Medical Center Cologne
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50677 Cologne | Germany
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The possible role of the dendritic cells in the biological immune response against malignancies (solid tumors) was discovered and clinically investigated...
In a review article published in Science Translational Medicine March 28, 2012, the investigators outline obstacles they say stand in the
way of making a huge dent in the cancer burden in the United States and around the world.
According to the American Cancer Society, an estimated 1,638,910 new cancer cases will be diagnosed this year in the United States.
Also this year, 577,190 Americans are expected to die of cancer. Only heart disease kills more people in this country.
“We actually have an enormous amount of data about the causes and preventability of cancer,” says epidemiologist Graham A. Colditz, MD, DrPH,
the Niess-Gain Professor at the School of Medicine and associate director of prevention and control at the Siteman Cancer Center.
“It’s time we made an investment in implementing what we know.” Colditz’s research has shown that these cancer prevention strategies
would reduce the burden of heart disease and other chronic conditions as well.
Mike Evans, MD is the founder of the Health Design Lab at the Li Ka Shing Knowledge Institute,
an Associate Professor of Family Medicine and Public Health at the University of Toronto, and a
staff physician at St. Michael's Hospital.
He answers the old question "What is the single best thing we can do for our health" in a completely new way.
Viscum album
How Dangerous is Acetaminophen (Tylenol)?
Do night lights cause cancer?
Before going to sleep in a 24/7 world, we watch TV, surf the web to catch the latest news,
check Facebook to connect with our friends, or glance at our smart phones for the latest emails.
Although it seems the normal thing to do, evening and night time light disrupts our biological rhythms and can affect our health and even increase risk from cancer.
Selenium and Lung Cancer: A Systematic Review and Meta Analysis
Selenium is a natural health product widely used in the treatment and prevention of lung cancers,
but large chemoprevention trials have yielded conflicting results.
A systematic review of selenium for
lung cancers was conducted and there were assessed potential interactions with conventional therapies.
The researchers reached to the conclusion that selenium may be effective for lung cancer prevention among
individuals with lower selenium status, but at present should not be used as a general strategy for lung cancer prevention.
Here is article which shows why a toxicologist won’t eat microwavable popcorn or why a
farmer will not eat non organic potatoes or why a fishery expert stays away from farmed salmon. Read on to
learn why, as well as other foods you should stay away from. Read more...
How heat helps kill cancer: An article about Local Hyperthermia
Hyperthermia is occasionally used to augment the efficacy of certain cancer therapies,
but how heat helps has been a mystery. Now, researchers have uncovered the details of one likely mechanism
- heating a tumor inhibits homologous recombination, a DNA repair system, so cancer cells cannot mend DNA
damaged by radiation or chemotherapy.
Cancer research: how to prevent and treat cancer (TEDMED 2010)
Conventional medicine has lost its battle with cancer. But that doesn't mean the war is over.
Let me explain why we may finally be heading in the right direction. .
I just returned from TEDMED, an extraordinary gathering of brilliant minds from science, medicine, business and technology--a veritable intellectual orgy. During the conference, there was a theme that emerged: synthesis. .
Instead of dividing everything into diseases and labels, emerging science is pointing to a different way of thinking about diseases. The thread that ran through the conference was that disease is a systemic problem and we have to treat the system, not the symptom; the cause, not the disease. This completely redefines the whole notion of disease. The landscape of illness is changing. .
At TEDMED I spoke about a new way to define disease, to navigate the landscape of illness. It is called functional medicine, which is a systems-biology approach to personalized medicine that focuses on the underlying causes of disease. That definition of functional medicine is a mouthful. But in a word, it is the medicine of WHY, not WHAT. .
Conventional medicine is focused on naming diseases based on geography, body location and specialty, instead of by the cause, mechanism or pathway involved. Doctors say you have a liver, kidney, brain or heart disease. But this approach to naming disease tells you nothing about the cause, and it is quickly becoming obsolete as we understand more about the mysteries of human biology. .
Instead of asking what disease you have and what drug should be used to treat it, we must ask WHY the disease has occurred--what are the underlying causes that lead to illness and how do we look under the hood to find out what's going on. Modern medicine is like trying to diagnose what's wrong with your car by listening to the noises it makes without ever looking inside to see what's going on. Functional medicine allows us to look under the hood. It gives us a method for identifying the conditions in which disease arises and shows us how to begin changing those conditions.
This shift toward a more functional, systems-based, environmental approach to treatment is happening in cancer research right now, and this change was one of the main topics explored at TEDMED this year. .
Looking at Cancer a New Way: Treatment in the 21st Century .
The problem with conventional cancer treatment is simply this: We look at the disease the wrong way. This reality was illustrated over and over again by the leading thinkers in the field of cancer treatment at TEDMED. .
For example, Greg Lucier, Chairman of Life Technologies, talked about how thinking about specific cancers is essentially flawed. How we label cancer is no longer synced up with what we know about the origins of cancer or the fact that two people who have cancer with the same name--like breast cancer--can have two completely different diseases which require different treatments. Just because you know the name of your disease, it doesn't mean you know what's wrong with you or what to do about it. .
Classifying tumors by body site--lung, liver, brain, breast, colon, etc.--misses the underlying causes, mechanisms and pathways involved in a particular cancer. The fact that cancer appears in a given region of the body tells us nothing about why the cancer developed in the first place. What's more it gives us no information about how it manifested in a given patient. Two people with cancers in different parts of the body may have developed it for same reasons. Similarly, two people with cancers in the same part of the body may have developed it for different reasons. A patient with prostate cancer and one with colon cancer may have more in common with each other than two patients who have colon cancer. Historically we have practiced medicine by geography--where a disease occurs in the body. That doesn't make scientific sense anymore. Now we have the potential to treat illness by understanding the underlying mechanisms and metabolic pathways. .
These and other misconceptions about cancer and cancer treatment are leading to terrifying results. From the perspective of curative and preventive therapy, we have lost the war on cancer. Clinton Leaf explained how fancy statistics manipulate the data to show that cancer deaths are going down, while they are in fact going up. Overall cancer rates and incidence are significantly increasing. Deaths from cancer are also increasing. In 2008, there were 565,000 deaths in the U.S. alone. One in two to three people will get cancer in their lifetime. While few are aware that solid tumors can grow slowly like for 30 years before they can be detected, 17 to 25 million Americans are walking around with cancer somewhere along the continuum from initiation of a cancer cell to detectable tumor. .
In the "war" on cancer, we are fighting a losing battle for one simple reason: We're focusing on the wrong target. As a physician I was trained to focus on the tumor--to burn, poison or cut it out, and then wait, watch and pray for the cancer to stay at bay. Newer gene-targeted treatments will help to improve chemotherapy and improve survival rates, but they won't prevent cancer in the first place or even prevent it from coming back once you've had it. Hope is not the only way to straddle the scary territory between remission and recurrence. There is a different way of thinking about how to treat the system, not just the cancer that holds promise for a proactive approach to helping both prevent occurrence as well as recurrence. .
Tending Your Garden: Treating the Soil in Which Cancer Grows .
Dr. Anna Barker, deputy director of the National Cancer Institute, explained how new groups of researchers are collaborating to think differently about cancer--to understand and treat it as a systemic problem. .
The problem with cancer--one which almost no oncologists think about--is not the tumor, but the garden in which the tumor grows. In caring for a garden, if the weeds get too big, we pull them out, just as we do with cancer using conventional therapies such as chemotherapy, surgery or radiation. But then what? .
Traditionally, we have focused on late-stage curative care, and in doing so, we have missed the thinking and the treatments focused on changing the underlying conditions that led to the cancer in the first place. Diet, lifestyle, thoughts, and environmental toxins all interact with our genes to change the landscape of our health. .
We have been asking the wrong question about cancer. We have asked "what": What tumor do you have? What kind of chemotherapy, surgery or radiation is needed for that tumor? What is your prognosis? Instead, we need to be asking "why" and "how": Why did this cancer grow? How can you change the conditions that feed and support cancer-cell growth? How did the terrain of your garden become a host to such an invasive weed? .
Surprisingly, scientific literature is abundant with evidence that diet, exercise, thoughts, feelings and environmental toxins all influence the initiation, growth and progression of cancer. If a nutrient-poor diet full of sugar, lack of exercise, chronic stress, persistent pollutants and heavy metals can cause cancer, could it be that a nutrient-dense, plant-based diet, physical activity, changing thoughts and reactions to stress, and detoxification might treat the garden in which cancer grows? Treat the soil, not the plant. It is a foundational principle of sustainable agriculture, and of sustainable health. .
In my oncology rotation in medical school, I asked my professor what percentage of cancer was related to diet. Expecting a gracious but insignificant nod to the role of diet as a cause of cancer, I was surprised when he said that 70 percent of all cancers were related to diet. The 2008-2009 report from the President's Cancer Panel found that we have grossly underestimated the link between environmental toxins, plastics, chemicals, and cancer risk. They have yet to acknowledge how thoughts, emotions and overall stress impact that risk--but it is sure to come. The facts that gravitate around cancer support evidence that will motivate us all to take a deeper look. .
Consider this fact: Sixteen percent of all cancers are new, primary cancers in patients who have already had one cancer, not recurrences. This means that people who have cancer are more likely to get a second and independent cancer. Could it be the garden? I recently saw a patient after her third cancer, wondering what she could do to prevent cancer rather than waiting around for another one. .
Consider this fact: The lifetime risk of breast cancer of those with the "breast cancer gene" or BRCA1 or 2 is presently 82 percent and increasing every year. Before 1940, the risk of getting cancer for those with the cancer gene was 24 percent. What changed? Our diet, lifestyle, and environment--both physically and emotionally. Might these factors be a better place to look for answers on how to address our cancer epidemic? .
Cancers arise from a disturbance in your physiological state. Addressing that disturbance is the foundation of future cancer care. This approach might be called milieu therapy. Rather than treating cancer per se, we treat the milieu in which cancer arises. .
And this is manageable. We can enhance immune function and surveillance through dietary and lifestyle changes, nutrient or phytonutrient therapies. We can facilitate our body's own detoxification system to promote the elimination of carcinogenic compounds. We can improve hormone metabolism and reduce the carcinogenic effects of too much insulin from our high sugar and refined carbohydrate diet. We can help the detoxification of toxic estrogens through modulation of diet, lifestyle and elimination of hormone-disrupting xenobiotics or petrochemicals. .
We can also alter how our genes are expressed by changing the inputs that control that expression: diet, nutrients, phytonutrients, toxins, stress and other sources of inflammation. And we can focus on less divisive and more generative thoughts that, in turn, create more uplifting emotions--all good fertilizer for the soil in the garden of our body. .
The future of cancer care must use medicine's understanding of the mechanisms of disease and we must use this information to create physiologic and metabolic balance, to design treatments that support and enhance normal physiology, and the immune system. The future of cancer care lies not in finding the best cocktail of chemotherapeutic agents, the right dose of radiation, or a new surgical technique, (all of which are still important and will continue to be refined) but in finding the right way to personalize treatment according to the individual imbalances in each person. .
The pieces of the puzzle that hold the answers for cancer prevention and treatment are strewn about the landscape of medical science. They need only be assembled into a story that can guide clinical care. The time is ripe to accelerate this process. Thankfully, more scientists are now exploring the story of how to tend the gardens of our body, mind and soul. .
To learn more about how to tend your garden and create metabolic and physiologic balance for yourself see
www.drhyman.com
To your good health,
Mark Hyman, MD
Follow-up note from Bill: I believe that local physicians—especially women—should at least be aware of Leuren Moret’s argument that elevated rates of cancer (such as characterize the San Francisco Bay Area in California, USA) are related to radioactive run-off into the Bay. < a href =” http://www.mindfully.org/Nucs/2008/Uranium-Populations-Moret1jul08.htm ”>See here !
Long term non-progressors – HIV
Gene research finds clues to AIDS survivers Read more...
The war against cancer is a stalemate since the 1950s. Author: Robert W. Gorter, MD, PhD.
Health professionals, the media and the public belief spending enough money will let find the cure for cancer. The perception already exist that medicine is quite successful in treating cancer. Yet with the spending of more that 105 billion dollars by the National Cancer Institute since 1971 and at least an equal amount by the pharmaceutical companies, the same percentage of people are dying now as in 1971 as shown in figure below.
It is obvious, through the past 55 years that this approach has been disappointing, to put it mildly. Cancer is on the rise: about 50% of all Americans and Europeans will get a cancer diagnosis in their life times. And still, about 70% to 80% of all people who get a cancer diagnosis die of the disease, although they have received all possible forms of therapies, directed at killing or eradicating the cancer cell. Despite a few rare successes such as the treatment for testicular cancer and acute myeloid leukemia can be controlled for years with medications, cancer death rates have not changed (Kolata, 2009). The war against cancer initiated by President Nixon in 1971 has been a failure. The death rate of cancer has decreased by about five percent unlike that of heart disease and flue and pneumonia. This implies that the current fundamental treatment model is incorrect and inappropriate.
The five percent decrease in the last fifty-five years suggests that the fundamental model of the war against cancer, to cut it out through surgery, to burn it out with radiation and cyber knife, to destroy by chemotherapy, or to block by hormone treatment seems to be the incomplete, and maybe the wrong approach. Most likely, the five percent decrease in cancer death rate is related to changes in life style or other unknown factors. Stopping smoking has had a greater impact reducing lung cancer (and other forms of cancer) than any known therapeutic treatment strategy; similarly, menopausal women stopping hormone replacement therapies has reduced breast cancer by 3% percent so far.
Cancer treatments are highly ineffective as compared to the treatment of the flu and pneumonia. Bacterial pneumonia (like tuberculosis or pneumococcal pneumonia) used to be a deadly disease; however, with the advent of the appropriate antibiotics, it is highly treatable with a 58 percent drop in death rate since the 1950s. Similarly, heart disease death rates have decreased by 64 percent with the changes in life style as the main factor, and appropriate medication and treatments.
Although we are taught that mammogram screening reduces the death rate of breast cancer, the research data is much more ambiguous. It is possible that early screening identifies cancers such as intraductal carcinoma in situ which is a precancerous condition characterized by proliferation of malignant-looking cells in the lining of breast ducts without evidence of spread outside the duct breast. It is often a precursor of breast cancer. However, in some cases intraductal breast carcinoma it will not spread and disappear in about 20 percent of people (spontaneous remission) (Lewison et al: 1976).
Yet, despite early diagnosis, the outcome of metastatic breast cancer has not shown much success; even with the aggressive and destructive treatment approaches the five year survival rate of metastatic breast cancer is about 20 %. This means that only one in five women with metastatic breast cancer will survive five years. It may even be possible that the aggressive treatments could increase the cancer death rates because general anesthesia, chemotherapy and radiation all act as carcinogenic agents and as immune suppressants which means that the immune system will be less competent to cope with spontaneous (new) cancer cells after treatment. Patients who receive chemotherapy and radiation are more likely to develop another (primary) cancer in their lifetime.
Progress occurs by leaps and bounds not by incremental change. Author Robert W. Gorter, MD, PhD.
Progress occurs by leaps and bounds not by incremental change Author: Robert W. Gorter, MD, PhD.
The incremental improvement of standard therapies through improved surgical techniques, radiation, chemotherapy or medications that can be patented or slight changes in treatment protocols are only cosmetic changes. They are procedures embedded within an incomplete paradigm. What is needed is a new and broader perspective that will offer a significant decrease in death rates.
Generally, clinical improvements, just as cultural changes, do not occur incrementally, they occur as large tectonic shifts. For example, in the early 19th century nearly 25% of women who delivered their babies in hospitals died from childbed fever (puerperal sepsis) which was caused by Streptococcus pyogenes bacteria.
The Austrian physician in the 1840’s, Dr. Ignazius Semmelweis, observed that woman in the maternity wards who were treated by medical students had three times higher death rates than those staffed by midwifes. He hypothesized that the medical students were carrying the infection directly from the autopsy room to the woman in labor.
He then ordered the students and physicians to wash their hands with chlorinated solution before and between examining patients. This resulted in a large drop in the death rate to less than one percent for the woman in labor.
Equally, it was the accidental re-discovery of penicillin by the British bacteriologist Alexander Fleming in 1928 that colonies of the bacterium Staphylococcus aureus could be destroyed by the mold Penicillium notatum. The same observation was made earlier in 1896 by a French medical student, Ernest Duchesne.
Fleming’s discovery demonstrated that disease causing bacteria could possibly be destroyed by antibiotics; however, the medical applications of this discovery was not recognized until the 1940’s when Howard Florey and Ernst Chain isolated the active ingredient and developed a powdery form of the medicine.
Like the discovery of penicillin, we argue that the hints and discovery for a more comprehensive pro-health approach in the treatment of cancer have probably already been discovered and re-discovered such as fever therapy and enhancing the body’s innate immune system. All that needs to be done is recognize and implement the new approach as a viable treatment. Culturally, we tend to be strongly attached to ideas and concepts we think are true; thus, most people do not change their minds easily (especially not doctors), one has to wait until the promulgators of the old incomplete/wrong ideas/concepts have retired or died.
Medical doctors tend to pose an extra hurdle to change concepts (paradigms) and improvement of new therapy modalities. To become a medical doctor is not too difficult. One needs to have a good memory more than being intelligent. A medical student succeeds when he can pass all his multiple choice exams.
The essence of multiple choice questions is that one eliminates all answers which are untrue or unlikely. At the end, one has one or two answering options which are most likely true. One is then chosen. But as a patient, one expects from his physician that he knows what the patient has and not what he most likely does not have. As for initiating a therapy or prevention, this is extremely important.
There are strong economic interests from the pharmaceutical industry not to change concepts (paradigms) of health and disease, and therapy. More than 85% of all “evidence-based” clinical studies are paid for by pharmaceutical companies. Pharmaceutical companies will only invest money in development of new medications if they can (hopefully) obtain a patent. To be rewarded a patent, the drug or medication must be new. If a drug company obtained a patent, it has a world-wide monopoly for the duration of 25 years. Therefore, there is no money of any significance available for development of established therapies or therapies, even successful, where the reward of a patent for the drug company is unlikely.
To our knowledge, there is not one university independent from the drug companies. Not only the clinical development is being paid for by the drug companies but also the salaries of personnel (including the professor and staff physicians) at university hospitals and they receive all or a main part of their salaries and other costs from the pharmaceutical companies. Therefore, one could postulate that, in case of medicine, universities are no longer independent centers of research.
After the initial discovery which is a radical change in perspective, the ongoing incremental changes in modifying and discovering different antibiotics continue to improve clinical outcome; however, it was the initial shift in perspective to use antibiotics that made most impact. The analogy is similar to transportation.
The radical shift occurred with the development of the internal engine and the car. It totally changed and replaced the horse-drawn transportation system. The conceptual change was the invention of the car; the small incremental improvements made the car more usable and comfortable; however, the initial invention was at the beginning of the 20th century the unappreciated ground shifting event.
Similarly, many inventions were initially unrecognized events at the time of discovery yet radically changed the world in which we live. Think of the discovery of electricity, the telephone, the air-conditioner, the computer, television, airplane, lasers, x-rays. Each was unrecognized at the time as a significant change agent and totally uprooted established industries (typewriter companies, trans Atlantic ships for passengers, etc.);
These are the unexpected events which are labeled Black Swans by Nassim Nicholas Taleb (2007) in his remarkable book, The Black Swan- The impact of the highly improbable. It is the highly improbably, which upon hindsight we would say, it is obvious and why did they not know it in the same way as we think of the stupidity of the 19th century physicians who did not wash their hands. In this example, hand washing was the unusual, the highly improbable which had a major impact on stopping diseases from spreading and health.
The five percent drop in cancer death rates since the 1950s suggests that we still live in a delusional mediocracy. We tend to accept the standard models of cancer treatments because of the cultural hypnotic induction that what is, must be true. Everyone, especially authorities such physicians and researchers, believes this to be true; thus, it must be true.
The status quo is strengthened by the financial incentives for pharmaceutical industry to earn money from patented drugs, for the high technology industry that supports the imagery industry such as mammograms and MRIs and the process of getting research grants from the government. Each supports and maintains the status quo.
Economic incentives and medical reimbursement continue the diagnostic and treatment strategies such as mammography and chemotherapy because it appears to be the correct model. To have a different opinion that the present treatment model is incomplete and possibly incorrect is to shout into the wilderness. It is much more reinforcing and safer to work on the incremental change without ever daring to ask, “Is this really an appropriate treatment approach or is it more of the same?”
To support the unconventional the out of the box models means making many investments with a very low return rate and the rare unique return which may not be recognized until years later. In the same way, the internet was not developed for public use but for rapid research and military information exchange.
Is it more like the emperor without clothes and some day we will look back at present day cancer treatments and shudder in our thought, how could medicine have been so deluded and destructive to think that by killing the cancer cells and also destroying the person many healthy cells, health can be created. We will look back in the same way as we look back now to the 19th century treatment of bloodletting which caused the death of George Washington, the first president of the United States of America.
The overwhelming scientific dogma and bias limits research in improbably but high return research and new clinical treatments. Also, the medical industrial complex with billions of dollars at stake in the present day treatment approaches such as mammograms and chemo therapy are resistant to change. At the same time, grants are awarded and research supported for the present dogma which is based upon historical and past perspectives. For cancer research, this dogma focuses on funding more of the same research which has lead to limited insignificant change in the death rate through research in chemotherapy, radiation, surgery, immunology, genomics, and viruses.
Treating Prostate Cancer with Immune Therapy, Using the Gorter Model Authors: Robert Gorter, MD, PhD, and Erik Peper, PhD
„I had a primary tumor. It is no long there. You can feel it when a large tumor in the prostate is gone and you can also see it on an ultrasound. Now my PSA is in the normal range, around 6.0. Not a single urologist will frown if somebody of my age has 6.0. I have changed my life. I feel healthy. I go for walks, swim, and cycle, and on holidays, go mountain climbing. Of course, I lost some muscle after the treatment. I need to work out, and that will take a while…but there are no other limitations.”[1]
(Mr. Karl Hagemeyer, treated by the Gorter Model. Six year survivor of stage IIIb prostate cancer with a Gleason Score of 9.
Clinical research on prostate cancer treatment has shown that watchful waiting and healthier life style frequently leads to a good clinical outcome.[i]
However, for advanced cases the outcome is much less promising, especially when metastasis has occurred. Prostate cancer treatment generally focuses on surgically removing the cancer, killing the cancer cells with radiation or chemotherapy, or temporary blocking or slowing the growth of the cancer with hormone-suppressing drugs.
Invasive treatment of patients with stage 3 and 4 cancers with high Gleason Scores in most cases postpones death by only a few months, while the patient’s quality of life tends to deteriorate due to the side effects of the therapy. These treatments also frequently damage other tissues.
Encouraging outcomes with newer treatments suggest that supporting and enhancing the body’s own immune capabilities offer significant promise in the fight against prostate cancer. This article outlines a protocol of immune therapies developed by Robert Gorter, MD, PhD, founder and director of the Medical Center Cologne, in Cologne, Germany, which provides integrative cancer treatment.
Dr. Gorter holds an MD degree from the University of Amsterdam, post-doctoral training from the University of California San Francisco Medical School, a PhD from Witten/Herdecke University in Germany, and post doctoral training in anthrophosophical medicine from the Wegman and Lucas Clinics in Arlsheim, Switzerland.
He has extensive clinical experience in immunology and HIV-related treatment gained through research and clinical practice working in AIDS programs in San Francisco in the 1980s and 1990s, initially as a physician in the famous Ward 86, and subsequently as medical director of the Department of AIDS Epidemiology and Biostatistics at UCSF for four years.
Building on his training and clinical experience, he has spent the past two decades developing a cancer treatment protocol that includes therapies to mobilize and improve immune function.
The Gorter Model includes a number of medical interventions that have been studied extensively in Europe, Japan, and worldwide. The details of this procedure are described in a book forthcoming from North Atlantic Press, Fighting Cancer (May, 2011). These therapies, combined in protocol for individualized cancer treatment, have been found to significantly enhance immune function:
Therapeutic fever (described in the literature as total-body, fever-range hyperthermia)[ii] br/>
Localized hyperthermia administered to the tumor tissue[iii]
A form of immune inoculation using dendritic cells to “restart” or improve immune activity[iv]
Other immune-enhancing approaches such as nutrient infusions[v] and oral supplements, as used in orthomolecular medicine
Hundreds of research studies have demonstrated the clinical efficacy of dendritic cell therapy, whole-body hyperthermia, and localized or regional hyperthermia. Patients treated with the Gorter protocol experience higher total remission rates, improved clinical outcomes, and significantly improved quality of life.
What makes the Gorter Model unique is the integrative approach in applying these immune-enhancing therapies in clinical treatment, particularly the integration of hyperthermia with dendritic cell inoculation. The model provides these therapies in targeted, finely tuned protocol, calibrated over more than two decades to maximize both clinical benefit and safety.
Hyperthermia, dendritic cell inoculation, and antioxidant infusions are given in a unique sequence so they activate and enhance the body’s own processes. Patients have no negative side effects other than temporary discomfort lasting a day or less, and the vast majority of patients report tangibly improved energy and quality of life—an experience very different from that associated with traditional chemotherapy, radiation, hormone suppression, and surgery.
This protocol can be used as a complete therapy and it can also be provided in tandem with conventional medical procedures to treat cancer.[vi]
Patient Outcomes
To date, of the 3,500 patients who have received care at Medical Center Cologne (MCC), 96% came to the center with an initial diagnosis of end-stage (stage IV) disease with no remaining therapeutic options. MCC was considered by them as their last hope.
Clinical data from MCC shows that, if patients lived long enough to receive three vaccinations with dendritic cells or more, approximately 380 of these patients have obtained complete and sustained remission. Depending on the type of cancer, if a patient lived long enough to receive three vaccinations with dendritic cells or more, rates of complete remission have averaged
18% for malignant
28% for breast cancer
48% for brain tumors (glioblastoma multiforme stage IV).
In addition, partial to complete remissions are seen in roughly 60 to 70% of all cancer patients with solid tumors, many surviving five to ten years with good quality of life.
The average complete remission rate at MCC for primary brain tumors such as Glioblastoma multiforme stage IV is 48% in contrast with a survival rate of 28% in the first year with conventional treatment (radiation in combination with Temodal). However, three-year follow-ups at MCC show a 43% survival rate for patients with brain tumors treated with the Gorter Model, in contrast to the 1% survival with conventional medicine.
Currently, there are hundreds of patients treated for end-stage cancer using the Gorter Model who have lived significantly longer than their statistical prognosis, without the debilitating side effects of toxic therapy. The majority of these patients experience significantly improved quality of life.
Of the end-stage cancer patients treated with the Gorter Model who have experienced complete remission, there is a 1% recurrence rate (all patients who were persistent smokers). Patients who show the best response have received at least three vaccinations with dendritic cells and are active participants in their own healing process.
Prostate Cancer Outcomes
Approximately 60% of all prostate cancer patients treated at MCC have experienced significantly prolonged survival time, typically from five to eight years, with improved quality of life. Most of them entered treatment with stage IIIb or IV cancer and a Gleason Score between 7 and 10. Prostate cancer patients typically show significant clinical improvement, with tangible quality of life.
The clinic has also had extensive experience with metastatic prostate cancer. In cases of far-advanced forms of prostate cancers and with a Gleason score of 9 or 10, 15% still experience complete and sustained remission.
The clinical protocol for metastatic prostate cancer involves the integration of the following therapies:
1) Immune inoculations. The vast majority of cancer patients have depressed immune function, reflected in lower levels of natural killer (NK) cell activity. In the vast majority of patients, immune surveillance and detection of malignancies are also impaired. This surveillance capability is normally carried out by dendritic cells, which are antigen-presenting immune cells that circulate throughout the body and inner organs, seeking abnormal and cancerous cells. When the dendritic cell finds a malignant cell, they initiate the destruction of that cell by alerting NK cells (and other cytotoxic cells) with the “ID” or antigen of the deviant cell. This triggers a targeted response to destroy the malignant cell.
When any of us develops clinical cancer, it is a sign that dendritic cells are no longer functional—no longer able to recognize malignant cells. By inoculating patients with millions of young and vital dendritic cells, the immune system is restored in its anti-cancer activities.
Specialized laboratories now have the capability of developing dendritic cell inoculations using autologous dendritic cells, extracted from the patient’s own blood. In the first year of treatment, these inoculations are applied at two-week intervals (six vaccinations in total) to restart immune function and sensitize the immune system to the presence of cancer. After the initial reintroduction of dendritic cells, these inoculations are given for the following three years, one vaccination every six months. After four years, it is recommended that patients receive one vaccination per year.
The vaccine is manufactured using 80 ml-100 ml of peripheral blood drawn from the patient, which is sent to a lab where the monocytes can be isolated. In a seven-day process, dendritic cells are then developed from the patient’s own monocytes. For each vaccination, a new batch of dendritic cells is created in the lab. This assures the vitality of the dendritic cells. Patient responses following vaccine administration indicate that in the majority of cases, each inoculation further augments the immune response.
2) Therapeutic fever. Almost all cultures have had some form of heat therapy, from Indian sweat lodges to contemporary infra-red saunas. The rationale for the therapeutic benefits of heat and induced fever are found throughout the medical literature.[vii] Research conducted over the past 150 years indicates that fever is the signal which activates the immune response. Once the immune system reaches an alarm phase of 101° F (38,5 °C) the level of immune activity begins to rapidly double. This activation is reflected in higher levels of interleukins,[viii] dendritic cells,[ix] heat shock proteins,[x] T cells, and other immune factors.
In terms of the effect of fever on cancerous tissue, at 38,5° and higher, cancer cells drop their escape mechanism and become more visible to dendritic cell detection. The cancer cells also begin overproducing lactic acid and eventually die from excessive intracellular lactic acid production.
Clinical data from the Medical Center Cologne indicate that the combination of “fever-range, total-body hyperthermia” and dendritic cell vaccinations is more effective than either treatment in isolation. Many of our patients who had been told to prepare for death are able to get back to living their lives and some experience complete remission.
Total-body hyperthermia is provided to approximately 70% of all MCC patients. Each of these hyperthermia treatments lasts about 4 hours, which includes the gradual heating and cooling of the body. During hyperthermia patients are carefully monitored for both temperature and pulse rate, and receive infusions to avoid dehydration and to restore levels of antioxidant nutrients. New patients are given at least six sessions of hyperthermia and six dendritic cell injections during the first year.
All patients are carefully screened for their appropriateness for hyperthermia– patients with a heart condition or brain tumor, and those who are too weak to withstand the four hours of heat stress are treated with other therapies such as localized hyperthermia, but not with whole body hyperthermia.
3) Localized or regional hyperthermia. In localized hyperthermia, heat is applied directly to the tumor tissue. In regional hyperthermia, a “region” or area of the body is selectively heated so that only the cancer cells increase in temperature. In the treatment of prostate cancer, these targeted heat treatments may be applied to the pelvis, the prostate region, and at locations where metastases are present. Localized hyperthermia is used with approximately 99% of our patients.
Each session of localized hyperthermia takes one hour. This targeted heating increases the temperature within the the malignant cells to 42 C (107.6 F) so they die due to the increased intra-cellular lactic acid production. Only the tumor cells are increased in temperature, which leads directly to cancer cell death (necrosis). Surrounding healthy cells are not affected. The localized temperature elevation and the resulting cancer cell death also usually activate an immune response.
Another reason localized hyperthermia is so effective is that cancer cells contain abnormal proteins which are coarser and thousands of times larger than normal proteins. During hyperthermia, these tumor proteins absorb the energy when exposed to a MRI-like electromagnetic field. This causes the targeted cells to heat up to a very high temperature—107.6°F (42°C).
The electro-hyperthermia equipment used for localized hyperthermia causes no risk of burns and can be focused exclusively on any area of the body. Unlike total-body hyperthermia, with this localized technique the tumor cells can be selectively heated. This enables us to provide interventions for areas of the body that would normally be difficult to treat, such as bone tissue, the lungs, and the head. The fact that localized hyperthermia can be efficacious in treating brain tumors was borne out by a recent Phase III study for patients with brain lesions, in which hyperthermia proved to support significantly better results in terms of illness-free time and survival when compared with radiation and/or medication (Temodal).
4) Infusion therapy. Patients are treated with infusions of vitamin C, magnesium, thymus and spleen peptides, minute amounts of selenium, meteoric iron, zinc, gold, antimony, and other immune enhancing supplements, given in conjunction with both localized and whole-body hyperthermia. Patients experiencing significant weight loss receive infusions of amino acids to prevent or reverse wasting.
The efficacy of infusions in cancer treatment has been documented in research from the NIH published in 2004, comparing the efficacy of vitamin C given orally and via IV.
When terminally ill cancer patients were provided with oral megadoses of vitamin C of 10 grams a day, no clinical benefit was observed.
By comparison, IV infusions produced blood levels of vitamin C that were “140-fold higher than those from maximum oral doses.[xi]
The conclusion of this NIH team (including Riordan and others) was that “only intravenous administration of vitamin C [and not oral vitamin C] produces high plasma and urine concentrations that might have antitumor activity.
5) Infusions of biphosphanates for bone metastases. In cases of metastases, we recommend patients receive monthly infusions with 4 mg of Zometa. This medication belongs to the group of biphosphanates that strengthen bone by increasing calcium content. This has been found to limit the development of existing bone metastases and also prevent new bone metastases. We have documented remarkable success in treating bone metastases and often these patients go into permanent and complete remission within a few months when we apply Zometa in combination with localized or regional hyperthermia. Usually patients receive monthly infusions of Zometa for a full year and then about one infusion every two months for the next six months. By then, there is often no need to continue giving Zometa routinely.
6) European mistletoe (Viscum album L.). In European oncology, mistletoe is one of the most studied of all botanicals. There are thousands of research studies showing beneficial effects in both cancer patients and in people living with chronic viral infections.[xii] One of the clinical benefits of mistletoe is the improvement of NK cell levels. These cytotoxic cells (and other similar immune cells) are responsible for destroying cancer cells.
At the Medical Center Cologne it was found that approximately 90% of all cancer patients have significantly decreased NK cell functions. That could explain why large cohort studies of mistletoe show great benefit in quality of life and significantly prolonged survival when cancer patients with solid tumors took mistletoe for at least three months. In Central Europe, it is estimated that about 70% of all cancer patients receive mistletoe on prescription from their treating oncologist or family practitioner. Patients generally self-inject the mistletoe subcutaneously, given every 3 days in the morning, approximately twice a week.
7) Lifestyle and self-care. Prostate cancer patients receive education on nutrition and lifestyle issues. They are also prescribed supplements, some in orthomolecular dosages. Supplementation typically includes vitamins A, B complex, C, D, and E, curcumin, and other immune-restoring substances, among them trace elements such as selenium and zinc and plant-derived medications from dandelion, chicory, and horsetail. Melatonin is recommended to help restore circadian rhythm,
All these protocol can be combined with conventional therapies such as chemotherapy or radiation, so patients are not forced to choose between treatment options. They simply continue working with their community oncologist and when the integrative treatment takes hold and their scans have confirmed this, the more toxic therapy is gradually phased out.
These protocol have been so successful, it is our hope that in the future cancer patients will have access to this type of treatment at a much earlier stage. Research on nontoxic therapies such as Newcastle Disease virus in stage II and III cancer patients found in long-term follow-ups that the majority of patients were surviving 10 and 15 years with good quality of life. These therapies expand the options for patients who are contraindicated for a more conventional approach, for example due to sensitivity to medication, impaired detoxification, very young or very advanced age, or other health issues that would preclude invasive treatment.
The website also includes documentary videos that provide a sense of the exceptional health and vitality of many of our patients using these non-toxic protocols. The documentaries feature patients who have experienced total remission even though they came to the medical center with stage IV cancer, having been told that they had no treatment options and only little time left.
This protocol is described in greater detail in the forthcoming book by Robert Gorter, MD, PhD, and Erik Peper, PhD. Fighting Cancer: Mobilize Your Immune System Using the Gorter Model, published by North Atlantic/Random House, May 2011.
Our thanks to Nancy Faass, MSW, MPH, director of WritersGroupLLC.com, for editorial support and research.
References:
[i] Ornish, D, Weidner, G, Fair, WR, et al. Intensive lifestyle changes may affect the progression of prostate cancer. Journal of Urology. 2005;174(3):165-169.
[ii] Atanackovic D, et al. Patients with solid tumors treated with high-termperature whole body hyperthermia show a redistribution of naïve/memory T-cell subtypes. Am J Physiol Regul Integr Comp Physiol. 2006 Mar;290(3):R585-594. Epub 2005 Oct 27.
[iii] Mukhopadhaya A, Mendecki J, Dong X, Liu L, Kalnicki S, Garg M, Alfieri A, Guha C. Localized hyperthermia combined with intratumoral dendritic cells induces systemic antitumor immunity. Cancer Res. 2007 Aug 15;67(16):7798-806.
[iv] Lemoine FM, Cherai M, Giverne C, Dimitri D, Rosenzwajg M, Trebeden-Negre H, Chaput N, Barrou B, Thioun N, Gattegnio B, Selles F, Six A, Azar N, Lotz JP, Buzyn A, Sibony M, Delcourt A, Boyer O, Herson S, Klatzmann D, Lacave R. Massive expansion of regulatory T-cells following interleukin 2 treatment during a phase I-II dendritic cell-based immunotherapy of metastatic renal cancer. Int J Oncol. 2009 Sep;35(3):569-81.
[v] Riordan HD, Casciari JJ, González MJ, Riordan NH, Miranda-Massari JR, Taylor P, Jackson JA. A pilot clinical study of continuous intravenous ascorbate in terminal cancer patients. P R Health Sci J. 2005 Dec;24(4):269-76.
[vi] Franckena M, et al. Radiotherapy and hyperthermia for treatment of primary locally advanced cervix cancer: results in 378 patients. Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):242-25-. Epub 2008 Nov 5.
[vii] Overgaard, J. (2006). Effect of hyperthermia on malignant cells in vivo: A review and a hypothesis. Cancer, 39(6), 2637-2646.
[viii] Dinarello CA. Thermoregulation and the pathogenesis of fever. Infect Dis Clin North Am. 1996;10(2):433–449.
[ix] Gorter, R. Clinical research unpublished and in press. Medical Center Cologne, Cologne, Germany.
[x] Dressel R, Heine L, Elsner L. et al. Induction of heat shock protein 70 genes in human lymphocytes during fever therapy. Eur J Clin Invest. 1996;26(6):499–505.
[xi] Padayatty SJ, Sun H, Wang Y, Riordan HD, Hewitt SM, Katz A, Wesley RA, Levine M. Vitamin C pharmacokinetics: implications for oral and intravenous use. Ann Intern Med. 2004 Apr 6;140(7):533-7.
[xii] Heinzerling L, von Baehr V, Liebenthal C, von Baehr R, Volk HD. Immunologic effector mechanisms of a standardized mistletoe extract on the function of human monocytes and lymphocytes in vitro, ex vivo, and in vivo. J Clin Immunol. 2006 Jul;26(4):347-59. Epub 2006 May 17.
Provenge, first autologous cellular immunotherapy to prolong survival in prostate cancer
PROVENGE(R) (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer
New England Journal of Medicine Publishes Data from Pivotal Phase 3 PROVENGE IMPACT Study First Autologous Cellular Immunotherapy to Prolong Survival in Cancer -
SEATTLE, July 28, 2010 /PRNewswire via COMTEX/ -- Dendreon Corporation (Nasdaq: DNDN) announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE(R) (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). The manuscript is published in the July 29, 2010 issue of the journal.
PROVENGE is the first product in a new therapeutic class known as autologous cellular immunotherapies to be approved by the U.S. Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic mCRPC.
The 512-patient multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrated that PROVENGE extended median survival by 4.1 months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5% compared to control (HR=0.78; P=0.032). Adverse events more commonly reported in the PROVENGE arm in this study included chills, fever, headache, influenza-like illness, muscle aches, hypertension and groin pain.
"These results represent the beginning of a new era in the treatment of cancer, one in which a patient's own immune system is harnessed to fight the disease," said Philip Kantoff, M.D., lead author of the publication, co-principal investigator of IMPACT and Chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place PROVENGE as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC."
Results of the published IMPACT study also showed that:
The survival benefit associated with PROVENGE was observed consistently across multiple patient subgroups, including those with prognostic factors known to be adversely correlated with overall survival, such as PSA, LDH, alkaline phosphatase, number of bone metastasis, Gleason score, performance status, and presence of pain;
Of patients that received PROVENGE, 97.1% received at least one infusion and 92.2% received all three infusions. In addition, the median time from the first to the third infusion was 28 days;
Sensitivity analyses provided no evidence that the use of docetaxel could account for the observed treatment difference with respect to overall survival;
Results were consistent with and confirmed the findings of D9901, a Phase 3, randomized trial, in which the PROVENGE group had a median increase in survival of 4.5 months, a median survival of 25.9 months, and a 3-year survival rate of 34.1%;
The time to objective disease progression was similar in the two study groups and consistent with results from other trials in this patient population; and
Overall, 0.9% of patients in the PROVENGE group were unable to receive all three infusions because of infusion-related adverse events.
"PROVENGE has opened a new door in the treatment of advanced prostate cancer, providing patients with a clear and meaningful survival benefit, as well as a minimal and readily manageable side effect profile, with a short duration of therapy," said Paul Schellhammer, M.D., professor of urology at the Eastern Virginia Medical School and co-principal investigator of the IMPACT study.
PROVENGE Safety
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence > to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full prescribing information or call Dendreon ON CALL at 1-877-336-3736.
About Active Cellular Immunotherapy
PROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Active cellular immunotherapy is designed to stimulate a T-cell response to cancer cells. An immune response is started by a specialized class of immune system cells called antigen-presenting cells (APCs). APCs take up antigen from their surroundings and process the antigen into fragments that are then displayed on the APC surface.
Once displayed, these antigens can be recognized by specific classes of immune cells called T lymphocytes (T-cells), which are activated as a result of their engagement with APCs and combat disease by seeking antigen-bearing cells directly. PROVENGE is designed to target the prostate cancer antigen prostatic acid phosphatase (PAP), an antigen that is expressed in more than 95 percent of all prostate cancers.
About Prostate Cancer
According to the American Cancer Society, prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than two million men in the United States have prostate cancer, with an estimated 217,730 new cases and approximately 32,050 men expected to die from the disease in 2010.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer. The Company is headquartered in Seattle, Washington and has manufacturing facilities in New Jersey, Georgia and California. Dendreon is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit
DCVax®-brain shows survival for patients with brain cancer
Long-Term Follow-Up of DCVax®-Treated Brain Cancer Patients Shows 33% of Patients Reached 4-Year Survival and 27% Have Reached or Exceeded 6-Year Survival
Long-Term Follow-Up
Long-Term Follow-Up of DCVax®-Treated Brain Cancer Patients Shows 33% of Patients Reached 4-Year Survival and 27% Have Reached or Exceeded 6-Year Survival
BETHESDA, Md., Aug. 3 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics, Inc. ("NWBT" or the "Company") (OTC Bulletin Board: NWBO) today announced further positive long-term follow-up data from its prior Phase I and Phase I/II clinical trials, in which patients with newly diagnosed Glioblastoma multiforme ("GBM"), the most rapid and lethal type of brain cancer, were treated with NWBT's DCVax®-Brain personalized immune therapy.
The data through July 1, 2010, show that no patients died during the 9-month period since the last data update (throughSeptember 2009). The data also show that median survival was 3 years, 33% of the patients reached 4-year survival, and 27% reached or exceeded 6-year survival (up from 22% who had reached or exceeded 6-year survival as of the last data update). The longest surviving patient to date has now exceeded 10 years.
GBM is a highly lethal cancer: with standard of care treatment (including surgery, radiation and chemotherapy), patients with newly diagnosed GBM have a median survival of only about 14.6 months, and less than 5% of such patients are still alive at 5 years.
"We're excited and encouraged by the continued extension of survival in the patients who received DCVax® in the prior clinical trials," commented Dr. Al Boynton, NWBT's CEO, "especially since DCVax® is non-toxic, unlike chemotherapies, and involves just a simple injection under the skin, like a flu shot."
DCVax®-Brain is a groundbreaking personalized vaccine designed to stimulate a patient's own immune system to fight cancer. DCVax®-Brain is made up of the patient's own "dendritic cells," the master cells which direct the immune system, that have been activated and "educated" to mobilize the whole immune system to recognize and destroy cancer cells bearing the biomarkers of the patient's own tumor. Each patient undergoes surgical removal of their tumor as part of the current standard of care, and also undergoes a blood draw to obtain their immune cells.
The biomarkers from the patient's tumor tissue are exposed to the patient's immune cells, along with certain other proprietary steps, in order to activate and "educate" the patient's dendritic cells.
These activated and "educated" dendritic cells are injected back into the patient, in a simple small injection under the skin in the upper arm, similar to a flu shot or insulin shot. These cell treatments are administered at a series of time points several weeks apart and then months apart. The dendritic cells are then able to mobilize the immune system to recognize and attack the cancer, and do so without toxicities of the kind associated with chemotherapies.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines and therapeutic antibodies.
The Company's lead clinical trial is a 240-patient Phase II trial in GBM. The Company also previously received clearance from the FDA for a 600+ patient Phase III trial in prostate cancer, and clearance from the FDA for Phase I trials in five other cancers. The Company has also conducted a Phase I/II trial with DCVax® for recurrent metastatic ovarian cancer. The Company's second technology platform, involving antibodies to CXCR4, is at the pre-clinical development stage.
For further information about clinical sites and Company information please visit the company web site at < a href=” www.nwbio.com. ”>
Biotherapeutics, Inc. (OTC Bulletin Board: NWBO; AIM: NWBT and NWBS)
Hieronder een artikel over deze studie en wat DCVax (R) - brain is.
("NWBT" or the "Company") today announced the most recent long-term follow-up data, through June 15, 2008, from its prior Phase I and Phase I/II clinical trials with DCVax(R)-Brain, which began in 2000 and 2003, for patients with Glioblastoma multiforme, the most lethal type of brain cancer.
This long-term data shows that 84% of patients who received DCVax(R)-Brain in these trials have so far lived longer than the median survival of 14.6 months under standard of care, 68% of the patients have so far lived more than 2 years, 58% of the patients have so far lived more than 2-1/2 years, 42% have so far lived more than 3 years, and 26% have so far lived more than 4 years, with patients surviving as long as 8 years to date.
The median survival in the patients from these trials is now 36.4 months, under a standard Kaplan Meier analysis.
DCVax(R)-Brain is a groundbreaking personalized vaccine that takes a patient's own immune cells and trains them in the laboratory to attack the biomarkers from that patient's own tumor cells.
The 10-day manufacturing process produces several years of personalized vaccine for a patient, making DCVax(R)-Brain an "off-the-shelf" product for that patient throughout the treatment period. DCVax(R)-Brain is administered as a simple injection under the skin, similar to a flu shot, and is not toxic as chemotherapies are.
The most recent data provides an update for the period since December 31, 2007, concerning both disease progression and overall survival. During that period, only one of the nineteen patients experienced disease progression (at 59.5 months), and only one patient died (at 37.8 months).
The long term data from these clinical trials shows that more than 80% of the patients who received DCVax(R)-Brain showed a clinical response. In contrast, the typical response rates for cancer drugs are in the range of 20 to 25% of patients, and have been as low as 13% of patients with some approved cancer drugs.
DCVax(R)-Brain is now in a large, Phase II clinical trial designed and powered as a pivotal trial, which is currently enrolling patients at 11 medical centers across the U.S. (listed at ).
