Avalon Pharmaceuticals Announces Positive Interim Results For AVN944 Phase I Trial
June 19 2007 - 6:29PM
PR Newswire (US)
-- 46% of Evaluable Patients Show Stabilized Disease; Biomarkers
Correlate with Clinical Effect and Demonstrate Potential for
Patient Stratification -- GERMANTOWN, Md., June 19
/PRNewswire-FirstCall/ -- Avalon Pharmaceuticals, Inc.
(NASDAQ:AVRX), today announced continued positive interim results
from its Phase I study of AVN944, for the treatment of hematologic
malignancies in elderly and refractory patients. Interim data
indicate AVN944 is well tolerated, has dose-dependent
pharmacokinetics, induces biomarkers of programmed cell death in
cancer cells from patients, and demonstrates stabilized disease in
almost half of the patients after one-month of treatment. "We
continue to be encouraged by the positive interim results from the
AVN944 trial," stated Michael Hamilton, M.D., Avalon
Pharmaceuticals' Chief Medical Officer. "We have observed important
indications of biological drug effect and disease stabilization in
a significant number of patients. We continue to believe the Phase
I trial will provide sufficient information to initiate multiple
Phase II studies." Background: AVN944 is an oral small molecule
drug that inhibits inosine monosphospate dehydrogenase (IMPDH), a
critical enzyme for synthesis of guanosine triphosphate (GTP), a
molecule required for DNA synthesis and cellular signaling. IMPDH
is over expressed in many cancer cells. Pre-clinical studies showed
that AVN944 is a highly specific inhibitor of IMPDH, suppresses
pools of GTP, and in cultured cells has a selective growth
inhibition effect on cancer cells vs. normal cells. An earlier
single-dose, dose-escalation, healthy volunteer clinical trial
conducted in the United Kingdom showed that AVN944 was well
tolerated at all tested doses with no notable side effects; had
good pharmacokinetic properties; and had a significant inhibitory
effect on IMPDH enzyme activity. Study Design: The current U.S.
Phase I study is a repeat-dose dose escalation trial in patients
with advanced hematologic malignancies. Patients are dosed for 21
days on a 28-day cycle. A minimum of three patients are treated at
each dose level. The study is divided into two arms, one for
treatment of leukemia patients and the other for treatment of
patients with lymphoma and myeloma. For the leukemia arm of the
study, patients are currently being treated at the tenth dose
level, 250 mg twice daily. For the lymphoma and myeloma arm,
patients are currently being treated at the sixth dose level, 150
mg twice daily. Positive Safety and Tolerability Data: The goal of
the Phase I study is to establish the safety, tolerability and
pharmacokinetics of the drug. Thus far, 104 one-month cycles of
AVN944 have been initiated in 46 patients and the compound is well
tolerated. Pharmacokinetics measurements indicate dose proportional
plasma levels of AVN944 during treatment and sustained plasma
concentrations at the dose levels tested thus far. Early Activity
Indicators: This Phase I study is designed to evaluate several
pharmacodynamic and efficacy-related endpoints. Upon entering the
trial, all patients have refractory, progressive disease and have
failed all prior therapies. Thus far, 18 of 39 evaluable patients
(46%) showed stabilized disease after one cycle of treatment with
AVN944. These include patients with both leukemia and multiple
myeloma. Patients who have achieved stable disease following
completion of a one-month treatment cycle with AVN944, as
determined by the clinical investigator, may be advanced to a
subsequent cycle. In the multiple myeloma cohort 60% of the
patients have achieved stabilized disease after one month. Two of
these patients completed five months of treatment and two others
completed one full year of treatment. One AML patient has completed
8 monthly cycles of treatment. Positive Dose Dependent Biomarker
Data: The AvalonRx(R) platform has identified selected biomarkers
from patient samples which show a correlation of changes in gene
expression in a dose dependent manner. Importantly, several of
these markers display a durable, sustained stress response
indicative of cancer cell death, particularly in cancer cells from
AML patients. As dose levels increase the biomarkers reflect an
even greater impact of AVN944 on the cancer cells. Direct markers
of apoptosis are induced at these higher levels, including members
of the Bcl2 gene family which play a critical role in programmed
cell death. Additionally, the IMPDH enzyme is inhibited and GTP
pools are also depleted for more sustained time periods in treated
patients. Potential Study Stratification Biomarker Data:
Additionally we have identified a genetic signature, existing prior
to drug exposure, which correlates strongly with disease
stabilization in the first cycle of therapy. While still
preliminary, based on a small patient sampling, this signature
could be the foundation for future patient stratification
strategies in phase II and III clinical trials. Teleconference and
Webcast: The company will host a conference call on Wednesday, June
20, 2007 at 8 a.m. Eastern Daylight Time to discuss the interim
results of the AVN944 Phase I clinical trial. Interested investors,
analysts, members of the media and the general public can listen to
the call live over the Internet from the investor section of the
company's Web site or by dialing the numbers listed below. A
detailed PowerPoint presentation will accompany the webcast.
Conference Call Details: Dial-In: (800) 291-5365 (U.S.) (617)
614-3922 (International) Pass code: 74005634 Webcast: Please go to
http://www.avalonrx.com/, Investor Relations, within 15 minutes
prior to the call and select the webcast link. If listening by
phone and viewing the slides, please choose the 'listen via phone'
option to view the slides in real time as there is a 30 second
delay otherwise. The conference call replay will be available
through August 15, 2007 on Avalon's website
(http://www.avalonrx.com/). About Avalon Pharmaceuticals Avalon
Pharmaceuticals is a biopharmaceutical company focused on the
discovery and development of potential first-in-class cancer
therapeutics. Avalon has a lead product in Phase I clinical
development (AVN944), preclinical programs to develop inhibitors
for the Beta-catenin and Aurora pathways, discovery programs for
Survivin and Myc pathway inhibitors, and value generating
partnerships with Merck, MedImmune, Medarex, and Novartis. By
utilizing AvalonRx(R) our platform technology, based upon the
proprietary use of large-scale gene expressions, we are uniquely
positioned to develop therapeutics focused on pathways that have
historically been characterized as "undruggable". Avalon was
established in 1999 and is headquartered in Germantown, Md. 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 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 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 The Trout Group LLC Fax: (301) 556-9910
Chad Rubin (Investors) Email: Tel: (646) 378-2947 DATASOURCE:
Avalon Pharmaceuticals, Inc. CONTACT: David D. Muth, Executive Vice
President of Avalon Pharmaceuticals, Inc., +1-301-556-9900, or fax,
+1-301-556-9910, ; or media, Wendy Lau of Russo Partners, LLC,
+1-212-845-4272, for Avalon Pharmaceuticals, Inc.; or investors,
Chad Rubin, Chief Business Officer of The Trout Group LLC,
+1-646-378-2947 Web site: http://www.avalonrx.com/
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