The smart money is starting to recognize that the probability of ENBREL (tnf) making it through Phase III trials is very high. See the safety study released today (below) for more information regarding the effectiveness of Enbrel. If Enbrel clears Phase III, the stock will probably double is a hurry. Phase III trials unblind in October.
SEATTLE, June 10 /PRNewswire/ -- Immunex Corporation (Nasdaq:IMNX) announced today that its drug ENBREL(TM)(TNF Receptor) was shown to be safe in a retreatment trial, with some patients receiving the drug for up to one year. Data from an ongoing study were presented in Singapore today at the International League of Associations for Rheumatology
(ILAR) conference by principal investigator Larry Moreland, M.D., of the University of Alabama at Birmingham.
``We, as rheumatologists, need new therapies like TNF Receptor to better treat the chronic disease of rheumatoid arthritis,''
said Dr. Moreland. ``These data are exciting because they support the efficacy we have seen to date and at the same time show that the drug can be given safely over a longer period of time.''
This ongoing, open-label, multi-center study is designed to measure the long-term safety of ENBREL in 106 rheumatoid arthritis patients. Patients are also being monitored for improvements in symptoms. All patients had previously received the drug for a maximum of three months in earlier clinical trials but had stopped the drug when the trial ended and subsequently had a recurrence of symptoms. In the study, clinical improvement is defined by at least a 20 percent improvement in tender and swollen joints.
Seventy-eight patients have received the drug for at least six months in this ongoing trial. At six months, 82 percent of patients
showed improvement in swollen joints and 88 percent had an improvement in tender joints. Eleven patients have received ENBREL for one year and 91 percent achieved a 20 percent improvement in swollen and painful joints. The results of laboratory tests (such as CRP) were consistent with clinical improvements seen in studies to date.
``We are very excited to see patients respond to the drug in this safety study,'' said Peggy Phillips, senior vice president of
pharmaceutical development for Immunex. ``If the results of our Phase III efficacy study are as strong, we believe doctors and
patients will be able to look forward to ENBREL as one of the first of a new class of drugs for treating rheumatoid arthritis, a
disease that for many patients is not controllable by current treatment.''
The drug was generally well tolerated. Injection site reactions, which are seen with some biologic drugs, were relatively mild
and infrequent occurring in two percent of all injections given (163 out of 6,857 injections). Thirty-nine out of 85 patients
reported infections (including colds) during treatment during 547 patient months. All infections resolved and no patient
withdrew from the study due to infections or injection site reactions. No antibodies against the drug were found in patients
tested to date.
This retreatment trial will continue until all patients have received ENBREL for a minimum of a year. The study is part of a
comprehensive program to investigate the drug's ability to alleviate the signs, symptoms and progression of rheumatoid arthritis.
A Phase III double-blind, randomized, placebo-controlled, multi-center study of ENBREL in rheumatoid arthritis patients is
also underway. |
