Date: 2015-08-21
Type of information: update on patient enrollment
phase: 3
Announcement: update on patient enrollment
Company: Northwest Biotherapeutics (USA - MD)
Product: DCVax®-L
Action
mechanism: îmmunotherapy product/cell therapy. DCVax® is comprised of activated, educated dendritic cells, that mobilize or help the entire immune system. Instead of aiming at a single target, DCVax is designed at to target the full set of biomarkers on a patient’s cancer. The DCVax technology is expected to be applicable to most cancers, and is embodied in several distinct product lines. One of the product lines (DCVax®-L) is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax®-Direct) is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. We believe the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering. For DCVax-L, the monocytes are differentiated into dendritic cells, and matured, activated and loaded with biomarkers (“antigens”) from the patient’s own tumor tissue (which is collected in a simple kit at the time of surgery to remove the tumor). The loading of biomarkers into the dendritic cells “educates” them about what the immune system needs to attack. The activated, educated dendritic cells are then isolated with very high purity and comprise the DCVax-L personalized vaccine. DCVax -L is administered to the patient through a simple intra-dermal injection in the upper arm, similar to a flu shot. The dendritic cells then convey the tumor biomarker information to the rest of the immune system agents (T cells, B cells and others), as “marching orders,” and the immune system agents then fan out through the body searching for anything with these biomarkers and attacking it.
Disease: glioblastoma multiforme
Therapeutic area: Cancer - Oncology
Country: Canada, Germany, UK, USA
Trial
details: The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax®-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain). (NCT00045968)
Latest
news: * On August 21, 2015, Northwest Biotherapeutics confirmed that its Phase III trial of DCVax®-L for newly diagnosed glioblastoma multiforme (GBM) is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. Over 300 patients have been recruited for the trial. The total anticipated enrollment is 348 patients. The only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the Company submits certain information from the trial for regulatory review. Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.) Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a “Temporary Halt” of the trial in Germany. In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the Company has only undertaken a temporary suspension of new screening. The Company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing. The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks. * On February 19, 2015, Northwest Biotherapeutics announced that the Company’s ongoing Phase III clinical trial of DCVax-L for glioblastoma multiforme brain cancer has been approved by Health Canada to proceed in Canada, has completed the approval processes at two sites, and is under way screening patients for enrollment. The two open trial sites are the Institut et hôpital neurologiques de Montréal (Montreal Neurological Institute and Hospital) and the Centre Hospitalier Universitaire de Sherbrooke, Hôpital Fleurimont, in Sherbrooke, Quebec. The Montreal Neurological Institute and Hospital is the largest specialized neuroscience research and clinical center in Canada, and one of the largest in the world. It is connected with McGill University, an important research center. The Sherbrooke Hospital is a major regional medical center for Quebec, serving over a million people, and is also a quaternary care center (i.e., a center for advanced and specialized medical treatments). * On October 14, 2014, Northwest Biotherapeutics announced that the DCVax-L Hospital Exemption Program that was approved by the German regulatory authority earlier this year is now under way. The first patient with glioblastoma multiforme (GBM) brain cancer has begun the treatment process, additional patients are being assessed and a waiting list has been established. NW Bio’s DCVax-L is the first immune therapy to be granted a Hospital Exemption approval under the German Drug Law. The scope of this Hospital Exemption includes all glioma brain cancers, both GBM (the most severe grade) and lower grade (less malignant) gliomas, and includes both newly diagnosed as well as recurrent patients. The patients must receive treatment in Germany, but may be either from Germany or from abroad. NW Bio is currently conducting a 348-patient Phase III clinical trial of DCVax-L for newly diagnosed GBM patients, in both the US and Europe. In two early stage trials, prior to the current Phase III trial, patients with newly diagnosed GBM who were treated with DCVax-L showed median survival of 3 years. With current standard of care (surgery, radiation and chemotherapy) median survival for such patients is about 14.6 months. Patients with recurrent GBM and patients with other glioma brain cancers are not eligible for the Phase III clinical trial, but all such patients are eligible for treatment under the DCVax-L Hospital Exemption. The first DCVax-L Hospital Exemption patient underwent surgery to remove his GBM tumor last week, and the manufacturing of his DCVax-L also began last week with the processing of his tumor tissue at the Fraunhofer facility in Leipzig, Germany. After recuperating from the surgery, the patient will undergo the blood draw to obtain his immune cells. During the following weeks, the DCVax-L manufacturing process and quality control testing will be completed for that patient. Additional patients who are being assessed will follow the same course. This first patient is a German citizen and has already submitted his application for approval of reimbursement. Discussions with the Sickness Funds (insurers) about pricing and reimbursement are ongoing.
