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Oxford BioMedica Announces Ocular Programme Update

June 22, 2011

OXFORD, England, June 22, 2011 /PRNewswire/ –

– RetinoStat(R) Progress in Phase I Study in Wet Age-Related Macular
Degeneration

Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a
leading gene therapy company, today announces that the first dose level of
RetinoStat(R) is safe and well-tolerated at one month following treatment.
RetinoStat(R) is a novel gene-based treatment for neovascular “wet”
age-related macular degeneration (AMD), designed and developed by Oxford
BioMedica using the Company’s proprietary LentiVector(R) gene delivery
technology. It is the lead programme of the ocular agreement the Company
signed with Sanofi (EURONEXT: SAN and NYSE: SNY) in April 2009.

The on-going Phase I study will enrol 18 patients with wet AMD at the
Wilmer Eye Institute at Johns Hopkins, Baltimore (USA). Led by Professor
Peter Campochiaro, the study will evaluate three dose levels and assess
safety, aspects of visual acuity and ocular physiology. Three patients
received the first dose level of RetinoStat(R) and one-month results have
been assessed by the study’s independent Data Safety Monitoring Board
(DSMB). First results from the study are expected to be announced in H1
2012.

Highlights of first patient cohort at one month (dose level 1)

        - Favourable safety profile with no serious adverse events
          related to RetinoStat(R) or its method of administration
        - No signs of inflammation in the eye
        - DSMB support received to proceed to dose level 2 in the next
          patient cohort

John Dawson, Chief Executive Officer of Oxford BioMedica, said: “This
clinical study is breaking new ground as the first to directly administer a
lentiviral vector-based treatment to patients in the US and the favourable
safety profile of RetinoStat(R) is encouraging. We continue to work closely
with the regulatory bodies in order to advance our novel ocular programmes
as rapidly as possible and, together with Sanofi, we look forward to further
progress during 2011.”

The second ocular product to enter clinical development is StarGen(TM), a
novel gene-based treatment for Stargardt disease, and the first patient in
the Phase I/IIa study was treated in the US in June 2011 at the Oregon
Health & Science University’s Casey Eye Institute. StarGen(TM) has received
European and US Orphan Drug Designation which brings development, regulatory
and commercial benefits and, with no currently approved treatment, this
novel product brings significant hope for the future to Stargardt patients.
The next product expected to enter Phase I/II clinical development is
UshStat(R) for the treatment of Usher syndrome type 1B in H2 2011.
UshStat(R) has also received European and US Orphan Drug Designation.

“We are delighted to see Oxford BioMedica’s lentiviral gene therapy
products successfully moving into human studies,”said Stephen Rose, Ph.D.,
chief research officer of the Foundation Fighting Blindness, a US non-profit
organisation that provided early funding for Oxford BioMedica’s pre-clinical
ocular programme. “The Company’s innovative treatments hold great promise
for saving vision in people affected by a broad range of devastating eye
diseases for which current treatments are limited or non-existent.”

Notes to editors

1. Oxford BioMedica(R)

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(R)
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 and its
partners include Sanofi, Sigma-Aldrich and Pfizer. Further information is
available at http://www.oxfordbiomedica.co.uk.

2. 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(R) for “wet” AMD, StarGen(TM) for Stargardt
disease, UshStat(R) for Usher syndrome 1B and EncorStat(R) for corneal graft
rejection. 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.

3. LentiVector(R) gene delivery technology

Oxford BioMedica’s LentiVector(R) platform 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.

4. Age-Related Macular Degeneration and RetinoStat(R)

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(R) 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(R) will
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. Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops
and distributes therapeutic solutions focused on patients’ needs. Sanofi has
core strengths in the field of healthcare with seven growth platforms:
diabetes solutions, human vaccines, innovative drugs, rare diseases,
consumer healthcare, emerging markets and animal health. Sanofi is listed in
Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

6. Foundation Fighting Blindness

The Foundation Fighting Blindness is a publicly-supported charity
raising money to fund research for macular degeneration, retinitis
pigmentosa (RP), Usher syndrome, Stargardt disease and related ocular
diseases.

        For further information, please contact:

        Oxford BioMedica plc:
        Lara Mott, Head of Corporate Communications

        Tel: +44(0)1865-783-000

        Media Enquiries:
        Emma Thompson/Katja Toon/Amber Bielecka
        M:Communications

        Tel: +44(0)20-7920-2342

SOURCE Oxford Biomedica Plc


Source: newswire