Investor got a sense of ‘deja vu’ this morning as Gene therapy company Oxford BioMedica (LSE: OXB) announced new data from it’s the ongoing Phase I/II trial of its gene therapy treatment of Parkinson's disease, Prosavin.
Yesterday saw Phytopharm (AIM: PYM) surge over 200% when it announced the successful completion of two key studies into the effect of its ‘Cogane™’ Parkinson’s treatment.
Oxford Biomedica rose more than 70% this morning to trade at 18.5p per share. Ultimately the positive results may lead to significant enhancements to the ProSavin product development.
Parkinson's disease (‘PD’) is a degenerative disorder of the central nervous system characterised by muscle rigidity, tremor and a slowing of physical movement, and in extreme cases, a loss of physical movement. The primary symptoms are the result of altered signalling in the area of the brain which is responsible for the control of movement.
Unlike Phytopharm’s ‘orally active’ Cogane™ treatment, Prosavin is a gene-based treatment for Parkinson's disease which is administered locally to the brain. ProSavin converts cells into a replacement ‘dopamine factory’ within the brain, to replace the patient's own lost source of the neurotransmitter.
In ProSavin’s phase I/ II trial, all patients treated at the second dose level have completed their six-month assessments and have shown further improvement in motor function. The results showed a maximum improvement of 53%, with the average being a 34% improvement relative to the patients' pre-treatment motor function.
Oxford Biomedica also announced the publication of pivotal preclinical studies of ProSavin. The findings were published in the 14 October issue of the interdisciplinary journal, Science Translational Medicine. The preclinical model used for these studies simulated severe Parkinson's disease by inducing selective degeneration of dopamine-producing neurons, which decreased dopamine to 27% of normal concentrations.
The results of the preclinical studies showed that ProSavin was safe and that it significantly increased dopamine production from 27% to 47% of normal concentrations. Overall disease severity was significantly reduced by ProSavin after six weeks. ProSavin provided sustained recovery of motor function and behaviour over the 12-month study. The recovery was maintained throughout a follow-up period that concluded after 44 months.
Movement and posture was significantly improved after two weeks, reaching 77% and 85% of respective normal levels. In a study of ProSavin versus an oral ‘L-DOPA therapy’, both treatments produced a similar correction of disease symptoms. However, the ProSavin group showed no dyskinetic side-effects.
Overall the preclinical data suggests that ProSavin may offer significant benefits in the clinical setting, treating the primary symptoms of Parkinson's disease as well as reducing the severe side-effects of long-term L-DOPA therapy. These conclusions are supported by initial data from human clinical trials.
Oxford BioMedica is seeking regulatory approval to escalate directly to a 5x dose level using a modified administration procedure that requires fewer needle tracks and thus reduces the surgery time. Enhancing the efficacy of ProSavin and reducing the surgery time could accelerate the overall development timelines and expand the market opportunity.
Oxford BioMedica's CEO, John Dawson’s comments emphasised the subsequent product enhancement that would be gained from increased dosage;
"The recent data from the Phase I/II study provide further evidence that ProSavin is effective at the current dose levels. With its excellent safety profile, we have the opportunity to escalate to a higher dose, which could be even more effective. This would enhance the product's value and could accelerate its development.”