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Cell Therapeutics Announces that the European Organization for Research and Treatment of Cancer Completes Enrollment in Phase II Clinical Trial of Brostallicin as First Line Therapy for Advanced or Metastatic Soft Tissue Sarcoma
Date:8/11/2008

of brostallicin (PNU-166196A) versus doxorubicin as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma." Hans Gelderblom, M.D., Ph.D., of Leiden University Medical Center in the Netherlands, is the Principal Investigator (PI) and Jean Yves Blay, M.D., 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."

About the Study

To participate in the study, patients had to be at least 60 years of age or at least 18 years of age and non suitable for intensive chemotherapy combination treatment, with a WHO performance status 0 or 1. The EORTC's protocol called for a maximum of 6 treatment cycles, unless the patient withdrew before completion of treatment due to disease progression, drug related event, concurrent illness, or patient refusal to continue therapy. A patient's tumor will be re-evaluated every 6 weeks during treatment, and at least 4 weeks after the first observation of a complete or partial response. After discontinuation of protocol treatment, patients who have not progressed will be re-evaluated every 12 weeks,
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SOURCE Cell Therapeutics, Inc.
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