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Max Planck Research leads to EU approval for cancer medication

The European Union has now approved SUTENT®. The basic mechanism behind the medication was discovered in the 1990s by Max Planck scientists, led by Prof. Axel Ullrich. The resulting patents were licensed by Garching Innovation GmbH, the technology transfer organisation of the Max Planck Society.

At the end of July, the EU commission approved SUTENT® for the treatment of two varieties of advanced cancers: renal cell carcinoma (RCC; kidney cancer), and gastro-intestinal stroma tumours (GIST, a rare form of gastro-intestinalcancer). The treatment can only be used if standard therapies fail, or the patient's body cannot tolerate these. SUTENT® has already been approved by the U.S. Food and Drug Administration (FDA), and will be available in Germany in coming days.

SUTENT® is based on research by Max Planck scientists. Prof. Axel Ullrich, cancer researcher and Director at the Max Planck Institute of Biochemistry in Martinsried, Germany, led a group of scientists at the beginning of the 1990s, who showed that tumour tissue can be slowed in its growth when blood vessel formation is inhibited. Blood vessels provide tumour cells with nutrients and oxygen. The strategy to inhibit blood vessel formation is to block the growth factor VEGF, which is secreted from tumour cells and triggers the building of blood vessels. Ullrich and his Ph.D. student, Birgit Millauer, working with their colleague Werner Risau at the Max Planck Institute of Neurobiology, discovered that shutting off a specific VEGF receptor – Flk-1/VEGFR2 – can suppress the creation of blood vessels and slow tumour growth. This discovery allowed for the development of 'anti-angiogenesis medications' (angiogenesis = creation of blood vessels).

The VEGF receptor belongs to the tyrosine kinase receptors, a class of proteins which stretch from the outside of the cell membrane to the inside. They function like a switch, turning on and off when they come into contact with certain growth factors. This contact triggers changes in the metabolism and gene activity in the interior of the cell, causing a complex cascade of signals. Tyrosine kinases and the signal cascades getting switched on and off are responsible, among other things during an organism's development, for the building of various tissues – for example nerves, blood vessels, and connective tissue. In cancer, the signals are often disturbed by the tumour – or activated, accelerating and controlling its own growth. The know-how and patents related to VEGF, Flk-1, and a number of other tyrosine kinases, were licensed through the Max Planck Society respectively Garching Innovation via SUGEN, Inc., founded by Axel Ullrich and Josef Schlessinger, the Max Planck Society and New York University in 1991. SUGEN was the first biotechnology company founded by the Max Planck Society.

SUGEN developed chemical substances which blocked the receptor Flk-1/VEGFR2, among others. In 1999, SUGEN Inc. was taken over by Pharmacia, and merged into Pfizer in 2003, where the development continued. SUTENT® (active ingredient Sunitinib) is now approved for the European market. It is a multi-specific tyrosine kinase inhibitor, which inhibits the development of not only blood vessels in tumours, but also proteins related to the illness, in the signal network of the tumour cells.

The reasons for approval, in the case of advanced renal cell cancer, arise from data in two open clinical Phase II studies*, with 169 patients for whom standard therapies had failed. 38% and 36.5% of patients treated with SUTENT® produced a response. The reasons for approval of SUTENT® as a therapy for GIST come from data from a
Phase III study*, on 312 GIST patients in an advanced stage who could not tolerate standard therapies or for whom standard therapies failed. The researchers were able to show that the time until new tumour growth was five times as long when treated with SUTENT® as with a control group under a placebo. 'SUTENT® is an important step forward in treatment, because the two types of cancer have for a long time been considered difficult to treat particularly in their advanced stages,' says Dr Michael Warmbold, Director Medical Affairs at Pfizer Germany. With SUTENT® the EU Commission has, for the first time, approved a medication under special conditions. The approval for treatment of advanced renal cell cancer succeeded on the basis of comparatively early data from clinical development, because there was great need for therapeutic options until more data becomes available. Data from a Phase III study at Pfizer are being presented to the EU in August 2006.

SUTENT® is currently being tested in patients with breast, lung, intestinal, prostate, and various other types of cancer. The studies are in various phases of clinical trials (Phase I to III), and are usually carried out in combination with other therapies.

SUTENT® is actually the second cancer medication that Ullrich has helped develop. Seven years ago, a breast cancer therapy called Herceptin® was brought onto the
market, and Ullrich took part. SUTENT® is one of the first therapies which inhibits tumour development at various sites at the same time. 'Such "multi-specific" medications make possible a therapy, using a combination of various active ingredients, that allows us to "beat out" tumour cells, before they quickly change,'  says Ullrich. 'We hope that multitargeted therapies will, in the future, lead to cancer treatments which allow patients to have better, longer lifes.' With a doctor's prescription, patients could take the medication orally, which prevents the need for ambulant treatments like chemotherapy.
Ullrich has some 500 publications. In 2003 Science Watch listed him as the most cited German scientist of the years 1983-2002. He and his staff have filed some 60
patents. It is not just as a scientist that he belongs among the world's most successful cancer researchers. He has founded four biotech companies, three on the Max Planck campus in Martinsried. Since 1988, he has been leading the department of Molecular Biology at the Max Planck Institute for Biochemistry. Since 2004 he has been leading and coordinating the "Oncogenome Project" at the Centre for Molecular Medicine at the Agency for Science, Technology, and Research (A*STAR) in Singapore. 

'The success story of SUTENT® shows how important it is to take results from basic research and turn them into useful products, through patenting and founding companies,' comments Jörn Erselius, Managing Director of Garching Innovation GmbH. 'We also are pleased that part of the revenue comes back to benefit the research.' 

Contact
Dr. Jörn Erselius
Ulrich Mahr
Garching Innovation GmbH, Munich
Phone: +49 (0)89 290919-0
Fax: +49 (0)89 290919-99
Email: gi@garching-innovation.de 

Prof Axel Ullrich
Max Planck Institute of Biochemistry, Martinsried
Phone: +49 (0)89 8578-2824 or -2512
Fax: +49 (0)89 8578-2943
Email: diehl@biochem.mpg.de; gmeinder@biochem.mpg.de 

Garching Innovation GmbH
Garching Innovation GmbH (GI) advises and supports Max Planck scientists in filing and registering patents. GI markets the resulting patents and technologies to industry, and supports founders of start-ups based on the results of basic research at the Max Planck Society.
Every year, GI evaluates some 130 inventions, and 80 to 100 of them lead to a patent application. In the last 5 years, GI has supported the founding of 28 companies, completed over 450 licensing contracts, and brought in about 90 million euros revenue for inventors, Max Planck Institutes, and the Administrative Headquarters of the Max Planck Society. GI is amongst the most important technology transfer organisations in the world.

*Before a cancer medication is approved for the market, its effectiveness has to be proven in clinical studies. These studies have three phases: Phase I: in a small group of patients, the dosage and tolerability of the active ingredients are tested. The only patients which participate are those for which there is no other therapy. Phase II: building on the results of the Phase I studies, a larger group of patients is used to test the effectiveness of the dosage. Phase III studies test how effective and tolerable a medication is on a larger number of patients.

Notice:
Pfizer Press Conference on SUTENT® 's entry into the market, with Prof. Axel Ullrich on September, 19 in Hamburg
Please direct enquiries for the Press Conference to Dr. Nina Demling or Martin Flörkemeier,
Edelman PR Agency.
Tel.: +49 (0)69 75 61 99-32 or -49
Fax: +49 (0)69 75 61 9913
nina.demling@edelman.com
martin.floerkemeier@edelman.com

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