Oxford Biomedica anuncia atualização de dados da fase I/II de estudo do Prosavin para doença de Parkinson 

Oxford, UK – 22 December 2010: Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a leading gene therapy company, announces new data from the on-going Phase I/II trial of ProSavin® for the treatment of Parkinson’s disease (PD). Three-month data from the third patient cohort show that ProSavin® continues to be safe and well-tolerated following treatment with a 2x dose using an enhanced administration technique developed by the Company. The enhanced technique has been shown to reduce the surgical delivery time, will facilitate higher dosing and has the potential to provide better reproducibility of administration as study centres expand.


By way of background, the current Phase I/II study is designed to assess the safety, efficacy and dose evaluation of ProSavin® in patients with mid-stage PD who are experiencing reduced benefit on L-DOPA “equivalent” therapy. To date, nine patients have been treated in cohorts of three. In June 2010, Oxford BioMedica reported 24-month results from the first cohort which received a 1x dose of ProSavin®, in addition to 12-month results from the second cohort which received a 2x dose of ProSavin®. Motor function is assessed according to the Unified Parkinson’s Disease Rating Score (UPDRS) in patients’ “OFF” state (i.e. after withdrawal of PD medication). Quality of life is assessed based on a standard measure of clinical benefit using a patient questionnaire known as PDQ-39. Patients from the third cohort who received a 2x dose of ProSavin® using the Company’s enhanced administration technique have now reached their three-month assessment: (segue...)

ProSavin é uma droga experimental para ser usada no tratamento da doença de Parkinson. É administrada no estriado cerebral, induzindo a produção de dopamina.

É fabricado pela Oxford Biomedica, que pretende iniciar a Fase I Européia e os ensaios clínicos de Fase II em 2007. Ensaios em animais têm sido um sucesso, com os níveis de dopamina restaurados sem os efeitos colaterais associados com outros tratamentos atuais para Parkinson, em especial, sem os movimentos bruscos involuntários associados com os medicamentos atuais. (segue...) Fontes: Drugs.com e Wikipedia.