BioChem Pharma Inc. (NASDAQ: BCHE;
TSE: BCH) announces the publication of a peer-reviewed paper
regarding Phase I
leukemia data on TroxatylTM (troxacitabine) in
today’s edition of the Journal of Clinical
oncology. Troxatyl is
BioChem’s investigational compound currently in Phase II
clinical trials
for the treatment of various forms of cancer.
The paper entitled, "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. The study evaluated Troxatyl in 42
patients with refractory leukemias (AML1:31 patients; MDS2:6 patients;
ALL3:4 patients; CML-BP4: 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."
1
acute myeloid leukemia
2 Myelodysplastic Syndromes
3 Acute lymphocytic leukemia
4 Chronic myeloid leukemia – blastic phase
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."
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, 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.