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Alchemia Reports Preliminary Positive Efficacy Data From HyCAMP,Phase II Trial

SYDNEY, Australia, April 26, 2007 /PRNewswire-FirstCall/ -- Australian drug development company Alchemia Limited today announced preliminary results from its randomised Phase II clinical trial in patients with metastatic colorectal cancer, where Alchemia's drug HyCAMP(TM) was compared to irinotecan which is considered to be a cornerstone drug for the treatment of colorectal cancer. This announcement is being made at a preliminary stage of the analysis in accordance with the ASX disclosure requirements once the company became aware of the results reported below.

Primary safety endpoint - Comparison of the incidence of late grade 3 or 4 diarrhoea in patients receiving HyCAMP(TM) versus irinotecan alone:

    -- not met due to lower than expected incidence of diarrhoea in the

       control arm


    Secondary safety endpoints:


    -- No major differences in overall adverse events between the two

       treatment arms


    Secondary efficacy endpoints:


    -- 38 of 41 (93%) HyCAMP(TM) patients compared to 28 of 35 (80%)

       irinotecan patients completed 2 cycles (p=0.099)


    -- 14 of 41 (34%) HyCAMP(TM) patients compared to 5 of 35 (14%) irinotecan

       patients completed the full 8 cycles (p=0.064)


    -- Patients on HyCAMP(TM) received a median of 6 cycles of therapy,

       compared to 2 for irinotecan alone (p=0.005)


    -- Median progression free survival for HyCAMP(TM) patients was 5.2

       months, compared to 2.4 months for the irinotecan arm (p=0.014).

The Phase II trial commenced in December 2004 and patient accrual closed on 30 June 2006. In the randomised trial, 80 patients with metastatic colorectal cancer who had previously failed treatment with the anti-cancer drug 5-fluoro uracil were eligible to receive up to eight cycles of chemotherapy in the form of irinotecan or HyCAMP(TM) intravenously. The primary endpoint of the trial was safety (incidence
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