TIDMHVO
hVIVO plc
31 October 2018
HVIVO PLC
("hVIVO" or the "Company")
NIH present partial preliminary results from the Phase I
first-in-man study of AGS-v, a Universal mosquito-borne diseases
vaccine candidate
- National Institutes of Health (NIH) presented partial
preliminary results for some of the primary endpoint evaluations at
the American Society of Tropical Medicine and Hygiene's
sixty-seventh annual conference, New Orleans, US
- Based upon currently available data the Phase I study met
Primary Objectives and Endpoints with regard to safety and humoral
response
- The remaining primary and secondary endpoints will be
evaluated once the full and final data are available
- Given favourable safety profile and results so far, the vaccine warrants further development
London, UK, 31 October 2018: hVIVO plc (AIM: HVO), an industry
leading clinical development services business pioneering human
disease models based upon viral and allergen challenge, confirms
that the National Institutes of Health (NIH), has presented partial
preliminary results from the recently completed Phase I study of
AGS-v at the American Society of Tropical Medicine and Hygiene's
(ASTMH) sixty-seventh annual conference, New Orleans, US.
The presentation at the conference focused on safety and certain
immunogenicity results of AGS-v, a mosquito saliva peptide vaccine
in the randomized, double-blind, placebo-controlled Phase I
trial.
Certain primary objectives and endpoints met.
- AGS-v did not cause any clinically significant adverse events
- Observed increase in vaccine -specific IgG antibodies with
adjuvant present which was long lasting
Additional assays of the immunogenicity response and in vitro
virus killing are ongoing and will be reported in due course. These
will enable determination of the remaining primary endpoint
analysis related to immunogenicity, along with the secondary
endpoints.
Given the safety profile of the vaccine observed in this study
further development of the vaccine will continue.
AGS-v is being developed by Imutex Limited, hVIVO's 49% joint
venture with the SEEK Group and the AGS-v Phase I study is being
conducted by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the NIH.
Trevor Phillips, Executive Chairman of hVIVO, said: "The
presentation of these partial preliminary results by NIH at the
ASTMH conference is encouraging regarding safety and immunogenicity
responses. We look forward to seeing the full data when the NIH
completes the sample analyses in due course, at which point, a full
assessment of the trial results will be possible".
For further information please contact:
hVIVO plc
Trevor Phillips (Executive Chairman) +44 207 756 1300
Graham Yeatman, (Chief Financial Officer & Business Officer)
Fleur Wood (EVP, Investor Relations & Communications)
Numis Securities Limited +44 207 260 1000
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black / Michael Burke (Corporate Broking)
FTI Consulting
Simon Conway / Victoria Foster Mitchell +44 203 727 1000
Further details on AGS-v randomized, double blind,
placebo-controlled Phase I trial:
Parasites and viruses carried within mosquito saliva appear to
initiate or enhance severity of host infection by taking advantage
of saliva-human host interactions. This leads to alteration of the
cutaneous environment and modulation of the host's innate and
adaptive immune responses, thereby providing a rationale for
creating vaccines against mosquito salivary proteins rather than
the pathogens contained within the saliva, or a combination of
both.
AGS-v is a vaccine composed of four salivary peptides isolated
from Anopheles gambiae salivary glands, but that are common across
a number of mosquitoes. This first-in-human study enrolled and
randomized 49 healthy adult participants to receive the AGS-v
vaccine with and without adjuvant (Montanide ISA 51) versus
placebo. Vaccinations occurred at Day 0 and Day 21 followed by an
uninfected Aedes aegypti mosquito feeding at Day 42. Primary
objectives were: 1) to assess safety via incidence of adverse
events and 2) to evaluate humoral and cellular immunity by
respectively measuring total AGS-v specific immunoglobulins and
Th1-associated cytokine release after incubation of peripheral
blood mononuclear cells with AGS-v antigens. Secondary objectives
are post-mosquito feeding measures of AGS-v specific
immunoglobulins and Th1-related cytokine release, mosquito survival
and fecundity, as well as the effects of immunized individuals'
peripheral blood mononuclear cells on Zika virus after stimulation
with Aedes aegypti saliva.
About hVIVO:
hVIVO plc ("hVIVO") is pioneering a human-based clinical trial
platform to accelerate drug and vaccine development in respiratory
and infectious diseases. Leveraging human disease models in flu,
RSV, HRV and respiratory indications, the hVIVO platform captures
disease in motion, illuminating the entire disease life cycle from
healthy to sick and back to health. Based in the UK, market leader
hVIVO has conducted more than 50 clinical studies and inoculated
over 2500 volunteers.
About SEEK Group (PepTCell Limited, trading as SEEK Group)
SEEK's strategy is to bring safe, effective and low-cost
medicines to patients as quickly as possible, to radically improve
human health in major disease areas.
We do this by:
-- Modifying existing medicines to improve their efficacy
-- Using existing medicines in new indications
-- Creating new chemical entities
Working in these different ways allows us to optimise the
regulatory approval pathway to ensure that we bring safe and
effective products to patients in the shortest possible time.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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