• Biolex Therapeutics Inc., of Pittsboro, N.C., and its development partner OctoPlus NV, of Leiden, the Netherlands, have started patient dosing in a U.S. Phase IIa clinical trial of Locteron, a controlled-release interferon alfa, for the treatment of hepatitis C. The PLUS trial expands on the positive results of a Phase IIa European trial, known as SELECT-1, and will evaluate the safety, tolerability, pharmacokinetics and viral kinetics of Locteron in up to 56 patients with chronic hepatitis C. The first phase of the PLUS trial will compare a low dose of Locteron with PEG-Intron, each in combination with ribavirin, in chronic hepatitis C patients who have failed prior treatment. The second phase will compare a higher dose of Locteron to PEG-Intron, each in combination with ribavirin, patients who have failed prior treatment. The final phase will evaluate 12 weeks of treatment in treatment-naïve patients with the genotype-1 variant of the virus, with patients randomized to receive either the low dosage or high dosage of Locteron, or PEG-Intron, each in combination with daily ribavirin.

• EpiCept Corp., of Tarrytown, N.Y., said preliminary results from its Phase II trial of EpiCept NP-1 Cream in 215 patients with diabetic peripheral neuropathy showed that all pain scores measured trended in favor of the NP-1 treated patients over the placebo group, indicative of an analgesic effect in that type of peripheral neuropathic pain. The drug, however, failed to meet its primary endpoint of statistical significance in the difference in changes in pain intensity between NP-1 and placebo over the four weeks.

• GeoVax Labs Inc., of Atlanta, said that results of a dose-escalation study showed that a one tenth dose and an anticipated normal dose of GeoVax HIV/AIDS vaccine both elicit antiviral CD4 and antiviral CD8 T cells, with the fuller dose eliciting a higher number of antibody responders. For the normal dose, 77 percent of the participants had responding CD4 T cells, 42 percent had responding CD8 T cells, and 88 percent experienced an anti-Env antibody response. The vaccine was also found to be safe. The firm said it is planning of a large Phase II trial tentatively scheduled to begin in mid-2008.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, said it has started a Phase I/II dose-ranging clinical trial of Triolex (HE3286), orally bioavailable adrenal steroid hormone analogue with anti-inflammatory and insulin sensitizing properties, in patients with ulcerative colitis. The study will evaluate the safety, tolerance, pharmacokinetics and activity of Triolex when administered orally for 28 days to patients with active, mild-to-moderate ulcerative colitis. The firm also plans to start a Phase I/II study of the drug in patients with rheumatoid arthritis on methotrexate in the second half of 2008.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., said its non-nucleoside reverse transcriptase inhibitor IDX899 reduced viral load in a Phase I/II HIV trial. In the first cohort of the ongoing trial, eight patients receiving 800 mg of IDX899 once-daily for seven days achieved a mean viral load reduction of 2.01 log10, or 99 percent. The company plans to explore dosing with cohorts of 400 mg and 200 mg once-daily.

• Nile Therapeutics Inc., of Berkeley, Calif., initiated a Phase Ib trial with CD-NP, a chimeric natriuretic peptide for acute decompensated heart failure. The 35-patient, open-label, dose-escalation study will assess safety and tolerability as well as clinical measures such as urine flow rate, sodium excretion rate and plasma cGMP levels. Data are expected later this year.

• RFS Pharma LLC, of Atlanta, said the combination of Amdoxovir (DAPD) and Retrovir (zidovudine, GlaxoSmithKline plc) produced a synergistic decline in viral load in a Phase II trial. Amdoxovir 500 mg plus Retrovir 200 mg or 300 mg produced a 2 log viral load decline and was significantly more potent than either Amdoxovir alone (p<0.04) or Retrovir alone (p<0.0001). Amdoxovir is a nucleoside analog prodrug and was previously under development by Foster City, Calif.-based Gilead Sciences Inc., which returned rights to the drug to Emory University in 2004 for strategic reasons. The data were presented at the 2008 Annual Conference on Retroviruses and Opportunistic Infections in Boston.

• Virxsys Corp., of Gaithersburg, Md., said interim data from its Phase II trial of HIV gene therapy VRX496 showed the approach inhibits HIV replication. VRX496 uses a lentiviral vector to deliver an antisense sequence targeting the HIV envelope protein. The data were presented at the 2008 Annual Conference on Retroviruses and Opportunistic Infections in Boston.