Sangamo Sinks On Interim Data
Lisa LaMotta, 06.06.08, 1:30 PM ET
Nothing could silence the outcries from Sangamo Biosciences shareholders on Friday when the company announced that it is adding patients and increasing the dosing schedule for its on-going phase 2 study of its diabetic neuropathy drug.
While Sangamo Biosciences chief medical officer Dale Ando called the data "encouraging," investors and analysts saw the shift in the study as a step back. Shares of the Richmond, Calif.-based company dropped 17.3%, or $1.89, to $9.16 in early-afternoon trading on Friday.
SB-509 treats the lower-leg nerve damage caused by diabetes. Diabetic neuropathy affects 10 million people in the U.S. and is the cause of at least 70% of the 100,000 amputations performed each year.
Current treatment options are painkillers and antidepressants; no drugs are approved to reverse the nerve damage that occurs when blood glucose levels remain too high for an extended period, but the condition can be reversed if patients control their blood glucose levels.
"Our initial review of data from SB-509-701, while preliminary, was quite encouraging," stated Ando. "Because of the definitive nature of the endpoint in this trial--recovery of nerve conduction velocity or NCV--these additional data may provide important information which could potentially expedite a Phase 3 study."
The company is increasing the number of patients in the study to 90 from 45 and will now dose all patients three times instead of twice.
"The NCV endpoint was not statistically significant in mild-to moderate diabetic neuropathy in Phase 1, and this endpoint must have appeared farther away at the Phase 2 moderate-to-severe DN interim than Sangamo expected," said Brean Murray Carret analyst Jonathan Aschoff in a note to clients. "We expect similarly underwhelming results from Sangamo’s 110-patient Phase 2 mild-to-moderate diabetic neuropathy trial to come in the fourth quarter of 2008, but with the final moderate-to-severe diabetic neuropathy Phase 2 result now delayed, we do not expect this result until perhaps late 2009. |
