12/20/2013 | 02:05am US/Eastern
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PRESS RELEASE
MolMed expands in Russia the Phase II trial of NGR-hTNF for the first line maintenance treatment of pleural mesothelioma
Milan (Italy), 20 December 2013 - MolMed S.p.A. (Milan:MLM) announces the enrolment of the first patient in Russia in the randomised Phase II study (NGR019) of its investigational drug NGR-hTNF for first line maintenance treatment of pleural mesothelioma, a poor-prognosis disease related to exposure to asbestos fibres and with increasing incidence worldwide.
For the same pathology the Company is running a pivotal randomised Phase III study on NGR-hTNF in relapsed patients, for which enrolment was completed in December 2012. The new study aims at extending the potential clinical benefit of the investigational drug to those patients who obtain a tumour response in first line, providing them with a long term maintenance therapy with a high tolerability profile.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: The treatment of the first patient in Russia is an important step in the challenge against mesothelioma, allowing our investigational drug NGR-hTNF to be tested also in those areas where the medical need could be highest in the next few years".
According to a 2006 publication of the US Geological Survey, in the thirty years prior to 2003 Russia was the largest user and producer of asbestos in the world. Based on the aforementioned, coupled with the strong correlation between the cumulative amount of asbestos produced and consumed and mesothelioma incidence, it is estimated that Russia and other countries of East Europe could experience a higher medical need in the next decade. NGR-hTNF, a novel vascular targeting agent, could provide an answer for a pathology currently lacking any approved therapy for first line maintenance and second line therapy.
The study, already ongoing in Europe, foresees the enrolment of 100 patients in Europe and Russia by the end of 2014.
About pleural mesothelioma
Pleural mesothelioma is a form of cancer strongly related with repeated exposure to asbestos fibres (for more information please refer to Park et al, Global Magnitude of Reported and Unreported Mesothelioma, Environmental Health Perspectives, 2011). With an incidence of approximately 1/100,000, pleural mesothelioma is still a relatively rare type of cancer, but has been progressing quickly in the past 20 years as incidence rates have continuously increased. Pleural mesothelioma 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 pleural mesothelioma may affect each year more than 10,000 people in the EU and the US. Currently, only one therapy has been approved for first line treatment, whilst the elevated need for first line maintenance and second line treatment remains unmet. Clinical development of NGR- hTNF - currently in Phase III for second line treatment and in Phase II in first line maintenance - is aimed at filling this therapeutic gap.
About NGR-hTNF
NGR-hTNF is a novel therapeutic agent for solid tumours which displays antitumor activity through its specific binding to blood vessels feeding the tumour mass. NGR-hTNF is being investigated in a large
FROM GENES TO THERAPY
MOLMED S.p.A.
Via Olgettina, 58 - 20132 Milan, Italy | Phone +39 02 21277.1 - Fax +39 02 21277.325 info @ molmed.com - www.molmed.com
Share capital € 27,070,992.30 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159
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PRESS RELEASE
clinical program, including a Phase III trial in malignant pleural mesothelioma (second line), a Phase II trial in malignant pleural mesothelioma (first line maintenance therapy) and five Phase II trials in colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas.
NGR-hTNF has been granted Orphan Drug designation for the treatment of mesothelioma and liver cancer in both the EU and the US.
About Phase II trial NGR019
NGR019 is a randomised, double-blind, placebo-controlled, international, multicentre Phase II trial on 100 adult pleural mesothelioma patients with non-progressive disease after a pemetrexed-based chemotherapy. The trial is powered to detect a progression-free survival benefit for NGR-hTNF, when combined with best supportive care (BSC). NGR-hTNF is administered according to the dose and schedule that were confirmed
as the most efficacious in Phase II trials: 0.8 µg/m2 weekly, until disease progression.
Secondary endpoints include overall survival, tumour response, safety and quality of life.
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14 May 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. MolMed's pipeline includes two antitumour therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of post-transplant immune-suppression, in Phase III in high-risk 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. The Company's shares are listed on the main market (MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)
For further information:
Marina Del Bue
General Manager Business & Administration
MolMed S.p.A.
phone: +39 02 21277.371 fax: +39 02 21277.325
e-mail: investor.relations @ molmed.com
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
FROM GENES TO THERAPY
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MOLMED PRESS RELEASE
statements or adapt them to future events or deve/opments. This document does not constitute an offer or invitation to subscribe or purchase any securities of Mo/Med S.p.A.
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