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Bee Venom Treatment Without Bee Sting - A Standardized Bee Venom Preparation_Apimeds, Inc.
Korea Health Industry Development Institute (KHIDI) South Korea flag South Korea
Abstract ID:
Bee Venom Treatment without Bee Sting - A Standardized Bee Venom Preparation...
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Background of Technology


(1)  Regulatory Status


-  New Drug Approval of KFDA (The 6th New Drugs in Korea, The first natural biological drug of its kind). The animal use of this drug (Apimellena) was approved as a New Veterinary Drug on May 2009.


-   US FDA IND Approval (Finished Phase IIa, 1989. IND #BB-3142)


-   US FDA New IND Approval, IRB Approval (2008.9 #13754)


-   (Additional Study) Completion of Phase IIa


-   Final Report of Phase IIa & Submission of Phase III Protocol (2010.3)


 


(2)  R&D History


-   A new biological drug developed by C.M.Kim, M.D. (International Pain Institute, New Jersey, USA) through 20 years of medical research and clinical experiences in the USA &


   7 years with the Apimeds, Inc.


-  Refer to the Table below


 



2.  Description on Technology Applied


(1)  Composition


-   Peptides & Enzymes: Core Biological Components of Mellitin, Apamin, MCD-Peptides, Adolapin.


Protease Inhibitors, Hyaluronidase


-   Key Titration Index of Assay : Mellitin, Phospholipase


-   Each Vial Contains 1mg of Freeze-Dried Bee Toxin (>0.4 mg of mellitin)


(2)  Identifications


  i. Melittin: 0.4-0.7 mg/mL


            ii. Phospholipase: 0.07-0.14 mg/mL


(3)  Specifications


        i. Total protein: 800-950 mcg/mL


  ii. Hyaluronidase activity: 40-100 HHU/mL (diluted to 100 UG/mL)


iii. Inhibition of gelatin induced aggregation of erythrocytes: 3-5 mm/H


 


l  Phase III Clinical Study for Multiple Sclerosis


A Phase III, Multi Center, Randomized, Double Blind, Placebo Controlled, prospective multi-center clinical study to evaluate the safety and efficacy of Intradermal injection of Apitox vs Histamine placebo in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) or Secondary-Progressive Multiple Sclerosis (SPMS) who are either intolerant to other medications or not receiving adequate clinical benefit from other medications or not receiving adequate clinical benefit from other medications in the improvement of Activities of Daily Living (ADL)


 


3. Differential Point, Superiority or Characteristics of Technology Applied


(1)  Apitox Profile


1)  Main Indications


Pharmaceuticals: Acute & Chronic Treatment for Inflammation and Pain of Arthritis, Neuralgia,


and for Autoimmune Diseases, Predominantly for Multiple Sclerosis


2)  Pharmacological Effects on


-  Control of Immune System


-  Anti-Inflammation


-  Anti-Bacterial/Fungal Effects


-  Protection of X-ray Side Effect


3)  Efficacy


-  Neural Diseases : Neuralgia


-  Skeletal Diseases : Acute Arthritis, Bursitis, Frozen Shoulder, Tennis Elbow, Golfers Elbow,


-  Muscular Diseases : Muscular Pain, Fibromyalgia, Chronic Fibrosis


-  Autoimmune Diseases : Rheumatoid Arthritis(RA), Psoriasis, Multiple Sclerosis (MS), Systemic Lupus Erythematosis (SLE)


 


l  Efficacy for MS -  450 Patients : 1987~1998 (12 Years),   IPI  (USA)



































 



  Before Treatment






  After Treatment






  Weakness (Extremities)






  ++++






  +






  Spasticity & Spasm






  +++++






  ++






  Bladder Control






  10~60%






  50~90%






  Balance






  Poor and Unstable






  Fair and Stable






  Fatigue






  +++++






  ++



 


   4)  Antiphlogistic Analgesis (Pain Killer Versus Apitox)


              PAIN KILLER                APITOX


 


Compatibility Drugs :       Biological Medicine :


- Serious Side Effects         - Less Side Effects


- Use in Acute Illness         - Chronic Disease Cure


- Symptoms Treatment        - Cause Treatment


 


(2)  Medical & Marketing Value of Apitox


 


1)  US FDA NDA Approval Vision (Lowest Cost & Shortest Approval)


-  Already approved as a new drug by KFDA


-  Potential of Unique Korean-Type Global Blockbuster as Natural New Drug


-  Biological Toxin/US FDA Center for Biologicals Evaluation & Research


-  US FDA Phase IIa Approval [1989,IND #3142)


-  Target Approval Date of US FDA NDA by March 2011


 


2)  Excellent Efficacy for Chronic Arthritis and Validated Safety of Natural Origin


-  Fundamental Therapeutics Not Existing for Chronic Arthritis, Rheumatoid Arthritis &


 

FEATURED
Last Updated Jun 2016
Technology Type THERAPEUTIC
Phase of Development REGISTERED / FDA APPROVED / FINISHED PRODUCT
GOVERNMENT INSTITUTE