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Arpida Provides Further Comments on the Pivotal Phase III Trials
Date:4/11/2008

Extensive Data to be Presented at the Upcoming ECCMID Conference

REINACH, Switzerland, April 11 /PRNewswire-FirstCall/ -- Further to the press release published on 9 April, Arpida Ltd. (SWX: ARPN) today elaborates on some additional elements of the clinical programme with intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI). Extensive data on ASSIST-1 has been presented at last year's ICAAC and IDSA meetings. Data on ASSIST-2 will be presented at the upcoming 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) which takes place in Barcelona, 19-22 April 2008.

As reported in November 2006 and July 2007, intravenous iclaprim achieved its pre-specified primary endpoint in both of the pivotal Phase III trials: ASSIST-1 and ASSIST-2. Generally, two independent trials are preferred by regulatory authorities to confirm the robustness of the data. ASSIST-1 and ASSIST-2 were similarly designed and importantly used the same comparator (i.e. linezolid) which could allow regulators to pool and further analyse the data. Noteworthy to say, that linezolid has been shown to be superior to vancomycin in cSSSI for patients with MRSA infections (Weigelt et al, AAC, June 2005, page 2260-2266).

The aim of these trials is to provide an unbiased assessment of the treatment effect and takes into account all populations; particularly relevant are the Intent-to-Treat (ITT) and the Per-Protocol (PP) population. It is essential and standard practice in any study to remove any significant imbalances, in order to properly analyse the results. As reported in July 2007, imbalances were noted in the ASSIST-2 trial - in particular due to the use of prohibited antibiotics. The correction for this imbalance in the PP population results in the Modified Clinically Evaluable ("MCE") population and shows that the MCE population is in close agreement with the ITT population. The pre-specified primary endpoint for both tria
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SOURCE Arpida Ltd.
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