Oxford Biomedica plummets on test results
Shares in Oxford Biomedica slumped to a 52-week low after a disappointing set of test results for ProSavin, its treatment for Parkinson's disease.
Shares in Oxford Biomedica slumped to a 52-week low after a disappointing set of test results for ProSavin, its treatment for Parkinson's disease.
In clinical trials it appears that while higher doses of the drug initially improved symptoms for patients, after six months the benefits of higher dosages ceased to be statistically significant in comparison with normal dosages.
The trials took place on four cohorts of people receiving the drug at 1x (one times), 2x and 5x dosage.
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On the bright side, the drug continues to demonstrate a long-term safety profile.
Professor Oiliver Rascol, Chair of the independent Data Monitoring Council said the council would "support investigation of a further dose escalation for this novel product as part of a Phase II development programme."
"The signals of improvements in motor function with decreased oral dopaminergic therapy observed to date are encouraging, particularly at the 5x dose. The functional imaging data also suggest possible dopamine provision attributable to ProSavin at this dose," the professor revealed.
John Dawson, Oxford Biomedica's Chief Executive said: "We believe that (the) data set supports exploration of a higher dose as part of a Phase II programme to ensure the greatest chance of success in randomised studies."
House broker Singer Capital Markets was doing its bit to cast the results in a positive light.
"Whilst this morning's news may be greeted with disappointment, given six month data for three patients administered the 5x dose of ProSavin failed to demonstrate a dose-related response, data was nevertheless positive, with these patients showing the strongest set of combined data to date," note Singer analysts Shawn Manning and Elizabeth Klein, in a research note on the company.
"Sadly, at six months, the higher (5x) ProSavin dose failed to demonstrate a higher mean improvement (measured by UPDRS; Unified Parkinson's Disease Rating Scale) ... versus lower doses. A mean UPDRS improvement of 24% (versus 34% and 43% for a 2x dose using the standard and improved methods of administration respectively) was observed, with a maximum improvement of 31% in one patient (versus 53% and 61% for a 2x dose using the standard and improved methods of administration respectively)," the broker note said.
Singer observed that the sample size was small, and is now awaiting six month data for the combined pool of six patients, "although in trials with small patient cohorts the higher 5x dose does not seem to confer an advantage," the broker conceded.
The broker has revised its sum of the parts valuation of the company down to 12p a share from 13p a share previously, and now expects that the launch date of ProSavin will be in 2019, versus previous expectations of a 2017 launch.
"Clearly it is now increasingly important that partner Sanofi agrees to progress RetinoStat (AMD) following Phase-I results by mid-2012. Otherwise, the elongation of development pathways aside, we believe Oxford BioMedica remains a compelling opportunity, with a relatively low-risk pipeline," the company's house broker concluded.
At 10:10am shares in the company had fallen 24% to 3.61p
BS
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