PRESENTATION ON NW BIO'S DCVAX-DIRECT TRIAL ANNOUNCED FOR ASCO ANNUAL MEETING Company to Report On Science And Progress Of DCVax-Direct Trial At World's Largest Cancer Conference
BETHESDA, Md., April 22, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that ASCO (the American Society for Clinical Oncology) has announced in its Annual Meeting program that the Company will present its DCVax-Direct clinical trial and technology in a general poster session at this year's ASCO meeting, taking place in Chicago May 30 through June 3. The abstract is number TPS3133, and the poster is number 189(a).
ASCO is the largest and most important annual conference on cancer treatments, with some 30,000 oncologists and other medical personnel, analysts and others attending from all over the world. Last year, immune therapy emerged as the top new focus area. This year, the focus on immune therapies like DCVax is expected to be even greater.
ASCO's acceptance of the abstract about the Company's DCVax-Direct technology and its large Phase I/II trial provides an opportunity for leading oncologists, analysts, investors and media to learn more about the unique DCVax-Direct program, now in trials on a range of multiple inoperable cancers. The abstract will be presented in a general poster session.
The Company will also have a large exhibit booth in the ASCO exhibit hall, where further information will be provided about the Company's DCVax technology. Its DCVax-L and DCVax-Direct clinical trial programs provide a series of customized vaccine injections which educate a patient's immune system to attack that individual's specific cancer without any toxic side effects. In clinical trials to date on a variety of solid tumor cancers, the results have been encouraging.
DCVax-Direct specifically is a personalized immune therapy for inoperable solid tumors, using dendritic cells (the master cells of the immune system) to mobilize the immune system to attack the patient's cancer. DCVax-Direct is administered by direct injection into the patient's tumors. It can be injected into any number of tumors, enabling patients with locally advanced disease or with metastases to be treated. DCVax-Direct can also be injected into tumors in virtually any location in the body (with ultra-sound guidance for interior locations).
Very large numbers of patients suffer from inoperable tumors today, and the outlook for these patients is bleak. The Company is currently conducting a 60-patient Phase I/II trial with DCVax-Direct for five main types of inoperable tumors, including lung, colon, breast with brain metastases, melanoma and pancreatic cancers, as well as some others. The University of Texas MD Anderson Cancer Center is the lead site of the trial. In pre-clinical animal studies, injection of DCVax-Direct into inoperable tumors was able to cause tumor cell death, and the shrinkage or elimination of existing solid tumors.
"Our increased presence at ASCO this year reflects the progress of our clinical programs with both DCVax-Direct and DCVax-L," commented Linda F. Powers, CEO of NW Bio. "We especially look forward to the opportunity to share information with key opinion leaders and clinicians about our DCVax-Direct technology and Phase I/II trial."
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. The Company's DCVax-L product for brain cancers recently became the first such newly developed product to be granted a Hospital Exemption approval in Germany, for a period of 5 years, for early access to DCVax-L treatment for patients outside the clinical trial, to treat any glioma brain cancers, both newly diagnosed and recurrent.
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 announced earlier this year, 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.
SOURCE Northwest Biotherapeutics, Inc.