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Biotech / Medical : ADVENTRX Pharmaceuticals Inc (Anx)

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To: ggamer who wrote (342)10/5/2007 6:36:55 PM
From: Keith FeralRead Replies (1) of 418
 
I think the mgmt bent over backwards to stress that they would be talking to their marketing partners about the clinical relevance. They have to show the partners the Cofactor group had some underlying cancer problems that caused the different results. And they have to discuss why the folate effect did not happen. They mentioned the method of administration negated the folate effect.

I listened to the whole call several times and took notes of all of Merritt's comments. They are worth going back to hear. I'm not going to wait for an answer from the company, which is why I'm going through all the clinical work.

It wasn't the infusional Cofactor and 5FU that was the problem, it was the 600 mg of 5FU that overloaded the folate. Normally, Cofactor is dosed with 50 mg per 450 mg of 5FU. The problem with the infusion was an extra 600 mg of 5FU added to the regimen in the 22 hour continous infusion. This must have prevented the supply of folate from increasing the RBC folate levels.

I hope for all our sakes the company can convince the marketing partners so they can get some money for the phase 3. I don't see 10 mg Avastin solutions interfering with Cofactor to express the folate effect. Plus, people are only getting dosed with Avastin every other week and they are getting bolus Cofactor or Leucovorin every week. Bottom line, I don't think they could have constructed the phase 3 any better. Maybe they could have done a 3rd arm to study 2 hour Cofactor infusion vs 2 hour Leucovorin for the same doses. However, I don't think there is any reason to suspect that the 2 hour infusion is the cause of the problem so much as the dilution of the Cofactor from the second infusion of 600 mg.
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