ImmLab’s Solution:  A Therapeutic Staphylococcal Lysate

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).

SL is administered subcutaneously (s.c.) or in nasal drops (or also 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 Immune System with the SL

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.

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 patent 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.  

The Road Ahead… Ultimate Accomplishment of the Mission

Due to the very substantial capital requirements, compared to the very limited financial resources available to ImmLab at this point, accomplishment of the mission, although quite probable, is projected to be a very lengthy process. And during this lengthy time period, the ultimate beneficiaries of the technology (humans and animals suffering from staphylococcal infections) will remain untreated. We expect the cost of waiting, in financial as well as physical terms, for the ultimate beneficiaries to be very substantial. Therefore, ImmLab’s stockholders and advisors have determined that it is in the best interest of all involved to aggressively pursue alternatives for expediting the process of bringing the products to the availability of practicing physicians, veterinarians and scientists throughout the world.

ImmLab’s business can be summarized into three, very basic, divisions: 

1.             Human applications

2.             Large animal applications

3.             Small animal applications 

ImmLab’s stockholders and advisors are very interested in the possibility of creating a strategic alliance with a mature pharmaceutical firm with the financial resources, as well as human capital, sufficient to bring the products to the marketplace for any (or all) of the three divisions. This alliance should enable ImmLab to continue scientific research projects to determine various uses for the current products, make improvements to the current products and develop new (but related) products. ImmLab’s scientists are confident that the pipeline will continue for many years to come as a result of the technology that is now in ImmLab’s possession.

At this point, it seems appropriate to create some form of a licensing agreement with the reputable firm that is most appropriate for, and capable of, implementing the most efficient plan to accomplish the ultimate mission. However, we are also open to discussion of other plans that would possibly achieve the desired outcome.

 At the foundation of ImmLab’s accomplishments is the highest level of ethics and integrity. We are unwilling to compromise that level of ethics and integrity. We will only consider transactions that will benefit all involved. 

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.
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