Cell Medica Announces First Patient Treated in Cytomegalovirus~ACE/ASPECT Clinical Trial

By Cell Medica, PRNE
Wednesday, February 9, 2011

Leading Collaboration Between Cell Medica, Leukaemia & Lymphoma Research, University of Birmingham and NHS Blood and Transplant

LONDON, February 10, 2011 - Cell Medica, a leading UK cellular therapeutics company that develops,
manufactures and markets cellular immunotherapy products for the treatment of
infectious disease and cancer, announces today that the first patient has
been treated in the CMV~ACE/ASPECT trial at University College Hospital
London. The Phase II randomised clinical trial is designed to demonstrate the
efficacy of adoptive cellular therapy for the pre-emptive treatment of
cytomegalovirus (CMV) infections in patients who have received a bone marrow
transplant from an unrelated donor.

Adoptive cellular therapy has been shown to prevent viral diseases in
patients post allogeneic haematopoietic stem cell (bone marrow)
transplant[1,2]. These patients, typically leukaemia or lymphoma patients,
have profoundly compromised immune systems and are at high risk of the
reactivation of latent CMV infection, often manifesting as interstitial
pneumonitis. CMV serostatus continues to be a risk factor which influences
the survival outcome of bone marrow transplant patients and improving the
treatment of CMV infections represents an important clinical need[3,4].
Patients undergoing bone marrow transplant from an unrelated donor are at
particularly high risk of infection and efficacy in this patient group will
add significantly to the market potential of the cell therapy.

The trial represents an important collaboration between leading players
from industry, the charitable sector, academic research and the National
Health Service with the shared aim of establishing adoptive cellular therapy
as routine clinical practice for the treatment of patients at high risk of
CMV infection following a bone marrow transplant.

Cell Medica is sponsoring the study and providing the majority of the
cell therapy products for the patients being treated. Cell Medica is
commercialising a proprietary form of the cell therapy referred to as Cytovir

Leukaemia & Lymphoma Research is a UK charity dedicated to research into
blood cancers including leukaemia, lymphoma and myeloma. The charity is
funding certain aspects of the trial.

The University of Birmingham is a research-intensive University and
haematology expert Professor Paul Moss, Head of Cancer Sciences, has been
pioneering the development of cellular immunotherapy.

NHS Blood and Transplant (NHSBT) is a Special Health Authority within the
NHS with responsibility for optimising the supply of blood, organs and
tissues and raising the quality, effectiveness and efficiency of blood and
transplant services. NHSBT is providing the cell therapy products for two of
the participating hospitals and analysing blood samples to determine patient
responses to the treatment within this trial.

Trial Design

The CMV~ACE/ASPECT is a randomised, controlled study and will include 36
patients across ten UK hospitals. Patients in the trial's treatment arm will
receive CMV-specific memory T cells while patients in the control arm will
receive only conventional antiviral treatment. The Chief Investigator is Dr.
Karl Peggs at the UCL Cancer Institute. The study is expected to be completed
by the end of 2012 with results published in 2013.

The CMV~ACE/ASPECT study is being carried out at the following hospitals
in the UK, subject to final local approvals: University College London
Hospital, Queen Elizabeth Hospital, Birmingham, University Hospitals Bristol,
King's College Hospital, Manchester Royal Infirmary, The Christie Hospital
Manchester, Nottingham City Hospital, Churchill Hospital Oxford, St James's
Institute of Oncology, Leeds, and The Royal Free Hospital.

The trial will complement an ongoing confirmatory (Phase III) study,
CMV~IMPACT, which is investigating the use of adoptive cell therapy in bone
marrow patients whose donors are siblings. The CMV~IMPACT Study is also
sponsored by Cell Medica and funded through a Translation Award from The
Wellcome Trust.

Gregg Sando, CEO of Cell Medica, commented:

"Cellular immunotherapy represents a new approach for the treatment of
infectious disease. In view of the important patient benefits, we are working
towards bringing cellular immunotherapy into routine clinical practice as
quickly as possible. We share this commitment with Leukaemia & Lymphoma
Research, NHSBT and University of Birmingham and all the participating
hospitals and look forward to working together on this exciting clinical


[1] Peggs KS, Thomson K, Samuel E, Dyer G, Armoogum J, Chakraverty R,
Pang K, Mackinnon S, Lowdell MW. Directly selected cytomegalovirus-reactive
donor T cells confer rapid and safe systemic reconstitution of virus-specific
immunity following stem cell transplantation. Clin Infect Dis. 2011

[2] Peggs KS, Verfuerth S, Pizzey A, Chow SL, Thomson K, Mackinnon S.
Cytomegalovirus-specific T cell immunotherapy promotes restoration of durable
functional antiviral immunity following allogeneic stem cell transplantation.
Clin Infect Dis. 2009 Dec 15;49(12):1851-60.

[3] Kroger N, Zabelina T, Kruger W, Renges H, Stute N, Schrum J, et al.
Patient cytomegalovirus seropositivity with or without reactivation is the
most important prognostic factor for survival and treatment-related mortality
in stem cell transplantation from unrelated donors using pre-transplant in
vivo T-cell depletion with anti-thymocyte globulin. British Journal of
Haematology. 2001 Jun;113(4):1060-71

[4] Ljungman P, Brand R, Einsele H, Frassoni F, Niederwieser D,
Cordonnier C. Donor CMV serologic status and outcome of CMV-seropositive
recipients after unrelated donor stem cell transplantation: an EBMT megafile
analysis. Blood. 2003; 102:4255-60.

Notes to Editors:

Background to the trial = building on the success of earlier clinical

Early-stage clinical trials conducted independently by members of Cell
Medica's Scientific Advisory Team and including over 40 patients have
demonstrated that adoptive cellular therapy can be used to prevent specific
infections in patients following bone marrow transplants. The CMV~ACE/ASPECT
study will build on these data to determine the level of immunological
benefit in a statistically robust manner. The study will also seek to
characterise the pharmaco-economics of treatment with Cytovir CMV.

About T cell immunotherapy for the treatment of CMV infection

T cell immunotherapy involves harnessing the power and precision of the
human immune system to treat disease. Extensive academic research in the
field of clinical immunology has shown that T cells have the ability to
recognise and eliminate infections and have the potential to be used in a
safe and efficacious manner as an antiviral treatment. Latent infection of
cytomegalovirus (CMV) is estimated in over 50% of all humans and reactivation
of the virus is one of the leading causes of potentially life threatening
illness in immunosuppressed patients, often manifesting as interstitial
pneumonitis. Adoptive T cell immunotherapy is based on the selection of
CMV-specific memory T cells from the same donor providing the bone marrow
(and hence closely matched with respect to tissue type) and infusion of these
cells in the patient to prevent or treat CMV infections following a bone
marrow transplant.

About Cell Medica

Cell Medica is a clinical cellular therapeutics company engaged in the
development, manufacture and marketing of cellular immunotherapy treatments
for infectious disease and cancer. The Company's lead cell therapy, Cytovir
CMV, targets the prevention of infections in immunosuppressed patients
following allogeneic bone marrow transplant. Certain cancers are also
targeted through the Company's antigen-specific T cell approach. Cell Medica
focuses on the commercialisation of cell therapies which have demonstrated
clear evidence of safety and efficacy based on Phase I/II clinical trials.

    Further more information, please contact:

    Gregg Sando, CEO
    Cell Medica Limited

    Mary-Jane Elliott/ Nick Francis/ Amber Bielecka

Further more information, please contact: Gregg Sando, CEO, Cell Medica Limited, Gregg.Sando at cellmedica.co.uk , +44(0)20-7554-4070; M:Communications: Mary-Jane Elliott/ Nick Francis/ Amber Bielecka, +44(0)20-7920-2300, healthcare at mcomgroup.com

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