Contact: Pam Rasmussen (847) 470-6163
JUNE 26, 1996 -- Skokie, IL -- G. D. Searle of Skokie, IL, a wholly owned subsidiary of Monsanto Company (NYSE:MTC), announced today favorable results from recently completed Phase II trials for celecoxib (SC-58635), a highly selective COX-2 inhibitor being evaluated for the treatment of arthritis and related painful conditions.
In Phase II clinical trials involving patients, celecoxib was significantly superior to placebo in treating the signs and symptoms of both osteoarthritis and rheumatoid arthritis, while having an overall side effect profile comparable to placebo. In addition, in a double-blind study in healthy volunteers, celecoxib's gastrointestinal safety profile was comparable to placebo and significantly better than that of naproxen, a leading currently marketed non-steroidal anti-inflammatory drug (NSAID). Celecoxib has also been found not to inhibit platelet aggregation, which is a common problem with current NSAIDs.
"These early results indicate that celecoxib may be a medication that can relieve pain and inflammation without putting the patient at risk for gastrointestinal damage," said Philip Needleman, PhD, president of research and development for Searle and Monsanto's chief scientist. "Toxicity from NSAIDs -- resulting in life-threatening GI ulcers, bleeds and perforations -- is a serious concern when physicians prescribe these drugs. If it lives up to its promise, celecoxib could represent a significant advance in the treatment of arthritis and related painful conditions."
NSAIDs work by depleting the body of prostaglandins (PGs), substances that can cause pain and inflammation in the joints, but that have protective effects in the kidneys and GI tract. This poses a significant treatment dilemma.
In the 1980s, Dr. Needleman and other researchers pointed the way toward a potential solution when they discovered that PGs are produced by two forms of an enzyme called "cyclooxygenase" -- COX-1 and COX-2. The COX-1 enzyme is found in most human tissue, and produces the beneficial PGs. COX-2 is responsible for the prostaglandins that are "summoned" by arthritis and other inflammatory stimuli, wreaking havoc in the joints.
Research has shown celecoxib is much more selective in its inhibition of COX- 2 than of COX-1, whereas current arthritis drugs now on the market have much lower levels of selectivity, if any at all.
"The current worldwide market for NSAIDs is $5 billion, illustrating the significant demand for relief from arthritis and related painful conditions," said Richard U. De Schutter, chairman, president and CEO of Searle. "This need will only increase as the population ages and longevity increases."
Searle, which developed celecoxib and currently ranks fifth worldwide in prescriptions for arthritis and pain products, expects to file a new drug application for celecoxib within a few years.
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