Alizyme in positive PIIa trial for Mucositis

Alizyme has successfully completed stage one (the dose escalation safety stage), of the Phase IIa clinical trial evaluating ATL-104 for the treatment of mucositis.

The trial is designed to recruit up to 60 cancer patients in two separate stages. During the first stage at least eight patients in each of three separate cohorts were treated with increasing dose levels of ATL-104 or placebo. On completion of treatment, a safety review was undertaken by an independent panel to identify any issues before recruitment into the next cohort. Stage one has now completed successfully with a total of 27 patients treated. No safety issues were identified by the panel.

Stage two is now actively recruiting up to a further 33 patients with randomised administration of each of the three dose levels of ATL-104 or placebo. Based on the current expectations of recruitment rates into the second stage, results of the trial are now expected by the end of 2005.

Commenting, Dr Richard Palmer, chief executive officer said: 'We are very pleased to have successfully completed stage one and received clearance from the independent safety panel to progress ATL-104 into the second stage of this Phase IIa clinical trial. In a challenging indication, this trial seeks to demonstrate proof of concept for this novel approach to treating a severe and debilitating side-effect of intensive cancer treatment.'

Mucositis

Treatment of cancer with chemotherapy or radiotherapy can result in mucositis in which the cells lining the mouth and gastrointestinal tract are damaged leading to inflammation, ulceration, pain, diarrhoea and difficulty in eating and drinking. Depending on the type of cancer and the treatment administered, it is estimated that up to 40% of patients receiving cancer therapy suffer mucositis. An effective drug would not only improve the quality of life for those receiving cancer treatment, but also could enable higher therapeutic doses and more effective treatment. Over one million of the cancer patients treated each year suffer from mucositis and the potential market for drugs to prevent/treat mucositis effectively is estimated to be in excess of $500m per annum.