First Case Study Announced While Broader Data Being Collected;
Evidence Indicates Substantial Tumor Necrosis and Initial Tumor Regression
BETHESDA, Md., May 15, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided an initial patient case study, showing signs of tumor necrosis (tumor death) and initial tumor regression, from the Company’s ongoing DCVax-Direct trial for all types of inoperable solid tumors. The Company plans to announce further case study information prior to the annual ASCO conference, while it continues collecting data from the trial. Although the trial is still at an early stage, with many of the patients only part way through the treatment regimen, the Company also plans to provide overall information about the data to date by the time of the ASCO conference.
The specific case study announced today involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient received the first 3 DCVax-Direct injections through the course of a month, starting in February. He received a fourth injection in early April and then was scanned for results in early May. At that time, this patient’s MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass, and a CT scan showed some early indication of shrinkage of one of the non-injected metastasized tumors. These results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies.
These encouraging results were further supported by tumor biopsies taken at the time of the most recent injection, which showed a high rate of tumor necrosis and appearance of T cells (immune cells) infiltrating into the injected tumor.
“We are excited to see signs of DCVax-Direct mobilizing the immune system to fight the tumors in these patients with advanced metastatic cancer, even while we are still so early in this ongoing trial and while patients are only part way through their treatments,” commented Linda F. Powers, CEO of NW Bio. “Immune therapies generally work much more slowly than chemotherapy or targeted drugs, so it is especially encouraging to see any such signs so soon. Today, for patients with advanced metastatic cancer the outlook is very bleak, and mostly only palliative measures are available. We are hopeful that our non-toxic DCVax-Direct may provide a significant new therapeutic option for such patients.”
DCVax®-Direct is a personalized immune therapy for all types of inoperable solid tumor cancers, using dendritic cells (the master cells of the immune system) to mobilize the full immune system to attack the patient’s cancer. DCVax®-Direct is administered by direct injection into the patient’s tumors in virtually any location in the body (with image guidance for interior locations).
The Company is currently conducting a 60-patient Phase I/II trial with DCVax-Direct for all types of inoperable solid tumors, including lung, colon, breast with brain metastases, pancreatic and other cancers, as well as melanoma and sarcoma. Phase I includes 36 patients and Phase II includes 24 patients. The endpoints of the trial are focused on tumor necrosis and tumor regression (shrinkage).
At the ASCO conference this year, the Company will have a substantial exhibit booth in the exhibit hall, where further information will be provided about the Company’s DCVax technology and Company personnel will be available to discuss the DCVax technology and clinical trials. The Company encourages anyone attending ASCO to visit the Company’s exhibit booth.
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 312-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. 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 recently received approval of a 5-year Hospital Exemption for treatment of glioma (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 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.
Lisa Sher (Investors)
Farrell Kramer (Media)