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Biotech / Medical : Biotechnology Value Fund, L.P. -- Ignore unavailable to you. Want to Upgrade?

To: RWReeves who wrote (756)	6/25/1999 7:01:00 PM
From: scaram(o)uche	Respond to of 4974

It's from the company PR..... Targretin capsules at an initial dose of 300 mg/m2/day were generally well tolerated. Adverse events were generally mild to moderate in severity and occurred more frequently in patients at initial doses greater than 300 mg/m2/day than in patients in the 300 mg/m2/day initial dose group. The most common adverse events (with incidence =>25% and without regard to relatedness to study drug) in the 84 CTCL patients in the 300 mg/m2/day initial dose group were hyperlipemia (79%), hypercholesteremia (32%), headache (30%), hypothyroidism (29%), and pruritus (25%). The only drug-related serious adverse event that occurred in more than one patient with CTCL was pancreatitis, occurring in association with elevated serum triglycerides in four CTCL patients, all of whom recovered. Institution of protocol amendments lowering the initial dose to 300 mg/m2/day in CTCL studies and specifying stricter monitoring and management guidelines for hypertriglyceridemia led to an apparent decrease in occurrence of pancreatitis. Hypothyroidism observed in association with Targretin capsules appears to be due to a thyroid axis alteration consistent with a temporary central hypothyroidism (suppression of thyroid stimulating hormone). This condition was readily managed by thyroid hormone replacement therapy, rarely required treatment discontinuation, was not associated with clinical sequelae, and appeared to be rapidly and completely reversible with cessation of Targretin therapy. A lower level incidence of leukopenia and neutropenia observed during the studies was rarely associated with severe sequelae or serious adverse events, infrequently required concomitant growth factor therapy, and resolved after dose reduction or discontinuation on average within 30 days in at least 93% of the patients with CTCL. In summary, although some toxicities (i.e., hypertriglyceridemia, hypothyroidism and, less frequently, neutropenia) often warranted concurrent administration of an additional drug, the required concurrent therapy was easily administered and monitored, and the toxicities were generally well-tolerated, easily managed, nearly always lacked clinical complications, and were reversible upon dose reduction, suspension or discontinuation. (snip) Ligand is also conducting a multicenter dose-ranging (0.5 milligram per kilogram to 3 milligram per kilogram per day) Phase II trial with Targretin capsules for the treatment of patients with moderate to severe plaque psoriasis, a condition that is estimated to affect between 1.4 and 1.9 million people in the U.S. To date, 34 patients have been enrolled at four study centers in The Netherlands and Belgium in this open-label study. An interim assessment of the first two dose panels, based on 12 patients in each panel, has revealed encouraging evidence of efficacy, with at least a two-grade improvement (on a nine-grade scale) in plaque elevation in up to 67% of patients, at least 50% improvement in Psoriasis Area and Severity Index (PASI) scores in up to 33% of patients, and at least 50% improvement according to a Physician's Global Assessment in up to 42% of patients. Encouraging interim results to date have led Ligand to explore further the therapeutic index profile in two additional dose level panels (one low and one high dose) in order to determine the optimal dose regimen. Targretin capsules have been generally well tolerated by patients with psoriasis, with a 17% rate of withdrawal due to treatment-related adverse events before completion of the 24-week treatment duration. The most common adverse events are hypertriglyceridemia and mucocutaneous dryness. Additional results are expected during the second half of 1999.