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Gilead and Elan Struggle with Clinical Trials


It's been a tough week for clinical trials: One drug got canned and another was re-tuned in the wake of failed end points and patient deaths.

Two drugs-one in late stage development-took a tumble this week.

On Wednesday, Elan announced that it was switching up Phase II studies on its Alzheimer’s disease treatment dubbed ELND005. According to a company press release, patients are being dropped from a high-dose version of the twice-daily treatment due to nine deaths among the 353 patients enrolled in the trials.

The company’s Independent Safety Monitoring Committee asked Elan-which is working on the drug in conjunction with Transition Therapeutics-to opt out of the trial after a spike in adverse reactions to the 1,000mg and 2,000mg doses of the treatment. Trials will continue for the 250mg version of the drug, and both companies claim that adverse reactions and safety data are within specifications for that version of the treatment.

"Today's decision speaks to our strong commitment to patient safety while allowing for the continued evaluation of ELND005 at the 250mg dose," stated Menghis Bairu, executive vice president and chief medical officer at Elan. "We expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment of Alzheimer's disease."

ELND005 received fast track-approval from FDA in April 2009 because it meets an underserved patient group-patients with mild to moderate AD.

In other somber clinical trial news, Gilead said that it will close the curtain on its Phase III trial for the hypertension treatment darusentan. According to the drug firm, the DAR-312 trial appears to be a failure, as it did not meet its end points by for the 14-week trial.

"We are disappointed that darusentan did not achieve its primary end points in this study," stated Norbert Bischofberger, Gilead's executive vice president, research and development, and chief scientific officer, in a release. "As a result, we think it would be challenging to define an expedient path forward. We would likely be required to initiate another Phase III study and would rather allocate our resources to other promising research and development opportunities in our pipeline."

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