Celebrex - New Arthritis Drug (cont.)
Dr. Isakson: Celebrex is specifically indicated for the treatment of osteoarthritis and rheumatoid arthritis. There currently is no data to support the use of Celebrex for other conditions. Nevertheless, we do have trials, either ongoing or soon to begin, in other potential uses, for example in back pain and sprains and strains.
MedicineNet: Because of the pharmacology of Celebrex, there might theoretically be a potential for use of Celebrex in Alzheimer's disease and colon cancer prevention. Any comments?
Dr. Isakson: Sure. One of the most exciting aspects of working on this whole COX-2 inhibitor program has been seeing it evolve from treating the signs and symptoms of arthritis and then seeing it broaden out into other areas as we have gained a better understanding of actually what the nonsteroidals do. There is a very compelling case for COX-2 being involved in treating colon polyps and eventually colon cancer, and this, of course, is a very serious disease and a major medical issue. There is very good epidemiological evidence that the nonsteroidals can reduce the occurrence of colon cancer by 40 or 50%. We have had a very active program in the research area, the preclinical animal model area, the results of which supported the notion that a drug such as Celebrex, a selective COX-2 inhibitor, might have some utility there. And we're just in the process of completing our first clinical trial in a patient population that is highly susceptible to developing colon polyps. We will know the results of that study fairly soon. Assuming the outcome will be positive, we'll be potentially moving into other areas of colon polyp prevention.
We also have a program for Alzheimer's where there is somewhat less compelling but nevertheless extremely interesting epidemiological data that suggests that nonsteroidals, the Aspirin-like drugs, might have a role in retarding the progression of Alzheimer's. The animal model data is harder to get, there are no good animal models, so we went directly into a clinical trial, which is moving along very well. We should know, probably by the end of the year, whether or not the concept of using Celebrex in the treatment of Alzheimer's has some merit. And if it does, that would clearly be another important advance and potential use of this class of drugs.
MedicineNet: In terms of effectiveness rate (efficacy), does Celebrex have advantages over other nonsteroidal anti-inflammatory drugs currently on the market?
Dr. Isakson: The data that we have obtained in our extensive arthritis trials, both for rheumatoid arthritis and osteoarthritis, suggests that the basic efficacy of a selective compound like Celebrex is roughly the same as the best NSAIDs, for example, naproxen. Our original hypothesis was that NSAIDs, in fact, are COX-2 inhibitors, and a specific COX-2 inhibitor, then, should have the same spectrum of antiarthritic activity as the NSAIDs, just without the side effects. In terms of the overall effectiveness for a patient, that may turn out to be different, because the side effect profile clearly affects the overall use of the drug and its effectiveness. Therefore, if you look more at how the patient overall is able to tolerate the drug and function in their daily life, there is certainly the potential for Celebrex to have an advantage over other NSAIDs.