PNB Vesper initiates Ph 2 trials of NCE PNB-001 for COVID-19 treatment
23 October 2020 | News
In the Phase 1 clinical trials, GPP Baladol® (PNB-001) was found extremely safe and was tested in 74 healthy humans
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PNB Vesper in Kochi, which had received approval from the Drug Controller General of India (DCGI) last month to conduct Covid-19 Phase 2 Clinical trials of their NEW CHEMICAL ENTITY PNB-001 (GPP-Baladol®), has been given the ethical committee approval to go ahead by the BJ Medical College and Sasoon General Hospital, Pune, on 14th October.
All necessary formalities have been completed with the Government to start the clinical trials in record time. The first patient, having COVID-19 pneumonia and breathing problems has been administered GPP-Baladol.
The principal Investigator of the Study is Dr Pradnya Bhalerao, MBBS, MD, Head, COVID-19 Department, at the medical college. A group of Doctors from the USA, the UK and India will monitor the studies on a daily basis. The study will be completed in 60 days. The interim efficacy results will be released within 30 days.
The effect of PNB 001 will be compared with Dexamethasone, currently the most used medication for COVID-19 treatment. The molecule has already been patented and the related Intellectual Property Rights (IPRs) have been secured by PNB VESPER in the US, Europe and rest of the world.
In the Phase 1 clinical trials, GPP Baladol® (PNB-001) was found extremely safe and was tested in 74 healthy humans.
Speaking on the breakthrough innovation, P N Balaram, CEO of PNB Vesper Life Science said, “This is indeed a very big step for mankind in its fight against the COVID-19 pandemic. The clinical trials would be completed in 60 days. Considering the novel mechanism of our molecule, we expect better results in the clinical trials, compared with Dexamethasone. In COVID-19, the main symptoms are Pyrexia, Body Pain and inflammation in the Lung and we lose patients mainly because of Cytokine Storms and ARDS. PNB 001 is found to be effective against all Covid-19 symptoms. PNB 001 is further found to be very effective in Small Cell Lung Cancer. If the molecule is found to work successfully in Covid-19 patients, PNB 001 may be the first New Chemical Entity in the world for COVID-19 treatment.”
