Dr Reddy’s gets nod for phase-3 Covid trials of cancer drug

NEW DELHI: Dr Reddy’s Laboratories has won approval to conduct phase-3 clinical trials of a potential cancer drug that showed efficacy in Covid-19 patients during phase-2 trials.

The subject expert committee, which advises the Drug Controller General of India on applications seeking approvals for new drugs, clinical trials and vaccines, recommended granting permission to conduct the phase-3 trials, subject to certain conditions.

The drug, 2-Deoxy-D-Glucose oral powder, also called 2-DG, works by blocking the supply of glucose molecules to cancerous cells. Without glucose, these cells die.

The committee asked Dr Reddy’s to appoint a medical monitor for co-ordination and monitoring of the trial at all sites. It said 28-day mortality should be included as one of the efficacy end points.

“If the firm intends to perform interim analysis, justification for the same along with a detailed statistical plan should be submitted for further review by the committee,” according to the minutes of the meeting dated October 29, which ET reviewed.

However, the committee turned down a proposal by Dr Reddy’s seeking approval for restricted emergency use of 2-Deoxy-D-Glucose oral powder for Covid-19 patients. The drug has not been approved for cancer treatment.

The company had conducted phase-2 trials of the 2-DG drug with the Institute of Nuclear Medicine and Allied Sciences, a department of the Defence Research and Development Organisation.