|
Dec. 1, 2000, Laval, Quebec, Canada — BioChem Pharma Inc. (NASDAQ: BCHE; TSE: BCH) announces that it will be initiating new studies of TroxatylTM (troxacitabine) in blastic phase chronic myelogenous leukemia (CML-BP) patients. These studies are intended to follow up on promising preliminary data in this indication first presented at the Chemotherapy Foundation Symposium XVIII on November 8, 2000 by Dr. Hagop Kantarjian, Chair of the Department of Leukemia at the M.D. Anderson Cancer Center (MDACC), Houston, TX.
Preliminary data is available from BioChem’s pilot Phase II monotherapy study in acute leukemias, in which 31 treatment-refractory patients were enrolled (chronic myelogenous leukemia in blastic phase: 17, acute lymphocytic leukemia: 6, acute myelogenous leukemia: 8). Of the 17 CML-BP patients enrolled in this study, data is evaluable on 13 patients, with seven achieving a major hematologic response. Four of these seven patients remain in chronic phase with response durations ranging from between two to greater than 18 months to date. Dose-limiting toxicities in this study were mucositis and hand-foot syndrome.
It is estimated that approximately 16,000 patients in the U.S. are afflicted with chronic myelogenous leukemia (CML). Diagnosis of CML is generally ascribed to one of three distinct disease stages: chronic, accelerated and blastic phase. Based on Leukemia and Lymphoma Society (U.S.) statistics, the number of new cases afflicted with CML in the U.S. each year is approximately 4,500, of which it is estimated that approximately 2,000 CML patients are in the most advanced stage, blastic phase, where there is a large unmet treatment need. Median survival duration in this phase of CML is typically in the order of six months.
"Troxatyl's activity in patients with CML blastic phase is truly exciting and, based on data available to date, may have a major role in the treatment of CML-BP patients."
Principal Investigator, Dr. Francis Giles, Associate Professor, Department of Leukemia, MDACC, Houston, TX, commented, "As a single agent, Troxatyl has significant activity in patients with advanced myeloid leukemias, including those who have failed intensive cytarabine therapy. Troxatyl's activity in patients with CML blastic phase is truly exciting and, based on data available to date, may have a major role in the treatment of CML-BP patients. Troxatyl's side effect profile is quite manageable with mucositis being the adverse event which will most likely dictate the maximum doses within combinations with established anti-leukemia agents."
To further explore the potential of Troxatyl therapy in CML-BP, BioChem will be initiating both multicentre open-label, single agent and randomized studies in chemotherapy-naive patients, but including patients who have failed the investigational tyrosine kinase inhibitor, STI-571.
In other hematologic indications, the Company is continuing to evaluate Troxatyl either alone or in combination with other approved treatments, including topotecan, ara-c, idarubicin, and Mylotarg. The combination trials of Troxatyl include patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). The activity of Troxatyl as a single agent is also being studied in multiple myeloma, lymphoma and chronic lymphocytic leukemia. Troxatyl and its potential as a combination agent in AML will be discussed by Dr. Elihu H. Estey, Section Chief of Acute Leukemias & MDS, Department of Leukemia, MDACC, at an educational program entitled ‘Newly Developed and Developing Therapies of AML’ during the 42nd American Society of Hematology Annual Meeting on Saturday December 2, 2000 in San Francisco.
Commenting on the various trials, Dr. Giles added, “In the absence of effective alternate therapy, we consider the rapid completion of the multicentre studies evaluating Troxatyl in CML-blastic phase patients to be a matter of urgency. We also intend to speed and expand accrual on our current Troxatyl combination studies in patients with AML and MDS and eagerly await preliminary data from ongoing studies in patients with advanced lymphoproliferative disorders.”
BioChem has conducted an extensive program to determine the safety and activity of Troxatyl in a number of solid tumours using an every-three-week administration schedule. Based on results to date, BioChem is continuing to evaluate the potential of Troxatyl in solid tumours using a different dosage regimen (daily X 5, monthly), beginning with studies currently underway in pancreatic and renal cancer. Additional Troxatyl trials in combination with cisplatin and Taxol are also ongoing in advanced solid tumours. TroxatylTM (troxacitabine) is the first dioxolane nucleoside analog to be investigated as an anticancer agent in clinical trials. Nucleoside analogs are among the most potent of anticancer agents. Discovered by BioChem Pharma, the unique structure of Troxatyl allows it to be potentially less susceptible to common mechanisms of resistance which affect other nucleosides. The Company is encouraged by the clinical development of Troxatyl and the results seen thus far. In addition to Troxatyl, BioChem Pharma is actively pursuing other therapeutic avenues in the treatment of cancer, including angiolytics, apoptosis, and chemotherapeutic nucleosides. BioChem Pharma is an innovative and fast-growing biopharmaceutical company focused on infectious diseases and cancer.
Source: BioChem Pharma Inc.
This site was last updated on Dec. 17, 2000 Copyright © 2000 CMLSupport.com
Or she will beat you up and stuff. |