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San Diego’s Polaris Moves to Late-Stage Test of Drug for Liver Cancer and Other “Arginine-Dependant” Tumors

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develop the drug for use in Taiwan and China, where the incidence of liver cancer is many times higher than in the United States.

But in 2004, he acquired Phoenix altogether (at an undisclosed price), and says he has raised at least $60 million from investors in Taiwan. “I never even tried to talk to any VCs in the United States,” Wu says. “When I met with people in Taiwan, the first question I asked was the liver cancer question—if they had any relatives who had died of liver cancer. They weren’t biotech people, but they are smart business people.”

He founded the Polaris Group and Polaris Pharmaceuticals in 2006, and eventually combined their operations with TDW and DesigneRx .

Wu says that one of the main reasons he acquired Phoenix was to see if he could improve upon the compound. He visited with cancer researchers at MD Anderson and elsewhere, hired a contract research organization to audit the results of research that Phoenix had conducted, and carried out his own mid-stage studies of ADI-PEG 20 in terminal cases of liver cancer and melanoma.

After that, Wu says Polaris worked to win an orphan drug designation for ADI-PEG 20, and spent nearly two years designing a Phase 3 clinical trial, which won FDA approval last month as a special protocol assessment, or SPA. The company says the SPA process allows the FDA and drug developers to reach an agreement on the study size and design before starting a Phase 3 trial, and will serve as the primary basis for an efficacy claim in a new drug marketing application.

The global trial, which is expected to cost $25 million, will enroll 600 terminal liver cancer patients who have failed prior systemic chemotherapy in a randomized, placebo-controlled test of ADI-PEG 20 at medical centers in the United States, United Kingdom, Italy, Taiwan, and China. The principal investigator is Ghassan Abou-Alfa, of the Memorial Sloan-Kettering Cancer Center in New York.

The company’s success in developing ADI-PEG 20, however, also led to a legal dispute several years ago with Enzon Pharmaceuticals of Piscataway, NJ, which Wu says was eventually settled. Enzon had tried unsuccessfully to develop the compound in the 1990s when Clark, the Phoenix Technologies founder, was Enzon’s vice president of research, according to Wu. Enzon sued Phoenix Technologies after Clark resumed work on the compound, and Wu says he inherited the case when he acquired Phoenix Technologies in 2004.

If that was a sign that the stakes have grown high, the stakes are even higher now.

Wu says the only drug currently approved for late-stage liver cancer is sorafenib (Nexavar), which had global sales of $934 million last year as a therapy for both liver cancer and renal cell carcinoma. U.S. regulators approved the drug in 2007, after Bayer showed that it adds just two to three months to the lives of most patients with late-stage liver cancer.

Wu says studies already conducted by Polaris shows that ADI-PEG 20 adds three to seven months to the lives of its late-stage cancer patients. He believes that can be extended even more, though, by treating patients diagnosed at a much earlier stage, when the tumor mass is smaller “and it’s easier to starve [tumor cells] to death.” He also says using ADI-PEG 20 in combination with chemotherapy would boost the drug’s potency even more. Cancer cells often can counter the effects of chemotherapy by repairing the damage done at the cellular level.

“With ADI,” Wu says, “cancer cells cannot make the enzymes and proteins needed to repair cell damage. This gives us a hope that maybe we can cure the cancer in certain cases.”

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