Students and Professionals from the Health Science/Allied Health Science/Life Science can look forward to a robust curriculum and training in the area of Clinical Research coupled with additional training in soft skills and internships in leading Clinical Research Organizations.

ACRI is proud to announce the commencement of its next Batch on 4^th June 2012 for PG Diploma in Clinical Research, Clinical Data Management and SAS.

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.

Regulators on opposite sides of the pond have come to different conclusions over the benefits of Roche’s Avastin (bevacizumab) in treating breast cancer.

The European Medicines Agency confirmed the benefits of Avastin in combination with paclitaxel outweighed its risks saying the combination was a valuable treatment option for patients suffering from metastatic breast cancer. However, this was tempered by the Agency’s Committee for Medicinal Products for Human Use conclusion that the drug in combination with docetaxel should no longer be used in the treatment of breast cancer – an indication that had been approved in September 2009 – as new data questioned the combination’s benefits. The Committee also concluded Avastin in combination with capecitabine should not be approved.

While the EMA did announce some positive news for breast cancer patients, the US Food and Drug Administration has come down heavy handed on Roche as it begins the process of removing the breast cancer indication from the drug’s label. After a review of four clinical studies, the regulator concluded Avastin in combination with paclitaxel neither prolonged overall survival in breast cancer patients nor provided a sufficient benefit in slowing disease progression and did not outweigh the risks associated with the drug.

This decision follows a July review by an independent advisory committee that voted 12-1 to remove the breast cancer indication from the drug’s label. Avastin in combination with paclitaxel was approved for this indication in February 2008 under the FDA’s accelerated approval programme.

However, Roche and manufacturer Genentech are not pleased with the FDA’s ruling and are putting up a fight by not agreeing to remove the breast cancer indication voluntarily. The company now has 15 days to request a hearing, which it has announced it will do.

“We are pleased that the EMA has confirmed the benefits of Avastin in combination with paclitaxel and that Avastin will continue to be available for women with metastatic breast cancer living within the European Union,” said Hal Barron, chief medical officer and head, global product development. “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA.”

Meanwhile, the FDA is also encouraging Roche to conduct additional research to see if there is a subset of patients who will benefit from the drug.