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.
We believe this study will further confirm the unique overall profile of the CINOD class, notably its superior cardiovascular effects.
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 January, NicOx announced that, following a review of results from the full phase II clinical program with HCT 3012, the lead compound in the CINOD class, an independent US Clinical Consultant Advisory Board (CAB) considered the overall results encouraging and recommended further development through to registration in the treatment of osteoarthritis.
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.
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.
Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs
(Cyclooxygenase- Inhibiting Nitric Oxide Donators).