Forsøksdyr: Therapy and toxicity of NNV therapy candidates in combination with other anti-cancer treatments

Godkjenningsdato 11.06.2018

Godkjenningsperiode 11.06.2018-11.06.2019

Nordic Nanovector is developing new radioimmunoconjugates for treatment of cancer. As part of the development programme the efficacy and toxicity of the radioimmunoconjugates and potential combinations with other anti-cancer treatments needs to be tested in mouse bearing human tumor xenografts.

As part of the development of a new therapy for use in humans, testing of biodistribution, toxicity and efficacy in mouse models bearing relevant human cancer cell xenografts is essential in order to verify the safety and efficacy of the drug product and justify clinical trials in patients. The overall aim is to do preclinical testing of potentially new therapeutics for hematological cancer which is not curable with current available treatments. The newly developed drug products and therapy combinations involving these products will potentially have greater effectiveness and fewer side effects than the products available today.

The aim of this application is to perform efficacy and toxicity experiments with Nordic Nanovector radioimmunotherapy candidates in combination with other anti-cancer treatments in immunocompromised mice bearing relevant human tumor xenografts. Such studies are necessary in order to verify efficacy of the combination treatment in mouse models, to be able to identify potential organs at risk, and also to terminate further development of candidate treatments showing lack of efficacy or an unfavorable toxicity profile.

For this project up to 168 immunocompromised mice bearing subcutaneous tumours from relevant human cancer cell lines will be used. The expected adverse effects of the animals will be mainly related to the tumour growth and slight toxicity from the treatment agents, which can manifest as reduced gain in body weight. Careful follow-up of the mice will be done so that humane end-points are respected. The number of animals has been reduced as much as possible by using results of in-vitro experiments, litterature search/experience of other groups, and use of Nordic Nanovector's more than 7 years of experience working with radioimmunotherapy in mouse models. During these years procedures and methods has been developed and refined, as to minimize the potential pain, stress or suffering of the animals and enhance animal welfare.