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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (3662)	12/1/2002 9:25:52 PM
From: fred hayes	Read Replies (1) \| Respond to of 10345

Rick, you have me fretting over Antegren. >>The projects are high risk, and everybody at both companies will be sweating it when the final data rolls in from the four phase III trials.<< I never take a drug in the clinic as a "gimme". I start with the rule of thumb that says about 60 percent of drugs entering phase 3 will go to market. I don't know the science, so I adjust the odds by what company is involved (Biogen is a plus) and what feel I have for phase 2 results, which I know I may be misreading. Following was lifted from a Dec 18, 2001 Elan press release as a reminder of the phase 2 results: >>Compelling Data Seen in Phase II MS Trial In September 2001, Biogen and Elan presented promising data from the Phase II trial of Antegren in MS at the annual meeting of the European Congress on Treatment and Research in Multiple Sclerosis. This was a double blind, placebo-controlled trial of 213 patients who had relapsing forms of MS. The primary analysis was based on magnetic resonance imaging ("MRI") scans and showed that patients treated with Antegren for 6 months had fewer new gadolinium-enhancing lesions than patients treated with placebo. In the placebo group (n=71), the cumulative mean number of new enhancing lesions during the treatment period was 9.6, while the Antegren 3 mg/kg group (n=68) had a mean of 0.6 new lesions and the Antegren 6 mg/kg group (n=74) had accumulated 1.2 new lesions during the same period. "The robust effects of Antegren in reducing MRI activity is promising and suggest that the agent's mechanism of action has potential as a new approach to treating MS. This will be investigated in further trials," said David Miller, M.D., Professor of Neurology, Institute of Neurology, London, United Kingdom. The number of MS relapses over the treatment period, one of the pre-specified clinical endpoints in the trial, was also reduced, with 34 relapses in the placebo group compared to 19 in the Antegren 3 mg/kg group and 14 in the Antegren 6 mg/kg group. Promising Crohn's Disease Data Seen in Phase II Trial Elan and Biogen presented positive data from a Phase II trial in Crohn's disease at the annual meeting of the American Gastroenterological Association during Digestive Disease Week. In that trial, a clinical response (decrease of > 70) points in the Crohn's Disease Activity Index (CDAI) was achieved in 74% of patients in the Antegren 3 mg/kg group (n=65) versus 38% of patients in the placebo group (n=63). Remission, defined as a CDAI score of less than or equal to 150, was achieved by 46% of patients in the Antegren 3 mg/kg dose group versus 27% in the placebo group. Tolerability Antegren was generally well tolerated by patients in both the MS and Crohn's disease studies. The most common adverse events were headache, asthenia and urinary tract infections (in patients with MS) and headache and abdominal pain (in patients with Crohn's disease). Certain adverse events occurred more commonly with Antegren compared to placebo, such as gastroenteritis, rash, urinary urgency, back pain and fever. Additionally, serious adverse events included infrequent hypersensitivity-like reactions. << Is there something here that I can't take at face value? Or are you just reminding us that Antegren can still fail even though it looks good so far? I'm thinking that the MS indication has, say, an 80 percent chance, and the Crohn's indication has a 65 percent chance. Do you think I'm too optimistic here? Or is this in the ballpark? fred