and availability of the transfusion blood supply by pathogen reduction or removal, reported today that its INACTINE(TM) technology was successful in eradicating the parasites that cause Chagas` Disease, malaria and babesiosis in red blood cells. The company also presented its overall clinical development program for INACTINE(TM) red blood cells including results of completed clinical trials. Additional study data on the chemistry and safety profile for the INACTINE(TM) pathogen reduction system will be presented in three scientific posters on Tuesday, August 27, the company announced.

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"These studies validate the unmatched capabilities of the INACTINE(TM) pathogen reduction system for red cells in reducing infectious disease risks of blood transfusions, as well as building upon the product`s safety profile," said John R. Barr, CEO of Vitex. "Ongoing research and development of the INACTINE(TM) pathogen reduction system demonstrates Vitex`s commitment to enhancing the safety and availability of the world`s blood supply."

In the first study, titled "The INACTINE(TM) PEN110 Chemistry Eradicates the Parasites that Cause Chagas` Disease, Malaria, and Babesiosis," the causative parasites Trypanasoma cruzi, Plasmodium falciparum, and Babesia microti, respectively, were evaluated for inactivation using standard INACTINE(TM) PEN110 red blood cell process conditions. The results showed that the INACTINE(TM) PEN110 treatment of the red blood cells infected with the parasites led to complete parasite eradication.

In the second presentation, titled "Clinical Studies of Red Blood Cells after Treatment with the INACTINE(TM) Pathogen Inactivation Process," results of Phase I and Phase II clinical studies were presented. Results from these studies established the clinical process parameters for INACTINE(TM) PEN110 treatment of red blood cells including a 42-day storage period, corresponding to currently FDA licensed red blood cells. These INACTINE(TM) PEN110 process conditions will be used in the company`s pivotal Phase III clinical program, which recently received concurrence from the FDA.

About Vitex

Vitex is developing products designed to improve the safety of the world`s blood supply. The Company`s revolutionary INACTINE(TM) technology is designed to inactivate a wide range of viruses, bacteria and parasites, and remove blood contaminants including prion and plasma proteins, while preserving the therapeutic properties of red blood cells. The technology works by binding to the RNA or DNA of the pathogen. Once bound, the compound forms an irreversible bond to the pathogenic nucleic acid, preventing replication and thereby "killing" the pathogens. The Company`s lead product is INACTINE(TM) Pathogen Reduction of red blood cells. The Company continues to report on its rapid progress in demonstrating the system`s ability to meet the three critical requirements for commercial success with a pathogen reduction system: broad pathogen kill, a wide safety margin for the patient, and maintenance of the therapeutic properties of the red blood cell. Over 40 million red cell units are transfused annually in the US, Europe and Japan, representing an over $4 billion market opportunity. The Company currently has partnerships with Pall Corporation, Haemonetics Corporation, and Amersham Pharmacia Biotech. In collaboration with Oxford University, Vitex is developing a diagnostic test for pathogenic prions using aptamer technology. In their pathogenic form, prions cause "Mad Cow Disease" in cows, or variant Creutzfeldt-Jakob Disease in humans, which is 100% fatal and for which no therapy or diagnostic currently exists. For more information on Vitex, please visit our Web site at: www.vitechnologies.com.

Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, such as quarterly fluctuations in operating results, anticipated clinical trial timelines or results, the timely availability of new products, market acceptance of the company`s products, the impacts of competitive products and pricing, government regulation of the company`s products and other risks and uncertainties set forth in the company`s filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.

V.I. Technologies, Inc.
Francesca Devellis (investors)
Sr. Director, Investor Relations and Corporate Communications
617-926-1551, x7475
Email: [e-mail]

Noonan Russo Presence Euro RSCG
Matthew Scampoli (media)
Account Supervisor
212.845.4256
Email: [e-mail]





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Source: V.I. Technologies, Inc.







STRONG BUY!!!!!!!!

[sl-class]

[felici]

@zocku
Danke für den Tip!

sieht wirklich gut aus...sehr intressant!


gruß

[GSG9]

[digex]

@sl-class@GSG9 habt ihr langeweile?

sonst wüßte ich nicht wieso ihr solche dumme smilies reinpostet!

Die aktie hat wirklich sehr viel chancen!


Die News ist sehr positiv zu bewerten.

[ORGASMATRON]

schiffe mucht unkoet muren feil !

[zocku]

Vitex wird explodieren!!!!!

[zocku]

Vitex develops innovative biotechnology-based products designed to improve the safety of the blood supply by reducing the number of pathogens either by inactivation or removal of pathogens in blood products intended for transfusion.

The Company’s revolutionary INACTINE™ technology uses nucleic acid chemistry to inactivate blood-borne viruses, parasites, lymphocytes and bacteria. Vitex’s lead product from this technology, INACTINE™ for red blood cells, is currently in clinical trials and targets the largest transfusion blood product market segment, estimated at $3.5 billion per year. The INACTINE™ system has also demonstrated its ability to remove prion proteins from red blood cells. Prion proteins in their pathogenic form are the agents that cause "Mad Cow Disease", or in humans, variant Creutzfeldt-Jakob Disease (vCJD). In addition, Vitex has a second very promising program underway using aptamer technology. The Company is applying this technology to the development of a method to selectively remove prions from complex solutions, and a specific test to diagnose pathogenic prions in blood.

Blood Safety is a Public Health Issue
Despite the great strides that have been made in blood screening over the past few decades to reduce the risk of pathogen transmission in the worldwide blood supply, transmission of pathogens via blood transfusion is still a risk. High-profile examples, such as HIV and Hepatitis B and C, demonstrate both the blood supply’s vulnerability to previously unknown pathogens, as well as the inevitable lag time required to develop and implement suitable screening tests. Currently, blood products intended for transfusion are only screened for four viruses and one bacterium. There is also the concern that additional pathogens could threaten the blood supply at some point in the future.






The Vitex Solution
Vitex’s core technology is based on a small molecule, which binds to the RNA or DNA of the pathogen. This irreversible (covalent) bond prevents replication, and subsequently “kills” the pathogen. The Company’s lead product is the INACTINE™ Pathogen Inactivation system for red blood cells. Pre-clinical studies using the INACTINE™ process have demonstrated a reduction in the number of pathogens as well as plasma protein, cytokines, platelets, white blood cells, membrane fragments, and, prion proteins in red blood cell concentrates. Vitex also has a promising collaboration with Oxford University targeted at developing a diagnostic specific for the pathogenic form of the prion.


INACTINE™ is a revolutionary technology that is designed to use nucleic acid chemistry to inactivate blood-borne viruses, parasites, lymphocytes and bacteria in red blood cells. The lead product from this technology, INACTINE™ for red blood cells, is currently in clinical trials and targets the largest transfusion blood product market segment, estimated at $3.5 billion per year.


Aptamer Technology The primary focus of Vitex’s program in this area is for the removal and detection of blood-borne pathogenic prions that cause brain-wasting diseases such as variant Creutzfeldt-Jakob Disease (the human version of “Mad Cow Disease”.



The INACTINE™ Process for Red Cells
The INACTINE™ technology is based on a small molecular compound that has been designed to inactivate a wide variety of blood-borne viruses, bacteria, and parasites by binding to their nucleic acid (DNA and RNA). The self-activating compound becomes reactive only when it comes in close proximity to the nucleic acid of a pathogen. Once bound, the compound forms an irreversible covalent bond to the pathogenic genome, preventing replication and thereby “killing” the pathogen.


Vitex’s lead product, INACTINE™ for red blood cells, has the potential to effectively reduce the risk of disease transmission from pathogens. Reducing pathogens in blood products without damaging red cells is currently a major challenge that Vitex is addressing.


The INACTINE™ system for red blood cells also potentially offers a significant commercial opportunity to Vitex. With over 41 million units transfused annually in the U.S., Europe and Japan, red cells are by far the largest transfusion product market segment; the premium associated with inactivating pathogens in red blood cells is $3-4 billion annually.




Clinical Development
The principal clinical focus of Vitex’s INACTINE™ pathogen inactivation process for red blood cells is establishing that the process maintains the therapeutic properties of the red cells while inactivating potential pathogens.


Phase I Clinical Trial
Results of Vitex’s Phase I clinical trial, which were presented at the 2000 American Society of Hematology Conference in San Francisco, demonstrated that transfusion red blood cells treated for six hours with the INACTINE™ system could be stored for 28 days and retain their viability following re-infusion.


Phase II Clinical Trial
The Phase II red blood cell study was a randomized, controlled, parallel-group evaluation of the safety and maximum storage time of a unit of INACTINE™-treated red blood cells, treated for 24 hours and administered to adult subjects. The results of the study were announced at the 2001 American Society of Hematology Conference. The Phase II study supports the conclusion that the critical parameters for evaluating red cell quality, i.e., in vivo 24-hour recovery, hemolysis, and neoantigenicity, were unaffected in red blood cell units treated with the INACTINE™ process and stored for up to 42 days.


Aptamer Technology
Prion proteins in their pathogenic form are the agents that have been implicated in several neurodegenerative diseases affecting animals (e.g., “Mad Cow” Disease), humans (e.g., variant Creutzfeldt-Jakob Disease) with incubation periods reported from 10 to 30 years. The disease is 100% fatal and there is no diagnostic or therapy currently available. Recent animal studies suggested the potential for the disease to be transmitted via a blood transfusion. Despite the fact that no case of Mad Cow Disease has ever been reported in the U.S., the FDA has implemented a series of increasingly restrictive donor deferral criteria preventing otherwise healthy donors from being eligible to donate blood. These criteria are based on cumulative time spent in countries with cases of Mad Cow Disease and/or vCJD, most notably the UK. The FDA has forecasted that the next, more stringent criteria set to go into effect in 2002, could remove an additional 5-8% of blood donors from eligibility.


In April 2001, Vitex signed a license agreement with Oxford University that grants Vitex exclusive access to Oxford’s proprietary RNA ligand (aptamer) technology. It is thought that the characteristics of aptamers are ideal candidates for the development of methods to selectively remove prions from complex solutions and a specific diagnostic for the pathogenic form of the prion. Using combinatorial chemistry techniques that enable high throughput screening of libraries of aptamer candidates, Vitex scientists, in collaboration with researchers at Oxford, are working to identify an aptamer that binds in a selective fashion to the pathogenic form of the prion.

[antec]

VITX sieht lecker aus




Float 2.50M

[megatip]

CDC Probes West Nile, Transfusion Link
Wed Sep 4, 6:05 PM ET
By LAURA MECKLER, Associated Press Writer

WASHINGTON (AP) - Health officials were trying to determine Wednesday if West Nile virus ( news - web sites) can be spread through blood transfusions. But any test to screen donated blood for the sometimes deadly disease is at least months, maybe years, away, they said.


AP Photo



Still, they emphasized that the blood supply is very safe and the risk of contracting West Nile from blood is significantly lower than the risk of forgoing any procedure that would require a transfusion.

West Nile, which emerged in the United States just three years ago, has exploded across much of the country this summer, with 673 cases and 32 deaths. But concern increased Tuesday when officials confirmed that at least three of four people who had received organs from a Georgia woman had contracted the disease. One died.

Officials said they are convinced that these patients got the disease through their transplants, though they do not yet know whether the virus can be spread through blood as well.

Dozens of epidemiologists at the Centers for Disease Control and Prevention ( news - web sites) in Atlanta and the CDC lab in Fort Collins, Colo., were trying to figure out how the organ donor, a Georgia woman who died in a car crash, got West Nile.

She had received blood from more than 60 donors before she died, and scientists were tracing those blood donors to see if any of them have the virus. They are also tracking down about a dozen other people who had received transfusions from the same donors.

It is possible the organ donor may have contracted West Nile from a mosquito bite, as others have. It also is possible that the virus can be spread through organ transplants but not through blood. Still, health officials suspect that blood can carry the virus, at least in some cases.

For now, they are reminding blood banks to be sure that no one with a fever or who appears ill donates blood, which could eliminate those with mild West Nile symptoms. They are also urging organ procurement organizations to be aware of the issue.

Ultimately, a screening test is probably needed, said Dr. Lester Crawford, acting commissioner of the Food and Drug Administration ( news - web sites). He said government would work with industry to stimulate faster development of a test.

Even so, testing for the virus is complicated. Some of the tests that are used to diagnose West Nile in sick people will not pick up the virus in donated blood. Other more promising tests would require significant improvements to be practical on a mass scale, enabling blood banks to screen millions of pints each year.

"I`m reasonably optimistic that if needed, it could be done," said Dr. Jesse Goodman, deputy director of the Center for Biologics, Evaluation and Research at the FDA.

He suggested that an early test could be used to screen blood going to patients who are particularly susceptible to West Nile. The FDA could allow use of the test as an experimental product before it is officially proven effective and licensed. That, he said, could give the blood supply some quick added protection.

Others are less confident.

"It`s going to take several years to have a test suitable for blood donors," said Dr. Harvey G. Klein, chief of the Department of Transfusion Medicine at the National Institutes of Health ( news - web sites) and past president of the American Association of Blood Banks.

The tests, he said, are very early in their development. "Prior to the appearance of West Nile in this country there was certainly no reason for U.S. manufacturers to develop a screening test."

He said that tests available today would produce some false positives, where healthy blood appears to be infected. Using these test could mean throwing away many pints of good blood at a time when the blood supply barely keeps up with demand.

West Nile is now diagnosed in patients using an antibody test, which looks for signs in the blood that the body is fighting off the disease.

That test cannot be used to screen donated blood because the virus lingers in the blood for at least a few days — maybe as long as two weeks — before a patient develops symptoms and detectable antibodies, which the body produces to fight off disease. Officials are worried about people who donate blood before they know they are sick.

Further, people with West Nile do not always get sick. Just one in 150 people with the virus gets severely ill with a potentially fatal brain inflammation. An estimated 30 in 150 people will get minor symptoms.

More promising, experts say, is a test that looks for the virus itself in the blood. Nucleic acid tests look for genetic material that is present in the blood and have already been successfully licensed to screen blood for HIV ( news - web sites) and hepatitis C.

But it will be difficult to transform this sort of test into reliable mass production.

"There are many challenges in taking something that works in a lab and moving it into the field," Goodman said. "Those are challenges that can be met if needed, but they are substantial."

___

On the Net:

Food and Drug Administration background: http://www.fda.gov/cber/safety/westnile.htm

Centers for Disease Control and Prevention background: http://www.cdc.gov/ncidod/dvbid/westnile/index.htm

[INXS]

http://www.bloodtransfusion.com/outlook/inactivate_pathogens…



A New Way to Inactivate Pathogens
Brian McDonough
President, North America Blood Products, Pall Medical

Brian McDonough is currently president in North America of Blood Products, Pall Medical, whose current focus is that of pathogen reduction, a term which replaces “pathogen inactivation.” Pall Medical is spearheading this effort with Pall’s partner, VI Technologies, or VITEX. Mr. McDonough introduced the audience to the Pall Purecell Pathogen Reduction System, which utilizes the INACTINE™ compound — the new name that Pall is coining for this technology. He said, “My mission tonight is to try to give you, from our perspective, the overall goal and benefits of this particular pathogen reduction technology, as well as information about the transfusion safety benefits, some of the results of our trials from safety assessment, and the overall red cell quality.”

“Our goal is to advance the safety of transfusion medicine. The chemistry that’s used — the INACTINE compound, otherwise known as PEN110 — was developed by our partners, VITEX. I think the evidence is clear that the spectrum of kill for the pathogens from this particular compound is, indeed, impressive.”

A Novel Approach to Blood Safety
The medical professionals are beginning to accept the technologies used to render these pathogens inactive — by stopping the replication of RNA and DNA. A critical question remains: By introducing these chemicals, are you, in fact, introducing into the original safety of the blood supply a greater harm than the original chemical — or via this chemical?

The approach that the Pall Purecell Pathogen Reduction system takes is quite a novel one. With an active process, this “red cell purifier” follows a two-prong approach:

1. It uses a very effective chemical that provides a broad spectrum of pathogenic kill;
2. A purification process is employed, using the Haemonetics cell washing technology. The intended benefits of the INACTINE technology are:

to reduce the vulnerability of the blood supply to unscreened pathologies;
to reduce the residual risk of screened pathologies;
to avoid the introduction of new screening tests; and
to expand the donor pool by relaxing restrictions.
Where Does the Chemical Go?
As for the overall process, all of these technologies involve putting a chemical in the unit, and all of the blood components have a different effect from any one particular chemical. There’s a fair amount of conviction that these chemicals are, in fact, very effective in the spectrum of kill. However, the question remains: What becomes of the chemical, and what are the potential toxic effects, or other effects of the chemical?

In the Pall Purecell process, we take a rather aggressive approach to “red cell purification.” This overall process of delivering the chemistry — incubating it at, for example, room temperature, then removing the chemical — is being developed for use in the blood center environment. This is our primary model for rolling this out in the future. Mr. McDonough said, “The washing process delivers to us, essentially, a 10,000-fold reduction. If we’re concerned about the chemical in the unit, we can quench the chemical — or we can take extraordinary measures to remove it. Pall and VITEX have agreed that we want to go to the extraordinary measures to remove the chemical. We think that there are exciting benefits to come from the pathogen reduction system. The Purecell System essentially introduces a chemical to effect the pathogen kill, and takes the necessary measures to remove that chemical – and what Rick Davey calls ‘the other junk.’ What we’re left with is a pure red cell. We believe that the pure cell, with INACTINE compound, is a promising approach to significantly advancing the safety of transfusion medicine.”

[HUGENEWS]

New technologies aim to ensure safety of blood supply
MARKET IS ESTIMATED AT $2.5 BILLION A YEAR
By Paul Jacobs
Mercury News

Two decades ago, Dr. Laurence Corash arrived at the University of California-San Francisco and began treating patients with rare bleeding disorders by giving them clotting factors extracted from donated blood.

Within a year, all were infected with HIV -- the virus that causes AIDS.

Corash`s patients were among the thousands around the world who got the virus from blood products intended to save lives. In the early days of the AIDS epidemic, before there was donor screening and blood testing, blood transfusions all too often had the opposite effect.

Today, Corash is co-founder and chief medical officer of Cerus in Concord, one of a few companies racing to win approval for technologies that can inactivate many viruses and other disease-causing microbes transmitted in donated blood -- including future threats to the blood supply, as yet unknown.

Whether these technologies, which work by locking up the microbes` genetic machinery, will be approved for marketing by regulators and adopted by U.S. blood banks is still uncertain. At issue is not just the safety and effectiveness of these methods for the recipients -- 4.5 million patients a year -- but the added costs that must be absorbed by taxpayers and consumers.

For the companies, the issue is simple. Safety should be paramount.

Blood banks, said Chief Executive Officer Stephen T. Isaacs, ``initially wanted to know what bugs can you kill, and then they wanted to know: Do the cells still work, do they still carry oxygen, do they stop bleeding? And now the concern is more about the economics -- who`s going to pay the bill?``

Isaacs believes the public will want the assurance of the safest possible blood supply.

``If you`re the patient, you want safe blood,`` he said. ``You don`t want to be the guy who gets HIV in Florida last week, especially if there is something that could have been done for just a little bit of money to prevent that from happening.``

Isaacs was referring to recent reports of two Florida patients infected by blood products from a donor whose own infection was too early to detect using the latest tests for the presence of HIV.

``Most people don`t believe that blood is safe,`` said John Barr, chief executive of Cerus` rival V.I. Technologies, known as Vitex, in Watertown, Mass. ``The perception is, if I can avoid transfusion, I will.``

Underscoring the potential of the new technology, the Food and Drug Administration later this week will hold a workshop on methods for reducing pathogens, which are disease-causing microbes, in blood products.

Today, there`s wide agreement among experts that the nation`s blood supply is safer than it`s been in the 65 years since the first U.S. blood bank was established. As recently as the 1970s, as many as 10 percent of transfusion patients caught serious forms of viral hepatitis. And then in the `80s the AIDS epidemic hit.

New, highly sensitive tests for HIV and hepatitis B and C have greatly reduced the dangers of transfusions. But the risk of infection from donated blood, now thought to be about one in 2 million for HIV, still persists.

Other diseases

And there are other infectious diseases carried in donated blood that can be harmful, even deadly, and are simply not tested for.

Blood platelets are small cell-like bodies vital to blood clotting and wound healing. They are widely used to control bleeding following surgery and chemotherapy. As many as one in every 2,000 platelet recipients is exposed to bacteria that can cause life-threatening illness.

Cerus has a system for chemically treating blood platelets that is likely to become the first of the new ``pathogen inactivation`` systems to reach the market. In June, the company and its partner, Baxter International, won a crucial European approval for their system. They hope to launch sales later this year, when they`ll also complete their application to the FDA for marketing in the United States.

The platelets will be the first big test for Cerus, which uses a class of chemicals called psoralens to cleanse blood products. Natural versions of these light-sensitive compounds are found in lemons, figs and parsnips. In the lab of University of California-Berkeley Professor and Cerus co-founder John E. Hearst, Isaacs designed synthetic psoralens that are strongly attracted to DNA and RNA, the chemical instructions for the duplication and maintenance of all living creatures, including bacteria and viruses. When exposed to light, these psoralens bind tightly to DNA and RNA, preventing cells and viruses from multiplying.

Potential

Corash realized the potential of psoralens to kill microbes without harming the main components of donated blood -- platelets, oxygen-carrying red blood cells, and plasma, the protein-rich liquid portion, because none of the three requires DNA or RNA.

As it turned out, light-activated psoralens worked fine in plasma and platelets, but not in red blood cells. So Cerus scientists developed another chemical that is activated when added to red cells, without the need for ultraviolet light.

An added benefit is that it also kills any white blood cells that remain in blood products and can cause severe, even life-threatening complications in transfusion patients.

At Vitex, which has its own pathogen inactivation system, the emphasis is on red blood cells.

``It`s the largest market, the most important transfusion product,`` says CEO Barr.

Cerus estimates the total market for pathogen inactivation of blood products to be $2.5 billion a year, with most of the total, $1.7 billion, coming from red cells.

Both companies are beginning clinical trials of their red blood cell systems for the replacement of blood lost in open-heart surgery, and for the repeated transfusions required by patients with sickle cell anemia and other inherited conditions. Even if results are positive, approval for U.S. marketing is still at least two years away.

Each of the companies argues that its system is superior.

For example, the Vitex system requires extensive washing of the red blood cells, which is seen as a potential problem by blood experts. But the company says that the added step should make it possible to remove prions, which are misshapen proteins that are thought to be responsible for a rare, but deadly human version of mad-cow disease.

A third company, Gambro in Stockholm, Sweden, is working on a system that uses light-activated riboflavin, vitamin B2, to inactivate microbes, but it has yet to begin testing treated products in patients.

All three companies have obtained patents for their systems.

Executives at Cerus, however, say a broad U.S. patent issued in June covers the Vitex technology. But Cerus must still satisfy the FDA that unlike other psoralens, the one it is using will not cause cancer. The company has conducted animal tests showing there is no problem; and it has added a step to remove excess amounts of the chemical from the final products.

``That still remains a question,`` said Dr. Paul M. Ness, director of transfusion medicine at Johns Hopkins in Baltimore and a past president of the American Association of Blood Banks.

Ness says Vitex also will have to convince regulators that its product is safe. (The Hopkins blood center has conducted clinical trials for Cerus; Ness has consulted for Gambro and for Vitex partner Pall Corporation.)

``One of my concerns is that none of these methods is the holy grail in terms of pathogen kill,`` said Dr. Michael P. Busch, vice president for research at Blood Systems, a non-profit consortium of blood banks that includes Blood Centers of the Pacific based in San Francisco. Busch has been a scientific adviser to both Gambro and Vitex.

Busch points out that the FDA now uses the term ``pathogen reduction`` and not ``pathogen eradication`` or ``pathogen inactivation.``

But he agrees that the systems could reduce the risk of unexpected microbes that might turn up in donated blood. ``People are discovering new agents each year,`` he said.

Stock analysts believe that once a new system is approved by the FDA it will be difficult for the blood banks to turn their backs on it.

``Eventually there will be universal adoption,`` said JPMorgan analyst Maged Shenouda, who estimates that the companies would tack on an additional $50 for each $200 unit of red cells. JPMorgan has no investment banking relationship with either company and Shenouda holds no stock.

RBC Capital Markets analyst Steve Hamill sees Vitex and Cerus neck-and-neck in the race to win approval for treating blood cells. Hamill holds no shares in the companies and RBC has no relationship with them.

``The market here is so large that if successful, they could become very large companies very quickly,`` Hamill said.

Once approved, there will be enormous political pressure on the blood banks to adopt the new systems, despite the increase in costs.

Says Hopkins` Ness: ``As director of transfusion medicine and a blood bank, I`m the advocate for patients who are transfused. . . . And I`m going to do my damnedest to reduce risk.``


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Contact Paul Jacobs at [e-mail] or [phone].

[HUGENEWS]

Cleansing blood comes at a price
Firms are working to develop technology that would eradicate pathogens, but the cost of processing a unit of blood would soar.
By WES ALLISON, Times Staff Writer
© St. Petersburg Times
published August 8, 2002


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BETHESDA, Md. -- To the experts ensconced at the nation`s mecca for medical research, the concept seemed quite appealing: Find a process that can cleanse donated blood of HIV, hepatitis and other bugs, further winnowing the risk of getting sick from a blood transfusion.

But when it came to determining how best to make that happen -- or even if it`s practical -- agreement did not come easily.

The giants of America`s blood-banking world, along with the makers of medical devices and federal regulators, convened Wednesday at the National Institutes of Health for a workshop on cleaning blood of HIV, hepatitis C and a host of viruses, bacteria and parasites, some of which may not even have been discovered.

Those who try to ensure the safety of America`s blood supply were jarred last month when Florida Blood Services, the Tampa Bay area`s main blood bank, announced that HIV-positive blood went undetected and that two unidentified transfusion recipients were infected.

It marked only the second known case since blood banks began using an extremely sensitive test in 1999, and the risk of contracting HIV from a blood transfusion is estimated at just in 1 in 2-million. But blood banks and the U.S. Food and Drug Administration, which is sponsoring this week`s workshop, would like to cut that risk even further.

The goal is "to get out that last, very small sleeve of risk that remains," said Dr. German Leparc, medical director of Florida Blood Services, who is attending the conference. The blood bank hopes to begin limited, experimental use of a blood-cleansing system by early next year. "More testing is not going to be the answer," he said. "We`re reaching the testing capability limits."

The industry calls this new technology "pathogen inactivation." Three firms, Cerus-Baxter, Gambro and Vitex, released data at the workshop Wednesday showing the technology kills a wide range of organisms, including HIV, malaria and mad cow disease. It also appears safe.

In general, the process works one of two ways:

A chemical is added to platelets, red blood cells or plasma to make the pathogens more sensitive to light. The blood is then zapped for about 20 seconds with ultraviolet rays or visible light.

The other way involves adding chemicals that attack the pathogens. In both cases, the goal is not to filter the blood, but to destroy the DNA -- the very soul -- of any bugs in it, rendering them inert.

Since 1999, American blood banks have used highly sensitive nucleic acid testing to look for HIV in donated blood. It works very well, with one large qualifier: If the donor gives blood up to 10 days after becoming infected, as is believed to have happened in the St. Petersburg case, there may not be enough virus in the sample for the test to detect.

But while HIV gets the headlines, experts said the technology`s biggest benefit may be in killing the wide array of bacteria, from staphylococcus to streptococcus, that likely contribute to 100 deaths and hundreds of illnesses each year stemming from transfusions.

These bacteria can come from the donor`s blood or the donor`s skin, or may be introduced during processing. However, it is difficult to test for them, and the illnesses they cause often are blamed on the patient`s underlying condition, said Dr. Matthew J. Keuhnert, an epidemiologist for the U.S. Centers for Disease Control and Prevention. He warned attendees Wednesday that bacteria is too often overlooked.

A joint study by the American Red Cross, the American Association of Blood Banks and the CDC found that the chance of contracting sepsis, a potentially fatal bacterial infection, from a transfusion is better than 1 in 100,000, the same as in 1983. Keuhnert said the risk is probably much greater.

Most susceptible are platelets, the blood`s clotting agent, which are syphoned from blood and given to very sick patients. Unlike other blood products, which are chilled or frozen, platelets must be stored at room temperature, allowing bacteria to grow.

"This is the most common cause of morbidity and mortality from a blood transfusion, way more than HIV, way more than hepatitis, way more than anything you`ve heard of," said Dr. Roslyn Yomtovian, director of the blood bank and transfusion medicine at University Hospitals of Cleveland. "And there`s nothing systemic being done about it."

But, as became apparent during a feisty, hourlong panel discussion, experts from the United States, Europe and Canada have many concerns about pathogen inactivation as well: Cleansing blood could double or even triple the cost of processing a unit of blood, to nearly $300.

The treatment damages blood cells, meaning blood banks may need to collect more blood than they do now -- a difficult prospect, because most banks are always scrambling for donors.

Blood bank officials and FDA scientists also worry about exposing millions of people to chemicals used in the treating process, especially when the risk of serious infection is low.

Dr. Steve Wagner, director of cell therapy for the main American Red Cross lab in suburban Washington, noted it will take years of surveillance to ascertain its safety. For instance, a girl who gets a blood transfusion as an infant must be watched to see if she is more likely to develop cancer as an adult, or if she gives birth to disabled children.

Cleansing also would not replace the rigorous, expensive testing that donor blood now goes through. And because so few transfusion patients become infected with HIV and hepatitis now, some wonder how the FDA will measure the long-term efficiency of the process and what the standard for the technology should be. Most acknowledge it will be impossible to kill everything, just as it`s impossible to screen everything.

What amount is acceptable?

"Is this really public health?" asked Dr. Roger Dodd, the Red Cross` executive director of biomedical safety. "Is this worth the cost? If this were a vaccine, I`m not sure we would be recommending it."

Leparc, of Florida Blood Services, put it this way: "Do we have to expose 2-million people to a new and unknown risk so that one of them is going to spared HIV? That`s a big question."

Despite the misgivings, the answer seems to be yes. Cerus Corp.-Baxter Healthcare has cleared the first of several regulatory hurdles for approval of its so-called Helix pathogen inactivation system in the European Union.

By early next year, Florida Blood Services hopes to be working with at least one local hospital to test one such system, Leparc said. Bacteria, not HIV, is the primary target.

The conference continues today with a discussion on the downsides of the new technology, especially the damage it does to blood.

But at least three companies have submitted early test results to the FDA. If the FDA licenses the process, declaring it safe and effective, blood banks probably won`t have a choice but use it. Most state laws, including Florida`s, protect blood banks from lawsuits, provided they use the best-available technology for testing and treating the blood.

FDA licensing of one system or another will likely lead to it becoming the "de facto standard of care," Leparc noted. "I don`t know how anyone could justify not doing it. Once the FDA gives the go-ahead, you can`t raise the specter of cost."

[mp7]

Vitex ist glasklarer kauf!!!!


Das könnte ein highflyer werden!




http://biz.yahoo.com/bw/020905/52549_1.html

In the U.S., the FDA`s Blood Products Advisory Committee, an independent board upon which the Federal Government relies to furnish expert advice, unanimously agreed that, "the benefit to risk ratio associated with leukoreduction is sufficiently great to justify routine leukoreduction of all non-leukocyte transfusion blood components...." Since this September, 1998 recommendation, leukocyte reduction by filtration in the U.S. has increased from about 16% to more than 40% today. The American Red Cross, which manages about 45% of the U.S. blood supply, has publicly stated its intention to filter all of its blood collections by the end of the year.

Pall Corporation, the market leader, offers the broadest range of advanced blood filtration products and the support services to help blood centers meet the challenges of implementing routine, high volume, blood filtration. The Company is prepared to meet the growing requirements of its customers for products, logistics and regulatory support. Pall reported fiscal 1999 blood filter sales in excess of $185 million and sales for the first nine months of fiscal 2000 have increased 19% in local currency, reflecting increased worldwide demand. The world market for blood filters is estimated at $1.2 billion.

The Company is also collaborating with V.I. Technologies (NasdaqNM: VITX) to be the first to commercialize pathogen inactivation technology for red cells. Red cells are the most frequently transfused blood component with over 50 million transfusions worldwide annually. Pathogen inactivation is breakthrough technology that promises to eradicate harmful pathogens, including HIV and Hepatitis C, from donor blood. When coupled with the market for pathogen inactivation technology, the size of the market is over $5 billion.

Pall is the acknowledged technology leader in the increasingly complex and demanding filtration industry and has been for more than 50 years. The Company serves more markets with more proprietary products than any other company in the $18 billion filtration industry. With annual sales of over $1 billion, Pall Corporation is based in East Hills, New York, USA and operates directly in 30 countries. The Company`s shares are listed on the New York Stock Exchange (PLL). Further information is available at http://www.pall.com and http://www.bloodtransfusion.com.


http://www.pall.com/investor/press_releases.asp?/www/whatsne…


http://biz.yahoo.com/prnews/020807/nyw048_2.html



Vitex and Pall Modify Partnership
- New Agreement to Advance INACTINE(TM) Commercialization -
WATERTOWN, Mass. and EAST HILLS, N.Y., Aug. 7 /PRNewswire-FirstCall/ -- V.I. Technologies, Inc. (Nasdaq: VITX - News; Vitex) and Pall Corporation (NYSE: PLL - News) announced today the modification of their worldwide collaboration for the INACTINE(TM) red blood cell pathogen inactivation system. Driven by the recent receipt of FDA approval to commence pivotal Phase III clinical trials in the United States, this modification seeks to accelerate clinical development and broaden geographic distribution in the United States and other international markets through the establishment of agreements with additional distribution partners.

As part of this modification, Pall will relinquish its exclusive worldwide distribution rights in return for a cap on its financial commitments to the program and a royalty per unit sold following commercialization. During the next twelve months, Vitex will assume sole responsibility for establishing additional partnership agreements designed to broaden geographic distribution capability for the INACTINE(TM) red cell system. At the end of the one-year period Pall will have the option of reverting to its exclusive marketing rights in any territories not covered by new partnerships in return for foregoing its potential royalty and committing to a future stream of R&D payments.


The key terms of the agreement include:
* Vitex will continue to work aggressively on the R&D and clinical
program while collaborating with Pall on priorities and on technical
initiatives. In particular, Pall and Vitex will ensure that
INACTINE(TM) technology and Pall filters, solutions and blood bags are
compatible in each country where the technology is licensed. Pall
filters will be used exclusively in the INACTINE(TM) system.
* Pall will fund the upcoming $4,000,000 equity milestone upon enrollment
of the first patient in the Phase III trials.
* Pall will extend a one-year $5,000,000 revolving credit facility to
Vitex. The amount of this facility approaches Pall`s financial
support over the past year.
* Vitex will retain all proceeds from new partnerships including upfront
rights fees, milestone payments and ongoing royalties or profit
sharing.
* Jeremy Hayward-Surry, President of Pall, will continue to serve on the
Vitex Board of Directors.


John Barr, Vitex`s President and CEO commented, "We believe that the INACTINE(TM) system holds the potential to be the worldwide standard for red blood cell pathogen inactivation. With the recent receipt of FDA approval to initiate the pivotal Phase III program, Vitex`s clinical development program is ready to shift into high gear in Europe and Japan. While Pall`s involvement and support continues to be an important element in the overall path to market, we welcome the opportunity to discuss possible areas for collaboration on the INACTINE(TM) red cell system with additional corporate partners in these and other geographies.

"We now have an excellent opportunity to add new partners complementary to Pall`s and Vitex`s capabilities. We would expect new partners to bring financial, distribution and technical resources to help ensure our success around the world. Given the late stage nature of the program, we believe this also provides a window for non-dilutive funding for the INACTINE(TM) program."

Eric Krasnoff, Pall`s Chairman and CEO, added, "We are committed to the rapid commercialization of the INACTINE(TM) program. Pall and Vitex have worked successfully to bring the technology to pivotal Phase III clinical trials. Our goal now is to spur widespread and early adoption of the technology globally.

"We believe this can be best achieved by a broader group of distribution partners and by having a single company, Vitex, responsible for advancing this strategy. Modifying our partnership was an essential first step in the process. Further, by capping our financial commitment to Vitex over the next year commensurate with our role in the project we are positioned to do what is in the best interest of both Vitex and of Pall`s investment in the Company."

About Vitex

Vitex is developing products designed to improve the safety of the world`s blood supply. The Company`s revolutionary INACTINE(TM) technology is designed to inactivate a wide range of viruses, bacteria and parasites, and has demonstrated its ability to remove prions, while preserving the therapeutic properties of red blood cells. The technology works by binding to the RNA or DNA of the pathogen. Once bound, the compound forms an irreversible bond to the pathogenic nucleic acid, preventing replication and thereby "killing" the pathogens. The Company`s lead product is INACTINE(TM) Pathogen Inactivation of red blood cells. The Company continues to report on its rapid progress in demonstrating the system`s ability to meet the three critical requirements for commercial success with a pathogen reduction system: broad pathogen kill, a wide safety margin for the patient, and maintenance of the therapeutic properties of the red blood cell. Over 40 million red cell units are transfused annually in the US, Europe and Japan, representing an over $4 billion market opportunity. The Company currently has relationships with Pall Corporation, Haemonetics Corporation, and Amersham Pharmacia Biotech. In collaboration with Oxford University, Vitex is developing a diagnostic test for pathogenic prions using aptamer technology. In their pathogenic form, prions cause "Mad Cow Disease" in cows, or variant Creutzfeldt-Jakob Disease in humans, which is 100% fatal and for which no therapy or diagnostic currently exists. For more information on Vitex, please visit our Web site at: http://www.vitechnologies.com.

About Pall Corporation

Pall Corporation is the global leader in the rapidly growing fields of filtration, separations and purification. Pall`s business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, municipal drinking water and aerospace. Pall is actively developing partnerships with companies that provide complementary services and technologies. Total revenues are $1.5 billion, after giving effect to the FSG acquisition. The Company is headquartered in East Hills, New York and has major operations in more than 30 countries. Further information is available at http://www.pall.com.

This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current Company expectations and are subject to risks and uncertainties, which could cause actual results to differ materially. With respect to Pall Corporation, such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company`s success in enforcing its patents and protecting its proprietary products and manufacturing techniques and in integrating the operations of FSG into the Company`s existing business; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company`s global markets. With respect to V.I. Technologies, Inc., such risks and uncertainties include but are not limited to quarterly fluctuations in operating results, anticipated clinical trial timelines or results, the timely availability of new products, market acceptance of the Company`s products, the impacts of competitive products and pricing, government regulation of the Company`s products. Additional information regarding these and other factors for both companies is included in each Company`s reports filed with the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at: http://www.sec.gov.

SOURCE: V.I. Technologies, Inc.