E-therapeutics Regulatory News (ETX)

e-Therapeutics plc

("e-Therapeutics" or "the Company")

Contract for iGCP trials with Infinitus Clinical Research consolidates

e-Therapeutics clinical evaluation infrastructure

e-Therapeutics plc (AIM: ETX), the drug discovery and development company, is pleased to announce that it has signed an agreement with Infinitus Clinical Research Ltd ("Infinitus") to carry out international Good Clinical Practice (iGCP) compliant trials of multiple drug candidates, for up to 500 patients (the "Infinitus Agreement").

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 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.

Professor Malcolm Young, Chief Executive of e-Therapeutics, commented: "This is an important agreement for e-Therapeutics that is designed to deliver high-quality clinical trial data that can inform discussions with Western regulators. e-Therapeutics' primary tool for market penetration of our products is the unique efficacy, safety, deliverability and compliance propositions that our drugs present for physicians and patients. I believe that these trials will provide the data we need to move our compounds forward toward the largest pharmaceutical markets."

Dr Roy Drucker, e-Therapeutics' Chief Medical Officer is currently also a director of Infinitus. Infinitus will shortly conduct a company reorganisation, whereby, inter alia, a new holding company will be introduced on top of Infinitus ("Infinitus Holding Company"). Following this reorganisation, it is currently anticipated that Dr Roy Drucker, will have a 53 per cent beneficial interest in Infinitus held via the Infinitus Holding Company. Accordingly, for the purposes of AIM Rule 13, the Infinitus Agreement is deemed a related party transaction.

The directors of the Company (with exception of Dr Roy Drucker) consider that, having consulted with the Company's nominated adviser, Canaccord Adams, the terms of the Infinitus Agreement are fair and reasonable insofar as shareholders of the Company are concerned.

In addition to this, but unconnected with it, the Company has been informed that Professor Malcolm Young, the Company's Chief Executive Officer, has transferred his shareholding of 20,620,482 ordinary shares in the Company into a CREST nominee account run by UBS. The 20,620,482 ordinary shares were previously held in certificated form in Professor Young's name and he remains the sole beneficial owner of these shares.

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Notes to Editors

About e-Therapeutics

e-Therapeutics plc pioneered network pharmacology in drug discovery. It has developed proprietary systems to swiftly and accurately analyse and predict how medicines interact with cells in the body. This optimises the probability of identifying drug candidates with desirable efficacy and low toxicity. The Company applies its novel, systematic approach to three areas of activity:

Amongst e-Therapeutics' pipeline of compounds in development are novel antibiotics that have been shown to kill the "superbug" MRSA and C.difficile, and a novel cancer chemotherapy that has been shown to kill malignant cells at safe doses in a very short time. Other candidate therapies in development are targeted at atherosclerosis, asthma and depression. The Company is currently in negotiation with a number of pharmaceutical companies, and is progressing the preclinical and clinical development of these products, two of which have completed Phase II trials successfully, and three of which have been out-licensed to pharmaceutical partners.

For further information on e-Therapeutics visit www.etherapeutics.co.uk. 

About Infinitus Clinical Research

Infinitus Clinical Research is a unique Clinical Research Organisation (CRO). It is the only Sino-Indian CRO in existence and conducts its clinical research exclusively in Asia. Benefitting from not having to bear the overheads of a large western infrastructure, the orientation is very much towards serving the needs of an international clientele. Based in Bangalore and Nanjing, it is led by a management team with extensive experience of conceiving and executing entire clinical drug development programmes for global registration purposes, as well as substantial hands-on operational experience in the relevant territories.

For further information on Infinitus visit http://www.infinitusglobal.com/