It wasn’t too long ago that OncoGenex Pharmaceuticals had high hopes that a drug called custirsen might make a big impact on the fast-moving treatment landscape for prostate cancer. A couple of failed trials later, however, the Bothell, WA, company has now hired a financial advisor to see if it still has a path forward.
OncoGenex (NASDAQ: OGXI) said this morning that custirsen has failed the second of three late-stage trials in prostate cancer. This time, in a study called Affinity, custirsen, when combined with the steroid prednisone and the chemotherapy cabazitaxel, didn’t help extend the lives of prostate cancer patients who had already failed a round of chemo. In 2014, custirsen failed a trial in newly diagnosed prostate cancer patients.
OncoGenex has one other ongoing trial called Enspirit, which tests custirsen in non-small cell lung cancer patients who haven’t responded to chemo. Enrollment in that trial is almost complete. But given custirsen has failed two studies already, the company plans to ask the FDA about getting an early analysis of the data, rather than finishing the trial as originally planned.
As of this writing, the company’s stock was down 41 percent, to 53 cents per share, in pre-market trading Tuesday.
Shares of OncoGenex already traded in penny stock territory prior to today’s announcement, a reflection of how far the company has fallen in the past few years. OncoGenex charged into a slate of late-stage trials of custirsen on some promising data from a mid-stage study and the belief in the way the drug is supposed to work. Unlike other prostate cancer drugs, custirsen is genetically engineered to block RNA that creates the protein clusterin. That protein is thought to serve as a defense mechanism tumors use to resist chemotherapy, so OncoGenex has been trying to show that disabling it with a drug could make chemotherapy like docetaxel more effective. At OncoGenex’s height in 2009, following custirsen’s successful Phase 2 trial, company shares were worth close to $40 apiece.
OncoGenex’s hypothesis on custirsen, however, has now failed twice. In the meantime, abiraterone (Zytiga, from Johnson & Johnson) and enzalutamide (Xtandi, Medivation and Astellas Pharma) have become mainstay treatments for prostate cancer.
“We are obviously disappointed that custirsen was unable to demonstrate a survival benefit in prostate cancer,” OncoGenex president and CEO Scott Cormack said in a prepared statement. “We would like to thank the patients who participated in the Affinity trial and their caregivers, as well as the investigators and their teams for their commitment to improving cancer care for patients who are in desperate need of new treatment options.”
OncoGenex is holding a conference call this morning to discuss the news. Here’s more on the history of the company and custirsen.