• Acadia Pharmaceuticals Inc., of San Diego, completed enrollment of its Phase IIb trial of ACP-104 in patients with schizophrenia and expects to report top-line results in the second quarter of 2008. The 248-patient study will evaluate the antipsychotic efficacy of ACP-104 (N-desmethylclozapine), as measured using the Positive and Negative Syndrome Scale.

• Adolor Corp., of Exton, Pa., started a Phase IIa study of ADL5859, a delta opioid agonist in development for pain. The study, expected to enroll 210 patients experiencing pain associated with diabetic peripheral neuropathy, will measure the change in mean pain intensity score after four weeks of treatment as the primary endpoint. ADL5859 is part of Adolor's potential $265 million deal with New York-based Pfizer Inc., signed earlier this month. (See BioWorld Today, Dec. 6, 2007.)

• BioMS Medical Corp., of Edmonton, Alberta, said the independent data safety monitoring board recommended that the company continue its pivotal Phase II/III trial of MBP8298 in secondary progressive multiple sclerosis, following its eighth scheduled review.

• Inhibitex Inc., of Atlanta, completed its initial Phase I trial of FV-100, a nucleoside analogue in development for shingles, in healthy volunteers. Results showed no serious adverse events observed and reported that the compound appeared to be generally well tolerated. Pharmacokinetic data demonstrated that all three doses of FV-100 achieved plasma levels of CF-1743, the active form of FV-100, which exceeded the EC50, with the 40 mg dose maintaining such levels for about eight hours. The company plans to advance FV-100 into a second Phase I study in additional single-ascending and multiple-ascending doses in healthy volunteers in the first half of 2008.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., said Dyloject (diclofenac sodium solution for injection) met its primary and secondary endpoints in the first of two pivotal studies. Patients in the four-arm study receiving higher or lower Dyloject doses or ketorolac had markedly better Sum of the Pain Intensity Differences scores than the placebo group. The trial, as in earlier Dyloject studies, did not reveal any unexpected safety signals. The company is under way with its second pivotal study of Dylojet in orthopedic surgery.

• Monogram Biosciences Inc., of South San Francisco, reported results showing that its HERmark assay is able to identify metastatic breast cancer patients who are most likely to respond to Herceptin (trastuzumab, Genentech Inc.). Those results were presented at the San Antonio Breast Cancer Symposium in San Antonio, Texas. Monogram also received confirmation last week from the College of Pathologists that the HERmark assays are approved for routine patient testing in Monogram's CLIA-certified clinical reference laboratory.

• Neuro-Hitech Inc., of New York, completed the double-blind part of its Phase II trial of Huperzine A in patients with mild to moderate Alzheimer's disease. Results of that trial, which was designed to compare the safety, tolerability and efficacy of either 200 mcg or 400 mcg Huperzine A administered orally twice-daily for 16 weeks vs. placebo, are expected in the first quarter of 2008. Huperzine A is a naturally occurring alkaloid compound derived from the club moss Huperzia serrata and is designed as a reverse inhibitor of acetylcholinesterase.

• NicOx SA, of Sophia Antipolis, France, completed enrollment of 1,020 patients in its pivotal Phase III study of naproxcinod, its COX-inhibiting nitric oxide-donating agent. The trial is designed to assess the drug's efficacy for treating osteoarthritis and is expected to provide additional blood pressure data. Results are anticipated in the third quarter of 2008.

• QRxPharma Pty. Ltd., of Sydney, Australia, started its second Phase III trial of Q8003IR, an immediate-release dual-opioid pain therapy, aimed at collecting longer-use patient safety data in support of a new drug application in the management of moderate to severe pain. The company's first Phase III study, initiated late last month, targets patients suffering acute post-surgical pain. The new study will enroll patients from the first trial, who will continue to receive doses of Q8003IR to control pain for up to 28 additional days. The primary endpoint is overall safety and side effect data for Q8003IR when used for up to 28 days of treatment, followed by a withdrawal period of up to three weeks, during which dosing is gradually reduced. Q8003IR is a combination of morphine and oxycodone.