Xenova Group plc announced that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for the revised Phase III clinical trial programme proposed for TransMID. Prior to its acquisition by Xenova, KS Biomedix Holdings plc (KS Biomedix) had obtained FDA agreement for a single Phase III clinical trial for TransMID under the SPA process.

Following the acquisition of KS Biomedix, Xenova submitted a revised programme involving two smaller sequential Phase III clinical trials rather than one larger study, which has now been agreed with the FDA. The adoption of a two study approach reduces the level of risk associated with a large single study.

The initial Phase III clinical trial is designed to enrol 323 patients with non-resectable, progressive or recurrent Glioblastoma Multiforme (GBM) who have failed conventional therapy. The study will be a randomised, open-labelled, multi-centre trial and will compare TransMID against a number of presently used chemotherapeutic agents regarded as "best standard of care" (BSC).

The 323 patients will be randomised in a 2:1 ratio of TransMID:BSC across approximately 50 sites in the EU, Israel and North America.
The primary end-point is overall survival time with a planned interimanalysis to be conducted after 50% of the required events have beenobserved.

In an earlier, open label, Phase II study, patientsreceiving TransMID achieved a significant increase in overallsurvival compared with historical survival figures. In this study,median survival for patients receiving TransMID was approximately37 weeks. This compares to the average life expectancy for thesepatients which is currently approximately 26 weeks.

Edward Oldfield MD, Chairman of the Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health, Bethesda, Maryland said: "Glioblastoma Multiforme has been a very difficult tumour to treat. This novel approach combines a potent new drug with a targeted delivery method that can distribute the drug directly to the region involved with tumour. In earlier Phase I and Phase II clinical trials, the combination produced complete and partial radiographic responses in several patients."

David A Oxlade, Chief Executive Officer said: "We are pleased to have reached agreement with FDA for the revised programme and we will be starting to enrol patients immediately. People with non-resectable Glioblastoma Multiforme currently have few treatment options and there is a clear need for improved outcomes for these patients."

TransMID received Fast Track status from the FDA in August 2001 and orphan drug status in December 2001. In addition, the European Commission granted TransMID(TM) orphan designation in March 2002.