Approval to work with the island on 'cancer vaccine' first in 40 years

By TRACEY EATON / The Dallas Morning News

HAVANA – For the first time in more than four decades, the U.S. government is allowing an American company to test experimental drugs from Cuba, the small California biotechnology firm announced Thursday.

"We're very pleased," said David Hale, chief executive of CancerVax, in Carlsbad, Calif. "But I'd have to say it's been a pretty complicated process."

U.S. law bans most trade with Cuba, and the Bush administration insists the country is bent on germ warfare. So trying to do business with the socialist nation – especially in biotech – is a daunting task.

But in this case, something transcended Cold War politics: the possibility of saving lives.

CancerVax plans to develop three so-called cancer vaccines, aimed at treating tumors. They will be tested on patients in Cuba, the United Kingdom and Canada. If they work and if American regulatory agencies approve, CancerVax would then try the drugs on U.S. patients.

Cuban scientists, who ridicule accusations that they would develop germ warfare, had no immediate comment on Thursday's announcement. They have said their vaccines are aimed at using the body's immune system to break down tumors.

Mr. Hale said he first learned about the drugs at a San Francisco medical conference in 2001. Cuban researchers had put up a poster describing their efforts.

"I thought it was a novel approach," Mr. Hale said. So he talked to the Cuban scientists and later told his company lawyer, "I found some great technology. I think she thought I was crazy."

He asked for U.S. approval to negotiate with the Cubans. Members of Congress and cancer researchers backed him, and CancerVax executives traveled to the island.

"We were very impressed by the quality and capability of scientists in Cuba," he said.

Two years later – last Friday – the U.S. government granted approval.

Under its agreement with Cuba, CancerVax is required to give Cuba up to $6 million in food or medicine over the next three years. The company can't pay cash because, as American authorities see it, that would only help sustain the socialist government.

If the drug is sold in the United States and benefits Americans, then the 175-employee firm would pay up to $35 million – half in cash, and half in food and medicine, Mr. Hale said. A smaller share of that would go to YM Biosciences, a Canadian company that first obtained licensing for two of the three drugs and is transferring rights to CancerVax.