DXVAX-L Hospital Exemption Program Now Under Way In Germany

Northwest Biotherapeutics

("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today 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 (i.e., early stage) as well as recurrent (i.e., late stage) 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. "DCVax-L is addressing a serious unmet medical need for new treatment options for brain cancer," commented Prof. Dr. Dietmar Krex, senior neurosurgeon at the Department of Neurosurgery, University Hospital of Dresden, Germany, and Medical Advisor to NW Bio's Hospital Exemption program. "The Hospital Exemption for DCVax-L is a groundbreaking step, giving hope and offering a new treatment modality to patients with the disastrous diagnosis of a malignant glial brain tumor. Of course, we are also looking forward to completing the Phase III trial as soon as possible to confirm the effectiveness of the DCVax-L treatment." Linda Powers, CEO of NW Bio observed, "It is very gratifying to see the DCVax-L Hospital Exemption program launched and under way with patients. It is the culmination of more than 4 years of planning, technology transfer, training, development of manufacturing capacity, regulatory submissions and reviews, inspections and certifications at both the Federal and local level in Germany, Ethics Committee approvals, contract negotiations, patient documentation and procedures, logistical arrangements and data collection arrangements. We are excited about the opportunity to provide a much needed new treatment option for patients, and to practice for commercialization, gradually ramping up our Hospital Exemption program while we work toward completing the Phase III clinical trial." To receive more information on this program, prospective patients may contact NW Bio at patients@nwbio.com.