GlobiFer

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GlobiFer

• New perspective on oral iron supplementation

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Iron in the diet

• There are only two forms of bio-available iron
• Heme iron from meat products Iron bound to
  natural hemoglobin or myoglobin
• Non-heme iron from plants, dairy and syntethic
  iron supplements Otherwise chemically bonded iron

Fe
Fe
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Iron absorption
Fe
Heme iron is easily absorbed as a whole structure
with high bio-availability.
Fe
Fe
Fe
absorption 15-20
Non-heme iron must be dissolved before uptake.
Because of low absorption reactive free iron ions
remain in the gut.
Fe
Fe
Fe
Fe
Fe
Fe
absorption 2-4
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Heme iron supplementation

• Bovine or porcine heme iron tablet
  supplementation originally pioneered by Cryoguard
  has been used in Scandinavia largely without any
  serious side effects reported for over 25 years.
• Because of the comparatively low iron content of
  hemoglobin in relation to its bulk all heme iron
  products until now have most of their iron
  content in the form of added non-heme iron salts.
  

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New form of raw material

• Iron integrated with hemolyzed hemoglobin in a
  special process is perceived by the body as heme
  iron.
• The added iron will be absorbed with the
  hemoglobin. No reactive free iron ions are left
  in the gut.

Fe
Fe
Fe
Fe
Fe
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Iron integrated hemoglobin

• Exclusive and unique raw material
• that derives from extensive
• development.
• Documented in vitro for binding and in vivo
  for absorption.
• High bio-availability, well tolerated.

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Efficient and well tolerated

• Uptake is not affected by low acid content in the
  stomach (achylia because of other simultaneously
  ingested food or medication such as antacids and
  proton pump inhibitors).
• No free iron ions are left in the gut. Hemoglobin
  not absorbed is inert and will not irritate.

Absorption (typical)
Side-effects (typical)
20-30
15-20
8-10
2-4
2-4
Heme iron
Non-heme iron
Non-heme iron
Heme iron
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GlobiFer
Typical non-heme tablet

• 18 mg iron, Fe
• Iron integrated hemoglobin
• Dosage 2 tablets/day
• 36 mg heme iron
• 5,8 mg Fe absorbed
• 5,8 mg bio-available iron

• 100 mg iron Fe
• Ferrous fumarate, sulphate or other non-heme
  complex
• Dosage 1 tablet/day
• 100 mg non-heme iron
• 4,6 mg Fe absorbed
• 4,6 mg bio-available iron

Source Z Ernahrungswiss. 1993 Mar32 (1) 67-70
Comparative absorption of ferrous and heme-iron
with meals in normal and iron deficient
subjects. Ekman M, Reizenstein P.
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Advantages of GlobiFer

• Simple dosage one or two tablets once per day
• Sufficient efficacy
• Iron absorbed in all situations
• Safe Cannot be overdosed

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Experience with GlobiFer

• Iron integrated hemoglobin tablets manufactured
  since 2006
• Marketed in the Nordic countries (JernBalans),
  Cyprus, Iran (GlobiFer) and China (Hemofolic)
• Olympic preparate for China in Athens and Beijing
• No side-effects reported
• Excellent therapy results

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OTC use

• There is a clear vacancy worldwide for a
  well-tolerated safe iron preparation as well as a
  steady growth for self-medication.
• The potential is great, almost one third of all
  fertile women continually need iron
  supplementation because of menstrual blood loss.

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Clinical use

• Many chronic patients in the field of Chronic
  Kidney Disease, gastro-intestinal diseases,
  Chronic Heart Failure and others have to resort
  to intravenous or intramuscular iron injections
  when their digestive system can no longer stand
  the side-effects of syntethic oral iron.
• GlobiFer products have the potential to replace,
  postpone or at least prolong the intervals
  between costly, inconvenient and painful
  injections. This means substantial savings for
  the community.

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Concluded studies

• In-vitro test
  
  In order to establish that iron integrated
  hemoglobin behaves like regular hemoglobin an
  in-vitro test was made with gastric juice and
  subsequent analysis of iron content of the
  filtrate. This showed an iron content of roughly
  1 mcg per 18 mg Fe added, which means that
  practically no free iron ions are released in the
  gut. AnalyCen 2005
• Comparative Dose-Response Study
• A cross-over test of initial absorption of
  GlobiFer tablets, Hemofer tablets and AproFer
  capsules of 18 mg Fe (heme iron) and Niferex
  capsules with 100 mg Fe (non-heme iron).
  Measurements Hb, serum iron, iron saturation and
  ferritin counts at three consecutive points with
  3 hour intervals. The bio-availability study had
  the objective of investigating absorption of a
  single dose over time. We know that non-heme iron
  is taken up in the first part of the digestive
  system only. This can be seen in a very sharp
  dose-response curve from a single administration.
  Heme iron has a slow absorption curve and is
  taken up much farther into the digestive system.
  The results gave a strong indication that
  iron-integrated hemoglobin is taken up throughout
  the digestive system. Conducted at Vasaparken
  Medical Center, Stockholm. End date January 2008.

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SUPLHEMO

• Cryoguard cooperates with Ellco Food and APC
  Europe in the Eureka-Project SUPLHEMO. Title
  Concentrated Haem (Heme) Iron As Bio-Available
  Iron Source For Humans Without Side Effects.
• SUPLHEMO is supported by state science foundation
  Vinnova in Sweden and comprises several clinica
  studies in order to evaluate iron integrated
  hemoglobin.
• Projekt E! 4192 EUROAGRISUPLHEMO.
• Runs 36 months from May 1st 2008.
• Area Medicine and biotechnology.
• Budget 2,41 Meuro.

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Clinical studies SUPLHEMO

• KIDNEY FAILURE
• Chronic Kidney Discease is a progressing stress
  anemia treated with oral iron salts and later
  intravenous iron and erythropoietin to enable
  kidney transplantation. Chronic patients have to
  resort to injections when their digestive system
  can no longer stand the side-effects of syntethic
  oral iron. GlobiFer products have the potential
  to replace, postpone or at least prolong the
  intervals between costly (a huge difference) and
  inconvenient injections.
• Oral iron salts haemoglobin iron has proven to
  be effective. A pilot test to investigate the
  efficacy of haem iron to improve anaemia and iron
  status in Chronic Kidney Disease patients stage
  III / IV and not receiving dialysis.
  Investigators Dr Paul Stevens (Cons,
  Nephrologist), Dr Ian John (Cons Nephrologist),
  Ns Karen Jenkins (Nurse Consultant). All work to
  be undertaken in the clinics and labs of Kent and
  Canterbury Hospital, UK.
• INFLAMMATORY BOWEL DISEASE
• Aims and purpose of the proposed investigation is
  to assess the tolerability and the effectiveness
  of oral haem compared to ferrous sulphate in iron
  deficiency anaemic patients with mild or
  quiescent IBD and to assess the effect of these
  interventions on disease activity.Hypothesis
  Oral haem iron supplementation is more effective
  and better tolerated than non-haem iron in
  patients with inflammatory bowel disease.
  Investigator Dr Tariq Iqbal, Department of
  Gastroenterology, Queen Elizabeth Hospital,
  Birmingham, UK.

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Clinical studies SUPLHEMO

• FERTILE WOMEN
• Preliminary trials in iron deficient women
  comparing the efficacy of hemolyzed and
  enrichened haemoglobin tablets have started at
  the gynecological clinic at Vasaparken Clinical
  Center in Stockholm. Preliminary results show
  good tolerance and high efficacy for haem iron
  preparations.
• PREGNANT WOMEN
• A comparison of the efficacy of haemoglobin-based
  products AproFer 1000 and GlobiFer is planned to
  take place at the University of Uppsala in
  collaboration with Center for Clinical testing of
  food CKPL and the gynaecological clinic of
  the University of Uppsala.
• COMPARATIVE DOSE-RESPONSE STUDY (Concluded)
• A cross-over test of initial absorption of
  GlobiFer tablets, Hemofer tablets and AproFer
  capsules of 18 mg Fe (heme iron) and Niferex
  capsules with 100 mg Fe (non-haem iron. The
  purpose is to establish and compare
  bio-availability. Measurements Hb, serum iron,
  iron saturation and ferritin counts at three
  consecutive points with 3 hour intervals.
  Conducted at Vasaparken Medical Center,
  Stockholm.
• ELDERLY PEOPLE WITH HEART INSUFFICIENCY
• Investigation of elderly people suffering from
  heart insufficiency treated with iron integrated
  haemoglobin. The objective will be to prevent
  myocardial infunction and therefore heart
  insufficiency by administration of haem iron in
  order to increase the Hb level and provide enough
  oxygen to the heart. This will take place at the
  University of Umeå (Sweden).

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