Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


CTI further refines Xyotax population in new Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A confirmatory Phase III trial of Cell Therapeutics' polymer-linked paclitaxel Xyotax is recruiting women with advanced non-small cell lung cancer who have premenopausal estrogen levels (>30 pg/mL). The PGT307 trial, designed under a special protocol assessment with FDA, will enroll 450 women with NSCLC performance status 0, 1, or 2, who will be randomized to Xyotax (paclitaxel poliglumex) plus carboplatin or paclitaxel/carboplatin. CTI has been highlighting its plans for a normal estrogen level protocol to support a "gender medicine" NDA (1Pharmaceutical Approvals Monthly, December 2006, p. 11). An earlier gender-specific trial, the PIONEER study, enrolled women with both normal and abnormal estrogen levels, but was terminated late last year due to early cycle deaths in both arms. CTI has been trying to isolate the effect observed in women in its STELLAR pivotal program. The traditional gender-neutral program failed to meet endpoints in the total NSCLC population, but showed a benefit in women...

You may also be interested in...

CTI Xyotax PIONEER Study Closes In Favor Of Normal Estrogen Level Protocol

Cell Therapeutics will submit a new Xyotax (paclitaxel poliglumex) trial protocol to FDA by the end of the month after closing its Phase III PIONEER gender-specific lung cancer trial

US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

COVID-19: US Acted To Beat Other Countries To Next 1.25M Doses Of Regeneron Cocktail

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts