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TRISENOX(R) Produces Durable Responses in Patients with Both High-Risk and Low-Risk Myelodysplasia
Preliminary Results of Two Phase II Clinical Studies Reported at American Society of Hematology (ASH)
SAN DIEGO, Dec. 7 /PRNewswire-FirstCall/ -- Preliminary data from two clinical trials of TRISENOX(R) (arsenic trioxide) injection in a total of 120 patients with myelodysplasia (MDS) were presented at the 45th Annual Meeting of the American Society of Hematology. MDS is a disease in which patients can become anemic and at risk for bleeding or infection as a result of the failure to produce red blood cells, platelets or infection fighting white blood cells.
High risk MDS patients are also at risk of progressing to acute leukemia, which is often rapidly fatal. TRISENOX is marketed by Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) for patients with relapsed or refractory acute promyelocytic leukemia.
Following treatment with TRISENOX, 28 of 120 patients (23 percent) with sufficient data for evaluation, in the two single-agent studies, including 14 high-risk (HR) and 14 low-risk (LR) patients, experienced a major or minor hematologic response (as defined by International Working Group). Responses were observed in each of the cell lineages and were seen after about eight to 24 weeks of TRISENOX therapy. In addition, TRISENOX treatment led to transfusion independence in 12 patients and a decrease of 50 percent or more in transfusion requirements for an additional five patients. Responses to TRISENOX were durable, lasting from just under eight weeks up to 46 weeks, with a median duration of approximately 15 weeks.
The following is a summary of data from the presentations in MDS at the meeting:
| Investigator |
Patients
Enrolled
|
Patients
Evaluable
|
Transfusion
Independence
|
Overall
Response
|
| A. List |
53* |
46 (21 LR, 25 HR) |
4 |
12 (26%) |
| N. Vey |
82* |
74 (27 LR, 47 HR) |
8 |
16 (22%) |
| Summary |
135 |
120 (48 LR, 72 HR) |
12 |
28 (23%) |
* Excludes patients who received no study drug or who are too early in treatment to assess. (<8 weeks)
"The multi-lineage hematologic response that TRISENOX has demonstrated in this difficult to treat disease makes it a promising new agent for the treatment of MDS," said Alan F. List, M.D. of the Moffitt Cancer Center & Research Institute and an investigator on one of the trials. "I am especially impressed with the durability of responses seen in these patients and the potential to incorporate TRISENOX into novel combination therapies."
Information on specific presentations:
Norbert Vey, M.D. of the Groupe Francais des Myelodysplasies, presented preliminary data from a phase II European multi-center, open-label study of TRISENOX in patients with MDS. Among 74 patients evaluable for efficacy, 16 patients (22 percent) including 10 high risk and six low risk patients had a defined hematologic response. Responses were observed across all hematologic lineages in HR patients, and in two lineages in LR patients. Eight of the
patients with hematologic response became transfusion independent and two additional patients decreased transfusion dependence by 50 percent.
In a separate presentation, List presented preliminary findings from a
phase II U.S. multi-center, open-label study of TRISENOX in patients with MDS. Among 46 patients evaluable for efficacy, 12 patients (26 percent) including four high risk and eight low risk patients had a defined hematologic response. Responses were observed in both high risk and low risk patients, including one high risk patient with CMML who achieved a complete remission that continues at 21 months.
To view the posters, visit the CTI website at http://www.cticseattle.com.
About TRISENOX(R)
TRISENOX(R) (arsenic trioxide) is marketed by Cell Therapeutics, Inc.
(CTI) (NASDAQ: CTIC). TRISENOX(R) was approved for marketing in 2000 by the U.S. Food and Drug Administration to treat patients with relapsed or refractory Acute Promyelocytic Leukemia. (APL), a rare, life-threatening form of cancer of the blood. TRISENOX(R) was granted marketing authorization from the European Commission in March 2002. APL, one of eight subtypes of acute myeloid leukemia (AML), represents 10-15 percent of the more than 20,000 patients diagnosed with AML each year. TRISENOX(R) is currently being studied in more than 40 clinical trials in a variety of cancers.
U.S. marketing approval for TRISENOX(R) was granted based on results from a U.S. multicenter study in which 40 relapsed APL patients were treated with TRISENOX(R) 0.15 mg/kg until bone marrow remission or a maximum of 60 days.
Thirty-four patients (85 percent) achieved CR. When the results for these 40 patients were combined with those for the 12 patients in a pilot trial, an overall response rate of 87 percent was observed.
WARNING: TRISENOX(R) should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients with acute promyelocytic leukemia (APL) treated with TRISENOX(R) have experienced APL differentiation syndrome - with symptoms similar to retinoic acid-acute promyelocytic leukemia (RA-APL) syndrome. Arsenic trioxide can cause QT prolongation (which can lead to torsade de
pointes) and complete atrioventricular block.
The most common adverse events associated with TRISENOX(R) have been generally manageable, reversible and usually did not require interruption of therapy. These have included hypokalemia, hypermagnesemia, hyperglycemia and thrombocytopenia as reported in 13 percent of the patients (n=40). Abdominal pain, dyspnea, hypoxia, bone pain and neutropenia were reported in 10 percent
of these patients, while arthralgia, febrile neutropenia and disseminated intravascular coagulation were reported in eight percent of patients.
About Cell Therapeutics, Inc.
Based in Seattle, CTI is a biopharmaceutical company committed to
developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.cticseattle.com.
This announcement includes forward-looking statements about preliminary data from clinical trials that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the continued development of TRISENOX(R) include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and
with TRISENOX(R) in particular including, without limitation, the potential failure of TRISENOX(R) to prove safe and effective for treatment of MDS, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling TRISENOX(R), and the risk factors listed or described from time to time in the Company's filings with the Securities and
Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K and 10-Q.
SOURCE Cell Therapeutics, Inc.
Web Site: http://www.cticseattle.com
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