Ariad begins clinical trial of oral AP23573 in cancer patients

By Lisa Kerner

Erie, Pa., Feb. 14 - Ariad Pharmaceuticals, Inc. began enrollment of cancer patients in a phase 1b clinical trial of its novel mTOR inhibitor, AP23573, in combination with doxorubicin, a chemotherapeutic agent and the current standard of treatment for patients with sarcomas.

AP23573 is a novel small-molecule inhibitor of the protein mTOR, which when blocked creates a starvation-like effect in cancer cells.

Doxorubicin is widely used in soft-tissue and bone sarcomas, as well as breast, ovarian and endometrial cancers, all of which are potential targets for AP23573 treatment, according to a company news release.

The non-randomized, dose-escalation trial will evaluate the safety and tolerability, pharmacokinetics and anticancer activity of AP23573 in combination with various doses of intravenous doxorubicin in up to 60 patients at three centers in the United States. Patients will have certain sarcomas, as well as breast, ovarian and endometrial cancers.

Once the tolerability and optimal dosing regimen of AP23573 in combination of doxorubicin are determined, the feasibility of adding ifosfamide, an alkylating agent often used in conjunction with doxorubic, will be assessed.

AP23573 is already under study in additional phase 1b clinical trials in combination with two other cytotoxic agents, paclitaxel and capecitabine.

Preliminary phase 2 clinical results demonstrated six-month progression-free survival in patients with advanced sarcomas who received single-agent AP23573.

Ariad plans to begin a phase 3 trial of single-agent AP23573 in advanced sarcomas later this year.

"Given the clinical-benefit responses observed to date with single-agent AP23573 in patients with advanced sarcomas and the strong mechanistic rationale for combining doxorubicin with mTOR inhibition, this trial represents an important step in our global development plan for AP23573," chairman and chief executive officer Harvey J. Berger said in the release.

"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."

Ariad is engaged in the discovery and development of breakthrough medicines to treat disease by regulating cell signaling with small molecules. The company is based in Cambridge, Mass.

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