RA drug that caused 'elephant man' side effect gets another chance
- Since 2006, when the investigational TGN1412 led to elephant man-like side effects during testing for rheumatoid arthritis (RA), researchers have changed the drug's dosing protocol and it's getting another chance in preclinical research, Reuters reports.
- TGN1412 was originally owned by Germany-based TeGenero, which went out of business after the side-effect debacle. Now it is owned by a German-Russian start-up company, TheraMAB LLC.
- The side effects of TGN1412 in 2006 were horrific, and included lost fingertips and toes.
In 2006, six healthy volunteers in London were hospitalized after being tested with TGN1412. Fortunately, no one died.
Since then, the drug has been tested by researchers in test tubes and dosing protocols have been modified and the drug has been re-dubbed TAB08. TAB08 is a CD28 superagonst, which activates regulatory T-cells in the immune system.
As researchers move forward with preclinical research and start planning clinical trials, they are using doses of TAB08 that are 10 to 20 times smaller than the original dosing used in 2006. Currently, TheraMAB is looking for larger pharmaceutical partners to move forward with R&D.