Bionor Will Conduct Further Trials of HIV Vaccine After Early Test Failure
Bionor Pharma ASA is proceeding with development of its experimental HIV vaccine even after it failed to keep patients off antiviral drugs in an early trial.
Buoyed by subsequent findings that the vaccine reduces the amount of virus that causes AIDS, Bionor is planning tests that it can finance on its own to confirm the results, and more extensive ones if it finds a partner, Chief Executive Officer Henrik Lund said yesterday in a telephone interview.
“We are looking for both private and public partners,” said Lund, who became CEO of the Oslo-based drugmaker in September. Lund spent the previous five years as head of research and development operations in Europe, Asia and Latin America for London-based AstraZeneca PLC.
The company’s shares fell 81 percent Oct. 1, when the results of the trial were first released. Bionor has since climbed almost fourfold in the past three months, making it the biggest gainer among Nordic drugmakers. Bionor in December secured funding through the first quarter of 2013 after selling trademarks for some nutrition products for 110 million kroner ($19 million), putting it in a “healthy financial situation,” Lund said.
Researchers have been looking for a vaccine that can harness the body’s own natural defenses to prevent and kill HIV infections. The search started about a quarter of a century ago, with the first trial beginning in 1988 at the Bethesda, Maryland-based National Institutes of Health. The virus’ ability to mutate and hide has slowed progress.
“What they’re trying to do is not easy,” said Gary Nabel, director of NIH’s Vaccine Research Center and one of the scientists who last year discovered an antibody that kills more than 90 percent of HIV strains.
“This is a product that has some potential and needs further testing,” Nabel said in a Jan. 26 phone interview. “It’s really a toss of the coin as to whether the study will replicate the effect and whether the effect will be clinically significant.”
In its October trial, Bionor sought to test whether its vaccine would strengthen the body’s immune system enough so patients could stay off anti-retroviral therapy, typically a combination of several drugs with side effects ranging from headaches and rashes to vomiting and fever. Results showed patients were just as likely to resume ART treatment.
Bionor, which has posted losses in 11 of the past 12 years, is designing another trial that, like the failed one, likely will test the vaccine’s effectiveness against a placebo in several treatment centers across several countries, Lund said. Unlike the first trial, the second will test to what extent virus levels fall in patients taking the treatment, he said.
Preliminary discussions with potential private investors and public partners also have begun, Lund said.
The initial trial may have failed because too few people took part, Richard Pollard, that study’s lead investigator and head of the infectious diseases division at the University of California, Davis’ Health System, said in an e-mail.
“All approaches to control viral replication are needed and should be pursued,” Pollard said in a Jan. 12 e-mail. “There are still multiple attempts going on to enhance immunity to one’s own virus, and it is only through continued exploration that we will get needed results.”
Other companies testing HIV vaccines include Novartis AG, Inovio Pharmaceutical Inc., Profectus BioSciences Inc. and GlaxoSmithKline Plc. Merck & Co. discontinued development of its vaccine V520 in 2007 after an early-stage trial failed.
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