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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (355)	2/7/2006 1:43:51 AM
From: zeta1961	Respond to of 447

My goodness Tuck and Miljenko..I came over here to find Miljenko to show him an abstract I found with intravenous Avastin to find out what he thought!.. here it is..it's from June of 2005..you probably know about it by now?..I was blown away as this was by systemic rootes..now , by my telephone calls etc., I'm told that DNA will do something re: the 'avastin problem in AMD'..in exact words from source which I'm not at liberty to disclose..but you know that I don't exaggerate claims from direct sources!!!...nevertheless, if I were an albanian opthamologist I would go for this! OT: I'm thinking of selling my entire DNA holdings..I don't like their ethic! : Ophthalmology. 2005 Jun;112(6):1035-47. Related Articles, Links Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration twelve-week results of an uncontrolled open-label clinical study. Michels S, Rosenfeld PJ, Puliafito CA, Marcus EN, Venkatraman AS. Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida 33136, USA. PURPOSE: To evaluate the short-term safety of systemic bevacizumab (Avastin, Genentech, Inc., South San Francisco, CA) and its effects on visual acuity (VA) and subfoveal choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration (AMD). DESIGN: Open-label, single-center, uncontrolled clinical study. PARTICIPANTS: Age-related macular degeneration patients with subfoveal CNV (N = 9) and best-corrected VA letter scores of 70 to 20 (approximate Snellen equivalent, 20/40-20/400). METHODS: Patients were treated at baseline with an infusion of bevacizumab (5 mg/kg), followed by 1 or 2 additional doses given at 2-week intervals. Safety assessments were performed at all visits. Ophthalmologic evaluations included protocol VA measurements and ocular examinations, along with optical coherence tomography (OCT) imaging, fluorescein angiography, and indocyanine green angiography. MAIN OUTCOME MEASUREMENTS: Safety assessments were performed, along with assessments of changes from baseline in VA scores, OCT measurements, and angiographic lesion characteristics. RESULTS: There were no serious ocular or systemic adverse events identified. By 6 weeks, the only adverse event identified was a mild elevation of systolic blood pressure (BP) (+12 mmHg; P = 0.035), and this elevation was controlled by either changing or initiating antihypertensive medication. By 12 weeks, the elevation of systolic BP was no longer significant (P = 0.51). In the study eyes, significant increases in VA were evident within 1 week of treatment, and by 12 weeks, the median and mean VA letter scores increased by 8 letters (P = 0.011) and 12 letters (P = 0.008), respectively. The median and mean central retinal thickness measurements decreased by 157 microm (P = 0.008) and 177 microm (P = 0.001), respectively. In the fellow eyes at 12 weeks, the median and mean VA letter scores increased by 27 letters (P = 0.018) and 16 letters (P = 0.012), and the median and mean central retinal thickness measurements decreased by 59 mum (P = 0.028) and 92 microm (P = 0.06). In all study eyes, angiography revealed a marked reduction or an absence of leakage from CNV. CONCLUSION: Overall, bevacizumab therapy was well tolerated, with an improvement in VA, OCT, and angiographic outcomes. Although these preliminary results are promising, a randomized controlled clinical trial is necessary before concluding that systemic bevacizumab therapy is safe and effective for patients with neovascular AMD. Publication Types: Case Reports Clinical Trial PMID: 15936441 [PubMed - indexed for MEDLINE]

To: Miljenko Zuanic who wrote (355)	2/7/2006 6:48:35 PM
From: tuck	Read Replies (1) \| Respond to of 447

Ricarduno of the YMB board provides notes on the ML conference: finance.messages.yahoo.com >>Here are my abreviated notes from the conference: 1) Very strong early EU Launch. Getting Tarceva into second line in EU should be easier than USA due to underserved population and less extensive chemo usage. Also no prior Iressa use in EU. 2) Medicare Part D reimbursement ( for prior gratis Tarceva ) off to a slow start, but should pick up going forward during this year 3) Possible approval of Tarceva before end of 2007 in Japan 4) Thrust in getting Tarceva usage in earlier stage and better performance status patient is moving forward nicely on the clinical and research study front 5) Macugen efficacy under-appreciated, especially in context of possible safety signals emerging from Lucentis. Pairing up of a pan-vegf agent in the acute setting with a selective vegf as maintenance may be an importance clinical trend and one which Dr. Goddard noted is an area of important potential study for OSI ( my comment: a warm strategic embracing of a competing but possibly complementary product ). Earlier referrals by opthalmologists to retinal specialists may increase utility of Macugen. Two year follow-up shows that Macugen is a very safe and extremely effective curtailer or stabilizer of retinal leakages creating a significant potential clinical utility in chronic maintenance therapies. 6) DP4 diabetes estate has 6 sub-licenses at 1-2% royalties each, with MRK and Novartis likely to file their respective compound candidates this year. 7)Phase I study of Tarceva dosing in NSCLC smokers begun with the prospect of a label change in 2007 time-frame. Earlier study in healthy volunteers suggested that a 300mg daily dose in smokers was required to produce an equivalent drug level to a 150mg standard dose in non-smokers ( due to p450 enzyme induction ). 8) Data on Tarceva dose-to-rash to be published this yeat. 9) Some doc's exploring Tarceva monotherapy in certain pancreatic patients and also using higher doses of Tarceva in combo ( recall the 41% one year survival in the Phase III in patients with grade 2 or greater rash ). 10) Room to increase Tarceva price but this has to be done fairly and judiciously. Ricardo << It'll be interesting to see if Tarceva gets into 2nd line in Europe as quickly as Goddard suggests. It'll also be interesting to see if the concept of a selective vegf agent for maintenance therapy after a "pan vegf agent" for acute therapy pans out. Anybody here buy that idea? It'll be about the only thing that saves Macugen, so I presume OSIP is indeed studying this concept good and hard. Good to know the DP4 royalty rates. Anyhow, a thousand thanks to Ricardo for the notes. Cheers, Tuck