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
Chicago (US)/Milan (Italy), 4 June 2012 – MolMed S.p.A. (MLM.MI) 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:
• Initial results on the survival of a randomised Phase II trial of NGR-hTNF in combination with standard chemotherapy for first-line treatment of non-small cell lung cancer (ASCO poster 7581). This ongoing trial is assessing two chemotherapy regimens with or without NGR-hTNF in 120 patients with either non-squamous or squamous histology. In patients with squamous histology, clinical benefits are observed in combination with NGR-hTNF compared to chemotherapy alone with a 30% relative reduction in the risk of tumour progression and a 50% relative reduction in the risk of death. The value of these results is reinforced by the lack of bleeding events that have severely hampered the use of antiangiogenic drugs.
• Long-term follow-up of two Phase II trials of NGR-hTNF in
combination with doxorubicin for the treatment of relapsed
small-cell lung cancer (ASCO poster 7085) and of relapsed ovarian
cancer (ASCO poster 5059). In these two relapsed tumours, the
combination with doxorubicin induces long-lasting tumour
regressions. In small-cell lung cancer, the antitumor activity of
the combination is independent of prior tumour chemosensitivity and
able to overcome the resistance to previous treatments, with
similar response and survival rates in both resistant and sensitive
patients. In ovarian cancer, 3-year follow-up data show prolonged
survival in those patients who achieved early disease control and
continued treatment (median > 18 months) compared with the
patients who progressed early and discontinued treatment (median
< 4 months). These results are the basis of the ongoing
randomised Phase II trial aimed at assessing standard chemotherapy
with or without NGR-hTNF in 100 patients resistant or refractory to
• Long-term follow up data of a completed Phase II trial in malignant pleural mesothelioma (ASCO poster 7076). The 3-year follow-up results on 57 patients in relapse, receiving NGR-hTNF given either every three weeks or once a week, show that the survival rates for patients receiving the dose-dense schedule are five-fold higher. These results confirm the validity of the design of the pivotal Phase III study, currently the only ongoing in mesothelioma in 2nd-line, aimed at assessing the survival duration in 390 patients receiving either NGR-hTNF or placebo; to date, the trial has enrolled over 200 patients.
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 n ° 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.
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. (Ticker Reuters: MLMD.MI).
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Posted: June 2012