Avalon Pharmaceuticals Advances AVN944 into a Phase II Clinical Trial in Solid Tumors
July 12 2007 - 6:00AM
PR Newswire (US)
GERMANTOWN, Md., July 12 /PRNewswire-FirstCall/ -- Avalon
Pharmaceuticals, Inc. (NASDAQ:AVRX), today announced the initiation
of a Phase II clinical trial in pancreatic cancer patients. The
protocol has been activated and is now open for enrollment as
patients are being evaluated to start study treatment. The first
active center is Yale University -- Yale Cancer Center. The Company
expects to enroll patients at approximately fifteen sites for the
trial. "The advancement of AVN944 into a Phase II trial in solid
tumors represents a significant milestone for AVN944 and Avalon
Pharmaceuticals," said Kenneth C. Carter, Ph.D., President and CEO.
"We believe AVN944 has the potential to provide patient benefit in
several cancer types." The trial will be conducted in two parts
(Part A and Part B), both using an open-label, non-controlled
design. Eligible patients will include adult patients with advanced
newly diagnosed pancreatic cancer. Part A is a dose- escalation
study with a primary objective to determine the maximum tolerated
dose or effective biologic dose of AVN944 in combination with
gemcitabine. Approximately 15-20 patients will be enrolled in Part
A. Part B is to establish the efficacy and safety of the
AVN944/gemcitabine combination and approximately 110-120 patients
will be enrolled. Patients will receive an initial treatment cycle
of AVN944 and gemcitabine and may receive additional cycles of
treatment every 28 days at the discretion of the Investigator and
with the agreement of the patient. Information on the trial is
available at the National Institutes of Health clinical trial
database and will be updated when additional sites initiate
treatment, http://www.clinicaltrials.gov/ (a service of the U.S.
National Institutes of Health developed by the National Library of
Medicine). 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 Gemcitabine HCI (GEMZAR(TM)) Gemcitabine is a chemotherapy
drug that is used to treat certain types of cancer (non-small cell
lung cancer, metastatic breast cancer, ovarian cancer, and
pancreatic cancer). Chemotherapy drugs act to control the growth of
rapidly dividing cells, including cancer cells. (Cancer cells are
abnormal cells which are growing at an uncontrolled rate.) The goal
of chemotherapy is to kill as many cancer cells as possible or to
stop them from dividing and making more cancer cells. Gemcitabine
works by interfering with the process by which cells divide and
repair themselves, thus preventing the further growth of cancer
cells and leading to cell death. About Avalon Pharmaceuticals
Avalon Pharmaceuticals is a biopharmaceutical company using its
proprietary technology, AvalonRx(R), to discover and develop cancer
therapeutics. Avalon has a lead product in Phase I clinical
development (AVN944 -- IMPDH inhibitor), as well as preclinical
programs to discover inhibitors for the beta-catenin and aurora
pathways now in late stage lead candidate optimization. Avalon also
has discovery programs on modulators of survivin function and a
drug discovery program targeting the MYC oncoprotein, one of the
most important and previously intractable cancer targets. The
Company has value generating partnerships with Merck, MedImmune,
Medarex, and Novartis. Avalon Pharmaceuticals was established in
1999 and is headquartered in Germantown, Maryland. 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 2006 Annual
Report, on Form 10-K and updates contained in subsequent filings we
make with the SEC. Contacts: Avalon Pharmaceuticals, Inc. Russo
Partners, LLC David D. Muth Wendy Lau (Media) Executive Vice
President & Tel: (212) 845-4272 Chief Business Officer Tel:
(301) 556-9900 Fax: (301) 556-9910 The Trout Group LLC Email: Chad
Rubin (Investors) Tel: (646) 378-2947 DATASOURCE: Avalon
Pharmaceuticals, Inc. CONTACT: David D. Muth, Executive Vice
President & Chief Business Officer, Avalon Pharmaceuticals,
Inc., +1-301-556-9900, Fax, +1-301-556-9910, ; or Media, Wendy Lau
of Russo Partners, LLC, +1-212-845-4272; or Investors, Chad Rubin
of The Trout Group LLC, +1-646-378-2947, both for Avalon
Pharmaceuticals, Inc. Web site: http://www.avalonrx.com/
http://www.clinicaltrials.gov/
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