Press Release

GangaGen Receives U.S. Patents

GangaGen is a biotechnology company focused on the development of bacteriophage- based products for the prevention and treatment of bacterial infections, particularly infections that are resistant to antibiotics. GangaGen’s vision is to be the first phage company to develop and commercialize effective therapeutic solutions to address the current crisis in treating antibiotic-resistant infections. GangaGen’s unique business strategy is to maximize efficiency through cost-effective R & D operations in Bangalore, India, pursuing the treatment of commercially significant infections that require the most straightforward and least expensive clinical trials, some with strategic partners. The Company is also developing phage products for controlling human pathogens in food animals through its subsidiary GangaGen Life Sciences, Inc. (GLSI) located in Ottawa, Canada. GLSI has demonstrated the efficacy and safety of its first phage product for the control of E.coli 0157 in cattle and expects to complete large scale field trials and get regulatory approval for the product next year. Most importantly, GangaGen has developed proprietary technology for the production of phage products that address the perceived concerns about phage therapy.

GangaGen has received the first broad US patent covering its proprietary technology entitled “Lysin-Deficient Bacteriophages with Reduced Immunogenicity “ (Patent No.: US 6,896,882 B2), issued on May 24, 2005 and the second patent entitled “ Incapacitated Whole-Cell Immunogenic Compositions “ (Patent No.: US 6,913,753 B2) issued on July 5, 2005. These two important patents grew out of the pioneering work carried out by GangaGen scientists at its R & D Facility in Bangalore to address the perceived and real limitations of bacteriophages as therapeutic agents.

Although phages have been used successfully in Eastern Europe and Russia for the treatment of a variety of bacterial infections, concerns about the potential for developing an immune response, the release of bacterial toxins due to the rapid action of phages on pathogenic bacteria and the potential of phages to transfer toxic genes to non-pathogenic (“good “) bacteria have prevented the development of phages as therapeutic agents in the developed world. Phages control bacterial infection by specifically injecting phage DNA into pathogenic bacteria, utilizing the bacterial machinery to reproduce rapidly and exponentially, and tearing down the bacterial cell wall to release the progeny phage, which repeat this cycle until all the pathogenic bacteria are eliminated. This natural process limits the utility of the phages due to the concerns described above.

Realizing that breaking down the bacterial cell wall is not necessary for controlling the infection but essential only for the phage progeny to come out, GangaGen scientists knocked out the phage gene that codes for the Lysin enzyme responsible for breaking down the bacterial cell wall and produced a Lysin-D eficient Bacteriophage that kills the bacterial host, undergoes one cycle of replication but remains inside the dead bacterium. This accomplishment of GangaGen scientists addresses all the above-mentioned concerns about phage therapy. Lysin-Deficient phages retain their specificity, kill the pathogenic bacterial host rapidly, but do not cause lysis (break-down of the bacterial cell wall) and are not released into the patient or the environment. Lysin-Deficient phages also permit linear dosing like antibiotics.

The second patent, “ Incapacitated Whole-Cell Immunogenic Compositions “ is a logical sequel to the first patent. Action of the Lysin-Deficient phage on a pathogenic bacterial host produces a dead bacterium that has been killed from inside by the Lysin-Deficient phage but looks more like the natural pathogen than heat or formalin-inactivated bacteria, and therefore, is a perfect vaccine. When mice were immunized with bacteria killed in the laboratory with Lysin-Deficient phage and challenged with live bacteria, 90% of the animals survived compared with only 20% of the control animals. The second patent enables the development of highly effective vaccine to protect against any bacterial infection in man or animals.

GangaGen is using its proprietary technology to develop human therapeutics. The Company is looking for partners to utilize its novel vaccine technology to develop effective proprietary vaccines for both human and animal applications.

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