Cell Medica Limited today announced that the European Medicines Agency's
(EMA) Committee for Orphan Medicinal Products has issued a positive
opinion on an application for orphan designation of a novel T cell
immunotherapy under development by the company. The cell therapy,
Cytovir ADV, targets the treatment of adenovirus infections in patients
following allogeneic hematopoietic stem cell (bone marrow) transplant
and is comprised of adenovirus-specific T-cells derived from allogeneic
donor leukocytes, expanded ex vivo. Adenovirus infections are a frequent
cause of complications and death in patients, particularly children, who
have received bone marrow transplants.
Cytovir ADV is based upon a new paradigm for the treatment of infections
in patients following bone marrow transplantation. Derived from T-cells
which provide immunity to the virus in the bone marrow donor, Cytovir
ADV is being investigated as a novel method for transferring adenovirus
immunity from the donor to the patient following the bone marrow
transplant procedure. These patients are often profoundly
immuno-compromised for a period of 6-9 months after the procedure and
hence vulnerable to life-threatening infections. No antiviral drugs are
currently approved for adenovirus infections post transplant. Cell
Medica is developing a related product, Cytovir CMV, for cytomegalovirus
infections in the same patient group.
Cytovir ADV is currently being investigated in the ASPIRE Phase I/II
clinical trial under way at Great Ormond Street Hospital (GOSH) in
London, one of the world's leading centres for bone marrow
transplantation in children.
"Cytovir ADV represents a potential breakthrough for the treatment of
life-threatening adenovirus infections in children following a bone
marrow transplant and we are very excited about the continued progress
for this cell therapy," said Gregg Sando, Chief Executive Officer of
Cell Medica. "Receiving orphan deignation for Cytovir ADV in the
European Union is a significant milestone for Cell Medica. The benefits
include 10 years of market exclusivity from product launch in the EU as
well as fee reductions."
The development of Cytovir ADV and the ASPIRE Phase I/II Clinical Trial
have been supported by collaborative research grants from the UK's
innovation agency, the Technology Strategy Board.
About Cytovir ADV
Cytovir ADV is comprised of naturally occurring T lymphocyte cells (T
cells) which demonstrate immune response functions when exposed to
adenovirus antigens. The ASPIRE trial will explore the safety and
activity of adenovirus-specific T cells infused in paediatric patients.
The development program will establish whether Cytovir ADV reconstitutes
immediate and long-lasting immunity against the virus, thereby
potentially avoiding the medical costs, hospitalization and mortality
associated with adenovirus infections in this patient group.
About Cell Medica
Cell Medica is a cellular therapeutics company engaged in the
development, manufacturing and marketing of T cell immunotherapy
approaches for the treatment of infections and cancers related to
oncogenic viruses. The Company's lead cell product, CytovirTM
CMV, for the treatment and prevention of cytomegalovirus (CMV)
infections in patients following allogeneic bone marrow transplant, is
available in the UK and is under development in other territories.
Cytovir ADV is being developed for the treatment of adenovirus
infections in pediatric patients following bone marrow transplantation.
Cell Medica is also working with the Center for Cell and Gene Therapy,
Baylor College of Medicine, to develop an autologous T-cell product,
CMD-003, for the treatment of malignancies associated with the oncogenic
Epstein Barr Virus, including lymphomas and nasopharyngeal carcinoma.
About Great Ormond Street Hospital for Children
Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) is
the country's leading centre for treating sick children, with the widest
range of specialists under one roof. With the UCL Institute of Child
Health, GOSH represents the largest centre for paediatric research
outside the US and play a key role in training children's health
specialists for the future.
About Technology Strategy Board
The Technology Strategy Board is the UK's innovation agency. Its goal is
to accelerate economic growth by stimulating and supporting business-led
innovation. Sponsored by the Department for Business, Innovation and
Skills (BIS), the Technology Strategy Board brings together business,
research and the public sector, supporting and accelerating the
development of innovative products and services to meet market needs,
tackle major societal challenges and help build the future economy. For
more information please visit www.innovateuk.org.
About Orphan Designation in the EU
The EU's Orphan Medicinal Product Designation is designed to promote the
development of drugs that may provide significant benefit to patients
suffering from rare, life-threatening diseases. Following approval for
the treatment of adenovirus infections in patients post bone marrow
transplant, Cytovir ADV will enjoy 10 years exclusivity in the market.
The designation also provides eligibility for protocol assistance and
possible exemptions or reductions in certain regulatory fees during
development or at the time of application for marketing approval.
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