NoBlood

Nika · #1 (**permalink**) 04-27-2005, 11:56 PM

Source:
PR Newswire

Treatment of Newly Diagnosed Acute Promyelocytic Leukemia With Arsenic Trioxide May Remove Need for Anthracycline Chemotherapy

PR Newswire Europe; 10/4/2004

SEATTLE, October 4 /PRNewswire/ --

- Long Lasting Complete Remissions Reported in 88% of Patients

An Iranian investigational study of single-agent arsenic trioxide for the treatment of acute promyelocytic leukemia (APL) was presented on Sept. 29 at the 16th Annual meeting of the European Organization for Research and Treatment of Cancers, National Cancer Institute and American Association for Cancer Research (EORTC-NCI-AACR). In the study, 63 patients with newly diagnosed APL were treated with arsenic trioxide and over the course of two treatments, 90 percent of the patients achieved a complete remission. Of the 11 patients who suffered a relapse, eight went back into remission after a third treatment. Currently, 88.5 percent of the patients in this ongoing study are still alive, with a mean survival time of nearly 34 months since the start of treatment. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) markets arsenic trioxide (TRISENOX(R)) in the United States and Europe for relapsed and refractory APL.

Data on a phase I study of CTI's polyglutamate camptothecin were also presented at the EORTC-NCI-AACR meeting. These data showed that CT-2106 was well tolerated with manageable toxicities and demonstrated evidence of anti-cancer activity in three tumor types. One pancreatic cancer patient with metastasis to the lungs has experienced a partial response, two patients with colorectal cancer experienced stable disease for more than 12 weeks and two patients with non-small cell lung cancer had disease stabilization for more than 35 weeks. The preliminary disease control rate was 33 percent (8 of 24 patients).

About TRISENOX(R)

TRISENOX(R) (arsenic trioxide) is marketed by CTI. TRISENOX 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 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 is currently being studied in more than 40 clinical and investigator-sponsored trials in a variety of cancers. U.S. marketing approval for TRISENOX was granted based on results from a U.S. multicenter study in which 40 relapsed APL patients were treated with TRISENOX 0.15 mg/kg until bone marrow remission or a maximum of 60 days. Thirty-four patients (85 percent) achieved complete remission. 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 should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients with APL treated with TRISENOX 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 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 Acute Promyelocytic Leukemia (APL)

APL, one of eight subtypes of acute myeloid leukemia (AML), is a malignant disorder of white blood cells. It can affect patients of any age. APL is characterized by a specific chromosomal abnormality -- a switch, or translocation, of genetic material from chromosome 17 to chromosome 15. This genetic alteration results in an abnormal protein that inhibits normal cell growth and prevents maturation of white blood cell precursors in the bone marrow, ultimately resulting in cancer. The standard treatment for newly diagnosed APL has been a combination of chemotherapy and all-trans-retinoic acid (ATRA), which results in a complete response in 70-90 percent of newly diagnosed patients. However, approximately 20-30 percent of patients who receive this treatment regimen relapse. This poor response to drug therapy has led to the use of allogenic stem cell transplantation (the transfer of healthy, young cells from the bone marrow or bloodstream of a donor) to prolong survival. TRISENOX provides another treatment option for this patient population.

About CT-2106

CT-2106 is the second agent in CTI's portfolio, after XYOTAX(TM) (paclitaxel poliglumex), to exploit the polyglutamate-conjugate technology, where an anti-cancer agent is conjugated to a naturally biodegradable poly-amino acid.

About Cell Therapeutics, Inc.

Headquartered 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 www.cticseattle.com.

Web site: http://www.cticseattle.com/media.htm

Web site: http://www.cticseattle.com/investors.htm

Web site: http://www.cticseattle.com

investors, Leah Grant, +1-206-282-7100, or fax, +1-206-272-4434, or invest@ctiseattle.com; or media, Kate Whitman, +1-206-272-4349, or fax, +1-206-272-4434, or media@ctiseattle.com, both of Cell Therapeutics, Inc.