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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?


To: rel4490 who wrote (2497)4/10/2007 2:28:02 PM
From: tuck  Respond to of 2515
 
Erbitux whiffs in pancreatic cancer. I think this was expected by most, so the share price damage is limited to a bit over 7% now:

>>NEW YORK, April 10 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL - News) and Bristol-Myers Squibb Company (NYSE: BMY - News) today announced that a Phase III study of ERBITUX® (Cetuximab) plus gemcitabine (a chemotherapy) in patients with locally advanced unresectable or metastatic pancreatic cancer did not meet its primary endpoint of improving overall survival.

Conducted by the Southwest Oncology Group (SWOG), a cancer center network sponsored by the National Cancer Institute, the open-label, randomized study compared ERBITUX plus gemcitabine to gemcitabine alone in more than 700 patients with pancreatic cancer in the first-line treatment setting. The study was conducted in centers throughout the United States and Canada. It was completed in a significantly shorter time than projected, providing a timely answer to an important research question. SWOG has informed ImClone and Bristol-Myers Squibb that the primary study endpoint of statistically improving overall survival was not met. The three parties -- SWOG, ImClone, and Bristol-Myers Squibb -- will engage in joint efforts to fully interpret these results.

"This study was designed to examine the Phase II results we previously observed for ERBITUX in patients with pancreatic cancer," stated Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "We still consider pancreatic cancer to be of the utmost priority and we intend to pursue additional evaluations with ERBITUX including a pilot study of ERBITUX and bevacizumab with or without gemcitabine, as well as our pipeline agents, to improve the outcome for patients with pancreatic cancer."

"Pancreatic cancer is a devastating disease with few effective treatment options, and it is unfortunate that the use of ERBITUX in this trial has not demonstrated the benefit it has shown in other tumors," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb. "We are anxious to understand these data in greater detail and are committed to exploring the potential benefits that ERBITUX may provide to cancer patients."

About Pancreatic Cancer

This year in the U.S., approximately 33,700 people will be diagnosed with cancer of the pancreas. Pancreatic cancer accounts for about six percent (6%) of all cancer deaths, or about 32,000 deaths per year. The current 5-year survival rate is about five percent (5%). The number of deaths from this disease highlights the importance of seeking better therapies for pancreatic cancer through clinical trials testing novel drugs. During the past 30 years, the numbers of new cases of pancreatic cancer (incidence) and deaths (mortality) have changed little.<<

snip

Cheers, Tuck