iGCP trials conform to a set of internationally recognised ethical and scientific quality requirements, providing assurance that data is credible and accurate. Ensuring e-Therapeutics’ clinical trials comply with these standards will provide data valuable for discussion with Western development partners and preparation for late-stage Western clinical development.
This agreement consolidates a substantial clinical trialling infrastructure for e-Therapeutics, which will enable phase I and phase II clinical development of several of e-Therapeutics’ current pipeline of eight drug candidates. The Infinitus agreement is for 150 patients in clinical trials to iGCP standard. At the discretion of e-Therapeutics, this can be extended to up to 500 patients at the same cost rate. e-Therapeutics have the discretion as to how many trials (subject to a minimum of 50 patients a trial) are conducted, and the clinical protocols to be implemented.
The company said that the presence of Dr Roy Drucker on the boards of both companies will smooth the transition of these drug candidates into this next phase of clinical trials with Infinitus. The iGCP trials will complement other clinical trials, including phase III registration trials which are being progressed by e-Therapeutics’ existing strategic partners in India.