In a major research and development effort in the international arena, Bangalore-based GangaGen Biotechnologies has developed a proprietary recombinant protein, P128 known as ‘StaphTAME’ to tackle the antibiotic resistant Super Bug which is now a major concern among the doctors globally and India.

The 10-year-old biotech research major which also has an office in the US known as GangaGen Inc completed the preclinical development of StaphTAME including toxicology studies required by US FDA. The company will now initiate phase I/II clinical trials in the US and India by 2010 end or early 2011 depending on regulatory approval.

StaphTAME is an antistaphylococcal protein derived from a bacteriophage and destroys all Staph bacteria including the Super Bug MRSA (Methicillin Resistant Staph Aureus), responsible for the high morbidity and mortality from hospital-acquired infection.

“Our phage-based products could be the solution to control the Super Bugs. StaphTAME is for the treatment of the Super Bug MRSA. We believe Gangagen is the first company globally to have reached this stage of development of a biological product for this indication. There is a nasal antibiotic (Mupirocin) cream that is available but not used much due to emerging resistance”, Dr. Janakiraman Ramachandran, chairman, GangaGen Inc. told Pharmabiz.

Antibiotic resistant genes like NDM-1 residing on plasmids express products like the metallo beta lactamase that inactivate antibiotics and give rise to the antibiotic-resistant Super Bug. “We have demonstrated efficacy of this protein in mouse and rat models of S.aureus nasal carriage. StaphTAME has been found highly effective in killing against clinical staph isolates from the USA, Canada, Japan and India and eliminates Staph in animal models. This drug could be the solution to control the Super Bugs because of its novel mechanism of action acting from outside the bacteria and therefore, immune to the resistant mechanisms like NDM-1 that plague antibiotic therapy,” stated Dr. Ramachandran.

Around 40 per cent of human population carry Staphylococcus aureus in their anterior nares of the nose which is a harmless resident, but capable of being transferred to any wound on the body surface. Once this occurs, there is a risk of systemic infection and in many cases, if the bacterium is drug resistant, can cause severe consequences.

All the research and development of GangaGen was carried out in Bangalore, which has a team of 25 scientists. Production of the protein for preclinical studies was undertaken at GangaGen labs under Good Laboratory Practices. Clinical supplies will be produced in a contract cGMP facility.

Among the other research efforts at GangaGen include the study of Pseudomonas aeruginosa which is viewed as another opportunistic pathogen that is dreaded in the burn wards of hospitals. The deadly organism, also heavily drug resistant, produces several toxins and often it is noted that a burns patient succumbs not to the wound, but to its infection by bacteria. A protein product effective against this bug and other potential pathogens of the burns and wounds infection is under early development at the company, said Dr. Ramachandran.