Tuck,
Thanks for posting the info from McCamant - I don't subscribe to MTSL, but this piece corroborates another Yahoo post that describes McCamant's recent statements:
messages.yahoo.com
Actually, I believe that MTSL is quoted correctly about the PhaseII trial, no typo here - they're referring to the most recently initiated C225 study, a phaseII trial of C225/cisplatin for refractory patients (pts who no longer respond to chemo) that was initiated just a few weeks ago. This trial does not yet even appear on the website, except for the initial press release, so folks can be forgiven some confusion. See
imclone.com
What McCamant is saying is that IMCL intends to file with data from this trial if it's good enough, and this represents the earliest possible approval of C225. They don't come right out and say this in the press release for the study, but for things like unmet life-threatening medical needs (such as chemo-refractory HNSCC), the FDA allows you to file with PhaseII data in some cases, and this is consistent with earlier company statements to Dow Jones back in March about their plans:
Imclone CEO:Sees Blockbuster Drug On Mkt Next Year
03/03/1999
Federal Filings Newswires <snip>
WASHINGTON (FFBN) -- <snip>
Imclone believes C225 will make it to the U.S. market next year. "The plan with C225 is to complete a number of pivotal studies this year," said Waksal. "Included in those trials is a study that is in failed patients, which we believe will be our first marketing opportunity."
"We are going to look at patients who are failing (the chemotherapy agent) platinum and one other chemotherapy drug," explained the CEO <read refractory patients, as in the recently initiated PhaseII trial>. "We add C225 (to the combination) and if we get a 20% response rate, we plan on going towards registration. We think we can complete that study this year and that would give us the ability to get on the market next year with this drug." <snip>
By the way, the Yahoo poster who posted the Jagnotes mention is the same one who posted excerpts from this Dow Jones piece back in March. As I mentioned, I have since gotten Dow Jones access, and one of the things I did after I got it was verify this piece. Incidentally, anyone wanting to verify any Dow Jones items can now search the publications library and see the first few lines of a piece for a free registration, and see whole pieces for a nominal $3 charge. Just go to dowjones.com and find your way to register for the publications search.
I believe McCamant is right, the PhaseII was greeted with a yawn, but most folks didn't see or remember the earlier statements about its significance. Because this study is very small, and in a refractory population, it can potentially be completed more quickly than the other PhaseIII C225 trials underway. This study has the potential to get C225 onto the market well in advance of closest EGFr competitors - lots of competition coming, so an early lead is important for near-term IMCL success. I'm going to call IMCL IR this afternoon to get one more verification that they do intend to file with this data if its good enough.
Cheers!
Gordon |
