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circumstances, these proteins play a major role in transporting another kind of protein called antigens within a cell (and thus they have an even more colorful nickname, chaperones) Antigens, for their part, stimulate the body s immune system to respond to infection or disease In theory, you could extract and purify the heat-shock proteins that had chaperoned an antigen that stimulated a response to a certain cancer Then the extracted heat-shock proteins could be made into a vaccine that would contain some trace of that specific antigen and its cancer the antigenic fingerprint of that cancer If a patient got that vaccine, unique to his or her cancer, the immune system might be reprogrammed to home in on cancer cells bearing the antigenic fingerprint It would not prevent anyone from getting cancer, but it could stop the cancer from spreading That was the theory, anyway.



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A number of universities and research institutes in the United States and Europe were also studying the heatshock protein process, and so far the buzz about Antigenics among scientists and on Wall Street was cautiously positive The vaccine, which was called Oncophage, had already proved itself in animal experiments, in tests for safety, and even in the first stage of clinical trials on cancer patients A trial of colorectal cancer patients had just reported some good news about survival rates Now 650 people with kidney cancer and 350 with skin cancer were participating in further tests at more than 130 sites around the world As soon as doctors removed a patient s tumor, the specimen was frozen in dry ice and rushed to Antigenics labs in Woburn and Lexington, Massachusetts, both near Boston.





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Where a new observation can be applied to more than one model, some method for consolidating these potentially con icting results will need to be established A popular choice is often a voting scheme where the majority wins or the mean response for continuous variables In addition to building different models based on different criteria, multiple models may be built using different methods Each model will provide a prediction and from these individual model predictions a nal prediction may be calculated that is some function of these individual values Techniques referred to as Bagging and Boosting can be used to accomplish this and further information on these methods is described in the further reading section of this chapter Once a model has been built, a useful exercise is to look at the observations that were not correctly predicted.

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There, scientists had 24 hours in which to extract the heat-shock proteins they needed a minimum of seven grams of tumor and process them into a vaccine For the next three weeks the vaccines were tested for purity, sterility, and composition Finally, at least four vials were flown back to each patient and injected one a week for four weeks, then biweekly The stuff looked like a small glass of Sprite Of course, these were only tests Oncophage was still far from being a safe, workable drug, let alone a cure for cancer The Antigenics scientists figured they would need at least two more years of clinical testing, checking to see if the cancer had spread, before they would be ready to seek official FDA approval So there really wasn t much reason to be hanging out at the FDA s headquarters in Rockville.

But Antigenics had requested this special meeting because a problem had cropped up The FDA had recently reorganized Some 200 reviewers who specialized in protein-based drugs, including staffers who had been.

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