Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2014/04/flu-scan-apr-30-2014
Flu Scan for Apr 30, 2014
Stop-work order for flu antiviral; H7N9 vaccine phase 1 results
Filed Under:
Influenza, General; H7N9 Avian Influenza
HHS stops research on long-acting antiviral laninamivir
The Department of Health and Human (HHS) has ordered Biota Pharmaceuticals to stop research on the experimental flu antiviral drug laninamivir, the Atlanta Journal-Constitution reported yesterday.
Biota President and Chief Executive Officer Russell Plumb said the company, of Alpharetta, Ga., was surprised at the stop-work order and did not know what led to the decision. HHS issued the order after a review of the company's work on the drug.
The drug is a neuraminidase inhibitor, the same class that includes oseltamivir (Tamiflu) and zanamivir (Relenza), the two most popular antivirals for influenza.
Biota is under contract with HHS's Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority to develop laninamivir, a long-acting drug for preventing influenza A and B.
Before the stop-work order, the company had been conducting a large phase 2 trial that involved adults with influenza. Biota's contract with HHS is designed to provide up to $231 million to complete the drug?s clinical development, the story said.
Apr 29 Atlanta Journal-Constitution story
Adjuvanted H7N9 vaccine shown fairly immunogenic in adults
Novartis researchers today said their company's adjuvanted cell-culture H7N9 influenza vaccine showed a good safety profile and yielded a moderate immune response in a phase 1 trial, according to their report in Science Translational Medicine.
The investigators divided 402 volunteers into one of four groups of increasing dosage, with all enrollees receiving two vaccine doses 3 weeks apart: (1) 3.75 micrograms (mcg) of antigen, plus 0.125 milliliters (mL) of the MF59 immune-boosting adjuvant; (2) 7.5 mcg antigen plus 0.25 mL MF59; (3) 15 mcg antigen plus 0.25 mL adjuvant; and (4) 15 mcg antigen with no adjuvant.
Seroprotection, as measured by a hemagglutination inhibition (HI) titer of 1:40 or greater, was 26%, 44%, 52%, and 3% for the four groups, respectively, 43 days after the first dose. When measured by microneutralization, seroprotection rates were 55%, 73%, 78%, and 7%, respectively.
The authors add, "Despite increased injection site pain and other mild effects with MF59, all formulations were well tolerated. These encouraging immunogenicity and safety data on the A/H7N9 vaccine provide a strong rationale for further clinical development."
Novavax reported phase 1 results of its virus-like particle H7N9 vaccine with and without adjuvant in a letter in the New England Journal of Medicine on Dec 26, 2013. And the National Institutes of Health (NIH) announced in September 2013 that phase 1/2 trials of a Sanofi Pasteur H7N9 vaccine with and without adjuvant should be completed this December.
Apr 30 Sci Transl Med abstract
Dec 26, 2013 N Engl J Med letter
Sep 18, 2013, CIDRAP News story on NIH-funded trials
Flu Scan for Apr 30, 2014
Stop-work order for flu antiviral; H7N9 vaccine phase 1 results
Filed Under:
Influenza, General; H7N9 Avian Influenza
HHS stops research on long-acting antiviral laninamivir
The Department of Health and Human (HHS) has ordered Biota Pharmaceuticals to stop research on the experimental flu antiviral drug laninamivir, the Atlanta Journal-Constitution reported yesterday.
Biota President and Chief Executive Officer Russell Plumb said the company, of Alpharetta, Ga., was surprised at the stop-work order and did not know what led to the decision. HHS issued the order after a review of the company's work on the drug.
The drug is a neuraminidase inhibitor, the same class that includes oseltamivir (Tamiflu) and zanamivir (Relenza), the two most popular antivirals for influenza.
Biota is under contract with HHS's Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority to develop laninamivir, a long-acting drug for preventing influenza A and B.
Before the stop-work order, the company had been conducting a large phase 2 trial that involved adults with influenza. Biota's contract with HHS is designed to provide up to $231 million to complete the drug?s clinical development, the story said.
Apr 29 Atlanta Journal-Constitution story
Adjuvanted H7N9 vaccine shown fairly immunogenic in adults
Novartis researchers today said their company's adjuvanted cell-culture H7N9 influenza vaccine showed a good safety profile and yielded a moderate immune response in a phase 1 trial, according to their report in Science Translational Medicine.
The investigators divided 402 volunteers into one of four groups of increasing dosage, with all enrollees receiving two vaccine doses 3 weeks apart: (1) 3.75 micrograms (mcg) of antigen, plus 0.125 milliliters (mL) of the MF59 immune-boosting adjuvant; (2) 7.5 mcg antigen plus 0.25 mL MF59; (3) 15 mcg antigen plus 0.25 mL adjuvant; and (4) 15 mcg antigen with no adjuvant.
Seroprotection, as measured by a hemagglutination inhibition (HI) titer of 1:40 or greater, was 26%, 44%, 52%, and 3% for the four groups, respectively, 43 days after the first dose. When measured by microneutralization, seroprotection rates were 55%, 73%, 78%, and 7%, respectively.
The authors add, "Despite increased injection site pain and other mild effects with MF59, all formulations were well tolerated. These encouraging immunogenicity and safety data on the A/H7N9 vaccine provide a strong rationale for further clinical development."
Novavax reported phase 1 results of its virus-like particle H7N9 vaccine with and without adjuvant in a letter in the New England Journal of Medicine on Dec 26, 2013. And the National Institutes of Health (NIH) announced in September 2013 that phase 1/2 trials of a Sanofi Pasteur H7N9 vaccine with and without adjuvant should be completed this December.
Apr 30 Sci Transl Med abstract
Dec 26, 2013 N Engl J Med letter
Sep 18, 2013, CIDRAP News story on NIH-funded trials