Guildford, UK, 16 June 2011: ReNeuron Group plc (LSE: RENE.L) (“ReNeuron” or the “Company”) announces that it has signed a patent and know-how license agreement with Schepens Eye Research Institute (“Schepens”), Boston, US, regarding the Company’s ReN003 stem cell therapy programme focused on diseases of the retina.
An affiliate of Harvard Medical School, Schepens recently announced that it is to join forces with the Massachusetts Eye and Ear Infirmary in Boston to create the world’s largest pre-clinical and clinical ophthalmology research centre. ReNeuron has been collaborating with Schepens in the early development of its human retinal precursor cells (hRPCs). Based on the successful results of this initial collaboration, the Company has, through this license agreement, secured the relevant intellectual property rights to develop and commercialise its hRPCs in the field of human retinal stem cell therapeutics. ReNeuron will continue to collaborate closely with lead Investigator Dr Michael Young and his team at Schepens to take the Company’s ReN003 programme through late pre-clinical development and into an initial clinical trial in the US in patients suffering from retinitis pigmentosa, a blindness-causing disease caused by degeneration of the photoreceptor cells in the retina.
Researchers at Schepens have already published data describing the ability of the hRPCs to integrate with host retinal tissue in rodent models of damaged retina and differentiate into the light-sensitive rod cells found in healthy retina. Subsequently, a novel and highly efficient proprietary cell expansion process has recently been optimised which does not involve genetic modification or other similar manipulation of the hRPCs. This expansion technology is currently being employed by ReNeuron to grow and bank clinical-grade hRPCs to the quantities required for future clinical studies.
Under the agreement, ReNeuron will take responsibility for the funding of the ReN003 programme and will pay Schepens license maintenance fees, together with milestone and royalty payments based on clinical and commercial success with the therapies developed. The initial phase of ReNeuron’s collaboration with Schepens has benefited from an industrial grant from a major US specialty healthcare company and ReNeuron intends to build upon this programme-specific funding as further late pre-clinical data emerges over the coming months.
Subject to regulatory advice and the results of IND-enabling late pre-clinical studies, the ReN003 programme is expected to enter its clinical phase in approximately 18 months. Importantly, although retinitis pigmentosa is the initial target disease, the hRPCs developed in the programme will almost certainly be applicable as cell therapy candidates for other blindness-causing diseases, such as age-related macular degeneration and diabetic retinopathy.
Dr Michael Young, Associate Scientist at Schepens, Associate Professor of Ophthalmology at Harvard Medical School, and lead Investigator on ReNeuron’s collaboration with Schepens, said:
“It is a tremendously exciting time to be working in the field of ocular regeneration. We are therefore delighted to be continuing our collaboration with ReNeuron under this new agreement, bringing us closer to the day when blindness can be treated with stem cells.”
Michael Hunt, Chief Executive Officer of ReNeuron, said:
“We are delighted to be building on our existing collaboration by signing this agreement with Schepens Eye Research Institute, a world leader in the research of regenerative and cell-based treatments for ocular diseases. This license agreement establishes and formalises the path to clinical translation of our highly novel ReN003 programme for diseases of the retina, a disease area acknowledged in the field as one of the most promising for a cell-based therapeutic approach.”
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About retinitis pigmentosa
Retinitis pigmentosa (RP) is the name given to a group of inherited diseases of the retina that all lead to a gradual and progressive reduction in vision. This decline in vision is caused by the death of photoreceptor cells (rods and cones) found in the retina.
Night blindness and difficulties with peripheral vision are the earliest and most frequent symptoms of RP, with reading and colour vision affected later. The age at which symptoms start is variable and the rate of deterioration of vision also varies from person to person.
RP is typically diagnosed in adolescents and young adults and most sufferers will be legally blind by the age of 40. The disease affects approximately 1 in 3000 to 4000 people.
Source: British Retinitis Pigmentosa Society; Foundation Fighting Blindness
About Schepens Eye Research Institute
Schepens Eye Research Institute fights blindness by developing new technologies, therapies and knowledge to preserve and restore vision. Through a continuum of discovery, the Institute works toward a future in which blindness is prevented, alleviated, and, ultimately, cured.
Founded in 1950 by famed retinal surgeon Charles L. Schepens, M.D., Schepens Eye Research Institute is the largest independent eye research institute in the United States and an affiliate of Harvard Medical School. Since its inception, the Institute has trained more than 600 postdoctoral fellows in various disciplines of eye research; trained more than 500 eye surgeons who now practice around the world; and published more than 4,600 scientific papers and books about health and eye disease.
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 the rapy is currently in clinical development. 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 USA-based Millipore Corporation.
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.