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Fast-acting rabies antibody moves into next phase of trials
Umesh Isalkar, TNN, Dec 19, 2010, 01.31am IST
Read more: Fast-acting rabies antibody moves into next phase of trials - The Times of India http://timesofindia.indiatimes.com/...-trials/articleshow/7125169.cms#ixzz18Zb0AXB1
PUNE: The first phase of clinical trials for a new anti-rabies drug, which claims to instantly deactivate the deadly rabies virus and provide immediate protection in severe dog-bite cases, has been successful.
The drug, developed by Pune-based Serum Institute of India (SII), is a monoclonal ready-made antibody. It was found to be safe and effective in phase I tests carried out on healthy adults in Mumbai and will now enter phase II and III of the clinical trials.
"A ready-made antibody is required to give immediate protection because a vaccine generally takes 14 days to produce antibodies," said S V Kapre, executive director of SII. "If the bites are severe or close to the brain, the virus may reach the brain within 14 days and cause rabies. The new antibody gives immediate protection," Kapre said.
When used in combination with the rabies vaccine it does away with expensive human rabies immunoglobulin (HRIG), making the treatment more cost effective.
The new anti-rabies antibody, however, is not a substitute for the existing rabies vaccine.
"Rabies infection can be prevented to a great extent using a rabies vaccine and human rabies immune globulin (HRIG) soon after exposure. But human rabies immune globulin, which is derived from human blood, is often not available in countries like India and is quite expensive. Currently, equine rabies immunoglobulin (ERIG) is used in many parts of the world. But equine (horse-derived) serum has several side effects," Kulkarni said. The recombinant technology used in producing the antibody does away with the expensive methods and makes treatment cost-effective, he said.
In phase I of the study, the rabies monoclonal antibody + rabies vaccine combination produced antibody levels in the blood which were similar to those produced by the HRIG + rabies vaccine combination.
"This gives us confidence that the new product should be as effective as the currently used product," Kapre said.
"The next trial will be carried out on patients above five years of age with category III dog bites at Mumbai, Mandya (Karnataka) and Hyderabad. The results of this trial should be available by the end of next year," Kulkarni said.
The World Health Organisation (WHO) defines category III animal bites as single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks, licks on broken skin and exposures to bats.
According to WHO, the vast majority of the estimated 55,000 deaths caused by rabies each year world-wide occur in the rural areas of Africa and Asia. In India alone, 20,000 deaths (about 2/1,00,000 population at risk) are estimated to occur annually.
http://timesofindia.indiatimes.com/...-next-phase-of-trials/articleshow/7125169.cms
Umesh Isalkar, TNN, Dec 19, 2010, 01.31am IST
Read more: Fast-acting rabies antibody moves into next phase of trials - The Times of India http://timesofindia.indiatimes.com/...-trials/articleshow/7125169.cms#ixzz18Zb0AXB1
PUNE: The first phase of clinical trials for a new anti-rabies drug, which claims to instantly deactivate the deadly rabies virus and provide immediate protection in severe dog-bite cases, has been successful.
The drug, developed by Pune-based Serum Institute of India (SII), is a monoclonal ready-made antibody. It was found to be safe and effective in phase I tests carried out on healthy adults in Mumbai and will now enter phase II and III of the clinical trials.
"A ready-made antibody is required to give immediate protection because a vaccine generally takes 14 days to produce antibodies," said S V Kapre, executive director of SII. "If the bites are severe or close to the brain, the virus may reach the brain within 14 days and cause rabies. The new antibody gives immediate protection," Kapre said.
When used in combination with the rabies vaccine it does away with expensive human rabies immunoglobulin (HRIG), making the treatment more cost effective.
The new anti-rabies antibody, however, is not a substitute for the existing rabies vaccine.
"Rabies infection can be prevented to a great extent using a rabies vaccine and human rabies immune globulin (HRIG) soon after exposure. But human rabies immune globulin, which is derived from human blood, is often not available in countries like India and is quite expensive. Currently, equine rabies immunoglobulin (ERIG) is used in many parts of the world. But equine (horse-derived) serum has several side effects," Kulkarni said. The recombinant technology used in producing the antibody does away with the expensive methods and makes treatment cost-effective, he said.
In phase I of the study, the rabies monoclonal antibody + rabies vaccine combination produced antibody levels in the blood which were similar to those produced by the HRIG + rabies vaccine combination.
"This gives us confidence that the new product should be as effective as the currently used product," Kapre said.
"The next trial will be carried out on patients above five years of age with category III dog bites at Mumbai, Mandya (Karnataka) and Hyderabad. The results of this trial should be available by the end of next year," Kulkarni said.
The World Health Organisation (WHO) defines category III animal bites as single or multiple transdermal bites or scratches, contamination of mucous membrane with saliva from licks, licks on broken skin and exposures to bats.
According to WHO, the vast majority of the estimated 55,000 deaths caused by rabies each year world-wide occur in the rural areas of Africa and Asia. In India alone, 20,000 deaths (about 2/1,00,000 population at risk) are estimated to occur annually.
http://timesofindia.indiatimes.com/...-next-phase-of-trials/articleshow/7125169.cms