Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee

The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.

Inclusion Criteria:

• osteoarthritis of one or both knees
• on stable NSAID or none due to intolerance
• women either post menopausal or on stable birth control
• no clinically significant disease or or abnormal laboratory values
• signed informed consent, communicate effectively, understand and comply with all study requirements

Exclusion Criteria:

• serious or unstable medical or psychological condition
• known sensitivity to honeybee venom, histamine or lidocaine
• history of asthma
• any clinically significant ECG abnormalities
• any clinically significant laboratory values OOR
• history of drug or alcohol abuse
• history of joint injury and forms of inflammatory arthritis