West Coast Editor

With one Phase III kidney cancer trial ongoing already, Onyx Pharmaceuticals Inc. and partner Bayer Pharmaceuticals Corp. started another Phase III study testing their compound in liver cancer.

"In each of these cases, we saw some very encouraging preliminary activity, and we're following up on that," said Julie Wood, spokeswoman for Richmond, Calif.-based Onyx.

The company's stock (NASDAQ:ONXX) closed Tuesday at $26.17, down 1 cent.

In the summer of 2003, Onyx restructured, cutting most of its staff and assigning the remainder of employees to work with Bayer on the lead compound, BAY 43-9006. (See BioWorld Today, June 13, 2003.)

The move is paying off. An orally active inhibitor of the enzyme Raf kinase and vascular endothelial growth factor receptor, the drug is the subject of a second Phase III study, that one geared to measure differences in survival, time to symptom progression and time to tumor progression of the compound vs. placebo in more than 500 randomized patients with advanced liver cancer.

Wood said the company "hasn't publicly projected" when the trial will finish.

Last fall, Onyx's stock sank on news that it would wait for Phase III data from the kidney cancer study before seeking approval for the drug in that indication. Some analysts had pointed to the possibility of a filing based on Phase II results. New York-based Pfizer Inc. also has a kidney cancer drug in Phase III trials - SU011248 (brand named Sutent), a multi-targeted tyrosine kinase inhibitor for anti-angiogenesis, originally from Sugen Inc. (See BioWorld Today, Oct. 26, 2004.)

"Certainly we hear different things about competitors' compounds, and all of that is obviously anecdotal," Wood said. "We will be the first player out there with randomized data for renal-cell carcinoma, and the first with survival data."

Onyx also has a deal with would-be competitor Pfizer. That collaboration, signed with Warner-Lambert Co. (now a unit of Pfizer), has identified a number of lead compounds that modulate the activity of key enzymes that regulate the process by which a cell replicates and divides. The Phase I study with the drug targeting a cyclin-dependent kinase, CDK4, began last fall and triggered a $500,000 milestone payment from Pfizer.

If the FDA lets Onyx file for accelerated approval of lead compound BAY 43-9006 in kidney cancer, the product could be available in 2006, she added. Meanwhile, the company has plans in the works for a pivotal trial with the drug in combination with chemotherapy against metastatic melanoma, and "a host of other trials" that are earlier stage, Wood told BioWorld Today.

As of Sept. 30, Onyx had about $71 million in cash and cash equivalents.