Xyotax studies initiated for ovarian, breast cancers.(polyglutamate paclitaxel)

2002 SEP 12 - (NewsRx.com & NewsRx.net) -- Cell Therapeutics, Inc., (CTIC) (CTI) announced the start of the first phase II study with Xyotax (polyglutamate paclitaxel) in breast cancer.

A. Hilary Calvert, MD, of Newcastle General Hospital will serve as Coordinating Investigator for the trial, which will be conducted by Cancer Research U.K. in the United Kingdom.

"The study is designed to investigate the response rate of Xyotax in patients who have metastatic breast cancer following up to two prior chemotherapeutic regimens for metastatic disease," said Calvert. "Through this study, we hope to determine the safety profile of Xyotax and its efficacy in terms of response rates."

Two cohorts of patients will be entered into the study in a two-step process, those who are taxane-naive, and those whose prior treatment regimen included a taxane. Both cohorts will receive the same initial dose of Xyotax at 235mg/m2 paclitaxel-equivalent, every 21 days.

"Worldwide sales of taxanes presently exceed $2 billion. Most taxane use is in four tumor types, including non-small cell lung, breast, ovarian, and prostate cancers. With the addition of this phase II trial to our development program, CTI has clinical trials ongoing in three of these indications: lung, ovarian, and now breast," said James A. Bianco, MD, president and CEO of CTI.

The company also announced that it has initiated its Xyotax phase III ovarian clinical trial. This multinational trial is expected to include clinical sites throughout the U.S. and Europe.

"Previous data have suggested Xyotax is more convenient and may improve the tolerability of treatment, compared to the use of paclitaxel," stated Maurie Markman, MD, principal investigator on the study and director of the Cleveland Clinic Cancer Center. "This study is designed to determine if Xyotax improves not only the survival in advanced ovarian cancer, but also the quality of life for women with this malignancy."