MolMed presents new data for its cell based therapy TK at the Annual Meeting of the American Society of Hematology (ASH)
New data reveal the role of Interleukin-7 in the mechanism of action of TK cells
The finding provides rationale to widen the use of the TK therapy
Milan (Italy), 7 December 2010 – MolMed S.p.A. (Milan:MLM) presented at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL an update on long-term follow up data of a completed Phase II trial (TK007) of its cell-based therapy TK for high-risk leukaemia. New data presented allow to further clarify the mechanism of action by which TK cells promote the immune-reconstitution of treated adult leukaemia patients, showing that the recovery of the patients’ immune system is mediated by Interleukin-7, a signalling molecule that plays a key role in several steps of the immune response.
Data from the Phase II trial of TK have previously shown (Ciceri, Bonini et al., JCO 2009; and ASCO 2010, abstract 6534) that TK cells exert a direct role in restoring a fully functional immune system and in fighting disease relapse, and thus are directly responsible for increased survival and reduced transplant-related mortality in adult patients affected by high-risk leukaemia.
Claudio Bordignon, MolMed’s chairman and CEO, comments: “These data offer an insight on how TK cells promote, through the induction of Interleukin-7 production, the recovery of a fully functional immune system that effectively protects patients both from infections and from disease relapse. This new finding not only elucidates how TK cells work, but it also provides the rationale to widen the use of TK cells to all haematopoietic stem cell transplants in which provision of an effective immune protection represents a critical therapeutic factor, as well as to adoptive immunotherapy approaches involving gene transfer procedures.”
TK therapy is currently investigated in a randomised Phase III trial (TK008) for high-risk leukaemia, addressing the issue of enabling safe and effective bone marrow transplants from partially compatible donors in adult recipients, without post-transplant immune-suppression or depletion of alloreactive cells, thereby opening the door of bone marrow transplant to all patients lacking a fully compatible donor. The main endpoints of the trial are overall survival and reduction of transplant-related mortality; secondary endpoints include disease-free survival, safety and patient quality of life.
MolMed will further pursue in 2011 the international expansion of its Phase III trial (TK008), including in the United States where the company filed earlier this year an IND (Investigational New Drug) application with the U.S. Food and Drug Administration (FDA). Currently, the Phase III trial of TK, whose initial data confirm the safety of the investigational therapy, is actively recruiting patients in Italy. At the ASH annual meeting, MolMed indicated that the clinical trial will be pursued also in clinical centres in France, Germany, Greece, Israel, and the United States. (Clinicaltrials.gov trial identifier: NCT00914628).
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999 as subsequently amended.
TK is a cell therapy product, based on the use of genetically engineered donor T cells in association with bone marrow transplants from healthy donors, and particularly from partially compatible family donors (haplo-transplants). Add-backs of TK allow to keep the immune-protection and anti-leukaemia effects of donor T cells, while promptly controlling and abrogating the possible onset of GvHD. TK has been granted Orphan Drug designation in both the EU and the US.
MolMed S.p.A is a biotechnology company focused on research, development and clinical validation of novel antitumour therapies. MolMed’s pipeline includes two investigational anticancer products: TK, in Phase III for high-risk leukaemia, and NGR-hTNF, a selective vascular targeting agent for the treatment of solid tumours, in Phase III for malignant pleural mesothelioma and in Phase II in colorectal, liver, small-cell lung, non-small-cell lung and ovarian cancer, and in soft tissue sarcomas. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy.
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This press release may contain certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.
Posted: December 2010