A Phase II trial with an investigational therapy called DCVax® (Northwest Biotherapeutics), a personalized vaccine that takes a patient’s immune cells and the biomarkers from that patient’s tumor tissue to mobilize the full immune system response to recognize and kill the tumor cells, resumes enrollment.

The purpose of the ongoing 240-patient, double-blind, randomized, placebo-controlled Phase II clinical study is to determine the safety and efficacy of DCVax in patients with newly diagnosed glioblastoma multiforme, the most aggressive and lethal of brain cancer, for whom surgery is indicated. Patients participating in the study must enter screening at a participating site prior to surgical resection of the tumor and will receive standard of care, including radiation and Temodar therapy, and two out of three will additionally receive DCVax.

To date, this trial has been conducted at 13 clinical sites across the U.S., with 33 patients already having been enrolled. These patients have continued to be treated with the DCVax regimen and follow-up during the last two years. The only aspect of the trial that stopped for a period of time was the enrollment of additional new patients beyond the 33 patients who were already enrolled and receiving ongoing treatment. Northwest Biotherapeutics, a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, is now resuming the process of accepting additional new patients to complete the trial.

Glioblastoma multiforme brain cancer is a highly lethal cancer with at least 12,000 new cases per year in the US, and at least 40,000 new cases per year worldwide. With standard-of-care treatment (including surgery, radiation, and chemotherapy), the median time to recurrence of the patient’s tumor is only about 6.9 months, and the median survival of the patient is only about 14.6 months. Less than 5% of such patients are still alive at 5 years. These clinical timelines for recurrence and survival have not changed significantly in decades.

DCVax, which is based on the Northwest Biotherapeutics dendritic cell-based vaccines and therapeutic antibodies platform technology, is designed to mobilize the immune system as a whole without toxicity. DCVax is a personalized therapy made from a fresh set of the patient’s own master immune cells (also called dendritic cells or DCs) and biomarkers from the patient’s own tumor.

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Prior clinical trials of DCVax for glioblastoma multiforme brain cancer have shown striking results. In the patients who received DCVax, the median time to recurrence of the tumor was more than 2 years (vs. 6.9 months with the standard of care), and the median survival was 3 years (vs. 14.6 months with the standard of care). In addition, according to the latest long-term follow-up data as of July 2010, 33% of the patients had reached or exceeded 4-year survival; 27% of the patients had reached or exceeded 6-year survival, and the longest surviving patient to date had exceeded 10 years.

According to Bob Gibbs, a 6-year survivor of brain cancer who has been treated with DCVax: “There is no question in my mind that I am alive today because of this vaccine. We need to finish this trial, and hopefully be able to make DCVax available to as many brain cancer patients as possible, as soon as possible, so that others can have the benefits that I have experienced. Any patients who would like to obtain more information about DCVax, the clinical trial or patients’ experiences are welcome to contact our organization, Miles for Hope (727-781-4783), and speak with Executive Director Barbara Gibbs or me.”

Dr. Linda Liau, Principal Investigator in the 240-patient Phase II clinical trial of DCVax? for GBM brain cancer, Professor and Vice Chair of Neurosurgery and Director of the UCLA Brain Tumor Program, commented that “after more than 10 years of development, DCVax is poised to make a real difference in the future treatment of brain cancer. DCVax is at the forefront of personalized therapy, which offers great potential for improving patients’ outcomes. DCVax is also non-toxic and allows our patients to carry on with their lives in a normal fashion. I’m excited to see the large Phase II trial moving towards completion.”

“Primary brain tumors are a major problem with an urgent need for new and better treatments,” said Dr. Michael Gruber, Clinical Professor of Neurology and Neurosurgery at the NYU Langone Medical Center. “Despite the significant advances in neurosurgery, radiation medicine, and new chemotherapy agents, such as Temodar, and targeted agents, such as Avastin, the median survival of newly diagnosed patients with GBM remains at approximately 15 months. Phase I studies on DCVax have shown promise, with a number of patients living more than 3 years. We are hopeful that by completing a larger study these results will be confirmed as statistically significant and lead to better outcomes.”

“The very promising results to date, coupled with the excellent safety profile, make DCVax a strong candidate for future standard of care for brain cancer patients,” commented Dr. John Trusheim, Medical Director of Neuro-Oncology at the Virginia Piper Cancer Institute at Abbott Northwestern Hospital in Minneapolis. “Resumption of enrollment in this important trial will bring that goal one step closer.”

Northwest Biotherapeutics recently received funding from a number of new institutional investors, as well as from existing individual and institutional investors. The new investors have expressed interest in providing further funding, and are anticipated to be a source of ongoing funding.

For more information:
– Study of a Drug [DCVax?-Brain] to Treat Newly Diagnosed GBM Brain Cancer. NCT00045968

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