Development Milestone
Oxford Biomedica PLC
22 January 2008
For Immediate Release 22 JANUARY 2008
OXFORD BIOMEDICA ANNOUNCES DEVELOPMENT MILESTONE IN ITS COLLABORATION WITH
MOLMED
Oxford, UK - 22 January 2008: Oxford BioMedica (LSE: OXB), a leading gene
therapy company, announced today that its partner MolMed has received regulatory
approval to start a Phase III trial of TK therapy for high risk acute leukaemia.
Under a license agreement with Oxford BioMedica, MolMed's TK therapy product
employs Oxford BioMedica's retroviral ex vivo gene delivery technology. The
start of a Phase III trial of TK therapy triggers an undisclosed milestone
payment to Oxford BioMedica. MolMed has today issued a press release relating to
the Phase III trial, as follows:
MolMed gets regulatory approval to start a Phase III trial in Italy of its TK
therapy for high risk acute leukaemia
Milan, Italy - 22 January 2008: MolMed S.p.A., a biotech company focused on
novel anti-tumour therapies, announced that the AIFA, the Italian Health
authority, authorised the start in Italy of a Phase III trial (TK008) of
MolMed's TK cell therapy in patients affected by high risk acute leukaemias and
receiving haematopoietic stem cell transplantation from a partially compatible
family donor (haplo-HSCT). AIFA clearance, the very first one in Italy for a
Phase III of a cell/gene therapy, requires the completion of analytical
characterisation of TK components within the treatment of 20% of patients
involved in the study, and follows approval of the clinical protocol, obtained
in December 2007 by the Ethical Committee of the first clinical centre involved.
In preparing Phase III, MolMed was supported by the EMEA, that provided protocol
assistance and scientific advice as granted by the Orphan Drug designation of TK
(Orphan Drug is awarded to therapeutics for life-threatening or chronically
debilitating conditions affecting not more than 5/10,000 people in the EU). The
multicentric, randomised Phase III trial will assess the very positive outcome
of Phase I/II trial TK007 that resulted in an exceptional improvement in
survival of patients by promoting rapid and sustained immune reconstitution, and
proved safety and efficacy of haplo-HSCT, thus enabling feasibility of
transplantation from partially incompatible family donors.
Claudio Bordignon, President and Chief Executive Officer of MolMed, commented:
'The remarkable results obtained in the Phase I/II trial show the importance of
TK therapy in making stem cell transplantation available for all candidate
patients lacking a fully compatible donor, who are approximately 60% of those
who could benefit from this potentially curative treatment'. Marco Dieci,
Director of Quality & Regulatory Compliance at MolMed, added: 'This approval is
particularly meaningful also because TK is one of the very few cell/gene
therapies in Phase III all over the world, and thus could be among the very
first ones to obtain marketing approval'.
This year, MolMed also plans to start a Phase I/II trial of TK in the US,
managed by the MD Anderson Cancer Center in Houston (Texas).
-Ends-
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
JPMorgan Cazenove Limited
James Mitford/Gina Gibson Tel: +44 (0)20 7588 2828
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000
Buchanan Communications
Scientific/Trade Press Enquiries:
Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020
College Hill Life Sciences
MolMed SpA Tel: +39 02 21277 1
Elena Lungagnani, Communication manager
US Enquiries:
Thomas Fechtner Tel: (646) 378 2900
The Trout Group LLC
Notes to editors
1. Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in
cancer immunotherapy and gene-based therapies. The Company was established in
1995, as a spin-out from Oxford University, and is listed on the London Stock
Exchange.
The Company has a platform of gene delivery technologies, which are based on
highly engineered viral systems. Oxford BioMedica also has in-house clinical,
regulatory and manufacturing know-how. The lead product candidate is TroVax(R),
an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis
for global development and commercialisation. A Phase III trial of TroVax in
renal cancer is ongoing and Phase III development in colorectal cancer is
planned. Oxford BioMedica has three other products in clinical development,
including ProSavin(R), a novel gene-based treatment for Parkinson's disease, in
a Phase I/II trial. The Company is underpinned by over 80 patent families, which
represent one of the broadest patent estates in the field. The Company has a
staff of approximately 85. Oxford BioMedica has collaborations with
sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees
include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk
2. Acute leukaemia
High-risk acute leukaemia is a haematological malignancy for which the only
potentially curative treatment is transplantation of haematopoietic stem cells
(HSCT) from a healthy donor. However, feasibility and effectiveness of HSCT are
heavily limited by the shortage of fully compatible donors, which are available
only for approximately 30-40% of the patient population. Partially compatible
(haploidentical) family donors would be available for nearly all patients, but
at present safety and efficacy of this type of transplant is limited by a high
rate of transplant-related mortality associated with delayed immune
reconstitution.
3. TK therapy
TK therapy is based on the use of genetically engineered (TK+) donor T
lymphocytes, used in association with haplo-HSCT. TK+ donor lymphocytes can
control the main complications associated with haplo-HSCT, while maintaining the
anti-leukaemia effects of the transplant, thereby increasing both patients'
survival and the number of available donors. Orphan drug designation for TK has
been granted by the EMEA in 2003 and by the FDA in 2005. MolMed's strategic
partner Takara Bio Inc. (Japan) is developing TK for the Asian markets.
4. MolMed
MolMed S.p.A is a biotechnology company focused on R&D and clinical validation
of novel anticancer therapies. MolMed has two other anti-tumour therapeutics in
clinical development: ARENEGYR, a novel vascular targeting agent (VTA), in Phase
II in four indications; M3TK, a therapeutic vaccine, in Phase I/II in advanced
melanoma. MolMed's clinical pipeline is supported by a broad portfolio of
therapeutic candidates. MolMed is headquartered at the San Raffaele Biomedical
Science Park in Milan, Italy.
This information is provided by RNS
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