Immunology Laboratories, Inc.
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Research

Our Solution

 

Staphylococcal Lysate (SL) is prepared by lysis of S. aureus culture with a polyvalent bacteriophage. Staphylococcal phages belong  mostly to the Siphoviridae family, e.g., phages with double-stranded  linear DNA and with long noncontractile tails. SL is a complex of  antigenic components of ribosomal, cytoplasmic, nuclear, cell wall, and  membranous origin of the staphylococcal cell.

SL has been  clinically effective in the treatment of all staphylococcal infections  of adults, as well as chronic conditions in pediatrics (chronic upper  respiratory diseases, bronchial asthma, chronic sinusitis, cystic  fibrosis) and in dermatology (acne vulgaris).


ImmLab  staphylococcal vaccines are created by introducing the genome of the  staphylococcal bacteriophage into the staphylococcal cell, resulting in  the production of highly immunogenic vaccine comprised of all  staphylococcal proteins and cell-wall components.

In  the animal experiments, SL is protective in the murine septic model  against lethal and sublethal challenges using laboratory and field  strains of S. aureus. The animal models show vigorous immune  responses in all tested species (rabbits, rats, mice, and calves). SL is  administered subcutaneously (s.c.), intramasculary (i.m.) in veterinary  medicine, or in nasal drops (pediatrics). It can be applied directly  into wounds in osteomyelitis as an addition to s.c. therapy. Laboratory  data suggested that the clinical improvement of patients (observed in  70-90% of cases) may be related to stimulation of peripheral blood  mononuclear cells and induction of metabolic burst in phagocytes.

Stimulation of the Human and Animal Immune System with the Staphylococcal Lysate

 Based  on the accumulated literature data, as well as our experimental  evidence, we (ImmLab) propose a hypothesis that explains  immunostimulatory mechanisms of SL. The lysate is prepared, as mentioned  above, by the activity of lytic phages producing two key proteins:  

  • holins, forming pores in the cell wall allowing access of the second component
  • enzyme(s), catalyzing degradation of cell wall yielding smaller peptidoglycans

As  a result, the whole staphylococcal cell finally bursts open and  extrudes bacteriophage particles. This is a very gentle procedure of  cell lysis yielding a complex mixture of proteins, lipids, lipoproteins,  lipoteichoic acids, peptidoglycans, DNA fragments, etc. We propose that  these compounds in their native or modified configuration are  recognized by the pattern recognition system and, by complex pathways,  induce innate response and stimulate adaptive immune response.

In  the end, the host’s immune system (originally not responding or  hyporesponding to a chronic staphylococcal infection) is re-activated  and capable of detecting and destroying the pathogens. This model is  supported by our findings on stimulation of circulatory cells in healthy  human volunteers. The whole blood stimulated with SL responds by  increased production of TNF alpha. SL activates CD4+ lymphocytes and  increases their production of interpheron gamma. In phagocytes, the  respiratory burst is increased. Together with induction of  antigen-specific antibodies, all these factors promote clearance of S. aureus infections. 

Conclusion

 In  summary, ImmLab’s scientists found that long-term application of SL  activates the host’s immune responses and leads, in a high percentage of  patients with chronic S. aureus infection, to the clearance of the pathogen or at least to a significant improvement.  The SL are prepared from selected S. aureus strains that are lyzed by selected bacteriophages. The resultant lyzate is thus a solution of S. aureus antigens in relatively native conformations. Our hypothesis is that SL  induces several innate and adaptive immune responses through multiple  mechanisms. 

Ultimately, the combined action of antibodies,  cytokines, activated cells, and increased capacity for respiratory burst  produces a milieu for the clearance of chronic infections. Furthermore,  in some specific applications, such as local treatment of wound  infections, the direct bacteriolytic activity of bacteriophages may also  play an important role. The above general information has been  respectfully submitted by ImmLab for the consideration of interested  parties. Further, more specific, discussion of ImmLab’s inventions and  plans may continue upon receipt of a properly executed confidentiality  agreement. 

ImmLab’s Progress to Date

 ImmLab’s  technological accomplishments are based on approximately forty years of  research and testing. The research and testing has continued for all  these years, primarily as a result of the unwavering determination and  persistence of the scientist who originated the mission and  unconditionally transferred the technology to ImmLab.

The following summarizes briefly our progress to date: 

The tremendous need is undeniable.

The viability of the mission has been established.

The huge, worldwide market is recognized.

Our initial patents have has been granted.

The application process for additional patents continues.

The current testing and patent process includes:

                    o    Prevention
                    o    Mode of action
                    o    Treatment
                    o    Technology

The team of scientists (including the original inventor), physicians and various associates continue to work tirelessly.

The products are ready for manufacture.

The  manufacturing process is relatively simple and economical. In April,  2001 ImmLab’s patent attorney, along with her associates and her entire  firm, committed to help ImmLab accomplish its mission. The firm has, and  will continue to insure that the investment in the mission is protected  by a sound intellectual property strategy.   

Microbiological Aspects of S. aureus Infections

 Staphylococci  are gram-positive bacteria represented by more than a dozen species  ranging from those indigenous to normal flora of the skin, and mucosal  surfaces, to highly virulent pathogens. Among the many staphylococci  species, S. aureus is among the most common and most virulent  forms of staphylococci encountered throughout history, from the  pre-antibiotic era to the present time.

Staphylococcal infections  are characterized by intense suppuration, necrosis of local tissues,  and a tendency for the infected area to form "walled off" abscesses. S. aureus can cause skin infections (furuncles, carbuncles, and impetigo) as well  as deep lesions from bacteria spread from skin lesions (bones, joints,  soft tissues, and deep organs). S. aureus is also a major cause of wound infections.  Surgical wound infections may be very severe and even fatal at times. S. aureus can produce various toxins causing scalded skin syndrome, toxic shock syndrome, and staphylococcal food poisoning.   

Treatments  of staphylococcal infections with antibiotics were originally very  successful. However, after many years use of beta-lactam antibiotics, S. aureus became resistant to many classes of antibiotics.  MRSA strains manifest  increasing prevalence in hospital-acquired infections as well as in  nosocomial and community-onset infections. Vancomycin, as the "last  resort" antibiotic, is still effective but reports on emergence of VISA  indicate that this situation is changing rather rapidly.  Antibiotic  resistance in a bacterium is usually conferred by plasmid-encoded genes,  and as such, resistance genes can be transferred to  antibiotic-susceptible strains from reservoir strains containing these  resistance genes.  

According to a July 13, 2005 Wall Street  Journal article, a Pennsylvania state agency conducted a study regarding  hospital-acquired infections. The article indicated that the “…agency  has found that 11,668 hospital-acquired infections were associated with  1,793 deaths, 205,000 extra hospital days and $2 billion in additional  hospital charges last year”. The article goes on to say, “Extrapolating  from the Pennsylvania data to the rest of the country suggests that more  than 125 people a day are dying from hospital-acquired infections with  an associated $50 billion of related hospital charges every year…”  

Most community-acquired infections of S. aureus are autoinfections, with strains being carried in the anterior nares or  on the skin.  Hospital epidemics, on the other hand, are caused by  highly virulent and antibiotic-resistant strains of S. aureus associated with patients undergoing invasive treatments. These epidemics are a continuing and recurrent problem. S. aureus strains produce a variety of substances that may contribute to their  virulence. The most important factors include alpha-hemolysin, pyrogenic  exfoliatins, coagulase, protein A, and other extracellular  enzymatically active substances. 

Although a variety of phenotypes and products appear to contribute to S. aureus virulence, no one factor can be singled out as the primary contributor  to its ability to multiply and cause lesions in the tissues. Therefore, a  single candidate for an effective immunization appears unlikely.  Natural immunity to staphylococcal infections is of short duration and  incomplete, although involving both humoral and cellular  mechanisms. Obviously, a different approach to vaccination is in order.  

Based  on years of research and development in Europe, a novel preventative  and therapeutical approach has been developed by ImmLab. This approach  is based on use of a broad-range of antigens derived from staphylococcal  cells.  

Immunity to Staphylococcal Infections

 

Resistance  of human organism against bacterial pathogens involves both innate and  adaptive immunity. Innate immunity provides mechanisms for immediate  protection against a wide variety of pathogens.

It includes:

  • a pattern recognition system for the pathogens
  • activation of effector mechanisms quickly destroying the pathogens pathways that can activate adaptive immunity

Adaptive  immunity provides responses to persistent pathogens, and has both  humoral and cellular components. Innate response to pathogens initiates,  controls and instructs the adaptive immune response. In order to  establish a persistent infection, bacterial pathogens posses a plethora  of mechanisms (so called virulence factors) to overcome the  multi-layered host defenses.

S. aureus is a human and animal pathogen with many virulence factors described. It targets native or adaptive immune responses. S. aureus has several mechanisms that allow the pathogen to prevent, or even  hijack, this response to its advantage. Not only can the bacteria  develop a resistance against antimicrobial proteins, they can also  survive inside neutrophils. This is likely an important factor in  persistent infections. In addition, various strains of S. aureus may posses some of the battery of toxins and enzymes and other products  that enhance infectivity and bacterial survival and proliferation.  Here, a combination of host’s cellular and humoral mechanisms comes into  place. Antibodies specific against toxins and enzymes and other soluble  products neutralize their activities while antibodies specific against  cells and cellular components opsonize the targeted cells and enhance  their phagocytosis. It thus seems very plausible to speculate that, in  patients with chronic S. aureus infections, one or more defense pathways may not be activated or functional.

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