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.
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.