We have previously criticized Celsion (NASDAQ:CLSN) for attempting to mislead investors by highlighting subgroups and trumpeting subgroup analysis that fails to reach statistical significance. Unfortunately, the Company still hasn't gotten straight with its investors, as evidenced by this morning's press release, which appears to have at least two potential problems with the data that is presented.
1. Celsion Reports Data from Only 47% of Enrolled Patients
Celsion would like investors to believe that Thermodox is a promising treatment for recurrent breast cancer at the chest wall and the Company highlights that "Clinically meaningful responses were reported in 14 of the 23 evaluable patients." While this may seem like an impressive 61% response rate, the truth is that the 23 evaluable patients are a minority subset of the 49 patients that were enrolled between the two trials. As can be seen here, the trial at Duke enrolled 29 patients and as can be seen here, the DIGNITY trial enrolled 20 patients. Between the two trials, 49 patients were enrolled. This is the intent to treat population and is almost always the population across which clinical results are measured. Celsion, however, decided to narrow the population to only 23 patients (47% of the intent to treat population) and to evaluate this subset. This type of data mining tends to produce positively skewed results and cannot be seen as meaningful.
2. Celsion Makes Up a New Metric
As a second point, we would note that Celsion is pointing investors to "clinically meaningful responses," without defining for people what this means. Many outcomes in cancer trials, such as Objective Response Rate, Overall Survival, and Progression Free Survival have well defined meanings such that further explanation to investors is unnecessary. Unfortunately, this is not the case for the term "clinically meaningful responses," and we are left to wonder what exactly this means. In most Phase I trials that report on an outcome rather than simply on safety and dosing, Objective Response Rate is measured, because this can be observed more quickly than either Overall Survival or Progression Free Survival. Objective Response Rate measures the percent of patients who experience either a partial response or complete response to treatment. As previously mentioned, this is best measured over the entire trial population (the intent to treat population). By providing investors with an alternative and undefined endpoint (clinically meaningful responses) over a subset of the trial population, Celsion simply leaves people guessing regarding the actual benefits seen in the trial, if any.
While we see a number of issues with Celsion's press release this morning, it would be too harsh to call this a failure. Instead, we simply see this as incomplete and largely irrelevant information - results measured against an undefined endpoint in a modified intent to treat population. In our opinion, there's nothing exciting here. We look forward to seeing the full trial data so that we can evaluate it at that time. We remain short Celsion's stock and our price target remains $0.68 per share.
Disclosure: I am short CLSN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.