RENE.L Regulatory News (RENE)

19 Mar 2008 07:00

ReNeuron Group plc19 March 2008 PRESS RELEASE Regulatory update Guildford, UK, 19 March 2008: ReNeuron Group plc (LSE: RENE.L) today provides afurther update on progress with its regulatory strategy for its ReN001 stem celltherapy for stroke. On 14 February, the Company met with the US Food and Drug Administration (FDA)to discuss and clarify the necessary steps to enable approval of the Company'sInvestigational New Drug (IND) application to commence initial clinical trialsin the US with ReN001. The formal minutes from that meeting have been received and reviewed by theCompany, detailing the further information and pre-clinical data to be providedto enable the IND to be approved. The Company will continue to liaise closelywith the FDA to ensure its approach to the provision of this further data isacceptable to them. The Company anticipates that several months will berequired to provide all of the data requested, depending on the final agreedstudy protocols. In the meantime, the Company is accelerating its pre-existing strategy to makeclinical trial applications for ReN001 in certain other territories beyond theUS with established and recognised regulatory frameworks. These applications arebeing made based on recent positive face-to-face meetings with the regulators inthese territories, and with the support of the clinicians and hospitalsconcerned. The Company will look to commence initial clinical studies in theseterritories ahead of the US, should approval be gained sooner in theseterritories. On this basis, the Company remains confident of gaining regulatoryapproval to commence an initial clinical study with ReN001 later this year. Michael Hunt, Chief Executive Officer of ReNeuron, said: "During our meeting with them, the FDA expressed their clear desire to work withus to enable initial clinical studies to commence in the US with ReN001. It isalso important to note that the wealth of pre-clinical data we have alreadygenerated shows ReN001 to be safe and efficacious, with no adverse safetyeffects arising. We continue to draw encouragement from these facts, and willcontinue to work with the FDA to provide the further data they have asked for. "That said, we now deem it prudent to accelerate the process of filing clinicaltrial applications for ReN001 in certain other territories where discussionswith the relevant regulators have given us high confidence that suchapplications will be treated favourably. Our principal near-term goal remains todrive the ReN001 programme into its clinical phase in a well-regulated territoryat the earliest opportunity. We are confident of achieving that goal over thecourse of this year." Enquiries: ReNeuronMichael Hunt, Chief Executive Officer Tel: +44 (0) 1483 302560Dr John Sinden, Chief Scientific Officer Financial DynamicsEuropeDavid Yates Tel: +44 (0) 20 7831 3113Lara MottUSRobert Stanislaro Tel : +1 212 850 5657 Collins StewartTim Mickley Tel: +44 (0) 20 7523 8000 About ReNeuron ReNeuron is a leading, UK-based stem cell therapy business. It is applying itsnovel stem cell platform technologies in the development of ground-breaking stemcell therapies to serve significant and unmet or poorly-met clinical needs. TheCompany operates from laboratories in Surrey, UK and Los Angeles, California,USA. ReNeuron has used its proprietary, patented cell expansion technology togenerate genetically stable neural stem cell lines. This technology platformhas multi-national patent protection and is fully regulated by means of achemically-induced safety switch. Cell growth can therefore be completelyarrested prior to in vivo implantation. ReNeuron has filed for approval to commence initial clinical studies in the USwith its lead ReN001 stem cell therapy for chronic stroke disability. There arean estimated 50 million stroke survivors worldwide, approximately one half ofwhich are left with permanent disabilities. The annual health and social costsof caring for these patients is estimated to be in excess of £5 billion in theUK and in excess of US$50 billion in the US. In addition to its stroke programme, ReNeuron is developing stem cell therapiesfor Parkinson's disease, Huntington's disease, Type 1 diabetes and diseases ofthe retina. The Company recently acquired the business assets of AmCyte Inc. inthe US, bringing clinically-tested cell encapsulation technology to ReNeuron'sReN002 diabetes programme. ReNeuron has leveraged its stem cell technologies into non-therapeutic areas -its ReNcell(R) range of cell lines for use in research and in drug discoveryapplications in the pharmaceutical industry. ReNeuron's ReNcell(R)CX andReNcell(R)VM neural cell lines are marketed worldwide under license by MilliporeCorporation. 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 atwww.reneuron.com. Data sources: UK Stroke Association; American Stroke Association. This announcement contains forward-looking statements with respect to thefinancial condition, results of operations and business achievements/performanceof ReNeuron and certain of the plans and objectives of management of ReNeuronwith respect thereto. These statements may generally, but not always, beidentified by the use of words such as "should", "expects", "estimates","believes" or similar expressions. This announcement also containsforward-looking statements attributed to certain third parties relating to theirestimates regarding the growth of markets and demand for products. By theirnature, forward-looking statements involve risk and uncertainty because theyreflect ReNeuron's current expectations and assumptions as to future events andcircumstances that may not prove accurate. A number of factors could causeReNeuron's actual financial condition, results of operations and businessachievements/performance to differ materially from the estimates made or impliedin such forward-looking statements and, accordingly, reliance should not beplaced on such statements This information is provided by RNS The company news service from the London Stock Exchange