December 13, 2010 / 11:28 PM / 9 years ago

UPDATE 1-Lilly halts melanoma drug trial, cites safety

* Places drug tasisulam on “full clinical hold”

* Company to continue with studies in other cancers

CHICAGO, Dec 13 (Reuters) - Eli Lilly and Co (LLY.N) suspended a late-stage study of a drug for advanced melanoma for safety reasons, the company said on Monday.

Lilly said it has put the experimental drug known as tasisulam on “full clinical hold,” meaning no new or existing patient would get another dose.

The company said it made the decision after consulting with an independent safety board. The suspension was for safety reasons, Lilly said, but did not specify the problems people in the trial had while taking the drug.

The drug is Lilly’s third since mid-August to be suspended in a late-stage clinical study. In October, the company and MacroGenics Inc pulled the plug on teplizumab, and experimental treatment for Type-1 diabetes, because it failed to slow the progress of the disease in patients in a late-stage study. [ID:nN20249456]

And in August, Lilly halted development of an Alzheimer’s drug known as semagacestat after it worsened patients’ symptoms in late-stage studies. [ID:nN17120793]

In the case of tasisulam, the company says it plans to continue its development efforts.

“We are thoroughly reviewing the clinical trial data to understand what modifications to the study protocol or dosing would be needed to improve patient safety on this trial,” Dr. Richard Gaynor, vice president of oncology product development and medical affairs for Lilly, said in a statement.

Lilly is testing the drug in several cancers, including soft tissue sarcoma, breast, ovarian and renal cancers, as well as non-small cell lung cancer and acute leukemia.

The company said it plans to continue clinical trials in these cancers without changes because the drug is being tested at different doses.

The late-stage melanoma trial, which enrolled 300 people in 18 countries, was intended to test the safety and effectiveness of tasisulam compared with paclitaxel as a second-choice treatment in people whose melanoma has spread.

Melanoma is the most aggressive form of skin cancer, affecting 160,000 people worldwide each year. When melanoma has spread, conventional chemotherapy is typically effective only in 10 percent to 20 percent of the cases.

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below