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Feasibility study for registration of medicine RIGVIR with the European Medicine Agency

Objective

Cancer is one of the most dangerous life-threatening disorders for humanity of which melanoma is considered to be one of
the most dangerous and aggressive. There are a number of therapies available to treat melanoma. However, these
treatments are generally marginally effective and very expensive.

Latima SIA develops and produces Rigvir® for virotherapy. Rigvir® is a unique anti-cancer medicine using non-pathogenic
virus. It has been demonstrated to be very effective in treating various cancers, and has a promising medical future .
RIGVIR is commercialised in Latvia, Georgia and Armenia. Rigvir® was approved and registered in Latvia in 2004 and has since been a front-line treatment for melanoma in Latvia. However,further use and commercialisation in the EU is prevented as EU regulations require cancer medicines to be registered centrally through the European Medicine Agency (EMA). National registrations are not considered. Therefore, the process for European Union registration must be started de novo.
Registration of a medicinal product requires significant costs and resources. The purpose of this H2020-SMEInst-2016-2017
application is to secure the financial support for an initial feasibility study that would provide the basis for subsequent clinical
trials necessary for the registration of Rigvir® with the EMA.

It is expected that after feasibility study we would continue with next phase of H2020-SMEInst-2016-2017 and perform the
clinical trials necessary for registration in EMA.

Call for proposal

H2020-SMEInst-2016-2017

See other projects for this call

Sub call

H2020-SMEINST-1-2016-2017

Coordinator

SABIEDRIBA AR IEROBEZOTU ATBILDIBU LATIMA
Net EU contribution
€ 50 000,00
Address
TEATRA IELA 9 - 7
LV-1050 RIGA
Latvia

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Latvija Latvija Rīga
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 71 429,00