SL is prepared by lysis of S. aureus culture with a polyvalent bacteriophage.

The lysate is prepared by the activity of lytic phages producing two key proteins. The whole streptococcal cell bursts extruding bacteriophage particles. The immune system destroys the pathogens.

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.

Based on the accumulated literature data, as well as ImmLab's experimental evidence, ImmLab's scientists propose a hypothesis that explains immunostimulatory mechanisms of SL. The lysate is prepared by the activity of lytic phages producing two key proteins:

1. Holins, forming pores in the cell wall, thereby allowing access of the second component;
2. Enzyme(s), catalyzing degradation of the cell wall yielding smaller peptidoglycans.

As a result, the whole streptococcal 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. ImmLab's scientists 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 ImmLab scientist's 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 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 a solution of S. aureus antigens in relatively native conformations. ImmLab's 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.

Preclinical

U.S. Patent # 6,929,798 dated August 16, 2005 claims a bacterial lysate derived from one of many S. aureus strains lysed with any one of a number of bacteriophages, the deposited strains of S. aureus, the deposited phage strains and and a method of treating S. aureus infection. The patent title is: Composition and Methods for Treatment of Microbial Infections.

U.S. Patent # 7,329,409 dated February 12, 2008 claims a method of inducing an immune response and methods of preparing a bacterial lysate.

U.S. Continuation-In-Part Application # 11/986,715 dated November 26, 2007 is currently in process. This application for our invention is relating to isolated immunogenic SPL proteins.

U.S. Continuation Application # 12/069,569 dated February 11, 2008 is also currently in process. This will provide specific patent protection of our preparation.

Our European patent was granted in June, 2008.

Our Hong Kong patent was granted and issued in June 2008. 

We currenly have international patent applications in process in Canada, Japan and South Korea.

 We feel confident that our product pipeline, and therefore our patenting process, will continue for many years into the future.

Our patent attorney is Mary Anthony (An) Merchant, Ph.D. with the firm of Ballard Spahr Andrews & Ingersoll, LLP in Atlanta GA, USA

ImmLab's stockholders and advisors are interested in forming a mutually beneficial strategic partnering alliance with a mature pharmaceutical or biotechnology firm with the financial resources, as well as experience and expertise, sufficient to bring ImmLab's products to the marketplace as efficiently as possible and continue development of the pipeline. This alliance could be related to any one (or all) of our three basic divisions:

1. Human applications,
2. Small animal applications, and/or
3. Large animal applications.

The 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 stockholders and advisors feel that a merger or an acquisition would be the most appropriate forms of alliance with another firm. However, we are also open to discussion of alternative plans having a high probability of achieving the desired results. 

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 being involved in transactions that will benefit all involved.

U.S. Patent: 6,929,798; U.S. Patent: 7,329,409; EU 1477273; Japan 4304077; Hong Kong:5102303.3; German: 603 25 945.6-08