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

To: George T. Santamaria who wrote (3207)	12/8/1997 4:11:00 AM
From: Miljenko Zuanic	Read Replies (2) \| Respond to of 6136

[RE: VRTX AND 75%] To all: Hope several of the active AGPH participants (my apologize to ones who do not fill this way) will one day find enough honesty and courage to write objective about other companies/drugs which may be future direct AGPH competitors. Fist let me say that I have great respect for AGPH science, R&D, and management from early 1990 (after my first contact with AGPH chemist group) and I stated this on SI several times in late 96/early 97. Second, I wrote before about data from VRTX VX-478 PII data: Message 2444800, and nobody didn't dare to respond. Still when AGPH stock price show weakness and company future appears not so bright (which is not my opinion and does not have anything to do with reality) you are turning to VRTX VX-478 and tried to discredit PII trials data as base that drug will not be serious competitor to Viracept PI-AIDS market. VX-478 PII data are preliminary and first one from series of the advance trials, now ongoing worldwide, and they can't be base for any serious guess. Nevertheless, for now, I will stick with this data and give you MATH LECTURE, as you deserve it well. 1) VX-478: >>At 12 weeks, patients taking 141W94 at the highest dose, 1200 mg twice daily, plus Retrovir(R) (AZT) and Epivir(R) (3TC) had a median 2.65 log reduction in viral load (greater than 99.8%) [who complete study, my note] from baseline as compared to a 1.33 log reduction for the control arm, Retrovir(R) and Epivir(R).<< And for comparison Merck RT Sustiva (TM) PIII data: >>After 16 weeks of treatment, the 25 patients who completed the study at the 600 mg dose achieved a 1.89 log10 average reduction in HIV-RNA levels out of a possible 2.04 log10, and 88 percent of them achieved HIV-RNA levels below the level of quantification (400 copies/mL). In addition, these patients experienced an average CD4 cell count elevation of 157 cells/mm3.<< As you can see, Sustiva has reduction in viral load of 1.89 log10 from max 2.04 log10 or 92.6% (88% for clinical response) and VX-478 has reduction of 2.65 log10 from max 2.655 log10 or 99.8% (??% for clinical response, [~100%]). 2) In VX-478 alone PI/II trials at 1200 mg x 2 per day dose viral load reduction was 1.95 log10 from max 1.97 log10 or ~99%. 3) In PII trials each arm had 20 patients. 3/20 patients in 900 mg arm didn't completed study (probably because trend toward viral load reduction didn't warrant positive results), all patients in 1050 arm (20/20) completed study, and 14/20 patients in 1200 mg arm (six patients didn't completed because of the side effects, the most serious was rash), compared to placebo arm where only 10 patients completed study. 70% [or 42 patients] clinical response is related to total enrolled patients. 15 % [or 9 patients] drooped and 15 % [9 patients} didn't achieve undetectable viral load. For AZT/3TC arm in clinical trials generally was observed ~40% of the clinical response for patients who completed study. For 900 mg VX-478 I will increase response rate (my best guess) to 60%. It means that 10 patients in 900 mg arm have positive response, and (42-10) 32 patients from arm 1050 and 1200 mg (32/34 or 94%). Because VX-478 did show dose related reduction in viral load, one can project response rate of ~85% for 1050 mg arm and ~100% for 1200 mg arm. This is projection because it is short study and small patient number are consider in statistic. 4) The problem is droop in 1200 mg arm (6/20) which is related to severe rash. Nevertheless, early data from other PIII trials indicate lower rash incidence (2/25 for 20 weeks). It appears the VRTX is not much concern with this early rash problem (all current trials are at 1200 mg dose). Probably alteration in sequence/timing of the drugs (RT and PI) consumption solve the problem. 5) I am not projecting that PIII VX-478 trials will have this strong results. However recent Lehman's report indicate strong potency for AZT/3TC/1592U89/VX-478 combination (PIII trials). Also, I am not saying that VX-478 will be inferior/superior than Viracept/Crix. Only that whoever is comparing other PI drugs should write with honesty and objective view. I think that with this my opinion majority of the AGPH shareholder agree. Good luck to all. mz