Argos Therapeutics Inc. (ARGS) got a nasty surprise on Wednesday when an independent data monitoring committee (DMC) concluded that its lead candidate, rocapuldencel-T, may not be able to achieve the primary endpoints in an ongoing Phase 3 clinical trial.
The interim data from the ongoing trial indicates that Argos' drug rocapuldencel-T, in combination with the standard therapy of Pfizer Inc.'s (PFE) Sutent (sunitinib), didn't result in any statistically significant improvement in overall survival (OS) in patients with metastatic renal cell carcinoma as compared to sunitinib alone. OS is the duration of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Recommends Trial Be Discontinued
Based on the observation of the interim data from the study, the IDMC concluded that the drug is likely to miss the desired results, and recommended that the trials be discontinued.
For the time being, the Durham, North Carolina-based Argos has decided to keep the trial open while it performs the necessary data review and looks forward to having discussions with the Food And Drug Administration (FDA) before taking a call on the drug program.
"Following our data analysis and these discussions, we expect to make a determination as to the next steps for the company and for the rocapuldencel-T clinical program," said Jeff Abbey, CEO of Argos Therapeutics.
Last month, the company announced expansion of its operations by leasing out 40,000 square feet of space at the N.C. State University’s Centennial Campus, where it planned to invest $10 million and create 70 new jobs over the next few years.
While it is unclear if rocapuldencel-T news will affect its expansion plans, the market reacted sharply to the development. Argos share price tanked by 67% to close at $1.48 per share on Wednesday. (See also: Top Cancer Drugs with High Future Sales Potential.)