New Delhi: Amid the global efforts to develop medicines and vaccines for COVID 19 and news of a vaccine trial being paused in the UK, there is some good news from Kerala.
Kochi-based PNB Vesper has got the approval of the Drugs Controller General of India (DCGI) for the second phase of human testing of the medicine (PNB001) it has developed.
The DCGI has granted the permission based on a pre-clinical trial report that said the medicine reduced mortality rate by up to 80 per cent.
Biosphere Clinical Research Company based in Thane in Maharashtra will conduct the clinical trial of the medicine amid reports that the trial of a vaccine candidate developed by pharma major AstraZeneca and the Oxford University has been paused in the UK after a volunteer developed "unexplained illness." The participant has developed neurological symptoms, according to the pharma company.
An alternative to multiple medicines
Since there is no medicine for COVID, many medicines are used on an experimental basis.
Pre-clinical trials have shown that ‘PNB001’ can be effective as an alternative to aspirin, which reduces fever, dexamethasone, which reduces pus, and tocilizumab, which is given in conditions such as cytokine syndrome that affects the lungs.
In experiments done on mice and other animals before the human trial phase, the drug was able to reduce mortality rate by up to 80%.
The medicine is also thought to help prevent depression and anxiety caused by COVID. It can also be used to fight lung cancer, said PNB Vesper.
40 patients in second-phase trial
The DCGI has given the permission for the 2B trial on humans. The trial will begin in 10 days on 40 patients with moderate COVID symptoms and in need of oxygen support, PNB Vesper CEO P N Balram told Manorama. It will be conducted at the BMJ Medical College in Pune.
In addition, discussions are underway to test the medicine in the US and UK, where it has received the patent.
The data obtained from the second phase of testing will be reviewed by a panel of experts, based on which the approval of the third phase will be granted. In the third phase, the experiment will be conducted on 350 COVID patients in six medical colleges.
‘‘Out of the 40 people with similar symptoms (selected for the second-phase trial), 20 will be given the new medicine and the remaining 20 will be given a medicine that is currently considered as being effective. The effectiveness of the two medicines will then be compared,” the Union Ministry of Health said.
