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Biotech / Medical : Nuvelo(NUVO)

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To: Arthur Radley who wrote (50)	11/27/2005 3:32:41 PM
From: Arthur Radley	Read Replies (1) of 140

Analyst reviews for recent data presentation at the American Heart Association are now in and across the board they were very positive as they relate to the results for the rNAPc2 trial. Personally, I thought the Needham report was the best and even liked their banner headline for their update report…”No Napping for rNAPc2, as Encouraging Phase 2 Safety and Efficacy Data Presented at AHA meeting sets stage for further trials.”Some highlights for the recent data--There were 203 patients in the trial(162 receiving rNAPc2 and 40 receiving only placebo.Wide dosing range of the drug with 10/kg dose showing best results. Good news is that dosing showed NO statistical differences in major or minor bleeding rates between the treated and placebo groups. This safety issue was the primary point of the trial but the efficacy results were also very encouraging in that the drug suppresses F1+2, the marker of new thrombin generation. We are now getting down to the crunch time IMO with rNAPc2. This data surely must have other major pharmas looking at NUVO and the potential for a partnership. IMO it will still be around mid-2006 before we get any confirmation on this front. My guess it will be around the time we get data for the current heparin replacement study that is expected to be revealed in the first half of 2006. The next scheduled event is the initiation for the second Phase 3 trial of alfimeprase for PAO(NAPA-3). Following this will be aforementioned data on the Phase 2b trial of rNAPc2 in heparin replacement study that “should” come by June, 2006. Also, around the same time we should see the IND for NU206 being filed with the FDA. As for NU206, I’m becoming more and more intrigued by the potential for this drug. The Science article back in August was very encouraging for this drug’s potential. It seems that NU206 acts as a specific stimulator of the human epithelial cells that line the gastrointestinal tract and mouth. Chemo and radiation therapy causes much damage to these areas of the body, resulting in a condition called mucositis. Remember…up to this point the data is based on animal studies but what I like is that NU206 studies have shown the epithelium shows the drug is transient and reversible in normal tissue. Meaning that once the drug is withdrawn, the tissue will cease to grow. Another big plus for the drug is that it has shown in animal models to reduce symptoms of diarrhea and weight loss while showing no signs of impeding the efficacy of the chemotherapy agent. IMO this is exciting!! As for ARC183……beginning to have my doubts on the future for this compound. Recent decision to stop the trial for current compound was based on economic factors showing that the cost of manufacturing would preclude the compound from being economically feasible as a therapy. I know that NUVO and Archemix are looking into the next generation for this drug because the trial did show that it showed a dose related anticoagulation activity that rapidly reversed, but the trial also revealed that several of the patients showed increased uric acid levels. This is probably directly related to the ARC183 drug because it is an aptamer that is derived from nucleic acids and it has been shown that high doses of this acid can elevate uric acid levels in the blood stream. Bottomline…much work has to be done to eliminate dosing levels that will not cause this to happen and plus they need to be able to make the drug less costly to produce.

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