Being treated with SB-509 isn't easy. The drug requires 20-30 injections in each leg per treatment. Results from two prior phase II studies in diabetic neuropathy have been mixed, with most of the favorable or positive data generated by combining the two studies and slicing and dicing retrospective and prospectively defined endpoints.
Sangamo has presented data at medical meetings correlating treatment with SB-509 to improvements in nerve fiber density and nerve fiber health. But these biologic measurements did not translate into significant or meaningful improvements in the "real world" clinical symptoms of diabetic neuropathy, particularly in patients with mild to moderate forms of the disease. Sangamo thinks SB-509 may have a stronger, positive effect on severe disease patients, so it restricted enrollment to these patients in the ongoing phase IIb study.
@chodems tweets, "@adamfeuerstein thoughts on the $vvus announcement re birth defects? They could actually have something here. Shock they haven't been bought"
I'm not as concerned about the risk of birth defects associated with Vivus' (VVUS) obesity drug Qnexa. The bigger risk -- not necessarily reflected in Vivus' stock price today -- is the FDA telling Vivus that Qnexa cannot be approved until the company conducts a cardiovascular outcomes study.
The Vivus bulls believe the FDA has already found Qnexa's heart-safety profile to be copacetic because no mention or request of cardiovascular safety issues were raised in the agency's letter rejecting Qnexa's approval last October. The only "approvability" issue raised by FDA, according to Vivus, was the possibility that the topiramate component of Qnexa could cause cleft lips or other malformations in babies born to women taking Qnexa while pregnant.On Wednesday, Vivus reported data from a retrospective observational study showing no risk of birth defects associated with topiramate use. Vivus is in the midst of conducting a second and larger safety observational safety study to examine the same birth defect issue. Results from this second study, dubbed "Fortress," are expected in the fourth quarter. If positive, Vivus plans to resubmit Qnexa to the FDA for a second shot at approval. My prediction: Fortress will come benign clean for birth defect risk. Vivus will resubmit Qnexa to the FDA. In early 2012, the FDA is convening a general advisory committee meeting to discuss cardiovascular safety and analysis of obesity drug candidates. [An exact date has not been set, but we know the meeting is planned because it was disclosed by Orexigen Therapeutics (OREX).]
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