Replies to post #96639 on Biotech Values

[dewophile]

zgen

Is the prospect of positive "ipi" results adversely affecting ZGEN or is there some other reason for this sharp drop in share price?

i don't think many people put much value on il-21 so i find it hard to believe upcoming data for competing compounds is really the cause of this drop - that said the timing near ASCO can't be ignored. the only way il-21 affects valuation imo is if zgen puts too much money into the program - i know the 2b is done with NCI canada and is relatively modest in size so i don't think it's money poorly spent, but perhaps others do

more likely the drop has to do with the significantly relaxed regulatory climate surrounding combination studies for HCV. this shortens the time frame for all oral cocktails to reach approval, assuming this is feasible. BMY is the first to come out with data from their trial at AASLD - it could hurt zgen if the non-inf arm does well, although the converse is also true and zgen could get a bump if the inf arm does better. of course bmy won't have svr data until next year, and relapses may very well be the reason why soc proves necessary so it won't exactly be game over for lamda even if the BMY non-inf data (evr, etc.) are strong

[iwfal]

Ipilimumab results in melanoma:

http://www.usatoday.com/news/health/2010-06-07-melanoma07_ST_N.htm

An experimental immune therapy may provide a new way to fight advanced melanoma, a devastating cancer that often kills patients within six months.
In a study of two novel treatments — a therapeutic vaccine called gp100 and an immune stimulator called ipilimumab — doctors found that ipilimumab nearly doubled the number of patients who survived one year, according to a study presented Saturday at the American Society of Clinical Oncology. About 25% of those given the vaccine lived one year, compared to 46% of those given ipilimumab.
Patients who received the vaccine lived a median of 6 months. Those given either ipilimumab alone or a combination of the two drugs lived about 10 months, according to the study of 670 patients, funded by Medarex Inc., which developed ipilimumab.

Doctors say that even modest success is reason for hope in this disease. Ipilimumab is the first drug to improve advanced melanoma patients' survival in a large, definitive trial, says study author Steven O'Day, director of melanoma research at The Angeles Clinic and Research Institute in Santa Monica, Calif.

Ipilimumab works by harnessing the immune system's power to fight cancer, says Lynn Schuchter, chief of hematology and oncology at the University of Pennsylvania's Abramson Cancer Center, who has used the drug with her patients. The drug "turns off the brakes" on key disease fighters called T-cells, Schuchter says.

But revving up the immune system can cause the body to attack healthy tissue, as well, O'Day says. In his study, those who got the most benefit from the drug were also the most likely to develop autoimmune problems.

About two-thirds of patients developed side effects such as skin rashes, diarrhea, thyroid imbalances or hepatitis. Although most complications were manageable with medication, 10% to 15% of side effects were severe.

About 1.5% of patients given ipilimumab died from the treatment, mostly because of intestinal perforations, O'Day says.

My only added commentary is that with a normal event count (about 75% of patients enrolled) the HR implied by the above numbers gives a very very low p value.