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Author: cliff Big red star, 1000 posts Old School Fool Add to my Favorite Fools Ignore this person (you won't see their posts anymore) Number: of 24983  
Subject: Imclone again, AGAIN! Date: 5/19/2002 12:49 PM
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Greetings to all;

I hope that some of you will not feel that I am beating a dead horse, but in view of all the pros and cons that have been posted on this Board about Imclone, it has seemed important to me to keep cancer-watchers up-to-date on the clinical results w/ IMC 225.

The latest from ASCO appears to reveal why the FDA was concerned enough about the original fast-track filing to deny reviewing it under the original patient selection criteria. This snip from TheStreet.com gives a teaser....there's more in the news release.

At last year's ASCO meeting, ImClone reported on 22 of these patients, and the results were impressive -- a 23% response rate. Another 3 patients were added subsequently, one of whom benefited from Erbitux, pushing the response rate to 24% -- or 6 of 25 patients.

But then, ImClone and its researchers at the M.D. Anderson Cancer Center in Houston, Texas, decided they needed more patients, so they made some important changes to the clinical trial last year. Simply put, they added another 53 patients, all of whom were deemed refractory to existing chemo treatments using a stricter, more "real world" definition of the term.

Importantly, these changes were made after the Food and Drug Administration rejected ImClone's approval application for Erbitux as a treatment for colon cancer in late December. One of the reasons regulators sent Erbitux packing was because the agency doubted many of the patients in its colon cancer study were, indeed, refractory, to existing treatments.

And when these 53 new head and neck cancer patients were given a combination of Erbitux and their chemo drugs, only 3, or 5.7%, of the patients responded.

http://www.thestreet.com/_yahoo/tech/adamfeuerstein/10023148.html

Joseph, you've been a good Board friend...I trust that you understand that I feel an obligation to others to sort this thing out to the endgame.

Cheers.....Cliff

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