14 de octubre de 2019
15 de mayo de 2009

Boehringer Ingelheim to Present New Phase II Clinical Data on Two Lead Oncology Compounds at ASCO 2009 (y 2)

Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world's leading cancer centres, Boehringer Ingelheim is committed to discovering and developing novel cancer treatments. This commitment is underpinned by using advances in science to develop a range of targeted therapies in areas of medical need, including various solid tumours and haematological cancers.

The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. BIBW 2992 entered Phase IIb/III clinical development in NSCLC earlier in 2008 and was granted Fast Track designation for a third/fourth line treatment indication in NSCLC by the US Food & Drug Administration. In addition, the LUME-Lung Phase III clinical trial programme, which is investigating BIBF 1120 in combination with standard second-line chemotherapy treatments for patients with advanced NSCLC, is currently ongoing. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing inhibitors of polo-like kinase 1 (Plk1), a protein that is involved in the processes of cell division. These molecules are in the early stages of clinical development.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of US$17 billion (11.6 billion euro) while spending one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For U.S. journalists, please visit http://us.boehringer-ingelheim.com

For journalists outside the U.S., please visit http://www.boehringer-ingelheim.com

Note:

Please be advised this release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document.

References

1. Shih J-Y et al. "A Phase II study of BIBW 2992, a novel irreversible dual EGFR and HER2 tyrosine kinase inhibitor (TKI), in patients with adenocarcinoma of the lung and activating EGFR mutations after failure of 1 line of chemotherapy (LUX-Lung 2)." Poster Discussion Presentation. 1 June 2009, Session Time: 8:00AM - 12:00PM. #8013

2. Ledermann, J. A. "A randomised Phase II placebo-controlled trial using maintenance therapy to evaluate the vascular targeting agent BIBF 1120 following treatment of relapsed ovarian cancer (OC)." Oral presentation, Clinical Science Symposium. Monday, 1 June 2009, Session Time 9:45AM - 11:15AM. # 5501

3. "Ask the Expert Online Q&A: Are the number of cancer cases increasing or decreasing in the world?" 1 April 2008. World Health Organization. 5 May 2009. http://www.who.int/features/qa/15/en/print.html.

4. Li D et al. "BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models." Oncogene 2008;27:4702-4711

5. Boehringer Ingelheim Pharmaceuticals. "BIBW 2992 and BSC Versus Placebo and BSC in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)" 23 April 2009. ClinicalTrials.gov. 5 May 2009. http://clinicaltrials.gov/ct2/show/NCT00656136?term=BIBW+299....

6. Lynch, T. J. et al. "Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib." N. Engl. J. Med. 350, 2129-2139 (2004). Available at: http://content.nejm.org/cgi/reprint/350/21/2129.pdf. Accessed on 5 May 2009.

7. Paez, J. G. et al. "EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy." Science 304, 1497-1500 (2004). Available at: http://www.sciencemag.org/cgi/reprint/1099314v1.pdf?maxtosho...

Accessed on 5 May 2009.

8. Pao, W. et al. "EGF receptor gene mutations are common in lung cancers from 'never smokers' and are associated with sensitivity of tumours to gefitinib and erlotinib." Proc. Natl Acad. Sci. USA 101, 13306-13311 (2004). Available at: http://www.pnas.org/cgi/doi/10.1073/pnas.0405220101. Accessed on 5 May 2009.

9. Riely G. J. et al. "Clinical Course of Patients with Non -Small Cell Lung Cancer and Epidermal Growth Factor Receptor Exon19 and Exon 21 Mutations Treated with Gefitinib or Erlotinib." Clin. Cancer Res, 12, 839-844(2006). Available at: http://clincancerres.aacrjournals.org/cgi/reprint/12/3/839. Accessed on 5 May 2009.

10. Balak, M. N. et al. "Novel D761Y and common secondary T790M mutations in epidermal growth factor receptor-mutant lung adenocarcinomas with acquired resistance to kinase inhibitors." Clin. Cancer Res. 12, 6494-6500 (2006). Available at: http://clincancerres.aacrjournals.org/cgi/reprint/12/21/6494. Accessed on 5 May 2009.

11. Yang C-H et al. "Phase IIb/III double-blind randomized trial of BIBW 2992, an irreversible, dual inhibitor of EGFR and HER2 plus best supportive care (BSC) versus placebo plus BSC in patients with NSCLC failing 1-2 lines of chemotherapy (CT) and erlotinib or gefitinib (LUX-Lung1): a preliminary report. General Poster Session: Lung Cancer - Metastatic." Saturday 30 May 2009, Session Time: 2:00PM - 6:00PM. # 8062

12. Hilberg F. et al. "BIBF1120 a novel, small molecule triple angiokinase inhibitor: profiling as a clinical candidate for cancer therapy." European Journal of Cancer Supplements. 2004; 2:50.

13. Lewis J. Kleinsmith. "Understanding Cancer and Related Topics: Understanding Angiogenesis." Rockville: National Cancer Institute, 2006. Available at: http://cancer.gov/cancertopics/understandingcancer. Accessed on 5 May 2009.

14. P Boyle and B Levin (eds). "World Cancer Report 2008.", World Health Organization: International Agency for Research on Cancer. Lyon: 2008.

15. American Cancer Society. "Cancer Facts and Figures 2008." Atlanta: 2008. Available at: http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf. Accessed on 5 May 2009.

16. American Cancer Society. "Ovarian Cancer Detailed Guide." Atlanta: 2008. Available at: http://documents.cancer.org/114.00/114.00.pdf. Accessed on 5 May 2009.

Corporate / Global Media Contact: Julia Meyer-Kleinmann, Head Science & Technology Communications, Boehringer Ingelheim GmbH, Tel.: +49-6132-77-8271, Mob: +49-178-2908178, Email: press@boehringer-ingelheim.com