Cell Therapeutics, Inc.'s (CTI) subsidiary Systems Medicine (SM) announced that planned enrolment is complete in the European Organization for Research and Treatment of Cancer (EORTC) randomized phase-II clinical trial of brostallicin in patients with newly diagnosed advanced or metastatic soft tissue sarcoma who have had no prior chemotherapy.

The primary endpoint of the trial is progression-free survival at six months. Patients are randomized in a 2:1 ratio either to receive brostallicin or the standard therapy, doxorubicin. The EORTC designed the study to enrol a total of 108 eligible and treated (evaluable) patients, and plans to conduct the final data analysis in early 2009.

"New therapies are needed to improve outcomes in patients with advanced non-GIST soft tissue sarcomas. This study is the second EORTC study of brostallicin in soft tissue sarcoma. The initial study used brostallicin as single agent salvage therapy in patients whose disease had progressed following initial chemotherapy. The EORTC considered the results in that trial to be of sufficient magnitude to conduct the current study, using brostallicin as first line therapy in patients with advanced or metastatic soft tissue sarcoma who have not received any prior chemotherapy," said Jack Singer, MD, EVP, chief medical officer of Cell Therapeutics. "A standard-of-care arm (doxorubicin) is included as a reference arm, although not used to determine comparative efficacy. If the study results are encouraging, a phase-III study in soft tissue sarcoma could be initiated in 2009."

The title of the trial is "Randomized phase-II study of brostallicin (PNU-166196A) versus doxorubicin as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma." Hans Gelderblom, MD, Ph D, of Leiden University Medical Center in the Netherlands, is the principal investigator (PI) and Jean Yves Blay, MD, Ph D, chair of the EORTC soft tissue and Bone Sarcoma Group, is overseeing it.

"Based on the results of the first EORTC study with brostallicin, we conducted the current study in patients with soft tissue sarcoma to further define the activity of this drug in this patient population," said Blay. "In the first study, two patients treated with brostallicin had confirmed partial responses and many others had prolonged disease control. Such activity is rare in this group of patients, and we very much hope to confirm or improve on those results and to expand our knowledge of brostallicin in the treatment of these patients."

"Brostallicin represents a promising new agent with a unique mechanism of action for patients with metastatic sarcoma where there is a clear unmet medical need," said Gelderblom. "The current standard approach for newly diagnosed patients with sarcoma is essentially limited to doxorubicin so clearly new treatment options are needed."

Brostallicin, a novel synthetic second-generation DNA minor groove binder, has potent cancer killing activity and has demonstrated synergism in combination with standard cytotoxic agents as well as with newer targeted therapies in preclinical experimental tumour models.

Created in 1962, the European Organization for Research and Treatment of Cancer (EORTC) is a not-for-profit international cancer research organization under the Belgian law. The EORTC has the mission to develop, conduct, coordinate and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patients' quality of life.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.

In July 2007, CTI acquired Systems Medicine (SM), a privately held oncology company, in a stock-for-stock merger. SM applies a systems biology approach to drug development, combining pharmacogenomics and bioinformatics with experienced preclinical, clinical and regulatory expertise to find and exploit a specific cancer's 'context of vulnerability.'