Relapsed Mesothelioma: Molmed Completes Enrolment In Pivotal Phase Iii Trial Of Ngr-htnf

Milan (Italy), 13 December 2012 MolMed S.p.A

Milan (Italy), 13 December 2012 MolMed S.p.A. (MLM.MI) announces completion of enrolment in the pivotal NGR015 Phase III trial of its investigational drug NGR-hTNF in relapsed malignant pleural mesothelioma, a poor-prognosis disease linked to asbestos exposure with increasing incidence worldwide. Primary efficacy results are expected in the third quarter of 2013.

NGR-hTNF, a novel vascular targeting agent, could represent a new treatment option to potentially extend the lives of patients with relapsed mesothelioma - an indication without specific regulatory-approved therapies. Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) granted NGR-hTNF Orphan Drug designation for this indication.

Claudio Bordignon, MolMeds Chairman and CEO, comments: We are very proud that the accrual completion in this 390-patient trial was achieved earlier than expected, and we would like to thank all patients and investigators who participated in this huge joint effort. The fact that over 40 clinical centres in 12 countries in Europe, with Italy and Great Britain leading, North America and Egypt participated in the study and the fast recruitment rate indicate the largely unsatisfied medical need that our drug addresses, and point out the high level of awareness and expectations of oncologists towards NGR-hTNF."

Currently, NGR-hTNF is the only drug in Phase III development for relapsed mesothelioma. Concomitantly with the Phase III study in the second-line setting, the Company is conducting a randomised Phase II trial with NGR-hTNF given as first-line maintenance therapy to assess whether earlier drug administration is able to increase the clinical benefit. The efficacy of NGR-hTNF is also being tested in three additional randomised Phase II trials in non-small cell lung cancer, soft tissue sarcomas and ovarian cancer.

About Phase III trial NGR015

NGR015 is a pivotal randomised, double-blind, placebo-controlled, international, multicentre Phase III trial on 390 malignant pleural mesothelioma patients, whose disease progressed after a pemetrexed-based chemotherapy. The trial is powered to detect a survival benefit for NGR-hTNF, when combined with best investigators choice (BIC), where BIC includes either best supportive care alone or in combination with chemotherapy (either doxorubicin, or gemcitabine, or vinorelbine). NGR-hTNF is administered according to the dose and schedule that were confirmed as the most efficacious in Phase II trials: 0.8 g/m2 weekly, until disease progression.

The NGR015 trial was based on NGR010 Phase II trial results in 57 chemo-pre-treated patients with malignant pleural mesothelioma who received NGR-hTNF as monotherapy - either every three weeks or weekly. The overall results showed a disease control rate of 46%, a median progression-free time of 4.7 months and a median survival time of 12.1 months, while the median survival time historically reported in this setting is approximately 6 months (Krug LM et al., European Multidisciplinary Cancer Congress 2011). The comparison of the 3-year overall survival rates between the weekly and every-three-week cohorts showed a clear advantage of the dose intensification approach.

About NGR-hTNF

NGR-hTNF is a vascular targeting agent with unique mode of action, and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumour vasculature. It consists of a tumour homing peptide (NGR) that selectively binds tumour blood vessels, fused to the human cytokine TNF. NGRhTNF is undergoing clinical development both as monotherapy and in combination therapy, in seven indications. Currently ongoing randomised trials of NGR-hTNF include a Phase III trial in mesothelioma and four Phase II trials in non-small-cell lung cancer, soft tissue sarcomas, ovarian cancer and mesothelioma as first-line maintenance therapy. Other Phase II trials of NGR-hTNF include completed trials for mesothelioma, colorectal, liver, ovarian and small-cell lung cancer. NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and liver cancer in both the EU and the US.

About malignant pleural mesothelioma (MPM)

MPM is a form of cancer that is almost always caused by repeated exposure to asbestos fibres. With an incidence of approximately 1/100,000, MPM is still a relatively rare type of cancer, but has been progressing fast in the past 20 years as incidence rates have continuously increased. MPM has a long latency period and symptoms are non-specific, so that in most cases diagnosis is difficult before the advanced stage of the disease is reached. Research indicates that MPM may affect each year more than 10,000 people in the EU and the US. No treatment of malignant mesothelioma has been approved for second line, leaving affected patients with a poor prognosis and limited survival time.

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.

About MolMed

MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anticancer therapies. MolMeds pipeline includes two novel therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in highrisk 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. MolMeds shares are listed on the main market (MTA) of the Milan Stock Exchange (Ticker Reuters: MLMD.MI).

Fonte: MolMed

by: Molmed

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