A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.

Start Date22 Feb 2006

Sponsor / Collaborator

Boehringer Ingelheim Austria GmbH

EUCTR2004-002143-27-AT / Not yet recruitingNot Applicable

A double-blind, stratified, randomised, parallel, placebo-controlled, multi-centre study to compare the efficacy and safety of duloxetine hydrochloride (40mg twice a day) and tolterodine tartrate (XL) (4mg once daily) with placebo in patients with symptoms of Urge Urinary Incontinence

Start Date15 Feb 2005

Sponsor / Collaborator

Boehringer Ingelheim Austria GmbH

EUCTR2004-001317-34-AT / Not yet recruitingNot Applicable

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. - RE-MODEL (Thromboembolism prevention after knee surgery)

Start Date02 Dec 2004

Sponsor / Collaborator

Boehringer Ingelheim Austria GmbH

100 Clinical Results associated with Boehringer Ingelheim Austria GmbH

0 Patents (Medical) associated with Boehringer Ingelheim Austria GmbH

Literatures (Medical) associated with Boehringer Ingelheim Austria GmbH

20 May 2016·Journal of Clinical Oncology

Evaluation of VeriStrat, a serum proteomic test, in the randomized, open-label, phase 3 LUX-Lung 8 (LL8) trial of afatinib (A) versus erlotinib (E) for the second-line treatment of advanced squamous cell carcinoma (SCC) of the lung.

Author: Goss, Glenwood D. ; Min, Young J. ; Lee, Ki Hyeong ; Georgoulias, Vassilis ; Göker, Erdem ; Soria, Jean-Charles ; Ehrnrooth, Eva ; Morabito, Alessandro ; Chand, Vikram K. ; Cobo, Manuel ; Felip, Enriqueta ; Solca, Flavio ; Close, Sandra ; Guclu, Salih Z. ; Syrigos, Konstantinos N. ; Dupuis, Nicholas ; Isla, Dolores ; Gibson, Neil ; Krämer, Nicole

e20510Background: Treatment (tx) options for patients (pts) with advanced SCC of the lung after progression on platinum-based chemotherapy are limited. In LL8, the irreversible ErbB family blocker, A, significantly improved OS, PFS and disease control rate vs E, a reversible EGFR TKI, in 795 pts with SCC of the lung. VeriStrat is a serum protein test that utilizes MALDI-TOF mass spectrometry to assign a ‘GOOD' (VS-G) or ‘POOR' (VS-P) classification and has demonstrated prognostic and predictive utility for EGFR targeted therapies in NSCLC.1 Here, the predictive ability of VeriStrat was tested in LL8; OS was the primary efficacy variable. Methods: Pre-tx serum samples, blinded to clinical outcome, were classified as VS-G or VS-P based on predefined reference groups. Clinical outcomes were analyzed with respect to VeriStrat status in the overall population (all pts with both clinical and VeriStrat data) and in predefined subgroups. Results: 675 pts were classified (VS-G: 412; VS-P: 263). In the VS-G group, ...

20 May 2013·Journal of Clinical Oncology

Open-label, phase I/randomized, phase II trial of the triple angiokinase inhibitor, nintedanib, versus sorafenib in previously untreated patients with advanced hepatocellular carcinoma (HCC).

Author: Ma, Yuk Ting ; Palmer, Daniel H. ; Hubner, Richard ; Meyer, Tim ; Studeny, Matus ; Peck-Radosavljevic, Markus ; Fartoux, Laetitia ; Loembe, Arsene Bienvenu ; Graham, Janet ; Hocke, Julia

TPS4160 Background: While sorafenib is established as the standard first-line treatment for patients with advanced HCC, its use can be complicated by the occurrence of drug-related adverse events (AEs). Nintedanib, a potent, oral triple angiokinase inhibitor that targets VEGF, PDGF and FGF signaling (as well as Flt3 and RET), has demonstrated clinical activity in various advanced solid tumors with a relatively low incidence of AEs typically associated with angiogenesis inhibitors (e.g. skin toxicity, hypertension, hemorrhage, and hematologic toxicity) and is currently in phase III for non-small cell lung cancer and ovarian cancer. In the Phase I, dose-finding stage of this ongoing, multicenter, open-label Phase I/II trial (NCT01004003), 200mg twice daily (bid) was established as the maximum tolerated dose of nintedanib in previously untreated patients with advanced HCC (Palmer D, et al. Ann Oncol 2012;23(Suppl 9):ix245[Abs 740P]). Nintedanib had an acceptable liver AE profile; the most common AEs were mild/moderate gastrointestinal toxicities. Methods: The randomized Phase II stage of the trial aims to assess the efficacy, safety, and pharmacokinetics of nintedanib in comparison with sorafenib. Eligible patients have pathologically confirmed, measurable HCC that is not amenable to local therapy, ECOG Performance Status of ≤2, Child-Pugh score of 5–6 (Class A), AST/ALT levels ≤2× upper limit of normal, and no prior systemic therapy. Patients are being stratified by macrovascular invasion and/or extrahepatic spread and then randomized 2:1 to receive nintedanib 200mg bid or sorafenib 400mg bid in continuous 28-day cycles until progression or unacceptable toxicity. Overall, 93 patients were randomized between Sept 2011 and Nov 2012. The primary endpoint is time to progression (TTP) by independent review, according to RECIST 1.0. TTP will be estimated in the treated set by Kaplan–Meier methodology with treatment effects compared using a Cox proportional hazards model. Secondary endpoints include overall survival, tumor response, progression-free survival, safety and pharmacokinetics. Results are due late 2013. Clinical trial information: NCT01004003.

20 May 2013·Journal of Clinical Oncology

Phase II efficacy and safety study of nintedanib versus sunitinib in previously untreated renal cell carcinoma (RCC) patients.

Author: MacLeod, Nicholas James ; Finnigan, Helen ; Shparyk, Yaroslav ; Eisen, Tim ; Temple, Graham ; Studeny, Matus ; Loembe, Arsene Bienvenu ; Bondarenko, Igor ; Jones, Robert ; Kaiser, Rolf

4506 Background: Sunitinib (S) is established as a standard first-line therapy for patients (pts) with advanced RCC. However, treatment can be limited by the occurrence of drug-related adverse events (AEs). This Phase II study assessed the efficacy and safety of nintedanib (N) – a potent, triple angiokinase inhibitor of VEGFR-1–3, PDGFR-α/β, and FGFR-1–3, as well as RET and Flt3 – vs S in previously untreated pts with RCC. Methods: Ninety-nine eligible pts (96 of whom were treated) with advanced, unresectable/recurrent clear cell RCC, an ECOG performance status of 0–1, and no prior systemic therapy were randomized 2:1 to receive N 200 mg twice daily (n=64; given in 4-week cycles) or S 50 mg once daily (n=32; 4 weeks on, 2 weeks off schedule). Treatment continued until disease progression or unacceptable drug-related AEs. Primary endpoints were progression-free survival at 9 months (PFS-9) and, in N-treated pts only, QTc interval change (baseline to day 15). Secondary endpoints included PFS, objective response rate (ORR; RECIST 1.1), overall survival (OS), time to progression (TTP), time to treatment failure (TTF), and AEs. Results: Baseline characteristics were balanced between the arms. PFS-9 was not statistically significantly different between N- and S-treated pts (43 vs 45%; p=0.85). There were also no statistically significant differences between N and S with regard to PFS (median: 8.44 vs 8.38 mo; hazard ratio: 1.16; 95% CI: 0.71–1.89; p=0.56), confirmed ORR (18.8 vs 31.3%; p=0.19), OS (median: 20.37 vs 21.22 mo; p=0.63), TTP (median: 8.48 vs 8.54 mo; p=0.52), and TTF (median: 8.41 vs 8.36 mo; p=0.46). Grade ≥3 AEs occurred in 47% of N-treated pts and 56% of S-treated pts. Common AEs (all grades; N vs S) included diarrhea (61 vs 50%), nausea (38 vs 34%), fatigue (both 25%), and vomiting (16 vs 22%). Dermatologic AEs (8 vs 47%) were less frequent with N than S. There was no increase from baseline in QTc >60 ms on days 1 or 15 in N-treated pts, and there was no relationship between N exposure and QT interval change. Conclusions: N demonstrated similar efficacy to S and had a manageable safety profile, including a lower incidence of dermatologic AEs vs S. In addition, N was not associated with QT prolongation. Clinical trial information: NCT01024920.

News (Medical) associated with Boehringer Ingelheim Austria GmbH

12 Mar 2024

·www.biospace.com

OncoOne Announces Formation of Clinical Advisory Board to Support Development of ON104 for Chronic Inflammatory Diseases

VIENNA--(BUSINESS WIRE)-- OncoOne, a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104. ON104 is a monoclonal antibody targeting the oxidized isoform of the macrophage migration inhibitory factor (oxMIF) for the treatment of chronic inflammatory diseases. “The growing amount of preclinical data for ON104 is very promising and illustrates its broad applicability in key indications such as RA, inflammatory bowel disease, asthma, and nephritis,” commented Randolf Kerschbaumer, Ph.D., CEO of OncoOne. “As we continue to validate our technology’s ability to effectively neutralize disease progression in autoimmune diseases, this board of distinguished experts will be invaluable to the clinical strategy for ON104 and will support OncoOne’s vision of supplying a new class of therapeutic solutions to patient populations with a high unmet medical need.” The members of the OncoOne Clinical Advisory Board include: Richard Bucala, M.D., Ph.D. Richard Bucala, is the Chief of Rheumatology, Allergy & Immunology at the Yale Institute for Global Health and the Waldemar Von Zedtwitz Endowed Professor of Medicine, Pathology, Epidemiology, & Public Health at the Yale School of Medicine. Dr. Bucala is renowned in MIF research and is recognized for discovering MIF's receptor CD74, as well as elucidating MIF's critical role in regulating glucocorticoid immunosuppression. He is an attending physician in the Yale New Haven Health System and is the past Editor-in-Chief of Arthritis & Rheumatology. Dr. Bucala was elected to the American Society for Clinical Investigation (ASCI) and the Association of American Physicians (AAP), in addition to having served on an advisory board for the United Nations and various other U.S. federal, academic, and pharmaceutical organizations. Daniel Aletaha, M.D. Daniel Aletaha is Professor and Head of the Clinical Department of Rheumatology at the Medical University of Vienna. Dr. Aletaha is the current president of the European Alliance of Associations for Rheumatology (EULAR). His research focuses on arthritis and other inflammatory rheumatic diseases, precision medicine, and the management of complex diseases. He has experience in the areas of novel therapies and treatment strategies, diagnosis, prognosis, outcomes, and biomarkers. He currently holds over 350 indexed publications. Seamas Donnelly, M.D. Dr. Seamas Donnelly is a Professor of Medicine at Trinity College Dublin. He is a global leader in translational medicine with a research focus on the development of novel compounds as anti-inflammatory/anti-cancer therapies. He has authored many MIF-focused publications in renowned peer-reviewed journals, including Nature Medicine and Molecular Medicine. Dr. Donnelly’s research epitomizes classical bench to bedside on an international scale, and, in recognition of this, has been awarded an Honorary Professorship in Translational Medicine by the University of Edinburgh. He is the current President of the Association of Physicians of Great Britain & Ireland, the leading academic medical association in the UK and Ireland. Dr. Donnelly is also the lead Trinity PI of Health Innovation Hub Ireland and has been a member of OncoOne’s scientific advisory board since 2022. Michael Freissmuth, M.D. Dr. Freissmuth is the Director of the Center of Physiology & Pharmacology as well as the Chairman of the Institute of Pharmacology at the Medical University in Vienna. He was appointed Professor of Pharmacology in 1995 and received many awards, including the Novartis Award for Medicine. Dr. Freissmuth is a member of numerous editorial boards and serves on several review panels and scientific advisory boards. His most recent appointments include positions on international panels such as the Scientific Advisory Board of the Institut Cochin de Génétique Moléculaire in Paris and of the Engelhorn Foundation for Life Sciences. He is also a member of the supervisory board of Boehringer Ingelheim Austria. Dr. Freissmuth is an inaugural member of OncoOne’s scientific advisory board, where he continues to support the development of the company’s pipeline of biotherapeutics. About OncoOne OncoOne seeks to overcome the limitations of targeting macrophage migration inhibitory factor by harnessing the disease-related isoform, oxidized macrophage migration inhibitory factor (oxMIF). The Company is focused on developing multiple proprietary drug modalities to leverage oxMIF’s potential as a target for systemic treatment of cancer, as well as for chronic inflammatory diseases. Equipped with a successful track-record in early-stage drug development, as well as a deep understanding of the target itself, OncoOne’s leadership will advance a pipeline based on oxMIF’s promise in inflammation and other disease areas. View source version on businesswire.com: Contacts For OncoOne: Randolf Kerschbaumer, Ph.D., CEO Website: E-mail: contact@oncoone.com Phone: +43 1 909 2208 - 6000 For Media Inquiries: Trophic Communications Desmond James E-mail: OncoOne@trophic.eu Phone: +49 1516 7859086 Source: OncoOne View this news release online at:

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