MolMed presents new data from four clinical trials on NGR-hTNF at European Multidisciplinary Cancer Congress
Milan (Italy), 27 September 2011 – MolMed S.p.A. (Milan: MLM) presented new data from four clinical trials on its investigational anticancer drug NGR-hTNF at the European Multidisciplinary Cancer Congress, taking place in Stockholm on 23-27 September 2011. The Company reported updated interim results from a randomised Phase II trial in non-small-cell lung cancer, and follow-up data from two completed Phase II trials in recurrent ovarian cancer and relapsed small-cell lung cancer. The clinical development update also included results from a Phase I trial at high doses.
Claudio Bordignon, chairman and CEO of MolMed, comments: “The new interim randomised data in lung cancer look promising particularly in patients with the squamous cell histological subtype, a severe form of lung cancer with high need of new treatment options. As to new follow-up data from the two completed trials, the long-term clinical benefit in two poor-prognosis tumours such as relapsed ovarian and small-cell lung cancer, observed in patients presenting normal lymphocyte counts, confirms the dual mode by which NGR-hTNF exerts its effect, destroying the tumour vasculature and exploiting the effectors of the immune system. There is a growing need for tools, among which predictive biomarkers, to identify patients responding to a specific drug: for NGR-hTNF, a simple blood test such as lymphocyte counts correlates with clinical benefit. This parameter, together with others, might contribute in the future to the identification of patients more likely to get prolonged therapeutic benefit.”
• Randomised Phase II trial in combination with cisplatin-based chemotherapy as first-line treatment of non-small-cell lung cancer (EMCC abstract 9014). The update of this ongoing trial concerns the first 100 patients enrolled. New interim data show continued evidence of improved disease control and enhanced duration of progression-free survival compared with chemotherapy alone, especially in patients with squamous cell histology. Absence of pulmonary haemorrhage or bleeding events (which are associated to the use of antiangiogenic drugs in patients with squamous cell histology) was also confirmed. Final results will be presented at forthcoming international congresses.
• Phase II trial of NGR-hTNF in combination with doxorubicin for the treatment of relapsed ovarian cancer (EMCC abstract 8030). The primary endpoint of the trial - six partial responses in the entire study population - was met after enrolment of less than half of patients. Updated follow-up data show that disease control was achieved in 50% of patients resistant/refractory to prior platinum-based regimens, with a median duration of 5.0 months, and in most patients partially sensitive to prior platinum-based therapy, with a median duration of 7.8 months. Resistant/refractory patients with a normal immune response (measured as normal/high baseline lymphocyte counts) experienced a prolonged clinical benefit, with median progression-free survival of 4.9 months and median overall survival of 15.8 months. On the basis of the positive outcome of this trial, MolMed has started a randomised Phase II trial of NGR-hTNF in combination with doxorubicin for the treatment of relapsed ovarian cancer resistant or refractory to platinum.
• Phase II trial of NGR-hTNF in combination with doxorubicin for the treatment of relapsed small-cell lung cancer (EMCC abstract 9103). Disease control was achieved in more than half the patients, with similar antitumour activity in terms of disease regression in both chemo-sensitive and chemo-refractory patients. Prolonged clinical benefit was also observed in patients heavily pre-treated with two or more prior therapies. Patients with a normal immune response (i.e. normal/high baseline lymphocyte counts) had an almost double median overall survival time (8.4 months) compared to patients with a weak immune response (4.6 months).
• Phase I and pharmacodynamics trial of NGR-hTNF at high doses (EMCC abstract 1205). The trial was designed to evaluate the administration of NGR-hTNF at escalating dose levels, higher than the previously established maximum tolerated dose. Results show that NGR-hTNF can be successfully administered at dose levels up to 325 μg/m2 by using a 2-hour infusion time and mild pre-medication with paracetamol. Antivascular effects were registered by dynamic imaging (DCE-MRI) in 80% of patients.
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.
NGR-hTNF is a vascular targeting agent with a unique mode of action. A first-in-class compound in the class of peptide/cytokine complexes, it is 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, liver cancer, colorectal cancer, small-cell lung cancer and ovarian cancer. NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and liver cancer 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 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; and NGR-hTNF, a novel vascular targeting agent (VTA), in Phase III in malignant pleural mesothelioma and in Phase II in six other 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, on the Standard segment (Class I) of the MTA managed by Borsa Italiana.
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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: September 2011