FlexNow with 100% SheaFlex70TM - PowerPoint PPT Presentation

1 / 49
About This Presentation
Title:

FlexNow with 100% SheaFlex70TM

Description:

I have built up muscle tone, finally. My limp is gone, finally. ... muscle. synovial fluid. tendon. synovial tissue. FlexNow mini 042109c ... – PowerPoint PPT presentation

Number of Views:359
Avg rating:3.0/5.0
Slides: 50
Provided by: richardd68
Category:

less

Transcript and Presenter's Notes

Title: FlexNow with 100% SheaFlex70TM


1
FlexNowwith 100 SheaFlex70TM
brought to you by BSP Pharma Inc.
2
Table of Contents
  • Value Proposition
  • Testimonials
  • Clinical Review
  • Destructive Inflammation Cascade
  • Alternative Interventions
  • Selected Clinical Trial Review
  • Safe / All Natural / Sustainable
  • Summary

2
3
The 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

4
The 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

5
Target 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)

6
Dose 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

7
Table of Contents
  • Value Proposition
  • Testimonials
  • Clinical Review
  • Destructive Inflammation Cascade
  • Alternative Interventions
  • Selected Clinical Trial Review
  • Safe / All Natural / Sustainable
  • Summary

7
8
Testimonials 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

9
Testimonials 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

10
Table of Contents
  • Value Proposition
  • Testimonials
  • Clinical Review
  • Destructive Inflammation Cascade
  • Alternative Interventions
  • Selected Clinical Trial Review
  • Safe / All Natural / Sustainable
  • Summary

10
11
Inflammation 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)

12
Joint Structure
13
Stages of Osteoarthritis
14
Destructive 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
15
Cytokines drive inflammation in the body, can
ramp up 1,000 fold when activated, often
resulting in a destructive inflammation cascade
16
How 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

17
Joint Structure
18
Composition 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

19
Healthy 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

20
Damaged 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

21
Inflammation 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)

22
FlexNow 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)

23
(No Transcript)
24
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

25
ACCMER 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

26
ACCMER 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

27
ACCMER 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

28
HTSNE 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

29

HTSNE 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
30
HTSNE 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

31
HTSNE 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
32
HTSNE 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
33
FlexNow 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

34
Table of Contents
  • Value Proposition
  • Testimonials
  • Clinical Review
  • Destructive Inflammation Cascade
  • Alternative Interventions
  • Selected Clinical Trial Review
  • Safe / All Natural / Sustainable
  • Summary

34
35
Safe 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.

36
Sustainable/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.

37
Shea nut harvesting in Burkina Faso, Ghana, and
the Ivory Coast
38
(No Transcript)
39
Table of Contents
  • Value Proposition
  • Testimonials
  • Clinical Review
  • Destructive Inflammation Cascade
  • Alternative Interventions
  • Selected Clinical Trial Review
  • Safe / All Natural / Sustainable
  • Summary

39
40
FlexNow 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
41
Table of Contents
  • Back-Up

41
42
BSP 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.

43
Contact
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
44
Clinical 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
45
Clinical 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

46
Clinical 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.

47
Clinical 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.

48
Clinical 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)

49
Clinical 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.
Write a Comment
User Comments (0)
About PowerShow.com