Clinical trials are all about numbers -- hemoglobin levels, months of extended survival -- the list could go on and on. But the most important number in any trial is the statistical significance. It tells the FDA the likelihood that the results were due to chance alone.
Developmental-stage drugmaker Novacea
The clinical trial is testing the effect of Novacea's lead compound, Asentar, on patients with advanced prostate cancer. The trial was originally designed to enroll 900 subjects, but Novacea has asked the FDA to increase the number to 1,200. That increase signifies that the company thinks it might be on the border of meeting its primary endpoint of overall survival. The increased number of subjects will increase the statistical power of the trial, and it might push it under the magical p-value needed to show statistical significance.
The trial has enrolled more than 770 subjects, at a current rate of about 65 patients per month. With the increased numbers, that would put completion of enrollment at the beginning of next year, so interim results of the trial might be available at the end of next year. All of this is subject to the FDA approving the plan; a more concrete timetable should be announced after Novacea's meeting with the FDA.
The additional subjects will also increase the cost of running the trial, but that's a small price to pay if it means a positive outcome. And it looks as if Novacea can afford it. The company had $46 million in the bank at the end of the quarter, but in late June, Schering-Plough
Reading between the lines, Asentar probably won't be an exceedingly potent drug like Onyx Pharmaceuticals