First Patient Has Begun Treatment Process; Additional Patients Being Assessed;
Waiting List Established
BETHESDA, MD, October 14, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (“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 email@example.com.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead program is a 348 patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. It has completed enrollment in the Phase I portion of the trial. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company has also received approval of a 5 year Hospital Exemption for the treatment of all gliomas (brain cancer) patients outside the clinical trial.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
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