The German drug multinational, Merck KGaA, which received the Indian marketing approval for its head and neck cancer drug Erbitux last month, plans to conduct first cancer vaccine trials in India.
The company will start the trials of this therapeutic vaccine-Stimuvax, being developed for non-small cell lung cancer by early next year at six centres in the country, said Wayne Paterson, regional head of Oncology Asia Pacific, Merck.
"We are currently in the process of deciding the drug trial portfolios, number of patients to be enrolled for the study and also the locations of trial centres in the country," Paterson said, adding since Merck had identified India as one of the important geographies in its global R&D map, it would continue investing in the country for drug development activities.
Stimuvax (L-BLP 25) is the first therapeutic vaccine from Merck's oncology portfolio and the first of this kind treatment for non-small cell lung cancer in the world.
Merck KGaA had earlier said over 1,300 patients with stage III unresectable disease from more than 140 centres in North America and Europe would be recruited for the NSCLC trial.
The major component of Stimuvax is the synthetic human MUC I protein consisting of a 20-amino
acid tandem repeat sequence on its extracellular domain that is highly antigenic. MUC I is expressed on normal epithelial tissue as well as NSCLC tumour cells, but on tumours it is abnormally glycated and therefore able to trigger an immune response.
The World Health Organisation estimated that over 900,000 new NSCLC cases of lung cancer were diagnosed worldwide in 2000. In India, most cases present to the physician in advanced stages when chemotherapy is the only available option.
Lung cancer is a major cause of cancer mortality, accounting for 20 per cent of cancer deaths worldwide. The survival statistics are dismal with an average 5-year survival of 14 per cent in the US, 10 per cent in Europe, India, China, and the developing countries.
The multinational company, which has an annual R&D budget of over $1 billion, has been working on oncology as one of its important research portfolios and currently it has about five very advance stage oncology leads in its broad oncology pipeline.
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