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Biotech / Medical : GTXi (GTXI) -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (14)	9/7/2006 4:00:49 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 85

I own some. Can't see getting hurt by it for a while. FLW.

To: nigel bates who wrote (14)	10/28/2006 9:12:40 PM
From: tuck	Respond to of 85

Just listened to the UBS presentation, which may be gone by the time you read this. Seems as though much of the clinical risk went away this summer; sorry I wasn't paying more attention, I would have bought some then. Looking for a pullback. Notes from presentation . . . Upcoming news flow: Asian Partner for Acapodene: in discussion. Likely by year end (my guess)? Acapodene PIII data for treatment of AST side effects 2H07 Acapodene PIII for prevention of prostate cancer in high risk men late '07 to early '08. Ostarine PIIb data for muscle wasting & bone loss by YE '06 (ahead of all competition in the SARM class) In bone, lipid, and pituitary tissue Acapodene is a weak estrogen, but is anti estrogenic in the prostate. In-licensed Fareston to control IP. The SEs of ADT (medical castration) are similar to those of menopause, but worse. ADT men lose bone faster and get fractures, incurring a 3 year reduction in life expectancy. Lipids get worse leading to CV issues. Painful breast swelling and hot flashes worse than those of post-menopausal women, and don't decrease over time. Interim BMD analysis got better results than raloxifene, and raloxifene reduced fractures by 55%. The latter is one of the primary endpoints. The lipid profile interim analysis showed improvement and thus the CV side effects are likely to be less, also an endpoint. So the risk for the final data got reduced this summer, without taking final p value away by looking directly at the endpoint itself. Tolerability equal to placebo, and safety has been demonstrated in 350,000 patient years in breast cancer. Dose is lower in these trials because at lower doses it is an ER alpha selective inhibitor, the "accelerator" for prostate cancer, while beta is the "brake." Thus efficacy is the main hurdle, and if proven, approval should be a slam dunk (famous last words). In the prevention trial there is an event driven interim efficacy analysis that if successful (50% reduction in prostate cancer), will result in NDA. Powered at 89% for p=.001. That's the late '07 date given above. So clinical program looks pretty smart to me. There's basically no competition to speak of for ostarine, not on the market at any rate. Denosumab from Amgen will only address osteoporosis. Zometa is a bit nasty. SARMs are anabolic on muscle and bone, but not androgenic. Thus ostarine does not cause virulization, skin disorders. Large market, including hospitalized elderly patients. Ipsen deal. A major player in the EU in ADT treatment, so it has the right sales force. Royalty from mid teens to twenties. The higher the price for Acapodene, the higher the royalty rate. Wilder, correct me if I botched anything. Gotta go cook now, so can't listen to the presentation multiple times to check. Cheers, Tuck