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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: michael_f_murphy who wrote (25)	2/19/2002 7:34:57 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 130

This is not real T-20 failure, but results were at lower end. Tuesday February 19, 7:07 am Eastern Time Press Release SOURCE: Trimeris, Inc. Trimeris: T-20 in Combination Therapy Achieves Viral Suppression and is Well-Tolerated Over 48 Weeks Results From Two Phase II Trials of T-20, First Investigational HIV Fusion Inhibitor, Among Treatment-Experienced Patients T20-206: First Controlled Study of T-20 in Combination with Oral Antiretrovirals Forty-eight week results of T-20 in combination with oral antiretrovirals suggest that the addition of T-20 to a standard antiretroviral regimen was well tolerated and provided additional decreases in plasma viral load than that provided by the antiretroviral control regimen alone. In the strict intent-to-treat, missing equals failure analysis, 55 percent of patients (28 of 51) in the combined T-20 arms achieved undetectable HIV-RNA levels of less than 400 copies/mL, and 47 percent (24 of 51) reached the lower threshold of HIV-RNA levels of less than 50 copies/mL. In the control group, 37 percent of patients (seven of 19) achieved HIV-RNA levels of less than 50 copies/mL and 400 copies/mL. CD4+ cell count increases were also higher in patients treated with T-20 containing regimens - 132 cells cells/(mu)l compared to 90 cells/(mu)l in the control group. <snip> Tuesday February 19, 1:50 pm Eastern Time Press Release SOURCE: Forest Laboratories, Inc. Forest Laboratories Announces ML-3000 European Study Results NEW YORK, Feb. 19 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - news), an international pharmaceutical manufacturer and marketer, announced today results of the recently concluded European studies with ML-3000, Forest's combined COX-1, COX-2 and 5-LO inhibitor under investigation for the treatment of osteoarthritis. The trials, part of a global development program consisting of both U.S. and EU clinical trials, were conducted in the EU by Merckle GmbH, the German pharmaceutical company that discovered the product. Full analysis of the placebo-controlled data with the EU studies indicates that ML-3000 did not meet all of the efficacy endpoints required by the FDA for pivotal studies for approval in the United States. No new safety findings were observed by comparison to the previous clinical experience reported with ML-3000. Endoscopy data from clinical trials demonstrated a reduced incidence of gastrointestinal ulcers by comparison to Naproxen. <snip>