Encouraged by earlier tests of a treatment for surgical bleeding, ZymoGenetics plans for the first time to take one of its drugs into the final phase of clinical testing.

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Encouraged by earlier tests of a treatment for surgical bleeding, ZymoGenetics plans for the first time to take one of its drugs into the final phase of clinical testing.

The genetically engineered product, Thrombin, is important to ZymoGenetics strategically because it represents the company’s initial attempt to develop on its own a product that could gain FDA approval. Before spinning off as an independent public company in 2000, ZymoGenetics discovered several drugs now on the market, but those were taken through clinical trials at other companies.

The Seattle biotech company said it hopes to get the trial started by year-end, after reaching agreement on methods with the Food and Drug Administration.

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ZymoGenetics expects to enroll 400 to 600 patients and show its treatment is effective at stopping bleeding in various types of surgery. Then, if it wins FDA approval, it could start selling its first home-grown product to doctors in 2007.

The decision to go ahead with the larger, more expensive trial was based on four smaller, placebo-controlled studies of patients undergoing surgery. ZymoGenetics said no serious adverse events could be traced to its product, Thrombin, and that one out of 83 patients developed an antibody reaction against it.

Studies of a rival anti-bleeding product derived from cow blood have suggested that up to 40 percent of surgery patients developed antibodies that attack it.

ZymoGenetics said the overall rate of surgical complications, such as infections, in patients taking Thrombin was comparable to those taking a placebo.


Seattle, South Lake Union

Bruce Carter


What it does:
Develops treatments to reduce surgical bleeding, autoimmune diseases and cancer. It is not selling any products yet, though it gets royalties on some drugs it developed.

The company said it also saw “positive trends” suggesting Thrombin was effective at stopping bleeding quickly, but it didn’t release detailed statistics to back up the assertion.

Doug Williams, the company’s chief scientific officer, said the company is withholding details on Thrombin’s effectiveness until the drug can be showcased in a peer-reviewed medical journal, or at a medical conference. He plans to discuss the broad results today at a Merrill Lynch investor conference in New York.

“If we can demonstrate efficacy in Phase III, when considering the safety advantage we’ll bring to the table, with a pure, reproducible product with no animal proteins, this will be a fairly straightforward sell,” Williams said.

ZymoGenetics isn’t forecasting the market potential yet for its human version of Thrombin, but it said the cow-derived competitor is expected to reach $165 million in sales this year. Williams said Thrombin could conceivably be used for up to half a million surgeries a year in America, even though the cow-derived product isn’t used that widely.

He said ZymoGenetics’ product will likely be priced at a premium over the cow-derived version, which commonly sells for $150 per surgery.

ZymoGenetics has two other products with bigger sales potential now in earlier stages of clinical testing: TACI-Ig for autoimmune disease and IL-21 for cancer.

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