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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: sds who wrote (1949)	4/25/1998 3:25:00 AM
From: marc ultra	Read Replies (1) \| Respond to of 4676

Many of your points are good but we must make a clear distinction between Crohn's and ulcerative colitis. Crohn's is generally not considered curable by surgery and when you cut some out you often get inflammation somewhere else so surgery is usually reserved for acute problems like megacolon and possible perforations. Ulcerative colitis in the other hand is considered curative with proper and extensive removal of the colon and surgical techniques have improved so quality of life usually pretty good. One reason why ulcerative colitis patients opt for surgery is there is a very high probability of developing colon cancer in these patients which increases with time and extent of activity and even in good situations usually requires relatively frequent colonoscopies to monitor for cancer or precancerous polyps. This situation is not as big a deal with Chrohn's. Based on this a Chrohn's patient wants a drug treatment and especially would want a drug that would limit the need for corticosteroid use. An ulcerative colitis patient however looking at the high probability of colon cancer and knowing that appropriate surgery is both curative of his colitis and practically eliminates the constant worry of colon cancer reasonably often opts for surgery.

To: sds who wrote (1949)	4/26/1998 4:13:00 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 4676

Hi sds: >>I'm begining to see a bearish picture here....<< It is a bit to early to be bearish, but being concern (for almost all bts) is OK. Only few note on 2302. 2302 PII trials was to test target validation for ICAM-1(because animal models do not address many questions and they had only 2302 PI in healthy volunteers) and antisense as modulator of ICAM-1. The only way to test drug was i.v. administration in PII trials. Isis got bit lucky with Crohn's and they rushed in to pivotal trials with current i.v. formulation. Contrary to Crohn's, other trials proceeded at much slower speed. Now I see current Crohn's trial as not the best choice. Not because drug will fail, contrary I think that results will be good. With 300 patients trial is long and expensive, still do not warrant NDA application as treatment drug. Because treatment protocol (dose, how often, period between cycle, remission period,..) was not sure thing from PII trial, more appropriate would be quick and smaller two-three PII trial with several modulation or/and drug formulation. Than large pivotal trials with 2302 or sec.gen. antisense. At this point Isis will need second trial or trials with different formulation/modulation to address patients convenience and drug performance for longer chronic therapy. Also, I am puzzled why Isis didn't expand current Crohn's protocol with post-trial open label study for patients who responded to drug. To asses drug safety for several therapy cycle and long-term efficiency. For other indications, 2302 do not have ICAM-1 problems, it is antisense nature. In each of this indication (and potentially others) problems are different and will be solved individually; by drug formulation, mode of administration, sec. gen., .... All this does not means that I am bearish on 2302, but I do have many questions and will be seeking answers at Open House/SM. mz

To: sds who wrote (1949)	4/27/1998 7:10:00 AM
From: Micawber	Read Replies (1) \| Respond to of 4676

SDS: I'm getting as frustrated as you are. Regarding 2302 and UC, the 10k said that the enrollment is going slowly because they are looking for steriod-dependent patients, who usually choose surgery over long-term steriod use. Does the study protocol mandate that they only test steriod-dependent patients? Also, what do you make of the RA study? One tiny wishy-washy paragraph for a potentially huge market? This does not give me the warm fuzzies. I'm holding, but I have both eyes on the dealer.