CombinatoRx Highlights Progress in Key Programs at 2008 R&D Day
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CAMBRIDGE, Mass.--(Business Wire)--
CombinatoRx, Incorporated (NASDAQ: CRXX) today provided a detailed
review of selected therapeutic programs and a general company update
at its annual Research and Development (R&D) day at its corporate
headquarters in Cambridge, MA.
Presentation highlights included:
-- Phase 2b clinical data for Synavive(TM) (CRx-102) in
osteoarthritis is on track for release in October 2008
-- Fundamental new understanding of mechanism of action for
Synavive(TM), with publication expected later in 2008
-- Successful aligned release formulation for Synavive(TM)
-- Progress updates on other clinical stage programs including
CRx-401 in diabetes and CRx-191 and CRx-197 in topical
dermatology
-- New data on emerging programs in B-cell malignancies and
Hepatitis C
-- New research information in rare disease franchise and
immuno-inflammatory area
"CombinatoRx is a leader in the development of multi-target
mechanism drugs. Through synergy we discover and deploy novel
mechanisms-of-action to create meaningful product candidates. Today's
presentations show the maturing depth of our science and the specific
product opportunities generated from this science," stated Alexis
Borisy, President and CEO of CombinatoRx. "This is a very exciting
time for CombinatoRx as we expect multiple data sets for Synavive(TM)
and other clinical candidates, progress on our business development
efforts and increasing visibility of our science through publication."
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Clinical Programs
Synavive(TM) (CRx-102)
CombinatoRx provided new scientific data during a detailed review
of the product's mechanism of action (MOA). This data supports
the understanding that Synavive's MOA leads to the suppression
of pro-inflammatory mediators without amplification of
glucocorticoid-induced side effects. A publication detailing the
mechanism of action is planned later in 2008.
The company also highlighted its success in developing a novel
formulation of Synavive(TM). This modified release formulation
provides unique time-released co-exposure of the components;
thereby maximizing efficacy while reducing the risk of headache,
a common side effect of the dipyridamole component. This was
demonstrated in a clinical study of 24 healthy volunteers in
which 0% of subjects given CombinatoRx's modified release
dipyridamole experienced a headache versus 41% for those who
were administered a conventional formulation of dipyridamole.
The modified release formulation also allows for once-daily
dosing.
Enrollment in the CRx-102 Phase 2b knee osteoarthritis clinical
trial (COMET-1) is complete and the company expects to report
results in October of 2008. The trial is over-enrolled with 279
subjects and so far approximately 80% of eligible subjects have
elected to roll-over into the 12-month active-drug extension
trial. Of note, all subjects who have reached 3 or 6 months in
the extension trial have remained on the study.
The Company announced that it has discontinued the CRx-102 Phase
2b rheumatoid arthritis clinical trial (MARS-1) based on a
number of considerations that compromised the timing of results
and therefore the strategic value of the trial compared to both
its cost and the expected benefit from the COMET-1 results
targeted for October. The Company faced challenges with finding
patients who are not already on glucocorticoids (highlighting
the opportunity for this product candidate) and issues with both
its third-party supplier of clinical trial material and clinical
contract research organization. Given current poor financial
market conditions, the reality that the MARS-1 data would not be
available in a timeframe material to the business development
discussions for CRx-102 and the promise of the upcoming COMET-1
results, the Company decided to discontinue the trial in order
to preserve financial resources.
As a result, the company will save approximately $20 million
during 2008 and 2009, providing the additional financial
flexibility needed to maximize the value of our portfolio of
assets and technology. Specifically, this action provides the
financial strength to secure a partner for Synavive(TM) based on
the COMET-1 results, invest appropriately in other promising
assets, and provides flexibility under multiple potential
scenarios to have the necessary capital reserves to operate for
at least two years going forward.
CRx-401
The company conducted a comprehensive review of the ongoing Phase
2a clinical trial of CRx-401 as "add-on" to metformin therapy in
Type-2 diabetes. The presentation also included a discussion of
the potentially favorable positioning of CRx-401 with respect to
the new FDA guidelines related to cardiovascular outcomes. With
dozens of years of clinical experience behind the components and
positive cardiovascular outcomes data previously demonstrated
with bezafibrate in particular, CRx-401 may offer a reduced risk
development pathway. Clinical data from this trial are expected
in the second half of 2008.
CRx-191
CombinatoRx reviewed Phase 2a clinical data for CRx-191 in plaque
psoriasis where statistically significant reductions in
psoriatic infiltrate thickness and erythema (redness) were
observed, as well as significant improvements in clinical skin
assessments. Importantly, when comparing the activity of the
CRx-191 combination versus its individual components, CRx-191
demonstrated statistically significant improvements versus its
individual components on the USE (Ultrasound Erythema) combined
clinical index of infiltrate and on erythema. A variety of
strategic options, including discussions with prospective
dermatology partners are ongoing.
CRx-197
CombinatoRx provided encouraging preclinical data for CRx-197
with strong activity in both in vitro and in vivo preclinical
inflammation models. CRx-197 is currently completing its healthy
volunteers safety study, and is on track for Phase 2a plaque
psoriasis and atopic dermatitis clinical trials in the second
half of 2008.
Preclinical Programs
CombinatoRx also gave an overview of select preclinical programs
including its rare disease research efforts, B-cell malignancies
and infectious disease development activities.
CombinatoRx updated the audience on progress made in its research
efforts to develop therapeutics for rare diseases such as
Huntington's disease, cystic fibrosis and Duchenne muscular
dystrophy, each of which represents a disease with very limited
or ineffective treatment options. The research in each of the
rare disease programs is funded through partners and CombinatoRx
retains rights to any products commercialized through these
programs. In Huntington's disease, two combinations have
advanced into preclinical testing.
In its B-cell malignancies program, CombinatoRx presented in
vitro and in vivo data on a promising family of multi-target
combinations that are both highly active, beyond standard-of-
care, as well as synergistic with multiple classes including
standard-of-care, such as bortezomib, lenalidomide and
dexamethasone. These combinations are highly selective to B-cell
malignancies, appear to be safe in preclinical tests with a wide
therapeutic window and show properties of enhanced activity in
the micro environment important to these diseases.
The Company also provided an update on its infectious disease
program, including CRx-808, thought to be a novel combination
host-factor drug candidate. The Company presented preclinical
data indicating that CRx-808 may be an excellent addition to the
HCV treatment armamentarium as it synergistically reduces viral
RNA levels and protein expression, suppresses viral RNA over one
month of repeat dosing without viral rebound, enhances in vitro
activity of current and future standard-of-care HCV
therapeutics, works equally well in protease and polymerase drug
resistant variant assays and concentrates well in the liver.
CombinatoRx is also continuing to identify second-generation
combination drug candidates in its infectious disease program.
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Webcast
CombinatoRx is providing an archived webcast of the 2008 R&D Day
event through the Investor Relations section on its website at
www.combinatorx.com.
About CombinatoRx
CombinatoRx, Incorporated (CRXX) is pioneering the new field of
synergistic combination pharmaceuticals and has a broad product
portfolio in phase 2 clinical development. Going beyond traditional
combinations, CombinatoRx creates product candidates with novel
mechanisms of action striking at the biological complexities of human
disease. The lead programs in the CombinatoRx portfolio are advancing
into later stage clinical trials based on the strength of multiple
positive phase 2a results. This portfolio is internally generated from
the CombinatoRx proprietary drug discovery technology which provides a
renewable and previously untapped source of novel drug candidates. The
Company was founded in 2000 and is located in Cambridge,
Massachusetts. To learn more about CombinatoRx please visit
www.combinatorx.com.
Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning CombinatoRx, its product candidates, their clinical
potential, its plans for clinical and formulation development of its
product candidates, its financial condition, its partnering and
business plans and its drug discovery technology. These
forward-looking statements about future expectations, plans and
prospects of CombinatoRx involve significant risks, uncertainties and
assumptions, including risks related to the unproven nature of the
CombinatoRx drug discovery technology, the Company's ability to
initiate and successfully complete clinical trials of its product
candidates, the Company's ability to develop a modified release
formulation of Synavive(TM), potential difficulty and delays in
obtaining regulatory approval for the sale and marketing of its
product candidates, the Company's ability to obtain collaboration
partners or additional financing or funding for its research and
development and those other risks that can be found in the "Risk
Factors" section of the CombinatoRx Annual Report on Form 10-K on file
with the Securities and Exchange Commission and the other reports that
CombinatoRx periodically files with the Securities and Exchange
Commission. Actual results may differ materially from those
CombinatoRx contemplated by these forward-looking statements.
CombinatoRx does not undertake to update any of these forward-looking
statements to reflect a change in its views or events or circumstances
that occur after the date of this release.
(c) 2008 CombinatoRx, Incorporated. All rights reserved.
CombinatoRx, Incorporated
Robert Forrester, 617-301-7100
Executive Vice President, Chief Financial Officer
rforrester@combinatorx.com
or
CombinatoRx, Incorporated
Gina Nugent, 617-301-7099
VP, Corporate Communications and IR
gnugent@combinatorx.com
Copyright Business Wire 2008
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