VIENNA, AUSTRIA and MILAN, ITALY--(Marketwire - Oct. 1, 2012) - MolMed S.p.A. (MILAN:MLM) presented, at the 37th ESMO Congress, three studies on its investigational biological drug NGR-hTNF, including updated results in non-small cell lung cancer (NSCLC) patients and two retrospective analyses evaluating potential predictors of outcome in patients enrolled in Phase I and Phase II trials.
NGR-hTNF, a novel vascular targeting agent, is currently tested in four randomised Phase II trials in NSCLC, soft tissue sarcomas, ovarian cancer and mesothelioma as first-line maintenance therapy. NGR-hTNF is also being evaluated in a pivotal Phase III trial in relapsed mesothelioma patients with accrual completion expected by the end of this year.
Long-term results (median follow-up of 20 months) presented by MolMed at the meeting validate previously presented data and confirm the potential clinical benefit of NGR-hTNF treatment in NSCLC patients with squamous cell histology and in those patients with non-squamous cell histology who were never or light former smokers.
Further, retrospective analyses of patients receiving NGR-hTNF treatment indicate an interesting correlation between infusion-related reactions and patients' response to the therapy: the early onset on treatment of chills could predict drug efficacy, and the reported findings regarding circulating TNF receptors are consistent with the hypothesized mechanism of action of the drug and also clarify why low doses of NGR-hTNF are more efficacious.
Summary of the posters presented at ESMO in Vienna:
Front-line chemotherapy with or without NGR-hTNF in non-small cell lung cancer (ESMO abstract # 1251P). This ongoing randomised Phase II trial is assessing two chemotherapy regimens with or without NGR-hTNF in 121 patients with either non-squamous or squamous histology. NGR-hTNF was safely given to NSCLC patients, including those with squamous cell histology and treated brain metastases: no bleeding events, which contraindicate the use of most anti-angiogenic and targeted drugs, were observed. In non-squamous NSCLC, evidence of NGR-hTNF activity was noted in patients who were never or light former smokers. In squamous NSCLC differences versus the control arm were observed in response rate (33% vs 18%), median progression-free survival (5.1 vs 4.3 months) and median survival (14.2 vs 10.2 months), with one third of patients alive at two years.
Correlation of infusion-related reactions and outcome in patients receiving NGR-hTNF treatment (ESMO abstract # 487P). The retrospective analysis of data from five completed single-arm Phase II trials including a total of 205 patients with resistant/refractory solid tumours (mesothelioma, colorectal, liver, ovarian and small cell lung cancer) shows that two thirds of patients experienced transient chills during the first infusions of NGR-hTNF. Patients treated with the once-per-week schedule had a statistically significantly higher incidence of chills than patients treated with the every-3-weeks schedule. The early onset on treatment of chills independently predicted drug efficacy. Indeed, patients reporting chills had a 4- to 10-fold higher likelihood of response and a 40% lower risk of disease progression or death than those who did not report these events. Similar correlations between adverse reactions and patient response have recently been reported for other approved antiangiogenic drugs.
Impact of soluble TNF-Receptors shedding on outcome in patients treated with NGR-hTNF (ESMO abstract # 488P). The retrospective analysis of data from two completed Phase I trials including overall 60 patients shows a strong, dose-related increase of circulating receptors. Patients receiving low drug doses or with low post-treatment levels of these molecules experienced higher disease control rates and longer progression-free survival than those receiving high drug doses or with high post-treatment levels. Importantly, the highest circulating receptor levels are associated with the worst survival rates.
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 anti-tumour 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).
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.