HOUSTON (TheStreet) -- The prestigious MD Anderson Cancer Center issued a stern rebuke to Northwest Biotherapeutics (NWBO) for making promotional, unjustified claims about results from an ongoing clinical trial of an experimental cancer vaccine known as DCVax-Direct.
"I have read the information that the company has put in the public domain. It is extremely unusual and inappropriate," said Dr. Aman Buzdar, vice president of clinical research at MD Anderson, a unit of the University of Texas system. Buzdar, an oncologist by training, spoke by phone about Northwest Bio on Wednesday.
MD Anderson is running the DCVax-Direct phase I/II clinical trial with funding from Northwest Bio, which makes the hospital's criticism of the company's tactics even more significant.
Northwest Bio has issued five press releases and held a conference call in the past month to disclose preliminary and unconfirmed results from individual cancer patients who have had single, inoperable tumors injected repeatedly with DCVax-Direct. Some of the injected tumors have reportedly shrunk, while others have no evidence of live cancer cells present, Northwest Bio claims. [None of the treated tumors have responded to DCVax-Direct using standard definitions used in clinical trials.]But Buzdar said investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all because patients are still being enrolled and treated. The statements being made by Northwest Bio about DCVax-Direct are derived from patient case report forms, which the hospitals are obliged to send to the company because it sponsored the study. "If you flip the coin and the trial results were negative, do you think the company would be disclosing this type of information? No, the company is trying to create tremendous hype about its product, which is very concerning to me as an academic oncologist," said Buzdar. "A patient or an investor may read these press releases and see a rosy picture, which may not be so rosy when the entire dataset is analyzed," he added. DCVax-Direct is a so-called personalized cancer vaccine consisting of dendritic cells harvested from a patient's white blood cells. The harvested dendritic cells are then re-injected directly into the tumor, where they are supposed to prime the patient's immune system to identify and kill cancer cells. "The weakness of this approach is that there have been many studies in which tumors are injected locally -- the injections could consist of anything -- and you see tumor regression because of necrosis caused by inflammation," said Buzdar. "But it is a tremendous leap to say that this is a real response, which is why what the company is saying is so inappropriate." Does MD Anderson plan to file a formal complaint against Northwest Bio, or ask the company to stop making claims about the DCVax-Direct study? Buzdar: "That is a very good question, but I don't know because I've never come across a company that has done something like this before."
-- Reported by Adam Feuerstein in Boston.
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