Cerus Interview, Concord, California – UV Blood Cleaning Solutions
What is Cerus first of all?
Cerus is a biopharmacutical company, we are a pioneer in the area of blood safety, we developed something called the helix technology to protect transfusion recipients from transfusion transmitted disease, we are developing inner set blood systems which incorporate this helinx technology, these products are in the clinic today and we are also using helinx in the oncology arena, we have trials going on for leukemia and some other earlier applications in cardiology and infectious diseases
Cerus is what are what are you trying to do?
Cerus is a pioneer in the area of blood safety, we really are a bio pharmaceutical company, we developed something called the helix technology, helix allows us to inactivate virus bacteria and other disease causing bacterium so that we can prevent transfusion transmitted disease, we are using helinx technology in the intercept blood system with out partner Baxter, these systems are in the clinic today and we are also using the Helinx technology in the oncology arena to treat advance leukemia and there are some other very exciting applications in cardiology and infections disease that we are perusing.
What do you think ing are the marketing potential in your product?
Well first of all the safety in the blood supply is really a global issue, anybody who gets a blood transfusion wants to make sure that they are not going to get a transfusion transmitted disease, this has created a very large demand for pathogen inactivation systems like intercept to keep the blood supply safe so for platelets, plasma, and red cells, we estimate the annual market in excess of two billion dollars.
You are the only technology that works for all three-blood products?
We are competiveley very well positioned, we are the only company to have all three blood systems in the clinical trials today we were the first to take platelets into the clinic, the first to take red cells into the clinic and we are very much ahead in those trials and furthermore we have Baxter as our partner, Baxter will use their worldwide manufacturing company to manufacture these products and their global distribution system to get them out to their customers and that gives us a very significant competitive edge
Why do you we need this technology?
It’s not on your list? Well there is a global need for safe blood, anybody who is going to have a transfusion wants to make sure that that transfusion is safe there is about 25,000 people who are infected with HIV who acquired that infection through the use of contaminated blood products and another 300 thousand people in the U.S alone are infected with Hepatitis C and the intercept blood systems are going to prevent that from happening again in the future when the next deadly virus or bacteria comes along and gets into our blood.
Okay so take me back to helinx technology
The helinx technology is a way that we can actually inactivate viruses that inactivate bacteria and inactivate other disease causing organisms so that they cannot replicate and that blocks their ability to cause transfusion-transmitted disease.
Cerus is a biopharmaceutical company and we a are a pioneer in the area of blood safety, we a re using our helinx technology to make transfusions safe for people all over the world.
The blood supply isn’t’ safe around the world?
Well the blood supply is safer than it ever has been before but the problem is that we protect blood by testing, there is no protection from new organisms that can emerge and can get into their blood because there are no pathogens inactivation systems available, Cerus and Baxter are developing the intercept blood systems to protect the blood supply and the future emerging pathogens which can cause infectious disease.
What do you mean inactivate pathogens?
About 90 percent of the people in the developed world will need to use some type of therapeutic derive from blood during the course of their lives and so that makes the safety of the blood supply very important for each of us. For our friends, for our family, for our children. The way that the blood supply today is protected is through testing, so we keep, we test each and every unit of blood that is collected. But testing is not enough because we can not test for what we don’t’ know about, the only way to protect the blood supply from the next HIV or the next Hepatitis is to use pathogen inactivation’s such as the intercept blood systems, to protect the blood supply from new and emerging pathogens.
The blood supply is safe and what is entering it?
Back in 1970 we didn’t’ really know what HIV was, HIV evolved, a jump species, it got into our blood supply, by the time we got a test into place to protect the blood supply from HIV, 25 thousand people had been infected with that virus, there is no way to protect the blood supply from happening again in the future without pathogen inactivation because you can not test for what you don’t’ know about and that is exactly what the intercept systems are designed to do, protect the blood supply from the next HIV, the next Hepatitis or the next bacteria which gets into our blood.
Are you happy with intercept in exchange for Cerus. So the blood supply, is it really safe?
Back in 1970, HIV came along and got into our blood supply and before we had the test to protect ourselves from that virus, 25 thousand people had been infected and developed AIDS as a result, there is absolutely any way to protect the blood supply from that happening again with the next HIV without pathogen inactivation and that is just what the Cerus products are developed to do, to protect us from the Next HIV, the next Hepatitis, or the next deadly bacteria that can get into our blood.
Cerus products are pathogen in activators. They stop the, what do they do?
It’s very important to understand the difference between testing the blood in an inactivating pathogen, testing can only work when you know what the pathogen is. Inactivation on the other hand works by locking up the genetic materials that these organisms and for a virus or a bacteria or a cell to replicate, it has to be able to replicate it’s DNA or RNA first and the Helinx technology that Cerus has developed blocks this replication from occurring, if you block replication you block infection and that is how the process actually works.
Cerus is biopharmaceutical company and what we really have is a replication control technology, we call this the helinx technology, it can block the replication of viruses and bacteria in cells, the first application is to apply helinx to make the blood supply safe for transfusion recipients all over the world and we do this by blocking the ability of a virus or a bacteria or another type of disease causing organism to replicate.
The ability to block replication is a very important technology, besides.
The ability to block replication is a very powerful technology, initially we are applying this to making transfusion safe for transfusion recipients but there are many other applications, we are also working in the oncology arena, we have a clinical trial going on using the Helinx technology to treat advance leukemia in three different clinical centers around the United States today and we have other earlier applications in the cardiology arena, in the infectious disease arena and several other applications as well.
Well when you think about the life process there is nothing really more fundamental than the ability to replicate whether you are a virus or a bacteria or a human being so using the helinx technology with our small molecule chemical switches and the ability to turn this process off is very very powerful. And again we are able to apply this to decontaminate blood products, to make transfusions safe, to treat certain types of white cells, to treat leukemia and we may also use it to intervene in the cardiology setting for treating resdinosis.
I think that it is very important because it has impact in many healthcare arenas, obviously many people get malignant disease, we think that it has an application there, there are millions of procedures to treat various types of cardiac disease, we think that we have an application there and clearly if you are receiving a blood transfusion, it is very important that that blood transfusion is safe, again 90 percent of the people in the developed world will need to use some type of therapeutic derive from blood, so it makes the issue very important for just about everyone.
I think that this technology will touch everyone in the developed world because people will need to use some sort of therapeutic derive from blood, it may not be a blood transfusion, it may be something like a Hepatitis A vaccination, it may be something like IVI G, it may be a travel medication, all of these things are derived from human blood so up to the extent that that blood is at risk from disease causing organisms and we are able to purify and decontaminate intercept blood systems, this is an issue again that will touch everyone.
Well I think that it is completely revolutionary because this is the first we are going to be able to prospectively protect blood from new and emerging organisms if the technology in Cerus hands had been available 20 or 30 yeasr ago, we believe that we could have prevent 25 thousand people from being infected from HIV and 300 thousand people from becoming infected with Hepatitis C, so it is very very important.
Because of all the issues related to the safety of the blood supply we expect the intercept blood systems that Cerus is developing will become the standard of care, out platelet process that we are going to be submitting for regularly approval very soon and we expect to see the platelet product in the market place by the end of next year or the beginning of 2002 in Europe and late in 2002 in the United Sates. Our plasma product will be available in Europe and U.S towards the end of 2002 or early 2003 and we see the red cell product in the late 2003 as well. So we are developing blood solutions for all three blood components, platelets, plasma, and red cells and we are going to be delivering that total package, really, in the near future.
Cerus is very well positioned from a competitive point of view; we are the only company to have systems for all three-blood components. For platelet, plasma, and red cells in the clinic today. We were the first to put platelets in the clinic, we are the only player in the clinic today, with the platelet we were the first to take red cells into the clinic and we also have a single unit of Plasma product in the clinic.
We’ve been working on the intercept blood systems using the Helinx technology for the past 9 years, we’ve gotten through all the pre-clinical test that are required, we’ve shown that the cells and the plasma protein work after the process, we demonstrated that it is non toxic, that it is safe, and we’ve demonstrated that we can inactivate it a very wide variety of viruses and bacteria and parasites along the way, we’ve also taken this into the clinic, we’ve run 10 successful clinical trials, we have 4 more clinical trials going on today and we are in the beginning process of submitting the regulatory applications for these products to be approved, both in Europe and in the United States .
What we try to evaluate in our clinical trials are the blood products themselves still work, that platelets still stop bleeding, that the plasma cualigation cascades still works and the red cells still contain oxygen. This is known as clinical homeostasis, the products still perform their job and we have done that in every clinical product that we have run, the second major clinical goal of the trial s is to show safety and we have been able to do this we have had absolutely no transfusion associated adverse events with our products in the patient population which we have tested.
If you look at the history of safety in the blood supply almost every safety associated measure has been widely and quickly adopted and we expect that this will be no exception, safety drives the type of adoption of this kind of products, this is a quantum leap in blood safety, there are no other competitive pathogen inactivation systems to protect cells for platelets nor red cells in the market today and we do expect very rapid and wide scale adoption.
Yes we’ve just submitted regulatory application for our intercept platelet product we’ve been working on for the past several years, that’s for CE mark approval in Europe, that application is going to be processed through out the coming year, we do expect approval for platelets towards the end of this year and shortly there after and we are not that far behind in plasma, our plasma product are also in phase three, we expect the be submitting the regulatory application by the end of this year and approval towards the end of 2002 or shortly there after and that will be followed shortly by red blood cells, so that program is coming along very well, we are running our clinical trials and we will look for approval of that in the following year.
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