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NeoRx Corporation (NERX) Message Board

  • eastside155 eastside155 Dec 13, 2001 10:37 AM Flag

    Phase II Is Substantial

    Mygameon, I fail to understand your logic about Nerx and Phase II vs. Phase III.

    It seems to me that they administered STR to 85 humans with MM, and those MM patients represented a reasonable reflection of the disease. The results indisputedly showed an extremely favorable profile of positive responses, including roughly a 50% CR. To the best of my knowledge these are the most promising results of anything ever tried on humans for MM on this scale. I don't see any kind of spin on these results (although I do recognize the safety issues).

    To me there is nothing to suggest that this response profile will not in fact be duplicated when it is done again, as it would in a P III. So I'm wondering why you seem to suggest that P III is really needed to prove it without any recognition that P II really offered significant proof, but that it still has to be (and logic says should be) "confirmed" in P III.

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    • You're taking this whole message board thing far too seriously. A person would have to be daft to act on anything they saw here. Not that there isn't good information, but you'd definitely want to verify--that is if you weren't an idiot of course.

      NeoRx has had the Denton facility for less than a year, and a major retrofit had to be developed to produce the pharma for STR. I don't expect them to be turning a profit with Denton until the second quarter of next year at the very earliest. I think Denton has a lot of great potential, and that's what I said before.

      Believe me, I'm not losing any sleep over my "position," but thanks for your concern. And don't worry, I won't say anything about your MURR/ABC "synergy" fantasies.

      Yours ever,
      Molly

    • you hate bios-
      rituxam mygameoff

    • One only "confirms" what is established.

      Nothing is established in PII other than effective dose and additional safety is (or in NERXs case not) established. This is accomplished via dose escalation and multiple administration (i.e daily, weekly, whatever the need is based on current standard of care or animal efficacy data).

      It is like coming out of PI again, but the go no go data this time around will indicate survival or death for a company like NERX

      NERX established an efficacious observation without knowing dosage strength and total human exposure, and unsafe side effects. Therefore, they must determine the dosage strength and human exposure without creating side effects. Thus the requirement of the dosimetry study before PIII patients can be dosed. A bad scenario would be that NERX determines that the dose given in PII was not supported by their animal toxicology data. Then they would have to either use a lower dose (potential that the same "efficacy" would not be achieved) or redo the animal tox study (a 9 month process). Hence when the dosage strength is not known and safety is an issue then the NERX PII data get very small market valuation.