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Press Release

Re. Statement regarding media coverage on pre-clinical integrin inhibitor study in animal model, published in Nature Medicine (22nd March 2009)

Merck Serono
Posted on: 24 Mar 09

Isolated preclinical animal experiment findings do not reflect the actual clinical experience

In a preclinical study published in Nature Medicine, findings from mouse models investigating integrin inhibitors in selected tumor types showed that continuous exposure to very low concentrations of our investigational drug cilengitide may increase tumor growth.

These data diverge from previous findings in numerous other preclinical models of cilengitide in vitro or in vivo. Moreover, the investigators’ negative conclusions for the use of such inhibitors in clinical therapy are not reflected in the actual clinical experience. In general, the relevance of preclinical models can only give ideas: the key proof is the clinical situation in humans. Unfortunately the current status of clinical development was misrepresented by the authors.

Cilengitide is currently in Phase III development for brain tumors (newly diagnosed glioblastoma) based on a number of promising Phase II studies, demonstrating clear activity by increasing progression-free and overall survival compared to historical controls. The ongoing Phase III study combining cilengitide with chemoradiotherapy is supported by the leading scientific associations European Organization for Research and Treatment of Cancer (EORTC) and the Canadian Brain Tumor Consortium (CBTC) in a formal collaboration.

Clinical results derived from long term therapy of more than 750 patients treated with cilengitide in various settings support the current development of cilengitide as an anti-cancer drug. Notably, the clinical data for cilengitide in the treatment of glioblastoma both as a single agent and in combination have been encouraging (Stupp et al. ASCO 2007, manuscript in preparation; Reardon et al., JCO 2008; Nabors et al, JCO 2007, Macdonald et al, JCO 2008; ongoing trials NABTC-0302, NABTT-0306).

As an example, we show an MRI scan of a patient in one of the Merck Serono trials below before and under treatment with cilengitide single agent. In a relevant number of cases, even with single agent cilengitide treatment, we observed durable remission of the brain tumor over the period of more than three years. Usually, these patients die within a few months. It might be misleading to draw conclusions concerning the clinical efficacy from results of preclinical experiments.

(Figure taken from Reardon et al., Randomized Phase II Study of Cilengitide, an Integrin-Targeting Arginine-Glycine-Aspartic Acid Peptide, in Recurrent Glioblastoma MultiformeJCO 2008, Vol 26, No 34 pp. 5610-5617)


In addition, all current Merck Serono studies are investigating cilengitide in combination treatment (either radiotherapy and chemotherapy or chemotherapy and another targeted therapy), which are therapeutic settings not investigated in but recommended by the Nature Medicine paper.

Cilengitide, developed in Merck’s own laboratories, is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III development, for glioblastoma. Integrin inhibitors target integrins – specific cell surface receptors that are improperly regulated in many tumor types and involved in cancer growth.


References:

1. Stupp R, Goldbrunner R, Neyns B, et al. Society for Neuro-Oncology, 12th Annual
Meeting, Dallas, TX, USA, November 2007, Abstract No. MA-10.
2. Reardon D, Fink K, Nabors L, et al. Society for Neuro-Oncology, 12th Annual Meeting,
Dallas, TX, USA, November 2007, Abstract No. MA-08.
 

For more information:
www.merckserono.com/en/index.html

Editor's Details

Merck Serono
www.merckserono.com/en/index.html

Last updated on: 27/08/2010

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