Her 2 Protein Auto Vac?

[DonnaNY]

Any news about the Her 2 Protein Auto Vac? Any trials in the US? Thanks for any info

[Christine MH-UK]

Hi Donna,

I have been watching what is going on at Pharmexa for about two years now and the company seems to be having trouble getting its her2 vaccine through the hurdles, partly because it has been tweaking it to get it more effective. For example, this is the second time that it is running a phase II trial, because it didn't get the results it would need to show effectiveness, presumably because of the design of the original trial. To get anywhere, it is going to need the support of a bigger partner and has been in talks with Glaxo.

Here are the results of the first phase II trial, announced late last year:
"Two out of seven treated patients have shown signs of tumor effect (a reduction of the tumor). These patients are still in treatment and will remain in treatment until their tumors progress. Two additional patients showed stable tumors after 8 weeks at which time the treatment was stopped according to the protocol due to a lack of a measurable antibody response, but the period was too short to say whether this constituted an effect."

As Pharmexa has run into hurdles, it has moved to cheaper countries. I believe that the European phase I trial took place in the UK a while back, and the phase II was originally supposed to take place in Germany and Italy. One stock analysis website lists the stock as a sell, partly because of its slow progress on its her2 vaccine http://www.dailywallstreet.com/analy...php?ID=1315705 and if other analysts feel the same way, this will hurt its ability to raise the money to run the trials. It has also recently been involved in a long-running lawsuit over patents on another protect, for which it has had trouble finding a partner, so I am somewhat skeptical that the company has the money for a U.S. trial at present, unfortunately. Right now the company has no products on the market and therefore is rather vulnerable and needs to be cautious.

It seems to be like the phase II might be as much to attract the interest of GSK, which has expressed an interest and might want to use some of Pharmexa's technology to improve its own vaccine, but that's just my guess.

[DonnaNY]

I thought Glaxo had purchased the rights to the vaccine? Hopefully this vaccine will reach the Us market and trials will begin here sooner rather than later, thanks for the info.

[Christine MH-UK]

I doublechecked and found this article from the magazine Manufacturing Chemist from April 2005. As far as I can tell, it's the latest. The Investor's presentation from February doesn't even mention GSK.

http://www.manufacturing-chemist.inf...toryCode=33062

"GlaxoSmithKline (GSK) has decided not to exercise a previously granted right to negotiate a licence agreement with Danish company Pharmexa for its HER-2 Protein AutoVac vaccine, which recently started Phase II trials in breast cancer. Pharmexa's strategy for the vaccine is to develop the product through phase II before a development and marketing partner is sought."

However, this article also makes clear that GSK will remain a possible partner for Pharmexa once the company has done the phase II trial using the vaccine combined with QS-21 in late 2006. I suspect that some of the problem may be that the first trial showed that Pharmexa's vaccine performed as well as herceptin, but maybe lapatinib has moved the goal posts a bit.

I wish I were more optimistic about when this one was going to see the light of day.

[DonnaNY]

Thanks for the info. Guess we will just have to wait and see.