Corona medicine candidate enters phase 2 of clinical trials
The country and the world have high hopes of getting the first medicine against the coronavirus. PNB Vesper Life Sciences has completed the Phase II clinical trial of its corona drug PNB-001 (GPP-Baladol). The company has said that it will soon seek permission from the government to use it in emergency.
The Kochi-based company has its lab in England. The Controller General of India (DCGI) had in September last year approved the company to start a clinical trial for the second phase of GPP-Baladol. The company was asked to do trials on patients with moderate levels of infection with oxygen support.
The company said on Monday that the second phase of the trial began in November last year. The test was carried out on 40 patients at BJ Government Medical College and Sassoon General Hospital in Pune and Victoria Medical College and Research Institute in Bangalore.
PN Balaram, the company’s promoter and CEO, said, “We will submit a clinical report to DCGI on Monday itself.” He said that the drug was tested on par with the standards set by the World Health Organization (WHO) and other international clinical trials. On September 11 last year, Prakr had reported that PNB Vespers had received approval from DCGI for a second phase clinical trial of the Corona drug. With this, the Kochi-based company became the first company in the world to start a trial of Corona medicine with a new chemical formula.
The company said that during the trial, 100 grams of GPP-Baladol were given to the patients three times a day. Safety was measured by assessing the adverse effects of the drug in patients and analyzing the condition of their kidneys, liver and major organs. All the assessments were done based on the criteria established by the Union Ministry of Health. He said that GPP-Baladol could be an option to save the lives of hospitalized Corona patients worldwide. Balaram said that no serious adverse effects have been observed in any of the patients involved in the trial.
