Zalicus Advancing Z160, Its Novel, Oral N-type Calcium Channel
Blocker, into Multiple Phase 2a Clinical Trials for the Treatment
of Pain
Optimal Formulation Selected For Clinical Use First Phase 2a Clinical
Trial to Initiate Third Quarter 2012
CAMBRIDGE, Mass., May 02, 2012 (BUSINESS WIRE) --Zalicus
Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and
develops novel treatments for patients suffering from pain and
immuno-inflammatory diseases, today announced that it is advancing Z160,
its novel, first in class, oral, N-type calcium channel blocker into
multiple Phase 2a clinical trials for chronic pain indications. Zalicus
has selected the most promising novel, proprietary formulation for
clinical use and is planning to initiate two Phase 2a clinical trials
with Z160 for the treatment of neuropathic pain; the first of which is
expected to begin enrolling patients in the third quarter of 2012.
Zalicus completed Phase 1 pharmacokinetic and safety studies with a
number of formulations and has selected the optimal formulation to move
into further clinical development. The selected formulation was well
tolerated and demonstrated a 6-fold improvement in Z160's
bioavailability compared to the previously studied formulation of Z160.
"The lack of adequate pain control in patients with chronic neuropathic
pain represents a significant unmet need and important opportunity for
novel agents with improved tolerability, enhanced efficacy, and better
long-term safety profiles," commented Mark H.N. Corrigan, MD, President
and CEO of Zalicus. "We look forward to initiating clinical trials with
Z160 this year to evaluate its potential for the treatment of
neuropathic pain."
About Z160 and N-type Calcium Channel Blockers
Z160 is a novel, first in class, state dependent oral N-type calcium
channel (Cav 2.2) blocker that has shown efficacy in multiple animal
models of neuropathic and inflammatory pain. In addition, Z160 was well
tolerated in previously conducted clinical trials involving
approximately 200 subjects. N-type calcium channels have been recognized
as key targets in controlling pain through modulation of the entry of
calcium into neurons. When a pain signal is initiated, calcium channels
open and the influx of calcium ions trigger the release of
neurotransmitters, which potentiates the signal to the brain where it is
perceived as pain. Zalicus has utilized its expertise in this field to
successfully discover high affinity, selective and orally available
compounds, such as Z160, that show promise for further development as
therapies for pain.
About Zalicus
Zalicus Inc. (Nasdaq: ZLCS) is a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain
and immuno-inflammatory diseases. Zalicus has a portfolio of proprietary
clinical-stage product candidates targeting pain and immuno-inflammatory
diseases and have entered into multiple revenue-generating
collaborations with large pharmaceutical companies relating to other
products, product candidates and drug discovery technologies. Zalicus
applies its expertise in the discovery and development of selective ion
channel modulators and its combination high throughput screening
capabilities to discover innovative therapeutics for itself and its
collaborators in the areas of pain, inflammation, oncology and
infectious disease.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning Zalicus, its product candidate Z160, its potential, and
Zalicus' plans for its clinical development. These forward-looking
statements about future expectations, plans, objectives and prospects of
Zalicus and Z160 may be identified by words like "believe," "expect,"
"may," "will," "should," "seek," "plan" or "could" and similar
expressions and involve significant risks, uncertainties and
assumptions, including risks related to the clinical development of
Z160, the unproven nature of the Zalicus Ion channel drug discovery
technology, the Company's ability to obtain additional financing or
funding for its research and development and those other risks that can
be found in the "Risk Factors" section of Zalicus' annual report on Form
10-K on file with the Securities and Exchange Commission and the other
reports that Zalicus periodically files with the Securities and Exchange
Commission. Actual results may differ materially from those Zalicus
contemplated by these forward-looking statements. These forward-looking
statements reflect management's current views and Zalicus 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 except as required by law.
