A team of researchers from the Indian Institute of Technology-Bombay (IIT-B) and doctors from the Tata Memorial Centre (TMC), Mumbai, will soon start the first clinical trial of indigenously developed CAR-T technology in the country for the treatment of blood cancer.
The central government’s National Biopharma Mission (NBM) -Biotechnology Industry Research Assistance Council (BIRAC) has now approved ₹18.96 crore to the team for conducting a first-in-human phase-1/2 clinical trial of the CAR-T cells. The novel CAR-T cells will act are drugs that were indigenously developed at IIT Bombay by Rahul Purwar, a professor from the Bioscience and Bioengineering (BSBE) department. The design, development, and extensive pre-clinical testing was carried out in a laboratory with clinical inputs from Dr Gaurav Narula, professor of Pediatric Oncology and Health Sciences, and his team from TMC. The team has filed for national and international patents for the product.
While the CAR-T cell technology is currently in use in developed nations with an intent to cure certain types of blood cancers, the technology is still unavailable in India. “One of the major reasons for its unavailability in India is that the drug is exorbitantly expensive. Pharmaceutical companies don’t see a market for such expensive treatments in India,” said Purwar. Two CAR-T products approved by the United States of America are Kymriah and Yescarta. However, the drugs could cost Rs5 crore per patient and could go up to ₹8 crore including hospital expenses.
The IIT Bombay and TMC team are working on reducing this cost. “A large part of the manufacturing cost goes towards skilled labour. While we are at the initial stage, we will try to bring the costs significantly down,” said Purwar. The drug is aimed at treating leukaemia and lymphoma. The BIRAC, in its statement, said that with the success of the trial, the drug will benefit cancer patients, who currently are forced to opt for palliative care.
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With the grant in place, clinical trials of the novel CAR-T cells will commence at TMC. “Current treatment strategies, such as chemotherapy, are aimed at promoting life by a few months or years. They are not intended to cure cancer. The CAR-T cells have been fairly successful in this matter in some developed nations,” said Purwar. Unlike chemotherapy, this drug is administered only once to the patient.
Dr Narula said that the clinical trial of the drug will be started in a trial set up where all variables are under control. “We have received the grant to start the trial. This is one step in a long process. We will start the trial as soon as the regulators give us a go-ahead,” he said. The team is now waiting for approval from the Central Drugs Standard Control Organisation.
Source: Hindustan Times
