There’s some aggressive jockeying going on in the prostate cancer market, and today Vancouver, BC and Bothell, WA-based OncoGenex Pharmaceuticals made some moves that it hopes will keep its lead horse in the race.
OncoGenex (NASDAQ: OGXI) and its partner Teva Pharmaceutical said today they are expanding one pivotal-stage clinical trial for men with prostate cancer, dropping another, and starting a newly designed trial that will seek to differentiate its experimental drug called custirsen.
The new trial, of 630 men, will look to see whether getting their second round of chemotherapy can live longer on a combo of custirsen and Sanofi’s cabazitaxel (Jevtana). That study will replace a trial known as Saturn, which struggled to recruit the 300 patients it had been seeking, and which was supposed to answer a different question, about whether custersin can relieve cancer-related pain. The other major OncoGenex/Teva trial, called Synergy, is expanding its enrollment goal from 800 to 1,000 patients to give the companies a bigger body of evidence they believe is needed to secure FDA approval for the drug.
By making these clinical moves, OncoGenex and Teva are agreeing to spend more money on developing the new drug, to give it the best chance to find a niche in a marketplace filled with aggressive contenders from Seattle-based Dendreon (NASDAQ: DNDN), New Brunswick, NJ-based Johnson & Johnson (NYSE: JNJ), San Francisco-based Medivation (NASDAQ: MDVN), and South San Francisco-based Exelixis (NASDAQ: EXEL). Each of those products has their own profile. Dendreon’s is an immune-booster aiming to treat patients before they get chemotherapy. J&J and Medivation have oral pills that are moving to treat that same group of patients, as well as sicker patients who previously got chemotherapy. Exelixis is hoping to distinguish its drug as the one that best relieves the excruciating pain that comes when prostate cancer migrates to the bones.
OncoGenex’s bet is essentially to try to help some of the sickest patients with prostate cancer, by helping them live longer, while many of the others duke it out in different segments of the prostate cancer market. About 30,000 men in the U.S. die of prostate cancer each year.
“I think there’s going to be a really important need for an agent like custirsen to improve on chemotherapy as the other agents migrate to the pre-chemotherapy setting,” OncoGenex CEO Scott Cormack said today on a conference call with analysts.
OncoGenex and Teva began collaborating back in December 2009 on the plan to co-develop custirsen as a new treatment for advanced prostate cancer. The OncoGenex drug is designed to work differently than the others, as it is genetically engineered to block RNA that gives rise to a protein called clusterin, which is thought to help tumors resist chemotherapy. When given in combination with chemotherapy in a small study of 82 men, the OncoGenex drug helped men with terminal prostate cancer live a median of 23.8 months, about 6.9 months longer than they did on chemo alone, according to data presented at the American Society of Clinical Oncology’s annual meeting in 2009.
OncoGenex’s best hopes to confirm that benefit hinge largely on the new Phase III study, as well as the ongoing Phase III study known as Synergy. The Synergy study will enroll 1,000 patients with prostate cancer who no longer respond to standard chemical castration treatment, and are opting to go to the next stage, by getting chemotherapy. The new 630-patient study, which OncoGenex didn’t name in today’s announcement, will enroll an even sicker patient population—those whose disease not only fails to respond to chemical castration, but has also worsened after the initial round of chemotherapy.
Even though the Synergy trial is growing from 800 to 1,000 patients, the company said it still expects to hit its prior deadline, by finishing enrollment by the end of 2012. That trial, designed to measure survival time, is expected to generate results by the fourth quarter of 2013, the company said.
Revamping the trials will cost OncoGenex and Teva more money. While OncoGenex didn’t disclose the budget of these trials, finance chief Michelle Burris said OncoGenex expects to burn more cash in 2012 than it had previously forecast. The company entered this year with $65 million of cash and investments in the bank, and expects to end the year with $20 million to $25 million. That should still be enough money left for OncoGenex to operate into 2014, because of the way its collaboration is structured with Teva, Burris said.
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