Date: 2011-12-02
Type of information: Clinical research agreement
Compound: epigenetic MGMT test, rindopepimut
Company: MDX Health (Belgium) Celldex (USA)
Therapeutic area: Cancer Oncology
Type agreement:
Action mechanism:
Disease: glioblastoma multiforme
Details: MDxHealth has entered into an agreement with Celldex Therapeutics. MDxHealth’s epigenetic MGMT test will be used during recruitment of a randomized, double-blind Phase III global clinical study of Celldex’s immunotherapeutic vaccine, rindopepimut, in newly diagnosed glioblastoma multiforme. Rindopepimut targets the tumor specific molecule called EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR). EGFRvIII is a common mutated form of the natural EGFR and is present in multiple cancer types. Unlike EGFR, EGFRvIII has not been detected at a significant level in normal tissues, and it can directly lead to cancer by providing a constant growth signal to tumor cells. Consequently, cells producing EGFRvIII have an enhanced capacity for unregulated growth. Rindopepimut is designed to activate the patient’s immune response against tumor cells specifically expressing the EGFRvIII mutation. The Phase III rindopepimut study is expected to enroll up to 440 patients to recruit 374 patients with newly-diagnosed, EGFRvIII-expressing GBM following gross total resection at over 150 clinical sites internationally. Patients expressing EGFRvIII will be tested with MDxHealth’s epigenetic MGMT prognostic assay to determine methylation status of the MGMT promoter gene. The MGMT methylation result will be used to ensure that the two arms of the clinical trial are balanced for the known prognostic influence of improved overall survival in MGMT methylated individuals. The study has begun screening patients.
Financial terms: Financial terms of the deal were not disclosed.
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