An Indian Biotech Company that is testing a novel anti-cancer drug on patients in Bangalore says it is not alarmed by the London trial where the use of a similar class of drug led to disastrous results.
Last month six healthy men in Northwick Park hospital developed horrific reactions and came close to death after receiving TGN1412, a monoclonal antibody, made by a German biopharmaceutical company, for treating leukemia and rheumatic arthritis. The trial was immediately halted by the British government and an enquiry is currently on.
In Bangalore, Biocon Limited is testing the efficacy of TheraCIM (h-R3), another monoclonal antibody for the treatment of neck and head cancer. Biocon imported this drug from a Cuban company. It is the first monoclonal drug ever allowed to be tested in India.
Results of the Bangalore trial are not available even though Biocon claims to have a 'transparent' drug trial policy.
Managing Director Kiran Mazumdar-Shaw said the details will be put in the company website 'after the drug is approved.'
Monoclonal antibodies are not chemicals but are biological products. They are genetically engineered 'humanized' proteins that home in on specific targets. "The results of London trial are not a matter of concern for us because all MABs are not the same," Mazumdar-Shaw said.
While the MAB in the London trial was being tested for the first time in humans, the Cuban MAB had undergone safety and efficacy tests in that country and elsewhere, she added.
However, Professor Janet Derbyshire, head of the UK Medical Research Council's Clinical Trials Unit told the British media on March 16 that 'anybody involved in monoclonal antibody trials will be reflecting very carefully on their protocols following this (London) event.'
Drug Controller General Ashwani Kumar in New Delhi did not reply to a question if India is going to review the policy of drug trials with monoclonals.
However, Anjali Karande, a professor of biochemistry at the Indian Institute of Science in Bangalore and an authority on monoclonals, has sounded a note of caution.
She said that while the MAB used in Bangalore trial is said to act by blocking receptors and thereby stops a cancer cell from dividing, the one used in London stimulates a cell into action.
"Being a blocking type, the Cuban MAB is less risky than the one used in London trial but all MABs must undergo long term tests because we do not know a lot of things about them," she said.
G Padmanabhan, a leading biochemist and former director of IISc said he would be worried if monoclonal drugs are introduced in haste.
He was reacting to Mazumdar-Shaw's recent announcement that her company will soon be marketing the Cuban monoclonals whereas, according to the Genetic Engineering Approval Committee, Biocon had tested the drug on just 20 subjects as of 23 November 2005.
Experts say a phase-III trial involving at least 600 patients would be required before monoclonal drugs can enter the market.
Discovered in 1975, monoclonal antibodies are widely used as diagnostic and research reagents but their introduction into human therapy has been much slower.
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