July 22 -- A ground-breaking new treatment in late-stage clinical trials is giving Cleveland area patients new hope in their battle against one of the most lethal forms of cancer: Glioblastoma multiforme (GBM) brain cancer. The DCVax®-L personalized cancer immune therapy (a therapeutic “cancer vaccine”), which has been under development by Northwest Biotheraputics (NWBO.OB) for a decade, teaches the patient’s own immune system to attack the cancer, and is demonstrating response rates much higher than typically seen with cancer drugs.
In addition to unprecedented extensions of survival in patients receiving this emerging new treatment option clinical trials to date, the side effects have been negligible (with no toxicity such as with chemotherapy), allowing patients to maintain their quality of life and continue their normal activities.
One Grade III brain tumor survivor, Bob Gibbs, is defying the odds thanks to the ground-breaking new DCVax®-L treatment. While most patients survive only about 14.6 months with every form of conventional treatment (surgery, chemotherapy and radiation), Gibbs has become a living example of the promise shown by the new treatment.
Over the past seven years, Bob – a 41-year old husband and father of 4 boys - has undergone 3 brain surgeries and 18 rounds of chemotherapy for an advanced Grade III tumor, which also caused him to lose sight in one eye. With little time to spare, Bob opportunely qualified for participation in the DCVax®-L personalized immune therapy clinical trial - and with a decidedly encouraging result: he recovered well and has now passed the 7-year survival mark with a disease that is normally a relatively rapid death sentence. Bob is one of the first patients who experienced the benefits of the new vaccine first hand.
“The biggest thing is that DCVax® has given me is the opportunity to be there for my wife and children. Standard treatments would not have afforded me that opportunity,” explains Gibbs. “From a quality of life perspective, I’ve been able to go out and do things with my family versus being fatigued and sick with chemo and radiation.”
Brad Silver, 41, who lives in the Cleveland suburb of Shaker Heights, was diagnosed with Glioblastoma multiforme (GBM) in 2003 and was told that he had, at best, two months to live. GBM is a Grade IV tumor, and is the most lethal form of brain cancer.
“I was 33 years old and my wife was seven months pregnant with my son,” said Silver, a college water polo instructor. ‘I didn’t think I was going to live to see my son born, let alone grow up.”
Silver sought a second opinion at UCLA and the golf-ball sized tumor in his left lateral lobe was removed. He underwent radiation and chemotherapy and enrolled in the DCVax®-L immune therapy clinical trial. Eight years later, he remains cancer free.
“I haven’t been on the cancer medications for years, and I am living my life at full speed.” Silver said. “I was a mess the first couple of years, undergoing chemotherapy and such. Now I’m 100 percent back to being me because of this immune therapy and that clinical trial. It’s almost unbelievable.”
The potential of DCVax®-L is. Newly diagnosed patients and interested media in the Cleveland can learn more about this from patients Bob Gibbs or Brad Silver, and/or from the local doctors conducting the trials as part of this potential major advance in cancer treatment.
The Game Changer
NWBO’s DCVax®-L represents a completely personalized and highly economical cancer vaccine developed from a patient’s own immune cells andbiomarkers from the patient’s own brain tumor cells. Patients who have received DCVax®-L in clinical trials to date have shown unprecedented survival, and negligible side effects. So the patients have been able to maintain their quality of life.
Leading U.S. brain tumor treatment authority Neil A. Martin, M.D. is professor and the W. Eugene Stern Chair of the Department of Neurosurgery in the David Geffen School of Medicine at UCLA. He says DCVax®-L, has the potential to become a standard therapy for various types of cancer. Doctors who treat patients suffering from Glioblastoma desperately need new treatment options for inoperable brain tumors and for the cancer cells that get inevitably get left behind.
“The body’s immune system is more intelligent than anything we could configure to recognize foreign cells or agents, and more effective than traditional treatments at leaving healthy cells alone,” says Dr. Martin. “This vaccine teaches the body to recognize and attack the patient’s own tumor cells.”
The Science
Simply stated, DCVax®-L is custom-made in a special clean room manufacturing facility by taking an individual’s own dendritic cells - the immune system’s master cells – and “educating” them to recognize biomarkers from that same individual’s own brain tumor cells extracted during surgery. During a 10-day manufacturing period, the dendritic cells are matured, activated, and “educated.” The dendritic cells digest the tumor cells and, in doing so, become primed to teach the body’s immune system to recognize the biomarkers from the digested tumor cells, and to seek out and kill other cancer cells bearing the same biomarkers. The activated and “educated” dendritic cells are shipped back to the patient’s doctor, where they are administered to the patient as a simple injection under the skin, like a flu shot. Once injected back into the patient, the “smart” dendritic cells educate the body’s other immune cells to similarly seek out, attack, digest and ultimately eradicate the brain tumor.
The Results
DCVax®-L has shown stunning and consistent positive results in clinical trials over the last 8 years by greatly delaying the time to disease progression (i.e., tumor recurrence), and substantially extending the survival time for patients. For example, in the case of Glioblastoma multiforme, the median time from initial diagnosis to death with full standard of care treatment today (surgery, radiation and chemotherapy) is only about 14.6 months. With NWBT’s DCVax®-L vaccine added, the survival time has been extended to a median of 3 years in clinical trials thus far.
Significantly, over 80% of the patients treated with DCVax®-L in the Company’s clinical trials have lived longer than the 14.6 months median survival time with standard of care. Furthermore, 33% of these patients have reached or exceeded 4 years’ survival, and 27% of the patients treated with DCVax®-L have reached or exceeded the 6-year survival mark. With standard of care treatment, less than 5% of GBM patients are still alive after 5 years
In contrast, with existing cancer drugs, typically only 25-30% of patients show clinical benefits (i.e., any extension of survival), and even those benefits are usually short-lived: the survival extension is usually only about 10 weeks.
In addition to showing such extended survival times, clinical trial patients treated with DCVax®-L Brain also have shown striking delays in disease progression (recurrence) of their tumor.. This is important, independent of the survival extension benefits, because tumor progression (recurrence) is generally associated with problematic symptoms. Typically, even with full standard of care today (surgical removal of the initial tumor, as well as radiation and chemotherapy),GBM brain tumors recur in just 6.9 months on average. In contrast, in the patients treated with DCVax®-L in NWBT’s clinical trials so far, the patients’ tumor did not recur for 2 years on average.
DCVax® has also been tested in other cancers besides GBM brain cancer, including prostate and ovarian cancers. In “hormone independent” (late stage) prostate cancer (HIPC) the extensions of survival in clinical trials to date have been similarly striking as with GBM brain cancer. In HIPC patients without metastases, median survival is about 36 months. In patients who received DCVax® the median survival was extended to 54 months (with the median not yet reached). In HIPC patients with metastases (the same patient population for which Dendreon’s Provenge was recently approved by the FDA) the median survival with standard of care treatment is 18.9 months, In patients who received Provenge, median survival was extended to 25.9 months. In patients who received NWBT’s DCVax®, median survival was extended to 38.4 months.
Importantly, clinical trial results over the last 8 years have also shown that, unlike chemotherapy, DCVax® immune therapies are non-toxic. In DCVax® clinical trials, the patients did not experience any serious adverse effects from the DCVax® treatments, and there was no need to take a second set of drugs to manage side effects (as is generally necessary with chemotherapy).
Also importantly. a combination of proprietary factors, including highly cost-effective batch manufacturing processes, will enable DCVax® to be priced at affordable levels. In addition, NWBT’s clinical trials are aimed at gaining approval for DCVax® to be used as part of front line therapy for patients when they are first diagnosed. As such, NWBT’s business model is also based on affordable pricing, so that DCVax® can be accessible for as many patients as possible.
The Implications
Personalized immune cell therapies such as NWBT’s DCVax® hold real hope and increasingly demonstrated promise for patients. There is a tremendous unmet need for more effective and less toxic cancer treatments on a worldwide basis. Datamonitor forecasts that emerging cancer immune therapies (sometimes referred to as “cancer vaccines”) will generate revenues of $3.12 billion by 2015. Northwest Biotherapeutics is leading the charge with its cutting edge dendritic cell technology-based personalized immune therapy, with its exciting clinical results to date and its affordable economics.
For his part, brain cancer patient Bob Gibbs concluded, “I anticipate that we will continue to see amazing results from this vaccine. I, and the other survivors who have received this vaccine, are blessed to have been part of these trials and this cutting edge research that will ultimately lead to many lives being saved and the quality of life being improved for others battling brain cancer.”
