• Avicena Group Inc., of Palo Alto, Calif., said it will proceed with a confirmatory Phase III trial of AL-02, its lead drug candidate for amyotrophic lateral sclerosis. The company previously completed two Phase III studies, including the study reported in May 2006 that demonstrated a positive trend toward increased survival at nine months though the drug missed its primary and secondary endpoints of various measures of muscle strength, muscle fatigue and functional scores. The new Phase III study, expected to start in 2008, will be designed to evaluate AL-02's potential to increase survival. (See BioWorld Today, May 10, 2006.)

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., started first Phase II study to evaluate BCX-4208/R3421. The trial, lead by partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland., is designed to evaluate BCX-4208 in patients with moderate to severe plaque psoriasis. BCX-4208 is an orally available small-molecule inhibitor of purine nucleoside phosphorylase, an enzyme essential for the proliferation of activated T cells.

• BioLineRx Ltd., of Jerusalem, completed a study determining the clinical binding properties of BL-1020 to the dopamine receptors in the human brain. The study has shown that BL-1020, the first GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia, blocks dopamine receptors in the human brain, providing direct evidence of antipsychotic efficacy. The study provides evidence that the 32-mg dose will be clinically efficacious and that BL-1020 can be given once daily, and BioLineRx expects to start its Phase II maximum tolerated dose clinical trial for BL-1020 later this quarter.

• Biota Holdings Ltd., of Melbourne, Australia, and MedImmune Inc., a Gaithersburg, Md.-based unit of AstraZeneca plc, began a Phase Ia trial of their respiratory syncytial virus antiviral drug, BTA9881. The double-blinded, placebo-controlled study in 72 healthy adult volunteers will evaluate the safety, tolerability and pharmacokinetics of the small-molecule fusion inhibitor. The start of the trial triggers a $3 million payment to Biota from MedImmune, which licensed the product in December 2005. (See BioWorld Today, Dec. 16, 2005.)

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said the FDA said it immediately could resume enrollment in the CX717 Alzheimer's positron emission tomography scan study at all requested dose levels. The FDA previously limited the dose levels allowed to be tested, based on preclinical animal studies. The study is being performed in mild-moderate Alzheimer's disease patients who are drug naïve or stabilized on cholinesterase inhibitors. The FDA decision also is favorable for Cortex in terms of development of the product for attention deficit hyperactivity disorder, in which Phase IIb trials are being planned. CX717 is an ampakine compound designed to enhance memory and cognition. Cortex's stock (AMEX:COR) gained 48 cents Tuesday, or 18 percent, to close at $3.15.

• Durect Corp., of Cupertino, Calif., reported positive results from a 122-patient Phase IIb trial of Posidur for treatment of postoperative pain in patients undergoing inguinal hernia repair. The trial demonstrated statistically significant reductions in pain and total consumption of supplemental opioid analgesic medications vs. placebo. The result triggered an $8 million milestone payment to Durect from partner Nycomed A/S, of Roskilde, Denmark, under their joint development agreement from November. Durect has scheduled an end-of-Phase II meeting with the FDA in preparation for a Phase III program. Posidur is a long-acting local anesthetic administered during surgery, where it releases therapeutic levels of bupivacaine in a controlled fashion designed to provide up to 72 hours of uninterrupted local analgesia. Durect's stock (NASDAQ:DRRX) gained 68 cents Tuesday, or 18.2 percent, to close at $4.41. (See BioWorld Today, Dec. 1, 2006.)

• GeoVax Labs Inc., of Atlanta, started the last two of four trials to test its HIV/AIDS vaccines, which are designed to prevent AIDS by vaccinating individuals with its DNA and MVA vaccines prior to infection with the virus. Those studies are beginning a month earlier than expected, following strong data from the first two trials showing positive anti-HIV immune responses in most of the vaccine recipients. Of the last two studies, one will test fewer vaccine doses and the other will evaluate immune response using only GeoVax's MVA vaccine.

• Light Sciences Oncology Inc., of Seattle, said it treated the first patient in its Phase III trial of Litx for colorectal cancer metastatic to the liver. The pivotal trial is the final study required before Litx can be submitted to FDA for marketing approval. The controlled, randomized study is expected to include about 450 colorectal cancer patients with liver metastases. It is designed to demonstrate the superiority of Litx treatment in combination with standard chemotherapy compared to that chemotherapy alone. Efficacy will be measured by progression-free survival, as well as overall survival. Litx, or light infusion therapy, uses light-emitting diodes to activate LS11 (talaporfin sodium), which is designed to produce singlet oxygen molecules that can kill target tissues with minimal side effects through vascular closure and apoptosis.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., started dosing of oral Trimesta (estriol), its proprietary therapy for multiple sclerosis, in a multicenter Phase II/III trial for the treatment of women with relapsing-remitting MS. The trial has received a $5 million grant from the National Multiple Sclerosis Society in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., said pharmacokinetic data from a Phase Ia study showing that healthy volunteers who were given SRT501 had an improved exposure as compared with other published studies, with both the area under the curve concentrations, as well as the maximal concentrations, shown to be improved as compared with literature values for resveratrol. SRT501 is in Phase Ib testing in Type II diabetics. Those results were presented at the Metabolic Disease Drug Discovery and Development World Summit in Chicago. Sirtris also presented preclinical data showing that SRT501 reduces glucose and improves insulin in models of Type II diabetes.

• Trimeris Inc., of Morrisville, N.C., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, started patient dosing in a trial designed to test the efficacy and safety of Fuzeon (enfuvirtide) in combination with an investigational integrase inhibitor. The study, designated AMICI, is expected to enroll at least 238 HIV-infected, three-class treatment-experienced adults who previously have not been treated with Fuzeon or an integrase inhibitor, whose HIV levels are greater than 1,000 copies per mL of blood and who have at least one fully active antiretroviral agent for inclusion in their treatment regimen. The study's primary endpoint will test the combination's efficacy as measured by the proportion of patients with undetectable HIV levels by week 12, and a secondary endpoint will determine whether Fuzeon 180 mg daily is as effective as Fuzeon 90 mg twice daily in maintaining viral suppression for an additional 24 weeks in patients who achieve undetectable HIV by week 12. Fuzeon, co-developed by Trimeris and Roche, is an approved fusion inhibitor for HIV.

• Trion Pharma GmbH, of Munich, Germany, and Fresenius Group, of Bad Homburg, Germany, said further secondary endpoint data from a Phase II/III study of the trifunctional antibody Removab (catumaxomab) in patients with malignant ascites confirmed clear benefits. Data showed Removab significantly increased time to tumor progression and had a positive influence on overall survival time. Results of the randomized study include treatment data from 258 patients with malignant ascites caused by various cancers, most with late-stage disease and a short life expectancy. The primary endpoint of the study already had demonstrated that patients receiving Removab had a fourfold increased puncture-free survival over a therapy with puncture alone. Fresenius confirmed that the submission for marketing authorization in Europe is expected in late 2007. Removab is a trifunctional antibody designed to bind both T cells and epithelial cell adhesion molecule. Immune effector cells with Fc receptors also can bind the Fc region of intact trifunctional antibodies.