Pharmexa obtains approval in Russia

13-Jan-2006

Pharmexa has obtained the required regulatory approvals for the phase II trial with the HER-2 Protein AutoVac(TM) breast cancer vaccine in combination with the adjuvant QS-21 in Russia and the doctors can now recruit patients there. On December 15, 2005 Pharmexa announced that the first patients have begun treatment on the study sites in Poland.

Patients in the phase II trial with HER-2 Protein AutoVac(TM) in combination with the adjuvant QS-21 will receive four initial immunisations over a six week period with 1.25 milligram HER-2 Protein AutoVac formulated with Alhydrogel adjuvant and mixed with QS-21 adjuvant, followed by booster immunisations every four weeks for up to 26 weeks. The trial will be carried out at 10-15 cancer research centres in Poland, Romania and Russia. According to plan the centres will recruit 40 patients with active HER-2 positive breast cancer.

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