BiondVax sees positive results in M-001 flu vaccine clinical trial

BiondVax reveals BVX-006 Phase II clinical trial results.
BiondVax reveals BVX-006 Phase II clinical trial results. | Courtesy of
BiondVax Pharmaceuticals, Ltd. said Monday that preliminary results are positive for its BVX-006 Phase II clinical trial for the company’s universal influenza vaccine candidate M-001.

For the clinical trial, researchers administered M-001 through intramuscular injections. The study’s volunteers included people between 50 and 65 years old. After the initial M-001 dose, the volunteers received a dose of the 2014/15 season trivalent vaccine. M-001 was found to be safe and induced humoral immune responses. The results showed that the vaccine aligns with the secondary immunogenicity endpoints and primary safety endpoints.

A 1 mg dose of M-001 is designed to prime immune systems. The results of this study indicate that BiondVax’s unique approach for creating a universal vaccine is successful, especially in widening the immune response against influenza strains.

“We are very pleased with the results of this trial, which provide us with additional supporting data that our M-001 increases the immune response against multiple flu strains,” BiondVax Chief Scientific Officer Tamar Ben-Yedidia said. “The results indicating that the 1 mg dosage level was well tolerated is very important and these positive results support our continued research and ongoing trials."

The 1 mg dose can be particularly beneficial to a population with weakened immunity, such as the elderly.  

"We are very happy with these results, as they demonstrate the importance and value to society of developing M-001,” BiondVax President and CEO Ron Babecoff said. “This successful trial brings us one step further towards the phase 3 clinical trial."

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