Date: 2013-12-20
Type of information: Initiation of preclinical development
phase: 2
Announcement: enrolment of the first patient
Company: MolMed (Italy)
Product: NGR-hTNF
Action
mechanism: 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. NGRhTNF is undergoing clinical development both as monotherapy and in combination therapy, in a total of seven indications.
Disease: first line maintenance treatment of pleural mesothelioma
Therapeutic area: Cancer - Oncology
Country: Russia
Trial
details: 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 ?g/m2 weekly, until disease progression. Secondary endpoints include overall survival, tumour response, safety and quality of life.
Latest
news: * On December 20, 2013, MolMed has announced 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. 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.
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.
