A pivotal brain tumor clinical trial involving a cancer immunotherapy from Celldex Therapeutics (CLDX) is approaching a key decision point. As you'd expect, the outcome will have a volatile impact on Celldex's stock price, up or down.
Let's take a closer look at the hot issues and burning questions.
What is this key decision point involving Celldex's drug?
I'm referring to the phase III study of Celldex's cancer immunotherapy Rintega in patients with newly diagnosed glioblastoma multiforme, or GBM, an aggressive brain tumor. An interim survival analysis of the Rintega "ACT IV" study is being conducted right now. Celldex has said results of this interim analysis will be announced "early in 2016," which just about everyone interprets to mean during the first quarter, so very soon.
Why is an interim analysis of the Rintega clinical trial so important? Won't we have to wait for final results to really know if the drug is working?
Rintega is the most advanced drug in Celldex's pipeline, so the outcome of the ACT IV study is a big deal for the company. Success, defined as a statistically significant survival benefit, means an FDA submission and a good shot at approval. Failure means back to the drawing board.
Independent monitors are conducting the interim analysis of the Rintega study after 75% of the patient deaths required to conduct the final analysis have already taken place. That's usually (but not always) deep enough into a study to determine whether a drug is benefiting patients or not.
Celldex's stock price has dropped by almost 40% since the beginning of the year. What are investors telling you about their expectations for the Rintega interim analysis?
A couple things: Some of the health care investors I spoke with this week regarding Celldex tell me they're gun shy about getting involved in any stock with a risky clinical trial catalyst. This risk-averse attitude reflects the current biotech bear market we're experiencing.
I've also talked to investors this week who are shorting Celldex on the belief that the interim analysis will come back with a negative result. They're betting on two outcomes. The first: Study monitors determine Rintega is futile, meaning the drug has no chance of demonstrating a survival benefit for GBM patients. Obviously, that's really bad news for Celldex. The second: Study monitors tell Celldex to continue the Rintega study through to the final analysis.