Cell Therapeutics to begin Xyotax trial in women with lung cancer

By E. Janene Geiss

Philadelphia, Dec. 6 - Cell Therapeutics Inc. said Tuesday that it plans to begin a clinical trial in women of Xyotax (paclitaxel poliglumex) versus paclitaxel chemotherapy for the treatment of poor performance status patients with chemotherapy-naïve advanced stage non-small cell lung cancer.

The trial, known as Pioneer 1, is the first approval trial for lung cancer exclusively targeting women and is expected to enroll 600 patients over the next 12 to 14 months, according to a company news release.

"Gaining a better understanding of the biological role of estrogen in the development and progression of lung cancer has become increasingly important, especially with the growing number of women, including nonsmokers, being diagnosed often at a younger age than men and with different outcomes than men," said Kathy Albain, professor of medicine, hematology/oncology and director of thoracic oncology and breast clinical research at Loyola University Health System.

New data suggests the scientific rationale of an enhanced survival benefit of women with non-small cell lung cancer treated with Xyotax versus standard chemotherapy.

Suresh Ramalingam, assistant professor of medicine at the University of Pittsburgh Cancer Institute, said at a recent medical conference that the estrogen receptor-mediated pathway plays an important role in lung cancer biology in both men and women. Preliminary data reported that exposure of lung cancer cells to estrogen increases the gene expression of cathepsin B, a critical enzyme that metabolizes Xyotax, releasing active paclitaxel within the tumor cell.

"These data suggest that patients with normal estrogen levels may benefit due to the favorable effect of estrogen on Xyotax metabolism," Ramalingam said in the release.

The Pioneer 1 clinical trial is expected to begin patient recruitment in December in the United States, Eastern Europe and Latin America with enrollment of 600 poor-performance status chemotherapy-naïve women with advanced stage non-small cell lung cancer.

Each study arm of about 300 patients will be randomized to receive either Xyotax 175mg/m2 or paclitaxel 175mg/m2 once every three weeks.

The primary endpoint is superior overall survival with several secondary endpoints including disease control, response rate in patients with measurable disease, time to disease progression and disease-related symptoms, officials said.

Cell Therapeutics is a Seattle biopharmaceutical company focused on developing cancer treatments.

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