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Biotech / Medical : Immunex -- Ignore unavailable to you. Want to Upgrade?

To: Brett Nelson who wrote (120)	11/9/1997 9:20:00 PM
From: Charles Hill	Respond to of 656

Here is some of the company press release regarding Enbrel Phase III data. Looks very strong to me. WASHINGTON, Nov. 9 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX - news) today announced the results of a Phase III clinical study of an investigative new treatment for severe rheumatoid arthritis (RA) called ENBRELL(TM). The interim results of a 12-month safety study were also announced today. Data from these studies were presented at the 61st Annual Science Meeting of the American College of Rheumatology (ACR), taking place in Washington, D.C. this week. The patients studied suffered from advanced RA and had already failed at least one, but no more than four disease modifying, anti-rheumatic drugs (DMARDs). Ninety percent of the patients had previously been treated with methotrexate -- a mainstay of RA treatment. Of the 2.5 million Americans with RA, approximately 500,000 fit into the advanced category. The results of the Phase III and 12 month study are consistent with the results of previously reported Phase II data published in the New England Journal of Medicine on July 17, 1997. The Phase III study was a double-blind, placebo-controlled and randomized trial that studied the effects of six months of ENBREL therapy. This pivotal study included 234 patients at 13 sites. ENBREL was administered by subcutaneous injection twice per week throughout the six-month period. The patients were divided into three groups: the first received a placebo; the second received 10mg doses of ENBREL; and, the third received 25mg doses of ENBREL. Primary and secondary endpoints of the study were met. In the Phase III study, patients with advanced RA treated with the 25mg dose of ENBREL experienced a 71 percent reduction in their painful joint counts compared to patients in the placebo group who experienced only a 6 percent reduction. Reduction in swollen joint counts was experienced by 51 percent of patients treated with the 25mg dose of ENBREL, while patients on placebo experienced a 2 percent reduction. Patients treated with the 10mg dose of ENBREL experienced a 55 percent reduction in their painful joint counts, and a 49 percent reduction in swollen joint counts. Numbers reported are median values. In the 12 month study, both the tender and swollen joint counts declined early in the treatment. This improvement was for as long as 12 months. As part of this long-term safety study, more than 50 patients have been treated with ENBREL for 12 months. ENBREL was found to be generally well tolerated, with primarily non-complicating side-effects. ''ENBREL represents a potential new therapy option for rheumatoid arthritis. We will continue to move forward with our plan to file with the Food and Drug Administration in 1998, once the long-term safety studies are completed,'' said Peggy V. Phillips, Immunex senior vice president of pharmaceutical development. Select measurements of RA symptoms, including joint pain, joint swelling, and patient and physician global assessment, are combined in a composite score called American College of Rheumatology (ACR) 20. A 20 percent improvement in ACR response is used to measure patient improvement and was the primary endpoint at three months in this study. In the Phase III study, 62 percent of the patients in the 25mg group reached 20 percent improvement by ACR criteria, compared to 23 percent of the patients in the placebo group. Of patients who were treated with the 10mg dose, 45 percent experienced at least a 20 percent improvement. A secondary endpoint measured the percentage of patients reaching 20 percent improvement by ACR criteria after six months of treatment. At that point in time, 59 percent of patients reached ACR20 at the 25mg dose, compared to 11 percent on placebo. Fifty-one percent of the patients at the 10mg dose reached ACR20 at 6 months. The Phase III study also reported how many patients experienced a 50 percent improvement on these composite measurements, called ACR50. After 3 months of treatment on ENBREL, 41 percent of the patients receiving ENBREL at the 25mg dose had at least a 50 percent improvement, compared to 8 percent of the placebo group. At the six month time point, 40 percent of the patients receiving the 25mg dose had 50 percent improvement, compared to five percent of the placebo group having similar improvement. Of patients receiving the 10mg dose, 13 percent reached ACR50 at three months and 24 percent reached ACR50 at 6 months.

To: Brett Nelson who wrote (120)	11/10/1997 7:05:00 PM
From: Bret Masterson	Read Replies (1) \| Respond to of 656

Brett, Apparently there seemed to be only positive news about IMNX coming out of the conference, however, the the stock couldn't hold on to most of its early gains and seemed to finish on the weaker side. Not sure if this is just "selling on the news" type phenomenon or something else. Volume today was back to normal as well. I think there were definitely some high expectations for something big, as I noticed that the option premiums on the Nov 70s, 75s dropped significantly, even though the stock ended the day up. There was also another drug for RA from a company called Centocor that was listed along with IMNX in a WSJ article, however, Centocor was down big today (9 big ones) as it seems that their drug has some major side effects, leading Merrill to issue a down grade. Still holding, and hoping for the best. Regards, Bret