Transcript Easyef ® Ointment

Easyef® Ointment
Recombinant Human Epidermal Growth Factor
Easyef® Ointment
General Information
What is EGF?
Epidermal Growth Factor (EGF) is a single-chain polypeptide consisting of 53
amino acids with a molecular weight of about 6,200 Daltons. Six cysteine
residues in the sequence of hEGF from three disulfide bonds are required for
hEGF to be biologically active.
EGF was first isolated from the submaxillary glands of adult male mice. Human
EGF was discovered in human urine as an inhibitor of gastric acid secretion.
Today, hEGF has become one of the most attractive growth factors in life
sciences as well as biotechnological fields.
Human EGF is a potent stimulator of epithelial and endothelial cells and
fibroblast proliferation both in vitro and in vivo, which results in its potential as a
promising healing agent for the treatment of various skin and corneal wounds. In
dermatology, EGF can be used as a healing agent for skin wounds, such as
diabetic ulcers, bed sores, venous stasis ulcers, skin burns and surgical incisions.
In ophthalmology, EGF can be utilized as a healing agent for corneal ulcers and
ophthalmic surgery, such as corneal transplantation and excimer laser
keratectomy, and the prevention of corneal degeneration. It is also a good
candidate for the treatment of gastric ulcers because it inhibits gastric acid
secretion and regenerates gastric mucosal layer.
1
Easyef® Ointment
Mechanism of EGF Action
1. Re-epithelialization
EGF promotes epithelial cells to proliferate and move to fill wounds.
2. Promotion of granulation tissue
EGF stimulates fibroblasts in dermal tissue to facilitate dermal cells to
differentiate and proliferate.
3. Angiogenesis
EGF promotes endothelial cells to proliferate to regenerate blood vessels.
2
Easyef® Ointment
Skin Regeneration and the Healing Effect
1. Non-clinical study
Skin regeneration rate (%)
Completely healed
in about 7.8 days
Completely healed
in about 9.8 days
Easyef® Ointment
C product
Duration of treatment (Days)
Full-thickness wound model in the pig
Wound size/depth: 4 x 4 cm, 0.05 mm
Administration and period: twice a day (0.4 g applied per administration), treated for 11 days
Ref) The Journal of the Korean Dermatological Association 1995
2. Clinical study
► Indication: Wound healing (Skin graft donor site model)
► Methodology: Placebo-controlled, randomized, double-blind, multi-center study
► Primary endpoint: Healing time by the direct evaluation(naked eye) of skin graft donor site
► Result: The test group displayed statistically significant 1.0 day faster healing time
compared to the control group (p=0.0005).
ITT
N=64
Healing time (day)
(mean±SD)
Healing time difference (day)
(mean±SD)
median (min, max)
p-value
1)
95% confidence interval
PP
N=61
Placebo
EGF 1 μg/g
Placebo
EGF 1 μg/g
8.109±1.492
7.609±1.344
8.107±1.528
7.598±1.363
0.500±1.098
1.000 (-1.500, 3.500)
0.508±1.116
1.000 (-1.500, 3.500)
0.0005
0.0007
0.500, 1.000
0.000, 1.000
1) Wilcoxon signed- rank test
Outstanding effect of skin generation
The wound applied with Easyef® Ointment demonstrated the quickest
healing ability.
Rapid wound healing ability
The shortest healing time was achieved in the same wound area.
3
Easyef® Ointment
Key Benefits and Features
Wound healing ointment with a new concept, containing EGF, a
granulation ingredient (granulation tissue) in the human body, offered
first in Korea.
Safe because it contains no steroids or antibiotics.
White blood cells or macrophages themselves, which are created during the
healing process in our body, suppress bacteria, to some extent. Therefore,
this medicine does not contain a steroid or an antibiotic of which the
excessive use may make us tolerant of the antibiotic.
Proven in its safety and healing effect through a clinical studies in
Korea.
Top medical staffs from three prestigious Korean Institutions (Asan Medical
Center, Severance Hospital, and Samsung Medical Center) joined the
clinical procedures, and approved the safety and remarkable healing effect
of EGF.
Table of Comparison with Competitors
Product name
API
Type
Tolerance/
Side effect
Easyef® Ointment
EGF
(Epidermal Growth Factor)
No antibiotic
No steroid
Same ingredient as
in the human body
(no side effect)
Efficacy/
Effect
Assistive topical treatment
of wound and skin ulcer
Storage
Store in a refrigerator
(2~8℃)
A
B
C
Sodium fusidate
Mupirocin
Centella asiatica
extract
Antibiotic
Antibiotic
Antibiotic, steroid
Tolerance
(antibiotic)
Tolerance
(antibiotic)
Tolerance
(antibiotic)
Side effect (steroid)
Pyoderma, acne,
folliculitis, boil, and
secondary infection
due to a burn and
wound
Room temperature
(1~30℃)
Bacterial skin
disease
Room temperature
(1~30℃)
Skin inflammation,
infected wound
Room temperature
(1~30℃)
4
Easyef® Ointment
Product Information
Component
In 1 g
Recombinant human epidermal growth factor ------------------------------ 1 μg
(Host: E. coli JM101, Vector: pTE105)
Ointment base: white petrolatum (KP) ------------------------------------ 700 mg
Ointment base: Light liquid paraffin (KP) ----------------------------- 298.45 mg
Preservative: propylparaben (KP) ------------------------------------------- 1.5 mg
Appearance
Colorless or pale yellow, translucent ointment in tube
Administration/Dosage
Apply it to the infected area several times a day as needed.
Efficacy/Effect
Assistive topical treatment of wounds and skin ulcers
Storage
Store in a refrigerator (2~8℃).
Easyef® Ointment
Release Date : 2010.12.30
http://www.daewoong.com
For More Information Contact:
Chang-woo Suh
Tel: 82-2-550-8737
E-mail: [email protected]
163-3, Samsung-dong,
Gangnam-gu, Seoul 135-715, KOREA