CTI still plans to continue development of Xyotax despite the setback. The drug has already failed three major lung cancer trials.
The company said it would submit a new protocol for the drug by the end of the year to the FDA. The trial will focus exclusively on women with normal estrogen levels, the subset where Xyotax has previously demonstrated the greatest survival advantage. Preclinical and clinical studies showed that Xyotax metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
The company commented that the high number of deaths were not due to contamination or toxicity and could not explain why there was a difference between the two groups. The termination of the trial could delay the company’s plans by six months.