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KOREAN SPONSOR : DAEWOONG PHARMACEUTICAL CO., LTD. CANADIAN SPONSOR/CRO: KRIGER RESEARCH CENTER INC. KRC INC. RESEARCH PROJECT: EGF03/CT PRODUCT: EASYEF
PROCEED TO CLINICAL TRIAL PROTOCOL SUMMARY PROCEED TO RESEARCH TEAM TASKS PROCEED TO RESEARCH TASKS SUBMISSION
EASYEF
Recombinant Human Epidermal Growth Factor 0.005%
GO TO EGF03/CT PROTOCOL
Product Information Stability Mechanism of EGF Action
PROJECT STATUS: KRC INC. is checking out the licensing and marketing potential of Epidermal Growth Factor in Canada. Daewoong Co., Ltd. - Korea has agreed to export this product.
KRC Inc. background checks are needed in order to enable our to decide whether we would be interested to file Phase I Clinical New Drug Application with TPP Canada or may be it would be more plausible for our Company to find a local Sponsor and Study serve as CRO in this project.
Pre-clinical Study Management Phase II Clinical Study Efficacy of EASYEF
Now we are working in close contact with Mr. Yi, So Yong from Business Development Daewoong Co., Ltd. - Korea.
KRC Inc. would be able to sign the contract with Daewoong Co., Ltd. on importing of initial quantities of the product for clinical trials upon successful completion of background checks
PROTOCOL
EGF03/CT
Phase II Study the Efficacy of the healing effect of recombinant human epidermal growth factor (rhEGF) on diabetic foot ulcers Double-blind, controlled Phase II study (Randomized comparative method, multi-center study)
EASYEF
Recombinant Human Epidermal Growth Factor 0.005%
Product Information
1. Bulk of rhEGF
Specifications Source Molecular Weight Appearance PH Sterility Identity Homogeneity Host-derived DNA Host-derived peptide Endotoxin PI Biological Activity
Parameters & Test methods Expressed in E. coli and purified from the culture media 5.7 0.5 kDa by SDS-PAGE & Coomassie staining White and amorphous lyophilized powder 6.5 1.0 by USP Sterile by USP SDS-PAGE & Coomassie staining, Western blot, RP-HPLC conform to standard EGF Purity : 98% by RP-HPLC Monomer : 98% by SE-HPLC 0.2 ppm by Slot blot hybridization 0.5% by ELISA 0.1 EU/g by LAL Test Single band , pI = 4.6 0.2 by Isoelectric focusing 0.9 mg/mg by Receptor binding assay 2.0 ng/ml of ED50 by Mitogenic assay
2. EASYEF
EASYEF was finished Phase II clinical trial in Korea, approved by Korea FDA for the treatment of diabetic foot ulcer as an orphan drug and launched in the Korea market in Sep. 2001.
Easyef is spray solution consisting of active ingredient and the diluent. Both are colorless, odorless and transparent liquid with pH 6.51.0.
For 2.5X2.5cm2 diabetic foot ulcer , patients should pump it 3~4 times. 1 time pumping amount is 50ul.
According to the result of clinical trial , 2~3 bottles are needed in order to complete healing in diabetic foot ulcer.
RhEGF 1mg ( Host cell: E. coli JM101, Vector : pTE105 ) Diabetic Foot Ulcer After mixing active ingredient with the diluent , applying it to an wound twice a day 20ml ( 50ug/ml ) , Amount used during about 40 days Keep it at 2~8C in a refrigerator. 2 years ( Upon mixing, the mixture is stable for 6 months at 2~8C )
EASYEF
Recombinant Human Epidermal Growth Factor 0.005%
Long Term Stability of DWP401 Powder (Relative Quantity ;A and Relative Activity ;B)
EASYEF
Recombinant Human Epidermal Growth Factor 0.005%
Re-epithelialization : EGF promotes epithelial cells to multiply and move to fill wounds Promotion of Granulation Tissue : EGF stimulates fibroblasts in dermal tissue to facilitate dermal cells to differentiate and multiply. Angiogenesis : EGF promotes endothelial cells to multiply to regenerate blood vessels.
Ref> 1. Drug News & Perspective 13(3), 158-168, April 2000 2. Advances in Plastic and Reconstructive Surgery, Vol. 11, 151-166