John, Izzy,
If you're reading the VRTX board, you know I'm trying to understand more about the VX-478 compound, both as an AGPH shareholder interested in potential competition, and as a potential VRTX shareholder (I think both companies and probably both products will be successful).
John, in your recent post you said:
"In a recent tech letter, I read that Glaxo was not impressed with the
70% response to VX-478 nad was planning to withdraw from the
collaboration"
Can you give a little more detail. what was the tech letter and could you quote what they said.
Izzy, in your post you said:
"With an estimated 30% failure rate of the VRTX PI so far (besides the
high reported drug side-effects), I understand that VRTX/GLX cannot even
get people to enroll in its USA clinical trials. Their drug is a dog and
you know it. I even doubt that it will come to market, and, if it does,
I sure as hell won't prescribe it unless there is clear proof that it is
a superior PI to all others on the market at that time, which I seriousl
y doubt."
You make a bunch of claims. Could you expand on them:
- "estimated 30% failure rate of the VRTX PI so far"
the PII results published in the press release 10/13/97 indicated that the 12 or 16 week data showed 70% of the patients undetectable on 400 ppl assay across the three dosing groups in combination with AZT and 3TC. The 1200mg BID dose (the high dose, and the target dose for the pivotal trials) had a mean 2.65 log reduction in viral count, hence undoubtedly a higher % undetectable than 70%. However, we weren't provided the % of patients undetectable on the 1200mg BID dose, just across all three dose groups (900mg BID, 1050mg BID, 1200mg BID). So, as I've said here and on the VRTX board, the 70% number may be misleading as a comparison of VX-478's optimal dosing compared to Viracept's or Crixivan's.
- "the high reported drug side-effects"
where are you getting your data. I know you're a physician active in this area, and have much better sources of info on this than most of us on this board, myself included ...
- "I understand that VRTX/GLX cannot even get people to enroll in its USA clinical trials"
same question as above. If true, obviously a material fact. Difficulties in recruitment always make me nervous. Just as an aside, how GLX got a PIII through the FDA and various IRBs with the comparison arm of the trial AZT and 3TC is beyond me. This is a trial that began in early 1997, if my memory is correct. I'd consider a head to head trial of any of the other PIs against saquinavir in combo therapy unethical (and of course unnecessary), but AZT and 3TC alone? This will generate interesting comparative data to Viracept and Crixivan who I think ran similar trials, but seems like a pretty bad deal for the patients on that arm.
Peter |
