Guildford, UK, 16 May 2012: ReNeuron announces that it has signed a new cell manufacturing contract with Angel Biotechnology Holdings plc (AIM:ABH), a biopharmaceutical contract manufacturer, to perform GMP drug product manufacturing services to serve the remaining part of the PISCES Phase I clinical trial of ReNeuron’s ReN001 stem cell therapy for stroke.
The final patient in the second dose cohort of the PISCES study was treated last month, as scheduled. The Glasgow clinical site has also identified potentially eligible patients for all of the remaining two dose cohorts in the study. Two further UK clinical sites are in the process of being approved to recruit patients into the PISCES study should this be necessary to meet recruitment targets. It is envisaged that these further clinical sites will also participate as centres in a Phase II clinical trial with ReN001 in due course.
As recently reported, the Company therefore expects that, subject to a continuing lack of cell-related adverse events and affirmative Data Safety Monitoring Board advice, the remaining dose cohorts in the PISCES study will have been treated within the next twelve months, leaving the Company on track to submit an application for a Phase II clinical study with ReN001 during the course of next year.
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are pleased to continue our manufacturing partnership with Angel to serve the needs of the ongoing PISCES stroke clinical trial, and we look forward to seeing the higher dose cohorts in the study treated with our ReN001 stem cell therapy over the coming months.”
- ReNeuron +44 (0) 1483 302560
Michael Hunt, Chief Executive Officer
Pat Huggins, Head of Finance
- Buchanan +44 (0) 20 7466 5000
Mark Court, Sophie Cowles
Cenkos Securities +44 (0) 20 7397 8900
Stephen Keys, Adrian Hargrave (NOMAD and Broker)
Andy Roberts (Sales)
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. This therapy is currently in clinical development. The Company is also developing stem cell therapies for other conditions such as peripheral arterial disease, a serious and common side-effect of diabetes, and 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 USA-based Merck Millipore.
ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. Further information on ReNeuron and its products can be found at www.reneuron.com.
This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as “should”, “expects”, “estimates”, “believes” or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron’s current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron’s actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.