Avalon
Pharmaceuticals, Inc. (Nasdaq and NYSE Arca: AVRX), announced that it will
present pharmacodymanic endpoint data from a phase I study of AVN944 at the
American Society of Hematology's 48th Annual Meeting to be held on December
9-12, in Orlando. AVN944 is the Company's lead product candidate for the
treatment of hematologic malignancies.
Dr. Jeffrey Strovel, Senior Scientist at Avalon, is scheduled to
discuss the data in a poster presentation titled, "Genetic and Biochemical
Biomarkers of IMPDH Inhibition in Phase I Dose Escalation of AVN944 for
Hematological Malignancies," on Sunday, December 10, 2006, at 6:00 p.m.
EST.
In addition to the phase I objective of defining the maximum tolerated
dose of AVN944, Avalon is examining a comprehensive set of pharmacodynamic
biomarkers using its proprietary gene expression platform, AvalonRx(R).
These markers, previously identified as responsive to AVN944 exposure in a
multitude of laboratory settings, correlate with biochemical effects of the
drug on protein function and guanine nucleotide levels, and can be used as
tools to select the optimal dose with which to initiate phase II studies.
This interim analysis of the trial data is intended to describe how these
biomarkers correlate with biologic activity of the drug in patients on
study.
An abstract of the Presentation is now available on the ASH website,
hematology.
About AVN944
AVN944 is an oral small molecule drug candidate that inhibits inosine
monosphospate dehydrogenase (IMPDH), an enzyme that is critical for cells
to be able to synthesize guanosine triphosphate (GTP), a molecule required
for DNA synthesis and cellular signaling. IMPDH is over expressed in some
cancer cells, especially in the case of hematological malignancies. In
laboratory experiments, AVN944 has been shown to inhibit IMPDH activity in
cells, and suppress pools of GTP. Anticancer activities of IMPDH inhibitors
correlate with sustained depletion of GTP pools both in cellular models and
in human subjects. AVN944 appears to have a selective effect on cancer
cells in that deprivation of GTP in normal cells results in a temporary
slowing of cell growth, while GTP deprivation in cancer cells induces cell
death, or apoptosis.
Results from preclinical studies of AVN944 indicate that AVN944
inhibited the proliferation of lymphoid and myeloid cells, the principal
cells involved in the most common types of human leukemias. In a
single-dose, dose-escalation phase I clinical trial of AVN944 conducted in
the United Kingdom in healthy volunteers, AVN944: (1) was well tolerated at
all tested doses with no notable side effects; (2) demonstrated good
pharmacokinetic properties; and (3) had a significant inhibitory effect on
IMPDH enzyme activity. Avalon filed an IND with the FDA in August 2005 and
initiated U.S. phase I clinical trials in January 2006 for the treatment of
hematological cancers.
About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using proprietary
technology, AvalonRx(R), to discover and develop cancer therapeutics.
Avalon has a lead product in phase I clinical development (AVN944 - IMPDH
inhibitor); preclinical programs to discover inhibitors for the
Beta-catenin, Aurora and Survivin pathways; and drug discovery
collaborations with MedImmune, Novartis, ChemDiv and Medarex. Avalon
Pharmaceuticals was established in 1999 and is headquartered in Germantown,
Maryland.
About AvalonRx(R)
AvalonRx(R) is a comprehensive, innovative and proprietary suite of
technologies based upon large-scale gene expression analysis. This platform
facilitates drug discovery by expanding the range of therapeutic targets
for drug intervention, including targets and target pathways frequently
considered intractable using conventional HTS approaches, allows more
informed decisions about which compounds to advance towards clinical
trials, and facilitates drug development through identification of
biomarkers of efficacy that can stratify patients or provide early
indicators of response.
Safe Harbor Statement
This announcement contains, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties, in
particular, related to progress in our drug discovery programs and our
collaborations, and clinical progress in the development of AVN944. Such
statements reflect the current views of Avalon management and are based on
certain assumptions. Actual results could differ materially from those
currently anticipated as a result of a number of factors, risks and
uncertainties including the risk that the discovery programs and
collaborations may not be successful and that AVN944 will not progress
successfully in its clinical trials, and other risks described in our SEC
filings. There can be no assurance that our development efforts will
succeed, that AVN944 will receive required regulatory clearance or, even if
such regulatory clearance is received, that any subsequent products will
ultimately achieve commercial success. The information in this Release
should be read in conjunction with the Risk Factors set forth in our 2005
Annual Report on Form 10-K and updates contained in subsequent filings we
make with the SEC.
Avalon Pharmaceuticals, Inc.
hematology