MolMed S.p.A. Release: Results of three Phase II Trials in Lung Cancer Indications Confirm Safety and Antitumour Activity of NGR-hTNF

MILAN, ITALY--(Marketwire - June 03, 2011) - MolMed S.p.A. (MILAN: MLM) today reports new clinical data of its investigational anticancer drug NGR-hTNF in three different lung cancer indications, which will be presented on 4 June at the 47th ASCO Annual Meeting in Chicago. Initial analysis of a randomised Phase II trial in non-small cell lung cancer, along with top line results of a Phase II trial in small-cell lung cancer and long-term follow up of a Phase II trial in mesothelioma, confirm the favourable safety profile as well as the promising antitumour activity of NGR-hTNF.

Claudio Bordignon, MolMed’s chairman and CEO, comments: “These new data represent another important milestone in the development of NGR-hTNF and show our commitment in the treatment of pulmonary tumours, from mesothelioma to non-small cell and small cell lung cancers. These are the results of a intense and diversified effort in clinical development: we have now ongoing several trials including a pivotal Phase III trial in mesothelioma and a randomised Phase II trial in non-small cell lung cancer. In the treatment of mesothelioma, we expect to have the final results of the Phase III study in 2013, while the results of the long-term analysis of the completed Phase II study confirm the efficacy of our treatment-intensification strategy. In non-small cell lung cancer, the first evaluation of the randomised Phase II trial suggests antitumour activity that is particularly evident in patients with squamous histology, and in patients with adenocarcinoma who received maintenance treatment with NGR-hTNF after completion of chemotherapy. These are important results, because this evidence, together with the lack of cumulative toxicity, led us to explore a new treatment option for NGR-hTNF as maintenance therapy. The first application of this new approach is represented by a randomised Phase II trial of first-line therapy in mesothelioma now open for patient accrual.”

• First results of a randomised Phase II trial of NGR-hTNF in combination with cisplatin-based chemotherapy as first-line treatment for non-small cell lung cancer (ASCO abstract 7568). This ongoing trial is investigating the impact of NGR-hTNF in combination with cisplatin-based chemotherapy. So far, 80 patients have been assessed for safety and preliminary antitumour activity. As far as safety is concerned, there were no pulmonary haemorrhage or bleeding events, which have been commonly associated with the use of antiangiogenic agents in patients with squamous histology. First data on clinical activity are promising; there is evidence of improved activity in terms of disease control and duration of progression-free survival in patients either with squamous or non-squamous histology who continued treatment with NGR-hTNF alone as maintenance therapy after completion of chemotherapy, thus confirming the effect of NGR-hTNF in long-term disease control. Recruitment of the trial will continue beyond the planned population of 102 patients in order to ensure the inclusion of an appropriate number of patients with squamous cell histology for a complete primary analysis of this tumour variant.

• Top-line results of a Phase II trial of NGR-hTNF in combination with doxorubicin for the treatment of relapsed small-cell lung cancer (ASCO abstract 7077). The trial enrolled 28 patients: over half of the patients showed disease control, with similar antitumour activity in terms of disease regression in both chemo-sensitive and chemo-refractory patients. One third of patients were progression-free at six months and alive at 1-year, with prolonged clinical benefit observed also in patients heavily pre-treated with two or more prior therapies. Additionally, we observed a double survival time in patients presenting a low Neutrophil to Lymphocyte Ratio (8.4 months) as compared to patients with high ratio (4.6 months). This biological index indirectly confirms the role of the effector immune system in the NGR-hTNF mechanism of action.

• Long-term follow up data of a completed Phase II trial in malignant pleural mesothelioma (ASCO abstract 7089). In this multicentre, single-arm trial, NGR-hTNF was tested as second line therapy in 57 relapsed patients, treated with the same dose of NGR-hTNF administered either every 3 weeks or every week. Long-term survival analysis confirms a strong advantage of the weekly over the tri-weekly administration schedule: the 2-year survival rate was three-fold higher considering the entire patient population and five-fold higher in patients who achieved disease control at the first tumour re-assessment. In both cohorts, patients who achieved disease control at the first tumour re-assessment and continued therapy had a double median survival time with respect to patients who progressed at the first tumour re-assessment and consequently discontinued treatment (16.7 v 8.3 months).

Evaluation of the weekly schedule of NGR-hTNF for the treatment of chemo-pretreated malignant pleural mesothelioma patients is currently being investigated in a double-blind, placebo-controlled randomised Phase III trial. Moreover, based on the long-term effect of the drug in disease control, MolMed announces the start of a randomised, placebo-controlled Phase II trial as first line maintenance treatment for patients who completed the pemetrexed-based chemotherapy. The trial is planning to enrol 100 patients and will investigate the effects of the administration of NGR-hTNF in prolonging the benefits attained with chemotherapy; the primary endpoint of the trial is progression-free survival.

Clinical data obtained by MolMed to date demonstrate the antitumour activity of NGR-hTNF in six different types of solid tumours; these include two orphan indications as well as more widespread diseases, which altogether account for more than 1.4 million new cases each year in Europe, North America and Japan.

Complete schedule of MolMed presentations at ASCO 2011

Abstract # Abstract title Presentation date & time (CDT) 5022 Phase II study of NGR-hTNF plus Friday, 3 June: doxorubicin in relapsed ovarian -- Poster: 2:00-6:00 PM cancer (OC) -- Discussion: 5:00 PM 6526 Mechanism of thymic renewal after Friday, 3 June: infusion of suicide gene-modified -- Poster: 2:00-6:00 PM donor T cells after hematopoietic -- Discussion: 5:00 PM stem cell transplantation (HSCT) in adult patients 2522 Phase I and pharmacodynamic study Saturday, 4 June: of high-dose NGR-hTNF in patients -- Poster: 8:00 AM-12:00 PM with solid tumors -- Discussion: 11:00 AM 7568 Randomised Phase II trial of NGR- Saturday, 4 June: hTNF and chemotherapy in chemo- -- Poster: 2:00-6:00 PM naive patients with non-small cell lung cancer (NSCLC): Preliminary results 7077 Phase II trial of NGR-hTNF and doxorubicin in relapsed small cell lung cancer (SCLC) 7089 NGR-hTNF in previously treated patients with malignant pleural mesothelioma (MPM) 

The six abstracts are available on the website of ASCO 2011 (http://chicago2011.asco.org). The posters will be published on MolMed’s website upon their exposure at ASCO.

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 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. NGR-hTNF is undergoing clinical development both as monotherapy and in combination therapy, in a total of seven indications. Currently ongoing randomised trials of NGR-hTNF include a Phase III trial in mesothelioma and four Phase II trials for 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, for liver cancer and for colorectal cancer, and ongoing trials for small-cell lung cancer and for ovarian cancer. NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and of liver cancer in both the EU and the US.

About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel antitumour therapies. MolMed’s 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 high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent (VTA), 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 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.

DISCLAIMER
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.