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Clinical Trials Update provides you with latest news about clinical trials conducted by MVA member companies. The update gives insight to progress in studies, results and possible indications.
BioInvent and ThromboGenics Report Positive Phase I Results for Anti-PlGF Cancer Therapeutic TB-403
3 June - BioInvent International AB and co-development partner ThromboGenics NV have reported that the results from the first Phase l study of novel anti-cancer agent TB-403 showed that it is safe and well tolerated, with pharmacokinetic properties enabling it to be developed for the treatment of cancer. The companies also announced that they have received approval from the regulatory authorities in Denmark to initiate a second repeat-dose Phase I clinical trial of TB-403 in patients with advanced solid tumours.
TopoTarget Reports Clinical Data Demonstrating Substantial Anti-Tumor Activity from a Phase II Trial
2 June - TopoTarget have announced positive data from its BelCaP (belinostat combined with standard doses of carboplatin and paclitaxel) program in patients with relapsed epithelial ovarian. BelCaP is well-tolerated presenting a safety profile consistent of that observed with chemotherapy alone.
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Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
2 June - Genzyme have reported preliminary data from a fully-enrolled pivotal, phase 2 study examining the safety and effectiveness of Clolar (Clofarabine) as a single agent in previously untreated, older adult patients with acute myelogenous leukemia. Results show that patients with unfavorable prognostic factors who received single agent clofarabine exhibited a 45 percent overall remission rate based on investigator assessment, with manageable treatment-related side effects.
Novo Nordisk and Neose Announce Completion of Initial Phase I Clinical Trial of NN7128
2 June - Novo Nordisk and Neose Technologieshave have announced that Novo Nordisk has completed the initial Phase 1 clinical trial with NN7128 (GlycoPEGylated factor VIIa), a long-acting version of NovoSeven coagulation factor FVIIa (recombinant) administered intravenously. In the trial a significant prolongation of the half-life of NN7128 was observed. Furthermore, single doses of NN7128 were well tolerated with no serious adverse events.
CAMURUS Reports Positive Clinical Phase II Results for a New Treatment Concept of Oral Mucositis Pain
30 May - In a recently completed clinical trial of CAM2028, based on Camurus' proprietary FluidCrystal drug delivery system, the product was shown to give an immediate and significant reduction of oral pain associated with oral mucositis. The company plans to have a product on the market during the first half of 2009.
Genmab Initiates Zalutumumab Combination Study in Colorectal Cancer
30 May - Genmab have announced that it has initiated a Phase I/II study of zalutumumab in combination with irinotecan chemotherapy to treat colorectal cancer. The study will include a maximum of 97 patients who have failed standard chemotherapy.
