Oxford BioMedica Announces Initiation of Phase II Collaborative Study for TroVax® in Colorectal Cancer

Informations

• Publié par: oxford-biomedica-plc
• Nombre de lectures: 14
• Langue: English

Extrait

Oxford BioMedica Announces Initiation of

Phase II Collaborative Study for TroVax® in

Colorectal Cancer

PR Newswire

OXFORD, England, July 10, 2012

OXFORD, England

,

July 10, 2012

/PRNewswire/ --

-- First patient treated at Cardiff University, Wales (UK) --

Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), the

leading gene-based biopharmaceutical company, today announces that its

partners at

Cardiff

University,

Wales

(UK) have initiated a Phase II trial to assess

the safety and immunological activity of TroVax

®

, a therapeutic vaccine

developed by Oxford BioMedica, in patients with inoperable metastatic

colorectal cancer (CRC). The study will be funded by

Cardiff

University, with

some funding awarded by Cancer Research Wales, and Oxford BioMedica will

provide TroVax

®

. The trial is supported by the Experimental Cancer Medicine

Centre (ECMC),

Cardiff

.

The randomised, open-label Phase II study, entitled "TaCTiCC" (TroVax

®

and

Cyclophosphamide Treatment in Colorectal Cancer), builds on four previous

Phase I/II trials conducted by Oxford BioMedica where TroVax

®

was given to

patients with CRC, in addition to research into CRC undertaken by Dr Andrew

Godkin and Dr Awen Gallimore at

Cardiff

University,

Wales

. Led by Dr Andrew

Godkin, the study will enrol up to 54 patients with inoperable metastatic CRC.

The study will evaluate whether TroVax

®

, administered alone or in

combination with cyclophosphamide, is effective in the treatment of CRC. The

study will assess anti-5T4 immune responses following treatment, in addition to

secondary measures of clinical benefit including progression-free survival,

objective response rate and overall survival.

Colorectal cancer is the second most common cause of cancer mortality in the

UK with an estimated 16,000 deaths per year (source: Cancer Research UK,

2010). TroVax

®

is a therapeutic vaccine that stimulates the immune system to

destroy cancerous cells expressing the 5T4 tumour antigen which is present on

most solid tumours. It is well documented that low doses of cyclophosphamide

can augment immune responses by decreasing the numbers of a class of blood

cell called a "regulatory T cell". By combining TroVax

®

with cyclophosphamide,

this study will determine whether the combination approach results in stronger

immune responses against 5T4 compared to patients treated with TroVax

®

alone.

Commenting on the collaboration, Stuart Naylor, Chief Scientific

Officer at

Oxford

BioMedica, said:

"We believe TroVax

®

holds great

promise in the treatment of colorectal cancer and very much look forward to

working with our colleagues at CardiffUniversity. This important study builds on

pioneering work undertaken by Dr Godkin and his team and we are pleased to

be able to support the transition into Phase II clinical development."

Dr Andrew Godkin, Principal Investigator at

Cardiff

University,

commented:

"We are very excited in Cardiff to be starting this study. It is a

truly translational study in as much as preliminary data have been generated

from a series of experiments which started over 10 years ago. There has been

a tremendous amount of support from various parties to drive this forward, the

logistic hurdles are crossed and we are now ready to go."

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, Emergent BioSolutions and ImaginAb. Further information is

available at http://www.oxfordbiomedica.co.uk.

2. TroVax

®

TroVax

®

is a therapeutic vaccine that stimulates the immune system to destroy

cancerous cells expressing the 5T4 tumour antigen which is present on most

solid tumours. The product comprises a modified vaccinia virus

Ankara

(MVA)

vector, encoding the 5T4 antigen. Vaccinia viruses are commonly used as

delivery systems for the development of antigen-specific vaccines. Results

from 10 previous clinical trials in colorectal, renal and prostate cancer have

shown that TroVax

®

is safe and well tolerated in over 500 patients; can be

administered in combination with various other treatments and show clear

indication of efficacy. Approximately 90% of patients treated with TroVax

®

mounted an anti-cancer immune response to the 5T4 antigen. TroVax

®

is

currently in Phase II development for hormone refractory prostate cancer.

3. The School of Medicine,

Cardiff

University

Cardiff

University's School of Medicine is recognised as a significant contributor

to healthcare in

Wales

, a major provider of professional staff for the National

Health Service and an international centre of excellence for research delivering

substantial health benefits locally and internationally. The School of Medicine is

based at the Heath Park Campus, a site it shares the University Hospital of

Wales

, the third largest university hospital in the UK. It has an all-

Wales

role,

contributing greatly to promoting, enhancing and protecting the nation's health

in partnership with the National Health Service (NHS) in

Wales

. The medical

curriculum followed at the School enables students to acquire and apply

knowledge, skills, judgement and attitudes appropriate to delivering a high

standard of professional care. The School is an international leader in basic

and clinically applied research activities and has been instrumental in

establishing and running many important national research initiatives including

the Wales Gene Park, Wales Cancer Bank, the Cardiff Institute for Tissue

Engineering and Repair and the Healing Foundation UK Centre for Burns

Research.

For further information, please contact:

Oxford BioMedica plc:

Lara Mott, Head of Corporate Communications

Tel: [phone]

Media Enquiries:

Mary Clark/Sarah Macleod/Claire Dickinson

Tel: [phone]

M:Communications