In the mid 80's, Dr. Daniel Zimmerman, inventor of the L.E.A.P.S.™ technology, and a long-time member of the team at CEL-SCI (AMEX:CVM) was working with a diagnostics company but he really felt it was time to make a change in direction. Luckily, he did.
He began searching to find a way to shift career gears and move into the area of therapy. An immunologist by trade and experience, he felt a drive to start looking more closely at other immune functions and systems.
"The one area that intrigued me, because of it's importance in a number of diseases, was the area of cellular immunology," explains Dr. Zimmerman.
That area concerns the interactions among cells and molecules of the immune system, and how such interactions contribute to the recognition and elimination of pathogens.
In the most simple terms, humans possess a range of nonspecific mechanical and biochemical defenses against routinely encountered bacteria, parasites, viruses, and fungi. The skin, for example, is an effective physical barrier to infection. Basic chemical defenses are also present in blood, saliva, and tears, and on mucous membranes. True protection stems from the host's ability to mount responses targeted to specific organisms, and to retain a form of “memory” that results in a rapid, efficient response to a given organism upon a repeat encounter. This more formal sense of immunity, termed adaptive immunity, depends upon the coordinated activities of cells and molecules of the immune system.
"We made a lot of progress over the years," says Zimmerman. "Even back then, we knew that the induction of an immune response was not a simple phenomenon involving a one-on-one type of relationship. We knew that it required multiple targets interacting simultaneously- or close to simultaneously- so as to initiate an immune response. Otherwise you would not induce an immune response, you might actually end up inhibiting it."
It was this idea of taking several different interactions and training the immune response to be more specific to a medical need that led him down the path towards developing L.E.A.P.S.™ - CEL-SCI's patented technology that is used to directly mimic cell/cell interactions on the T-cell surface with synthetic peptides.
Until recently, there hasn't been much attention paid to the development of this platform, but the scientific data and studies which have been making their way into various journals and presentations are starting to paint a picture full of hope for those suffering from any number of diseases for which antigenic epitope sequences have been identified. Those include infectious diseases, cancer, autoimmune diseases, allergic asthma and allergies. Select diseases of any component of the brain or the spinal cord, such as Alzheimer’s are also potential candidates for this technology platform as well.
"We started putting these things together with outside collaborators like Dr. Ken Rosenthal (Professor, Microbiology, Immunology and Biochemistry, Northeastern Ohio Universities Colleges of Medicine and Pharmacology) and directing our research in the area of different immune conditions because there are areas of tremendous need for this- a market and medical need," explains Zimmerman. "We found that we could induce the disease and we found that we could also treat them with these L.E.A.P.S™ vaccines.
"Because we're a small company we really had to focus on areas where some of the major needs are in Autoimmune diseases [the list is quite long]. Obviously Rheumatoid Arthritis (NYSE:RA) is one of them, there are several others, such as Multiple sclerosis (NYSE:MS), Insulin-dependent diabetes (IDDM), but we've really had to concentrate our focus and that's what we've been doing for the last two years now and we're starting to see the results [as presented this past weekend at the American College of Rheumatology's annual meeting in Philadelphia].
"I should also mention that our collaborators at Northeastern Ohio, have actually taken the technology and have been working on some of the mechanisms of action and they'll be presenting some of that later at some upcoming conferences and meetings so that's also quite encouraging."
L.E.A.P.S™ has also captured a great deal of attention in the area of H1N1, but details about the company's dealings with the U.S. Food and Drug Administration (FDA) and its first clinical trial to evaluate the effect of its investigational LEAPS-H1N1 treatment for hospitalized H1N1 patients are still hard to pry from the doctor, who becomes more pensive as he carefully navigates the disclosure minefield.
"Actually, I'm not really at liberty to talk about that," Zimmerman acknowledges. "We are in the process of collecting data, assimilating it and will surely present it at the appropriate time and place, but we've taken the basic concepts that we've identified with these other systems and applied them to our knowledge base for H1N1.
"There's a large amount information available now on H1N1. For example, we know that there are a number of epitopes that are what we call 'highly conserved' and are found in regions of the virus that are essential for life function so they can't readily mutate. We've focused our technology on those regions because one of the problems with H1N1 and other influenza viruses is the large amount of genetic mutations that occur so we wanted to minimize the impact of those as part of any vaccine program that we might develop. We've looked at the varioous genetic sequences of the strains, combined them with our knowledge of the L.E.A.P.S™ technology from previous work in other models, we've had the conjugates prepared and I'm really... Um... I can't go into any more detail... But," says a suddenly smiling and confident Zimmerman, "It's quite exciting! I can say that much about it."
"It's consuming a lot of our time. We've had to put a large amount of resources on it and it's really quite an opportunity for us. Our work in Rheumatoid Arthritis will go on because we feel this is a better therapy with better benefits, but the H1N1 crisis is such an emergency that we really could not ignore it. I think we would be remiss if we had tried to ignore it, so we're taking all we've learned from these other systems and we're applying it here.
"This is the way science is done. In little steps. It's one thing to do a research study where you don't have to worry about all this documentation, but when you're doing it like we are, you have to have very good documentation of what you've done and you can reproduce it. Then you can present it to an agency like the FDA and show that you know what you're doing. It's well documented. it's founded in science and it's safe- which is one of the primary concerns of any regulatory agency- and that its efficacious and will do what you claim it will do.
"The H1N1 program is moving so fast that the normal considerations are a bit different here, but we still have to be aware of all of that. The FDA is quite concerned that any vaccine or therapy be safe and effective and no one can fault the agency for wanting that."
Disclosure: Long CVM