ONCO Life Sciences, the Pune based consultancy company for life sciences, is planning to commercialise individualised gene therapy for treating cancer in India. It is waiting for the final approval from Drug Controller General of India (DCGI) for the therapy. The company has received No Objection Certificate (NOC) from the Department of Biotechnology for import of gene therapy from its partner, Mologen Inc, Germany.
The cell based gene therapy will be commercialised within 15 days after getting the final approval from DCGI, according to Ashish Agarwal, founder and CEO of ONCO Life Sciences. He said that the approval is expected within a month. The company has commenced preliminary works for commercial introduction of the product in a few patients in New Delhi and Mumbai.
The first of its kind individualised cell based gene therapy for treating cancer will be treated in patients in Leelavathi Hospital, Mumbai and Sir Gangaram Hospital, New Delhi.
"ONCO, which have already added many firsts to its profile, would pioneer in providing individualised therapy through the partnership with Mologen. As this is our initial project, we have not identified more hospitals at present, but is planning to conduct the therapy in more hospitals as per the increase in number of patients," said Ashish.
The company, which has signed an agreement with the Berlin-based Mologen Inc in the end of 2006, will purchase all individualized therapy components for patients in India from Mologen as stipulated in a separate purchase and supply agreement. The cell based gene therapy is a tailor made therapy based on the condition of the patient, and thus in the current situation, mass volumes similar to Monoclonal antibodies and other chemical entities cannot be easily reached at Mologen's manufacturing facility, he added.
The company, earlier announced that it has plans either to distribute the therapy through a network of hospitals or to grant a sub-license to a major Indian pharmaceutical company. Plans are to target 1000 cancer patients suffering in the tertiary stages, as an adjuvant and compassionate therapy in the first year of marketing the product in India, involving oncology specialists with 25 to 30 major corporate hospitals in the country.