MolMed: New Phase II Data on Investigational Drug NGR-hTNF Presented at ASCO
First data of a randomised 1st-line study indicate an extension of survival in squamous cell lung cancer Combination with doxorubicin induces long-term responses in small-cell lung cancer and in ovarian cancer In mesothelioma, 3-year follow-up data confirm the benefit of dose intensification and validate the design of the ongoing pivotal Phase III study
(firmenpresse) - CHICAGO, ILLINOIS and MILAN, ITALY -- (Marketwire) -- 06/04/12 -- MolMed S.p.A. (MILAN: MLM) presented, at the 48th ASCO Annual Meeting, new data on four Phase II clinical trials of its investigational drug NGR-hTNF in as many different types of solid tumours, together with an update on the clinical development of the TK therapy in association with bone marrow transplantation for acute leukemia patients.
Claudio Bordignon, MolMed's chairman and CEO, comments: "In the last few days, we presented at ASCO an overview of our extensive effort in the clinical development of NGR-hTNF, our molecule selectively active on the tumour vasculature, currently the only drug under investigation in Phase III in recurrent pleural mesothelioma. I would like to emphasize that the analysis of long-term results of phase II studies presented this year confirms the extension of survival as the most common clinical benefit observed in these studies. It is of importance that this finding is also confirmed by the primary analysis of patients with squamous cell histology enrolled in the first randomized study of NGR-hTNF presently ongoing in non-small cell lung carcinoma. Another important novelty emerged from these studies and in particular from our efforts to identify potential predictors of response, is the correlation among chills during drug infusion, lymphocyte counts and a prolonged clinical benefit, consistently with the hypothesized mechanism of action of NGR-hTNF."
In synthesis, the presented study data:
In all these indications, the onset of chills during infusion and high levels of circulating lymphocytes predict for greater treatment benefit, consistent with the drug mode of action.
An update on clinical development of TK therapy (ASCO poster no. 6541) will be presented today in a session dedicated to the best ongoing clinical trials. Further, an extension of the indication of TK treatment to patients in relapse will be presented.
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 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 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 Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana. (MILAN: MLM).
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.
Tax identification number 11887610159
Office of Milan Company Register number 11887610159
Share capital as of 30/05/2011: EUR 43,609,036.42 fully paid
Contacts:
MolMed S.p.A.
Holger Neecke
Director Business Development & Investor Relations
+39 02 21277.205
+39 02 21277.325 (FAX)
MolMed S.p.A.
Elena Lungagnani
Communication manager
+39 02 21277.207
+39 02 21277.325 (FAX)
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Datum: 04.06.2012 - 05:00 Uhr
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