Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD). AC-1204 is a formulation of caprylic triglyceride designed to improve cognitive function in mild to moderate AD. The randomized, double-blind, placebo-controlled, parallel-group, multicenter trial will be conducted at 60 sites in the U.S. and is expected to enroll more than 400 patients. The study will evaluate the effects of once

The Journal of the American Academy of Dermatology published results from two pivotal trials by Valeant Pharmaceuticals International Inc., of Montreal, of efinaconazole 10 percent topical solution for onychomycosis, a nail infection caused by fungi. The primary endpoint of the randomized, double-blind, vehicle-controlled study enrolling 1,655 subjects was complete cure rate at week 52. In Study 1, 17.8 percent of subjects given efinaconazole achieved complete cure, compared to 3.3 percent of

MediciNova Inc., of San Diego, started enrolling a Phase IIa trial testing MN-166 (ibudilast) in prescription opioid or heroin abusers. The trial will be conducted at Columbia University and the New York State Psychiatric Institute and is funded by the National Institutes for Drug Abuse. MN-166 is a first-in-class, orally bioavailable small-molecule glial attenuator designed to suppress pro-inflammatory cytokines IL-1 beta, TNF alpha and IL-6, and may up-regulate the anti-inflammatory cytokine

Astex Pharmaceuticals Inc., of Dublin, Calif., said results from the dose-escalation portion of a Phase I/II study showed that SGI-110, a DNMT inhibitor, is well tolerated at doses higher than the biologically effective dose. Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with

Aeterna Zentaris Inc., of Quebec City, said perifosine, its oral AKT inhibitor, combined with temsirolimus was well tolerated in an investigator-driven Phase I trial in recurrent or progression malignant glioma. The study, which involves 32 patients with recurrent or progression glioma, anaplastic astrocytoma, anaplastic oligodendroglioma and transformed low-grade gliomas, currently is accruing to dose level five after two dose-limiting toxicities in the dose level seven group and dose level

Pfizer Inc., of New York, said top-line data from a Phase III study testing pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicated that the product had a statistically significant positive effect compared to placebo in the primary endpoint, defined as time to loss of therapeutic response. The trial is the second of three Phase III studies testing the CR formulation for once-daily therapy. The first study in partial onset seizures did not meet its primary endpoint

Pfizer Inc., of New York, said top-line results from a Phase III study testing the 165-mg dose and the 330-mg dose of pregabalin controlled-release (CR) formulation in adults with partial onset seizures showed that the trial did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well tolerated. The study is one of three Phase III trials designed to test pregabalin CR for use as a once-daily therapy. The other two studies are testing the

CytRx Corp., of Los Angeles, presented results from a Phase Ib/II study of tumor-targeting doxorubicin conjugate aldoxorubicin (formerly INNO-206) in advanced soft-tissue sarcoma at the Connective Tissue Oncology Society meeting in Prague, Czech Republic. Patients treated with aldoxorubicin were delivered doxorubicin in a cumulative dose of more than 3.5 times the peak cumulative dose of standard doxorubicin with no observed cardiac toxicities. Trial data showed clinical benefit, defined as

Acceleron Pharma Inc., of Cambridge, Mass., said the Gynecologic Oncology Group started a Phase II study testing dalantercept, a protein therapeutic designed to target the activin receptor-like kinase 1 pathway, in patients with recurrent or persistent endometrial cancer. The open-label study will measure progression-free survival and objective tumor response. The study is receiving financial support from the National Cancer Institute. Anthera Pharmaceuticals Inc., of Hayward, Calif., said an

Merck & Co. Inc., of Whitehouse Station, N.J., presented data from a post-hoc subgroup analysis of three studies, which found that integrase inhibitor Isentress (raltegravir) demonstrated consistent long-term viral suppression and a well-established safety profile in adults co-infected with HIV-1 and hepatitis C virus and/or hepatitis B virus, compared to adults with HIV-1, at 240 weeks. Data were presented at the International Congress on HIV and Drug Therapy in HIV Infection meeting in

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban. The Phase III study will investigate the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or peripheral artery disease. About 20,000 patients will be enrolled.

Agenus Inc., of Lexington, Mass., reported that the second complete set of results from the Phase III trial of London-based GlaxoSmithKline plc's RTS,S malaria vaccine candidate (also known as Mosquirix), which contains Agenus' QS-21 Stimulon adjuvant, were published online in The New England Journal of Medicine and announced at the International Vaccines for Africa Conference in Cape Town, South Africa. The Phase III study met its primary endpoint and demonstrated statistically significant

DM-1992 and the generic drug were each administered over a 10-day period that included a six-day dose optimization period, followed by a three-day patient self-assessment period and one in-clinic day for clinician evaluation and pharmacokinetic measurements

Array BioPharma Inc., of Boulder, Colo., reviewed the abstracts released ahead of the American Society of Hematology meeting next month, showing that ARRY-520, a dual p38/Tie2 inhibitor, plus low-dose dexamethasone produced a 22 percent overall response rate in patients with triple-refractory multiple myeloma who have had a median number of 10 prior treatment regimens. In a related abstract assessing the same group of patients, the company said that prospective screening for the acute phase

Taiho Pharmaceutical Co. Ltd., of Tokyo, presented early stage data for multiple oncology compounds at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Irealnd, including Phase II results showing that TAS-102 produced an improvement in overall survival in patients with metastatic colorectal cancer. Additional presentations focused on TAS-114, a dUTPase dual and DPD dual inhibitor, and TAS-115, a dual inhibitor of hepatocyte and vascular endothelial growth

Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said results were published in The Lancet from the firm's 78-week pivotal Phase III study of lomitapide in adult patients with homozygous familial hypercholesterolemia. The compound was recommended for approval by an FDA advisory panel last month. (See BioWorld Today, Oct. 18, 2002.) Aerie Pharmaceuticals Inc., of Bedminster, N.J., disclosed positive top-line results from its Phase IIa study evaluating AR-13324 for the treatment of glaucoma

Aegerion Pharmaceuticals Inc., of Cambridge, Mass., said results were published in The Lancet from the firm's 78-week pivotal Phase III study of lomitapide in adult patients with homozygous familial hypercholesterolemia. The compound was recommended for approval by an FDA advisory panel last month. (See BioWorld Today, Oct. 18, 2002.) Aerie Pharmaceuticals Inc., of Bedminster, N.J., disclosed positive top-line results from its Phase IIa study evaluating AR-13324 for the treatment of glaucoma

Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said the independent data and safety monitoring board for its three ongoing trials approved the enrollment and treatment of two additional patients with dry age-related macular degeneration, representing the final patients in the trial's three-patient second cohort. Each will be injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial cells. Aerie Pharmaceuticals Inc., of Bedminster, N.J., reported top-line

Asahi Kasei Pharma America Corp., of Waltham, Mass., said it started an 800-patient Phase III trial of ART-123 (recombinant human thrombomodulin, sold as Recomodulin in Japan) in severe sepsis patients with coagulopathy. The study is designed to measure 28-day all-cause mortality as its primary efficacy endpoint; primary safety measures include serious adverse events, adverse events and major bleeding events. Secondary endpoints include all-cause mortality at three months and resolution of