NicOx Announces Initiation Of First Phase 1 Study Of Investigational Nitric Oxide-Donating Agent In Hypertensive Patients By Merck & Co., Inc.
NicOx S.A.
(Eurolist: COX) announced that Merck & Co., Inc. has initiated the
first in a series of planned clinical studies, in mild to moderate
hypertensive patients, under the companies’ collaborative agreement to
develop new nitric oxide-donating antihypertensive agents using NicOx’
proprietary technology. Three drug candidates have now been selected from
the companies’ joint research program, of which two have completed initial
dose ranging studies in healthy volunteers under the exploratory clinical
study paradigm with encouraging results.
Merck plans to conduct a number of clinical studies in hypertensive
patients involving single and multiple ascending dosing, prior to the
selection of a compound to be advanced into phase 2. The most advanced
candidate is now being evaluated in the first of these studies, which is a
single ascending dose trial in mild to moderate hypertensive patients. The
main objectives of this study are to assess the efficacy, safety,
tolerability and pharmacokinetics of single ascending doses of this
candidate. Subsequent studies will assess multiple ascending doses.
"The initiation of this series of clinical studies in hypertensive
patients is a very important step towards delivering a new treatment
paradigm for hypertension, where the medical need remains significant,"
commented Jacques Djian M.D., NicOx’ Cardiometabolic Area Leader. "We
believe these drug candidates have considerable potential as improved
antihypertensive agents based on their nitric oxide-donating properties and
we hope they will deliver a major advance in antihypertensive treatment for
patients worldwide."
In July 2007, NicOx announced the initiation of the first in a series
of studies in healthy volunteers for the selected candidates (see press
release of July 16, 2007). Merck is responsible for funding and performing
the development of these compounds going forward.
To date, NicOx has received euro 19.2 million from Merck under this
agreement. NicOx also stands to receive potential additional milestone
payments of euro 269 million and industry standard royalties on the sales
of products which result from the agreement. Furthermore, NicOx has the
option to co-promote resulting products, on a fee-for-detail basis, to
specialist physicians in the United States and certain major European
countries.
"We are delighted that less than one year after the first drug
candidate entered human testing, we now have three drug candidates
identified and that the first of these has started patient dosing," said
Buy generic diflucan Michele Garufi, Chairman and CEO of NicOx. "We look forward to continued
rapid progress in our collaboration with Merck and to the future
introduction of a new anti-hypertensive class on the market."
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx
is applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of NCEs in the therapeutic areas of inflammatory and
cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary
NCE and the first compound in the Cyclooxygenase Inhibiting Nitric
Oxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase
3 clinical studies for the treatment of the signs and symptoms of
osteoarthritis, with final phase 3 results anticipated in 2008.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric
oxide-donating NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent
and underserved diseases, such as atherosclerosis, hypertension, glaucoma
and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext
Paris Stock Exchange (Compartment B: Mid Caps).
This press release contains certain forward-looking statements.
Although the Company believes its expectations are based on reasonable
assumptions, these forward-looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially
from those anticipated in the forward-looking statements.
For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of NicOx S.A. to
differ from those contained in the forward-looking statements, please refer
to the Risk Factors ("Facteurs de Risque") section of the Document de
Reference filed with the AMF, which is available on the AMF website
() or on NicOx S.A.’s website
().
NicOx S.A.
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Tags: health, hypertension