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09-12-2007, 03:41 PM | #1 | ||
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Oxford Biomedica are moving ProSavin to trial in the next few months. The pre clinical results have been outstanding, the Chairman has refused to sell the product "at any price". Lets hope this one lives upto the hype and expectation.
Notes Oxford Biomedica Interim results (to June 2007) : "ProSavin is the Company’s lead gene therapy product based on its proprietary LentiVector® gene delivery technology. ProSavin has the potential to revolutionise the treatment of Parkinson’s disease. The product uses the LentiVector system to deliver the genes for three enzymes that are required for the synthesis of dopamine. It is administered locally to the region of the brain called the striatum, converting cells into a replacement dopamine factory within the brain, thus replacing the patient's own lost source of the neurotransmitter. In the first half of 2007, Oxford BioMedica completed non-clinical safety studies of ProSavin, required for a regulatory submission to start trials. In July 2007, the Company submitted a Clinical Trials Application (CTA) to the French Health Products Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé - AFSSAPS). The CTA includes a proposed Phase I/II trial to be conducted at the Henri Mondor Hospital in Paris, France, which is a centre of excellence for neurosurgery. The proposed trial will enrol up to 18 patients who are failing on the current standard therapy of L-DOPA but who are not experiencing disabling dyskinesias (movement disorders that occur following prolonged treatment with L-DOPA). There will be suitable intervals between the treatments of each patient in the early stage of the trial. This cautious approach is commensurate with a “first in man” trial and has been discussed with AFSSAPS. Oxford BioMedica hopes to begin the clinical trial at the end of 2007 or in early 2008. In an industry-standard preclinical model of Parkinson’s disease, ProSavin’s therapeutic effect from a single administration has been maintained for over 20 months. Efficacy was similar to that expected with standard daily treatment with L-DOPA but with no evidence of the disabling dyskinesias associated with L-DOPA treatment". Hope springs eternal, if I was a rat I would be cured by now ! Neil. |
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