• Celgene Corp., of Summit, N.J., said data from an ongoing Revlimid study in chronic lymphocytic leukemia patients who had at least two prior therapies showed an overall response to monotherapy of 58 percent, with 18 percent achieving a complete remission and 40 percent achieving partial remission. The median time to best response was 5.9 months, with a range of 1.6 to 18.3 months, and median progression-free survival of all 45 enrolled patients was 19.4 months, with a range of 1.2 months to 31.8-plus months. Those data were reported at a CLL workshop in London. Investigators also presented data from a second ongoing study of Revlimid, given at a lesser dose, to pretreated CLL patients with progressive disease. Results from that trial demonstrated a 34 percent overall response rate to single-agent Thalomid among 44 patients, among whom 7 percent achieved a complete remission, 2 percent achieved a nodular partial remission and 25 percent achieved a partial remission. Stable disease was observed in 23 percent of the patients.

• DOR BioPharma Inc., of Miami, said a clinical review of orBec (oral beclomethasone dipropionate) in gastrointestinal graft-vs.-host disease, published in the Expert Review of Clinical Immunology, concluded that orBec fulfills a critical need in the allogeneic hematopoietic cell transplantation populations in mild to moderate GI GVHD. According to the expert paper, orBec, as a steroid-sparing agent, facilitates rapid withdrawal of systemic corticosteroids after the disease is controlled and prevents recurrence during the subsequent maintenance period. The paper included results from two randomized trials, including DOR's 129-patient, pivotal Phase III study. A new drug application is on file with the FDA, with a PDUFA date of Oct. 21.

• Genta Inc., of Berkeley Heights, N.J., said the FDA allowed its investigational new drug application for G4544, a tablet formulation that enables oral absorption of the active ingredient of Ganite (gallium nitrate injection), a drug marketed by Genta for cancer-related hypercalcemia that is resistant to hydration. The initial study is a dose-ranging, single-dose evaluation, and Genta reported that the first cohort of six normal volunteers has been treated with single doses without experiencing significant side effects. From a regulatory standpoint, the company said, it seeks to establish bioequivalence to Ganite.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, filed an investigational new drug application for HE3286 for inflammatory disease. Upon clearance of the IND, the company plans to start a Phase I/II trial in rheumatoid arthritis patients in the fourth quarter, and also might consider exploring HE3286 in one or more acute inflammatory conditions where evidence of activity against well-accepted clinical endpoints potentially could be generated with 28-day dosing. In preclinical testing, HE3286 demonstrated activity in animal models of RA, multiple sclerosis, lupus, ulcerative colitis and cystic fibrosis.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., dosed the first patient in a Phase I trial of IMO-2125, a Toll-like receptor 9 agonist, in hepatitis C virus infection. The study is evaluating four doses of the subcutaneously administered drug in HCV patients who have failed to respond to previous combination therapy with ribavirin and pegylated interferon-alpha. Target enrollment for the trial is 40 patients, with 10 patients per dose cohort.

• NeuroSearch A/S, of Ballerup, Denmark, reported positive data from a Phase IIb proof-of-concept and dose-finding study of tesofensine for the treatment of obesity. Data from the study in 203 patients showed 24 weeks of treatment with 0.25 mg, 0.5 mg and 1 mg of tesofensine resulted in a dose-dependent average weight loss of 6.5 percent, 11.2 percent and 12.6 percent, respectively (against a weight loss of 2 percent in the placebo group). In all treatment groups, the primary endpoints were met with high statistical significance (p< 0.0001), NeuroSearch said. Secondary endpoints, including relative reduction in body mass index as well as feelings of satiety and appetite, also were met (p<0.0001 for BMI). The company said the new and previous data supported preparation for a pivotal Phase III program of the product, a triple monoamine re-uptake inhibitor.

• Oculus Innovative Sciences Inc., of Petaluma, Calif., said it has enrolled and randomized 42 patients of the total 60 targeted for its ongoing Phase II study of topical Microcyn technology for treating mildly infected diabetic foot infections, and now expects the study to be completed in the fourth quarter, with results available in the first quarter of 2008. The study is designed as a proof-of-concept trial, and Oculus anticipates it will serve as the required basis for taking Microcyn technology into Phase III testing. The Microcyn platform is a controlled slow-release solution containing active chlorine and other gases resulting in a biocompatible technology for treating pathogens such as antibiotic-resistant bacteria strains.

• Pharmacopeia Inc., of Princeton, N.J., started a Phase IIa trial of PS433540, a dual-acting angiotensin and endothelin receptor antagonist (DARA) in development for hypertension and diabetic neuropathy. The trial is expected to enroll 170 patients with Stage I and Stage II hypertension, to be randomized into three study arms after a lead-in period. Patients will receive one of two doses of PS433540 or placebo once daily for 28 days, and investigators will evaluate patients' change in baseline in mean 24-hour ambulatory systolic blood pressure, mean 24-hour ambulatory diastolic blood pressure and mean seated systolic and diastolic blood pressure.

• Phosphagenics Ltd., of Melbourne, Australia, said it plans to begin a Phase I transdermal oxycodone trial aimed at providing chronic pain sufferers with a sustained-release pain management patch. The trial will involve up to 30 healthy volunteers and is expected to start within six weeks. Phosphagenics showed in previous studies that its technology is effective in delivering opiates through the skin without causing disruption or irritation.

• Schering-Plough Corp., of Kenilworth, N.J., initiated two large Phase III study of vicriviroc, its investigational CCR5 antagonist, administered once daily as a single 30-mg tablet, in combination with an optimized background therapy that must include a protease inhibitor boosted by ritonavir (Abbott) in treatment-experienced adult HIV patients with R5-type virus only. The studies will enroll about 375 patients, and will measure the proportion of patients with plasma HIV-1 RNA levels of less than 50 copies/mL at 48 weeks as the primary endpoints. Vicriviroc is a next-generation extracellular inhibitor designed to block entry of infectious virions into uninfected CD4 cells via antagonism of the CCR5 co-receptor.

• Syngis Pharma, of Heidelberg, Germany, said an analysis of results from its 44-patient Phase IIa study of AX200 in acute ischemic stroke showed the drug was safe and appeared to have efficacy in stroke patients. The trial was designed to evaluate safety, as well as to monitor multiple dimensions of stroke outcome, including clinical and imaging parameters. Syngis said all primary and secondary endpoints of the study were achieved. Data were presented at a neurological meeting in Berlin.

• Tengion Inc., of East Norriton, Pa., initiated a Phase II trial of its neo-bladder construct, derived from a patient's own cells, involving 10 adult patients with neurogenic bladder due to spinal cord injuries. The study is evaluating the safety and effectiveness of the neo-bladder construct at one year after implantation. The company previously reported the completion of enrollment in its first Phase II study in patients with neurogenic bladder due to spina bifida.

• Vasogen Inc., of Mississauga, Ontario, said it plans to conduct a confirmatory study to support regulatory approval of Celacade technology in patients with NYHA Class II heart failure. The study's design indicated that as few as 300 patients could provide sufficient data to confirm findings of the company's 2,414-patient Phase III ACCLAIM (Advanced Chronic Heart Failure Clinical Assessment of Immune Modulation Therapy) study, which demonstrated a 39 percent reduction in the risk of death or cardiovascular hospitalizations for the pre-specified subgroup of 689 NYHA Class II heart failure patients, though the trial missed its endpoint for the overall patient population. In May, the FDA recommended a confirmatory study to support a marketing application for subgroup patients. As in the ACCLAIM study, the primary endpoint is expected to be death or first cardiovascular hospitalization.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said an investigator-sponsored trial was initiated on Cloretazine (VNP40101M) in combination with Temodar (temozolomide, Schering-Plough Corp.) in relapsed or progressive adult malignant gliomas. The study's objective is to establish the maximum tolerated dose and safety profile of the drug, with cohorts of three to six patients receiving escalating doses. A subsequent Phase II study will evaluate response rates, progression-free survival and overall survival. Cloretazine, an alkylating agent, also is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia, as well as additional trials in small-cell lung cancer.