FDA Publishes Preliminary Finding of No Significant Impact on Oxitec's Self-limiting Mosquito

Oxford, England (ots/PRNewswire) -

The US Food and Drug Administration's Center for Veterinary
Medicine (FDA-CVM) today released in the Federal Register a
preliminary finding of no significant impact (FONSI) on Oxitec's
self-limiting OX513A Aedes aegypti mosquito for an investigational
trial in the Florida Keys. The finding agrees with the draft
environmental assessment (EA) submitted by Oxitec, Ltd., that
concludes a field trial of the Company's genetically engineered (GE)
OX513A mosquitoes in Key Haven, Florida, will not result in a
significant impact on the environment. This follows an FDA-led
evaluation of potential impacts on health and the environment of the
proposed trial.

(Logo: http://photos.prnewswire.com/prnh/20150630/227348 )

Oxitec's Chief Executive Officer Hadyn Parry said, "We are pleased
that the FDA-led team has released this preliminary FONSI. The Aedes
aegypti mosquito represents a significant threat to human health, and
in many countries has been spreading Zika, dengue and chikungunya
viruses. This mosquito is non-native to the US and difficult to
control, with the best available methods only able to reduce the
population by up to 50%, which is simply not enough. We look forward
to this proposed trial and the potential to protect people from Aedes
aegypti and the diseases it spreads."

The purpose of the proposed trial is to determine the efficacy of
Oxitec's self-limiting mosquitoes for the control of the local
population of Aedes aegypti in Key Haven, Monroe County, Florida.

Oxitec's self-limiting mosquitoes have been genetically engineered
so that their offspring die before reaching adulthood. Male Oxitec
mosquitoes, which do not bite or spread disease, are released to mate
with wild female Aedes aegypti so that their offspring die, reducing
the population. Efficacy trials in Brazil, Panama, and the Cayman
Islands have tested this approach, and in these trials the population
of Aedes aegypti was reduced by more than 90% - an exceptional level
of control compared to conventional methods, such as insecticides.

The FDA review team consisted of experts from the Center for
Veterinary Medicine (CVM), the Centers for Disease Control and
Prevention (CDC), and the Environmental Protection Agency (EPA). The
FDA led an extensive review of evidence from trials in urban
environments performed in Brazil, Panama and the Cayman Islands since
2009, and data from numerous safety studies, site inspections and
independent experts.

ots Originaltext: Oxitec Ltd
Im Internet recherchierbar: http://www.presseportal.de

Contact:

Oxitec Florida Keys Project FAQ:
http://www.oxitec.com/health/florida-keys-project/
Florida Keys Mosquito Control District:
http://keysmosquito.org/latest-gm-information/
About Oxitec
Oxitec is a pioneer in using genetic engineering to control insect
pests that spread disease and damage crops, and was founded in 2002 as
a spinout from Oxford University (UK). Oxitec is a subsidiary of
Intrexon Corporation (NYSE: XON), which engineers biology to help
solve some of the world's biggest problems.
Oxitec Contact:
Matthew Warren
Press Officer
Tel: +44-(0)7972-103372
info@oxitec.com