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news.Ariad Pharmaceuticals has initiated enrollment of advanced cancer patients in a phase Ib clinical trial of its candidate, AP23573, in combination with doxorubicin - the mainstay of treatment for a broad range of cancers and hematologic malignancies.
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In particular, doxorubicin is widely used in soft-tissue and bone sarcomas, as well as breast, ovarian and endometrial cancers – all potential targets for AP23573 treatment.
AP23573 is a novel small-molecule inhibitor of the protein mTOR, a “master switch” in cancer cells. Blocking mTOR creates a starvation-like effect in cancer cells by interfering with cell growth, division, metabolism, and angiogenesis.
Preliminary phase II clinical results have demonstrated striking clinical-benefit responses and 6-month progression-free survival in patients with advanced sarcomas who received single-agent AP23573. The company is on track to initiate a phase III trial of single-agent AP23573 in advanced sarcomas later in 2006.
“We believe that this clinical study is the first trial aimed at evaluating the combination of an mTOR inhibitor and doxorubicin and highlights the favorable safety profile that we have seen with AP23573,” said Dr Harvey Berger, chairman and CEO of Ariad.
AP23573 is already under study in additional phase Ib clinical trials in combination with two other widely used cytotoxic agents, paclitaxel and capecitabine.