Mologen ◄◄DNA Vaccine zugelassen - das Beste kommt noch►► FORUM 42 ( Seite 10)

Antwort auf Beitrag Nr.: 31.372.836 von SFJL am 03.09.07 12:34:15Cell-based gene therapy for cancer patients
14 Aug, 2007, 0126 hrs IST,Khomba Singh

NEW DELHI: How about a personalised cancer medicine that is tailor-made to match your genes? The country’s first cell-based gene therapy will be available for cancer patients in the next few months, which claim to extend a cancer patient’s lifetime by up to five years when other drugs have failed.

Mumbai-based Onco Lifesciences has got the regulatory nod and will start marketing the unique cell-based gene treatment for breast cancer, lung cancer, renal cell carcinoma and colorectal cancer. The therapy is developed by Berlin-based biotechnology company Mologen AG which has given exclusive marketing rights to Onco Lifesciences.

Onco Life Sciences CEO Ashish Agarwal told ET: “The therapy will cost around Rs 15 lakh and comprises 10-12 injections, which will be given over a period of two and half months. The therapy can be given to a patient at any stage, but currently will be provided in compassionate and palliative situations.”

Preliminary clinical reports in Germany on stage four patients (last stage of a cancer patient) show personalised gene treatment can prolong the lifetime of a cancer patient by 2-5 years, Mr Agarwal added.

Doctor refers to cell-based gene treatment when conventional cancer drugs and standard therapy fail to work on a patient. Once the gene of the patient is identified, Mologen will prepare a tailor made drug for the patient, subject to availability of the matching tissue type in its tissue bank in Germany.

Mologen will manufacture the personalised injection at their facilities in Berlin. Onco Life Sciences will import the individual components of the therapy in liquid nitrogen at -196 degree Celsius. Onco Lifesciences plans to get around 1,000 patients in the first year. But once the volume attains a critical mass, the company may set up a formulation facility in India which will substantially reduce the cost of the therapy. The company also plans to sub licence its marketing rights in India.

Onco Lifesciences, which applied for the approval in 2005, finally received the import approval from the department of biotechnology (DBT) recently. The company has also sought a no objection certification from the Drug Controller General of India (DCGI). Onco Lifesciences will promote the therapy through selected few hospitals such as Ganga Ram Hospital (Delhi) and Lilavati Hospital (Mumbai).

Being a new therapy, cell-based gene treatment is marketed by only a handful of companies worldwide. Besides India, Mologen has received marketing licence in Germany, China, Kuwait and UAE. For the US market, the company is planning to develop in the form of a drug as there is no regulation controlling cell-based gene therapy drugs while in Europe, it has received an orphan drug status from the European Medicines Agency (EMEA).

Mologen is expected to tie up with Indian Council Of Medical Research and Rajendra Memorial Research. Institute of Medical Sciences, Patna to conduct clinical trials for a first of its kind Kala-Azar vaccine in India.