Immunology Laboratories, Inc. has developed a novel vaccine with immunomodulation activity which is derived from the lysates of the Company's deposited, patent protected strains of S. aureus isolated from natural infection in cattle.

Immunology Laboratories, Inc.'s staphylococcal lysate is prepared by lysis of S. aureus culture with a polyvalent bacteriophage.

Immunology Laboratories, Inc. (ImmLab) has developed novel, non-antibiotic, preparations for the prevention and treatment of microbial infections in humans and animals. One of ImmLab's proprietary intellectual properties is a vaccine with immunomodulation activity for the prevention of bovine mastitis. ImmLab's staphyloccal lysate (SL) is prepared by lysis of one of ImmLab's deposited, patented strains of Staphylococcus aureus (S. aureus) isolated from natural infection in cattle with one of ImmLab's deposited, patented polyvalent bacteriophages.

Bacteriophages (phages) are viruses of bacteria that have an exceptional ability to kill and lyse the bacteria they infect. Phages first bind to a specific receptor on the host cell surface. This binding is highly specific and therefore limits the host range of a phage to a particular species, if not strain, of bacteria. The phage genome is injected into the host bacterium, and phage genes are expressed using the host's cell enzymes. With virulent phages, the phage genome is replicated, and structural components are produced, ultimately leading to the lysis of the host cell by phage lytic enzymes and release of hundreds of progeny phage. This process can occur in as little as 15 minutes. The progeny phage can then continue the cycle by infecting other bacterial cells. The ability of virulent phages to rapidly kill and lyse infected bacteria, the specificity of phages for particular bacteria, and the ability of phages to increase in number during the infection process make phages excellent potential therapeutic agents for fighting bacterial disease. However, temperate phages (phages that become "dormant" after entering the host's cell) are of little use in preparation of SL. ImmLab's products are based on fifteen years of testing hundreds (into the thousands) of strains. Therefore, ImmLab's technology is based on the most effective combination of a bacterial strain with a phage that together exhibit a stable relationship and provide quantitative reproductible lysis of bacterial cells.

ImmLab's SL is a complex of antigenic components of ribosomal, cytoplasmic, nuclear, cell wall, and membranous origin. It is prepared due to the activity of lytic phages producing two key proteins: holins, forming pores in the cell wall allowing access of the second component, enzymes, catalyzing degradation of cell wall and yielding smaller peptidoglycans. Consequently, the staphylococcal cell finally bursts open and extrudes bacteriophage particles. This is a very gentle procedure of cell lysis yielding a complex mixture of bacterial 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 an innate response and stimulate an adaptive immune response. As a consequence, the host's immune system (originally not responding or hyporesponding to a staphylococcal infection) is re-activated and capable of detecting and destroying the pathogens and neutralizing their components.

In order to assure maximal safety of SL, bacterial strains to be used were tested for production of known staphylococcal toxins. The resultant SLs were further tested for acute and chronic toxicity in vivo using animals. The patented strains that are used to produce SL do not produce any toxins.

Preclinical

U.S. patent # 6,929,798 was granted 08/16/2005 and U.S. patent # 7,329,409 was granted 02/12/2008. U.S. continuation application # 11/170,972 is dated 07/25/2005 and the USPTO has entered a Notice of Allowance. U.S. continuation-in-part application # 11/986,715 dated 11/26/2007 is in process.

European patent # 1487273 was granted 06/26/2008, Japanese patent # 4304077 was granted 05/01/09 and Hong Kong patent # 05102303.3 was granted 07/08/2009. Canadian appliction # 2,476,405 dated 08/12/2004 and South Korean application # 2004-7012621 dated 08/12/2004 are in process.

German patent # 603 25 945.6-08 was granted 01/21/2009. Other individual European country applications in the Czech Republic, Slovakia, France and the United Kingdom dated 01/21/2009 are in process.   

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

1. Human applications
2. Large animal applications (primarily related to mastitis)
3. Small animal applications (primarily related to skin diseases)

ImmLab's stockholders and advisers are very interested in forming a mutually beneficial strategic partnering alliance with a mature pharmaceutical or biotechnology firm having vaccine development capabilities along with the financial resources, experience and expertise to bring ImmLab's lead products to the marketplace and continue development of the pipeline. ImmLab's scientists and advisers are confident that the product pipeline will continue for many years into the future as a result of the technology that is currently in ImmLab's possession. We prefer the fund raising option of an investment for equity in our company by means of a merger or acquisition. We feel that this is the most efficient and economical method and is in the best interest of the future end users of our technology. However, we are open to the possibility of a licensing agreement or other option with a high probability of achieving success.

We feel that we have substantially completed the preclinical phase but we have not initiated plans to begin the clinical phase. At this point we have no third-party liabilities on our books and we have entered no third-party committments or relationships.  

ImmLab's success to this point has been based on determination, hard work, ethics and integrity. We want to maintain that by being involved only in transactions that will benefit all involved.

Thank you for your kind consideration of our worthy ideals.

US 6,929,798; US 7,329,409; Europe 1487273; Japan 4304077; Hong Kong 05102303.3; German 60325945.6-08