Navigation Links
NicOx Announces Initiation of First Phase 1 Study of Investigational Nitric Oxide-Donating Agent in Hypertensive Patients by Merck & Co., Inc.
Date:5/13/2008

SOPHIA ANTIPOLIS, France, May 13 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today 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 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 (http://www.amf-france.org) or on NicOx S.A.'s website (http://www.nicox.com).


'/>"/>
SOURCE NicOx S.A.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. NicOx Reports TOPIGEN to Advance TPI-1020 Into Phase 2 for COPD Following Promising Clinical Results
2. NicOx and Ferrer Present Promising Clinical and Preclinical Results in Dermatology
3. NicOx Naproxcinod ABPM Data Presented at American Heart Association
4. NicOx Naproxcinod Phase 3 Results Presented at American College of Rheumatology
5. NicOx Announces TOPIGEN Initiates Phase 2 Proof of Concept Study in COPD for TPI 1020
6. NicOx Completes Enrollment in Second Pivotal Phase 3 Study for Naproxcinod and Provides Development Update
7. NicOx Announces Pfizer Initiates Phase 2 Clinical Development for PF-03187207 in Japan
8. Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs
9. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
10. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
11. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... PARSIPPANY, N.J. , March 23, 2017 /PRNewswire/ ... ) (the "Company"), a fully integrated commercial company ... pathology services, today announced that it has entered ... with the former RedPath Shareholders ("RedPath") and concurrently ... The Company,s outstanding secured debt to RedPath ...
(Date:3/23/2017)... LITTLE SILVER, N.J. , March 23, 2017 ... device company, today announced that it has kicked ... in-growth into their 3D printed bone segments. ... of Engineering, "Our unique variable honeycomb lattice structures ... bone in-growth as compared to current allograft wedges ...
(Date:3/23/2017)... 2017 Newborns are highly vulnerable to ... because their young immune systems typically mount weak ... report achieving strong vaccine responses in newborn animals, ... human trials — by adding compounds known as ... simultaneous papers, they also describe improved adjuvant formulations ...
Breaking Medicine Technology:
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... “Vintage and ... a retired minister and college Bible teacher residing in North Carolina with his wife, ... who have blessed them with six grandchildren. David is also the author of “Shadow ...
(Date:3/23/2017)... Greensboro, NC & Seattle, WA (PRWEB) , ... March 23, 2017 ... ... international public health emergency and now estimates that there could be four million Zika-related ... fastest growing epidemics to date with numbers of US cases reported per year skyrocketing ...
(Date:3/23/2017)... ... March 23, 2017 , ... Demonstrating ... communities, 16 more public health departments have been awarded national accreditation through the ... million people into the expanding network of communities across the nation whose health ...
(Date:3/23/2017)... ... 23, 2017 , ... The IoT (Internet of Things) is revolutionizing the way ... impact on businesses and individual consumers alike. Laboratories can maximize their profit margin ... anywhere from $4 trillion to $11 trillion dollars by the year 2025. McKinsey expects ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... families and businesses of the Norwalk and Vermillion areas, celebrates the newest ... (N.O.R.A.) is a nonprofit, community-based substance abuse prevention and peer recovery support ...
Breaking Medicine News(10 mins):