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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (226)	6/14/2004 7:10:54 AM
From: Icebrg	Read Replies (1) \| Respond to of 946

TRISENOX(R) Produces Hematologic Responses in 27 Percent of MDS Patients Monday June 14, 7:02 am ET Responses Seen in Both High-Risk and Low-Risk Patients GENEVA, June 14 /PRNewswire-FirstCall/ -- At the 9th Congress of the European Hematology Association (EHA) preliminary data were presented from a phase II study of TRISENOX® (arsenic trioxide) injection in myelodysplasia (MDS). The multicenter European study, led by Norbert Vey, M.D. of Institut Paoli-Calmettes in patients with both high-risk (HR) and low-risk (LR) MDS, showed that single-agent TRISENOX produced a defined hematologic response rate of 27 percent (nine of 39 LR, 18 of 62 HR). Encouragingly, nine of 48 patients (19 percent) who had single-lineage red blood cell transfusion dependence became transfusion independent after TRISENOX treatment. Median duration of response on the study was approximately four months (range 2-10 months). The full duration of these responses is not yet known as twenty patients were still responding at the time of data release. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) markets TRISENOX in the United States and Europe. "These results establish the clinical activity of TRISENOX in MDS. Most notable were the high number of patients achieving transfusion independence. Given this positive activity in both low- and high-risk MDS patients and the good safety profile, TRISENOX is a prime candidate to investigate in combination therapy," stated Vey. The objectives of the study are to determine the safety and efficacy of single agent TRISENOX in patients with low-risk and high-risk disease. TRISENOX was administered at a dose of 0.3 mg/kg for five days in the first week and 0.25 mg/kg twice weekly thereafter. Responses were observed across all hematologic lineages in high-risk patients and included one complete response (CR). In low-risk patients, responses were seen in two lineages. In addition to the nine patients who became red blood cell transfusion independent, five others had their red blood cell transfusion requirements reduced by more than 50 percent. There were also a total of three of 38 patients (seven percent) who became platelet transfusion independent, with two others experiencing a reduction in transfusion dependence by 50 percent. Most treatment-related adverse events were mild to moderate with one reported case each of grade 4 thrombocytopenia, neutropenia and edema NOS. "This is the second largest study of TRISENOX in MDS to demonstrate a clinically beneficial response in platelet and neutrophil as well as red blood cell lineages in both high- and low-risk patients," noted Jack W. Singer, M.D. and Chief Medical Officer at CTI. "With more than 180 patients treated in phase II studies, we are now planning investigational trials of TRISENOX in combination with the recently approved demethylating agent, 5 azacytidine. We believe treatment of MDS still has a significant unmet need and that TRISENOX may supplement the utility of 5 azacytidine and other experimental agents to improve the response rates and outcome for patients with MDS."