What is Care Oncology?
Care Oncology Clinics prescribe a repurposed combination of existing, licensed medications which are used to treat conditions other than cancer. This standard of practice is known as off-label use. Research suggests that these drugs may complement and enhance the effect of traditional, standard-of-care cancer therapies.
What is drug repurposing?
Drug repurposing, also known as drug repositioning or re-profiling, is the application of known drugs to treat a different disease. Repurposing takes advantage of the many “off-target effects” of already-approved medicines to treat new diseases. If done carefully this practice can have several important advantages. First, the drugs have typically been widely prescribed, therefore the safety profile and side-effects are well-known and documented. Second, there is a large repository—about 60 FDA approved drugs that have extensive, peer-reviewed, published research showing promising anti-cancer activity. This article in Cancer Today Magazine gives a general overview on the drug repurposing strategy.
Why aren’t these drugs already being used?
Mostly due to financial reasons. Drugs that are candidates for repurposing are typically “off-patent.” Therefore, pharmaceutical companies are unable to make a profit from winning approval for new indications. Putting “off-patent” or generic drugs to use in oncology immediately presents much needed therapies to cancer patients with minimal side-effects.
Care Oncology was conceived to bridge this gap—finally realizing the potential of repurposing promising generic medicines in a thoughtful, responsible, and ethical manner.
Why use a combination or a “cocktail” of repurposed drugs?
It is well-established that most cancer therapies are more effective when used in combination. The scientists at the SEEK Group—the parent pharmaceutical company of Care Oncology—specifically selected a combination of drugs that target multiple metabolic and signalling pathways within the cancer cell.
The drugs were carefully selected based on three criteria:
- The scope and quality of research establishing anti-cancer effects
- Very good safety profile (low side-effects)
- Safe to combine with other cancer treatments e.g. chemo-, radio-, hormone- or immuno-therapy.
This resulted in the COC Protocol™, a patented combination.
Which cancers do you treat?
The COC protocol is intended as an adjunctive treatment for ALL cancer patients with disease of any type or stage (solid tumors as well as blood cancers).
The treatment has broad application because it is metabolic in nature i.e. aimed at inhibiting the processes which cause cancers to grow and proliferate.
Cancer cells have been found to alter their metabolism relative to normal cells, and all the COC protocol medicines target key metabolic alterations thereby disrupting cancer cells’ access to and processing of the specific energy sources they need.
Due to altered metabolic features being observed generally across many types of disease, reprogrammed metabolism is now considered a hallmark of cancer. And, as a result, there is abundant existing research data on the COC protocol medicines in the context of the different types of cancer seen in the community.
Which patients are eligible?
Our treatment is designed to democratize cancer care — it is Care Oncology’s mission to make our safe and evidenced-based adjunctive protocol widely accessible and deliverable immediately.
As long as a patient is relatively well in themselves (able to swallow oral medication, getting adequate nutrition, not confined to bed, not suffering from severe and prolonged nausea) and has satisfactory baseline blood results and organ function, they would normally be eligible for the COC adjunctive protocol.
Do all your patients get the same treatment?
The COC protocol is a 4-drug proprietary combination treatment.
Although all eligible patients will receive the same 4 drugs, the combination is personalized for each individual.
The precise combination and dosing schedule is tailored to the patient and also to the type of cancer being treated.
Can patients take the COC protocol alongside conventional cancer treatments and other medications?
The short answer in most cases is “Yes”. All the COC protocol medicines have a low drug interaction burden, which generally means they can be taken alongside standard treatments such as chemo-, radio-, hormone-, and immuno-therapy.
There is substantial data on the potential of the medicines to complement standard treatments e.g. Rendering cancer cells more sensitive to chemo or radiotherapy. Therefore, your Care Oncology physician may recommend running our metabolic protocol in conjunction with conventional therapy as long as it is safe to do so.
In that case, is treatment still effective when a patient is not receiving chemo or other conventional therapies?
Yes, all the medicines have demonstrated beneficial mechanisms of action in cancer which are not dependent on the co-administration of standard therapies.
As metabolic treatment is intended to run long-term, patients may also take the protocol as a maintenance regime after standard treatment has been completed or during breaks from standard treatment and as part of a long-term strategy to mitigate the risk of recurrence or metastatic spread.
How quickly will there be results?
The nature of our treatment, with its metabolic mechanism of action (impacting cancer cells’ access to and processing of the specific sources of energy they need, and modulating the genetic expression of important oncogenic pathways) means it’s likely to be much slower acting — several months rather than weeks — compared to what are known as cytotoxic therapies such as chemo and radiotherapy.
However, every person has a unique genetic make-up, and every tumor is unique in its compliment of genetic lesions and overall metabolic and epigenetic characteristics. Therefore, every patient responds to any therapy differently.
A prospective patient’s prognosis and performance status is therefore a key consideration for us. We always aim to ensure that a patient is well enough to safely proceed with metabolic treatment and for there to be a realistic chance of them deriving some clinical benefit from our protocol.
How long should a patient have to take the COC protocol for?
The COC protocol is to be taken long-term. All the medicines in the protocol are drugs designed for long-term use. In addition, all medicines are low toxicity and have an excellent safety profile, having been used by millions of people worldwide for their labelled indications. We review patients every quarter and make an assessment at each of these checkpoints about whether treatment should continue, taking into account the current clinical picture, potential for ongoing treatment benefit and quality of life.
In a situation where a patient has long-term stability, no evidence of disease or indolent residual disease, we may switch their protocol from a treatment to a maintenance regimen. This is only ever done on a case by case basis following an assessment of the patient in question at a Clinical Team meeting.
What are your results?
Care Oncology has the dual aim of:
1) providing a structure for the safe delivery of adjunct metabolic treatment to patients today
2) collecting and reporting on data in large numbers of patients.
Our first cohort analysis is in an area of great unmet need – Glioblastoma Multiforme, the most common and aggressive type of malignant brain tumour in adults.
It has a median overall survival of 14.8* months with the best standard of care treatment. The median overall survival of our analysed cohort of 95 patients is almost double, at 27.1 months.
On a case by case basis, we believe we are seeing the same type of encouraging results in other cancer types too. We can gauge this through observing prolonged periods of stability or improvement in some patients who (based on publicly available statistical data) would be much more likely to experience disease progression. This also bears out the encouraging observations in the third-party research literature in other cancer types.
Over time and once we have patient cohorts of sufficient size, we will analyse and report on data in other cancer types as well – e.g. lung, colon, breast.
What is the process?
First, contact us to schedule a consult. Our physicians will conduct an extensive, one-on-one consultation with you. They will review the relevant labs and reports, explain the strategy of drug repurposing, the mechanisms-of-action of the medications in the protocol, discuss potential side effects, and answer all your questions, and then, if indicated, prescribe the indicated protocol.
The exact combination prescribed is determined by the patient’s type of cancer, medical history, baseline blood results and performance status.
If indicated, you will be prescribed a three-month supply of the medications comprising the protocol from our partner pharmacy. Follow up consultations are preformed every three months, at which time new scans and blood work are reviewed and adjustments to the protocol are considered.
In advance of the initial consultation we require blood work (CBC and CMP) results from the last 4 to 6 weeks, pathology report, the most recent radiology scan reports, a recent oncology letter summarizing diagnosis and treatment to date, and a list of current medications. If you don’t have the reports your oncology clinic will provide them to you upon request.
Who are your Doctors and what are their backgrounds?
Care Oncology Medical Doctors have a diverse range of experience but share one commonality: a passionate belief that cancer patients desperately need better treatment options.
Our team is made up of physicians from a variety of specialties: from oncologists, neurologists, surgeons, and primary care physicians. All our physicians at Care Oncology are trained to safely administer the COC Protocol to cancer patients undergoing a range of different treatments. The passed-down expertise is born from years of clinical experience administering the COC protocol to thousands of patients. At Care Oncology we foster an atmosphere of curiosity and learning, and the diversity of our providers’ backgrounds has proven to be one of our greatest strengths―our doctors never stop learning from each other.
What role does the Care Oncology Physician play on my medical team?
The best outcomes in any medical scenario always come from having a great team of doctors—each playing a specific role. Your oncologist is there to guide you through the best possible clinical pathway, providing you with most proven standard-of-care therapies available at every point in your treatment process. Your primary care physician is there to look out for your overall health through the process: making sure you get the necessary screenings, helping to manage side-effects, and helping to navigate you through medical specialists.
Care Oncology Providers are here to play a very specific and focused role on your team: to safely provide you with the best possible adjunctive therapy to both enhance the effectiveness of standard-of-care therapies and offer you the best chance of preventing recurrence once your tradition therapy has ended. Although our doctors do not interfere with or take-on the responsibilities of your oncologist or primary care provider, they do encourage openness and collaboration.
Because your oncologist or PCP may not have heard of the COC Protocol we will provide them with a detailed doctor’s letter explaining the logic and data behind the therapy upon request and will always be available for questions or concerns.
How much does it cost? Is it reimbursable?
The initial consultation is $800.00. The bundled-cash price of the medications from our partner pharmacy averages $60.00 per month.
Follow ups are $295.00 every three months; for a total cost of $2,390 the first year. The subsequent annual costs total $1,880.
Because the COC protocol uses medications outside of their designated indications (off-label), our treatment typically falls outside of insurance coverage.
I know what the four drugs are, can I just ask my Oncologist or Primary Care Provider to prescribe the COC protocol?
The COC Protocol is a trademarked and patent protected protocol that has taken many years to develop and validate through an ongoing clinical trial. Other providers are not allowed to prescribe these four medications for cancer without Care Oncology’s permission. To do so risks prosecution for patent infringement. However, it is our goal for every patient to have access to our treatment.
Patients that are interested in Care Oncology’s treatment yet reside in a state outside of our current service range can still receive treatment. Care Oncology has an established procedure to work with a patient’s oncologist or primary care physician to provide treatment for patients in these states.
Physicians that wish to prescribe our protocol for their patients should follow the outlined procedure:
- The patient must first conduct an initial consultation with a Care Oncology Physician.
- The protocol consisting of the recommended dosage, timing, and cycling of the medications will then be sent to the prescribing physician and the patient.
- Follow-up consultations with a Care Oncology Physician will be scheduled every three months. Dosage adjustments may be recommended at this time.
- A line of communication, via email and phone, will be provided and will always be open between the prescribing physician and the Care Oncology physician for any questions or concerns that are raised and should be discussed.
The COC Protocol™: a Multi-Targeted Adjunctive Therapy for Cancer
What is the COC Protocol?
The COC Protocol is a fully supported treatment regimen specifically developed for people diagnosed with cancer of any type, or stage. The COC protocol is intended as an adjunctive treatment. It is designed to work alongside a patient’s normal standard-of-care treatment, potentially enhancing it.
At the core of the COC Protocol is a patented combination of four medications, metformin, atorvastatin, doxycycline, and mebendazole. These medications have each already been fully approved by the regulatory authorities for other common conditions and are widely and safely prescribed to a large number of patients across the world every year.
What’s important is that anticancer activity has also been demonstrated individually for each of these medications. A large amount of research supports their individual potential as a cancer treatment. And thanks to the patients involved in our own Care Oncology Clinic research programme, the preliminary evidence we’re generating supports these findings – demonstrating that the COC Protocol can provide real benefit to patients with cancer.
How the COC Protocol works
Why were these four drugs selected?
Care Oncology scientists selected the four COC Protocol medications from a huge number of potential candidates, following a detailed analysis of their biology and associated anticancer data. Final selection was based on the strength of the existing evidence in certain key areas, including:
- ability to target and slow down the growth of cancer,
- predicted capacity to work together in a complementary way against cancer, and enhance the activity of standard-of-care treatments,
- excellent safety profiles.
Targeting cancer from different angles
Using a combination of treatments to fight cancer is now a cornerstone of modern cancer therapy. Simultaneously targeting tumours in different ways can help reduce or overcome treatment resistance, and enhance the overall effectiveness of therapy. Care Oncology scientists specifically selected these four COC Protocol medications not only because they have anticancer activity, but because evidence also suggests they work well in combination, and use different, complementary, mechanisms to combat cancer.
Together, the COC Protocol medications are thought to block many different molecular processes needed by cancer cells to generate (metabolise) energy. Emerging research is also beginning to demonstrate how these medications can modulate other important factors in cancer, including reducing overall availability of nutrients to cancer cells, targeting cancer stem cells, and potentially helping to stimulate immune system cells to fight cancer.
Working alongside other cancer treatments
The COC protocol is designed to be used alongside traditional anticancer therapies. Emerging evidence shows clear potential of the COC Protocol medications to enhance the effectiveness of a patient’s usual standard-of-care treatment; either by weakening the cancer cell and making it more susceptible to traditional therapies, or by slowing cancer growth and spread before, during, and after use of other therapies. Care Oncology doctors are specialised in managing patients who take the COC Protocol alongside their standard treatments. They are very experienced in tailoring the dosage and treatment regimens to produce maximum potential benefit while minimising and managing side-effects.
Excellent safety profile, with well-managed side-effects
Each of the four COC Protocol medications has a well-established safety record, based on years of clinical use for other conditions. Side-effects are well known, well managed, and generally relatively mild compared to other traditional anticancer treatments. This helps make the COC Protocol an excellent candidate as an adjunctive treatment, as it can potentially be taken by patients already experiencing heavy side-effects from other treatments, without significantly impacting quality of life.
Our own research suggests most patients who take the COC Protocol can tolerate it very well, and with regular monitoring, any potential side-effects can be appropriately managed. However, cancer is a complex condition, and we make patient safety a top priority. This is why it is important that patients remain under the care of our specialist oncologists and receive regular monitoring and support throughout the duration of treatment with the COC Protocol.
Will the COC Protocol help me?
The COC Protocol was developed to have wide-ranging anticancer activity with the potential to benefit patients with cancer of any stage, or type. Abundant existing data supports the individual use of each of the COC protocol medications in cancers of all types (including solid tumours and blood cancers).
Care Oncology has been treating patients in the clinic since 2013. Our oncologists are experienced in working with many patients with different types of cancer, and alongside many standard-of-care regimens. Please to get in touch with the clinic to discuss your individual situation further.
Where’s the evidence?
The COC protocol is evidence-based
Hundreds of peer-reviewed published studies support the use of these medications in cancer, and this research is growing. Two medications used in the COC Protocol are widely prescribed for blood sugar and lipid control and the body of research supporting their anticancer activity has accumulated over a number of decades. For the antibiotic and antihelminth medications used the research is comparatively quite new, but compelling. These studies include large epidemiology and population studies (which track the cancer outcomes of people who happen to be taking a medicine for its labelled indication, eg, metformin for type 2 diabetes), in vitro laboratory studies, in vivo human tissue studies, patient case reports, and human clinical trials up to phase 2. In addition, a large number of ongoing clinical trials are currently listed on Clinicaltrials.gov.
However to date there have not been any phase 3 randomised control trials conducted which might result in giving these drugs a new label for cancer. The primary reason is that the drugs used are available generically and are relatively low cost, which means that the funds required for a phase 3 trial could not be recouped.
So with the support of our patients, we’ve developed our own clinical research programme, called METRICSplus, which is carefully designed to generate high-quality evidence demonstrating the clinical benefits of the COC Protocol.
Positive results for the COC Protocol pilot study
An initial pilot retrospective analysis of 95 patients attending the clinic with glioblastoma multiforme type IV (GBM IV, the most aggressive type of primary brain cancer) revealed striking results, with highly significant improvement in overall survival when compared to published data in a comparable patient population (ie, Public Health England data for patients under 70 years old diagnosed with GBM IV between 2007-10):
- Median survival for patients receiving the COC Protocol alongside maximal care (surgery plus chemo-radiotherapy) was 27.1 months, compared to just 14.8 months for GBM patients receiving maximal care in the Public Health England dataset.
- 2-year overall survival for patients receiving the COC Protocol alongside maximal care was 55.8%, almost double the 2-year survival for GBM patients receiving maximal care in the Public Health England dataset.
This analysis has been independently audited and verified by external biostatisticians, and is now being prepared for peer-review and publication.
Although preliminary, these data are hugely promising and represent a real potential breakthrough, especially for patients with aggressive cancers like GBM, who have limited treatment options. We recognise there is now an urgent need for more high-quality research into the potential benefits of the COC Protocol. That’s why patients who join the Care Oncology Clinic are asked to join our research programme, to help generate the data needed to make the COC Protocol available to everyone who needs it.
For more information about these initial research results, and about the METRICSplus research programme please contact the Care Oncology Clinic.
Who is Care Oncology?
The COC Protocol was developed by Care Oncology, which is believed to be the first privately-funded initiative with the specific aim of repurposing and redeveloping existing drugs for use in cancer, and making them accessible to patients in a clinical setting. Over 200 licensed medications are thought to have additional potential as an anticancer agent, but it traditionally takes a lot of research and enormous financial backing to get these drugs successfully ‘repurposed’ for use in cancer. So far very few have successfully managed to make the transition. Care Oncology was founded to bridge this gap, and find a new way to bring the best of these medications with the most promise to patients with cancer
Care Oncology’s dual aim is to generate high quality clinical evidence demonstrating the anticancer impact of the COC Protocol, while simultaneously ensuring that these drugs are immediately available at a fair cost to the patients who need them. Our approach is systematic and cautious, with the patient’s safety and wellbeing always to the fore.
Why can I only access the COC Protocol through the Care Oncology Clinic?
Safety is our first priority, and patients must attend our clinic and come under the care of our own clinicians to receive the COC Protocol. Our clinicians have years of experience of treating patients with the COC Protocol. They are specialists in prescribing these medications for people with cancer. They know the right dose, and the right timings, which side-effects to look out for and how to manage them. The COC protocol is used alongside standard-of-care in many different regimes and cancer types and this requires careful consideration and experience. They will only prescribe the COC Protocol if they believe it will be safe and has potential to be of benefit, and patients receive regular support throughout treatment.
Where can I find out more?
To find out more about the COC Protocol, and to discuss whether this treatment is right for you, please contact the Care Oncology Clinic 800-392-1353 (US).
Care Oncology can help you navigate the science behind the COC Protocol; please contact the clinic for more detailed scientific information about the COC Protocol, how it works, how it might help you, and about our research programme METRICSplus.
Further scientific reading
Articles about drug repurposing in cancer:
Too affordable: how can we overcome the drug repurposing paradox? Geddes, L (2016) Online article Cancerworld, November 2016, No. 73-74. http://cancerworld.net/featured/too-affordable-how-can-we-overcome-the-drug-repurposing-paradox/
Pantziarka P, Sukhatme V, Meheus L, Sukhatme VP, Bouche G. Repurposing non-cancer Drugs in Oncology — How many drugs are out there? 2017 Oct 6; Available from: http://biorxiv.org/lookup/doi/10.1101/197434
Pantziarka P, Bouche G, Meheus L, Sukhatme V, Sukhatme VP, Vikas P. The Repurposing Drugs in Oncology (ReDO) Project. Ecancermedicalscience. 2014;8:442.
Articles about cancer metabolism:
Chen X, Qian Y, Wu S. The Warburg effect: Evolving interpretations of an established concept. Free Radical Biology and Medicine. 2015 Feb;79:253–63.
Kroemer G, Pouyssegur J. Tumor Cell Metabolism: Cancer’s Achilles’ Heel. Cancer Cell. 2008 Jun;13(6):472–82.
A few review articles about the anticancer effects of the COC Protocol medications (for more information please contact the Care Oncology Clinic):
Rosilio C, Ben-Sahra I, Bost F, Peyron J-F. Metformin: A metabolic disruptor and anti-diabetic drug to target human leukemia. Cancer Letters. 2014 May;346(2):188–96.
Yu X, Mao W, Zhai Y, Tong C, Liu M, Ma L, et al. Anti-tumor activity of metformin: from metabolic and epigenetic perspectives. Oncotarget [Internet]. 2017 Jan 17 [cited 2018 Apr 27];8(3). Available from: http://www.oncotarget.com/fulltext/13639
Matusewicz L, Meissner J, Toporkiewicz M, Sikorski AF. The effect of statins on cancer cells—review. Tumor Biology. 2015 Jul;36(7):4889–904.
Peiris-Pagès M, Sotgia F, Lisanti MP. Doxycycline and therapeutic targeting of the DNA damage response in cancer cells: old drug, new purpose. Oncoscience. 2015 Aug 24;2(8):696–9.
Pantziarka P, Sukhatme V, Meheus L, Sukhatme VP, Bouche G. Repurposing non-cancer Drugs in Oncology — How many drugs are out there? 2017 Oct 6 [cited 2018 Apr 25]; Available from: http://biorxiv.org/lookup/doi/10.1101/197434
Reference to the comparison PHE dataset in the Care Oncology pilot study:
Brodbelt A, Greenberg D, Winters T, Williams M, Vernon S, Collins VP. Glioblastoma in England: 2007–2011. European Journal of Cancer. 2015 Mar 1;51(4):533–42.