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in its press release back in December whether the survival finding reached the FDA’s threshold to show it was statistically significant, and therefore unlikely to be due to chance. That threshold is a p-value of 0.05 or lower. The OGX-011 study, as you can see in this abstract, had a p-value higher than that, 0.07.
OncoGenex is hoping that investors and partners won’t be scared away by that uncertainty, pointing out that the study’s primary goal wasn’t to show improved survival times, and it is extremely difficult, in a mathematical sense, to achieve statistical significance in a small study of 82 patients, said Jason Spark, a spokesman for the company. Plus, this isn’t the final word on the study, because the abstract uses relatively old data from November, while the formal presentation at ASCO will provide more follow-up data needed for the final analysis—which may produce a different p-value, Spark says.
The drug is interesting to scientists because it uses “antisense” technology, essentially designed to serve like a genetic mirror image that shuts down the production of clusterin, a protein associated with helping tumors resist chemotherapy. The original work was done by Martin Gleave, a urologist at the Prostate Centre Vancouver General Hospital. OncoGenex hopes the ASCO presentation will generate enough interest from potential partners, and investors, to raise enough money to complete a pair of pivotal clinical trials, with more than 700 men, which it will need to win FDA approval of the product.
—Cell Therapeutics (NASDAQ: CTIC) will present data on its experimental drug for non-Hodgkin’s lymphoma, pixantrone. Nothing much new appears in the abstract—the Seattle-based company repeated that a study called PIX-301 of 140 patients found that 20 percent of those randomly assigned to get the drug had their tumors completely disappear, compared with 5.7 percent who did that well in a control group. These patients were quite sick, having failed to respond to at least two prior rounds of therapy.
Pixantrone is modified to be less toxic to the heart than other drugs in the anthracycline class of chemotherapies. The trial was originally designed to enroll 320 patients, but was cut down to 140 because of slow enrollment. The company disclosed in its annual report that there were more “severe cardiac events” among patients who got the drug, than in the control group.
—Calistoga Pharmaceuticals, the Seattle-based biotech company that raised $30 million in venture funding this month, will offer an early peek at its cancer drug data at ASCO.
The company’s drug, CAL-101, is made to block a target on cells known as the PI3 kinase that controls tumor formation and metabolism, and is one of the hottest in cancer biology at the moment. Preliminary data to be presented at ASCO shows that six patients got the drug, an oral pill, twice a day at low doses for relapsed forms of chronic lymphocytic leukemia or select types of non-Hodgkin’s lymphoma. Two of the six patients had at least partial tumor shrinkage, and the other four had their tumors stabilize, researchers said. No moderate or severe side effects were reported, researchers said. More updated data will be available at the meeting.
A study of eight patients with liver cancer tested the company’s Litx therapy, in which patients get an inert small-molecule drug, talaporfin sodium, that is activated when a doctor sticks a catheter with a light emitting diode into a tumor. One of the eight patients had their tumors completely disappear after the procedure, another five had their disease stabilize, and two had their tumors spread. There were no moderate or severe adverse events in the study, researchers said. This finding will have to be reproduced in a larger, pivotal trial that is nearing completion, researchers said.
—Alder Biopharmaceuticals, a Bothell, WA-based company that seeks to make better antibody drugs in yeast, presented some Phase I clinical trial data on ALD518 for patients with advanced cancer. This drug is also being developed as a treatment for rheumatoid arthritis.
The drug, which is made to hit a target on cells called IL-6, is being developed to block excess inflammatory cells that contribute to extreme fatigue in cancer patients, and muscle atrophy known as cachexia. The study of nine patients looked at an intravenous infusion of the Alder drug at three different doses. Just five of the patients completed all the visits called for by the study protocol, while three withdrew as their tumors worsened. There were no severe side effects reported, and the drug was able to reverse fatigue in this small study, researchers said.