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This article describes a long-term, multi-site study demonstrating potent anti-cancer and antiviral effects of glyco-benzaldehydes and related compounds developed under the tradename Salicinium®.2 Results from 675 cancer patients show that Salicinium effectively treats many different types of cancer, significantly extending survival for all groups studied (including a majority of patients with treatment-resistant Stage IV cancer). In related studies, Salicinium effectively treated chronic viral infections, including Epstein-Barr virus (EBV), hepatitis C virus (HCV), cytomegalovirus (CMV) and herpes viruses (HVs). Additional data presented here demonstrate that Salicinium safely and effectively treats cancer and viral infections by disrupting glycolytic metabolism in cancer and virus-infected cells, causing cell death (apoptosis). Additionally, Salicinium restores and potentiates healthy immune function in patients with cancer and chronic viral infections by disrupting synthesis and reducing blood levels of the immune-suppressive enzyme "nagalase" (alpha-N-acetylgalactosaminidase).
Cancer is the second leading cause of death in the US and other developed nations. The National Cancer Institute (NCI) reported 8.2 million cancer-related deaths and 14.1 million new cases diagnosed worldwide in 2012. In the US alone, the NCI projected over 600,000 cancer deaths and 1.73 million new cases for 2018. New cancer diagnoses worldwide are expected to rise to approximately 24 million by 2030. Current standard of care treatment for cancer typically involves a combination of surgery, chemotherapy, radiation, and hormonal therapy. Each of these treatment modalities imposes significant morbidity and health risks, including high risks of infection, impaired healing and regeneration, and immunosuppression.
Despite decades of advances in cancer diagnosis and treatment, the need for new modalities and tools for cancer prevention, treatment, and management grows ever more urgent. A related need exists for new methods and agents to treat chronic viral infections, which often beset cancer patients opportunistically and contribute to cancer incidence and morbidity. The instant study, funded and coordinated by Cognate 3 Inc. in conjunction with a large consortium of medical and naturopathic experts and study facilities in the US and abroad, makes a substantial contribution toward fulfilling these needs.
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Clinical Cancer Study of Salicinmiu
Salicinium® is a tradename for glyco-benzaldehydes and related compounds that impair glycolytic metabolism in cancer and virus-infected cells. For this report, the glyco-benzaldehyde, helicidum (alt. helicin), was selected for its proven activity, safety, and tolerance.
Clinical Study Protocol: 675 Stage IV cancer patients were treated and monitored through four participating medical and naturopathic clinics following standard therapeutic monitoring and reporting protocols for each patient tracked over a minimum study period of 60 months.3 All patients entered the study with Stage IV cancer, diagnosed according to standard methods (e.g., using tumor visualization, cytology, biopsy, blood markers and other diagnostic tools). For the purpose of this study "Stage IV" means that the subject cancer had spread from a primary site to other, distant sites in the patient's body, such as the lungs, bones, skin, liver, gastrointestinal (GI) tract, brain, or distant lymph nodes. In the case of head and neck cancer patients, this "metastatic" staging requirement corresponded to a Stage IVC disease diagnosis. In the case of lymphoma subjects, the Stage IV entry criteria were met by 1) cancer present in two or more groups of lymph nodes above or below the diaphragm and in one or more organs outside the lymph system not near the affected lymph node(s); or (2) cancer found in groups of lymph nodes both above and below the diaphragm and in any organ outside the lymph system. For all study subjects, cancer types were grouped by confirmed primary cytology/histochemistry, patient history, and other standard criteria. The following therapeutic and diagnostic/monitoring protocols were employed.
Each patient was provided an initial aggressive treatment of intravenous (iv) Salicinium® therapy, comprising 15 iv treatments administered over a treatment period of between 15-30 days. These treatments were typically scheduled over three blocks of five-day treatment periods with two-day intermissions, with oral dosing of Salicinium® as described below on non-iv days. During each of the 15 iv treatments, patients were administered 500 ml iv Salicinium comprising a 0.06% helicidum solution (3.0 g of helicidum in 500 ml saline) over a two-hour administration period. In certain cases, all 15 iv treatments were administered over a consecutive 15-day period, while in others the 15 iv treatments were scheduled over an extended period, up to one month, to accommodate patient scheduling factors.
After the initial aggressive iv treatment period, all patients were switched to oral Salicinium® treatment. A 3 g/day helicidum dosing protocol was carried out for one year or until a subject was evaluated to be in disease remission. Subjects self-administered three 500 mg Salicinium doses (either solid-form gelatin capsules, or in liquid dosage form) twice daily between meals. Subjects who progressed rapidly to partial or complete remission remained on oral Salicinium for one month after positive diagnosis of remission, while other subjects remained on oral treatment for a full treatment period of one year.
All subjects were regularly examined for diagnostic cancer indicators throughout the study, according to standard methods. Study subjects were evaluated monthly, quarterly, or biannually based on their prior status and other oncologist-determined criteria. Patient status was assessed using CT scans, PET scans, blood work, cytology, biopsy, and other standard diagnostic methods. Disease status was monitored throughout the 60-month study period for each subject, and all substantial changes in status were noted for each subject. This monitoring was scheduled and conducted at the discretion of the responsible physician, depending on each patient's unique circumstances. Further, as expected, patients in different cancer groups, and within groups, showed considerable variation in their timing and/or rates of disease recovery or progression. For these reasons, compiled mid-term data from this study are not analyzed or presented here to show rates of disease recovery or progression over time for subjects throughout the study period. Rather, the data presented here focus exclusively on disease status at the beginning and endpoints of the study (i.e., from confirmed Stage IV diagnosis at the beginning of Salicinium treatment, to final status determined 60 months later).
Disease status was scored according to NIH standard criteria,4 as follows. Subjects were determined to be in "complete remission" when there was no detectable cancer using conventional diagnostic measures (e.g., negative PET scan, CT scan, MRI, biopsy, blood marker tests, blood count tests, histopathology [e.g., PAP], colonoscopy, ultrasound, radiography, or combinations thereof). A subject was scored as being in "partial remission" when quantitative evidence was determined showing "a decrease in the size of a tumor, or in the extent of cancer in the body" (NCI Dictionary of Cancer Terms). For the purposes of this report, each subject's original status was compared to the status at 60 months, and "partial remission" was scored in most cases when there was a substantial reduction in detectable tumor number, tumor distribution, and/or tumor volume. For certain cancer types (e.g., leukemias), partial remission was determined based on changes in diagnostic quantitative biopsy, histopathology, blood count, and/or tumor marker levels, among other conventional methods. Subjects were classified as presenting with "stable disease" when the monitoring physician observed persistent disease with no detectable disease reduction or progression (for example, stable tumor number and size, no new metastases, and no substantial increase in tumor blood marker levels). Other subjects exhibited disease progression and mortality as noted. Cancer-related symptoms (e.g., pain, fatigue, mood disorders, functional limitations, etc.) were also monitored; and the severity of these symptoms generally paralleled the patients' disease status.
All patients who did not reach a state of complete remission within the first year completed a full, one-year oral Salicinium dosing regimen. Certain patients presenting with high risk diagnostic indicators (e.g., new tumors or actively growing tumors by CT and/or PET scans, high levels of cancer blood markers, etc.) continued oral Salicinium® as long as these risk indicators remained high, though for most patients oral treatment was determined to be completed/successful by 12-18 months .
Of the 675 enrolled patients, 128 patients entered the study with diagnosed Stage IV breast cancer, 91 with Stage IV colon/rectal cancer, 34 with Stage IV head/neck cancer, 86 with Stage IV lung cancer, 32 with Stage IV non-Hodgkin's lymphoma (NHL), 28 with Stage IV melanoma, 36 with Stage IV ovarian cancer, 37 with Stage IV pancreatic cancer, 76 with Stage IV prostate cancer, 18 with Stage IV renal cancer, 23 with Stage IV sarcoma, and 34 with Stage IV uterine cancer. A majority of study subjects enrolled after one or more failed rounds of standard oncotherapy (typically surgery, chemotherapy, radiation and/or hormone therapy) and presented at enrollment with disease progression to Stage IV, or Stage IV relapsed cancer. These subjects were classified as "treatment resistant" or "refractory" Stage IV cancer patients. Less than 10% of participants had not received prior, conventional oncotherapy; therefore, the data here represent treatment-resistant classes for all studied cancer types.
As noted, all patients remained throughout the study period in contact with medical providers who maintained regular monitoring of the subject's disease condition (with regular exams, including blood work testing for cancer markers, cytology, CT scans, PET scans, biopsy where indicated, and other diagnostic monitoring). Fifty-two percent of study subjects maintained or initiated some form of standard oncotherapy (commonly low dose chemotherapy, and in some cases additional surgery, radiotherapy, and/or chemotherapy) during the course of this study. Many patients with breast cancer, ovarian cancer, uterine cancer, and prostate cancer remained on oncologist-prescribed hormonal therapy throughout the study.
Cumulative data for 675 study subjects reveal potent anti-cancer efficacy of Salicinium®. As summarized in Table 1, Salicinium therapy is highly effective to transition patients from intractable Stage IV cancer to stable disease, partial remission, or complete remission, with few or no adverse side effects.5
The clinical study results summarized in Table 1 demonstrate that Salicinium® potently stabilizes and frequently eradicates cancer of all types evaluated, including Stage IV, treatment-resistant cases in all groups. Stage IV breast cancer patients showed a 69% survival rate 60 months after initiation of Salicinium treatment. This contrasts starkly with a 16% median five-year survival reported for all Stage IV breast cancer subjects by the National Institutes of Health (NIH). Of the 128 Stage IV breast cancer patients enrolled in this study, more than 16% were diagnosed as essentially cured (i.e., in "complete remission,"), and 53% were diagnosed with "stable disease" or in "partial remission" at the end of the study term. Comparable results were observed for all cancer types.
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