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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: Joe E. who wrote (4659)	6/30/1998 4:43:00 PM
From: Steve Fancy	Respond to of 6136

Experimental AIDS Drugs Work Faster, Better, Companies Say In Geneva Dow Jones Online News, Tuesday, June 30, 1998 at 16:31 WASHINGTON -(Dow Jones)- Drug companies said Tuesday their experimental AIDS drugs worked better than previous medicines or even helped reboot the immune system, according to presentations at the 12th World AIDS Conference in Geneva Tuesday. Hoffman-LaRoche Inc., for instance, claimed its protease inhibitor, Fortovase, performs better when compared to Merck & Co.'s protease inhibitor Crixivan. Hoffman-LaRoche is a unit of Roche Holding AG (ROHHY). Both drugs reduced HIV levels in patients when taken in a so-called drug cocktail with AZT and 3TC. Fortovase helped increase patients' CD4 cell levels more, Roche said. CD4 cells, sometimes called T-helper cells, aren't infected and help fight off the virus. Also at the conference, Hoffman-LaRoche presented data on a Fortovase study of patients taking the drug plus two members of a class of drugs known as nucleoside analogues, such as AZT. Of those patients, 78% showed the virus levels drop below detection levels. "We are excited that Fortovase has continued to be effective in patients out to the one-year mark," said Dr. Frank Duff, associate director of clinical science at Hoffman-LaRoche. "Fortovase has clearly shown that it will play a significant role in the treatment of HIV." The Food and Drug Administration approved Fortovase last November. The drug is a more powerful version of Roche's Invirase, which was the first protease inhibitor on the market when it came out in December 1995. Meanwhile, DuPont Merck Pharmaceutical Co. announced more good news about its experimental drug, Sustiva. The company said combining Sustiva with a common therapy suppressed HIV levels below detectable amounts quicker and in more patients. The 24-week study of 184 patients compared a group of patients taking a protease inhibitor and two nucleoside analogues with a group of patients given the same drug combination plus Sustiva. In the Sustiva group, HIV levels fell below detectable amounts in 74% of patients, compared with 45% of patients who weren't taking Sustiva. Also, more Sustiva patients had HIV levels under distinguishable levels after eight weeks of treatment. On Tuesday, DuPont Merck also said its ongoing study of combining Sustiva with Agouron Pharmaceuticals Inc.'s (AGPH) Viracept has benefited patients so far. After 16 weeks, the 63 patients in the study showed the combination significantly reduced HIV levels, while increasing CD4 cell counts. DuPont Merck filed its Sustiva new drug application with the FDA earlier this month. The FDA designated the once-a-day drug a fast-track product, meaning that because it is designed to treat a life-threatening disease, the agency plans to decide on the drug's application within six months. DuPont & Co. (DD) announced in May that it will buy Merck & Co.'s (MRK) 50% interest in their DuPont Merck venture. The new company will be called DuPont Pharmaceuticals Co. after the deal closes July 1. The company plans to present additional Sustiva studies at the AIDS conference Thursday. Other Sustiva news was released Monday. Also Tuesday, Glaxo Wellcome PLC (GLX) said Tuesday that its experimental protease inhibitor amprenavir may be effective in helping the recovery of immune systems in HIV patients. The data suggests that amprenavir, when used in combination with its experimental Ziagen drug, suppresses viral load and may support "immune reconstitution." Ziagen belongs to a class of drugs known as reverse transcriptase inhibitors Other data also suggests that amprenavir may have a unique resistance profile. The question of whether the immune system can be restored following its deterioration is key to HIV patients, as the virus progressively damages the body's immune system. A Swiss study involving the use of an amprenavir/Ziagen combination found that after 48 weeks of treatment, viral load was undetectable in eight of the nine patients tested. Pierre-Alexandre Bart, who conducted the study, said the data raises the possibility that long-term viral suppression allows the immune system to begin repairing the damage caused by HIV infection. In other news Tuesday, Agouron said it licensed a potential protease inhibitor, code named JE-2147, from Japan Energy Corp. for $26 million. Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved.

To: Joe E. who wrote (4659)	6/30/1998 6:55:00 PM
From: margie	Respond to of 6136

They do acknowledge they used three different methods, but it is hard to figure out what the numbers were, or how many were undetectable. I did not analyze it correctly, All did, and I thought I knew what "intent to treat" means but I guess I don't either. They also differentiate between 'intent to treat and "on treat." I don't have time to check it out now. Later. Unless someone else knows. I did not realize that the arm they refer to as "Sustiva 600 mg+AZT+3TC" actually had patients who were on Sustiva 600 mg+d4t+3TC+Crixivan; if they had detectable viral loads at 16 weeks, crixivan was added and d4t was subsituted for AZT, but the results refer to the superiority of the Sustiva+2 nukes arm. Kind of deceptive, to report it that way. Their explanation of terms: 1. Observed data analysis: imo, what you end with at the end, and I think the same as "intent to treat" data 2. * Last-observation-carried-forward data analysis is a method of analyzing data in which missing viral load data is assumed to be equivalent to the last recorded data for that patient. Analysis performed at only 16 and 24 weeks. 3. Non-completer = failure data analysis is a method of reporting data in which missing data is reported as equivalent to failure (i.e., above quantifiable viral load). Only if a patient's viral load measurement is missing or unavailable at one time point in the study, the patient's results are not included in the analysis at that point -- if the patient's viral load was BQL both before and after that point. Study 005: <<This study showed Sustiva, given once daily incombination with two nucleoside analogues, Retrovir(R) (zidovudine, AZT) and Epivir(R) (lamivudine, 3TC), suppresses HIV-RNA to BQL after 36 weeks and may therefore offer physicians and patients a new initial HIV treatment regimen. In the 137-patient study, all 11 patients randomized to Sustiva (600mg)/AZT/3TC who had reached the 36-week time point achieved HIV-RNA BQL. Using a more conservative 36-week LOCF analysis, 82 percent of the patients in this arm achieved BQL. The CD4 cell counts of patients in this arm of the study increased an average of more than 100 cells/mm3 at 36 weeks.>> >>Yesterday, similar data were presented at the Conference from DuPont Pharmaceuticals Study 006 in which, when using the most rigorous analysis for reporting data (a method known as non-completer = failure), 19.2% more patients receiving Sustiva/AZT/3TC achieved HIV-RNA BQL compared to patients receiving Crixivan/AZT/3TC, which was statistically significant.>> Study 006 >>Patients taking the four-drug combination containing Sustiva had statistically superior reduction in HIV-RNA levels less than 50 copies/mL(using an ultrasensitive assay) by multiple methods of data analysis. For example, 74 percent of patients taking the combination containing Sustiva achieved HIV-RNA BQL in the ultrasensitive assay (less than 50 copies/mL)compared to only 45 percent of patients taking a standard three-drug regimen, according to an observed data analysis. Patients taking both regimens achieved CD4 cell count increases of between 85 and 115 cells/mm3 at 24 weeks, using LOCF analysis, and between 95 and 130cells/mm3 using observed data analysis.>> <<Yesterday, similar data were presented at the Conference from DuPont Pharmaceuticals Study 006 in which, when using the most rigorous analysis for reporting data (a method known as non-completer = failure), 19.2% more patients receiving Sustiva/AZT/3TC achieved HIV-RNA BQL compared to patients receiving Crixivan/AZT/3TC, which was statistically significant.>>