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the 26 patients have died yet for statisticians to calculate the median survival time for patients on this study. But patients on the low-dose group appear to be living about the same amount of time as patients on the Bayer/Onyx drug, and there is a statistically significant advantage for those on the high dose of the Jennerex treatment, according to an interim analysis of the data, Kirn says.
The traditional way to visualize the trend of a cancer survival trial over time—expressed through what’s known as a Kaplan-Meier curve—shows a “striking advantage” for the Jennerex high dose group, compared with the low-dose, and historical studies of patients on other therapies, Kirn says.
Researchers have seen a safety profile consistent with what was observed in earlier clinical trials, Kirn says. Since the drug is designed to partly work by fighting tumor-feeding blood vessels, I asked whether Jennerex has seen any serious side effects, like bleeding episodes, which have been observed with another drug that works to choke off blood flow to tumors—Genentech’s bevacizumab (Avastin).
“We haven’t seen it to date,” Kirn says. “It’s something we watch for very carefully. To date (JX-594) has been extremely selective to the tumor.”
Any time a study this small shows a provocative early result, researchers naturally want to see if it can be confirmed as the real thing in a much larger study. Jennerex’s plan is to complete enrollment in the small study early this year, continue to follow the patients, and hopefully present more statistically mature, detailed results at the American Association for the Study of Liver Diseases meeting in November in San Francisco, Kirn says.
Before that, Jennerex hopes to charge ahead with a Phase 2b study in relapsed, treatment-resistant liver cancer patients, which could be considered a pivotal study in the eyes of the FDA, providing the basis for the drug to be sold in the U.S., Kirn says. That bigger study should get underway in mid-2011, followed by another pivotal study in newly-diagnosed patients, which could get underway in the first half of 2012.
Jennerex presented some of this early data in private meetings with investors at the JP Morgan Healthcare Conference last month in San Francisco, but awareness really took off after Amgen wrote its big check for BioVex on January 24th. Like anything in biotech, the nanosecond some new technology gets validation, investor instinct is to look for companies with similar technology that can essentially be found on the bargain basement rack. So a lot of people suddenly started paying attention to Jennerex and oncolytic virus technology.
“We have always believed very strongly that this was a breakthrough platform for cancer, but have we gotten more calls from bankers and investors since the BioVex news? Yes,” Kirn says. “It does give some sense of the importance of this technology to the outside world.”
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