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Has MedaSorb found the Holy Grail which has eluded medicine for decades?

Anna Nicole Smith clearly didn't think she needed medical attention for systemic sepsis syndrome, a lethal blood infection, when she passed away at the Seminole Hard Rock Hotel and Casino resort in Hollywood, Florida.

Even as I write this report, Etta James remains hospitalized in Southern California as she recovers from sepsis, an infection, her manager said was caused by a urinary tract infection.

And as we read headlines that toxic cleaners are believed to be an underlying factor in Jett Travolta’s (son of actor John Travolta) untimely death at the age of 16, his father and mother held a fundraiser just last night in Ocala Florida for a detoxification project for local firefighters, policemen and emergency workers who have been exposed to toxins.

Severe sepsis is a life-threatening condition, which can affect anyone, and most often develops in patients with pneumonia, trauma, surgery, burns or cancer. Over 18 million cases of severe sepsis occur each year – that’s equivalent to the entire population of Denmark, Finland, Ireland and Norway added together each year.

The number of severe sepsis cases is growing at a rate of 1.5% per year, due mainly to the growing use of invasive procedures and increasing numbers of elderly and high-risk individuals such as cancer and HIV patients. Older people are at increased risk of sepsis as they are more prone to infections due to aging, co-morbidities, use of invasive surgical techniques and other problems.
According to various medical publications, massive resources have been invested in developing and evaluating potential therapies, and considerable effort has been undertaken to understand the systemic inflammation and multiple-system organ failure characteristic of severe sepsis.

Three years ago, I nearly died when my blood became infected after a severe bout with diverticulitis.  I fell very ill and ended up in the hospital for nearly three weeks as doctors fought, first to calm the severe infection that threatened to shut down my kidneys before sending me off to surgery.

The demands made on hospital staff by patients with these types of infections, place a significant burden on healthcare resources and one publication says it accounts for 40% of total ICU expenditures. When I showed some of those same doctors who had treated me images and descriptions of MedaSorb Technologies’ (MSBT.OB) flagship CytoSorb™ therapeutic device, most of the doctors could not believe it and some felt they could really use a device like this.

These days, the first-line of treatment doctors rely on to try to eliminate the underlying infection is antibiotics. Indeed, I remember having six or eight different antibiotic drips going into a main line and my blood was being tested every few hours in an effort to monitor how my body was responding. Depending on the patient’s clinical status, additional therapies are initiated, including drug therapy and supportive care, such as mechanical ventilation and kidney dialysis.  

There has been considerable excitement recently among critical care clinicians who care for patients like me.  For the first time there are trials showing positive results involving new therapeutic interventions like MedaSorb’s device. I spoke to Phillip Chan, MD, PhD, the Chief Executive Officer of the company. Dr. Chan is a Board-certified internal medicine physician with a strong background in clinical medicine and research, having completed his residency at Harvard Medical School at the Beth Israel Deaconess Medical Center. Dr. Chan received his MD/PhD from Yale University School of Medicine and his BS in cell and molecular biology from Cornell.

BioMedReports: Can you tell us about your company?

Dr.Chan: Sure. MedaSorb Technologies Corporation is a publicly traded development stage therapeutic device company working to save lives through blood purification. At MedaSorb, we’ve developed a highly bio-compatible, porous, polymer bead purification technology that can remove things as small as drugs and toxins to things as large as antibodies from blood and physiologic fluids. Right now we are currently conducting a randomized, controlled clinical trial of up to 100 patients in Europe with our product CytoSorb to treat patients with severe sepsis, which is often called “overwhelming infection” in the lay press.  CytoSorb is a highly efficient cytokine filter designed to treat severe sepsis and septic shock by reducing potentially deadly cytokine-storm which is a well-known, major cause of organ failure and death with this disease. We’re currently driving to complete our European sepsis trial and if the outcome is positive, plan to apply for CE Mark approval for CytoSorb in the EU and, if approved, subsequently commercialize. If our European trial results are positive, we plan to present the data to the U.S. FDA and seek approval to conduct a clinical study in the United States.

We recently announced preliminary positive proof of concept in humans, using CytoSorb to treat severe sepsis patients in the setting of lung injury in a 22 patient randomized, controlled pilot study. We reported a summary of clinical data from all 13 patients that had fully monitored, completed data sets – this is 7 treated, 6 control patients – that demonstrated improvements with CytoSorb treatment in key clinical endpoints such as 28-day and 60-day all-cause mortality, ventilator-free days, pace of ventilator weaning, organ failure scores, vasopressor use, as well as days in the intensive care unit.  To date the therapy has been safe and well tolerated by patients. There have been no serious device related adverse events in more than 500 human treatments, more than 150 of which have actually been in patients with sepsis.  

The underlying technology is protected by a broad intellectual property portfolio of now 27 issued patents that range from composition of matter to clinical application patents, with multiple applications pending.  A key part of our know-how is related to polymer production, which we conduct at our manufacturing facility in New Jersey under strict, well-documented, reproducible processes that meet FDA clinical trial standards.

BioMedReports: You just said something interesting that I wasn’t aware of – you said that the CytoSorb technology can also clear a person of drug substances?

Dr. Chan: Our polymer platform technology is a highly porous polymer bead.  Although not quite the perfect analogy, imagine tiny sponges if you will.  But unlike natural materials, we can change the size and distribution of these pores in a highly reproducible way to enable the removal of different things of different sizes from blood and physiologic fluids. The CytoSorb resin is specifically designed to remove substances in the molecular weight range of 10-50 KiloDaltons in size, where most cytokines reside, a range that we call the cytokine ‘sweet spot’. But we also have the ability to change the porous nature of these beads to be able to remove other things that we want to target.  For instance, we have developed novel, highly efficient resins that can remove a variety of drugs that are common in drug overdose from blood and physiologic fluids.  

BioMedReports: What is the market potential for this product. Can you tell us a little about that?

Dr. Chan: Severe sepsis is one of the leading causes of death in the world. It afflicts people of all ages, particularly the very old and the very young, and it also afflicts all walks of life and all ethnicities. Unfortunately, most of your readers know someone who had developed a severe infection. It could have been something as catastrophic as a ruptured appendix, or something more common as pneumonia, maybe a bad urinary tract infection or even influenza - where the infection got out of hand and sent that person to the intensive care unit on life support, with failing critical organs like the hearts, lungs, and kidneys. This is severe sepsis and it afflicts more than a million people in the United States, roughly 1.5 million people in Europe, and an estimated 18 million people worldwide every single year. Despite the best medical care here in the United States, one in every three patients die of this disease, and in fact, more people die of severe sepsis in the United States than from either heart attacks or strokes or any single form of cancer.  It remains a major unmet medical need.

Without better treatments for severe sepsis and its more deadly cousin septic shock, which has a mortality rate of 50% or more, the numbers are only expected to increase with trends like an aging population, an increase in antibiotic resistant bacteria, the increased use of implantable devices like artificial hips and knees, diseases like diabetes and cancer, and others that put people at high risk of infection and sepsis. All of these are driving the incidence of sepsis higher.

BioMedReports: You know it’s interesting, we spoke to doctors about your technology to get their feel for it and the reaction we heard most was “Wow, is this real? And if it is, we could really use something like this.”  Do you get the same type of reaction out there?

Dr. Chan: We do. We have talked to a number of thought leaders in this space. As clinicians should react, they were cautiously optimistic. They wanted, obviously, to see data, but they felt that this was a promising approach worth pursuing and an approach that could actually work. And so hopefully with some of the early data that we’ve discussed from our pilot study, and pending data from the current European sepsis trial, we’re getting to that point.

BioMedReports: What is the potential impact that MedaSorb can have in that market we just talked about?

Dr. Chan: In order to understand our potential impact, it is important to understand how our science and technology works and how it could affect the pathophysiology of severe sepsis. Severe sepsis is primarily caused by two problems. The first is the infection, which can often be effectively treated by antibiotics, anti-virals, or other types of agents. However, the other facet of sepsis is the body’s immune response to the infection. Normally the body produces small proteins called cytokines that help stimulate and regulate the immune system, and they’re normally helpful. But in many people with severe infection, the body’s immune system goes haywire and produces massive amounts of these cytokines, often called ‘cytokine storm’, to the point where they’re no longer helpful, but are in fact toxic to the body, causing direct cell death, damaging organs, leading to organ failure and, in many cases, death.

For instance, certain cytokines can cause blood vessels in the lungs to become leaky, allowing inflammatory fluid, cells and other cytokines to fill up the lungs, essentially drowning the person in their own fluids. Cytokine storm can also lead to hemodynamic collapse, where the heart can no longer get blood and oxygen to critical organs, leading again, to organ injury. Cytokine storm can also shut down the kidneys, which is another major risk factor for death from severe sepsis. The role of cytokine storm in sepsis is widely accepted by clinicians and researchers, and has been very well researched.  Interestingly, if you do a Pub-med search on cytokines and sepsis you’ll literally bring up 10,000 articles.

To drive the point home, in 2006, there was a Phase I safety study done by another company that was trying to stimulate the immune system to fight cancer with a specialized monoclonal antibody. This was reported in the New England Journal of Medicine. When they actually injected this antibody into six healthy young male volunteers, who did not have infection or cancer –they all developed cytokine storm along with the hallmarks of severe sepsis including acute lung injury, renal failure, clotting disorders, and shock.  In fact, two of the volunteers who had the worst cytokine storm actually developed severe septic shock and acute respiratory distress syndrome.

This is just an example of how it is not the infection, but rather cytokine storm that causes multi-organ failure and sepsis. The reduction of cytokine storm has been the Holy Grail of the industry for the past 2 to 3 decades, and unfortunately most of the approaches that have been tried have only been capable of removing one cytokine or one inflammatory mediator at a time.  The problem is that different cytokines have overlapping functions and there’s so much redundancy in the immune response that if you remove one cytokine, even if it’s an important one, twenty others will take its place. So what is really necessary is a broad spectrum approach to try and remove cytokines across the board, and reduce them to a level where they are no longer toxic, but not reduce them so much that they can no longer help the body fight infection. With our product CytoSorb, we are one of the leaders in the research of reducing the effects and improving recovery from severe sepsis and cytokine storm.

CytoSorb is a cytokine filter that can broadly remove cytokines from blood. The treatment is very simple and similar to hemodialysis, the most widely used blood purification treatment in the world. You use a standard dialysis machine found in most hospitals by leading vendors like Fresenius, Baxter, B. Braun and others, to essentially pump blood out of the body through our cartridge. The blood goes directly through our cartridge and contacts the resin. Cytokines are adsorbed and removed from blood and that “purified” blood is then put back into the body. In our clinical study we are treating for 6 hours a day for 7 days, each day with a new device. We have the ability to treat an entire person’s blood volume 20 to 30 times over the course of a 6 hour treatment. So the goal is to reduce cytokine storm, prevent and limit organ damage and allow the body time to heal and recover.

We know that from our in vitro studies we can remove 50 to 70% of certain cytokines in the first hour of treatment, and over the course of several hours, remove 90 to 95% of certain cytokines, in our bench top circulation system that simulates human treatment.

Our polymer resin is highly hemo-compatible. It meets what is called the ISO-10993 standard for 30-day medical device implantables. That includes things like bio-compatibility, hemo-compatibility, cyto-toxicity, geno-toxicity, acute sensitivity and other factors. Our device also has massive capacity, unlike a standard hemo-dialyzer that has very limited capacity to bind cytokines because of very limited surface area. A single one of our cartridges has 7 football fields worth of surface area on which to bind cytokines. This massive capacity is really important in trying to reduce cytokine storm and is a major differentiator between our technology and others.

Our technology is also what we call a ‘razor blade in other people’s razor’ model, because it is compatible with standard hemo-dialysis equipment.  Hospitals would only need to purchase our CytoSorb cartridge to use it.  They have all of the other necessary equipment. It also contains no cells, no antibodies, nothing that can degrade over time, so it has excellent shelf life stability. We currently have 3 year shelf life stability at room temperature. It really has a number of significant advantages over other technologies.

BioMedReports: Let’s talk about the trials in Europe. Has it been easier to recruit patients there then if you had done the trials in the US?

Dr. Chan: We continue to make good progress. We’re working with a stellar group of experienced and motivated investigators, many of whom are thought leaders in critical care in Germany. That’s very important. Germany, as you know, is the largest medical device market in the EU and the 3rd largest in the world, so it makes a great first market for us. There have been a number of issues related particularly to distance, language, as well as time, differences that pose a number of challenges, but we’ve learned to adapt.

BioMedReports: Tell us about any additional goals for the company for 2010?

Dr. Chan: Our major goal is the successful completion of our trial, which will hopefully lead to CE Mark approval.

BioMedReports: What are the challenges you see for the company in 2010?

Dr. Chan: One of the major challenges for us is that we have a lot going on at the company with a lot of moving parts. There are many things we need to work toward this year including completing our clinical trial, seeking CE Mark approval, having regulatory discussions with the FDA, and other things required if we can successfully commercialize our technology.  As a development stage company we also put a lot of effort into our financing strategy so that we can continue to raise capital to fund our operations.  We have a very strong management team and we are working diligently to execute on our vision.

BioMedReports: Have you discussed any strategic partnerships to go to market or to do the trials for example?

Dr. Chan: If our technology works as we hope, it really has the potential to be a blockbuster product that can impact the top and bottom lines of most potential strategic partners. We have a very active business development program under way at the company that’s been going on now for more than a year. CytoSorb is an extensively patented product. It has a highly profitable business model. It’s in a market that has little competition and literally has a world of opportunity in front of it. We believe it’s a technology that is attractive to potential strategic investors and hopefully with positive data from our trial we can make something happen there, but we aren’t dependent on a strategic partnership. Whether we partner with a larger company or take the product to market directly, we’re prepared to do either.

Safe Harbor Statement: Statements in this interview that are not historical fact are considered forward-looking statements and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Please see the Company’s SEC filings for additional details. 

Disclosure: Long MSBT