National Cancer Institute Ends Colon Cancer Trial with NicOx SA's NCX 4016
The decision is a precautionary measure due to results observed in non-clinical, in vitro genotoxicity tests on NCX 4015, a potential, specific metabolite of NCX 4016. NicOx is in the process of evaluating a further program of testing in order to assess the relevance of these results.
NicOx has successfully completed the full range of genotoxicity tests recommended by international guidelines for all the clinical development candidates in its pipeline, including NCX 4016. The recent results from in vitro genotoxicity tests on NCX 4015 are not in-line with the results of these earlier tests on NCX 4016 and with an in vivo test suggesting no genotoxicity with NCX 4015. NCX 4015 may be a metabolite of NCX 4016 but cannot be a metabolite of other compounds in NicOx' portfolio, due to its distinct chemical structure, and therefore NicOx' other portfolio programs, including the development of naproxcinod and the programs with Merck & Co., Inc. and Pfizer Inc, will not be affected.
The Company will delay the start of planned phase 2 studies of NCX 4016 in type 2 diabetes pending the completion of additional testing on NCX 4015.
NicOx (Bloomberg: COX: FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of the signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of EuronextTM Paris (segment: Next Economy).
The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference.
CONTACTS: http://www.nicox.comNicOx: Karl Hanks - Manager of Corporate Relations and Market Analysis - Tel +33 (0)4 97 24 53 42 - hanks@nicox.com
Investors in the United States - Burns McClellan: Lisa Burns - lburns@burnsmc.comLaura Siino- lsiino@burnsmc.com - Tel +1 212 213 0006
Media in the United States - FD - Jonathan Birt - Tel +1 212 850 56 34 - jbirt@fd-us.com
Media in Europe - Citigate Dewe Rogerson: Valérie Auffray - Tel: +44 (0)207 282 2979 - valerie.auffray@citigatedr.co.uk
David Dible - Tel +44 (0)207 282 2949 - david.dible@citigatedr.co.uk
NicOx S.A.,
Les Taissounières - Bât HB4 - 1681 route des Dolines - BP313, 06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 - Fax +33 (0)4 97 24 53 99
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Contact: Source: NICOX