Allos anticancer drug RH1 fails to produce tumor response in phase 1 study

By Angela McDaniels

Seattle, Nov. 17 - Allos Therapeutics Inc. said interim data from an ongoing phase 1 study of the company's anticancer agent RH1 shows that while the drug is well-tolerated at doses up to 1430 microg/m2, it has elicited no objective tumor responses thus far.

However, significant, accumulative dose-dependent DNA cross-linking has been seen in peripheral blood lymphocytes at all doses greater than or equal to 200 microg/m2, the company said.

The data was presented Thursday at the European Organization for Research and Treatment of Cancer, National Cancer Institute and American Association for Cancer Research International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

The 15-patient multicenter, dose escalation phase 1 trial is designed to determine the toxicity profile, maximum tolerated dose and dose limiting toxicity of RH1 in adult patients with advanced solid tumors, who receive RH1 daily for five days every three weeks at doses ranging from 40 microg/m2 to 1905 microg/m2 for up to six cycles.

Clinically significant toxicities observed to date include neutropenia, thrombocytopenia and mild to moderate phlebitis.

RH1 is a small molecule chemotherapeutic agent that is activated by the enzyme DT-diaphorase, which is more heavily concentrated in many tumors than in normal tissue, including lung, colon, breast and liver tumors.

Allos is a Westminster, Colo.-based biopharmaceutical company that develops small molecule therapeutics for the treatment of cancer.

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