Phase I/II Trial for Colon Cancer - Second Leading Cause of Cancer Deaths
BETHESDA, Md., Nov. 6 , 2012 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) (NW Bio) a biotechnology company developing DCVax® personalized immune therapies for cancer, announced today that it has initiated a collaboration with Sarah Cannon Research UK and the Leaders in Oncology Care (LOC) on a Phase I/II trial with DCVax®-Direct for metastatic colon cancer. Sarah Cannon Research UK is the UK arm of the Sarah Cannon Research Institute, which specializes in cancer drug development and has a network of more than 700 physicians in the US and UK.
Colon cancer is the second leading cause of cancer deaths (after lung cancer), exceeding even deaths from breast cancer or prostate cancers. DCVax®-Direct offers an important potential new treatment option for colon cancer patients whose cancer has spread and is no longer operable. DCVax®-Direct is specifically designed to treat inoperable cancers in various tissues through direct injection into the tumors. It can be injected into any number of tumors, and virtually any location in the body (with imaging guidance for interior tissues).
As previously reported, the Company has received FDA approval for a 36-patient Phase I/II trial in any solid tumor cancers. The primary endpoint of the trial will be a measure of tumor response (regression) in patients' existing, established tumors. As part of the collaboration with Sarah Cannon Research UK and LOC, the Company will pursue UK regulatory approval of Phase I/II trials.
Sarah Cannon Research UK is the London-based arm of Sarah Cannon Research Institute (SCRI), a global strategic research organization focusing on advancing therapies and accelerating drug development. It is one of the largest clinical research programs, conducting community-based clinical trials in oncology through a network of more than 700 physicians in the US and UK. SCRI also has seven strategic oncology sites with over 200 investigators who see 75,000 new patients each year.
The Leaders in Oncology Care (LOC) was formerly known as the London Oncology Clinic, and is renowned in the UK as the leading private cancer center. LOC is well known for its patient-centered focus, and its continuous innovation bringing the latest cutting edge technologies and new treatments to its patients.
According to the US Center for Disease Control (CDC) and the American Cancer Society, colon cancer is the second leading cause of cancer deaths. Colon cancer is particularly problematic as it often does not show symptoms until it is already at an advanced stage. More than half of all colon cancer patients are first diagnosed when their cancer has spread beyond the colon to the liver and/or other locations. By that time, the cancer is typically no longer operable and the tumors cannot be removed. The outlook for such patients is bleak. The seriousness of this medical problem is reflected in the special public awareness campaign about colon cancer which the CDC has launched.
DCVax®-Direct offers a potentially significant new treatment for inoperable metastatic cancers such as colon cancer, involving multiple tumors. It is comprised of the patient's own dendritic cells (the master cells of the immune system), which are activated in special proprietary manner and directly injected into the patient's tumors, to pick up the tumor biomarkers onsite in the tumors and mobilize the immune system to attack any tumors bearing those biomarkers.
In pre-clinical animal studies with multiple tumors, regression (shrinkage or elimination) was observed not only in the tumors that were injected with DCVax®-Direct but also tumors on the opposite side of the animal's body which were not injected, indicating a systemic immune response. Further, when the animals were subsequently challenged (i.e., injected) with cancer cells, the animals did not re-develop cancer, indicating immune memory.
"We are excited to collaborate on this program with Northwest Bio," said Dr Hendrik-Tobias Arkenau, Medical Director Sarah Cannon Research UK. "There is an urgent need for better treatments for colon and other cancers. We believe that innovative immune therapies such as DCVax may offer significant improvements in cancer treatment and outcomes."
"Partnering with major institutions such as Sarah Cannon and LOC will enable us to benefit from their extensive oncology experience and broad reach, and will help accelerate our clinical trials with DCVax-Direct ," commented Linda Powers, the Company's CEO. "We are very pleased to partner with them for this program."
For further information about the Company and its programs, please visit the Company's website at www.nwbio.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 300-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal brain cancer. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I/II trials in multiple other cancers. The Company has also conducted a Phase I/II trial with DCVax® for metastatic ovarian cancer.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients with GBM 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," "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 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, the uncertainty of the clinical trials process, uncertainties about the timely performance of third parties, and whether the Company's products will demonstrate safety and efficacy. 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.