Vaccine Is Safe and Immunogenic in Phase Ib Dose-Ranging Clinical Study
SAN FRANCISCO, CA, USA I January 9, 2014 I Vaxart, a privately held company developing recombinant vaccines that are administered by tablet rather than by injection, today announced positive safety and immunogenicity data from a phase Ib clinical dose-ranging study with its oral H1N1 seasonal influenza vaccine candidate. This study follows a phase I study, the positive results of which were announced in June 2013.
In this latest study, the Vaxart oral H1N1 influenza vaccine induced anti-hemagglutinin antibody responses in 88 percent of subjects. Four-fold increases in neutralizing antibodies as determined by hemagglutination inhibition assay (HAI) and microneutralization (MN) assay were detected in 45 and 55 percent of subjects, respectively.
“These results demonstrate that the Vaxart oral vaccine can protect against flu and represent a significant milestone on our way to the world’s first oral seasonal flu vaccine,” said Vaxart CEO Wouter Latour, MD. “We are accelerating the program and look forward to the day when the ‘flu shot’ can be administered conveniently as a simple tablet at the work place, the local pharmacy, or even at home after receiving Vaxart’s room temperature stable tablet vaccine by mail.”
In its next step toward developing a complete oral quadrivalent seasonal influenza vaccine, Vaxart plans to conduct further clinical studies in 2014 with its tablet vaccines for H1N1 influenza A, H3N2 influenza A and influenza B.
“The success of public vaccination programs depends to a large extent on logistics, and each year the annual flu vaccination campaign puts the system to the test,” said Vaxart chief medical officer David Liebowitz, MD, PhD. “Currently, about 45 percent of more than 300 million eligible Americans are vaccinated against flu each year, according to recent figures from the CDC. A tablet vaccine would remove multiple bottlenecks in distribution and dramatically improve access and acceptance.”
Vaxart’s H1N1 influenza vaccine candidate has demonstrated an excellent safety profile in all studies to date, with no vaccine-related significant adverse events. Adverse events that did occur were all mild.
Vaxart produces its influenza vaccine tablets utilizing industry-standard cell-culture and solid-dose manufacturing processes, which enable manufacturing and distribution of the annually updated vaccine to the public considerably faster than egg-based influenza vaccine manufacturing technologies.
About Vaxart
Vaxart is a privately owned company developing oral recombinant vaccines based on its proprietary delivery platform. The Vaxart platform is suitable to deliver any protein vaccine antigen such as those used in currently marketed influenza, hepatitis B and human papilloma virus (HPV) blockbuster vaccines. Care Capital of Princeton is the lead investor in the company and its largest shareholder. For more information, please visit www.vaxart.com.
SOURCE: Vaxart
Post Views: 145
Vaccine Is Safe and Immunogenic in Phase Ib Dose-Ranging Clinical Study
SAN FRANCISCO, CA, USA I January 9, 2014 I Vaxart, a privately held company developing recombinant vaccines that are administered by tablet rather than by injection, today announced positive safety and immunogenicity data from a phase Ib clinical dose-ranging study with its oral H1N1 seasonal influenza vaccine candidate. This study follows a phase I study, the positive results of which were announced in June 2013.
In this latest study, the Vaxart oral H1N1 influenza vaccine induced anti-hemagglutinin antibody responses in 88 percent of subjects. Four-fold increases in neutralizing antibodies as determined by hemagglutination inhibition assay (HAI) and microneutralization (MN) assay were detected in 45 and 55 percent of subjects, respectively.
“These results demonstrate that the Vaxart oral vaccine can protect against flu and represent a significant milestone on our way to the world’s first oral seasonal flu vaccine,” said Vaxart CEO Wouter Latour, MD. “We are accelerating the program and look forward to the day when the ‘flu shot’ can be administered conveniently as a simple tablet at the work place, the local pharmacy, or even at home after receiving Vaxart’s room temperature stable tablet vaccine by mail.”
In its next step toward developing a complete oral quadrivalent seasonal influenza vaccine, Vaxart plans to conduct further clinical studies in 2014 with its tablet vaccines for H1N1 influenza A, H3N2 influenza A and influenza B.
“The success of public vaccination programs depends to a large extent on logistics, and each year the annual flu vaccination campaign puts the system to the test,” said Vaxart chief medical officer David Liebowitz, MD, PhD. “Currently, about 45 percent of more than 300 million eligible Americans are vaccinated against flu each year, according to recent figures from the CDC. A tablet vaccine would remove multiple bottlenecks in distribution and dramatically improve access and acceptance.”
Vaxart’s H1N1 influenza vaccine candidate has demonstrated an excellent safety profile in all studies to date, with no vaccine-related significant adverse events. Adverse events that did occur were all mild.
Vaxart produces its influenza vaccine tablets utilizing industry-standard cell-culture and solid-dose manufacturing processes, which enable manufacturing and distribution of the annually updated vaccine to the public considerably faster than egg-based influenza vaccine manufacturing technologies.
About Vaxart
Vaxart is a privately owned company developing oral recombinant vaccines based on its proprietary delivery platform. The Vaxart platform is suitable to deliver any protein vaccine antigen such as those used in currently marketed influenza, hepatitis B and human papilloma virus (HPV) blockbuster vaccines. Care Capital of Princeton is the lead investor in the company and its largest shareholder. For more information, please visit www.vaxart.com.
SOURCE: Vaxart
Post Views: 145
