OncoGenex Drug Helps Prostate Cancer Patients Live Longer in Small Study

OncoGenex Pharmaceuticals’ stock has busted out from obscurity in the past couple of weeks, and today it’s showing what the fuss is all about. The Bothell, WA-based biotech company (NASDAQ: OGXI) is reporting that its experimental prostate cancer drug was able to help men live longer in a small clinical trial, a finding which suggests it may have the potential to be as good or better than the more heralded new drug coming soon from Seattle-based Dendreon.

OncoGenex’s experimental drug, OGX-011, when tested in combination with docetaxel chemotherapy, was able to help patients live a median time of 23.8 months with terminal forms of prostate cancer. That survival time is about 6.9 months better than patients who got docetaxel by itself, the current standard of care, researchers are reporting today at the American Society of Clinical Oncology meeting in Orlando, FL. Side effects included fever, chills, and reduced kidney function. The trial, which enrolled 82 patients, justifies taking this drug to the next step of a more rigorous pivotal trial, researchers said.

The company first trumpeted results from an earlier peek at the data back in December, which suggested the survival benefit advantage for the OncoGenex drug might even be better, at 10.6 months. That finding sent OncoGenex (NASDAQ: OGXI) stock up three-fold from a little over $2 to more than $6 in one week. Trading volume rocketed from 3,100 shares the day before the news to more than 570,700 when it first hit the wires. Even more investors began to discover this little stock after Rodman & Renshaw analyst Simos Simeonidis called it “one of ASCO’s sleeper hits” in a note to clients May 15. That helped give OncoGenex a second wind heading into the cancer confab this weekend, driving it up to $17.65 at Friday’s close.

If this kind of survival benefit can be confirmed in pivotal clinical trials, OncoGenex could reach a big market of patients in need, and tap a lucrative market. About 30,000 men die from prostate cancer in the U.S. each year, according to the American Cancer Society. The standard of care for patients in the final stages is Sanofi-Aventis’ docetaxel (Taxotere), which was approved by the FDA after it showed it could boost median survival times by just 2.4 months. Seattle-based Dendreon recently made waves in the prostate cancer field when its immune-boosting therapy, sipuleucel-T, showed it could improve survival times by a median of 4.1 months, with minimal side effects—a combination that analysts predict will make it $1 billion a year hit. So OncoGenex could also be in strong position if it can duplicate a 6.9 month survival advantage in a bigger trial.

“This is a remarkable result in every context,” says Scott Cormack, OncoGenex’s CEO. Kim Nguyen Chi, an oncologist at BC Cancer Agency in Vancouver, and a principal investigator on the study, said the finding justifies advancing the OncoGenex drug to the final stage of development. The survival edge “would represent a significant improvement” over current chemo, he said in a company statement.

Besides doctors and patients, this drug also has significant interest among scientists. The drug has its origins in work done by Martin Gleave, a urologist at the Prostate Centre Vancouver General Hospital. His idea was that if you could block clusterin, a protein associated with helping tumors resist chemotherapy, then the chemo would do a lot better job of killing cancer cells. OncoGenex negotiated for a license from Carlsbad, CA-based Isis Pharmaceuticals to develop an antisense drug that would provide specific strands of RNA that would shut down production of clusterin. The drug is given in a 2-hour intravenous infusion once a week.

There’s sure to be plenty of parsing through this data set this weekend, as people dive deep into the statistics to see if the effect is real. One of the key stats people will look at is the hazard ratio of patients who got OGX-011, which essentially says that patients had a 39 percent lower risk of death during the 32-month study than if they got the chemotherapy alone. This finding is stronger than Dendreon’s hazard ratio from its most recent trial, which suggested a 22.5 percent lower risk of death for patients taking Provenge.

Of course, the Dendreon trial was from 512 men, and is a more rigorous kind of trial that can be the basis of an FDA approval. OncoGenex is planning to run a pair of pivotal clinical trials enrolling a combined 1,100 patients, but it will need help from a bigger partner, or will have to tap the capital markets to get enough money to pay for them, Cormack says. As it stands now, OncoGenex has enough cash to run until February. So Cormack, as you might imagine, has been a pretty busy guy trying to get all the support needed to take this drug to the next level.

“I may well fall over,” Cormack said, as I caught him on his cell phone during a layover in the Denver airport before the meeting. “I don’t think I’ve run so fast in my life. It’s going at sprint pace, and it feels like I’ve been doing it at that pace for a full marathon.”

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