Pfizer and Celldex Announce Amendment to ACT III Study of CDX-110 in Glioblastoma Multiforme
News Dec 19, 2008
Celldex Therapeutics and Pfizer Inc. have announced plans to amend the ongoing ACT III clinical trial involving the investigational compound, CDX-110. ACT III is a randomized open-label, two-arm, Phase 2b/3 trial comparing CDX-110 combined with temozolomide to temozolomide alone in patients with newly diagnosed Glioblastoma Multiforme (GBM).
Only the Phase 2b portion of the trial has been open to enrollment. This amendment will convert ACT III to a single-arm Phase 2 clinical trial in which all patients will receive the study medication, CDX-110, in combination with temozolomide, and will continue to enroll to approximately 60 patients.
The companies' decision to amend the ACT III clinical trial, which follows the recommendation of the Independent Data Monitoring Committee, was based on the observation that the majority of patients randomized to the control (standard of care) arm withdrew from this open-label study after being randomized to the control arm. Patients currently participating on the control arm of the study will be offered the option to receive treatment with CDX-110.
Under this amendment, the ACT III study will provide a multi-center non-randomized dataset for CDX-110 in patients with newly diagnosed GBM. These data will provide additional information on the overall clinical profile for the development of CDX-110.
The companies will be working in collaboration with investigators and regulatory authorities to determine the best development path for this novel vaccine with the hope of providing doctors and patients with a new treatment option for this devastating disease.
CDX-110 is an investigational immunotherapy vaccine that targets the tumor specific EGFR mutant EGFRvIII. It is under development in GBM, the most common form of brain tumor.
In April 2008, Pfizer and Celldex entered into an agreement that granted Pfizer an exclusive worldwide license to CDX-110.