The results of an interim analysis of an open-label study, supported by Ortho Biotech Products LP, of Raritan, N.J., showed that both once-weekly (QW) dosing of Procrit (epoetin alfa) and three-times-weekly (TIW) dosing in HIV-positive patients were well tolerated.

The data were presented at the 41st annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago. It runs through Wednesday.

This multicenter study, which enrolled patients receiving antiretroviral therapy with hemoglobin levels of <12 g/dl, compared the efficacy and tolerability of QW vs. TIW subcutaneous administration of Procrit. Efficacy endpoints were Hb normalization and quality of life assessments using the Linear Analog Scale Assessment and HIV-Medical Outcomes Health Survey. Patients were randomized to receive either 100 U/kg epoetin alfa TIW or 40,000 U epoetin alfa QW for 16 weeks, both administered subcutaneously.

An interim analysis of the 16-week data included 174 patients with no significant difference in age, weight, viral load and CD4 cell count at baseline. The mean change in Hb from baseline to final in the QW group was 2.8 g/dl +/- 1.9 and 2.4 g/dL +/- 2.4 in the TIW group. A significant improvement was noted in Hb levels and quality of life in both arms at week eight (p<.05) that was maintained until the end of the study.

There were no significant differences (p>.05) between the QW and TIW dosing arms in Hb levels or quality of life at 16 weeks or last measurement.

Procrit is owned by Johnson & Johnson, Ortho Biotech¿s parent company, and was licensed from Amgen Inc., which sells the same product for other indications as Epogen.

In other news from the conference:

¿ Achillion Pharmaceuticals Inc., of New Haven, Conn., summarized results from its Phase I study of ACH-126,443 (beta-L-Fd4C), an L-nucleoside analogue with potent in vitro activity against both chronic hepatitis B and HIV. Six dose levels of the analogue were evaluated in healthy volunteers. The blood concentration achieved in single-dose administration exceeded the quantities required in preclinical studies to suppress wild-type and 3TC-resistant HBV infection. Pharmacokinetic data show that it can be given once daily and also provide information to help identify the efficacious dose in later Phase II studies.

¿ GeneLabs Technologies Inc., of Redwood City, Calif., reported in vitro data on a new family of antifungal compounds, cationic polyheterocyclic small molecules, and said they were fungicidal. Fungicidal compounds kill the fungi rather than inhibit their replication. GeneLabs¿ first presentation reported on the synthesis of its initial lead compound, GLO47296. One of the most potent derivatives demonstrates activity with a minimum inhibitory concentration (MIC) range of 0.7 to 2.7 ug/mL against seven common Candida albicans species and an MIC of 3.0 ug/mL against Aspergillus fumigatus. A second presentation reported that GL663142 showed a trend toward prolonging survival of mice with systemic candiosis. Also, this compound demonstrated potent synergy with fluconazole against a fluconazole-resistant C. albicans isolate.

¿ Novirio Pharmaceuticals Inc., of Cambridge, Mass., said results from the first human study of LdT, its new treatment for chronic hepatitis B, indicate rapid and profound reduction of virus replication at all dose levels in patients with the virus, and a median reduction of 3.63 log¹⁰ among patients taking the highest dose evaluated to date, 400 mg once daily for four weeks. The randomized Phase I/II study was designed to evaluate safety and short-term antiviral activity of LdT in adults and to assess optimal dosing levels of LdT for future large-scale trials.

¿ Versicor Inc., of Fremont, Calif., said results from clinical and preclinical studies of anidulafungin, one of a new class of antifungal agents called echinocandins, conclude that it is well tolerated at doses as high as 260 mg loading and 130 mg/day maintenance for 10 days. In a Phase I sequential dose-escalation study, 29 healthy volunteers received intravenous infusions of anidulafungin daily for 10 days. No dose-limiting toxicities or serious adverse events were observed. In a second, single-dose, open-label study, 12 patients with mild to moderate hepatic impairment received a single 50-mg intravenous dose. The results showed no dosage adjustment was required. Separately, Versicor said results of a Phase I trial of dalbavancin, its antibiotic candidate for Staphlococcal and other Gram-positive hospital infections, demonstrated it was well tolerated and showed promise as a potential once-weekly injectable antibiotic. Fifty-two patients were randomized to receive single or multiple doses of dalbavancin or placebo. Dalbavancin pharmacokinetics were dose-proportional over a wide range of doses, with an overall mean half-life of 166 hours.