Zalicus Initiates Phase 1b Clinical Study of Z944, Its Novel, Oral, T-type
Calcium Channel Blocker, for the Treatment of Pain
Experimental Clinical Study Expected to Complete During the Fourth Quarter
CAMBRIDGE, Mass. -- September 9, 2013
Zalicus Inc. (Nasdaq Capital Market:ZLCS) a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain,
today announced that it has initiated a Phase 1b clinical study with Z944, its
novel oral T-type calcium channel blocker, in an experimental clinical model
of neuropathic pain using Laser-Evoked Potentials (LEP). Results from the LEP
study are expected in the fourth quarter 2013.
"Measuring Laser Evoked Potentials is an experimental clinical model that
offers both subjective and objective measures to assess the potential of Z944
to modulate pain signaling,” commented Mark H.N. Corrigan, MD, President and
CEO of Zalicus. “T-type calcium channels are known to be widely implicated in
the frequency and intensity of pain signals and the results of this study will
further inform Zalicus’ development plans for Z944 in a variety of potential
indications as we work to optimize a modified release formulation of Z944 for
future clinical trials.”
The LEP clinical model is a type of experimental medicine study designed to
provide both objective and subjective data on a drug’s ability to modulate
pain signaling. In this model electrical voltage fluctuations evoked by laser
thermal stimulation are quantified with vertex-Electroencephalography (EEG) in
addition to a subject-reported pain score. Many currently approved and
emerging pain drugs have been evaluated using the LEP model, providing the
ability to benchmark the efficacy of Z944 against other therapies.
About Z944 and T-type Calcium Channel Blockers
Z944 is a novel, oral, state-dependent, selective T-type calcium channel
blocker that has demonstrated preclinical efficacy in multiple inflammatory
pain models. T-type calcium channels have been recognized as key targets for
therapeutic intervention in a broad range of cell functions and have been
implicated in pain signaling. Zalicus has completed Phase 1 single and
multiple ascending dose clinical studies evaluating the safety and
tolerability of Z944 and is continuing the clinical development of Z944 during
Zalicus Inc. (Nasdaq Capital Market:ZLCS) is a biopharmaceutical company that
discovers and develops novel treatments for patients suffering from pain.
Zalicus has a portfolio of proprietary clinical-stage product candidates
targeting pain such as Z160 and Z944 and has 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. To learn more
about Zalicus, please visit www.zalicus.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 concerning Zalicus, its
product candidate Z944, its potential and the plans for its further clinical
preclinical development, the Zalicus selective Ion channel modulation
technology and its other business plans. These forward-looking statements
about future expectations, plans, objectives and prospects of Zalicus and its
product candidates 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 development and regulatory approval of Zalicus’ product
candidates, including risks relating to the clinical development of Z944, the
unproven nature of the Zalicus drug discovery technologies, 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.
(c) 2013 Zalicus Inc. All rights reserved.
Justin Renz, 617-301-7575
Gina Nugent, 617-460-3579
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