Pharmacyclics says Xcytrin not effective against brain metastases in non-small cell lung cancer study

By Ted A. Knutson

Washington, Dec. 19 - Pharmacyclics, Inc. announced Monday that a phase 3 study shows Xcytrin (motexafin gadolinium) Injection was not effective in treating non-small cell lung cancer patients with brain metastases where lung cancer has spread to the brain from another part of the body.

The randomized, controlled phase 3 trial, known as the Smart trial - Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy - was designed to compare the safety and efficacy of whole brain radiation therapy alone to whole brain radiation therapy plus Xcytrin. The primary endpoint of the study was time to neurologic progression as determined by a blinded events review committee.

The trial enrolled 554 patients from 94 centers in North America, Europe and Australia. The treatment arms were well balanced for all known prognostic factors.

There was no significant difference in survival, a secondary endpoint of the trial. There were positive trends observed in favor of the Xcytrin-treated patient arm with respect to reduced steroid usage and less need for salvage radiation therapy to the brain, the company said in a news release.

"While we are disappointed the trial did not meet the primary endpoint, the data do show a favorable trend in this very sick, difficult-to-treat advanced lung cancer patient population," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics, in a press release. "We will complete our analysis of the data and discuss it with the [Food and Drug Administration].

"We believe this study demonstrates that Xcytrin has clinical activity in lung cancer and we will continue to focus resources on its potential use in the systemic therapy of this disease."

Three trials with Xcytrin for the systemic therapy of relapsed lung cancer are in progress evaluating its use as a single agent and in combination with other agents. Additional trials in hematologic malignancies and other advanced cancers are also underway.

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis or programmed cell death. Xcytrin is a redox active drug that has been shown to disrupt redox dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity to be used in a broad range of cancers.

Pharmacyclics is a Sunnyvale, Calif.-based pharmaceutical company developing a patented new class of drugs intended to treat cancer and atherosclerosis.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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