• Alfacell Corp., of Somerset, N.J., said it confirmed that 290 evaluable events (patient deaths) have occurred in the Phase IIIb trial of its lead compound, Onconase, for the treatment of patients with unresectable malignant mesothelioma. In accordance with the statistical plan for the study of the ribonuclease-based agent, the company must wait until 316 evaluable events to conduct the analysis required to complete a new drug application. It expects that number of events will occur later this year. Enrollment in the trial is scheduled to close Sept. 30. Alfacell said it has sufficient cash resources to complete the Phase III program and the potential rolling NDA submission.

• Allon Therapeutics Inc., of Vancouver, British Columbia, began enrollment in a Phase II trial evaluating AL-108 as a treatment for schizophrenia-related cognitive impairment. The double-blind, placebo-controlled study will evaluate cognitive impairment as well as functional outcomes and safety measures. It also will include an imaging-biomarker component. It is the third Phase II study of AL-108.

• Cell Therapeutics Inc., of Seattle, launched a Phase III trial, PIX303, of pixantrone for patients with indolent non-Hodgkin's lymphoma who have relapsed following first-line therapy. The trial, being run under a special protocol assessment with the FDA, will examine progression-free survival following treatment with pixantrone, fludarabine and rituximab compared to fludarabine and rituximab. The randomized trial is expected to enroll 300 patients. An interim analysis is targeted in 2009. Pixantrone is the subject of two ongoing studies in aggressive NHL, a Phase III single-agent trial known as EXTEND and a Phase II/III combination study known as RAPID.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., submitted an investigational new drug application on CX717 for treating attention deficit hyperactivity disorder. The move follows promising data generated last year in a small Phase IIa pilot study in ADHD. Separately, Cortex reported CX717 has demonstrated in rats the ability of Ampakine drugs to block the risk of fatal overdose with the opioid fentanyl.

• GeoVax Labs Inc., of Atlanta, announced an earlier presentation of successful human trial results for its HIV/AIDS vaccines. Data showed the GeoVax DNA and MVA vaccines are safe and immunogenic at both low and full doses. The vaccines also were well tolerated. Results led to the start in June of two new trials of the vaccine in humans, trials being conducted by the HIV Vaccine Trials Network in Seattle.

• Living Cell Technologies Ltd., of Melbourne, Australia, received New Zealand Regional Ethics Committee approval to begin a Phase I/IIa trial of its DiabeCell product for Type I diabetes. DiabeCell is a porcine islet cell product, in which pig cells are injected into the peritoneal cavity to produce insulin and help regulate blood glucose levels. It has been designed to eliminate the need for immunosuppression. The trial is expected to start late this year in eight insulin-dependent diabetics, and is expected to take about 12 months.

• NanoBio Corp., of Ann Arbor, Mich., said a Phase I trial showed its topical lotion penetrates the skin deeply enough to target and eliminate serious skin infections, but without being systemically absorbed. It also demonstrated safety and tolerability in patients with onychomycosis, or toenail fungus. Data on the lotion, NB-002, will be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting next week in Chicago.

• Pharmacopeia Inc., of Princeton, N.J., said a Phase I ascending-dose study of its lead internal product candidate, PS433540 (DARA), showed no safety or tolerability issues in healthy volunteers. As a result, the study will be expanded to include a 1,000-mg dose. The company expects to report findings from the new dose later this year. PS433540 is a dual-acting angiotensin and endothelin-receptor antagonist that is being developed for hypertension and diabetic nephropathy.

• Pharmasset Inc., of Princeton, N.J., reported positive preliminary safety and antiviral activity with R7128 following 14 days of monotherapy in 40 patients chronically infected with hepatitis C virus who have failed prior interferon therapy. The product demonstrated dose-dependent antiviral activity across the four patient cohorts in the dose-ascending Phase I trial. Based on the results, Pharmasset and partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, plan to initiate a 28-day study of R7128 with Pegasys and ribavirin in treatment-naive patients later this month. R7128 is a prodrug of PSI- 6130, an oral cytidine nucleoside analogue HVC polymerase inhibitor.

• Phosphagenics Ltd., of Melbourne, Australia, received approval to begin a Phase II trial of its transdermal insulin, TPM/Insulin. The trial, to begin this month, will be single-blind, placebo-controlled, randomized, three-way crossover study in up to 60 patients. The trial in Australia will evaluate efficacy and is expected to be completed in the first half of 2008.

• Phynova Group plc, of Oxford, UK, completed patient enrollment in its Phase I/II clinical trial of PYN17 in the U.S. The product, based on a formulation of four plant extracts, is aimed at treating debilitating symptoms, impaired health-related quality of life and liver inflammation in chronic hepatitis C. The double-blind, placebo-controlled trial has enrolled 39 patients. Phynova anticipates working toward starting a Phase IIb study early in 2008.

• ProMetic Life Sciences Inc., of Montreal, is expanding the clinical program for PBI-1402 for anemia in patients with myelodysplastic syndrome, following positive data seen in a Phase Ib/II trial for chemotherapy-induced anemia. It said it plans to begin patient enrollment in Canada this month.

• Repros Therapeutics Inc., of The Woodlands, Texas, said the investigational new drug application on Proellex became effective. The first study will be a placebo-controlled Phase II trial in 75 patients designed to assess the improvement of symptoms associated with endometriosis. Doses to be used previously were tested in an encouraging 40-patient, 24-week study in Europe. Proellex is a selective blocker of the progesterone receptor.

• Sunesis Pharmaceuticals Inc., of South San Francisco, began patient dosing in trials to evaluate the anticancer product candidates SNS-595 and SNS-314. The lead product, SNS-595, is being evaluated in combination with cytarabine in a Phase Ib trial in patients with relapsed and/or refractory acute leukemias. It will evaluate safety, tolerability and initial indications of activity of escalating doses. SNS-314, an Aurora kinase inhibitor, is being studied in its first clinical trial, a Phase I, dose-escalating study in patients with advanced solid malignancies. The open-label trial will examine safety and tolerability, as well as preliminary activity.

• XOMA Ltd., of Berkeley, Calif., began a second Phase I study of XOMA 052, a monoclonal antibody targeting interleukin-1 beta, in patients with Type II diabetes. The European-based study is designed to assess the safety and pharmacokinetics of XOMA 052, as well as disease-specific outcome measures, in up to 36 patients. XOMA in July started a Phase I trial of the product in patients in the U.S.