BENGALURU: Dr Vishal Rao and his team of researchers are shortly going to write to the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) seeking permission for Phase-2 of the clinical trials of cytokine therapy citing “initial success in Phase-1 of clinical trial,” Dr Rao told The New Indian Express. He is the principal investigator of Phase-1 clinical trial of cytokine therapy for healthy volunteers in Karnataka and noted oncologist from the HCG group
of hospitals.
“We are going to write to the DGCI and ICMR that we have successfully completed the first in-human Phase-1 clinical trials (WHO registered) for healthy volunteers and initial results from the animal studies are very promising,” he said. We have sought their permission for clinical trial Phase-2, he added.
“We have completed our cytokine study for six subjects, who had voluntarily enrolled for it. Our team of doctors at HCG comprising cell biologists, immunologists and clinicians have developed the cytokine-mediated anti-Covid therapy using human donor blood. We found that the key to successfully decreasing the disease fatality could be the stimulation of the immune responses in the early stages of infection.
This could be done through the administration of Cytokine-Interferons (IFNs) concoction -- a group of signalling proteins made by human host cells in response to the virus — which play a vital role in inducing and modulating an array of immune responses in a controlled manner. It has been shown to play a crucial role in bridging innate and adaptive immunity,” explained Dr Rao.
The first subject for Phase-1 was screened on May 30 and the last one on June 16 at the HCG in the City, he added.“We found that there was no adverse reaction in any of them and all the volunteers were safe. We believe this therapy will also help target future viruse,” said Dr Rao.