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2-DG Cancer Treatment Begins Human Trials

Senior Female Scientist Works with High Tech Equipment in a Modern Laboratory. Her Colleagues are Working Beside Her.

Dr. Lampidis Collaborates on Groundbreaking 2-DG Clinical Trial in Germany

We are delighted to announce today that the Lampidis Cancer Foundation, along with the MCS Foundation for Life, is actively preparing to collaborate with clinics worldwide on implementing protocols using 2-DG for patients who have failed standard treatment. This is a massive step towards making 2-DG accessible to cancer patients worldwide.

We expect leadership from clinics in countries where the legal and regulatory framework is in place to support the implementation of 2-DG protocols.

Our team will focus initially on Germany, which has a long tradition of allowing new substances with known toxicity profiles and strong scientific data supporting their anti-cancer potential to be given to patients who have failed standard treatments. Clearly, 2-DG fits this profile. In addition, for logistical reasons, Germany is an excellent initial country for us to focus on building collaborations with clinics since patient-grade 2-DG is available in German compounding pharmacies, such as Apotheke Koenigstein.

Working with Dr. Daniel Stanciu (scientist and founder of the MCS Foundation) and Dr. Metin Kurtoglu, we have formed a team to begin exploring collaborations with clinicians in Germany and elsewhere implementing protocols that involve metronomic (slow-release) delivery of 2-DG.

We began examining this delivery system when the results of our previous clinical trial demonstrated that oral ingestion of 2-DG induced an insulin response, thereby redirecting 2-DG to fat and muscle and away from the tumor site.

This result prompted us to go back to the lab, where Dr. Lampidis found that metronomic delivery of 2-DG, at a rate and concentration that is below an insulin-inducing dose, showed significant anti-tumor activity in animal cancer models.

Although the data is still at an anecdotal stage, it is encouraging to know that at least four patients are reporting excellent tolerance with metronomic 2-DG treatment as well as a reduction in the size of their respective tumor types and markers. Since these patients are being co-treated with other agents it is difficult to definitively assess whether 2-DG is contributing to these positive results.

The information collected by patients and their clinicians regarding 2-DG is of great value. Even the three patients above provide some initial information on tolerance and safety. As a reference, Phase 1 Clinical Trials, which are focused on establishing Maximum Tolerated Dosage, typically run at around 20 patients.

Our expectation is that the outcome of the global clinical collaboration we are launching will be to gather enough data to establish the level of contribution of 2-DG, along with an evaluation of the more complex data available from numerous patients co-treated with multiple agents including 2-DG.

With the launch of this collaboration, we hope and expect to have an immediate positive impact on the lives of advanced cancer patients at the collaborating clinics. Simultaneously, we look forward to gathering the resulting clinical data in order to provide convincing evidence to the medical community here in the US and abroad that 2-DG can be an effective anti-cancer treatment when combined with other therapeutic agents to eliminate tumor cells that are resistant to standard anti-cancer protocols.

 

Our International 2-DG Team

Dr. Metin Kurtoglu holds an MD and Ph.D. in cell biology and is one of the world’s leading experts in the mechanisms by which 2-DG works as well as its clinical application. We have worked closely together and have published extensively on 2-DG as an anti-cancer agent. Dr. Kurtoglu, based in Washington DC, is also developing a novel CAR T immunotherapy that is currently in Phase I clinical trials.

Dr. Daniel Stanciu, based in the Netherlands, holds a Ph.D. in physics and has become an expert in traditional as well as alternative cancer treatments since his beloved wife Mihaela, who recently passed away, was diagnosed with cancer in 2013. Mihaela’s spiritual, mental and physical abilities to fight her disease, combined with Daniel’s research abilities and a supporting network of scientists and physicians from across the world, gave them the ability to enjoy a healthy and prolonged time together for years beyond what they were told to expect when she was first diagnosed.

Daniel is now devoting his life and career to helping others suffering from this devastating disease, through the MCS Foundation for Life. He has attracted a following of more than one million views to his blog, where he presents scientific information consolidated around new or improved approaches to treat advanced cancer.

Dr. Theodore J. Lampidis, Ph.D. is a professor of cell biology at the Miller School of Medicine in Miami, trained at the Dana Farber Cancer Institute, Harvard Medical School, and whose lab is internationally known for its work on developing 2-DG as a universal treatment for numerous cancer types. Dr. Lampidis is a leading authority on exploiting cancer glucose metabolism with sugar analogs.

Updates on patients’ responses to this treatment will be provided on this and Dr. Stanciu’s website (Blog and Foundation) as they become available.

As we describe above, the goal of this effort is to help provide clinical data on 2-DG to the world. Therefore, for every patient who decides to use metronomic 2-DG, a critical contribution they can make is to provide the Foundation with as much information as possible on the specifics of patient treatment and response. While in some cases this function will be filled by the clinics, our expectation is that there will be numerous collaborating clinics that will offer the treatment but will not have the bandwidth to take the crucial additional step of documentation and communication. From our experience, often the function of documentation and communication can be fulfilled by family members or loved ones.

This information will be essential for evaluating the efficacy of our treatment protocol and of course the names of the patients and their relatives will be kept confidential in accordance with HIPAA rules and regulations.

Disclaimer: We wish to make it clear that although slow-release 2-DG treatment has been tested in animals and shown to have anti-tumor activity, to our knowledge it has not been considered by the FDA for approval. We do plan to submit this 2-DG delivery method to the FDA but until the time it is approved, it must be considered experimental and should only be used under medical supervision and only in countries where 2-DG is approved for use in patients. 

Those patients who have taken metronomic 2-DG in the last 3 months according to our protocol, and of those who have corresponded with us, have reported no life-threatening side-effects nor have they observed any negative effects that would necessitate discontinuance of this treatment. Although most if not all of these patients are suffering stage 3 or 4 cancer, they have reported lowering of tumor markers and tumor load. However, this data must be considered anecdotal since they are all on co-treatment with other agents and other treatments. Moreover, the numbers to date are too small to evaluate either safety or efficacy.

Accordingly, we are providing information on how to use 2-DG with the guidelines set in Germany (as noted above), for patients who have exhausted the use of approved drugs and treatment options.

Moreover, metronomic 2-DG in humans is at an experimental stage, therefore patients and their respective physicians who would like to use this protocol should be aware of this and the following:

  • In clinical trials where 2-DG was administered orally as a bolus treatment, at the highest doses achieved, transient QT prolongations were observed. Thus, it will be important to reevaluate this side-effect when 2-DG is given metronomically.
  • If there is a need in patients on chemotherapy for anti-nausea medication, 5-HT3 antagonists which are known to induce QT prolongations should be avoided and alternative drugs such as palonosetron which are known not to prolong QT should be used. Daily ECG monitoring while the patient is on 2-DG infusion is recommended and the infusion should be discontinued if the QTc rises above 480 milliseconds.
  • Our 2-DG team has designed a treatment protocol for physicians, detailing our view on how to increase treatment effectiveness in advanced cancer patients. We will gladly share this treatment protocol with interested oncologists and are available for further discussions upon request.

The above disclaimer is intended to make it clear that we are providing information on how to use 2-DG treatment strictly within the legal and medical guidelines in countries where its use is approved for cancer patients that have failed traditional therapies. Since we do not yet have definitive data on the safety and or effectiveness of metronomic 2-DG in patients, we state this disclaimer for anyone using our protocol and relieve ourselves of any responsibility if indeed there are negative effects as a result of using it. This is tantamount to what a patient would agree to and sign even when entering an FDA-approved Phase I or II clinical trial at any medical facility in the United States. Thus, patients who do decide to undergo metronomic 2-DG treatment are doing so with this understanding and agreement.

Our academic research relies largely on philanthropy to keep moving forward. Please consider donating to our cause. Our goal is to raise $300,000/year to provide the necessary research to bring this treatment protocol through the relevant clinical trials in order to make it available to patients worldwide. We would appreciate your help by donating using the link above.

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Medical Research

How 2-DG Can Boost Cancer Immunology

Cancer immunology research

It has long been recognized that the highly complex immune system plays a significant role in protecting the human body from various foreign particles including viruses, bacteria, and parasites. A component of the immune system known as “T cells” are thought to act as “policemen” that are constantly on the lookout for cancer cells considered to be foreign and when found, destroy them.

However, tumor cells have evolved means of escaping T cells’ surveillance by either masking themselves from being recognized as foreign or by actually lowering the number of T cells.

Since 2-DG falsely incorporates itself into the sugar proteins or glycoproteins of tumor cells, it is able to increase the cancer cell’s “foreignness” – thereby making it more recognizable by T cells. Additionally, it has been shown that when combined with radiation, 2-DG increases the number of T cells.

Thus, given the amount of research being done on boosting cellular immunity to act as a natural defense against cancer, exploring how 2-DG may increase this effectiveness seems to be another promising mechanism by which this remarkable sugar analog may be used to fight the devastating effects of cancer.

 

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Medical Research

Hazy Cancer–Sugar Association Becomes Clearer

Top view of white sugar cubes on turquoise background

The BBC recently reported that a UK-based cancer charity, Macmillan, has appointed a nurse to combat “fake news” about cancer online. “Digital nurse,” Ellen McPake said she was there to “make sure people affected by cancer have a real person they can turn to online for information about their symptoms, cancer diagnosis, and treatment”. She explains that: “Once the doctor says ‘cancer’, people who are diagnosed with this devastating disease automatically shut down and they don’t take in the information that they’re given. So they go home, speak to their family. And then they’ll sit online that night and get themselves into a frenzy with what they’re reading. There’s quite a lot of myths out there,” – and she is, therefore, attempting to address some of them online.

Although I agree with her intent and some of the opinions she sets forth on these so-called myths, caution should also be taken with her views as the last word since new findings on cancer and treatments, as well their interpretations, are being reported almost daily that change our knowledge and perception of this devastating disease.

One particular case that is striking, and close to what we have been researching at the Lampidis 2-DG Innovation Lab, is her thoughts on the association between cancer and sugar. She says there is no hard evidence that sugar causes cancer even though it has long been known that there is a link between obesity and diabetes and by extension an increased risk of cancer. As of last month, however, this link became a lot clearer in a report in GEN magazine titled, “Hazy Cancer–Sugar Association Becomes Clearer” – in which new evidence from a collaborative team of Belgian researchers at the University of Leuven (KU Leuven), the University of Brussels (VUB), and the Vlaams Institute for Biotechnology (VIB) clarified how rapid breakdown of sugar stimulates tumor growth.

Their discovery that a breakdown product of glucose metabolism known as fructose-1,6-bisphosphate is directly linked to stimulating the expression of RAS, one of the most widely found cancer-causing genes (oncogenes), provides evidence for a positive correlation between sugar and cancer, which may have far-reaching implications on tailor-made diets for cancer patients.

This new breakthrough data further supports our development of 2-deoxy-D-glucose, better known as 2-DG, as a universal treatment for cancer by blocking the utilization of glucose in tumors and thereby preventing the stimulation of cancer-causing genes.

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Latest 2-DG Breakthrough Raises Hope of Non-Toxic Cancer Treatment

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New Study Shows That Combining 2-DG and Fenofibrate Kills a Wide Variety of Cancers
May 10, 2016, Miami, FL :: Dr. Theodore J. Lampidis, Professor of Cell Biology at the University of Miami Miller School of Medicine, today announced a major breakthrough that paves the way for a viable non-toxic treatment of a wide variety of cancers.
Dr. Lampidis is a pioneer in the exploration of glucose metabolism in cancer cells and the discovery of how to exploit this process by using simple sugars such as 2-Deoxy-D-glucose (2-DG). 2-DG has been found to inhibit glycolysis, which the most malignant cancer cells found in the inner core of all solid cancers rely on to survive. It is these cells that by nature of their slow growth are resistant to conventional cancer treatments such as radiation and chemotherapy, which are limited to attacking the rapidly dividing cells located in the outer part of a tumor.
Although a Phase 1 clinical trial proved that this strategy using 2-DG was successful, the toxic side-effects of chemotherapy remained an issue. However, this latest study, published today in Oncotarget, shows that by combining 2-DG with fenofibrate, a compound that has been safely used in humans for over 40 years to lower cholesterol and triglycerides, the entire tumor can effectively be targeted without the use of toxic chemotherapy.
“We found that the unique combination of 2-DG and fenofibrate simultaneously provokes two types of stress, known as energy and ER stress, which most of the cancer types tested cannot overcome,” according to Dr. Lampidis.
Due to uncontrolled growth and to the abnormal micro-environment in which cancer cells exist, they are under more stress than normal healthy cells. Thus, in addition to 2-DG taking advantage of the universal cancer trait of increased glucose uptake, adding fenofibrate effectively exploits a second common feature of cancers: increased stress.
Dr. Lampidis concludes: “We believe our findings effectively pave the way for using this combination to provide non-toxic treatments for a wide variety of cancers.”
Full article published here: http://www.genengnews.com/gen-news-highlights/non-toxic-method-for-treating-cancer-reportedly-developed/81252741

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The Man with the Cure for Cancer?

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Theodore J. Lampidis from Brooklyn is a man of many talents: accomplished musician, songwriter, and stand-up comedian (his friends describe him as a cross between Woody Allen and Billy Crystal). This Harvard educated research scientist is also a Professor of Cell Biology at the University of Miami Miller School of Medicine. And he could just be sitting on one of the holy grails of medicine – a universal cure for cancer.

Dr. Lampidis has published more than 100 research papers in respected scientific journals, but it is his latest review article, The Wonders of 2-DG, which is causing a stir in the scientific community and receiving rave reviews from his peers around the world. It is a distillation of his work over the last 30 years into glucose metabolism and its effect on cancerous tumors.

There is an elegant simplicity to Dr. Lampidis’ groundbreaking research which has universal appeal. He is a pioneer in exploring and exploiting the unique usage of glucose in cancer cells using a simple sugar compound called 2-Deoxyglucose (2-DG). His discovery is based on the fact that the cancer cells most resistant to chemotherapy found within the inner core of all solid tumors do not receive enough oxygen (a state known as hypoxia) and therefore must rely exclusively on sugar to survive. Dr. Lampidis hypothesized he could trick these hypoxic tumor cells by feeding them 2-DG and effectively starving them to death. This process (glycolysis) is so fundamental, it has survived a billion years of evolution dating back to a time when there was no oxygen in our atmosphere and the only source of energy that could be used to keep tiny microbes alive was sugar.

Dr. Lampidis’ eureka moment led to two consecutive five-year awards from the National Cancer Institute, which stated in the reviews of his research that “Dr. Lampidis’ work could eventually lead to cures in certain cancers.”
In addition, working in collaboration with Dr. Tim Murray, a world leading expert in the investigation and treatment of children with eye cancer (retinoblastoma), Dr. Lampidis and his colleagues have provided the first proof of principle that 2-DG targets and kills the hypoxic portion of cancerous tumor cells. According to Dr. Murray, “2-DG may turn out to be best thing to come along in this disease in the last 10 years.”

Based on Dr. Lampidis’ work, an FDA-approved Phase I clinical trial was conducted to determine the tolerable dose level of 2-DG. The results of the Phase I trial (which have recently been published) establish the safety of this drug and its remarkable effectiveness in killing cancerous tumors. The next stage is to investigate and develop the most effective combination treatments and drug delivery method before progressing to a Phase II clinical trial.

And that’s where he has hit a roadblock. The unfortunate reality is that since 2-DG cannot be patented, pharma companies are not interested in devoting their resources to bring this wonder drug to market. “If 2-DG could be patented, this drug would already be available to cancer sufferers worldwide. That’s the tragic reality,” says Lampidis ruefully.

A dedicated group of volunteers have banded together and established a not-for-profit foundation in 2013 to raise awareness for Dr Lampidis’ groundbreaking work. Their goal is to raise $10 million to accelerate the journey through clinical trials and FDA approval and bring this miracle cure to market.

“Every day, people are out there raising money to cure cancer,” says Leyan Phillips, Executive Director of the Lampidis Cancer Foundation. “The sad reality is that very little of that money ends up going to research scientists who are actually working on a cure. This is where the funding is needed the most.”

Phillips continues, “I find it shocking that some cancer foundation executives earn salaries in excess of $500,000 a year, and have advertising budgets the size of a major corporation. If Dr. Lampidis had a fraction of that funding, we would have a cure for cancer by now.”
Dr. Lampidis’ work has recently attracted support and interest from an eclectic group of celebrities, including Jose Feliciano, the virtuoso guitarist, singer and songwriter, and Mexican TV novella actress Lorena Rojas, herself a breast cancer sufferer. Rojas has been instrumental in raising awareness among the Hispanic community, where cancer has now overtaken heart disease as the single biggest killer.
According to Rojas, “What I love about Dr. Lampidis’ work is that his research offers a universal approach to treating all types of cancer. His work offers sufferers like me hope.”

He also has a fan from an unlikely source in music maestro DJ Irie, the official DJ of the Miami Heat who was recently recognized at an award ceremony in New York as NBA DJ of the Year. “Dr Lampidis rocks!” exclaims DJ Irie, who spent time last month visiting the Professor in his lab to learn more about his research. “I will do what I can to spread the word about his work.”
Whilst the University of Miami has been very supportive of his work, resources are limited due to budget cuts and reductions in federal funding from the National Institutes of Health, and from a team of five post graduate researchers in his lab he finds himself left with just one technician, who has been with him for 15 years.

Despite the lack of resources, he continues to be the global leader in his field, with his research attracting international interest and acclaim from as far afield as Spain and Japan, all inquiring about 2-DG’s availability for further clinical testing.
“Whenever we come up with an idea using 2-DG and cancer, we review the literature and find that Dr. Lampidis has already beaten us to it!” says one of his overseas colleagues who is now collaborating with Dr. Lampidis on rhabdomyosarcoma, a rare form of cancer that attacks skeletal muscle tissue.

“We’ve made such great progress over the last few years, the science is solid, and I really feel we’re on the brink of a universal treatment for cancer,” says Dr. Lampidis. “But without funding, there is a risk that cancer sufferers will be unable to access this treatment.”
“We’re hoping that a major benefactor will come along and see the opportunity to leave their mark on the world, to leave behind a legacy for mankind,” says Phillips.

As a call to action, they don’t come much more compelling than that.

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Lampidis Lab Awarded 2014 Lab of the Year

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It is with great pleasure that I share with Friends of the Lampidis Cancer Foundation the Lab of the Year Award Dr. Lampidis received this week. A rigorous assessment was conducted by the Office of Environmental Health & Safety at the University of Miami, and the award was made in recognition of outstanding performance in compliance and safety practices. Not only does Dr. Lampidis’ lab come up with life-saving discoveries, it is conducted at a safety and environmental level which is worthy of their outstanding work!

Dr. Theodore Lampidis Laboratory located at Pap 124 receiving the award.
Left to right; Melanie Peapell from EHS, Huaping Liu (Sr. Research Associate),
Dr. Lampidis and Lizzeth Meza from EHS.

At the Foundation, we are doubling our efforts to ensure that Dr. Lampidis’ Lab and his groundbreaking cancer research are adequately funded for the remainder of the current fiscal year. We are still some way from our goal of funding 2-DG through Phase 2 clinical trials. Your support and contributions are now needed more than ever.

To make a donation, please click here.

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Using a False Sugar to Kill Cancer

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At the heart of Dr Lampidis’ groundbreaking cancer research is a process so fundamental that it has survived a billion years of evolution. This process, termed glycolysis originating from Greek “glyco” meaning sweet and “lysis” meaning breakdown, evolved as the only means by which tiny microbes could survive at a time when there was no oxygen in our atmosphere.

There are three basic energy sources from which humans derive energy – carbohydrates, fats and proteins – but without oxygen, only sugar (a form of carbohydrate) can be used to sustain life.

The most difficult cancer cells to successfully treat are found in the center of a tumor where there is little or no oxygen, a condition known as hypoxia (see figure below). These hypoxic cancer cells are not only resistant to chemotherapy and radiation but also give rise to metastases (spreading of the cancer from the original site to other parts of the body). Dr Lampidis reasoned that because they depend on sugar to exist (similar to the microbes of a billion years ago), he could selectively kill these hypoxic cancer cells by blocking glycolysis with a false sugar, 2-deoxyglucose (2-DG).

He proved his idea in cancer cells growing under hypoxic conditions in a petri dish and from there in laboratory animals where the tumors naturally contain hypoxic cells. With the outstanding help of several physicians his idea was brought to reality with the completion of an FDA approved Phase I trial in humans.

Unfortunately, 2-DG is not patentable and so pharmaceutical companies are not interested in investing in future clinical trials. Hence the Lampidis Cancer Foundation has been campaigning to raise funds to support Dr Lampidis’ pioneering work on 2-DG through the next stages of clinical trials, with the single-minded goal of making it readily available to cancer sufferers around the world.

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