Prostate Cancer Drug Vaults OncoGenex Onto Investor Radar Screens

12/16/08Follow @xconomy

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but by the National Cancer Institute of Canada, and was supported with a grant from the Canadian Cancer Society. A fuller picture of the data is expected to be presented at the American Society of Clinical Oncology (ASCO) 2009 meeting in Orlando.

This 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 Isis to develop an antisense drug that could serve as like a genetic mirror image that would shut down production of clusterin. The drug is given in a 2-hour intravenous infusion once a week.

The science and clinical trial results were a lot to absorb for most people on the Street, Cormack says. An earlier peek at the data was presented at the ASCO meeting in 2007 in Chicago. The trial showed it reached its main goal of lowering PSA scores, a measurement of tumor aggressiveness that’s thought to correlate with survival. It also showed that it could slow the spread of tumors, but again, that’s just a “surrogate” goal that’s supposed to give researchers a sense of whether the drug is reaching the gold standard measurement of prolonging lives.

Now that the survival data is pointing in the right direction, and it will be another six months before we get to see a full picture at ASCO, Cormack is getting peppered with questions about what comes next. He’s looking to sign a partnership to help him finish a pair of Phase III clinical trials of OGX-011. One has a primary goal of prolonging lives of men on a second round of chemotherapy for their terminal prostate cancer, and the other aims to relieve cancer-related pain.

The first survival trial will enroll about 765 patients randomly assigned to OGX-011 and docetaxel or docetaxel on its own. The second trial will enroll about 300 patients on the same head-to-head comparison. The total budget for these studies is about $70 million, and OncoGenex had $17 million in cash in the bank at the end of September, so that’s why Cormack needs to rustle up a partner, and fast.

The clinical development team responsible in carrying this out for OncoGenex has a couple of familiar names from Seattle-based Corixa. Cindy Jacobs is the company’s chief medical officer, and the vice president of regulatory affairs is Monica Krieger, who both played a part in getting tositumumab (Bexxar) approved by the FDA. The team is a lean one, with just 27 total employees between Vancouver, BC and Bothell. Cormack isn’t in either office a whole lot, spending more of his time in New York, Boston, and San Francisco in an effort to boost his company’s stock price.

Cormack notes that there aren’t many prostate cancer drug candidates in late-stage development, other than candidates from Seattle-based Dendreon, Los Angeles-based Cougar Biotechnology, London-based AstraZeneca, and San Francisco-based Medivation. Cougar Biotech, he notes, has a market valuation of more than $500 million, and doesn’t have data showing its drug boosts survival like Oncogenex’s. His company, meanwhile, has a stock market value of $33 million at Monday’s close.

For now, Cormack sounds like he’s content to let the “data speak for itself” rather than issue a press release with a bunch of bold quotes from leading cancer physicians. He wants to save the scoop for when it will have a bigger impact at next year’s ASCO meeting, the largest annual confab of cancer docs.

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  • Chris

    Great to hear a Seattle biotech success story. The writeup didn’t mention a key design issue, which is whether the randomized study was a blinded or open-label trial. Since an open-label study frequently introduces bias in study conduct, it is important to include this information in describing the study.