Cell Therapeutics plans to submit interim data from a confirmatory trial in women to support an NDA for its lung cancer treatment Xyotax (paclitaxel poliglumex), the company announced June 1.

FDA's review of Xyotax based on the interim data could shorten the approval process by more than 12 months compared to a filing based on full results, the firm said.

The NDA would be filed in the first half of 2007 assuming the PIONEER trial meets an interim endpoint. The interim data would accompany results from two prior Phase III trials, STELLAR 3 and 4.

In STELLAR 3 and 4, Xyotax failed to meet the primary endpoint of superior survival benefit. However, the drug did produce a benefit in women, leading the company to focus its NDA on treatment for advanced non-small cell lung cancer exclusively in women (¹ Also see "Cell Therapeutics Will Pursue Xyotax Approval For Women With NSCLC" - Pink Sheet, 24 August, 2005.).

The PIONEER trial, which initiated in Q4 last year, will enroll 600 performance-2 chemotherapy naive women with advanced NSCLC in two arms: one receiving Xyotax and the other receiving Bristol-Myers Squibb's Taxol (paclitaxel).

The company is anticipating a priority review.

Xyotax is a biologically-enhanced chemotherapeutic that binds paclitaxel to a water soluble polyglumate polymer, which, according to Cell Therapeutics, results in "a potentially more effective treatment by delivering more paclitaxel to tumor cells."

Although unusual, FDA has approved drugs for specific subgroups based on gender or ethnicity in the past. For example, Nitromed's BiDil was approved in June 2005 for treating African Americans with heart failure (² Also see "NitroMed's BiDil Approved For Heart Failure In Self-Identified Black Patients" - Pink Sheet, 23 June, 2005.).

According to Cell Therapeutics, pharmacogenomic research indicates that estrogen may play a role in the way women respond to lung cancer treatment.

"Developing therapies that are favorably influenced by estrogen may provide a gender-targeted therapeutic approach to the treatment of NSCLC," the company said.

Jonathan Block

Cell Therapeutics Expects 2007 NDA Filing For Xyotax

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