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MolMed starts a randomised Phase II trial of NGR-hTNF in a new indication, soft tissue sarcomas

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Thursday, October 28, 2010

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Milan,Italy -- MolMed S.p.A. (Milan:MLM) announces the enrolment of the first patient in a randomised Phase II trial (NGR016) of its investigational anticancer drug NGR-hTNF for the treatment of soft tissue sarcomas (STS).

The trial, expecting to enrol 96 patients, will investigate the administration of NGR-hTNF either as single agent or in combination with doxorubicin. The objectives of the trial include evaluation of the clinical activity in terms of progression-free survival (PFS), and of the biological effect in terms of tumour metabolic response analysed by PET scan.

Claudio Bordignon, MolMed’s chairman and CEO, comments: “We decided to explore the therapeutic potential of NGR-hTNF in this new indication because it represents a high unmet medical need, and also on the grounds of a strong scientific rationale. Soft tissue sarcomas are highly vascularised tumours, and the efficacy of TNF in their treatment, used as loco-regional therapy at high doses for isolated limb perfusion, has already been extensively documented”.

About soft tissue sarcomas (STS)

Sarcomas are a heterogeneous group of malignancies, including more than 50 different subtypes, that develop in tissues which connect, support, or surround other structures and organs of the body. Soft tissue sarcomas (STS) can develop from muscles, tendons, fibrous tissues, fat, blood vessels, nerves, or synovial tissues: the majority occurs in the limbs (i.e. arms or legs). STS are uncommon, accounting for approximately 1 percent of all new cancer cases. As far as therapeutic options are concerned, surgery with a goal of limb salvage is useful for locally recurrent disease, while radiotherapy may provide substantial control of symptoms, particularly for patients with unresectable localised disease. Pharmacotherapy is used as loco-regional treatment for isolated limbs: melphalan is the drug most commonly used, and the addition of TNF - approved in Europe for this kind of treatment - may further improve results. Systemic pharmacotherapy has a palliative role. Despite the availability of these treatments, prognosis for patients with advanced disease is poor.

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, randomised trials of NGR-hTNF include a Phase III trial in malignant pleural mesothelioma and two Phase II trials, for non-small-cell lung cancer and for soft tissue sarcomas. Additional 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 - in both the EU and the US - for the treatment of mesothelioma and of liver cancer.

About MolMed

MolMed S.p.A is a biotechnology company focused on research, development and clinical validation of novel antitumour therapies. In addition to NGR-hTNF, MolMed’s pipeline includes another anticancer therapeutic in clinical development, TK, a cell-based therapy enabling bone marrow transplant from partially compatible donors, in Phase III for high-risk acute leukaemias. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The company’s shares (MLM) are listed at the Standard segment (class I) of the MTA managed by Borsa Italiana.


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.

For further information, please contact:

Holger Neecke
Director Business Development, Investor Relations
MolMed S.p.A.
phone: +39 02 21277.205
fax: +39 02 21277.325

Elena Lungagnani
Communication Manager
MolMed S.p.A.
phone: +39 02 21277.207
fax: +39 02 21277.325


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.

Source: MolMed S.p.A.
2.8 from 8 votes
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