Avalon Pharmaceuticals Initiates AVN944 Phase I Clinical Trial in Cancer Patients
January 09 2006 - 5:30AM
PR Newswire (US)
GERMANTOWN, Md., Jan. 9 /PRNewswire-FirstCall/ -- Avalon
Pharmaceuticals, Inc. (Nasdaq and ArcaEx(R): AVRX), a
biopharmaceutical company focused on the discovery and development
of small molecule therapeutics, today announced the initiation of a
Phase I clinical trial of AVN944 in patients with advanced
hematological malignancies. The first patient was treated last week
at the University of Arkansas for Medical Sciences. The trial is
also expected to enroll patients at The University of Texas MD
Anderson Cancer Center, Stanford University, and The Ohio State
University Comprehensive Cancer Center -- Arthur G. James Cancer
Hospital and Richard J. Solove Research Institute. "The dosing of
cancer patients in this first U.S. trial of AVN944 represents
another milestone for Avalon Pharmaceuticals," said Kenneth C.
Carter, Ph.D. President and Chief Executive Officer of Avalon. "We
believe that AVN944 has the potential to offer oncologists and
cancer patients improved options in several types of cancers where
other therapies fail." The Phase I clinical trial is designed as an
open-label, repeat dose-escalation study for the evaluation of the
safety and tolerability of AVN944 in adult patients with advanced
hematological malignancies including those with leukemia, lymphoma
or myeloma. The study is designed to determine the optimal dose
with which to advance Phase II efficacy trials. In the current
study, as many as 36 patients could receive AVN944 at or near this
optimal dose. Current plans are to conduct this trial at five
leading cancer centers in the United States. Information on the
trial, including other site locations when they initiate treatment,
will be available at the National Institutes of Health clinical
trial database at http://www.clinicaltrials.gov/ (a service of the
U.S. National Institutes of Health developed by the National
Library of Medicine). AVN944 is an oral, small molecule inhibitor
of the enzyme inosine monophosphate dehydrogenase (IMPDH), an
enzyme that is essential for the de novo synthesis of the
nucleotide guanosine triphosphate (GTP). AVN944 appears to inhibit
cell proliferation by denying dividing cells of the GTP necessary
for synthesis of DNA and RNA. IMPDH is highly upregulated in
hematologic cancers and many other types of cancer cells are also
sensitive to IMPDH inhibition. AVN944 was in-licensed by Avalon
from Vertex Pharmaceuticals Incorporated in February of 2005.
Vertex conducted a Phase I trial in the U.K. in normal human
volunteers where AVN944 was shown to be orally bioavailable and
well-tolerated. About Avalon Pharmaceuticals, Inc. Avalon
Pharmaceuticals is a biopharmaceutical company focused on the
discovery and development of small molecule therapeutics. Avalon
seeks to discover and develop novel therapeutics through the use of
a comprehensive, innovative and proprietary suite of technologies
based upon large-scale gene expression analysis which it calls
AvalonRx(R). Avalon Pharmaceuticals was established in 1999 and is
headquartered in Germantown, Maryland. This announcement contains,
in addition to historical information, certain forward-looking
statements that involve risks and uncertainties, in particular,
related to 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. There can be no assurance that such 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.
Contacts: Avalon Pharmaceuticals, Inc. Noonan Russo Gary Lessing
Wendy Lau (Media) Chief Financial Officer Tel: (212) 845-4272 Tel:
(301) 556-9900 Fax: (301) 556-9910 Jane Petrino (Investors) Email:
Tel: (212) 845-4274 DATASOURCE: Avalon Pharmaceuticals, Inc.
CONTACT: Gary Lessing, Chief Financial Officer of Avalon
Pharmaceuticals, Inc., Tel - +1-301-556-9900, Fax -
+1-301-556-9910, ; or Media - Wendy Lau, +1-212-845-4272, or
Investors - Jane Petrino, +1-212-845-4274, both of Noonan Russo Web
site: http://www.clinicaltrials.gov/
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