Marshall Edwards prostate cancer drug gains fast track status

According to Marshall Edwards, the FDA has granted the investigational
anticancer drug, phenoxodiol, fast track status for its intended use in
patients with hormone-refractory prostate cancer.
   
27 Jan 2005, 17:05 GMT - The successful application for fast track
status was based on data derived from a phase Ib/IIa study, conducted in
two Australian hospitals, in which men with late stage
hormone-refractory prostate cancer (HRPC) were treated with the oral
dosage form of phenoxodiol as a monotherapy.
In the study, dosages of phenoxodiol ranging from 200mg to 400mg
eight-hourly had a significant effect on disease progression, as
evidenced by falls in PSA levels, and suppression of those levels for a
period of at least six months. Most of the patients remain on
phenoxodiol therapy for periods up to 18 months without evidence of
disease progression.
Of particular relevance to the FDA is that prostatic adenocarcinoma that
is refractory to both hormonal therapy and cytotoxic chemotherapy is
associated with severe morbidity and a life expectancy of less than one
year, and as such meets the criteria for a serious and life-threatening
disease.
"This decision of the FDA underpins our confidence in phenoxodiol being
an effective therapy for late-stage prostate cancer. The next step is to
take phenoxodiol into a pivotal study where we will test its ability to
halt disease progression in men with prostate cancer who have failed the
standard treatment of hormone therapy and docetaxel chemotherapy," said
Dr Graham Kelly, executive chairman of Marshall Edwards.
Phenoxodiol in intravenous form was granted fast track status by the FDA
in November 2004 for its intended use in patients with recurrent ovarian
cancer.

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
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