MolMed gets regulatory approval to start a Phase III trial in Italy
of its TK therapy for high risk acute leukaemia
MILAN, Italy – January 22, 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).
About 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.
About 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 allow to control the main complications associated with
haplo-HSCT, while keeping 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.
About 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.
For further information, please contact:
Elena Lungagnani, Communication manager
e-mail: info@molmed.
http://www.pharmali
articleid=507442&
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