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The paper titled, 'Troxacitabine (BCH-4556), A Novel Dioxolane
Nucleoside Analog, Has Activity in Patients with Advanced Leukemia,' authored
by Dr. Francis J. Giles, et al., documents a single center, open-label Phase I
study conducted at the M.D. Anderson Cancer Center (MDACC) in Houston, Texas.
"Troxatyl's activity has been observed in subsequent studies and we are
very committed to further investigation of Troxatyl, particularly in patients
with AML and blastic phase CML."
The study evaluated Troxatyl in 42 patients with refractory leukemias
(AML(1):31 patients; MDS(2):6 patients; ALL(3):4 patients; CML-BP(4): 1
patient). Early results indicated that Troxatyl demonstrated broad anti-
leukemic activity. Three complete remissions and 1 partial remission were
observed in 30 evaluable AML patients. Marrow hypocellularity was achieved in
22 of these 30 (73%) evaluable AML patients. One MDS patient achieved a
hematologic improvement. The patient with CML-BP achieved a return to chronic
phase disease. Stomatitis and hand-foot syndrome were the dose limiting
toxicities.
The study's principal investigator, Francis Giles, M.D., Associate
Professor, Department of Leukemia, MDACC, commented, "The Phase I study
documented in the JCO today shows that Troxatyl is an active anti-leukemia
drug. Troxatyl's activity has been observed in subsequent studies and we are
very committed to further investigation of Troxatyl, particularly in patients
with AML and blastic phase CML."
Jacques Jolivet, M.D., Director of Clinical Development - Oncology at
BioChem Pharma added, "We have been conducting a very extensive clinical
development program for Troxatyl, both in hematologic malignancies and in the
solid tumours. The potential is exciting, especially in the leukemias, where
the development program is more advanced."
Troxatyl(TM) (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, 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.
BioChem Pharma is an innovative and fast-growing biopharmaceutical
company focused on infectious diseases and cancer.
On December 11, 2000, BioChem entered into an agreement to merge with
Shire Pharmaceuticals Group plc, to form a leading global specialty
pharmaceutical company.
Source: BioChem Pharma
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