It announced in June 2010 the trial had received local site approvals in Scotland, enabling the commencement of patient recruitment for the trial. The trial has attracted a high level of interest from disabled stroke patients from the local Glasgow community and beyond, it said today.
As a result, the clinical team, led by Professor Keith Muir, has been able to progress the selection of initial patients meeting the eligibility requirements for the trial.
“Given the complexities of the PISCES trial and the highly novel nature of the ReN001 therapy, we are greatly encouraged by this progress. Assuming a successful pre-treatment evaluation period once enrolled, we maintain our expectation of initial patient dosing in the PISCES trial towards the end of the year,” the group said.
It is continuing its dialogue with regulatory authorities in key territories, including the UK and the US, in respect of its ReN009 stem cell therapy for peripheral arterial disease. Late pre-clinical testing of this therapy is underway, ahead of commencement of clinical development scheduled for early 2012.
The ReN003 programme for retinal diseases, partnered with the Schepens Eye Research Institute at Harvard Medical School in the US, continues to progress well. Late pre-clinical development of this therapy is scheduled to commence in 2011, ahead of initial clinical testing planned for 2012, focused on patients suffering from the blindness-causing disease, retinitis pigmentosa.
It continues to be encouraged by the progress being made to optimise the manufacture and scale-up of its second-generation frozen cell product, CTXcryo. This new formulation of its lead CTX stem cell line has been developed to address the logistical issues typically associated with the distribution and wide-scale clinical use of whole cell-based therapies such as those ReNeuron is taking forward into clinical development.
The company's operating costs and cash position remain in line with forecast, with current cash resources - excluding undrawn funding available under its existing equity finance facility with Matrix Corporate Capital - projected to last well into the second quarter of 2011.
ReNeuron is a leading, clinical-stage stem cell business. Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop cell-based therapies for significant disease conditions where the cells can be readily administered "off-the-shelf" to any eligible patient without the need for additional immunosuppressive drug treatments.
ReNeuron's lead candidate is its ReN001 stem cell therapy for the treatment of patients left disabled by the effects of a stroke. A ground-breaking first-in-man clinical trial of ReN001 has recently commenced in the UK. ReNeuron's ReN009 stem cell therapy is being developed as a treatment for peripheral arterial disease, a serious and common side-effect of diabetes. The company is also developing stem cell therapies for other conditions such as blindness-causing diseases of the retina.
ReNeuron has also developed a range of stem cell lines for non-therapeutic applications - its ReNcell products for use in academic and commercial research. The Company's ReNcell CX and ReNcell VM neural cell lines are marketed worldwide under license by US-based Millipore Corp.
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