SEATTLE, Dec. 8 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) announced that Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) has launched TRISENOX(R) (arsenic trioxide) in Japan after receiving pricing approval from the Japanese Ministry of Health to market the drug for patients with relapsed or refractory acute promyelocytic leukemia (APL). CTI markets TRISENOX in the United States and Europe.
"We're pleased that our partner Nippon Shinyaku will now be able to provide relapsed/refractory APL patients with this potentially life-saving therapy," stated James A. Bianco, M.D., President and CEO of CTI. "We will continue to invest in the development and commercialization of TRISENOX as we believe it provides patients with a safe and effective alternative to standard chemotherapy."
CTI also announced today that it has signed agreements with five new distributors of TRISENOX in Latin America, Eastern Europe, Israel, Turkey and South Africa. Earlier this year, the Company announced that the U.S. Patent and Trademark office had issued a patent directed to TRISENOX, extending CTI's marketing exclusivity for the drug from 2007 to 2018. Following the patent extension, to accelerate TRISENOX sales in Europe, the Company expanded its European sales force with additional representatives in eight major market countries.
"We're seeing more access to TRISENOX for patients worldwide and these distributor agreements will lay the groundwork for further market expansion," stated Bianco. "We look forward to strong and productive relationships with our new partners."
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 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 http://www.cticseattle.com/.
Cell Therapeutics, Inc.
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