Looking ahead to the weekend, many eyes on Wall Street and beyond will be focused on a presentation titled A Therapeutic Vaccine Arrests Disease Progression in the Collagen Type II (Bovine) Murine Model for Rheumatoid Arthritis by Altering Cytokine Environment which is scheduled to take place at the 2009 ACR/ARHP Annual Scientific Meeting being held in Philadelphia on Sunday.
For those not familiar with it, the American College of Rheumatology (ACR) is an organization of physicians, health professionals, and scientists aiming to advance the treatment of rheumatology through programs of education, research, advocacy and practice. Those who gather are typically involved in the care of people with arthritis and rheumatic and musculoskeletal diseases.
And while the Annual Scientific Meeting draws thousands of rheumatologists and arthritis health professionals from around the world, investors and many outside those circles will be keeping a close look at the presentation scheduled by Daniel H. Zimmerman, Ph.D., of CEL-SCI Corporation for the L.E.A.P.S. technology.
Daniel H. Zimmerman, Ph.D.
Zimmerman holds over a dozen US patents as well as many foreign equivalent patents, and is the author of over 40 scientific publications in the area of immunology and infectious diseases. Over his long career, he has been awarded numerous grants from NIH and DOD and it's expected that his presentation will focus on the evaluation of the L.E.A.P.S. platform as a new therapeutic vaccine for Rheumatoid Arthritis (RA)- a long-term disease that leads to inflammation of the joints and surrounding tissues and which can affect other organs.
That the L.E.A.P.S. (Ligand Epitope Antigen Presentation System) is being presented as a therapy to arrest the progression of RA disease bodes well for those hoping that the technology's same anti-inflammatory properties and ability to direct an immune response against specific disease epitopes will produce strong evidence and a case for CEL-SCI’s investigational LEAPS-H1N1 treatment. That is the same treatment platform which has thrust L.E.A.P.S. into the spotlight as the U.S. Food and Drug Administration (FDA) recently gave the company an expedited nod to proceed with its first clinical trials to evaluate the effect of its investigational L.E.A.P.S. based H1N1 treatment.
As reported by Reuters earlier this week, the Journal of the American Medical Association published an alarming picture of how younger, previously healthy people quickly developed severe respiratory failure, forcing doctors to use extreme measures to save them. In a press release issued in early October, Ken S. Rosenthal, Ph.D., Professor, Microbiology, Immunology and Biochemistry, Northeastern Ohio Universities Colleges of Medicine and Pharmacology, explained that CEL-SCI's dendritic H1N1 treatment utilizes the same L.E.A.P.S. vaccine technology to convert an individual's white blood cells into cells targeted to killing influenza.
"This unique action promotes the production of inducer cytokines without the tissue damage and flu-symptom promoting cytokines (pro-inflammatory cytokines), tumor necrosis factor alpha or interleukin 1," wrote Rosenthal. "This helps prevent or get around the issue of cytokine storm in which the production of too many pro-inflammatory cytokines contributes to the clinical decline and death of the patient."
According to the Reuters report, once swine flu patients are sick enough to need hospital care, they decline very fast, requiring ventilators and advanced treatments that quickly strain scarce hospital resources.
"The fact that they develop this very rapid, very severe respiratory failure means hospitals need to be prepared to manage these patients at any time of the day or night," said Doug White of the University of Pittsburgh School of Medicine, who wrote a commentary in the journal.
Rheumatoid arthritis is an autoimmune disease in which the body's immune system attacks itself. The pattern of joints affected is usually symmetrical, involves the hands and other joints and is worse in the morning. Rheumatoid arthritis is also a systemic disease, involving other body organs, whereas osteoarthritis is limited to the joints. Over time, both forms of arthritis can be crippling.
The L.E.A.P.S. technology has been shown in several animal models to preferentially direct immune responses and it makes sense that the treatment's properties and data might serve as a treatment for H1N1. Especially when one considers that L.E.A.P.S. is a novel T-cell modulation platform technology that enables CEL-SCI to design and synthesize, non-recombinantly, proprietary immunogens. Meaning also that the technology combines a small peptide that activates the immune system with a small peptide from a disease-related protein, such as the H1N1 hemagglutinin molecule, to make an investigational product that induces defined immune responses.
It's obvious to most observers that the urgent medical need is clear and the company's investigational LEAPS-H1N1 treatment is being developed specifically for hospitalized H1N1 patients.
"This is one of the most difficult conditions I've ever had to treat," said Dr. Anand Kumar of St. Boniface Hospital in Winnipeg, Manitoba, a hotspot of infection during the first wave of the swine flu in May and June.
Kumar said he normally sees only a few patients a year who become severely ill from an infection.
"In the case of Winnipeg, we saw 40 people on ventilators struggling for their lives simultaneously. It's a bizarre and somewhat frightening experience," he said in a telephone interview.
"At one point, 50 percent of the available ICU (intensive care unit) beds in the entire city were filled with H1N1 patients," Kumar said. "We basically maxed out our capacity."
In order for FDA to fully consider that next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, the FDA asked CEL-SCI to submit a detailed follow-up regulatory filings with extensive additional data. Insiders tell BioMedReports that a great deal of that paperwork submission has been going as well as planned and expected given the ramp up on an expedited basis.
Although this specific H1N1 virus strain was only first identified months ago, the company continues to move as fast as possible to investigate the potential of LEAPS-H1N1 to help already infected Swine Flu patients who are at high risk of dying. The initiation of the clinical development program builds on CEL-SCI’s pioneering work with its L.E.A.P.S. and if the presentation by Dr. Zimmerman goes well, it could also signal that Cel-Sci is serious about developing the platform as an eventual replacement treatment (vaccine) to the blockbuster drug ENBREL, which is currently indicated for reducing signs and symptoms of Rheumatoid Arthritis.
While ENBREL works by decreasing a certain protein produced by the immune system so that the immune system doesn't mistake the body's own cells for invaders and attacks them, in medical studies, the drug also lowered the ability of the immune system to fight certain infections - and serious infections have happened in patients taking ENBREL- including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that spread throughout the body. Some patients have even died from these complications.
In theory, Cel-Sci's L.E.A.P.S. vaccine against RA would deliver many of the benefits without on-going need for treatment and without the toxic side-effects. L.E.A.P.S. may also offer a number of potential advantages over other existing rheumatoid arthritis treatments since it is potentially a disease-type specific therapy and could be useful for patients who are not able to take or who may be unresponsive to those existing anti-arthritis therapies.
Neither Dr. Zimmerman nor anyone at Cel-Sci was available for comment about the upcoming presentation, but you can bet that many will be monitoring the results closely.
Disclosure: Long CVM
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