Washington Editor

Maxim Pharmaceuticals Inc. released quality-of-life data from a Phase III study of Ceplene in advanced metastatic melanoma patients showing that survival was achieved without adversely affecting quality of life.

Ceplene (histamine dihydrochloride) is being studied in several cancers and is familiar to the FDA as Maxamine, its name in December 2000 when the agency rejected it as a treatment for metastasized liver cancer patients. (See BioWorld Today, Dec. 14, 2000.)

After the defeat, Maxim, of San Diego, went home, changed its drug's name because it was similar to another drug's, and began trying to figure out what went wrong with the drug application.

On Thursday, the company said an independent health outcomes assessment group compared the quality-of-life effects of combination treatment with Ceplene and interleukin-2 vs. interleukin-2 alone in advanced metastatic melanoma patients and found a significant increase in median quality-adjusted survival in the combination treatment group.

"This speaks to quality of life and safety. It is not very meaningful to extend life if your treatment is so horrific that you are in the hospital or a coma," Larry Stambaugh, Maxim's chairman, president and CEO, told BioWorld Today. "We think it is important that patients can self-administer the drug at home, stay at work or with their families, and have quality of life during their treatment and hopefully have extended survival."

The data are from a multicenter, randomized Phase III "M01" trial. Twenty-four-month and 36-month data from 305 randomized patients suggested a statistically significant improvement in survival in the treatment group, the company said.

Maxim filed the previous drug application on M01, but has commissioned another Phase III trial referred to as M0104 to be submitted as a confirmatory trial. M0104 is identical to M01, Stambaugh said.

He said M0104 should be enrolled in the U.S. this year, and if everything goes according to plan, Maxim could seek regulatory approval in the latter part of 2004 or in early 2005. Ceplene likely would receive priority review.

Maxim intends to develop Ceplene independently, but plans to seek a global partner to help market it worldwide. The company plans to file in Europe this year based on current data.

In addition to advanced metastatic melanoma, Ceplene also is in a Phase III trial for the treatment of acute myeloid leukemia. Phase II trials of Ceplene also are under way for the treatment of chronic hepatitis C and advanced renal cell carcinoma.

Ceplene is based on histamine, a naturally occurring molecule that has demonstrated the ability to reduce oxidative stress, which is identified in many diseases. Researchers believe Ceplene has the potential to prevent or reverse damage induced by oxidative stress, thereby protecting critical cells and tissues, including the liver.

Maxim's stock (NASDAQ:MAXM) gained $1.60 Thursday, or 32 percent, to close at $6.60.