*_Christine MH_*
08-21-2005, 08:34 AM
Pharmexa: Promising preliminary results with breast cancer vaccine (http://www.pharmexa.com/site.asp?p=364&PressRelease_XMLURL=http://cws.huginonline.com/P/131680/PR/200508/1006680.xml)
"Pharmexa has now received data from the first seven breast cancer patients in a phase II trial of the HER-2 Protein AutoVac™ vaccine formulated together with the adjuvant Alhydrogel. All seven patients were recruited and treated in Poland. Two out of seven treated patients have shown signs of tumour effect (a reduction of the tumour). These patients are still in treatment and will remain in treatment until their tumours progress. Two additional patients showed stable tumours after eight weeks at which time the treatment was stopped according to the protocol due to a lack of a measurable antibody response, but the period was too short to say whether this constituted an effect. With due reservation for the numbers involved, the preliminary data are encouraging and compare favourably with results observed with the antibody Herceptin as monotherapy in a comparable patient population. No adverse events were observed in relation to the treatment."
They are redesigning the trial protocol so that women can stay on until their tumours progress. New centers will be opened for trials in Russia, Romania and Poland. They have received approval for new trials in Poland and Hungary.
"Pharmexa has now received data from the first seven breast cancer patients in a phase II trial of the HER-2 Protein AutoVac™ vaccine formulated together with the adjuvant Alhydrogel. All seven patients were recruited and treated in Poland. Two out of seven treated patients have shown signs of tumour effect (a reduction of the tumour). These patients are still in treatment and will remain in treatment until their tumours progress. Two additional patients showed stable tumours after eight weeks at which time the treatment was stopped according to the protocol due to a lack of a measurable antibody response, but the period was too short to say whether this constituted an effect. With due reservation for the numbers involved, the preliminary data are encouraging and compare favourably with results observed with the antibody Herceptin as monotherapy in a comparable patient population. No adverse events were observed in relation to the treatment."
They are redesigning the trial protocol so that women can stay on until their tumours progress. New centers will be opened for trials in Russia, Romania and Poland. They have received approval for new trials in Poland and Hungary.