12:00 AM
 | 
Sep 08, 2008
 |  BioCentury  |  Product Development

Hurry up and wait

When Cyclacel Pharmaceuticals Inc. started the Phase II APPRAISE trial of seliciclib in non-small cell lung cancer (NSCLC), the company hoped to learn enough about the compound's efficacy in a short and inexpensive trial to enable it to make a quick decision about future studies in the indication. Based on last month's interim data, Cyclacel will have to wait until next year to get an answer.

Cyclacel ran the APPRAISE trial to get an idea of whether the inhibitor of cyclin dependent kinases 2E, 2A, 7 and 9 could work as a single agent in NSCLC, President and CEO Spiro Rombotis told BioCentury. The company did not want to run a larger, more expensive trial unless it could be used as part of a regulatory submission package.

The company originally planned to enroll 160 patients who had undergone at least two previous treatment regimens, but ended up enrolling 173. In the lead-in, open-label portion of the trial, all patients were treated with 1,200 mg seliciclib twice a day for three days for at least...

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