Guilford, RPR plan clinical test Companies seek expanded use for chemotherapy wafer


January 15, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

Baltimore-based Guilford Pharmaceuticals Inc. and Rhone-Poulenc Rorer Inc., the French pharmaceuticals giant, said yesterday that they would move ahead with a large clinical trial of a chemotherapy-loaded wafer to see how effective it is in treating early brain cancer.

The dissolvable wafer, Gliadel, is already marketed in the United States for treating a recurrent form of brain cancer known as glio-blastoma multiforme. It is one of the fastest-growing and most deadly types of brain cancer.

"This clinical trial is an important component of efforts to expand development opportunities for Gliadel," said Dr. Craig R. Smith, president and chief executive officer of Guilford.

Gliadel, which is loaded with carmustine, a common chemotherapeutic agent, is approved for use in the United States as an implant in cavities following surgery to remove recurrent brain tumors.

The wafer delivers chemotherapy directly to the tumor site, slowing progression of the disease.

Guilford developed the wafer, and Collegeville, Pa.-based RPR, a subsidiary of Rhone-Poulenc SA of France, holds the license to market it globally except in Scandinavia.

The FDA cleared it for treating recurrent glioblastoma multiforme in June 1996. It was also approved for sale this week in Brazil.

The companies hope to show in the new trial that Gliadel significantly improves survival rates of people diagnosed with primary brain cancer, said Dr. Gary T. Shearman, RPR's senior vice president for drug development.

In a small clinical study involving 32 primary brain cancer patients in Europe, conducted in 1992, 63 percent of the patients were still alive a year after treatment compared to 19 percent given a placebo, the companies said.

Should the FDA approve an expanded use for Gliadel, the market for the wafer would grow significantly.

Approximately 35,000 primary brain tumors are diagnosed annually in the United States.

It is estimated that 20,000 people in the United States are diagnosed annually with recurrent tumors of the type Gliadel is approved for treating.

Between Feb. 25 and Sept. 30, 1997, about 900 Gliadel treatments were sold in the U.S. market, said Andrea Scibelli, a spokeswoman for Guilford.

Each treatment costs $9,600.

Guilford received $1.5 million in revenue from RPR as a result of Gliadel sales and royalties in the third quarter, which ended Sept. 30.

Analysts had expected to see neurosurgeons use the wafer for brain cancers other than glioblastoma multiforme, particularly in treating primary brain cancer.

But that has not occurred yet. Scibelli at Guilford said that RPR has found in market studies that neurosurgeons are being cautious in its use.

"They are trying it for the given indication," said Scibelli.

In the new human study, 200 brain cancer patients, aged 18 to 65, will be enrolled in 12 countries, including the United States.

The patients will first undergo surgery to remove the tumor, and then either the wafer or a placebo will be implanted. All patients will be treated with radiation therapy as well.

Shares of Guilford closed yesterday at $19.625, down $1.125.

American depository receipts of Rhone-Poulenc rose $1.5625 to

$48 on the New York Stock Exchange.

Pub Date: 1/15/98

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