Cell Therapeutics' Xyotax Wins Fast-Track Status in NSCLC Indication

Cell Therapeutics has announced that Xyotax, a biologically enhanced version of Taxol, has been granted fast-track designation for the treatment of poor-performance status women with first-line, advanced, non-small-cell lung cancer (NSCLC).

The company recently filed a special protocol assessment (SPA) with the FDA for the design of its Phase III trial of Xyotax (paclitaxel poliglumex) in women with advanced NSCLC. The trial, PGT306, will focus exclusively on women with normal estrogen levels -- the subset where Xyotax demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 patients who have not received prior chemotherapy.

Xyotax initially won fast-track designation in 2003 for poor-performance status NSCLC patients, both male and female. Fast-track designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug if it demonstrates the potential to address an unmet medical need, according to the company.

"We also submitted an SPA to the FDA for PGT307, a Phase III trial of combination therapy for women with advanced lung cancer," James Bianco, president and CEO of Cell Therapeutics, said. "Pending FDA feedback, we anticipate that one or both of these trials would begin enrollment in the second quarter of 2007 with a targeted interim analysis in the first half of 2008."

Xyotax links paclitaxel, the active ingredient in Taxol, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue from exposure to high levels of unbound, active chemotherapy and its associated toxicities, according to the company.