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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

unless they have started a new anti-cancer therapy. The primary end-point is proportion of patients who are progression free at 6 months (26 weeks) after start of treatment according to RECIST. Secondary objectives are progression free survival (PFS), objective tumor response based on RECIST, duration of response, and overall survival. A total enrollment of 108 eligible and evaluable patients was required (36 in the doxorubicin arm, 72 in the brostallicin arm).

About Brostallicin

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 tumor models. Brostallicin binds covalently to DNA within the DNA minor groove, interfering with DNA division and leading to tumor cell death. More than 230 patients have been treated with brostallicin in single-agent and combination studies. Brostallicin had predictable and predominantly hematologic toxicities. Activity was demonstrated in a number of solid tumor types. A phase II study of brostallicin in relapsed/refractory soft tissue sarcoma had sufficient activity based on 3 and 6 month progression free survival and safety profile, which resulted in the first-line phase II study that is currently being conducted by the EORTC.

Context of Vulnerability

CTI and SM are employing a new method of drug development, the "context of vulnerability" approach. Using cutting-edge genomic profiling tools, the Company creates a profile of which cells react to certain drugs in an effort to discover cells' vulnerabilities (weak spots) and where the drugs are the strongest. With these data, investigators can target those patients with the highest probability of benefiting from a particular drug. By treating only the patients with the genetic characteristics known to react well to the drug, scientists may be able to decrease
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SOURCE Cell Therapeutics, Inc.
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