Boehringer Ingelheim Initiates First Phase III Clinical Trial in Ovarian Cancer

Ingelheim, Germany (ots/PRNewswire) - Boehringer Ingelheim
announced today the initiation of a new phase III clinical trial to
evaluate one of its two late-stage oncology pipeline compounds for
the treatment of patients with advanced ovarian cancer. The clinical
study, called LUME-Ovar-1 trial, investigates the compound BIBF 1120,
a novel oral anti-angiogenic agent[1], for its efficacy and safety as
first-line treatment in combination with standard chemotherapy
compared to placebo in combination with standard chemotherapy in
patients with advanced ovarian cancer.

The LUME-Ovar 1 trial / AGO-OVAR 12

AGO-OVAR 12 or LUME-Ovar 1 is an intergroup study conducted by an
international consortium of study groups led by the AGO Study Group
(Arbeitsgemeinschaft Gynaekologische Onkologie Study Group, Germany),
and Boehringer Ingelheim. BIBF 1120 (planned brand name Vargatef(TM))
is a novel oral compound that works by simultaneously inhibiting
three receptors involved in the formation of blood vessels, a process
also called angiogenesis, which is needed for tumours to grow and
spread.

"Anti-angiogenic compounds are one of the most promising new
approaches in treating cancer, and ovarian cancer appears to be
particularly sensitive to these novel agents, as suggested by early
clinical trials." said Andreas du Bois, MD, PhD, of AGO Study group
and International Coordinating Investigator of this trial. "BIBF 1120
inhibits several aspects of the pathway that controls the growth of
new blood vessels, and it has already been shown to be both effective
and well tolerated in previous trials, including a recently completed
phase II trial of BIBF 1120 in ovarian cancer."

The AGO Study group has already performed a phase I/II study and
developed the combination now evaluated. "Based on our good
experience with this combination," said Dr. Philipp Harter MD , of
AGO study group and principal investigator of the starting trial, "we
look forward to continue investigating this novel compound in ovarian
cancer patients in the first line setting."

The decision to progress BIBF 1120 into a phase III trial in
ovarian cancer was based on previous study results which indicate
that the agent may be both efficacious and well tolerated as
maintenance therapy in patients with relapsed ovarian cancer who had
responded to prior chemotherapy. Data presented this year at the
annual meeting of the American Society of Clinical Oncology (ASCO)
showed that in the trial women with ovarian cancer treated with BIBF
1120 were less likely to experience progression of their disease
compared to those treated with placebo: at 36 weeks, 14.3% of women
taking BIBF 1120 were progression-free compared to 5% of women taking
placebo.[2] This phase II trial represents the first published
randomised, placebo controlled data of an anti-angiogenic agent in
ovarian cancer.

As angiogenesis plays a pivotal role in the growth of all solid
tumours, BIBF 1120 is currently being investigated in a number of
cancers including advanced non-small cell lung cancer (NSCLC),
colorectal cancer (CRC), renal cell cancer (RCC) und hepatic cell
cancer (HCC).

BIBF 1120 is one of Boehringer Ingelheim's most advanced
compounds along with BIBW 2992 (planned trade name Tovok(TM)), both
of which are currently in phase III development for the treatment of
patients with advanced non-small cell lung cancer, a patient
population with limited treatment choices.

LUX-Lung 1 Trial: Development progress with BIBW 2992

In the clinical development of the compound BIBW 2992, a
milestone has been reached recently. The company completed patient
recruitment for a Phase III Lung cancer trial, the LUX-Lung 1 trial.
LUX-Lung 1 investigates BIBW 2992 (planned brand name Tovok(TM)) plus
best supportive care (BSC) versus placebo plus BSC in non-small cell
lung cancer patients who have experienced a failure of treatment with
erlotinib or gefitinib (EGFR TKI failures).

Boehringer Ingelheim believes in evidence-based, scientific
progress; its extensive oncology clinical trial programme involves
more than 800 study centers in 47 countries. Boehringer Ingelheim has
a dedicated cancer research center in Vienna where scientists are
focused on the discovery and development of new treatments to combat
or alleviate cancer.

About Ovarian Cancer

Ovarian cancer often goes undetected until an advanced stage, and
is sometimes referred to as the "silent killer". According to the
2008 World Health Organization World Cancer Report, as of 2002,
ovarian cancer was ranked as the 6th most common cancer in women, and
is considered the most lethal of gynaecological malignancies.
Approximately 204,000 new cases were diagnosed worldwide and 125,000
women died from the disease in 2002.[3] The ACS estimates that about
21,550 new cases of ovarian cancer were diagnosed in the United
States (U.S.) during 2008. Only forty-five percent of women with
ovarian cancer are still alive five years after diagnosis in the U.S.
[4]

About AGO

The AGO Study group is a German cooperative study group active in
clinical research in gynecological oncology for almost 20 years with
great experience in developing and optimizing therapeutic standards
in first and second line treatment of ovarian cancer. Together with
other European and overseas cooperative study groups, AGO has
developed the current standard regimens.

About 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. Working in
close collaboration with the international scientific community and a
number of the world's leading cancer centers, 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 is currently in Phase III
clinical development in NSCLC, 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 program, which is investigating BIBF 1120 in combination with
standard second-line chemotherapy treatments for patients with
advanced NSCLC, is 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.

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 11.6 billion
euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit
http://www.boehringer-ingelheim.com

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[1] An anti-angiogenic agent inhibits angiogenesis, the process
of formation of vessels toward the tumour. The vessel supplies the
tumour with oxygen and nutrients to enable its further growth, a
pre-requisite for the tumour to spread.

[2] Ledermann J, et al. J Clin Oncol 2009; 27 (Suppl 15):
Abstract 5501

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

[4] 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.

ots Originaltext: Boehringer Ingelheim GmbH
Im Internet recherchierbar: http://www.presseportal.de

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