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Lund, Sweden and Leuven, Belgium – 16 May 2011 – BioInvent International AB (OMXS: BINV) and co-development partner ThromboGenics NV (Euronext Brussels: THR) announce today that their partner Roche (SIX: RO, ROG; OTCQX: RHHBY) has dosed the first patient in a phase Ib/II study with the novel antibody anti-cancer agent TB-403 (RG7334). The trial is in patients with glioblastoma multiforme, the most common and aggressive type of primary brain tumour in humans.
The multi-center, phase Ib/II trial will examine the safety and clinical effect of TB-403 in combination with Avastin® (bevacizumab) in patients with recurrent glioblastoma. Secondary objectives include safety, tolerability and pharmacokinetics of the combination. The trial will also include an evaluation of candidate biomarkers. The study will recruit approximately 100 patients.
The start of the phase Ib/II glioblastoma study has triggered a €4 million milestone payment to ThromboGenics and BioInvent. This is the second clinical milestone that they have received from Roche. The first milestone of €10 million was paid last year when Roche initiated an imaging study in patients with colorectal and ovarian cancer.
In March 2011, Roche initiated a phase Ib study of TB-403 in patients with primary liver cancer (hepatocellular carcinoma). This study will determine the safety, tolerability and dosage of TB-403 in combination with Nexavar® (sorafenib), as well as pharmacokinetics and pharmacodynamics. The study will recruit 60-70 patients.
Svein Mathisen, CEO of BioInvent commented, “We are very pleased that Roche has decided to take TB-403 to the next stage of its development. We believe that TB-403 could make a major contribution to the armamentarium used to treat cancer. In glioblastoma, the medical need is significant and it is our hope that this unique product candidate could improve the prospects for this patient group whose current treatment options are very limited.”
Dr Patrik De Haes, CEO of ThromboGenics, added, “The start of these trials reflects a great interest in evaluating TB-403, in combination with more established oncology drugs, in a range of cancer indications. The glioblastoma study, using TB-403 together with Avastin, is designed to find better treatment options for patients with this very aggressive form of brain cancer. I believe that these studies will confirm that the further development of this novel selective anti-angiogenic antibody is warranted.”
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Notes to Editors:
The novel mechanism of action of TB-403 represents a potentially promising cancer therapy. It is a humanized monoclonal antibody directed towards placental growth factor (PIGF), expected to act by blocking the formation of the new blood vessels that are required for tumour growth. Preclinical exploration of PIGF biology suggests a role in tumour angiogenesis and metastasis and a limited role in the maintenance of normal vasculature. This mode of action could result in therapeutic benefit with an acceptable side effect profile.
Two phase I clinical trials have found that TB-403 was well tolerated with no reported dose limiting toxicity.
BioInvent International AB, listed on the NASDAQ OMX Stockholm (BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company currently has four clinical development projects within the areas of thrombosis, cancer and atherosclerosis. The Company has signed various strategic alliances to strengthen the product pipeline and increase the likelihood of success. These partners include Genentech, Human Genome Sciences, Roche and ThromboGenics.
The company’s competitive position is underpinned by an in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as Bayer HealthCare, Daiichi Sankyo, Mitsubishi Tanabe, UCB and XOMA. More information is available at www.bioinvent.com.
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product ocriplasmin (microplasmin) has completed two phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (sVMA). Ocriplasmin is also being evaluated in phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long acting anti-coagulant in phase II, and TB-403 (anti-PlGF) in phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on NYSE Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.com.
For further information, please contact:
BioInvent International AB
Executive Vice President
Tel: +46 (0)46-286 85 51
Mobile: +46 (0)708-16 85 70
College Hill (media enquiries)
Melanie Toyne Sewell, Anastasios Koutsos
Tel: +44 (0)20 7866 7856
Rebecca Skye Dietrich
Tel: +1 (857) 241-0795
Dr. Patrik De Haes Dr. Steve Pakola
Tel : +32 (0) 16 75 13 10 Tel: +1 (212) 201-0920
Citigate Dewe Rogerson
David Dible, Nina Enegren, Sita Shah
Tel: +44 (0) 207 638 95 71
BioInvent International AB (publ) ThromboGenics NV
Co. reg. No. 556537-7263, Gaston Geenslaan 1
Address: Sölvegatan 41 B-3001 Leuven
Mailing address: SE-223 70 LUND Belgium
Tel: +46 (0)46 286 85 50 Tel: +32 (0) 16 75 13 10
This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Information disclosed in this press release is provided herein pursuant to the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was submitted for publication at 7.30 a.m. CET, on 16 May, 2011.
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