OPAXIO^™ press kit

What is OPAXIO?

OPAXIO (Oh-packs-ee-oh) (CT-2103, paclitaxel poliglumex; formerly known as XYOTAX) is our biologically enhanced chemotherapeutic that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects.

Because the polymer is water-soluble, OPAXIO can be administered without solvents and infused over an average of ten to twenty minutes. OPAXIO remains stable in the bloodstream for several days after administration; this prolonged circulation allows the passive accumulation of OPAXIO in tumor tissue.

We are studying OPAXIO as potential treatment for ovarian, non-small cell lung (NSCLC), and other cancers.

OPAXIO in Ovarian Cancer

CTI and the Gynecologic Oncology Group (GOG) are presently evaluating OPAXIO as monthly maintenance in a phase III clinical trial in ovarian cancer patients who have achieved a complete response following standard first-line chemotherapy.

OPAXIO in Non-Small Cell Lung Cancer

Two randomized phase III trials, STELLAR 3 and STELLAR 4, compared OPAXIO alone or in combination with carboplatin to standard therapy in PS2 patients with advanced NSCLC. STELLAR 2, also phase III, compared OPAXIO to docetaxel in patients with relapsed disease. Another phase III trial, PIONEER (PGT305), compared OPAXIO to paclitaxel in first-line treatment of PS2 women with advanced NSCLC. These studies treated more than 1,900 patients.

The STELLAR trials did not meet their endpoints of superior survival. Instead single-agent OPAXIO resulted in similar efficacy, and with the exception of neuropathy, improved tolerability in both first-line and second-line treatment of advanced NSCLC. Hypersensitivity reactions were rare on the OPAXIO arms of the studies despite the lack of required premedications.

In December 2006, in agreement with the Data Safety Monitoring Board, we closed the PIONEER trial and took patients off both treatment arms. Our decision was due in part to the diminishing utility of the PIONEER trial given our plans to submit a new protocol to the U.S. Food and Drug Administration (FDA).

Clinical Trials for Women with Lung Cancer

As a follow-up to the PIONEER trial, we have initiated a phase III trial for women with premenopausal estrogen levels (> 30pg/mL), the subset where OPAXIO demonstrated the greatest survival advantage in the STELLAR trials. The trial, known as PGT307, will study first-line OPAXIO in combination with carboplatin versus paclitaxel/carboplatin in female patients with performance status of 0, 1, or 2. We received Special Protocol Assessment (SPA) approval from the FDA on the design of the trial.

Statistics on lung cancer in women: