From the latest SEC Form S-1 from NWBO:
Our platform technology, DCVax®, uses a patient’s own dendritic cells, the starter engine of the immune system. The dendritic cells are extracted from the body, loaded with tumor biomarkers or “antigens”, thereby creating a personalized therapeutic vaccine. Injection of these cells back into the patient is designed to initiate a potent immune response against cancer cells resulting in delayed time to progression and prolonged survival. Our lead product candidate is DCVax®-Brain which targets Glioblastoma Multiforme (“GBM”), the most lethal form of brain cancer. DCVax®-Brain has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval). Following this trial, we anticipate filing a biologic license application (“BLA”) with the FDA for DCVax®- Brain. DCVax®-Prostate, which targets hormone independent (i.e. late stage) prostate cancer, has also been cleared by the FDA to commence a Phase III clinical trial, which is also designed and powered as a pivotal trial. Additional activities have included pre-clinical development of antibody drugs targeting CXCR4, a chemokine receptor that plays a central role in all three phases of cancer progression: expansion of the primary tumor, migration of tumor cells and establishment of distant metastases.
In February 2007, we, through our legal representative, applied to the Bundesamt für Gesundheit (“BAG” or “Office Fédéral de la Santé Publique”) in Switzerland for an Authorization for Use (“Autorisation”). In June 2007, we, through our legal representative, received such Autorisation from the BAG to make DCVax®-Brain available at limited selected medical centers in Switzerland as well as an authorization (“Autorisation pour activités transfrontalières avec des transplants”) to export patients’ cells and tissues from Switzerland, for vaccine manufacturing in the United States, and to import patients’ DCVax®-Brain finished vaccines into Switzerland. These authorizations are conditional upon certain implementation commitments which must be fulfilled to the satisfaction of Swissmedic (“Institut Suisse des Agents Thérapeutiques”) before the product may be made available (e.g., finalizing our pending arrangements for a clean-room suite for processing of patients’ immune cells). Implementation of these commitments is underway.
In the BAG’s processing of and decision on our application and data with respect to the authorizations described above, Swissmedic conducted an inspection of our facilities. A comprehensive evaluation of DCVax®-Brain will be conducted by Swissmedic within the assessment of a Marketing Authorization Application (“MAA”). We plan to submit an MAA to Swissmedic by the end of 2007. The assessment by Swissmedic of our MAA will include a full review by Swissmedic of the safety and efficacy data generated in our DCVax®-Brain clinical studies to date. This review could take up to one year from the date the MAA is submitted. If Marketing Authorization is granted for DCVax®-Brain by Swissmedic, we would have the right to fully market and commercialize the product in Switzerland. However, if and until such a Market Authorization is granted, and assuming the Company completes its implementation committments to the satisfaction of Swissmedic, DCVax®-Brain may only be made available at the selected Medical Centers in Switzerland under the Autorisation granted by the BAG. The term of the BAG Autorisation expires in June 2012.
We are also conducting a DCVax-Brain® Phase II pivotal trial in 141 patients in the U.S. Presently, we have four clinical sites with open enrollment. We plan to seek product approval in both the U.S. and European Union in 2009, based upon the results of the pivotal trial.
DCVax®-Brain has been granted orphan drug status in both the U.S. and the European Union. Such status will afford DCVax®-Brain 7 years of market exclusivity in the U.S. and 10 years in the European Union, if DCVax®-Brain is the first product of its type to obtain product approval. |
