• Adeza Biomedical Corp., of Sunnyvale, Calif., said the FDA granted orphan drug designation for Gestiva, the company's therapeutic candidate for preventing preterm birth in women with a history of preterm births. The designation would guarantee Adeza seven years of marketing exclusivity upon approval of the drug.

• Argos Therapeutics Inc., of Durham, N.C., said it began dosing in a Phase I/II trial to test the activity and safety of AGS-005 in B-cell chronic lymphocytic leukemia. AGS-005 is a personalized dendritic cell-based immunotherapy, designed to stimulate the immune system to target and destroy cancer cells. The trial will enroll up to 22 patients with previously treated disease. The primary objective is to measure patient-specific anti-tumor responses of the agent following treatment with low-dose cyclophosphamide.

• Athenagen Inc., of South San Francisco, said it completed a Phase I study of ATG3, an eye-drop formulation of mecamylamine for treating neovascular age-related macular degeneration. The study of ATG3, an antagonist of the nicotinic acetylcholine receptor pathway that mediates angiogenesis, demonstrated safety and tolerability in 80 healthy volunteers. A Phase II trial in 330 patients is expected to begin this quarter.

• Biolex Therapeutics, of Pittsboro, N.C., has begun the Phase IIa trial of its lead product candidate Locteron, a best-in-class controlled-release interferon alfa being developed as a treatment for chronic hepatitis C. This trial follows a successful Phase I trial that demonstrated the safety and tolerability of Locteron when administered as a single dose. The Phase IIa study is designed to evaluate Locteron in combination with the anti-viral drug ribavirin in previously untreated chronic hepatitis C patients. Clinical investigators in the study have commenced patient dosing, and top-line results are expected in the middle of 2007.

• Can-Fite BioPharma Ltd., of Petach Tikva, Israel, began patient enrollment in a Phase II trial of CF101 for the amelioration of dry-eye symptoms. The trial will be conducted at four centers in Israel and include 50 patients who will be treated for 12 weeks. Two weeks ago the company said it completed enrollment of 250 patients in a Phase IIb trial of the same product in rheumatoid arthritis.

• CeNeRx BioPharma Inc., of Research Triangle Park, N.C., a clinical stage company that develops treatments for diseases of the central nervous system, has initiated human clinical trials of Tyrima, a new drug candidate with a triple mechanism of action for the treatment of depression and anxiety. The Phase I safety trials began this month following a successful review of the Investigational new drug application for Tyrima by the U.S. Food and Drug Administration. Tyrima is a member of a novel class of drugs known as reversible inhibitors of monoamine oxidase A, or RIMA. RIMA antidepressants elevate the levels of three key neurotransmitters that affect mood and anxiety - serotonin, norepinephrine and dopamine - in contrast to the leading antidepressants available today that affect the single neurotransmitter serotonin. That triple mechanism has the potential for enhanced efficacy and an improved therapeutic index compared to current therapies. CeNeRx has raised approximately $25 million to fund development of Tyrima and the RIMA antidepressant series. Tyrima could be the first RIMA antidepressant available in the U.S. market, and it has patent protection through 2026. The company plans to enter Phase II trials for Tyrima later this year.

• Curis Inc., of Cambridge, Mass., said partner Genentech Inc., of South San Francisco, treated the first patient in an open-label Phase I trial of a small-molecule Hedgehog antagonist in advanced, refractory cancers. The primary objectives of the 50-patient Phase I trial are to evaluate safety and tolerability of escalating doses.

• Gemin X Biotechnologies Inc., of Montreal, initiated a Phase I/II trial of GX15-070 in combination with docetaxel (Taxotere) in patients with non-small-cell lung cancer, and a Phase I trial in combination with bortezomib (Velcade) in patients with mantle cell lymphoma. GX15-070 is a small molecule designed to inhibit all relevant members of the Bcl-2 protein family. The open-label trial in NSCLC will enroll up to 41 patients with relapsed or refractory disease. The open-label trial in MCL will enroll up to 18 patients with relapsed or refractory disease.

• NeuroDerm Ltd., of Ofakim, Israel, completed a pilot trial of ND0601, a transdermal skin patch for the continuous delivery of levodopa, which is approved as an oral treatment for Parkinson's disease. The trial's main objective was to assess the pharmacokinetic profile of levodopa in the blood of healthy volunteers following application of ND0601. The trial was funded by the Michael J. Fox Foundation for Parkinson's Research.

• NexMed Inc., of East Windsor, N.J., said dosing of patients in a Phase III trial for NM100060, its topical treatment for nail fungus, has begun by its collaborator, Novartis AG, of Basel, Switzerland. The trial consists of about 1,000 patients in two parallel group studies, and will assess efficacy, safety and tolerability. The trial is being conducted in the U.S., Europe, Canada and Iceland. NM100060 is a topical application of Lamisil formulated with terbinafine and the NexACT permeantion enhancer.

• Pharmion Corp., of Boulder, Colo., has received acceptance from the FDA of an investigational new drug application for an oral formulation of azacitidine. The company currently markets a parenteral formulation (Vidaza) for patients with myelodysplastic syndromes. A Phase 1 study of oral azacitidine will be begin soon in patients with MDS, acute myelogenous leukemia and malignant solid tumors. The trial will assess the safety, tolerability, bioavailability and pharmacokinetics of escalating single doses of orally administered azacitidine.

• Theratechnologies, of Montreal, has enrolled the first patient in its second Phase III trial testing TH9507 in HIV-associated lipodystrophy. The study is designed to confirm the results of an earlier Phase III trial and is examining the safety and efficacy of a daily administration of 2 mg of HT9507 for 26 weeks. The primary endpoint is a reduction of visceral adipose tissue, which is a risk factor for cardiovascular disease and type 2 diabetes. The multi-center trial is being conducted in more than 60 centers in the U.S., Canada and Europe.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., has begun enrolling patients in a Phase II trial evaluating the dosing, safety and activity of glufosfamide in patients with platinum-resistant ovarian cancer. Platinum-based therapy is the most widely used chemotherapy to treat ovarian cancer, but some women develop resistance to it. The current standards of care in treating platinum-resistant ovarian cancer are a variety of single agent and combination regimens. The study will evaluate two dosing schedules of glufosfamide, a once weekly schedule and the schedule currently utilized in pancreatic cancer trials which is every three weeks. The trial will explore the administration of slightly higher aggregate doses utilizing the weekly schedule as compared to every three week dosing. Forty-five patients may receive up to six 21-day cycles at various sites in the U.S. In addition to safety, the trial is investigating the efficacy of glufosfamide as determined by response rate, duration of response and progression-free survival based on changes in the serum tumor marker level CA-125, tumor assessments and overall survival.