BiondVax Pharmaceuticals Ltd. (TASE:BNDX) today reported that it has successfully completed the Phase I/II clinical trial of its Multimeric-001 universal flu vaccine.
The second stage of the study involved people aged 55-75. The single-blind trial, conducted at Sourasky Medical Center (Ichilov Hospital) in Tel Aviv, included 60 patients, who received two flu shots in the arm muscle. The two shots were of increasing dosages, with and without adjuvant. The participants also received the usual commercial seasonal flu vaccine in a third shot.
BiondVax reported that the vaccine was found to be safe at all the dosages administered, both with the adjuvant and without it. The vaccine resulted in a statistically significant immune response compared with the control group. The vaccine was also found to be most effective at the higher dosage of 500 milligrams with the adjuvant.
In December 2009, BiondVax reported success in the first trial of the vaccine, conducted on 63 people aged 18-49.
In view of these two successes, BiondVax plans to conduct the first study of the Phase II trial of the Multimeric-001 at Sourasky Medical Center and at Hadassah Medical Center Ein Kerem in Jerusalem, beginning in the second half of 2010. The trial will include 160 participants aged 18-49. The company said that it will finance the cost of the trial from the proceeds of its secondary offering held in December 2009.
BiondVax president and CEO Dr. Ron Babecoff DVM said, "We especially welcome the positive results obtained from the older group. They exceeded our expectations, since it is harder to obtain an immune response in an older population. The results achieved give us the assurance for beginning the Phase II trial."
BiondVax's share price rose 5.4% in morning trading to NIS 3.25, giving a market cap of NIS 116 million.
Published by Globes [online], Israel business news - www.globes-online.com - on April 28, 2010
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