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news.UK biotech firm Antisoma has reported positive interim findings from its ongoing phase II trial of AS1404 in hormone-refractory prostate cancer.
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Men receiving AS1404 plus standard docetaxel chemotherapy had a substantially higher PSA response rate than men receiving chemotherapy alone. As previously reported, among the first 64 of 74 patients randomized, PSA response rates were 57% with the AS1404-docetaxel combination and 35% with docetaxel alone. Addition of AS1404 to chemotherapy also produced a near halving in the frequency of progression judged by PSA (17% with AS1404 plus docetaxel versus 29% with docetaxel alone).
Final PSA data are expected during the first half of this year, with time to tumor progression and survival data to follow in the second half.
The trial was consistent with earlier reports in showing that the addition of AS1404 to chemotherapy was well tolerated, with no evidence for exacerbation of chemotherapy-related side effects.
“The PSA findings from the AS1404 prostate cancer trial are very encouraging, as they suggest a marked improvement in activity when AS1404 is added to standard docetaxel therapy,” stated lead investigator in the trial, professor Mark Rosenthal of the Royal Melbourne Hospital, Australia. “If these findings translate into improved time to progression and survival, that would be a really exciting development.”
Prostate cancer is among the most prevalent cancers in the developed world. It often responds initially to hormonal therapies, but each year some 200,000 men across the US, Europe and Japan develop ‘hormone-refractory’ disease. The taxane drug docetaxel has become an important treatment for such hormone-refractory prostate cancer. AS1404 has shown synergistic anticancer effects in combination with docetaxel and other taxanes in preclinical tests. Recently, phase II trials have found that combination of AS1404 with another taxane, paclitaxel, considerably extended survival in lung cancer and increased response rates in ovarian cancer.
Antisoma is currently in talks to license AS1404 to a development and marketing partner. Given the growing evidence for activity in several tumour types, a key consideration in these talks has been potential partners’ ability to explore the drug’s full potential across a variety of cancers. Antisoma announced last week that it expects to conclude a deal with a strong partner during the first half of 2007.