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Easyef ® Spray Recombinant Human Epidermal Growth Factor.

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Presentation on theme: "Easyef ® Spray Recombinant Human Epidermal Growth Factor."— Presentation transcript:

1 Easyef ® Spray Recombinant Human Epidermal Growth Factor

2 General Information 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.  What is EGF? Easyef ® Spray 1

3  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 ® Spray

4 Clinical Study  Diabetic Foot Ulcer (Phase II) ► Indication: Diabetic foot ulcer, Grade 2 and 3 by Wagner classification ► Methodology: Double-blind, controlled, randomized comparative method, multi-center study ► Dose strength: Easyef ® Spray (10 μg/ml and 50 μg/ml), placebo ► Treatment: Sprayed on wound area twice a day for 12 weeks ► Primary endpoint: Complete healing rate of foot ulcer ► Result: Easyef ® Spray accelerated healing of diabetic foot ulcer and apparently increased the percentage of complete healing. Comparison of Complete Healing Rate Case Example 3

5 Easyef ® Spray  Radiation-Induced Oral Mucositis (Phase II) ► Indication: Oral mucositis in patients receiving radiation therapy with or without chemotherapy ► Methodology: Double-blind, placebo-controlled, randomized comparative method, multi- center study ► Dose strength: Easyef ® Spray (10 μg/ml, 50 μg/ml and 100 μg/ml), placebo ► Treatment: Sprayed on wound area twice a day for 5 weeks ► Primary endpoint: Radiation Therapy Oncology Group (RTOG) scale for acute mucosal morbidity ► Result: Easyef ® Spray conveys a therapeutic effect and local application of Easyef ® Spray significantly reduces the incidence of severe oral mucositis. Proportion of Patients with Oral Mucositis (RTOG scale: ≥ 3) Case Example (a)(b) Appearances of oral mucosa at treatment week four. (a) No change of oral mucosa over baseline (RTOG grade 0) in responders to EGF (b) RTOG grade 3 confluent mucositis in placebo arm 4

6 Easyef ® Spray  Oral Mucositis Induced by Chemotherapy with SCT (Phase II, Interim analysis) ► Indication: Oral mucositis induced by intensive chemotherapy with SCT for hematologic malignancies ► Methodology: Double-blind, placebo-controlled, randomized, prospective study ► Dose strength: Easyef ® Spray (50 μg/ml), placebo ► Treatment: Sprayed on wound area twice a day ► Primary endpoint: Incidence and duration of oral mucositis ► Result: Easyef ® Spray significantly reduced the limitation of swallowing and drinking, the duration of TPN use and hospitalization in patients with WHO grade 3-4 oral mucositis. Effects on WHO grade 3-4 Oral Mucositis: Duration Secondary Endpoints: Patients with WHO Grade 3-4 Oral Mucositis 5 Grade 3-4 OM rhEGFPlacebo P Median (range) Duration – days8.0 (2.0-23.0)18.5 (2.0-34.0)0.108 Oral Mucositis Daily Questionnaire (OMDQ) Variables (AUC of score) rhEGFPlacebo p Median (range) Q3. Limitations in daily activities A. Swallowing B. Drinking C. Eating D. Talking E. Sleeping 26.0 (8.0-75.0) 25.0 (7.0-73.5) 40.5 (15.0-90.0) 32.0 (6.0-74.0) 14.0 (0.0-72.0) 51.5 (19.0-92.0) 55.5 (20.0-86.0) 70.3 (22.0-104.0) 56.5 (3.0-97.0) 46.0 (0.0-72.0) 0.039 0.042 0.121 0.203 0.124 Variables – days rhEGFPlacebo p Median (range) Duration of rhEGF treatment28.0 (17.0-44.0)39.5 (17.0-61.0)0.050 Duration of TPN use7.0 (0-25.0)16.5 (10.0-32.0)0.012 Duration of opioid analgesics use6.0 (0-25.0)17.0 (0-48.0)0.117 Duration of hospitalization27.0 (18.0-65.0)41.0 (27.0-90.0)0.047

7 Easyef ® Spray Non-clinical Study  Pharmacokinetics (ADME) 6  Toxicity Studies ItemAnimalRoute Single dose toxicity ICR mouse, SD ratS.C./P.O. Cynomolgus monkeyS.C./I.V. Repeated dose toxicity ICR mouse, 13 weeksS.C. SD rat, 13 weeksS.C Cynomolgus monkey, 4 weeksI.V. Genotoxicity In vitro chromosomal abbreation Chinese hamster ovary (CHO) cell - Reverse mutationSalmonella typimurium- Bone marrow micronucleusMale and female miceI.P. Reproductive toxicity Fertility and early embryonic development SD ratS.C. Embryofetal development Newzealand white rabbitS.C. Embryofetal development SD ratS.C. Prenatal and postnatal toxicity SD ratS.C. Other toxicity Skin irritation / Eye irritation Newzealand white rabbitTopical Skin sensitization Guinea pigTopical ItemAnimalRoute Pharmacokinetics SD ratS.C./I.V. Cynomolgus monkeyS.C./I.V. MetabolismSD ratI.V. Biliary ExcretionSD ratS.C./I.V. Pharmacokinetics after Local Administration hairless mouseTopical SD ratTopical Pharmacokinetics after Repeated AdministrationSD rat, 1 weekS.C. Pharmacokinetics after Repeated Local Administration SD rat, 3 daysTopical

8 Easyef ® Spray CMC Result 7 ItemMethodsResults Structural characterization and confirmation Amino acid sequence Identical to natural form of human EGF Amino acid composition Terminal amino acid sequence N-terminal C-terminal Peptide mapping Disulfide bridges Physicochemical properties Molecular weight or size SDS-PAGE SEC-HPLC MALDI-TOF MS Isoform pattern Electrophoretic Patterns Non-reducing Reducing Liquid chromatographic patterns RP-HPLC SEC-HPLC Spectroscopic profiles UV Circular dichroism Immunological characterisation Western blotting Immunoelectrophoresis Radioimmunoassay Biological activity Mitogenic assay Thymidine incorporation assay Similar to NIBSC standard BrdU incorporation assay Receptor binding assay

9 Key Benefits and Features  First pharmaceutical EGF product to gain worldwide approval in the world Currently marketed in Jordan, Vietnam and many other countries Highly potent and safe compared with other EGF products  Identical to natural human EGF, ultra-pure and homogeneous Manufactured by the innovative and proprietary E.coli expression system  INN (generic name): Nepidermin Ref) WHO Drug Information (2008), 22(1):59 Easyef ® Spray 8

10 Product Information [Composition] Active ingredient: 1mL contains Recombinant human epidermal growth factor ------------------------------ 0.5mg (600,000 IU) (Host cell: E. coli JM101, Vector: pTE105) Solvent: 9mL contains Methyl parahydroxybenzoate --------------------------------------------------- 20mg [Appearance] Both active ingredient and solvent are colorless, odorless and transparent solution with pH of 6.5±1.0 [Indications] Diabetic foot ulcers [Dosage & Administration] After mixing active ingredient with attached solvent, apply to wound twice a day. [Storage] Store at 2~8 ℃ in a refrigerator. [Package] Box of 1 set of 10mL [Shelf-Life] 2 years before use (not mixed) 6 months after use (mixed) 9 Release Date : 2012.01.27 For More Information Contact: Chang Woo Suh Tel: 82-2-2059-1632 E-mail: 163-3, Samsung-dong, Gangnam-gu, Seoul 135-715, KOREA Easyef ® Spray

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