ABOVE: IMMU’s Stock Chart.
Immunomedics, Inc. (Nasdaq: IMMU) announced that veltuzumab mounted a comparatively high complete response rate of 27% in patients with follicular lymphoma, and that such results were achieved even when given at doses about 75% lower than rituximab’s (a rival agent) approved dose.
The results were obtained from an open-label (non-randomized, not blinded), multi-center, Phase II Clinical trial in which 82 adult patients with Non-Hodgkin’s Lymphoma (NHL), most of whom had relapsed after prior therapies.
I have engaged in scientific research throughout my career in medicine. As well, I am an American trained physician that practices medicine and has also engaged in clinical research. Although this study seems impressive, in my opinion, it is not.
IMMU may very well have a good therapeutic premise in developing therapeutic antibodies. In addition, veltuzumab may prove to be an effective treatment for lymphoma but this study does not prove it. First of all, this study is open label and not “blind”. In an open label (not blind, non-randomized) study the people that are administering the drug know that it is an experimental agent. Open label studies induce bias because the personnel that are giving the drug may act differentially than they might act if they were dispensing a placebo. Moreover, the fact that many of the study subjects were previously treated brings in the question what is being tested? Are you testing the response of veltuzumab in treating lymphoma or are you testing the response that both agents have on lymphoma? Is there a cross reaction or a temporal relationship that allows veltuzumab to be more effective after a patient has been treated with rituxmab?
I would continue to watch this stock for upcoming results on Phase III, randomized, clinical trials before assuming that Veltuzumab will increase IMMU’s bottom line.
