Presentation of Ocular Clinical Data at ARVO

RNS Number : 8105C

Oxford Biomedica PLC

08 May 2012

 

Oxford BioMedica Announces Presentation of Ocular Clinical Data at 2012 ARVO Annual Meeting

-- Early RetinoStat^® data indicate sustained, dose-related therapeutic protein expression in the eye --

Oxford, UK - 8 May 2012: Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that data from its ocular programmes partnered with Sanofi (EURONEXT: SAN and NYSE: SNY) were presented at the 2012 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida (USA).

Four posters were presented on Monday, 7 May 2012 which summarised the latest developments for the four ocular products partnered with Sanofi: RetinoStat^® for "wet" age-related macular degeneration (AMD), StarGen™ for Stargardt disease, UshStat^® for Usher syndrome type 1B and EncorStat^® for corneal graft rejection.  All four products were designed and developed by Oxford BioMedica using its proprietary LentiVector^® gene delivery technology.  Please see notes to editors for further information on these product candidates.

Highlights from the 2012 ARVO poster sessions

·      LentiVector^® platform technology

-      Favourable safety profile with over 25 patients treated with the Company's gene-based products¹

-      No serious adverse events related to any of the products or the methods of administration

·      RetinoStat^®

-      Samples from six patients treated to date in ongoing Phase I study confirms a substantial increase in expression of endostatin and angiostatin proteins in the eye following administration of RetinoStat^®

-      Protein expression is sustained, now out to six months post-treatment at dose level 1 (n=3)

-      Preliminary data show a clear dose response², with the 10-fold escalation to dose level 2 (n=3) yielding a similar increase in average protein expression

·      StarGen™: favourable safety profile 11 months post-treatment in ongoing Phase I/IIa study

·      UshStat^®

-      Clinical study underway

-      Pre-clinical data indicate long-term safety and efficacy

·      EncorStat^®: proof of concept demonstrated in established pre-clinical model

1.     Includes ProSavin^® for Parkinson's disease and Oxford BioMedica's ocular products

2.     Unverified data, time point = 8 weeks post-treatment

Dr Stuart Naylor, Chief Scientific Officer of Oxford BioMedica, said: "The RetinoStat^® Phase I study is the first US clinical study to directly administer a lentiviral vector-based treatment to patients, and we believe this is the first time that therapeutic protein expression has been directly demonstrated in the eye following the administration of a gene therapy.  The sustained therapeutic clinical expression further validates our LentiVector^® platform technology as a means of treating chronic diseases with minimal intervention."

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For further information, please contact:
Oxford BioMedica plc: Lara Mott, Head of Corporate Communications	Tel: [phone]
Media Enquiries: Mary Clark/Sarah Macleod/Claire Dickinson M:Communications	Tel: [phone]

Notes to editors

1. Oxford BioMedica

Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs.  The Company's technology platform includes a highly efficient LentiVector^® gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy.  Through in-house and collaborative research, Oxford BioMedica has a broad pipeline with current partners and licensees including Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, VIRxSYS, Emergent BioSolutions and ImaginAb.  Further information is available at www.oxfordbiomedica.co.uk.

2. LentiVector^® gene delivery technology

Oxford BioMedica's LentiVector^® gene delivery technology is one of the most advanced gene delivery systems currently available, which has many applications in product development and discovery research.  It is the system of choice for gene-based treatments addressing chronic and inherited diseases.  Oxford BioMedica has established a dominant intellectual property estate in the field of lentiviral-vector mediated gene delivery through its in-house research and from work conducted by the Company's co-founders at Oxford University.

3. Oxford BioMedica's agreement with Sanofi

Under the terms of the agreement signed with Sanofi in April 2009, Oxford BioMedica is responsible for the pre-clinical and initial Phase I/II studies of four lentiviral vector-based product candidates in the field of ophthalmology: RetinoStat^® for "wet" age-related macular degeneration, StarGen™ for Stargardt disease, UshStat^® for Usher syndrome 1B and EncorStat^® for corneal graft rejection.  Oxford BioMedica will receive committed funding of up to US$24 million over the initial phase of development.  Oxford BioMedica granted Sanofi a license to develop the products and an option for further development, manufacture and commercialisation on a worldwide basis.  At any time prior to or within a defined period after completion of each Phase I/II study, Sanofi can exercise its option to license the products and will then assume responsibility for on-going activities.  Sanofi also has rights to broaden its license to develop the four products in additional indications, and has rights of first refusal to license other lentiviral vector-based products for the treatment of ocular diseases.

4. Age-Related Macular Degeneration and RetinoStat^®

Age-related macular degeneration (AMD) is a major cause of blindness affecting an estimated 25 to 30 million people worldwide and the incidence of AMD is expected to triple by the year 2025 (source: AMD Alliance International). Neovascular "wet" AMD accounts for the majority of all severe vision loss from the disease. RetinoStat^® delivers two anti-angiogenic genes, endostatin and angiostatin, directly to the retina and aims to preserve and improve the vision of patients through anti-angiogenesis which blocks the formation of new blood vessels. On the basis of pre-clinical data, it is anticipated that RetinoStat^® could require only a single administration which would give the product a significant advantage in the market over currently available treatments that often require frequent, repeated administration.

5. Stargardt disease and StarGen™

Stargardt disease is the most common juvenile degenerative retinal disease which affects approximately 80-100,000 patients in the US and Europe. The disease is caused by a mutation of the ABCR gene which leads to the degeneration of photoreceptors in the retina and vision loss. StarGen™ uses the Company's LentiVector® platform technology to deliver a corrected version of the ABCR gene. On the basis of pre-clinical data, it is anticipated that a single application of StarGen™ to the retina could provide long-term or potentially permanent correction. There are currently no approved treatments available for Stargardt disease. StarGen™ has received European and US Orphan Drug Designation which brings development, regulatory and commercial benefits.

6. Usher syndrome type 1B and UshStat^®

Usher syndrome is the most common form of deaf-blindness which affects approximately 30,000-50,000 patients in the US and Europe. One of the most common subtypes is Usher syndrome type 1B. The disease is caused by a mutation of the gene encoding myosin VIIA (MY07A), which leads to progressive retinitis pigmentosa combined with a congenital hearing defect. UshStat^® uses the Company's LentiVector^® platform technology to deliver a corrected version of the MYO7A gene to address the vision loss associated with the disease. On the basis of pre-clinical data, it is anticipated that a single application of UshStat^® to the retina could provide long-term or potentially permanent stabilisation of vision. There are currently no approved treatments available for Usher syndrome type 1B. UshStat^® has received European and US Orphan Drug Designation which brings development, regulatory and commercial benefits.

7. Corneal graft rejection and EncorStat^®

Approximately 60,000 corneal transplants are performed in the USA and EU each year. There are currently no treatments available to prevent corneal graft rejection.  EncorStat^® is a gene-based treatment for the prevention of corneal graft rejection.  Corneal grafting arises from a need to remove and replace pathology arising in the cornea causing 'clouding'.  Although one of the most successfully transplanted tissues, a significant number of grafts are rejected due to vascularisation.  EncorStat^® uses the Company's LentiVector^® platform technology to deliver endostatin and angiostatin ex vivo to donor corneas prior to transplant in order to block vascularisation and to prevent graft rejection.

 

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