MolMed: NGR-hTNF: increased recruitment rate – with completion foreseen by the end of the year – in the Phase III mesothelioma trial, and new European patent granted

Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: "The first half-year confirms the positive trend already outlined in the first three months of 2012 in two fields of the Company’s activities. The Phase III trial of NGR-hTNF in mesothelioma recorded a constant increase in the rate of patient recruitment, confirming the forecast of recruitment completion by the end of the year. At the same time, we would like to point out that revenues from development and GMP production for third parties in the field of gene therapy have more than doubled. Regarding TK, we are implementing protocol changes to include in the TK008 Phase III trial patients with more advanced disease. We believe that these changes will offer patients a better chance of cure and will help to increase the recruitment rate in the trial, which has been progressing below our expectations. Based on results accumulated in the Phase II trial and the initial data of the Phase III, the Company is pursuing a request through the Conditional Marketing Authorisation procedure, which might allow the Company to maintain its anticipated timelines for market authorisation in Europe."

Research & Development activities

In the first six months of 2012, the Company’s activities were mainly focused on pursuing the clinical development of its investigational anticancer therapeutics, NGR-hTNF for the treatment of different types of solid tumours and TK for the treatment of high-risk leukaemia.

Main progress achieved in the development of NGR-hTNF included:

  • increase of patient recruitment rate and further international expansion of the Phase III pivotal trial for the treatment of malignant pleural mesothelioma: as of 30 June 2012, well over half of the planned trial population was enrolled in 39 active centres in Europe, USA, Canada and Egypt, allowing MolMed to substantially confirm the foreseen patient recruitment completion by the end of 2012;
  • progress of patient recruitment in four ongoing randomised Phase II trials, in non-small cell lung cancer (NSCLC), ovarian cancer, soft tissue sarcomas and mesothelioma as first-line maintenance therapy;
  • presentation at ASCO 2012 of new data from four Phase II trials in as many types of solid tumours. The first randomised data for overall survival, available from the trial in metastatic NSCLC, are promising in the variant with squamous histology and confirm the extension of survival as the most significant clinical benefit common to the other three trials – in mesothelioma, ovarian cancer and small cell lung cancer. In all these trials, the onset of chills during drug infusion and high levels of circulating lymphocytes predict greater benefit from the treatment, consistently with the mode of action of the drug;
  • grant of a new European patent (EP2285416) covering the therapeutic use of NGR-hTNF for the treatment of mesothelioma, affording protection until 2029 with the possibility of further term extension.

About MolMed

MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anti-tumour therapies. In addition to NGR-hTNF, MolMed’s pipeline includes another novel therapeutic in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in high-risk acute leukaemia. 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 Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana. (ticker reuters:MLMD.MI).

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Last update: March 06, 2014. 08:41:31 pm.