SOPHIA ANTIPOLIS, France, Nov. 17 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: NICOX) today announced it has signed a Master Services Agreement with PRA International , one of the world’s leading contract research organizations (CROs), to assist with the implementation of the phase 3 program for HCT 3012, its lead product in development for osteoarthritis. NicOx has decided to initiate the phase 3 program for HCT 3012 following recent discussions with the U.S. Food and Drug Administration (FDA). The service contract for the first pivotal efficacy study has been executed and the trial is expected to start before the end of the year in the United States. HCT 3012 is a novel, proprietary, nitric oxide-donating derivative of naproxen, which NicOx aims to develop as the drug-of-choice for osteoarthritis patients, particularly those with coexisting hypertension (high blood pressure).
Millions of people rely on non steroidal anti-inflammatory drugs (NSAIDs) to treat chronic pain and inflammation relating to a range of conditions, including osteoarthritis. COX-2 selective NSAIDs and to a certain extent non-selective NSAIDs, have recently been linked to an increased risk of serious cardiovascular events, such as heart attack and stroke, creating a pressing need for new drugs with improved safety profiles. This demand is particularly acute among patients with coexisting cardiovascular risk factors, such as hypertension, who represent around 40% of osteoarthritis sufferers.
Michele Garufi, Chairman and CEO of NicOx, commented: “The recent concerns surrounding COX-2s and NSAIDs pose a stark dilemma for osteoarthritis patients with hypertension, due to the lack of alternatives for treating the chronic pain associated with this pathology. NicOx is committed to the development of HCT 3012 through phase 3 trials in this area of high medical need and we look forward to the imminent initiation of the first study.”
Based on recent discussions with the U.S. Food and Drug Administration (FDA), NicOx is confident that its phase 3 plan will be adequate to satisfy the U.S. regulators with regards to demonstrating the efficacy of HCT 3012 for treating the signs and symptoms of osteoarthritis. In parallel, discussions with the FDA are continuing concerning the requirements for long-term safety data needed for the approval of HCT 3012, including any possible cardiovascular outcome study. NicOx also discussed its plans for blood pressure monitoring and was satisfied with the FDA’s guidance regarding the types of measurements required to generate blood pressure data that could potentially be reflected in future product labeling. The increase in blood pressure seen with existing NSAID treatments is viewed as one of the potential factors responsible for the apparent heightened risk of serious cardiovascular events observed with currently available drugs. In phase 2 trials, HCT 3012 appeared to show no unwanted increase in blood pressure in contrast to the NSAID comparators, especially in hypertensive patients, and NicOx aims to confirm these findings during the phase 3 program using a variety of controlled methods.
NicOx will communicate further when the first phase 3 trial has begun, including the design of the study, and also once the details of the entire program for obtaining marketing approval in the United States and Europe has been defined.
NicOx S.A. is an emerging pharmaceutical company involved in the research and development of nitric oxide-donating drugs with superior efficacy and safety profiles in the inflammation, pain and cardiovascular therapeutic areas.
NicOx seeks to commercialize its products through partnerships and co-development agreements where it maintains future marketing rights for specialist products.
NicOx S.A. (Bloomberg: COX:FP, Reuters: NCOX.LN), headquartered in Sophia-Antipolis, France, is a public company listed on the Eurolist of Euronext Paris (segment: Next Economy).
PRA International is one of the world’s leading global clinical development organizations, with over 2,500 employees in North America, Europe, South America, Africa, Australia, and Asia. PRA, an ISO 9001:2000 registered company, delivers services to its clients through a unique approach called Project Assurance(SM), which represents PRA’s commitment to reliable service delivery, program-level therapeutic expertise, easy, global access to knowledge, and involved senior management. To learn more about PRA International, please visit http://www.prainternational.com/ or call their World Headquarters at +1 (703) 464-6300.
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:
NicOx: Karl Hanks, Manager of Corporate Relations and Market Analysis, Tel +33 (0)497 15 22 03, hanks@nicox.com, http://www.nicox.com
Investors in the United States - Burns McClellan: Lisa Burns, lburns@burnsmc.com / Laura Siino, lsiino@burnsmc.com, Tel +1 212 213 0006
Financial Dynamics: Jonathan Birt, Tel +1 212 850 56 34, jbirt@fd-us.com / Julia Phillips, Tel +44 (0)20 7831 3113, julia.phillips@fd.com
NicOx S.A.
CONTACT: Karl Hanks, Manager of Corporate Relations and Market Analysis ofNicOx, +33-0-497-15-22-03, hanks@nicox.com; or Investors in the UnitedStates - Lisa Burns, lburns@burnsmc.com, or Laura Siino,lsiino@burnsmc.com, +1-212-213-0006, both of Burns McClellan for NicOx; orJonathan Birt, +1-212-850-5634, jbirt@fd-us.com, or Julia Phillips,+44-0-20-7831-3113, julia.phillips@fd.com, both of Financial Dynamics forNicOx
