Swedish’s IVY Brain Tumor Center Launches Two New Clinical Trials to Treat Brain Cancer

New treatment approaches use the DCVax tumor vaccine and C-14 labeled Temozolomide to improve outcomes in brain cancer

SEATTLE, Wash. – September 21, 2011 – The Swedish Neuroscience Institute today announced that the Ivy Brain Tumor Center has launched two separate clinical trials for treating brain cancer.

The first trial (IND No. 10206, Protocol No. 020221, Study Agent: DCVax Brain – Autologous Dendritic cells and GBM tumor lysate) sponsored by Northwest Biotherapeutics, Bothell, Wash., is a Phase II clinical trial to investigate a groundbreaking personalized vaccine that uses a patient’s own master immune cells combined with biomarkers from that patient’s tumor tissue, to activate the master immune cells so they can mobilize the full immune system to recognize and kill the tumor cells. This type of tumor vaccine is used to strengthen the patient’s own immune system to fight off the recurrence of the disease.

The second trial (IND No. 111046, Serial No. 000, “Phase 1 Study of the Metabolism and Distribution of a Subpharmacologic Dose of Lightly-labeled 14C-Temozolomide in Newly Diagnosed Glioblastoma Patients”) tests a new approach to measure the effectiveness of the drug, Temozolomide (TMZ), in its activity against a patient’s tumor. This study is being done in partnership with Accium BioSciences in Seattle. A goal for the trial is to identify patients who are poor responders to TMZ early in their treatments so that physicians can pinpoint and select more effective drug strategies for each patient.

GBM is the most common primary malignant brain tumor and one of the most fatal known to humankind. The incidence of GBM affects 22,000 people nationwide, including about 600 people in Washington state. A typical survival rate for the disease is about 16 months.

The Ivy Center is currently enrolling patients in both of these studies. The principal investigator for these studies is Greg Foltz, M.D., director of the Ivy Center at Swedish and a nationally recognized brain cancer physician and researcher.

Brain Tumor Vaccine Explored

The first trial will test the DCVax immunotherapy agent, and is being sponsored by Northwest Biotheraputics, based in Bothell, Wash. This national trial will study the safety and potential efficacy of autologous tumor lysate antigen.

DCVax is Northwest Biotherapeutics’ platform technology, and uses a patient’s own dendritic cells, which have been called “the starter engine of the human immune system.”

Tumor vaccines are used to strengthen a patient’s own immune system to fight off the recurrence of the disease, as well as to decrease or stabilize existing tumors. In this new study, the patient’s own immune cells are extracted and trained to target the tumor. They are then re-introduced into the patient, where they can contain the tumor’s growth or reduce its metastasis.

“So far, research results from the DCVax clinical trial have been promising and have attracted significant national attention from clinical centers nationwide,” said Dr. Foltz. “We want to find new treatment options as quickly as possible. These trials hold great promise for researchers working to develop new, improved treatments for brain cancer tumors.”

DCVax is an experimental autologous cellular therapy designed to create a specific immune response against a patient’s own cancer. DCVax is manufactured using a patient’s dendritic cells, loaded with a tumor cell lysate prepared from surgically resected tumor tissue. The dendritic cells are generated from monocytes obtained through a single leukapheresis.

In prior clinical trials of DCVax immune therapy for brain cancer, the results were striking: patients who received DCVax showed a median survival of three years, compared with median survival of slightly longer than 14 months, for patients who received today’s standard of care (surgery, radiation and chemotherapy).

In addition, patients treated with DCVax did not have recurrence of their tumor for approximately two years, on average, as compared with tumor recurrence in just seven months with standard of care today. Moreover, the patients treated with DCVax did not experience any toxic side effects, in contrast to chemotherapies.

At this time, DCVax is available at the Ivy Center to patients with newly-diagnosed GBM.

“The number one thing brain cancer patients want is to have more treatment options, and to know that they can fight this disease from every angle,” said Dellann Elliott, president and CEO of the Chris Elliott Fund for Glioblastoma Research, who co-founded CEF 3 weeks before her husband, Chris, died of GBM in 2002. “I know firsthand the words, we’re sorry, there’s nothing more we can do. The new brain tumor clinical trial studies at the Ivy Center bring hope to patients, and bring us one step closer to a cure.”

Second Trial Tests Temozolomide

The second clinical trial directly tests the amount and activity of a chemotherapy drug, Temozolomide (TMZ) as it interacts with the tumor in individual patients. TMZ, a drug which received FDA approval in 1999, is standard therapy for treatment of newly-diagnosed GBM and melanoma. TMZ is taken by mouth and interferes with cell growth via DNA methylation, which triggers cell death. When given to patients with brain cancer, clinical studies have found that TMZ has been shown to improve median survival from 12 to 15 months. Not all patients benefit equally from TMZ administration, however. Tumor cells in some patients are able to repair the DNA methylation caused by TMZ, diminishing its therapeutic efficacy.

The goal of this trial is to identify early on patients who are poor responders to TMZ treatment. This early identification will facilitate future clinical trials designed to optimize a patient’s treatment plan by using other treatment modalities. The trial is made possible by accelerator mass spectrometry (AMS), an ultra-sensitive techniquethat measures TMZ-induced changes in individual patient’s tumors. Accium is leading the development of new AMS applications that cover a wide range of research, from in vitro cell culture studies to understanding tumor uptake of drugs in individual patients, a goal of the current study.

The study is designed to ensure that existing methods of drug delivery and AMS measurement are adequate to measure the activity of TMZ in an individual patient’s tumor at the time of surgery. If successful, the results will be used to design an appropriately powered follow-up study to identify those biomarkers that predict TMZ response. The study will also test whether patients, who are classified as TMZ high-responders and low-responders, are distinguishable based upon one or more TMZ-derived biomarkers. All of these tests can help identify a biomarker that is predictive of clinical response to TMZ therapy for each patient.

“This research is promising and these trials hold great promise for identifying a biomarker that is a more accurate predictor of clinical response to TMZ therapy,” Dr. Foltz said. “These trials should help us discover which GBM patients respond better to this treatment than others. In turn, this will allow the design of more effective clinical trials testing new treatment modalities in combination with TMZ in the low-responder patient population.

Funding provided by Seattle Brain Cancer Walk and the National Cancer Institute

Funding for the C-14-labeled Temozolomide trial has been provided partially by the National Cancer Institute and proceeds from the 2008 Brain Cancer Walk and 2009 Seattle Brain Cancer Walk as well as Accium BioSciences.

The 2011 Seattle Brain Cancer Walk is scheduled to occur this Saturday, September 24, 2011 at the Seattle Center. With less than a week to go, we are thrilled to announce an anonymous $500,000 Challenge Gift for this year’s walk. A current donor to the Ivy Center is making the anonymous gift to inspire additional gifts to the walk and to fund research like this. The donor will match all gifts made in support of the Seattle Brain Cancer Walk through December 31, 2011. (All donations made up to this point will count towards the Challenge Gift.) For more information about the walk, visit www.braincancerwalk.org or www.Facebook.com/braincancer.

About the Ben and Catherine Ivy Brain Tumor Center

Opened in 2008, the Ivy Brain Tumor Center gives brain-tumor patients and their families access to a unique multidisciplinary team of skilled neurosurgeons, oncologists, radiologists and a specialized nursing staff to deliver coordinated care and innovative treatments for both benign and malignant brain tumors. The Ivy Center’s unique design places its world-class research facility directly adjacent to the out-patient clinic, providing patient instant access to promising new therapies discovered through gene-sequencing technologies. As part of the Swedish Neuroscience Institute located in Swedish Medical Center’s Cherry Hill Campus, the Ivy Center is the first brain tumor-specific community-based facility of its kind in the Pacific Northwest that enables scientists, researchers, doctors and patients to work collaboratively toward new treatment options for those diagnosed with all stages of brain tumors, including brain cancer.

About the Swedish Neuroscience Institute

In 2004, Swedish expanded its neuroscience services by establishing the Swedish Neuroscience Institute. The team of leading neurosurgeons and other specialists are building a world-class institute dedicated solely to the treatment and advancement of neurological disorders for patients in the Pacific Northwest and around the world. The Swedish/Cherry Hill Campus is the hub for the Institute and has been upgraded with four state-of-the-art operating rooms with intra-operative MRI and CT scanning, neuro-interventional radiology capabilities, a renovated neuro intensive-care unit, and a radiosurgery center with CyberKnife and Gamma Knife technologies for radiosurgical treatment of tumors throughout the body as well as other neurological diseases and disorders.

About Swedish

Swedish has grown over the last 100 years to become the largest, most comprehensive non-profit health provider in the Greater Seattle area with 8,500 employees, 3,000-physicians and 1,200-volunteers. It is comprised of four hospital campuses (First Hill, Cherry Hill, Ballard and Edmonds); emergency departments and ambulatory care centers in Issaquah, Redmond and Mill Creek; Swedish Visiting Nurse Services; and Swedish Medical Group – a network of more than 70 primary-care and specialty clinics located throughout the Greater Puget Sound area. Swedish recently opened a new emergency department and medical office building (MOB) on its Ballard campus and as well as its Issaquah campus. It will open a new hospital in the Issaquah Highlands in November. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatric specialties, organ transplantation and clinical research. For more information, visit Swedish online at www.swedish.orgwww.swedishcares.orgwww.facebook.com/ swedishmedicalcenter or www.twitter.com/swedish.

In 2007, Swedish embarked upon an ambitious $100 million fundraising campaign. Campaign investments are used to support a wide-variety of initiatives throughout the health-care system, including cancer, heart and vascular, women and children, neurosciences, and orthopedics as well as programs to support underserved populations. To date, the campaign has secured gifts totaling more than $82 million. For more information or to support the campaign, visit www.campaignforswedish.org.

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