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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: NeuroInvestment who wrote (20660)7/27/2006 10:51:30 PM
From: Arthur Radley  Read Replies (1) | Respond to of 52153
 
Data on nearly 1700 patients and these results don't sound positive to me...
ABSTRACT

Background NXY-059 is a free-radical–trapping agent that is neuroprotective in animal models of stroke. We tested whether it would reduce disability in humans after acute ischemic stroke.

Methods We conducted a randomized, double-blind, placebo-controlled trial involving 1722 patients with acute ischemic stroke who were randomly assigned to receive a 72-hour infusion of placebo or intravenous NXY-059 within 6 hours after the onset of the stroke. The primary outcome was disability at 90 days, as measured according to scores on the modified Rankin scale for disability (range, 0 to 5, with 0 indicating no residual symptoms and 5 indicating bedbound, requiring constant care).

Results Among the 1699 subjects included in the efficacy analysis, NXY-059 significantly improved the overall distribution of scores on the modified Rankin scale, as compared with placebo (P=0.038 by the Cochran–Mantel–Haenszel test). The common odds ratio for improvement across all categories of the scale was 1.20 (95 percent confidence interval, 1.01 to 1.42). Mortality and rates of serious and nonserious adverse events were each similar in the two groups. NXY-059 did not improve neurologic functioning as measured according to the National Institutes of Health Stroke Scale (NIHSS): the difference between the two groups in the change from baseline scores was 0.1 point (95 percent confidence interval, –1.4 to 1.1; P=0.86). Likewise, no improvement was observed according to the Barthel index (P=0.14). In a post hoc analysis of patients who also received alteplase, NXY-059 was associated with a lower incidence of any hemorrhagic transformation (P=0.001) and symptomatic intracranial hemorrhage (P=0.036).

Conclusions The administration of NXY-059 within six hours after the onset of acute ischemic stroke significantly improved the primary outcome (reduced disability at 90 days), but it did not significantly improve other outcome measures, including neurologic functioning as measured by the NIHSS score. Additional research is needed to confirm whether NXY-059 is beneficial in ischemic stroke. (ClinicalTrials.gov number, NCT00119626 [ClinicalTrials.gov] .)

My money is on NUVO in this area of acute ischemic stroke, as they plan trials in the near future with their Phase III candidate for PAO.



To: NeuroInvestment who wrote (20660)7/27/2006 11:46:31 PM
From: dr.praveen  Read Replies (2) | Respond to of 52153
 
Paion

Hi Harry,

What do you think of paion?

Their latest presentation

wsw.com

This is from an old post of mine:

I like Paion for the foll reasons:

1) Low market cap of approx 350 Mil

2) good management( Family )

3) Desmoteplase(plasminogen activator) and Enecadin(neuroprotectant) combination which is reco by intl stroke experts. Smart choice which RNVS doesn't have.

3) Pipeline also consists of Solulin(If successful?) which is a thrombin inhibitor used to treat CVS/stroke.

Solulin acts only from the moment thrombin is formed and could therefore deliver a much more targeted effect than other products.

4)About the lead drug desmoteplase, A plasminogen activator derived from the saliva of the vampire bat Desmodus rotundus with approx. 70% structural homology to t-PA

5)Administration time after 3–9h Stroke onset,which is a good time period to administer in the pt and in bolus.

6) Good fibrin selectivity which decreases risk of bleeding and faster action

7)Safe in elderly pts

8)Elimination half life from 2-4.7 hrs which is a good period to prevent reocclusion.

9)Clinical outcome, reperfusion, Volume change of the infarct are very good and dose dependant which shows that the drug is effective.

10)Good partnership's for Desmoteplase with FRX in US and Lundbeck for rest of the world.(Royalty rates are not disclosed)

Thanks,
Praveen