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John R. LaMontagne Memorial Symposium on Pandemic Influenza Research April 4-5, 2005 Institute of Medicine. Working Group Four: Antivirals and Non-Specific Approaches, Treatments and Immunotherapies Research Recommendations. Research Priorities: Short-term (1-2 Years).

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John R. LaMontagne Memorial Symposiumon Pandemic Influenza ResearchApril 4-5, 2005Institute of Medicine

Working Group Four: Antivirals and Non-Specific Approaches, Treatments and Immunotherapies

Research Recommendations

research priorities short term 1 2 years
Research Priorities: Short-term (1-2 Years)
  • Clinical trial development for antivirals and immunotherpaeutics
    • Develop pandemic protocols now
    • Obtain data on virologic course, host immune responses, and response to therapy following human H5 infections and other potential pandemic infections
  • Safety and tolerability of available drugs:
    • Oseltamivir PK + tolerance in infants <1 yr
    • Determine PK and tolerability of IV/IM peramivir (parenteral drug)
    • Assess long-term (12-20 weeks) tolerability of oseltamivir and inhaled zanamivir prophylaxis
    • High risk patient populations: pregnant women, IC Hosts
research priorities short term 1 2 years1
Research Priorities: Short-term (1-2 Years)
  • Study H5N1 resistance emergence in animal models and strategies for prevention
  • Assess probability of licensure for orally inhaled zanamivir for disease prophylaxis (because of oseltamivir resistance and two well controlled published studies)
research priorities short term years 1 2
Research Priorities: Short Term (Years 1-2)
  • Accelerate drug development and discovery programs, including assessment of orphan drugs
  • Support ‘Operational Infrastructure Research’:
    • Clinical trials of drugs administered > 48 hours
    • Site of care
    • Drug deployment and response times
    • Research on physician use of antiviral agents
  • Test systematic approaches to influencing inflammatory cytokine expression in disease
research priorities mid term 2 5 years
Research Priorities: Mid-term (2-5 Years)
  • Accelerated clinical trials of antivirals:
    • Test oseltamivir monotherapy vs combination with M2 or ribavirin or other novel therapies in high-risk population
    • Test therapeutic efficacy of parenteral peramivir in hospitalized influenza patients
    • Test prophylactic efficacy and tolerability of topical LANI
  • Develop contemporary virus challenge pools for studies of experimental human influenza
    • Test candidate immunomodulators and antivirals
  • Development of immune based therapies (mab’s, polyclonal antibodies, etc.) for therapy and prophylaxis
inhibitors of influenza a and b virus neuraminidases
Inhibitors of Influenza A and B Virus Neuraminidases
  • Potent and specific inhibitors of influenza NAs in nM range
  • Varied potencies for NAs of different types (A and B) and subtypes
  • Zanamivir (RelenzaTM) and oseltamivir (TamifluTM) are commercially available
  • Peramivir (BCX-1812, RWJ - 270201) and A-315675 are investigational.
investigational anti influenza agents
Investigational Anti-Influenza Agents
  • Neuraminidase (NA) inhibitors

- Peramivir (oral/IV), A-315675 (oral)

  • Long-acting NA inhibitors (LANI)
    • R-118958 (topical), Flunet (topical)
  • Conjugated sialidase
    • Fludase™ (topical)
  • HA inhibitors- cyanovirin-N
  • Polymerase inhibitors
    • siRNA; ribavirin (aerosol/IV/PO)
  • Protease inhibitors
    • Aprotinin
research priorities longer term 5 10 years
Research Priorities: Longer-term (5-10 Years)
  • Support ongoing small molecule discovery programs
    • siRNA as a systemic or topical antiviral
    • New antiviral targets and agents (e.g., polymerase)
    • Address incentives for industrial partners
  • Support innate immune effector molecule development:
    • Surfactants
    • Mannose-binding lectins
    • Defensins
  • Support innate immune activation molecules
    • TLR-3, 4, 7, 8. 9 agonists
    • NOD receptors
  • Promote the development of modulators of inflammatory cascades
what should be done now
What Should Be Done NOW?
  • Clinical trial infrastructure for therapeutics
    • Conduct studies in SE Asia now
    • Protocol development, data capture
  • Research on transmission and treatment factors to develop public health policy
  • Operational research to define the optimal infrastructure for distribution of drug, etc.
  • Stockpile oseltamivir or other efficacious agents
  • Develop antiviral agents as quickly as possible