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MolMed expands in the United States the Phase III trial of TK for the treatment of high-risk leukaemia
MolMed S.p.A. (MLM.MI) announces the enrolment of the first patient in the United States, initiating the cross-Atlantic expansion of the pivotal Phase III trial (TK008) of its proprietary TK
cell/gene therapy for high-risk leukaemia patients.
The study, already ongoing in Europe, foresees patient enrolment in 16 clinical centres worldwide.
Based on cumulative efficacy and safety data and on the Orphan Drug designation, the Company expects to file a request for Conditional Marketing Approval of TK with the European Medicine Agency in 2013, and subsequent extension in the US.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: “The treatment with TK cells of this first US patient opens new frontiers to the dissemination of MolMed’s technology. A technology that offers an original and relevant contribution to the solution of the problem of identifying a donor for each high risk leukaemia patient candidate for bone marrow transplantation”.
TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a “suicide gene”. These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high-risk leukaemia. TK therapy allows to avoid the need for post-transplant immunosuppression, thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic disparity with the donor, known as Graft versus Host Disease (GvHD).
About Phase III trial TK008
TK008 is a pivotal randomised Phase III trial in adult patients affected by high-risk leukaemia undergoing transplant of haematopoietic stem cells collected from partially compatible (haploidentical) family donors. The trial design has disease-free survival as the primary end-point -which includes both transplant-related mortality and disease relapse - evaluated on a patient population of 170 patients. The trial will compare the outcome of haplo-transplants with or without TK add-backs, with a 3:1 randomisation ratio in favour of the TK arm. Secondary end-points include overall survival, reduction of transplant-related mortality, safety and patients’ quality of life.
With the aim to provide additional clinical benefit to patients and to significantly increase the potential participation of centres in the trial, the Company implemented in 2012 two important changes in the protocol design of Phase III trial TK008. The first consists in broadening the enrolment criteria to include patients in leukaemic relapse, in addition to those in disease remission; the second change introduces a further treatment option in the control arm, based on the use of an unmanipulated transplant followed by cyclophosphamide administration during the post-transplantation period.
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMed’s pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells.MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)