Argos Therapeutics Inc (NASDAQ:ARGS) has recently been the target of a class action lawsuit, initiated by several independent law firms. The complaint alleges that the company issued false and misleading statements, regarding its ongoing phase-3 ADAPT trial. The study is aimed at testing AGS-003, as a treatment for metastatic renal cell carcinoma. The statement further alleges that the misleading announcements had caused the stock to surge dramatically, all of which was reversed when an independent committee recommended the discontinuation of the trial.
As per the lawsuits, shareholders of the company have until May 15, 2017, to take action against Argos, for their losses. Any shareholders that come forward would be appointed as lead plaintiff for the lawsuit. In a recent press release, ARGS released the interim results of the phase-3 study, as well as details of its perspective to continue with the trial. The company noted that it had enrolled a total of 462 patients in the trial, which was randomized 2:1, between two patient groups: a combination arm, which was administered a combination of sunitinib and Rocapuldencel-T and a control arm, which was administered a mono-therapy of sunitinib.
Argos further noted that the trial was evaluated by an independent data monitoring committee, in February 2017, after 75% of the company’s initial target of adverse events, 290, had occurred. The hazard ratio for the study stood at 1.1, which was greater than the pre-defined futility boundary of 0.98. The company claimed that this was why the committee recommended that the trial be discontinued for futility. However, ARGS has decided to continue with the trial and use the resultant data for further discussions with the FDA. Argos has stated that the decision was reached after extensive discussions with the principal investigators of the study, Robert Figlin MD and Christopher Wood MD. Moreover, the company also took into account the committee’s recommendation of the combination drugs safety profile.
Argos Therapeutics Inc (NASDAQ:ARGS) declined by 3.76%, during the April 28 trading session, to close at $0.43 per share.