SPC Flakes

Able to reduce intratumoral interstitial fluid pressure, reducing growth and treatment resistance
Pilot studies in glioblastoma show promising early results indicating significant response in some groups
Trials are being continued and extended to other cancers including egg based sister products

Anti-secretory factor is produced in the gut in response to acute inflammation and present in most tissues. An ASF-activating diet improves symptoms of IBS, Crohns and Meniere’s. Egg based ASF dietary supplement acts directly. ASF can reduce localized fluid pressure in tumors which both increase hypoxia driven growth and spread but also prevent oncology drug penetration.

In a 2023 pilot study with salovum based ASF in glioblastoma shows promise. Improved drug delivery increased two year survival rates to 50% vs control group 20%. And one patient remained in long term remission, with no evidence of disease.

Clinical trials are expanding quickly including a phase III study in early stage breast cancer, and phase II in colorectal and anal cancers (see References).

As a supportive treatment studies show a reduction of gastrointestinal side effects of oncology drugs especially from tyrosine kinase inhibitors, for instance used in kidney and lung cancer therapy

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the treated patients displayed higher median OS (23.0 months versus 14.8 months) and PFS (10.2 months versus 9.4 months) compared to controls….As the effect of TMZ on survival is predominantly associated with tumors with methylated MGMT, we hypothesize that the effect of Salovum would be most pronounced against MGMT-methylated tumors. Figure 2 illustrates one of the study patients with methylated MGMT, who displayed excellent response to therapy and remains free from recurrence 26 months after diagnosis.

Our studies show that a peptide situated between position 35 and 50 in the AF protein sequence has potent anti-inflammatory and anti-secretory actions…A significant decrease of bowel movements in response to Salovum®, was registered, combined with a further reduction of bowel movements during the SPC-flakes® period. It seems that patients with carcinoid tumours may improve clinically following use of the AF concept

In a model for traumatic brain injury, it was found the AF-16 reduced the oedema induced high intracranial pressure. This finding led to an open clinical study at the department of Neurosurgery Sahlgrenska University hospital, in which patients with high intracranial pressure due to a traumatic brain injury were treated with Salovum in addition to standard medical treatment. AF in this form was found to significantly reduce the intracranial pressure

Antisecretory factor is a protein with anti-inflammatory and antisecretory properties…SPC-flakes are specially processed cereals (SPC) that induce endogenous production of antisecretory factor. Experimental data suggest that Salovum and SPC-flakes may decrease the interstitial fluid pressure within malignant brain tumors, and by this mechanism possibly relieve the perilesional edema and the associated neurological symptoms. There are also preclinical data suggesting that antisecretory factor may enhance the antitumoral effect of radiochemotherapy.

TABLE OF REFERENCES

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https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-023-03119-4	3.5	It is a well-known issue that GBM-patients included in clinical trials constitute a highly selected group with better prognosis than the general GBM population [32]. This is presumably because more than half of newly diagnosed GBM-patients do not fulfil the inclusion criteria of most clinical trials, including our study. To make a meaningful comparison of survival, we selected an age and treatment matched retrospective cohort. Compared to this cohort, the treated patients displayed higher median OS (23.0 months versus 14.8 months) and PFS (10.2 months versus 9.4 months) compared to controls, but this was not statistically significant.	Most recently, a study of AF16, an active peptide from the AF protein, showed that AF16 increased the secretion of typically proinflammatory cytokines from human and mouse M0 macrophages, and that intratumoral co-administration of TMZ and AF16 resulted in synergistically increased survival in glioma-bearing mice. Taken together, the antisecretory and immunomodulatory mechanisms exerted by AF may contribute to suppressing tumor progression by reducing tumor-promoting inflammation and lowering tumoral IFP, as well as giving symptomatic relief by reducing brain edema. This is however still speculative and further research is needed to confirm these hypotheses.
https://www.researchgate.net/publication/9011894https://www.sciencedirect.com/science/article/abs/pii/S0261561403000578	2.5	Treatment with AF-egg resulted in a decrease of bowel movements in seven patients (P<0.01). Registrations of bowel movements from both SPC and CC diet periods were obtained from five patients. The daily number of bowel movements was lower during the SPC-period compared to the period with CC	All patients had low levels of AF-activity in serum at baseline. During treatment with AF-egg, the mean level increased slightly. AF-activity was higher (P<0.05) after SPC compared to the CC diet. Conclusions: In a group of patients with endocrine diarrhoea, AF-activity could be induced, and AF-therapy reduced the number of bowel movements.
https://www.gu.se/en/research/eva-jennische	1.5	In a model for traumatic brain injury, it was found the AF-16 reduced the oedema induced high intracranial pressure. This finding led to an open clinical study at the department of Neurosurgery Sahlgrenska University hospital, in which patients with high intracranial pressure due to a traumatic brain injury were treated with Salovum in addition to standard medical treatment. AF in this form was found to significantly reduce the intracranial pressure. However, a more defined method for AF-treatment is desirable. In this aim a phase I study with AF-16 is terminated and a Phase II study of treatment with AF-16 in patients with traumatic brain injury has started.	In collaboration with Aroldo Cupello in Genua, we have identified the α6-subunit of the GABA-A receptor as a binding site for AF-16 in granular cells from rat cerebellum. Immunohistochemistry show that these cells have a high expression of receptor with the α6-subunit. We and other groups have shown that AF-therapy decreases the symptoms in patients with Meniere’s disease, especially reducing vertigo. It is possible that the positive effects of AF in these patients is mediated through interacting with α6-subunit on granular cells which are regulating the balance system. Further studies are necessary to investigate if, and to what extent, interaction between AF and the α6-subunit of the GABA-A receptor can explain known effects of AF in various experimental systems.
https://aacrjournals.org/mcr/article/16/5/777/89874/Antisecretory-Factor-Mediated-Inhibition-of-Cell	1	Interstitial fluid pressure (IFP) presents a barrier to drug uptake in solid tumors, including the aggressive primary brain tumor glioblastoma (GBM). It remains unclear how fluid dynamics impacts tumor progression and can be targeted therapeutically. To address this issue, a novel telemetry-based approach was developed to measure changes in IFP during progression of GBM xenografts. Antisecretory factor (AF) is an endogenous protein that displays antisecretory effects in animals and patients. Here, endogenous induction of AF protein or exogenous administration of AF peptide reduced IFP and increased drug uptake in GBM xenografts.	As a result, AF induced apoptosis and increased survival in GBM models. In vitro, the ability of AF to reduce GBM cell proliferation was phenocopied by bumetanide and NKCC1 knockdown. Next, AF's ability to sensitize GBM cells to the alkylating agent temozolomide, standard of care in GBM patients, was evaluated. Importantly, combination of AF induction and temozolomide treatment blocked regrowth in GBM xenografts. Thus, AF-mediated inhibition of cell volume regulation represents a novel strategy to increase drug uptake and improve outcome in GBM
https://lucris.lub.lu.se/ws/portalfiles/portal/119045695/s41598_022_08618_x.pdf	1	. In our results, AF16 alone and in combination with temozolomide leads to cure in immunocompetent mice with orthotopic GL261 gliomas, as well as prolonged survival in immunocompromised mice. We recorded decreased tumor size and changes in infltration of macrophages and T cells in the murine glioma microenvironment. Human and murine macrophages increased expression of proinfammatory markers in response to AF16 treatment and the same efect was seen in human primary glioblastoma cells. In summary, we present AF16 as an immunomodulatory factor stimulating pro-infammatory macrophages with a potential to be implemented in glioblastoma treatment protocols.	fer intratumoral administration, TMZ (n=16), AF16 (n=16) and the combination AF16+TMZ (n=16) increased the overall survival (OS) of C57BL/6 mice with GL261 gliomas compared to control animals (n=16) without any treatment (survival proportions controls 0/16, AF16 3/16, TMZ 7/16 and AF16+TMZ 12/16; log-rank test p values against controls AF16=0.0048, TMZ=0.0007 and AF16+TMZ= <0.0001, Fig. 1a). When we subjected NODPrkdcscid mice to the same therapy, we recorded prolonged survival in AF16 (n=5) and AF16+TMZ (n=5) but not in the TMZ (n=4) group. Furthermore, in this immunocompromised mouse model, there was a signifcant improvement of survival in the AF16+TMZ group compared to only TMZ
https://www.intramed.lu.se/evenemang/erik-ehinger-institutionen-kliniska-vetenskaper-lund	N/A	Experimental data suggest that Salovum and SPC-flakes may decrease the interstitial fluid pressure within malignant brain tumors, and by this mechanism possibly relieve the perilesional edema and the associated neurological symptoms. There are also preclinical data suggesting that antisecretory factor may enhance the antitumoral effect of radiochemotherapy. Here, we explore these hypotheses through pragmatic clinical trials.	The worst symptoms are generally alleviated within days by high-dose corticosteroid treatment, which can often be tapered within weeks after surgery. When the tumor - almost inevitably – progresses, long-term use of corticosteroids is often prescribed to keep symptoms in control. Long-term use comes at a price, with a wide range of debilitating side effects. Antisecretory factor is a protein with anti-inflammatory and antisecretory properties. Salovum is an egg-yolk powder enriched for antisecretory factor. SPC-flakes are specially processed cereals (SPC) that induce endogenous production of antisecretory factor.
https://aacrjournals.org/cancerres/article/83/5_Supplement/OT3-30-01/718216/Abstract-OT3-30-01-A-randomized-double-blind	N/A	Secondary objectives: Occurrence of any-grade diarrhea according to CTCAE v. 5.0, health-related quality of life (QoL), other adverse events related to abemaciclib, adherence to planned abemaciclib treatment, adherence to and pharmacodynamic effect from study products, safety of investigational products, sick leave duration, breast cancer recurrence. Investigational product, dosage and mode of administration: Salovum/placebo egg powder high in antisecretory factor, 4 g. Four sachets, ie 16 g q 8 h for 5 - 7 days before start of abemaciclib	ll included patients will be followed using questionnaires up to 12 weeks from initiation of abemaciclib. After 12 weeks, all the patients will be followed through electronic medical records until the end of abemaciclib treatment (up to two years) for collecting potential adverse events and information on sick leave. Data from electronical medical records regarding recurrence and subsequent therapy will be collected until breast cancer recurrence or up to 5 years from initiation of abemaciclib.
https://ctv.veeva.com/study/role-of-antisecretory-factor-in-dihydropyrimidine-treatment-of-colorectal-cancer	N/A	Interestingly from an oncological perspective, provision of exogenous ASF and induction of endogenous ASF has been shown to reduce interstitial fluid pressure (IFP) in tumours, increase tumour uptake of cytotoxic drugs and improve survival in animal tumour models. Thus, to raise body ASF by administration of ASF in the form of Salovum or its endogenous induction by SPC-flakes is seemingly a promising strategy worthwhile to investigate in cancer, both for treatment and counteraction of adverse effects, notably gastrointestinal mucositis, and for improvement of drug cancer treatment. While a clinical trial on administration of ASF as a strategy to improve cancer therapy, notably in glioblastoma, is in a pilot early phase, there is no study ongoing with the aim to counteract chemotherapy induced mucositis.	With this background the present study will investigate if administration of ASF in the form of Salovum combined with induction of endogenous AF by intake of SPC-flakes might be beneficial in colorectal cancer (CRC) patients to prevent dihydropyrimidine based chemotherapy induced gastrointestinal mucositis. Since the study team has also experience from measurements in patients of tumour IFP using 15O-labeled water PET, a pharmacodynamic pilot study for assessement of Salovum/SPC induced changes in tumour IFP will be included as an add on to the main study and open for 10 patients with liver metastatic disease.
https://ctv.veeva.com/study/role-of-antisecretory-factor-in-curative-radiochemotherapy-for-anal-carcinoma	N/A	The acute toxicity derives from the combined effects of radiation and chemotherapy and is dominated by localized skin mucositis, diarrhoea and pain from radiation and nausea, fatigue, anemia/leukopenia, diarrhoea and general skin dryness from chemotherapy. Cholera induced diarrhoea, as well as other forms of diarrhoea-inducing agents, has been shown to elicit a stimulated, endogenous production of a protein, named "antisecretory factor" (ASF). This protein has been chemically characterized in detail. ASF acts by modulating secretion of water and ions but also counteracts inflammatory processes. With this background the present study will investigate if induction of endogenous ASF by intake of SPC-flakes might be beneficial in AC patients to prevent RCT induced adverse events (AEs) and if administration of ASF from Salovum provides additional benefit (explorative).	The acute toxicity derives from the combined effects of radiation and chemotherapy and is dominated by localized skin mucositis, diarrhoea and pain from radiation and nausea, fatigue, anemia/leukopenia, diarrhoea and general skin dryness from chemotherapy. These adverse effects are treated symptomatically with mostly modest effect and sometimes leads to the need for in-patient care and temporary stop of the RCT. Long-term toxicity is caused by radiation fibrosis and is dominated by impaired anal sphincter function leading to faeces incontinence, pelvic pain and reduced sexual function. Thus, new ways to efficiently counteract the RCT induced adverse effects are urgently needed.
https://www.old-herborn-university.de/wp-content/uploads/publications/books/OHUni_book_22_article_8.pdf	N/A	Dietary intake of Specially Processed Cereals, (SPC-flakes®), in- creases endogenous AF synthesis in man. Thus, positive effects of treatment with SPC-flakes® have been shown in patients suffering from inflammatory bowel disease and Ménière's disease. Intake of SPC-flakes® also prevented mastitis in lactating women. In a con- trolled study treatment with AF-rich egg yolk, B221® (Salovum®) was shown to reduce diarrhoeal disease in infants and children in a developing country. Recently, we have demonstrated that AF-16, i.e. a peptide representing the antisecretory/anti-inflammatory AF domain is capable of preventing neurological malfunctions by reducing an ex- perimentally induced raise of the intracranial pressure. Together, these results advocate that the AF concept can be used clinically both by stimulation of the endogenous synthesis via intake of SPC-flakes®, and also by administration of the AF-16 peptide	The AF protein regulates transports of water and ions across various forms of biological membranes, and is capable of mediating and modulating a multi- tude of biological reactions. Our studies show that a peptide situated between position 35 and 50 in the AF protein sequence has potent anti-inflammatory and anti-secretory actions, and consequently stands out as an interesting candidate for future drug development

SPC FLAKES

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