Download Executive Summary - FC1122 Malachite Green Alternative

Executive Summary - FC1122 Malachite Green Alternative
Scientific Progress

Demonstrated the target animal safety of salmonid eggs to Pyceze
treatment in a GLP tolerance stydy.

Test model for Saprolegnia developed for artificial infection of salmonid
eggs in incubators.

Performed a dose titration study in salmonid eggs to establish the
proposed dose.

Complete dose confirmation study in Rainbow trout to illustrate the
efficacy of the proposed dose. Performed a GLP tolerance trial in
salmon and trout which demonstrated that Pyceze is well tolerated by
the target species.

Conducted a pilot radio labelled study at the contract laboratory to
identify the marker residue in fish tissue.

Performed in vitro minimum inhibitory concentration (MIC) study of
Pyceze to Saprolegnia parasitica.

Completed two ecotoxicological studies to determine the effects of
Pyceze and bronopol on the growth of Scenedesmus subspicatus.

Established the proposed treatment recommendations following
homogeneity testing of Pyceze in water.

Developed a tissue residue method suitable for residue monitoring in
the EU.
Industrial Progress

Close liaison with industrial partner to enable manufacturing process
and controls to be developed for manufacturing of Pyceze in-house.

Three pilot batches manufactured for stability studies.

Six months product stability data has been generated.

Submitted an application for an Animal Test Certificate (ATC) to
conduct field efficacy studies with Pyceze in fish in the UK>

Submitted an application for an Investigational New Animal Drug
(INAD) to conduct field efficacy studies with Pyceze in eggs in the
USA.

Response s to Environment Agency and SEPA questions regarding
environmental impact of Pyceze and been prepared.

Respond to efficacy and tolerance points raised by the Veterinary
Assessor at the VMD.
Pyceze may be a suitable product for other indications such as Rainbow Trout
Fry Syndrome (RTFS), Bacterial Gill Disease and other bacterial infections.
Simple look-see studies have been or are being performed in Canada on
ornamental fish. These are external but complimentary to the project. A
potential screening trial against Amoebic Gill Disease has been set up in Eire.
This project also links with FC1123 ‘Malachite Green Alternative - CEFAS
Component’ and FC1124 ‘Improving the efficacy of medicines in aquaculture’.