First Patients Enrolled and Being Treated
Penn’s Center for Research on Early Detection and Cure of Ovarian Cancer and Northwest Biotherapeutics, Inc. (OTCBB: NWBO; AIM: NWBT and NWBS) (“NWBT”) announce that a Phase I/II clinical trial in at least 30 patients, using DCVax®-L for recurrent ovarian cancer, has begun at The University of Pennsylvania Center for Research on Early Detection and Cure of Ovarian Cancer and the Abramson Cancer Center. The first patients have been enrolled and have undergone initial treatment steps in preparation for receiving DCVax®-L. The trial involves two sequential studies, and comprises an innovative combination of multiple treatment modalities. DCVax®-L forms the cornerstone of the treatment regimen, and is complemented by administration of low doses of certain existing approved drugs to help improve the immune system environment, as well as by adoptive transfer of patients’ DCVax®-L primed T cells. The principal investigators for the trial are Dr. George Coukos and Dr. Sarah Kim, and the Penn IND sponsor is Dr. Carl June. The funding is being provided by the Ovarian Cancer Vaccine Initiative. (See below for more information about this Initiative.)
DCVax®-L is a personalized immunotherapy for cancer, which is made from a patient’s own dendritic cells (the master cells which initiate and manage the overall immune system response to a disease), and the “antigens” (biomarkers) from the patient’s own tumor tissue which has been surgically removed as part of the standard of care. Such immunotherapy is sometimes referred to as a “therapeutic vaccine,” as it is designed not to prevent cancer but to treat patients who already have cancer.
In the first study being conducted by NWBT and Penn, patients will first undergo standard surgery to reduce their tumor burden. Patients will then receive limited doses of two existing drugs to improve the immune system environment and modify the tumor vasculature. Cancer researchers have become increasingly focused on the role of tumor vasculature and the tumor microenvironment, as well as the possible role of a certain kind of cells called “regulatory T cells,” in causing a patient’s immune system to become unresponsive to the patient’s tumor, and on the potential importance of modifying these factors in order to achieve robust and durable immune responses against tumors.
Following the preparatory treatments, the patients in this ovarian cancer trial will receive a series of three immunizations with DCVax-L, each two weeks apart, while continuing to receive the low doses of two drugs intended to keep the immune system and the tumor microenvironment in a beneficial condition.
The second study, which will be a follow-on to the first study but covered by a separate Investigational New Drug (IND) filing, will compare two treatment arms continuing further with the drug and DCVax-L regimen, and adding the adoptive transfer of DCVax-L primed, expanded T cells.
By combining multiple diverse treatment modalities, structured around DCVax-L as the cornerstone, this clinical trial is designed to implement evolving research findings on the complex interactions between tumors and the “host” tissues in patients, and evolving findings on the many facets of the immune system and what may be required for effective anti-tumor responses.
The trial is also designed to minimize any potential toxicity for patients. Clinical trial experience to date with DCVax®-L products in over 100 treatment cycles in brain cancer patients has shown no toxicity from the DCVax®-L treatment (no grade 3 or 4 adverse events). This multi-modal ovarian cancer trial has been designed to maintain this minimal-toxicity approach, by using only low doses of the two drugs complementing DCVax-L for preparatory effects.
The first patients have been enrolled in the study by Dr. George Coukos. Dr. Coukos stated, “this is a very significant event for patients at the University of Pennsylvania and nationwide who are diagnosed with ovarian cancer. We are excited to work with Northwest Biotherapeutics on this cutting edge clinical trial, and to test the DCVax® platform on an additional cancer that carries a poor prognosis”.
Dr. Carl June, the Penn sponsor on the trial, stated, “the combination of DCVax® -L for ovarian cancer with adoptive immunotherapy using T cells primed by DCVax® -L is an innovative approach that deserves testing in clinical trials”.
“We are very pleased to add Ovarian cancer to the DCVax® platform, and to have Dr. George Coukos and Dr. Carl June lead this effort as the principal investigators for this clinical trial,” stated Alton Boynton, President and Chief Executive Officer of Northwest Biotherapeutics. “Drs. Coukos and June are world renowned experts in immunotherapy and in ovarian cancer. They are playing a major role in the pioneering of novel cancer treatment strategies -- particularly by combining multiple different therapeutic approaches.”
Ovarian cancer is the fourth leading cause of cancer death among women in the U.S. Approximately 22,430 new cases were diagnosed in the U.S. in 2006, and about 15,280 deaths occurred. In the majority of ovarian cancer cases, the disease has already reached late stage, and spread beyond the ovaries, before it is detected and diagnosed. After initial surgical removal of tumors, and treatment with currently available drugs, the median time to disease recurrence is 18 to 20 months. Recurrent disease is considered incurable and usually results in death, even with aggressive chemotherapy treatments. Accordingly, there is a major unmet medical need for new and more effective treatments for ovarian cancer – especially recurrent ovarian cancer.
The DCVax® platform uses a patient’s own tumor, surgically removed as part of the standard of care, to prepare a mix of their personal cancer biomarkers. These personal cancer biomarkers are then loaded onto the patient’s own dendritic cells (the master cells responsible for starting and managing the body’s overall immune response), and injected back into the patient through a simple intra-dermal injection, similar to an insulin shot, at various intervals over a period of up to three years.
For more information about the trial call 215-662-3316 or 800-789-PENN (7366).
PENN Medicine is a $3.5 billion enterprise dedicated to the related missions of medical education, biomedical research, and excellence in patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.
Penn's School of Medicine is currently ranked #3 in the nation in U.S. News & World Report's survey of top research-oriented medical schools; and, according to most recent data from the National Institutes of Health, received over $379 million in NIH research funds in the 2006 fiscal year. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.
The University of Pennsylvania Health System includes three hospitals — its flagship hospital, the Hospital of the University of Pennsylvania, rated one of the nation’s “Honor Roll” hospitals by U.S. News & World Report; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center — a faculty practice plan; a primary-care provider network; two multi-specialty satellite facilities; and home care and hospice.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines, and therapeutic antibodies. The Company is currently conducting a large clinical trial in Glioblastoma multiforme, which is designed and powered to serve as a pivotal trial. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company also has a second technology platform, involving monoclonal antibodies to CXCR4, which is at the late pre-clinical development stage.
For further information, please visit the company web site at www.nwbio.com.
About the Ovarian Cancer Vaccine Initiative
The Ovarian Cancer Vaccine Initiative (OCVI) is a private philanthropic organization that is funding this NWBT trial at the Hospital of the University of Pennsylvania. Fundraising to underwrite the clinical trial, and translational research that supports it, is actively sought by the OCVI campaign heads and lead donors, Patricia Dunn and Randall Caudill. Donations in cash or stock, which qualify for tax-exemption, may be directed to:
Ovarian Cancer Vaccine Initiative
Schwab Charitable Fund
101 Montgomery Street
San Francisco, CA 94104
About the Center for Research on Early Detection and Cure of Ovarian Cancer at the University of Pennsylvania
The Center for Research on Early Detection and Cure of Ovarian Cancer, directed by Dr. George Coukos, is a newly founded Research Center at the University of Pennsylvania. The Center comprises several full time translational and clinical scientists whose focus is to identify new detection methods, develop new therapies, and ultimately prolong and improve the quality of life for women with ovarian cancer.
Recent discoveries at the Center include the beneficial impact of immune response in advanced ovarian cancer; the contribution of inflammatory cells to the tumor vasculature; the role of tumor vasculature and tumor microenvironment in controlling the outcome of antitumor immune response and immune therapy; the identification of novel proteins expressed in ovarian cancer vasculature that can be targeted for early detection and therapy; and the identification of several gene alterations in ovarian cancer including miRNA genes.
The clinical research activities of the Center focus on developing individualized therapy approaches to patients with ovarian cancer, combining surgery and conventional therapy with novel immune therapies. A number of novel immune cellular therapeutic tools are under development in collaboration with the Cell and Vaccine Production Facility at the Abramson Cancer Center, directed by Drs. Carl June and Bruce Levine.
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expects,” “believes,” “intends,” 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 of DCVax® -Brain and complete the trials on a timely basis, the uncertainty of the clinical trials process, the timely performance of third parties, and whether the Company’s products will demonstrate safety and efficacy, and the timely performance of third parties. Additional information on these and other 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 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.