2008-10-22

Boehringer Ingelheim Broadens Oncology Pipeline With Promising New Data for Potentially First in Class Plk1 Inhibitor


Ingelheim, Germany (ots/PRNewswire) -

- BI 6727, a Highly Potent and Selective Plk1 inhibitor,Represents Latest Advance in Company's Plk1 Programme

- For non-US Healthcare Media

Boehringer Ingelheim's most promising new cell cycle kinaseinhibitor and potentially first-in-class compound, BI 6727, has shownencouraging results in a phase I clinical trial in patients withadvanced tumours who have failed to respond to other treatments.(1)The data, presented today at a prestigious plenary session andincluded in the official press conference of the 20th EORTC-NCI-AACRSymposium in Geneva, Switzerland, is testament to the company'songoing commitment to research and development of innovative cancertreatments in areas of significant unmet medical need. BoehringerIngelheim's research efforts are focused on three main areas:angiokinase inhibition, signal transduction inhibition and cell cyclekinase inhibition, under which BI 6727 falls.

Unlike established anti-cancer agents, BI 6727 works byselectively blocking a part of the cell's make-up that is crucial forcell division. BI 6727 is one in a series of compounds beingdeveloped by Boehringer Ingelheim in this field. By inhibiting theactivity of Polo-like kinase 1 (Plk1), which is highly expressed inproliferating cells and most tumours, BI 6727 effectively disruptsthe cell division and induces cell death, thereby inhibiting cancergrowth. Due to its unique mode of action, typical side effectsinduced by established anti-mitotic agents such as neuropathy havenot occurred.

According to Professor Patrick Schöffski, Head of the Departmentof Medical Oncology at the University Hospitals Leuven, Belgium,Chairman of the scientific committee for the congress, secretarygeneral of the EORTC and lead investigator in the trial, the resultsindicate an exciting scientific advance.

"Compelling new science in fields such as cell cycle kinaseinhibition brings us a step closer to better understanding themultiple pathways involved in the growth and spread of tumours andwill hopefully provide us with better treatments to add to thearmoury against this deadly disease," said Professor Schöffski.

"Results to date for BI 6727 have indicated that the drug can besafely administered to patients with advanced solid tumours and thatit has potential anti-tumour activity. This agent certainly warrantsfurther investigation," he added.

In the study, which assessed the maximum tolerated dose, overallsafety, pharmacokinetics and preliminary efficacy of BI 6727, a totalof 50 patients were treated at doses of 12 to 450 mg. Results wereencouraging; 32% of patients had stable disease and two patients withadvanced bladder and ovarian cancers showed confirmed responses, bothof whom had previously failed other standard and experimentaltreatments. The clear anti-tumour activity demonstrated, nottypically seen in a phase I trial, illustrates the significance ofthese findings. Furthermore, BI 6727 was shown to be well-toleratedwith no serious side effects detected.

Preclinical data(2) were also presented at the meeting whichshowed highly selective target inhibition, cellular activity at verylow levels and long-lasting tumour exposure for BI 6727. This,combined with the phase I data presented suggests a promising futurefor BI 6727, supporting Plk1 as a therapeutic target and warrantingfurther investigation.

The new results presented today complement Boehringer Ingelheim'sadditional progress in the fields of signal transduction inhibitionand angiokinase inhibition. Boehringer Ingelheim recently announcedthe commencement of pivotal phase III trials for its most advancedcompound, signal transduction inhibitor Tovok(TM) (BIBW 2992) and itsnovel triple angiokinase inhibitor(3) Vargatef(TM) (BIBF 1120) isplanned to enter phase III in the near future.

Commenting on the growth of the Boehringer Ingelheim oncologyportfolio, Dr Manfred Haehl, Corporate Senior Vice President Medicineat Boehringer Ingelheim said, "The latest data for our Plk1 inhibitorBI 6727, including initial safety and efficacy results, furtherreinforce our continued growth in oncology research and are evidenceof our sustained leadership in Plk1 inhibition. As a company, we arereally excited by the potential these impressive first results holdand look forward to ongoing growth within our oncology pipeline."

Based on the encouraging results presented at the EORTC-NCI-AACRSymposium, BI 6727 will advance further in clinical development. ThePhase II programme will assess the efficacy and safety of BI 6727 inseveral tumour types.

About Boehringer Ingelheim in Oncology

Building on scientific expertise and excellence in the fields ofpulmonary and cardiovascular medicine, metabolic disease, neurology,virology and immunology, Boehringer Ingelheim has embarked on a majorresearch programme to develop innovative cancer drugs.

Boehringer Ingelheim is committed to discovering and developingnovel cancer treatments that have the potential to providesignificant clinical and quality of life benefits for patients. Thiscommitment is underpinned by using advances in science to develop arange of targeted therapies in areas of medical need, includingvarious solid tumours and haematological cancers.

The current focus of research includes compounds in three areas:angiogenesis inhibition, signal transduction inhibition andcell-cycle kinase inhibition.

Boehringer Ingelheim is working in close collaboration with theinternational scientific community and a number of the world'sleading cancer centres to research and develop these potential newtreatments for cancer.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 135 affiliates in 47 countries and 39,800employees. Since it was founded in 1885, the family-owned company hasbeen committed to researching, developing, manufacturing andmarketing novel products of high therapeutic value for human andveterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billioneuro while spending one fifth of net sales in its largest businesssegment Prescription Medicines on research and development.

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

Please be advised

This release is from Boehringer Ingelheim Corporate Headquartersin Germany. Please be aware that there may be national differencesbetween countries regarding specific medical information, includinglicensed uses. Please take account of this when referring to theinformation provided in this document. This press release is notintended for distribution within the USA.

References

1. Schöffski, P et al. A phase I single dose escalation study ofthe novel polo-like kinase I inhibitor BI 6727 in patients withadvanced solid tumours. Presented Thursday 23 October 2008 at the20th EORTC-NCI-AACR. Plenary session 5. Molecular targets-state ofthe science 10:15-12:00. Abstract Number: 36.

2. Rudolph, D et al. Characterisation of BI 6727, a novelpolo-like kinase inhibitor with a distinct pharmacokinetic profileand efficacy in a model of taxane-resistant colon cancer. PresentedThursday 23 October 2008 at the 20th EORTC-NCI-AACR. Poster DisplayPeriod: 12:00PM -15:00PM; Abstract Number: 430.

3. Hilberg F et al. Eur J Cancer Suppl. 2004;2:50.

ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de

Contact:Contact: Julia Meyer-Kleinmann, Science & Technology Communications, Boehringer Ingelheim GmbH, Tel.: +49-6132-77-8271, Email: press@boehringer-ingelheim.com

Boehringer Ingelheim

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