NicOx's reacquisition of the CINOD rights follows AstraZeneca's decision not to advance the lead product, AZD3582, into Phase III trials.
Michele Garufi, chairman and CEO of NicOx, commented: "Although surprised by the strategic decision of AstraZeneca to discontinue the program on CINODs, we remain fully convinced of the potential of this class and we are confident of attracting new partners for these compounds and for the other projects in our pipeline.
In particular, Staffan Stromberg brings a specific and deep knowledge of HCT 3012 from his time as project manager of the CINOD
program at AstraZeneca.
This decrease is directly related to the Company's decision to reorganize its activities to focus on its most advanced drug candidates, particularly preparations for phase III clinical development of the lead CINOD compound HCT 3012.
We believe recent developments in the field of COX-2 inhibitors are encouraging for the profile of CINODs and we are working with our clinical advisors to put together the most appropriate phase III program for HCT 3012 in the light of these new findings.
HCT 3012, the first in the new CINOD
class, offers the potential to bring to osteoarthritis sufferers an effective new pain treatment with an improved cardiovascular and gastrointestinal safety profile.
AZD3582, a CINOD
, differs significantly from Rofecoxib in having a Neutral Effect on Blood Pressure in Patients with Osteoarthritis: Results of a randomized controlled trial
In June, NicOx communicated the Phase II clinical results on its lead CINOD
compound, HCT 3012 (ex AZD3582) presented at the EULAR (European League Against Rheumatism) Congress Germany.
Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, said: "We are very pleased to be presenting these important data from our most advanced CINOD
Maarten Beekman, Vice President of Clinical Development at NicOx, commented: "The completion of patient enrollment in this pivotal phase 3 trial for naproxcinod is a further important step in our plan for the regulatory filing of the first CINOD
in the US and Europe.
This increase in operating expenses was mainly due to the ongoing phase 3 clinical studies for naproxcinod, NicOx' lead investigational drug and the first compound in the CINOD
class, for the treatment of the signs and symptoms of osteoarthritis.
Recently, the CINODs
have been developed by adding a nitric-oxide-donating group to a NSAID, with early trials of naproxcinod showing good efficacy but less risk of CV and GI events.