Title: FlexNow with 100% SheaFlex70TM
1FlexNowwith 100 SheaFlex70TM
brought to you by BSP Pharma Inc.
2Table of Contents
- Value Proposition
- Testimonials
- Clinical Review
- Destructive Inflammation Cascade
- Alternative Interventions
- Selected Clinical Trial Review
- Safe / All Natural / Sustainable
- Summary
2
3The Next Generation of Joint Care
- Proven Over 30 clinical trials and studies
prove FlexNow with 100 SheaFlex70 - Reduces inflammation by 9 times
- Improves cartilage retention by 44
- Increases bone retention by 10
- Alleviates pain by 45
4The Next Generation of Joint Care FlexNow with
100 SheaFlex70
- New, Unique and Incremental
- Not a building block (like GS), Not a lubricant
(like HA), Not a COX-inhibitor - Single ingredient product, Not a compound formula
- Exclusive, Patented and available only through
BSP Pharma - Safe and All Natural
- No contraindications, No side effects, No
allergies - Active material High Triterpene Shea Nut
Extract HTSNE - Source material Shea Nuts
- not a nut, but the pit of the shea fruit
- used to make shea butter, common in cosmetics
- Shea butter contains less than 6 shea
triterpenes FlexNow with 100 SheaFlex70
contains 70 shea triterpenes - Sustainable
- Wild-crafted/harvested
- Processed in concert with the UN Development
Programme
5Target Consumers
- Target Market Joint Health
- 60mm joint care consumers
- 45mm Osteo-Arthritis sufferers
- 30mm GS users
- FlexNow with 100 SheaFlex70 is effective for
individuals who experience or are experiencing
joint discomfort or pain, stiffness, loss of
flexibility or mobility anyone who may not be
as active as they would like, due to joint
issues - Arthritis sufferers
- Athletes Professional, amateur and occasional
- Menopause
- Accident prone consumers
- Genetic predisposition to joint issues
- GS/CS and other joint care product users who have
not realized complete relief Add FlexNow to
existing regimen (not a replacement solution)
6Dose Regimen FlexNow with 100 SheaFlex70
- Take one dose of 3 softgels per day, with or
without food - Effective with or without other joint care
products. Recommended with building block
products (eg, GS/CS) - 4-6 week dosing cycle required for clinical
benefits
7Table of Contents
- Value Proposition
- Testimonials
- Clinical Review
- Destructive Inflammation Cascade
- Alternative Interventions
- Selected Clinical Trial Review
- Safe / All Natural / Sustainable
- Summary
7
8Testimonials FlexNow with 100 SheaFlex70
- Hundreds of consumers have contacted us and
shared stories of how FlexNow has changed their
lives - Arthritis Hands, Knees, Shoulders, Feet, Neck,
Elbows, Spine - Chronic and Acute Pain
- Bone repair
- Endurance
- Representative testimonials may be found at
www.PowerOfShea.com/testimonials
9Testimonials FlexNow with 100 SheaFlex70
- The Skeptic
- Being an RN with over 30 years experience...
- I decided to try it for the horrible inflammatory
arthritic condition I was experiencing in my
hands. - I had tried all the over the counter and
prescription NSAIDs and nothing worked to relieve
the pain and swelling. I was desperate for help,
and I could no longer turn the key to start my
car, open a jar, turn a door knob, or hold a hair
dryer. - After 7 days the swelling had improved, and I was
close to making a fist again. Now, after taking
FlexNow with 100 SheaFlex70 for 3 months, my
hands are pain free and I can wear my rings
again. I am so glad I tried FlexNow with 100
SheaFlex70 - Maridel - AL
- Joint Replacement/Replacement
- My left knee was rebuilt twice. My last surgery
was in 1999. - When I blew out my good knee in 2007, I
realized it was time to put away my bike for
good. Very depressing but I figured its just
part of getting old. - My health food store talked me into trying
FlexNow with 100 SheaFlex70. - In two weeks I felt good enough to try my
stationary bike. By the end of March, I could
ride my bike outdoors again. Without PAIN. - Both of my knees are pain-free. I have built up
muscle tone, finally. My limp is gone, finally.
Ive lost almost 20 pounds due to the exercise. I
FEEL GOOD. Your product is fantastic. At age 50,
I feel like I have a new lease on life. I feel
healthy - Sharon - PA
- Relapse
- I once ran out of your product, and had trouble
finding it. By the time I got re-supplied, I had
slipped back into agony. - Kathy - FL
10Table of Contents
- Value Proposition
- Testimonials
- Clinical Review
- Destructive Inflammation Cascade
- Alternative Interventions
- Selected Clinical Trial Review
- Safe / All Natural / Sustainable
- Summary
10
11Inflammation the root of disease
- Diseases of the heartblood vessel inflammation
- Malignant neoplasmsinflammation proven to
contribute to oncogenesis - Cerebrovascular diseaseblood vessel inflammation
- Chronic lower respiratory diseasebronchi chronic
inflammation - Diabetesespecially Type II, excessive
inflammation impacts blood sugar metabolism - Influenza and pneumoniaover-expression of
inflammation at immune system trigger - Alzheimers Diseaseinflammation predisposes
neurofibrilary plaques and tangles - Nephritis and nephroseschronic kidney
inflammation - Chronic liver disease/cirrhosischronic liver
inflammation - Source National Vital Statistics Report, Volume
53, Number 5 (October 2004)
12Joint Structure
13Stages of Osteoarthritis
14Destructive Inflammation Cascade
- When the body is injured or infected with a
pathogen, the immune system releases cytokines - Cytokines target the area of concern, increase
vascularity (allowing the body access to fight
and repair) and drive inflammation - Joint stress (eg, wear and tear micro cartilage
tear or bone fissure) often results in a
destructive inflammation cascade - Cytokines released vascularity increases
- Inflammation builds in the affected area
- Pain, tenderness and discomfort are evident
- Cytokines strip cartilage and erode bone tissue
- Body sends bone tissue and cartilage repair
elements to affected area - Inflammation impedes proper repair
- bone spurs and/or hard/dense bone build up,
further damaging already weakened and inflamed
cartilage - Inflamed cartilage is challenging to repair
properly raw material may be challenging to
deliver to the inflamed areas, increasing
likelihood of additional bone damage - incremental damage occurs through use of poorly
repaired site - More cytokines are released -- cytokine
production can multiply 1000 fold when activated - Inflammation builds further, and the destructive
inflammation cascade continues
14
15Cytokines drive inflammation in the body, can
ramp up 1,000 fold when activated, often
resulting in a destructive inflammation cascade
16How it works FlexNow with 100 SheaFlex70TM
- Managing cytokines and the destructive
inflammation cascade is key to reducing pain and
effectively repairing the affected areas. - FlexNow with 100 SheaFlex70 modulates the
production of cytokines and controls the
destructive inflammation cascade - Cytokine management FlexNow with 100
SheaFlex70 reduces cytokine production IL-6 by
31 and TNF-a by 24, resulting in - Inflammation reduction Reduces inflammation by
9X - Cartilage retention Decreases breakdown in
collagen / cartilage by 44 - Bone regulation Reduces Osteocalcin (a measure
of bone destruction) by 10 - Pain management Alleviates pain by 45
17Joint Structure
18Composition of Joint Cartilage
- The least abundant part of cartilage is
proteoglycans, representing 30 - The shock absorbing part of the cartilage matrix
- Glucosamine/chondroitin impacts proteoglycans
- The most abundant part of cartilage
- is collagen, representing 70
- The meshwork that holds proteoglycans in place in
cartilage - FlexNow with 100 SheaFlex70 High Triterepene
Shea Nut Extract impacts the collagen portion of
the cartilage matrix
19Healthy Joint Cartilage
- Healthy Cartilage structure
- Collagen Golden bands
- 70 of cartilage
- Impacted by FlexNow with 100 SheaFlex70 High
Triterepene Shea Nut Extract - Proteoglycans Turquoise
- 30 of cartilage
- Impacted by GS/CS
20Damaged Joint Cartilage
- When joint injury occurs
- Collagen meshwork (golden bands) breaks and
shreds - Proteoglycans (turquoise) leak out, reducing
joint lubrication / shock absorbing qualities - Destructive inflammation cascade
- Cytokines are released
- Inflammation increases
- Proper repair of the joint is challenged
- Additional damage occurs, and the cycle continues
- FlexNow with 100 SheaFlex70 High Triterepene
Shea Nut Extract has been proven to reduce
cytokine production, resulting in - Inflammation reduction Reduces inflammation by
9X - Cartilage retention Decreases breakdown in
collagen / cartilage by 44 - Bone regulation Reduces Osteocalcin (a measure
of bone destruction) by 10 - Pain management Alleviates pain by 45
21Inflammation Categories of Allopathic
Intervention
- Non-steroidal anti-inflammatory drugs
(NSAIDS)--COX 1 and 2 blockade ibuprofen
(Motrin), naproxen (Aleve), ketoprofen (Orudis) - Steroidsbroad spectrum suppression of immune and
inflammation response prednisone, dexamethasone
(Decadron), hydrocortisone - COX 2 Inhibitors celecoxib (Celebrex)
22FlexNow vs Alternatives
- Relative to other remedies, FlexNow with 100
SheaFlex70 offers more relief and is better for
the body than - Steroids Clinical benefits are similar, without
the side effects - Analgesics Taken every day, FlexNow
joint-specific pain management exceeds the
benefits of analgesics, without the side effects - Glucosamine
- 48 better than GS even better with GS.
- GS targets 30 of the cartilage matrix
(proteoglycan) FlexNow impacts the other 70
(collagen)
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24Over 30 Clinical Trials and studies prove
FlexNow with 100 SheaFlex70
- Reduces inflammation by 9 times
- Improves cartilage retention by 44
- Increases bone retention by 10
- Alleviates pain by 45
25ACCMER Trial Parameters
- Randomized Placebo Controlled Trial on the Safety
and Efficacy of BSP-201 in Osteoarthritis.
ACCMER. Cheras PA, Myers SP, Outerbridge K,
Nielsen G. Sept. 4 2007. - A randomized, double-blind, placebo-controlled
single center study. - Active FlexNow with 100 SheaFlex70
- Subjects
- 117 participants, 58 active, 59 placebo
- Radiologic and clinical evidence of
osteoarthritis of the knee and/or hip - Measures
- WOMAC (Western Ontario and McMaster Universities
OA index) - COAT Scores (Comprehensive Osteoarthritis Test)
- Duration 15 weeks
- Note At the end of the study, scores were not
at plateau, trending downward. Longer studies in
the future may yield even more optimal results. - Australian Centre for Complementary Medicine
Education Research
26ACCMER Overall Trial Results
- Cytokine Reduction
- 17.9 TNF-a overall reduction 23.9 reduction in
group with elevated TNF-a - IL-6 fell by 30.9
- CRP was reduced by 20.6
- Cartilage retention CTX-II cartilage marker
- Reduction of 28.7 in subjects with elevated
levels, - Placebo group increased 17.6
- 46.3 reduction in cartilage destruction
- Bone retention Osteocalcin (marker of bone
destruction) 9.2 reduction in elevated group - Pain management statistically significant pain
reduction for both men and women
27ACCMER Highest Risk Group Results
- Cytokine Reduction
- 24 reduction in TNF-a
- IL-6 fell by 22
- CRP was reduced by 22
- Cartilage retention CTX-II cartilage marker
- Reduction of 39
- Placebo group increased 31
- 70 reduction in cartilage destruction
- Bone retention Osteocalcin (marker of bone
destruction) 7.8 reduction in elevated group - Pain management statistically significant pain
reduction for both men and women
28HTSNE and Dexamethasone (steroid) produce similar
Arthritis Clinical ScoresControls Arthritis
- High Triterpene Shea Nut Extract Screening for
Effect on Rat Type II Collagen Arthritis.
Jorgensen JD, Weidner MS. Unpublished
pharmacological report. April 10, 2003 - Level of statistical significance plt0.0001,
Mann-Whitney U test
29HTSNE and Dexamethasone (steroid) exhibit similar
infammation reduction properties Reduces
inflammation
Level of statistical significance plt0.0001,
Mann-Whitney U test HTSNE High Triterpene Shea
Nut Extract
30HTSNE and Ibuprofen produce similar inflammation
controlReduces inflammation
- BSP 201 Screening for Antiinflammatory effect in
the Rat-carrageenin induced paw edema assay.
Jorgensen JD, Weidner MS. Unpublished
pharmacological report. Dec. 20, 2002 - Levels of statistical significance
plt0.001, Mann-Whitney U test -
plt0.0001, Mann-Whitney U test -
31HTSNE and Ibuprofen produce differentiated
Stomach and Intestinal Ulcers/Damage profilesNo
gastrointestinal damage
Level of statistical significance plt0.0001,
Mann-Whitney U test HTSNE High Triterpene Shea
Nut Extract
32HTSNE Exercise Induced Pain and Inflammation
Trialwith Visual Analog Scale (VAS)
Significantly reduces pain and inflammation
A Double-Blind Randomized Placebo Controlled
Parallel Group Study Demonstrates Analgesic
Effects of Sheanut Oil Extract BSP-201 in
Exercise Induced Muscle Tenderness.
Srendt-Nielsen L, Rosetzsky A, Weidner MS. Sept
15, 2003 HTSNE High Triterpene Shea Nut
Extract
33FlexNow with 100 SheaFlex70TM The Next
Generation of Joint Care
- Over 30 clinical trials and studies
- Reduces cytokine production 24-31, producing
breakthrough results - 1) Reduce inflammation by 9 times
- 2) Improve cartilage retention by 44
- 3) Increase bone retention by 10
- 4) Alleviate pain by 45
- Safe and Natural substitute for Steroids and
Analgesics - Better than GS even better with GS
34Table of Contents
- Value Proposition
- Testimonials
- Clinical Review
- Destructive Inflammation Cascade
- Alternative Interventions
- Selected Clinical Trial Review
- Safe / All Natural / Sustainable
- Summary
34
35Safe All Natural
- Clinically proven FlexNow with 100
SheaFlex70 has been the subject of over 30
clinical trials and studies, and has been
commercially available for a few years. Over the
course of hundreds of clinical trial subjects and
tens of thousands of consumers, just like you,
there have been - no adverse effects (no side effects)
- no allergies (the shea nut is not a nut, but the
pit of the shea fruit) - no contraindications (no interactions with
pharmaceutical or OTC products) - FDA-approved FlexNow with 100 SheaFlex70 is
accepted by the FDA as having met every safety
and toxicological requirement for a dietary
supplement. FlexNow with 100 SheaFlex70 was
one of only seven dietary supplements accepted by
the FDA in 2004, given the overwhelming evidence
supporting the products efficacy and safety. - Centuries of use All natural shea oil and shea
butter, the raw materials used to produce
FlexNow with 100 SheaFlex70 have been used as
a food and food ingredient in Africa and Europe,
for hundreds of years shea oil and shea butter
are common ingredients in both baked goods and
chocolate production. - Et al FlexNow with 100 SheaFlex70 contains
no added sugars (sucrose, fructose, or lactose),
no salt (sodium chloride), no nuts, yeast, wheat
(gluten-free), corn, fish, or milk, and no
artificial colors or preservatives.
36Sustainable/Green
- Good for the plant/Green farming
- Shea trees grow wild in West Africa, where all of
our shea nuts are grown. The shea nuts (actually
the pit of the shea fruit) used in the
manufacture of FlexNow with 100 SheaFlex70 are
wild-crafted/harvested and processed in concert
with the UN Development Programme. - Wild-crafted plants are carefully gathered from
their natural, wild habitat, where they have not
been sprayed with pesticides or fertilized with
synthetic fertilizers. - Wild-crafting is a sustainable agricultural
process that respects the living plant. Only the
shea fruit is taken during harvest the tree is
left unharmed. - Good for the community
- Local villagers collect ripe shea fruit which has
fallen to the ground, process a portion for local
use and sell the bulk of the shea nuts to our
company, food companies and skin care companies. - The UN Development Programme has established
education and training programs to support the
commercialization and management of the
wild-craft farming, harvesting, processing and
sale of shea fruit and shea nuts. - The UN Development Programme has helped tens of
thousands of villagers, particularly West African
women, to become independent and improve their
economic position.
37Shea nut harvesting in Burkina Faso, Ghana, and
the Ivory Coast
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39Table of Contents
- Value Proposition
- Testimonials
- Clinical Review
- Destructive Inflammation Cascade
- Alternative Interventions
- Selected Clinical Trial Review
- Safe / All Natural / Sustainable
- Summary
39
40FlexNow with 100 SheaFlex70 The New
Generation of Joint Care
- Proven Over 30 clinical trials and studies
prove FlexNow - Reduce inflammation by 9 times
- Improve cartilage retention by 44
- Increase bone retention by 10
- Alleviate pain by 45
- Safe and Natural substitute for Steroids and
Analgesics - Better than GS even better with GS
- New, Unique and Incremental
- Single ingredient product, Not a compound formula
- Exclusive, Patented and available only through
BSP Pharma - Acts uniquely, and synergistically, with other
joint care - Safe and All Natural
- No contraindications, No side effects, No
allergies - Source material Shea Nuts (not a nut, but the
pit of the shea fruit)
40
41Table of Contents
41
42BSP Pharma Inc.
- BSP Pharma Inc. is a North American
pharmaceutical, OTC and dietary supplement
developer/marketer, focused on identifying and
commercializing novel, natural substances with
the following characteristics - Clinically proven to have substantial and
meaningful clinical benefits - Safe and approved by the FDA
- Derived from nature and naturally occurring
materials - BSP Pharma Inc. is
- incorporated in Delaware,
- a subsidiary of BSP Pharma A/S
- conducts business in Europe, Asia and North
America - owned by Innoventure, a private equity firm,
based in Denmark. - BSP is an acronym for ButyrSpermum Parkii, the
latin name for shea butter, the source material
for our first commercial product, FlexNow with
100 SheaFlex70, the subject of over 30 clinical
trials and studies.
43Contact
If you have any questions/issues or would like to
order, please contact
BSP Pharma Inc. 500 Scarborough Drive Suite
301 Egg Harbor Twp., NJ 08234 Office
1-877-778-1212 CustomerService_at_BSPPharmaInc.com
43
44Clinical Dossier
- The efficacy of FlexNow on Rheumatoid Arthritis
Full Trial Dr. Kawano, University Hospital,
Japan 2010 Study in development. - The efficacy of FlexNow on Rheumatoid Arthritis
Pilot Study Dr. Kawano, University Hospital,
Japan 2009 Pilot trial/in progress, 3 month
duration, positive trend required and confirmed. - FlexNow and Glucosamine Synergism in
Osteo-Arthritis Duke University, Durham, NC,
USA 2009 Study in development. 10-month,
guinea pig OA animal model. 4 study arms
placebo, FlexNow, Glucosamine and FlexNow
Glucosamine. Outcome measures inflammatory,
bone and cartilage biomarkers together with
histological examination. - Safety and Efficacy on Japanese Osteo-Arthritis
Patients Dr. Kawano, University Hospital,
Japan 2009 Safety parameters, plus pain and
stiffness measures. Results pending. - Meta Analysis of BSPPEMS GIBPEMS Tonny
Jorgensen, CSO BSP Pharma A/S 2009
Preliminary results show the pain level in the
glucosamine group is 73 higher than in the
FlexNow group. - Randomised placebo controlled trial on the
safety and efficacy of BSP-201 in
Osteo-Arthritis, Dr. Phillip Cheras ACCMER,
University of Queensland, Brisbane, Australia
2007 Substantial and statistically significant
anti-inflammatory effect in humans, plus
chondroprotective and bone remodelling effects. - 7) GIB Evaluation of Glucosamine Sulphate and
Ibuprofen versus Placebo Dr. Allan Rosetzsky
Klifo, A/S, Copenhagen, Denmark 2005
Treatments revealed no significant effect except
from Glucosamine Sulphate which had a higher VAS
pain score compared to placebo, which is the
opposite of what was expected.
44
45Clinical Dossier
- Evaluation of The Efficacy and Safety of a
Sheabutter Extract on Cold Sores (Acute and
Prophylactic) Dr. Phillip A. Cheras ACCMER,
Brisbane, Australia 2005 The product was able
to significantly reduce the reoccurrence of cold
sores. - A Randomized Double-Blinded Placebo Controlled
Study of BSP-103 for the Treatment of Patients
With Moderate To Severe Plaque Psoriasis Dr.
Frederic Boudjema Pharmascan, Villeurbanne,
France 2004 Post hoc data analysis revealed
that the subgroup with initial PASIgt20 achieved a
statistical reduction of gt30 after 3 months. - A Double-Blind Randomized Placebo Controlled
Parallel Group Study Demonstrates Analgesic
Effects of Sheanut Oil Extract BSP-201 in
Exercise Induced Muscle Tenderness (BSPPEMS)
Lars Arendt-Nielsen, DmedSci, Ph.D. Aalborg
University, Denmark Journal of Musculoskeletal
Pain, Vol. 17, Issue 1, February 2009, pages
8-14 2003 Study found a significant 49 pain
reduction in the active group compared to
placebo. Product was found to be safe. - Mouse Micronucleus Karin Kaaber, DVM ScanTox
2003 No genotoxicity observed. - Ames Test Karin Kaaber, DVM ScanTox,
Denmark 2003 No genotoxicity observed. - 13) "Acute Oral Toxicity" Karin Kaaber, DVM
ScanTox, Denmark, 2003 LD50 gt2000mg/kg
46Clinical Dossier
- "Ulcerogenic Effect Karin Damm Jorgensen, DVM,
Study Director BioAdvice, Vedbaek, Denmark
2003 This ulcerogenic safety study confirmed
that BSP201 caused no gastrointestinal lesions in
contrast to Ibuprofen, which was used as the
control. - Determination of Anti-Inflammatory Properties of
Topical Formulations Containing Shea Butter
Extract on Lesional Skin of Patients With Atopic
Dermatitis J. Gassmüller, MD BioSkin Institute
for Dermatological Research, Hamburg, Germany
2003. - Evaluation of the irritating and sensitizing
potential by repeated 48-hours epicutaneous
applications under patch-tests (Marzulli
Maibach method) Dr. Yvette Weltert,
dermatologist Pharmascan, Villeurbanne, France
2003 The product can be considered
hypoallergenic. The product was not associated
with any clinically significant photo allergenic
response. - Cutaneous Irritancy by MTT Assay on Human Skin
Biopsies Alain Deguercy Laboratoire Dermscan,
Villeurbanne, France 2003 The product is
non-irritant in this model. - Evaluation of Ocular Irritancy. (HET-CAM
Assay) Alain Deguercy Laboratoire Dermscan,
Villeurbanne, France 2003 The product is
non-irritant in this model. - 19) Topical Safety Study Photosensibility Dr.
Marlena Nowakowska, MD Group Dermscan, France
2003 The product is non-photosensitising.
47Clinical Dossier
- Evaluation of The Acute Cutaneous Tolerance.
48h Occlusive Patch Test Under Dermatological
Control Dr. Yvette Weltert Palmer
Research-Dermscan Group St. Etienne, France
2003 Product is non-irritant. - Screening of Anti-Inflammatory Effect in The
Repeated Oxazolone Mouse Ear Oedema Assay
Morten Sloth Weidner, Ph.D. Department of
Dermatology, Bispebjerg Hospital, Copenhagen,
Denmark 2003 This model simulates chronic
inflammatory conditions. When administered
systemically, the product demonstrated a dose
dependent anti-inflammatory response. The
highest concentration was approximately twice the
response as the positive control 10/mg methyl
prednisolone. - Screening For Anti-Iinflammatory Effect in The
TPA Subchronic Mouse Ear Oedema Assay Hans
Christian Wulf, Dr. Med. Morten Sloth Weidner,
Ph.D. Department of Dermatology, Bispebjerg
Hospital, Copenhagen, Denmark 2003 This model
simulates chronic inflammatory conditions. The
product had a statistical significant inhibitory
effect on repeated TPA induced oedema (very
strong inflammation) (x4) formulation
optimisation tests. - 23) Screening of Anti-Iinflammatory Effect in
The Oxazolone Mouse Ear Oedema Assay Hans
Christian Wulf, Dr. Med. Morten Sloth Weidner,
Ph.D. Department of Dermatology, Bispebjerg
Hospital, Copenhagen, Denmark 2003 Confirmed
topical anti-inflammatory effect as well as a
significant dose dependent systemic
anti-inflammatory effect equal in the highest
dose to 30mg/kg methyl prednisolone.
48Clinical Dossier
- Screening For Anti-inflammatory Effect in The
Arachidonic Acid Mouse Ear Edema Assay Hans
Christian Wolf, Dr. Med. Morten Sloth Weidner,
Ph.D. Department of Dermatology, Bispebjerg
Hospital, Copenhagen, Denmark 2003 Product
provided anti-inflammatory effect. - Collagen II Rat Arthritis Assay Karin Damm
Jorgensen, DVM, Study Director BioAdvice,
Vedbaek, Denmark 2003 This chronic joint
inflammation model confirmed the alleviation of
joint specific chronic inflammation to a level
equal to dexamethasone. - Carrageenin Induced Rat Paw Oedema assay Karin
Damm Jorgensen, DVM, Study Director BioAdvice,
Vedbaek, Denmark 2002 This acute inflammatory
model confirmed the dose dependent
anti-inflammatory effect of BSP201. The effect
of a daily dose was comparable to a moderate dose
of Ibuprofen. (x3) - The Effect of Sheanut Oil on Serum Lipids and
Lipoproteins in Normocholesterolemic and Mildly
Hypercholesterolemic Humans Eric Berg Schmidt
Department of Medicine, Hjorring/Bronderslev
Hospital Journal of the American College of
Cardiology, Abstract 2894, May 1, 2002, Vol. 39,
Issue 9, Suppl. B 2001 LDL cholesterol
decreased 8 in active group. Product was found
to be safe. - 28) Screening For Anti-Inflammatory Effect in
The Mouse Ear Oedema Assay (TPA) Karin Damm
Jorgensen, DVM Panum Institute, Copenhagen,
Denmark 2001 All versions of the product
demonstrated a statistically significant dose
dependent anti-inflammatory effect. A dosage of
1mg demonstrated the same inhibition as 0.2mg
hydrocortisone-17-butyrate. (x2)
49Clinical Dossier
- TNF-a/IL-6 Study Morten Weidner Astion A/S,
Copenhagen, Denmark 2001 This test showed a
strong reduction of pro-inflammatory cytokines
TNF-a and IL-6 equal to the effect obtain with a
comparable dosage of methyl prednisolone. (x2) - NF-?B Mechanistic Study PanLabs Taiwan Ltd.,
Taipei, Taiwan 2000 FlexNow was shown to
inhibit NF-?B dependent transcription response. - Receptor Binding PanLabs Taiwan Ltd., Taipei,
Taiwan 2000 Confirmed safety. FlexNow did not
bind to the glucocorticoid receptors suggesting a
different mode of action and side effect profile
than steroids. - 32) Evaluation of Anti-Viral Effect James H.
Gilbert, Ph.D., MDS PanLabs Biosafety, Bothell,
WA, USA 1999 Product demonstrated antiviral
activity against herpes simplex and to a lesser
extent Influenza A. It did not show an effect
against rhinovirus.