JOM Volume 27, Number 3, 2012
Case Reports
Cancer and Related Case Studies
Involving Salvestrol and CYP1B1
Brian A Schaefer, D.Phil;1 Gerard A. Potter, PhD;2 Robbie Wood, BDS, D.Orth. R.C.S.(Eng), D.D.Orth.R.C.P.S(Glasg);3 M. Danny Burke, PhD41Corresponding author: Clinical Intelligence Corp., 205-1095 McKenzie Avenue, Victoria, BC Canada V8P 2L5; email:;2Professor, Head of Cancer Drug Discovery Group, De Montfort University, Leicester, England;3CARE Biotechnologies (UK) Ltd., Leicester, England;4Professor Emeritus of Pharmaceutical Metabolism, Salvestrol Natural Products (UK) Ltd., Leicester, England.
Abstract Salvestrols are naturally occurring, metabolically active substances that act as anticancer
prodrugs when metabolically activated by the Cytochrome P450 enzyme, CYP1B1. They are phy- toalexins and as such are induced in response to pathogens. As phytoalexins they do not fall neatly into any of the classes of phytonutrients. Some are stilbenes, some are antioxidants, some are phytoestro- gens while others fall outside of these categories. Salvestrols obtain their anticancer activity not as a member of some phytonutrient class but rather through their metabolism by CYP1B1. Unfortunately, Salvestrols are deficient in western diets due to the modern agricultural practices that minimize the risk of predation through the use of fungicides with the consequence of minimizing the conditions for induction of these compounds. It is in organically grown foods that salvestrol levels are highest. To illustrate the breadth of a nutritional approach to cancer treatment using Salvestrols, cases are pre- sented here that cover stage 1 breast cancer, squamous cell carcinoma of the anus, chronic lymphocytic leukaemia, primary peritoneal carcinoma and a case of benign prostatic hyperplasia. Four of these cases highlight how rapidly one can recover once nutritional deficits are addressed without recourse Introduction
diagnostics for early cancer detection and Salvestrols represent a class of naturally occurring metabolically active substances that act as prodrugs through their activation by and CYP1B1 results in a highly targeted, dietary rescue mechanism for killing can- cer cells.3,5 Modern agricultural practices, trols to produce a metabolite within the can- through the widespread use of fungicides, cer cell that induces apoptosis.3,4 CYP1B1 have significantly depleted Salvestrols from has been found to be expressed in all can- our foods making it difficult to take full ad- cers, regardless of oncogenic origin, while vantage of this rescue mechanism through being absent from healthy tissue.5-8 It is now our diet alone.12,13 Salvestrols are second- widely regarded as a universal cancer marker ary plant metabolites that are induced in a and the therapeutic and diagnostic implica- pathogen specific manner in the face of a tions have been outlined.9,10 CYP1B1 is cur- threat to plant health. When fungicides are rently being utilized in the development of used there are minimal signals to induce Journal of Orthomolecular Medicine Vol 27, No 3, 2012 production of these secondary plant metab- is described in terms of a “total Salvestrol olites. This is why organically grown produce points” scale rather than milligrams of active contains significantly higher levels of Salves- ingredient. Adequate nutrition supplies dif- trols.14 Within the context of a nutritional ferent Salvestrols varying widely in poten- approach to cancer this Salvestrol-CYP1B1 cy.17 This diversity is reflected in Salvestrol rescue mechanism appears to significantly nutritional supplements. In combating active reduce the number of cancer cells in the disease it is the delivery of sufficient potency body and to increase the chances of a suc- per volume of ingredients that is important. not be a meaningful way of ensuring that an ticipate in case studies.15 The cancers in- adequately potent intake is achieved. Salves- volved included: stage 2-3 squamous-cell trol points have therefore been devised as a carcinoma of the lung; stage 4 melanoma; metric to standardize intake appropriate to a prostate cancer; aggressive, stage 3 breast mixture of Salvestrols with differing individ- cancer; and bladder cancer. Each of these ual potencies. Standard therapeutic dosing individuals had a complete recovery from falls between 4,000 and 6,000 points per day their cancer. In 2010, an additional six in- depending on the patient’s body mass index dividuals agreed to participate in case stud- (BMI). Patients are advised to ingest a mix- ies.16 The cancers that these individuals were ture of Salvestrols providing 4,000 points diagnosed as having included: stage 3 breast if their BMI is below normal, 5,000 points cancer; stage 2 liver cancer; colon cancer; a if their BMI is normal, and 6,000 points if recurrent prostate cancer; a further prostate their BMI is above normal. This dosing can cancer with a Gleason score of 6 (3+3); and be adjusted upwards depending on the re- a stage 3B Hodgkin’s lymphoma. Again all sponse rate of the patient.
six individuals had a complete recovery from Case #1: Stage 1 Breast Cancer
cases represent a variety of therapeutic ap- at the surface of her right breast while show- proaches such as: declining conventional ering. Her doctor ordered a biopsy which treatment in favour of a purely nutritional came back negative. A second biopsy was ordered and this biopsy confirmed that the proach but turning to a nutritional approach lumps were cancerous. She was told that after dissatisfaction with the conventional she had Stage 1 breast cancer but was not therapy; partial acceptance of conventional told the type of breast cancer. The treatment therapy for a first diagnosis but rejection offered was a pharmaceutical aromatase in- of conventional therapy in favour of a nu- hibitor, Femara® (letrozole), 2.5 mg tablet to tritional approach for the second diagnosis; be taken daily. She declined this treatment. and acceptance of both conventional therapy A friend suggested that she supplement her and a nutritional approach in tandem. A di- diet with Salvestrols. The patient immedi- verse array of cancer is represented includ- ately began a three week course of Salves- ing breast cancer, squamous cell carcinoma trols comprising two Salvestrol Professional of the anus, chronic lymphocytic leukaemia, capsules and two Salvestrol Gold capsules primary peritoneal carcinoma and a case of per day. Professional and Gold capsules con- benign prostatic hyperplasia. These cases are tain a different Salvestrol respectively, with presented to convey the breadth of applica- this particular combination providing a total bility of Salvestrols as a nutritional approach daily intake of 1,400 Salvestrol points. One in the hopes that clinicians and patients capsule of each Salvestrol was taken with will see the benefits of including nutritional breakfast and one of each taken at the end of the day. No additional supplements, alterna- Throughout these cases Salvestrol intake tive treatments, or prescription medications Cancer and Related Case Studies Involving Salvestrol and CYP1B1 were taken, and no other dietary or lifestyle changes were made. The patient has always included walks into her daily routine and has later he was re-diagnosed. The second diagno- sis of squamous cell carcinoma was again con- firmed by biopsy. The patient was again ad- days of Salvestrol supplementation, through vised that an abdominoperineal resection was breast self-examination, she could feel that required and without it a three year life expec- the lumps had started to shrink. During the tancy was predicted. The patient declined the third week of Salvestrol supplementation resection and carried on with mental wel ness she could no longer feel any lumps in her exercises and twice weekly application of Al- breast. She also experienced no side effects dara®. The patient found treatment with Al- from the supplementation, a situation that dara® an uncomfortable and painful way to In the month following her diagnosis her doctor ordered both computerised tomogra- the disease progressed to the point where the anal lesions were appearing much more cancer was found. Femara® (2.5 mgs once frequently. The patient went for a consulta- per day) was again prescribed, this time to tion with a surgeon who specialized in laser protect against recurrence of the cancer. She has taken Femara® for two years since she became cancer free and has a check-up ev- the laser surgery option, the patient began ery three months. During this time she has treating the condition with a combination suffered from nausea and dizziness. When of Salvestrols and XM8 cream (i.e., a natural her attending physician confirmed these to borage oil based cream) and stopped use of be side effects of the Femara® she decided Aldara®. For a period of three months the to stop taking Femara® and resumed Salves- patient took one Salvestrol Platinum (1,000 trol supplementation. She is now taking one or two Salvestrol Platinum capsules per day. Each Salvestrol Platinum capsule provides four different Salvestrols with a combined mental wellness and daily physical exercises, intake of 1,000 points. The lack of side ef- took a multi-vitamin, ate a diet that included fects with Salvestrols was a deciding factor a high proportion of raw vegetables and took in her decision to decline further Femara® a “green shake” each day. No pain medica- treatment and to return to Salvestrol supple- tions were taken and no additional supple- mentation. She is healthy, happy and very ments were consumed. After a period of six weeks since starting to take the Salvestrols the lesions were no longer visible. At the Case #2: Squamous Cell Carcinoma of
all clear. Although he requested a biopsy to confirm his cancer free status, his doctor has squamous cell carcinoma of the anus. The di- agnosis was confirmed with a biopsy and his Case #3: Chronic Lymphocytic
resection. The patient declined the resection Leukemia
and was told that he had a life expectancy of just three years without it. He embarked family doctor with an “egg sized” tumour on upon a series of mental wellness exercises the left side of her neck. She was referred aimed at a positive health outlook along to an oncologist and then an ear, nose and with twice weekly applications of Aldara® throat specialist who took a biopsy of the tumour. Soon after seeing the specialist her Journal of Orthomolecular Medicine Vol 27, No 3, 2012 condition deteriorated. The lymph glands in while continuing Salvestrol supplementa- her groin and armpits were swollen and a tion, the tumour in her neck had almost dis- appeared. At the end of the third month of The biopsy confirmed a diagnosis of Salvestrol supplementation the tumours in chronic lymphocytic leukaemia. Chronic her neck had completely disappeared. She lymphocytic leukaemia has a variable prog- returned to the oncologist and was informed nosis and an exceptionally rare rate of spon- that he could find no evidence of cancer. The taneous remission, especially among indi- oncologist mentioned being very surprised viduals who were not diagnosed in the early by her current good health and weight gain.
stage of disease progression.18 The woman was told that it was difficult to provide her ing Salvestrols but carried on with her more with an accurate prognosis – it could be any- relaxed lifestyle and dietary change. She has time between two days and two years.
recently returned to Salvestrol supplementa- Subsequent to receiving her diagnosis tion to prevent recurrence of the cancer and her condition declined further. She suffered is currently taking one 1,000 point Salvestrol from severe pain in her throat causing great Platinum capsule per day. She is feeling very difficulty eating and sleeping. She began to good and hopes that her experience will be lose weight. She returned to the ear, nose of assistance to others.
and throat specialist who took a biopsy of an ulcer on her tonsil. The biopsy revealed Case #4: Benign Prostatic Hyperplasia
that the tonsil ulcer was part of the chronic lymphocytic leukaemia. She was referred for physician with lower urinary tract symptoms including weak flow and nocturia. A digital rectal examination revealed a significantly ginning to show on the right side of her neck enlarged prostate. His prostate specific an- and the swelling in the groin and armpits con- tigen test results were within normal limits. tinued. While discussing her situation with a The patient was diagnosed with benign pro- friend she learned about Salvestrols and be- static hyperplasia (BPH) and was informed gan a three month course of two Salvestrol of the various medication options to control Platinum (1,000 point) capsules per day. One his condition. These would include a low was taken with breakfast and one was taken dose alpha blocker, followed by a higher at dinner. She also decided concurrently to dose alpha blocker if relief was not found. If take a more relaxed approach to life, dropping relief was still not found a 5alpha-reductase some of her obligations and modified her diet inhibitor would be tried. Whichever option to include more fruits and vegetables.
produced relief would be required for life – a situation the patient found distressing.
mentation she started feeling much better and the tumours in her neck had started to 0.4 mg, of the alpha-adrenergic blocker, soften and shrink. This early result coincided Flomax® (tamsulosin) to be taken once daily with her appointment with the radiotherapist. and asked to minimize his fluid intake af- She attended the appointment, but told the ter early evening. The patient initially com- radiotherapist that she was feeling so much plied with moderating his fluid intake, but better. She chose to decline the radiotherapy, quickly found this too difficult to maintain. and instead wanted to see if these positive No beneficial change was noted in the first results would continue. The radiotherapist week of Flomax® use. In the second week respected her decision, and told her that she of use there was stronger urinary flow and could always call and book radiotherapy at diminished nocturia. These benefits lasted another time if she changed her mind.
for two months at which time the benefits slowly diminished, and by the end of the cline the radiotherapy and after two months, four month prescription little lasting benefit Cancer and Related Case Studies Involving Salvestrol and CYP1B1 3 peritoneal carcinoma, a rare and aggressive max® treatment the patient experienced a cancer, with metastases in the ovaries. The low grade, dull headache upon waking in the patient was in a high risk category for cancer morning. The headache subsided as the day due to the occurrence of abdominal cancers in her immediate family. She was told that With the first prescription for Flomax® the condition was treatable and a course of finished and knowing that the next treatment three rounds of chemotherapy, a month of option was simply a higher dose the patient rest, a hysterectomy, a further month of rest, began looking for alternatives. After hearing followed by the three remaining rounds of anecdotal accounts of relief from BPH using chemotherapy was recommended. The pa- Salvestrols the patient began a course of tak- tient accepted her physician’s recommenda- ing one Salvestrol Gold capsule (350 points) tion and commenced an intravenously de- livered course of Paclitaxel (for three hours) dence of nocturia had dropped down to once followed by Carboplatin (for one hour) every a night, sometimes not at all and the flow was three weeks. Ondansetron was prescribed as strong or stronger than it had been dur- twice daily for two days following chemo- ing the period when Flomax® was working therapy to manage nausea and vomiting; most effectively. After three months of Gold however, its use was intermittent due to its the patient switched to Salvestrol Platinum constipating side-effect.
(1,000 points per capsule). He reported that there was a noticeable improvement in terms therapy, the patient embarked on an alterna- of decreased incidence of nocturia and in- tive treatment plan under the direction of a creased strength of flow. Although unable to homeopathic physician and a medical herb- quantify the improvement, he noted that he alist. She commenced a course of Salvestrol no longer had to be as mindful of his evening supplementation consisting of three Salves- trol Platinum (2,000 point) capsules per day Concurrent with his treatment for BPH comprising a daily total of 6,000 Salvestrol the patient maintained a daily regimen of points. In addition she took three astragalus vitamin supplementation, which included a capsules per day. The homeopathic remedies multivitamin, a B-complex vitamin, and vita- included: Lachesis (three times daily); Kali Phosphoricum (twice daily); Phosphoricum changes were made throughout this period. Acidum (twice daily for 3-5 days following The patient enjoys a healthy, balanced diet chemotherapy); and Natrum Muriaticum that includes organic foods whenever practi- (twice daily for 10 days following chemo- The patient, still taking Salvestrol Plati- chemotherapy sessions to increase appetite num, is enjoying a level of relief from BPH and energy level. The patient had an ongo- symptoms that is at least as good, if not bet- ing practice of meditation and visualization ter than the Flomax®. Unlike Flomax®, the which was continued throughout and after symptom relief found with Salvestrols has treatment, and she maintained a positive at- not diminished over time, and has not been titude. In terms of dietary changes, the pa- tient cut out coffee consumption, increased her consumption of fruits, vegetables and Case #5: Stage 3 Primary Peritoneal
green tea, and reduced her consumption of Carcinoma
meat. Exercise consisted of daily walks.
physician with a very swollen abdomen, loss sistent side-effects common to Paclitaxel/ of appetite, and fatigue. A CT scan, a cancer Carboplatin chemotherapy, including: anae- antigen (CA-125) result of 7,250 and a sub- mia; neutropenia; thrombocytopenia; loss sequent biopsy all led to a diagnosis of stage of appetite; tiredness; loss of energy; face Journal of Orthomolecular Medicine Vol 27, No 3, 2012 reddening as if sun burnt; weakness in knees; ing a week after starting chemotherapy and trouble walking; dizziness; trouble sleeping; alternative therapies. She also experienced numbness in arms, hands and feet; cold feet; unexpectedly dramatic reductions in CA- noticeable bruising; aching legs; abdominal 125 levels by week seven and continual fur- pain; nausea; and a candida infection in the ther reductions in these levels until reaching mouth and a loss of taste. These side-effects re- normal limits during week 19. This is a very sulted in the need for three blood transfusions impressive response for stage 3 peritoneal before the six chemotherapy sessions were cancer or ovarian cancer. Given the simi- completed. Although the side-effects were se- larities between peritoneal carcinoma and vere it was the loss of her thick, long, beautiful ovarian cancer they are typically treated in hair that caused her the most anguish.
the same way. If we look at the clinical trial literature for surgery plus Paclitaxel/Carbo- tive therapies, dietary change and walks platin chemotherapy we find quite a varied throughout her treatment course. One week rate of complete response (defined as no after starting her chemotherapy and alter- sign of cancer pathology remaining). Vasey native therapies there was a significant re- reports a 28% complete response rate for duction in her abdominal swelling. By week Paclitaxel/Carboplatin for the 296 patients four her CA-125 level had dropped to 4,593. studied (there were 538 patients were en- Her CA-125 level was measured the day she rolled in this arm of the study19). In a smaller received her third course of chemotherapy trial, Neijt reports a complete response rate (week seven from onset of treatments) and of 40% in the relevant arm of his trial for the it had dropped to 510. Her physician noted 67 patients that they used for this analysis that she had never seen such a huge fall in - 100 patients were enrolled in this arm of CA-125 levels in all her career and was quite the study.20 In a further trial, du Bois reports taken aback by the results thus far.
a complete response rate of 31% for the 99 During the twelfth week of treatment patients that they used for this analysis – 397 she received a hysterectomy. The surgeon re- were enrolled in this arm of the study.21 ported that most of the cancer had been re- moved except for “sugar grain-like” residual for people failing to complete a clinical trial. cancer. The post-operative pathology report Such patients are either removed from the noted a very good response to the therapy study by attending physicians or they re- that she had been receiving. Unfortunately, move themselves. It can be argued that in the operation also left the patient suffering calculations of complete response rate for an intervention one should use the total num- Three weeks after the surgery the CA-125 ber of eligible people enrolled in each arm of level had fal en further to 52 and the doses for the study otherwise these response rates are the fifth and sixth chemotherapies were con- artificially inflated. If we do this the com- sequently reduced by 20%. By week 19 of her plete response rates in the Paclitaxel/Car- treatment, the CA-125 had fal en to within boplatin studies described above fall to 15% normal limits. Chemotherapy was completed (from 28%), 27% (from 40%) and 8% (from during week 22, and the CA-125 level was 31%). These are not impressive complete re- measured as 15 (within normal limits) the sponse rates, given that surgical debulking of week fol owing. At week 25 the CA-125 had the tumour was performed, but they provide fallen to 13. A CT scan was performed dur- a context for the physician’s surprise at her ing week 28 and during the 29th week after rapid recovery.
treatment onset, the patient was told that she was cancer free. Her three month fol ow up treatment plan and lifestyle changes, al- confirmed this with a CA-125 level of 11.
though she has returned to coffee consump- tion. She benefits greatly from her daily ment in the reduction of abdominal swell- practice of meditation and visualization and Cancer and Related Case Studies Involving Salvestrol and CYP1B1 is currently writing a book on her cancer ex- trols. Whether this is due to a known anti- perience along with producing a visualization inflammatory function of some Salvestrols, CD for cancer patients. Her hair is growing or whether there were indeed cancer cells back and she enjoys the unexpected benefit present for this patient, or a combination of of looking younger with short hair. She be- both, we cannot tell. Nevertheless, CYP1B1 lieves that Salvestrols, and the other facets of could well have been involved because BPH her alternative treatment plan, played a key cells, although neither a cancer nor a precur- sor to cancer, over-express CYP1B1 relative to normal prostate.22 Furthermore, in some Discussion
men diagnosed with BPH their prostate also These cases provide further evidence for contains PIN cells,23 which are a precursor the role that nutrition can play in recovery to cancer and also over express CYP1B1.22 from cancer. In particular they highlight the In light of this patient’s success, Salvestrols role that metabolism of dietary Salvestrols could be tried for further situations involv- by the universal cancer marker CYP1B1 ing BPH, especially when conventional can play in bringing about a successful out- treatment has failed to provide relief.
one, two and three all represent situations Conclusion
where the patient utilized Salvestrols with- out any concurrent conventional treatment. sicians and patients that wish to pursue a These cases highlight how some individuals nutritional approach to cancer management respond very quickly with a relatively low whether in isolation from conventional Salvestrol intake (case one: 1,400 points per treatment or in concert with conventional day, all clear in one month; case two: 1,000 treatment. points per day, all clear in three months; case three: 2,000 points per day, all clear in three Statement of Informed Consent
months). There is one further, important point to make and it relates to an example of these patients for publication of this report. Salvestrols perhaps fortifying the patient to The editor provides his assurance that all withstand the rigours of chemotherapy and identifying characteristics have been altered enabling a better chemotherapy result. This to protect patient anonymity, but, while do- is case five, the peritoneal cancer patient, ing so, care has been taken not to affect the who utilized both conventional treatment technical aspects of this article.
and Salvestrols, whose physician expressed such surprise at the extent of her recovery Competing Interests
ously against the odds for this type of cancer quired Intelligence Inc, the Canadian and (case 5: 6,000 points per day, all clear in less US distributor of Salvestrols; Professor Gerry Potter, Dr. Robbie Wood and Professor Dan Compounds, be they synthetic drugs or Burke are shareholders of Salvestrol Natural naturally occurring substances, rarely have Products, the UK developer of the Salvestrol only one pharmacological action. Case four, technology.
benign prostatic hyperplasia, has been in- cluded to highlight the fact that Salvestrols References
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7. McFadyen MCE, Melvin WT, Murray GI: Cyto- 22. Carnell DM, Smith RE, Daley FM, et al: Target chrome P450 CYP1B1 activity in renal cell carci- validation of cytochrome P450 CYP1B1 in pros- noma. Br J Cancer, 2004; 91: 966-971.
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