“The data from Phase 2 trials here and Phase 3 global trials can be analysed to arrive at a conclusion. It is up to the regulator to take a call, and then we will launch the vaccine with the regulator’s approval,” he said.
DRL is restoring applications and recovering data after it faced a cyber attack earlier this month. All critical operations are being restored in a controlled manner, it said.
As of now, no data breach has been reported during the investigation so far.
The company had to shut down all its plants after the attack, which was a ransomware attack. DRL did not comment on whether the company had to shell out any money to the hackers.
Meanwhile, the company also indicated that it was open to partnerships for more vaccine candidates (for distribution) as well Covid-19 therapies.
DRL itself is working on some investigational therapies for treating Covid. It has got nod to conduct phase 3 clinical trial of a potential cancer drug (2-Deoxy-d-Glucose oral power, or 2-DG) to see if it works as a therapy for Covid-19 patients.
The drug 2-DG stops glucose supply to the cells, which then start dying. It is a potential cancer drug as it works by preventing supply of glucose to cancerous cells. 2-DG is not yet an approved drug, but there have been multiple studies across the globe for treatment of cancers.
The idea is that along with other anti-virals, 2-DG can help prevent replication of the Sars-CoV-2 virus in inflammed lung cells of Covid-19 patients.
DRL will conduct Phase 2 trials on 100 subjects and the data would be submitted to the Drug Controller General of India. This would be a multi-centre and randomised controlled study, which would include safety and immunogenicity study. Upon receiving nod from the regulator, DRL can proceed to Phase 3 trials on 1,400 subjects.
The company had tied up with Russian Direct Investment Fund (RDIF) in September to conduct clinical trials and distribute the vaccine here. RDIF will supply 100 million doses to DRL.
Sputnik V is also undergoing Phase 3 clinical trials in Russia and other parts of the globe on 40,000 volunteers