True story, did you guys know when they started mispronouncing UR-Anus to URanus, it was Dan Rather who refused to read the teleprompt, which read that they had discovered new rings around it. LOL
Another one for Mondays watch list: IMCL as a sympathy play to NVS, Novartis
ImClone's IMC-C225 With Chemo Shrinks Colorectal Tumors
By Beth M. Mantz
Of DOW JONES NEWSWIRES
SAN FRANCISCO (Dow Jones)--The combination regimen of a new kind of
drug and a gold standard chemotherapy agent may offer hope to
sufferers with advanced colorectal cancer.
Results from a highly-anticipated trial, testing ImClone Systems
Inc.'s (IMCL) targeted compound IMC-C225 and irinotecan chemotherapy,
have demonstrated the combination produces responses in some patients
with advanced colorectal cancer who no longer respond to standard
chemotherapy.
Presented at the 37th annual meeting of the American Society of
Clinical Oncology in San Francisco, the study findings showed that
tumors shrank more than 50% in 27 of the 121 patients given the
combination regimen.
Researchers from Memorial Sloane Kettering Cancer Center in New York
considered the 22.5% response rate a major response. They were looking
for at least a 15% response rate to conclude the compound induced
activity.
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ImClone IMC-C225-2: To Be Tested For Prolonged Survival
Despite any hard evidence of survival, Memorial Sloan-Kettering's
Saltz suspects ImClone's IMC-C225 and irinotecan could prolong
survival. However, he said nothing conclusive can be determined until
a randomized study compares the combination therapy against a control
group.
ImClone plans to conduct a national pilot study to test the
combination of IMC-C225 and irinotecan in 1200 patients who have never
been treated before and haven't developed resistance to any
chemotherapy treatments to see if the tumors shrink and survival is
extended. The study would begin this summer.
Saltz said it would be inappropriate and unethical to test for
survival in patients who have become resistant to chemotherapy in a
study pitting the combination regimen against irinotecan alone. The
patients given irinotecan would derive no benefit from the treatment
but would experience the toxic side effects.
ImClone isn't waiting for results from the first-line study to file
for approval of IMC-C225.
The company has spoken with the Food and Drug Administration and
plans to submit the first part of its filing in June. As more
information is gleaned, the company will add to its application that
will receive a shortened review because the FDA granted IMC-C225
fast-track status for its fulfilling an unmet medical need. Usually,
the fast-track review lasts six months. |
