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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Casaubon who wrote (14726)	12/17/2004 11:51:26 AM
From: former_pgs	Read Replies (2) \| Respond to of 52153

My bet is that the 800 mg dose is causing problems. I don't think anyone in the Celebrex prime revenue population takes 800 mg routinely, especially daily over 12-18 months. This was a special case for the FAP population in the stipulated phase IV follow up. I would wager that long term investors could do worse than picking up PFE here for 24-25 per share.

To: Casaubon who wrote (14726)	12/17/2004 12:03:29 PM
From: olivier benrubi	Read Replies (1) \| Respond to of 52153

One NiCOX compound CINOD CLASS LEAD COMPOUND : HCT 3012 OSTEOARTHRITIS Phase II In September 2004, a comparative clinical study has been started to evaluate the effects of HCT 3012 and rofecoxib on arterial blood pressure in patients with mild essential hypertension. The aim of the study is to provide definitive proof of data observed in analysis of the OASIS pivotal Phase II trial in patients treated for osteoarthritis. This analysis suggested that HCT 3012 decreased systolic blood pressure on average by 3mm Hg, while rofecoxib tended to raise systolic blood pressure by a similar extent. This study will be conducted at the University of Pennsylvania, with Professor Garrett FitzGerald as the Principal Investigator. The trial is a cross- over, randomized, double- blind study in 50 hypertensive patients treated for 6 weeks with each of the trial medications. The primary objective is to assess whether rofecoxib 25 mg qd causes a significant increase in blood pressure compared to HCT 3012 375 mg bid (dose equiactive with rofecoxib 25mg qd ). Results are expected in the first quarter of 2005. In June 2004, Phase II OASIS trial clinical results have been presented at the EULAR (European League Against rheumatism) Annual Congress. The results demonstrated that after six weeks’ treatment with HCT 3012 osteoarthritis patients experienced pain relief equivalent to rofecoxib. At equi-analgesic doses, patients treated with rofecoxib experienced an increase in systolic blood pressure (SBP), an effect particularly evident in hypertensive patients). In contrast HCT 3012 showed no statistical difference in SBP compared to placebo .The differences in SBP between the HCT 3012 and rofecoxib treatment groups were statistically significant. Clinical data were generated during the OASIS trial, a randomized, double-blind study conducted to evaluate the efficacy and safety of the first compound in the CINOD class, HCT 3012. In January 2004, an independent US Clinical Consultant Advisory Board (CAB), after reviewing the results from the full phase II clinical program with HCT 3012, considered the overall results encouraging and recommended further development through to registration in the treatment of osteoarthritis. In September 2003, NicOx announced that it is to reacquire full rights to the new proprietary class of anti-inflammatory and analgesic compounds, CINOD, from AstraZeneca plc, including the two lead compounds in the class, HCT 3012 and NCX 285. HCT 3012 (CINOD lead compound) is the first of this new class of analgesic and anti-inflammatory drugs known as COX-inhibiting nitric oxide donators (CINODs) designed for the treatment of acute and chronic pain. AstraZeneca has completed a Phase II clinical program involving more than 3000 subjects in September 2003. In this program, HCT 3012 has demonstrated efficacy, gastric tolerability and cardiovascular safety. HCT 3012 has achieved very good safety and efficacy endpoints in the Phase I and II studies thus confirming the additional benefits from nitric oxide donation