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Boehringer Ingelheim to Initiate First Phase III Pivotal Study forNew Oncology Compound BIBW 2992

New Data on BIBW 2992(i), a Potent, Irreversible, Second-Generation Oral Signal Transduction Inhibitor Provides Glimpse of Next Chapter in Lung Cancer Care   

INGELHEIM, Germany, Sept. 6 /CNW/ -  Boehringer Ingelheim announced today from the 12th World Conference on  Lung Cancer (WCLC) that the company plans to commence Phase III pivotal trials  in lung cancer with BIBW 2992(i), its novel, second generation, potent,  irreversibly binding, dual inhibitor of EGFR and HER2 and thereby further  demonstrated its commitment to discovery and development of novel compounds in  oncology. Details of this important stage in the clinical development of BIBW  2992(i) are currently being finalised with regulatory authorities in both the USA (FDA) and Europe (EMEA).      

This significant milestone represents an important advance for Boehringer Ingelheim's evolving oncology portfolio and coincides with the presentation of  key data at WCLC for BIBW 2992(i).      

In a phase I study(1) by Spicer et al, evaluating the activity of BIBW  2992(i) in patients with various solid tumours, encouraging results were  obtained in patients with non-small cell lung cancer (NSCLC) with mutated  EGFR. Initial signs of clinical efficacy were observed with durable partial  responses seen in 20% of patients with NSCLC (two female and one male) with at  least two of them having deletions in EGFR exon 19 - a genetic mutation known  to be more common in females, never smokers and in patients with  adenocarcinoma. In addition, BIBW 2992(i) was found to be well tolerated at an oral dose of 50mg daily.      

Study investigator, Dr. James Spicer, Senior Lecturer and Consultant in  Medical Oncology at King's College School of Medicine, Guy's Hospital, London,  U.K., commented on the findings: "More effective treatments for lung cancer,  with fewer side effects, are badly needed. Novel, irreversible EGFR inhibitors  like BIBW 2992(i) provide us with a glimpse of the next chapter in the  evolution of lung cancer care, as they may bridge significant gaps in existing  therapy, for example, addressing issues of resistance to treatment."  "We also need to recognise that not all lung cancer is the same, and an  era of personalised prescribing in oncology is not far away. In particular,  patients most likely to benefit from drugs designed to hit EGFR and related  targets are female, light or never smokers, or those from East Asian  populations, a group who often have adenocarcinoma tumours with mutated EGFR,"  he added.      

Currently in phase II development, BIBW 2992(i) holds promise for  activity against tumours resistant to first-generation inhibitors, due to its  unique, irreversible dual inhibition of EGFR and HER2(2),(3), two oncogenes  associated with poor prognosis and advanced stage cancer. In studies to  date(4), BIBW 2992(i) has been shown to have effect particularly in lung  cancer patients with specific genetic mutations, reinforcing the need for  further research in this field.      

Phase I and Phase II study results from three trials in advanced NSCLC  patients were also presented at WCLC for the triple angiokinase inhibitor BIBF  1120(i), another of Boehringer Ingelheim's key oncology compounds,  simultaneously acting on vascular endothelial growth factor receptor (VEGFR),  platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor  receptor (FGFR).(5)      

In both Phase I studies(6),(7), the dose for BIBF 1120(i) in combination  with pemetrexed or carboplatin/paclitaxel has been determined to be 200mg  twice daily. In all three trials, BIBF 1120(i) has been shown to be safe and  well tolerated. Furthermore, encouraging signs of efficacy have been observed  in the Phase II trial by Reck et al(8) with a considerably high rate of  disease stabilisation (48%) for all patients.      

These data, coupled with the company's commitment to enter its first  pivotal Phase III trial in oncology, mark significant progress for Boehringer  Ingelheim's evolving oncology pipeline, which currently spans three key areas:  signal transduction inhibition, angiokinase inhibition and cell cycle kinase  inhibition.      

Dr. Andreas Barner, Vice Chairman of the Board of Managing Directors at  Boehringer Ingelheim, said of the company's emergence into the field of  oncology "We are using advances and breakthrough science to actively develop  targeted therapies - biologicals and small molecules - in areas of unmet  medical need, with a particular interest in lung cancer. With the progress  made we have again underlined our commitment to discovering and developing  innovative cancer treatments that provide high therapeutic value for patients,  physicians and healthcare providers."     

BIBW 2992(i) and BIBF 1120(i) are the most advanced compounds in the  Boehringer Ingelheim oncology pipeline.      

Founded in 1972, the International Association for the Study of Lung  Cancer (IASLC) is an international organization of 2,000 lung cancer  specialists, spanning 53 countries. IASLC members work towards developing and  promoting the study of etiology, epidemiology, prevention, diagnosis,  treatment and all other aspects of lung cancer. IASLC's mission is to enhance  the understanding and education of lung cancer to scientists, members of the  medical community and the public. In addition to the biannual meeting, the  IASLC publishes the Journal of Thoracic Oncology, a prized resource for  medical specialists and scientists who focus on the detection, prevention,  diagnosis and treatment of lung cancer.   

Boehringer Ingelheim in Oncology   

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, aiming to bridge therapeutic  gaps in cancer therapy. Using technological advances and breakthrough science,  Boehringer Ingelheim actively develops targeted therapies - biologicals and  small molecules - in areas of unmet medical need including both solid and  haematological cancers.       Boehringer Ingelheim is currently focusing on three areas: Angiogenesis  Inhibition, Signal Transduction Inhibition and Cell Cycle Kinase Inhibition.       A dedicated drug discovery facility for new cancer medicines, located in  Vienna, Austria is Boehringer Ingelheim's centre of excellence in oncology  research where more than 200 skilled and highly motivated scientists work to  discover tomorrow's cancer therapies. The heart of the oncology clinical  development is based in Boehringer Ingelheim's site in Biberach, Germany. Both  centres operate in close collaboration with independent research institutes  and experts across the globe.   

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 137 affiliates in 47 countries and 38,400 employees. Since it  was founded in 1885, the family-owned company has been committed to  researching, developing, manufacturing and marketing novel products of high  therapeutic value for human and veterinary medicine.      

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while  spending one fifth of net sales in its largest business segment Prescription  Medicines on research and development.   


     (i)  This compound is an investigational agent. Its efficacy and safety have not yet been fully established.   

     (1). Spicer J et al. Activity of BIBW 2992, an oral irreversible dual EGFR/HER2 inhibitor, in NSCLC with mutated EGFR. Abstract D7-02. Presented at WCLC September 6 2007.   

     (2). Solca F et al. AACR-NCI-EORTC Proceedings, AACR-NCI-EORTC International Conference on Molecular Targets and Cancer            Therapeutics. 2005;118 (Abstract A244).   

     (3). Solca F et al. AACR-NCI-EORTC Proceedings, AACR-NCI-EORTC International Conference on Molecular Targets and Cancer            Therapeutics. 2005;118 (Abstract A242).   

     (4). Data on file, Boehringer Ingelheim   

     (5). Hilberg F et al. Eur J Cancer Suppl. 2004;2:50.   

     (6). Hanna N et al. A Phase I study of continuous oral treatment with the triple angiokinase inhibitor BIBF 1120 together with pemetrexed            in previously treated patients with NSCLC. Abstract P3-091. Presented at WCLC September 5, 2007.   

     (7). Camidge R et al. A Phase I study of continuous oral treatment with the triple angiokinase inhibitor BIBF 1120 together with carboplatin            and paclitaxel in patients with advanced NSCLC. Abstract P3-138. Presented at WCLC September 5 2007.   

     (8). Reck M et al. Phase II double blind study to investigate efficacy and safety of the triple angiokinase inhibitor BIBF 1120 in patients            suffering from relapsed, advanced NSCLC. Abstract B1-03. Presented at WCLC September 4 2007. 

Posted: September 2007