Troxatyl First-line Therapy Study in Acute Leukemia Opens Today

29-Mar-2001

BioChem Pharma Inc. (NASDAQ: BCHE; TSE: BCH) announced that the M.D. Anderson Cancer Center (MDACC), Houston, Texas, is initiating today an exploratory Phase III study of TroxatylTM (troxacitabine) as a component of first-line therapy in previously untreated patients with poor prognosis acute myelogenous leukemia (AML). Troxatyl is BioChem Pharma’s investigational compound currently in clinical trials for the treatment of various forms of cancer.

The study will compare Troxatyl administered in association with either ara-c or idarubicin to a control regimen of ara-c and idarubicin using a Bayesian design (adaptive randomization). This approach will allow identification of the most promising treatment arms after treating a relatively small number of patients. This study is designed to include up to 100 patients. Should initial results hold promise, this study will be expanded to include a larger number of patients to confirm any interesting findings.

The study’s principal investigator, Francis Giles, MD, Chief, Developmental Therapeutics, Department of Leukemia, MDACC, commented, “The ultimate test of a novel anti-leukemia drug is whether or not it will benefit previously untreated patients. After seeing promising results with Troxatyl in heavily pre-treated AML patients, we are very committed to moving Troxatyl rapidly forward with this exciting new study for patients who have not been previously treated for AML.”

Co-principal investigators of this study, also at the MDACC Department of Leukemia, are Dr. Hagop Kantarjian, Chairman and Dr. Eli Estey, Section Chief of Acute Leukemias & MDS.

AML is the most common type of leukemia in adults with a median age of 65 at the time of diagnosis. AML is not a single disease but rather a group of neoplastic disorders characterized by proliferation and accumulation in the bone marrow and peripheral blood of immature hematopoietic cells. Left untreated, AML is usually fatal within weeks to months after diagnosis. However, for those patients treated with presently-available chemotherapy, the American Cancer Society places the 5-year survival at 10-15%.

According to GloboCan, worldwide there were some 257,000 new cases of leukemia in 2000. Specifically, in the developed world during the year 2000, it is estimated that there were more than 27,000 new cases of AML and approximately 63,000 persons afflicted with the disease. That same year in the United States alone, the American Cancer Society estimated that there were nearly 10,000 new cases of AML. It is estimated that close to 21,000 persons were afflicted in the US in the year 2000.

TroxatylTM (troxacitabine) is the first dioxolane nucleoside analog to be investigated as an anticancer agent in clinical trials. Discovered by BioChem Pharma, Troxatyl is a complete DNA chain terminator and DNA polymerase inhibitor. It acts by incorporating itself into the growing DNA chain of cancer cells, interfering with their ability to replicate further. Currently, Troxatyl is being evaluated as a single agent or in combination therapy in a number of ongoing single and multi-center clinical trials in hematologic malignancies, including AML, chronic myeloid leukemia – blastic phase (CML-BP), and in lymphoproliferative disorders such as lymphoma, chronic lymphocytic leukemia (CLL), and myeloma. It is also being evaluated as a single agent in pancreatic cancer and in combination therapy in a number of solid tumours.

https://www.chemeurope.com/en/news/2250/troxatyl-first-line-therapy-study-in-acute-leukemia-opens-today.html