Xcyte Therapies, the sole biotech company from Seattle to go public last year, was dealt a setback yesterday when one of its key clinical...

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Xcyte Therapies, the sole biotech company from Seattle to go public last year, was dealt a setback yesterday when one of its key clinical trials against cancer was delayed because of questions from regulators.

The company said after the market’s close that it has withdrawn a plan for the pivotal clinical trial, in patients with chronic lymphocytic leukemia, because the Food and Drug Administration requested additional discussions about how the study would be conducted. Xcyte said it intends to resubmit the plan, but said the trial may not start until the second half of this year.

Xcyte’s chief business officer, Bob Kirkman, said he expects the delay to be measured in months, not years. He would not describe the nature of the FDA’s questions, but said they did not concern the safety of Xcyte’s product, nor Xcyte’s ability to manufacture it consistently.

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Xcyte Therapies




Founded:
1996


Located:
Seattle and Bothell

CEO: Ron Berenson

IPO debut: March 2004

Employees: 83

What it does: Researches and develops therapies that stimulate the immune system against cancer and other diseases. It has no products yet on the market.

Cash & investments: $27 million at end of September

Spending rate: $6.8 million in the third quarter

Manufacturing is a key point, because Xcyte’s process requires withdrawing a patient’s cells, stimulating them against cancer, and re-infusing them, a complex process the FDA has never approved before against cancer.

To craft a pivotal clinical trial that could bring its therapy to the market, the company had been meeting with the FDA since September and reviewing an earlier study of 17 patients with chronic lymphocytic leukemia.

Xcyte’s treatment was found to successfully shrink the cancerous, swollen lymph nodes of 12 patients and the cancerous spleens of 13 patients. The treatment did not, however, wipe out cancer cells in the blood. The reason for the discrepancy isn’t fully understood.

In order to reach the market, Xcyte proposed a trial which would start patients on Campath, an antibody drug that has some success killing cancerous blood cells. Once patients failed on that, they could switch over to Xcyte’s treatment. Kirkman said his company thought it had a mutual understanding with the FDA on the study design, including the proper measurements of success.

He said the company was surprised to learn in a letter this week that the FDA wanted more discussions about the trial design.

“We’ve always had an outstanding relationship with the FDA,” Kirkman said.

Xcyte has no products on the market and is relying on capital it has raised from investors. It had $27 million in cash and investments at the end of September, and raised another $29.9 million in November. It spent $6.8 million in the third quarter on its operations.

The company has not developed a large fan base on Wall Street, and the delay most likely won’t help. Its stock has fallen from its initial price of $8 in March to $2.29 yesterday.

Besides the leukemia trial plan, the company also has two other ongoing clinical trials, for multiple myeloma, a bone-marrow cancer, and for non-Hodgkin’s lymphoma.

Daniel Burge, senior vice president of clinical development at Trubion Pharmaceuticals, another Seattle biotech startup, said it is not unusual for disagreements with the FDA to delay a clinical trial. He said Xcyte appears to be doing the right thing by fixing the situation now.

“It’s obviously not what you want to see, but you’d much rather have a delay of a quarter than have the FDA reject you after the fact,” Burge said.

Luke Timmerman: 206-515-5644 or ltimmerman@seattletimes.com