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Biotech / Medical : ADVENTRX Pharmaceuticals Inc (Anx) -- Ignore unavailable to you. Want to Upgrade?

To: Keith Feral who wrote (339)	10/5/2007 4:56:08 PM
From: Keith Feral	Respond to of 418

Gamer, everyone keeps asking why they did the phase 2b. The company said several months ago they were planning to expand the phase 3 in Europe and do a single phase 3 trial for the US and Europe for bolus Cofactor and Avastin. However, there was no way for the company to proceed to phase 3 in Europe unless they did a phase 2, even if that particular one didn't work. The EMEA can still decide to enable ANX to proceed with the single phase 3 study that is being run in the US and Europe. No one should defend the 22 hour infusion of 5FU. Leucovorin doens't have a folate effect, so it was impossible to predict that the excess 5FU would eliminate the Folate Effect for Cofactor. The 22 hour 5FU infusion of 5FU must have eliminated the folate effect. Coupled with the underlying tumor problems, the Cofactor arm actually had more AE's than the Leucovorin group even though the efficacy results are better. The method of 5FU dosing was a disaster for the Folate Effect. In the phase 3, there is nothing to indicate that bolus Cofactor will not trigger the folate effect. There is only 10 mg of Avastin administered every 2 weeks. There is nothing to suggest that Avastin will interfere with the folate effect or the delivery of the 5FU. The anti cancer effect is already well documented by LV, and it has been documented that Cofactor can increase the concentration of 5FU in the tumors. At the same time, there should not be any negative biofeedback from the Avastin to interfere with the Folate Effect. The method of delivery here can not get any better. However, we still don't know what the results are going to be. I think the company can still apply to the EMEA for phase 3 approval that is ongoing. I don't see any reason for the FDA to have any kind of response to a blown phase 2 trial in Europe. The only negative response could be from the late stage marketing partner(s). If they all get cold feet, it will really put a lot of pressure on the company. I still think they have the cash to finish the enrollment of the trial through 2008 on their own, plus the completion of Vinorelbine and Docetaxel. It all comes down to a marketing deal. Can they get one or not? Otherwise, the company has to start living off of Vinorelbine revenues in 2009. Additionally, they could have success for Docetaxel at that point too.