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MolMed S.p.A. announced that the AIFA authorised the start in Italy of a Phase III trial 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
MILAN, Italy | January 22, 2008 | MolMed S.p.A., a biotech company focused on novel anti-tumourtherapies, announced that the AIFA, the Italian Health authority, authorised the start in Italy of a Phase IIItrial (TK008) of MolMed’s TK cell therapy in patients affected by high risk acute leukaemias and receivinghaematopoietic stem cell transplantation from a partially compatible family donor (haplo-HSCT). AIFAclearance, the very first one in Italy for a Phase III of a cell/gene therapy, requires the completion ofanalytical 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 thefirst clinical centre involved. In preparing Phase III, MolMed was supported by the EMEA, that providedprotocol assistance and scientific advice as granted by the Orphan Drug designation of TK (Orphan Drugis awarded to therapeutics for life-threatening or chronically debilitating conditions affecting not more than5/10.000 people in the EU). The multicentric, randomised Phase III trial will assess the very positiveoutcome of Phase I/II trial TK007 that resulted in an exceptional improvement in survival of patients bypromoting rapid and sustained immune reconstitution, and proved safety and efficacy of haplo-HSCT, thusenabling feasibility of transplantation from partially incompatible family donors. Claudio Bordignon,President and Chief Executive Officer of MolMed, commented: “The remarkable results obtained in thePhase I/II trial show the importance of TK therapy in making stem cell transplantation available for allcandidate patients lacking a fully compatible donor, who are approximately 60% of those who could benefitfrom this potentially curative treatment”. Marco Dieci, Director of Quality & Regulatory Compliance atMolMed, added: “This approval is particularly meaningful also because TK is one of the very few cell/genetherapies in Phase III all over the world, and thus could be among the very first ones to obtain marketingapproval”.
This year, MolMed also plans to start a Phase I/II trial of TK in the US, managed by the MD AndersonCancer Center in Houston (Texas).
About acute leukaemia
High-risk acute leukaemia is a haematological malignancy for which the only potentially curative treatmentis transplantation of haematopoietic stem cells (HSCT) from a healthy donor. However, feasibility andeffectiveness of HSCT are heavily limited by the shortage of fully compatible donors, which are availableonly for approximately 30-40% of the patient population. Partially compatible (haploidentical) family donorswould be available for nearly all patients, but at present safety and efficacy of this type of transplant islimited 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 associationwith 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 survivaland 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 anticancertherapies. MolMed has two other anti-tumour therapeutics in clinical development: ARENEGYR, a novelvascular targeting agent (VTA), in Phase II in four indications; M3TK, a therapeutic vaccine, in Phase I/II inadvanced melanoma. MolMed’s clinical pipeline is supported by a broad portfolio of therapeuticcandidates. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy.For further information, please contact:Elena Lungagnani, Communication managere-mail:
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SOURCE: MOLMED
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