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Merck Serono: Patient Enrollment Completed for Cilengitide's Pivotal Phase III Trial CENTRIC


June 9, 2011 - Darmstadt, Germany

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that patient enrollment in the global pivotal Phase III clinical study CENTRICa has been completed. CENTRIC was designed to assess the efficacy and safety of the investigational integrin inhibitor cilengitide in combination with standard treatment in a biomarker-defined subgroup of newly diagnosed patients with glioblastoma (GBM). More than 500 patients have been successfully recruited into this global trial. The primary endpoint of the study is overall survival.

“Completing patient enrollment in the CENTRIC study is a very exciting milestone for us and takes us a step closer to evaluating the efficacy and safety of cilengitide in patients with this aggressive form of brain cancer, an area of high unmet medical need,” said Dr. Oliver Kisker, Senior Vice President for the Global Clinical Development Unit, Oncology at Merck Serono.

Developed in Merck Serono’s own laboratories in scientific collaboration with external partners, cilengitide is the first in a new class of investigational anti-cancer therapies, known as integrin inhibitors, to reach Phase III development. Cilengitide is thought to control tumor growth by working in two ways: through attacking the tumor cells directly in a targeted manner and through starving tumor cells by stopping the formation of new blood vessels that feed the tumor.1 Cilengitide is an investigational agent and has not been approved for commercial distribution.

In Europe, two to three people in 100,000 develop glioblastoma each year.2 In the United States, about three new cases per 100,000 are reported anually.3 Though rare, glioblastoma is the most aggressive form of primary brain tumors and has a poor prognosis in adults with a two-year overall survival rate of 27.2% with standard of care treatment (radiotherapy plus temozolomide).4

About cilengitide’s clinical development program

CENTRIC is a randomized Phase III clinical trial assessing the efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment (radiotherapy plus temozolomide, followed by temozolomide maintenance therapy) versus standard treatment alone in newly diagnosed glioblastoma patients with a methylated methylguanine-DNA methyltransferase (MGMT) gene promoter in the tumor tissue. Other exploratory randomized controlled cilengitide trials currently underway include the Phase I/II COREb companion trial investigating cilengitide in newly diagnosed glioblastoma patients with an unmethylated MGMT gene promoter in the tumor tissue, the Phase I/II CERTOc trial in non-small cell lung cancer and the Phase I/II ADVANTAGEd trial in squamous cell carcinoma of the head and neck.

For more information on studies with cilengitide log on to: http://www.clinicaltrials.gov

a. CENTRIC: Cilengitide in combination with temozolomide and radiotherapy in newly diagnosed glioblastoma Phase III randomized clinical trial

b. CORE: Cilengitide in patients with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter

c. CERTO: Cilengitide and cetuximab (Erbitux®) in combination with platinum-based chemotherapy as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC)

d. ADVANTAGE: Cilengitide in combination of different regimens of cisplatin, 5-FU, and cetuximab to evaluate the safety and efficacy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN)

References

1. Oliveira-Ferrer L, et al. Journal of Experimental & Clinical Cancer Research 2008; 27:86: 1-30.

2. van Rij CM, et al. Pharm World Sci 2005; 27:92-95.

3. CBTRUS (2011). CBTRUS Statistical Report: Primary Brain and Central Nervous System Tumors Diagnosed in the United States in 2004-2007. Available at: http://www.cbtrus.org/2011-NPCR-SEER/WEB-0407-Report-3-3-2011.pdf; last accessed 14 March 2011.

4. Stupp R, et al. Lancet Oncol 2009; 10:459-66.

About cilengitide

Cilengitide is currently being developed by Merck Serono. Cilengitide is the first in a new class of investigational anti-cancer therapies called integrin inhibitors in Phase III of development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC.

Integrins are cell surface receptors that are improperly regulated in many cancer types. This lack of regulation enables them to enhance tumor growth, survival and invasiveness. Integrins are fundamental in the process of angiogenesis (blood vessel growth) – a process that is essential for tumors as it enables them to grow past a finite size.

In addition to the Merck Serono-sponsored studies, the U.S. National Cancer Institute (NCI) is sponsoring a number of clinical trials under a Cooperative Research and Development Agreement (CRADA) with Merck Serono for the development of cilengitide. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride), (Egrifta™, tesamorelin), as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.com or www.merck.de

CONTACTS : Merck Serono Dr. Raphaela Farrenkopf Phone +49 6151-72 2274

Source: Business Wire India

BusinessWireIndia

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