Antisecretory Factor Glioblastoma Phase 2 (AFGB2)

Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study

This is a randomised, double blinded and multiple center , Phase 2 study in patients with newly diagnosed glioblastoma. Participants will receive an egg powder enriched for antisecretory factor (AF), Salovum, or a placebo egg powder daily from 2 days before concomitant radio-chemo therapy or chemotherapy until 14 days after finalisation plus during adjuvant chemotherapy.The primary aims of are overall survival at 6 and 12 months after diagnosis

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Dietary supplement: Salovum; Dietary supplement: Placebo egg yolk powder

Detailed Description

Glioblastoma (GB) is the most common primary brain tumor and also has the worst prognosis with a mean survival time below 1 year and a 5-year survival rate of less than 2%. AF is a 41kilodalton endogenous and essential protein with antisecretory and anti-inflammatory effects. Endogenous AF activity increases after exposure to bacterial toxins and endogenous triggers of inflammation. The active amino-terminal portion of AF has been synthesized as a 16 amino acid peptide (AF-16) and has been used in animal experimental studies. Salovum® is a product based on egg yolk powder B221® and contains high levels of AF. Salovum® is classified as food for special medicinal purposes (FSMP) by the European Union an din other countries.

Many tumors show elevated interstitial fluid pressure (IFP) compared to the surrounding tissue due to vascular leakage, providing a barrier for drug uptake in solid tumors, as well as poor perfusion, resulting in hypoxia and relative resistance to radiochemotherapy.

AF-16 was reported to significantly reduce the IFP in xenotransplanted human glioblastoma by inhibiting an ionic pump, NKCC1, in the tumor tissue. Both Salovum® and AF-inducing specific processed cereals (SPC) prolonged survival in the same models. Systemic temozolomide treatment combined with AF inducing SPC completely blocked tumor growth in GBM xenografts. Likewise, SPC treatment abrogated 90% of pre-established syngeneic tumors in immune competent animals.

Intratumoral delivery of AF-16 potentiated the effect of intratumoral temozolomide in an experimental model of glioblastoma.

Mechanistically, it remains unclear whether AF's effect in tumor models is mediated through decrease of IFP and/or immunomodulation. Also, an effect on the complement system through modulation of circulating complement complexes with proteasome units has been proposed.

Salovum® has been administered to patients with various diseases as, inflammatory bowel disease, Mb Ménière and mastitis and traumatic brain injury without signs of any adverse effects.

In a completed phase1-2 trial in participants with primary gliobalstoma the add on of Salovum during concomitant radiochemotherapa was considered safe and feasible.

The current study is aimed at assessing the efficacy of Salovum in a RCT (randomised controlled trail).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Peter Siesjö, MD, PhD; Phone Number: +4646171274; Email: peter.siesjo@med.lu.se
• Study Contact Backup: Name: Johan Bengzon, MD, PhD

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Recruiting
    • Skåne University Hospital
    • Contact: Peter Siesjö, MD; Phone Number: +46705655778; Email: peter.siesjo@med.lu.se
    • Contact: Erik Ehinger, MD; Phone Number: +46707970783; Email: erik.ehinger@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pathology verified glioblastoma or astrocytoma grade 4
2. Age 18-75 years
3. Surgical treatment-resection.
4. Scheduled concomitant radiochemotherapy, or only chemotherapy.
5. Informed consent

Exclusion Criteria:

1. No informed consent
2. Egg yolk allergy
3. Only surgical biopsy
4. Only radiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Salovum; Salovum, an egg yolk powder will be orally at dose of 11 g 3 times daily.	Dietary supplement: Salovum; Salovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals) and contains increased amounts of the endogenous protein antisecretory factor.; Other Names: Antisecretory factor
Placebo Comparator: Placebo; Placebo, an egg yolk powder will be orally at dose of 11 g 3 times daily.	Dietary supplement: Placebo egg yolk powder; Egg yolk powder derived from hen fed with normal feed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Survival	up to 12 months from primary surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress free survival at 6 and 12 months	Progress free survival as a compound assessment by a multidisciplinary conference (MDC)	At 6 and 12 months from primary surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Assessed by Montreal Cognitive Assessment (MoCA)	up to 1 year
Neurological function	Assessed by Neurologic Assessment in Neuro-Oncology (NANO) scale	up to 1 year
QOL Assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30	Assessed by European Organization of Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 questionnaire	up to 1 years
quality of life (QOL) assessed by brain cancer module (BN20) questionnaire	Assessed by brain cancer module (BN20) questionnaire	up to 1 years
Performance Assessed by Eastern Oncology Cooperative Group (ECOG) performance scale	Assessed by Eastern Oncology Cooperative Group (ECOG) performance scale	up to 1 year

Collaborators and Investigators

• Sponsor: Peter Siesjö
• Collaborators: Lund University
• Investigators: Study Chair: Charlotte Edwardsson, Skåne University Hospital; Study Chair: Erik Ehinger, MD, Skåne University Hospital

Publications and helpful links

General Publications

• Ehinger E, Darabi A, Visse E, Edvardsson C, Tomasevic G, Cederberg D, Kinhult S, Rydelius A, Nilsson C, Belting M, Bengzon J, Siesjo P. Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype: study protocol for a randomized double-blind placebo-controlled trial. Trials. 2025 Mar 13;26(1):86. doi: 10.1186/s13063-025-08792-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Trials, Randomized Clinical; Antisecretory factor
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Gastrointestinal Agents; Antidiarrheals; antisecretory factor
• Other Study ID Numbers: FPAFGB2ver6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used and analysed in the current trial will be available in anonymized form after completion of the study, on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No