ProSavin
 

There appears to be an interesting trial just starting at Henri Mondor Hospital in Creteil France involving ProSavin gene therapy. The first patient is being injected about now and efficacy should be demonstrated within a few weeks although results are not due until June. if the results are as positive as preclinical then we should hear news before then.

From Oxford Biomedica website
CLINICAL STATUS
ProSavin is currently being evaluated in a Phase I/II trial in France. Long-term efficacy data in the industry-standard preclinical model of Parkinson's disease have shown that ProSavin induces almost complete recovery from movement disorders and restores other behavioural and metabolic measurements to near normal levels.

thanks
 

Let's hope everything about this treatment moves as quickly as it did with animals!

paula

oxfordmedica -pdf prosavin -
 

PRODUCT DESCRIPTION
ProSavin® is Oxford BioMedica's gene-based therapy for Parkinson's disease that has the potential to revolutionise the treatment of this chronic neurodegenerative disorder. Using the Company's proprietary LentiVector® gene delivery technology, ProSavin delivers genes for three enzymes required for dopamine synthesis directly into the brain. Target cells are converted into a dopamine factory restoring levels of the key neurotransmitter that is depleted in patients with Parkinson's disease.

INDICATION
Parkinson’s disease.

MARKET
Parkinson's disease affects 1% of the population over 50 and about 10% of the over 60s. The estimated worldwide market is US$3 billion. None of the current treatments provide patients with long-term relief from symptoms.

TECHNICAL DESIGN
ProSavin consists of a LentiVector carrying three genes encoding three enzymes needed for dopamine synthesis (tyrosine hydroxylase, GTP-cyclohydrolase 1 and aromatic amino acid dopa decarboxylase).

CLINICAL STATUS
ProSavin is currently being evaluated in a Phase I/II trial in France. Long-term efficacy data in the industry-standard preclinical model of Parkinson's disease have shown that ProSavin induces almost complete recovery from movement disorders and restores other behavioural and metabolic measurements to near normal levels.

In this preclinical model, the therapeutic effect of ProSavin following a single administration has been maintained for over 27 months with no diminishment. Preclinical studies demonstrated that ProSavin is safe and well tolerated, with no evidence of side-effects, even at doses that are hundreds of times higher than those to be evaluated in humans.

Ongoing Phase I/II Trial
Moderate to late-stage Parkinson's disease.
Eighteen patients failing on current treatment with L-DOPA, who have not progressed to drug-induced movement disorders.
Two-stage trial, firstly to evaluate two dose levels of ProSavin and secondly to confirm efficacy of the optimal dose.
Primary objectives of trial are to assess safety and efficacy of ProSavin.
Patient recruitment is ongoing.
DEVELOPMENT AND COMMERCIALISATION STRATEGY
Commercial partners sought to co-develop and market the product in certain territories.

Website by College Hill - Life Sciences
http://www.oxfordbiomedica.co.uk/pdf...heet_Jan08.pdf