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

AB Science SA, of Paris, reported Phase III results showing that masitinib in combination with Gemzar (gemcitabine, Eli Lilly and Co.) significantly extended overall survival in patients with pancreatic cancer by six months and 2.7 months in two independent patient populations, representing 65 percent and 45 percent of the overall population – namely, patients with a genetic biomarker indicative of aggressive disease progression. AB Science also said the European Medicines Agency accepted for

Bioheart Inc., of Sunrise, Fla., said it will start its ANGEL trial in Mexico and said NorthStart Biotech LLC, a consortium of Bioheart directors and shareholders, agreed to fund the study, which will test the safety and efficacy of LipiCell (adipose-derived stem cells) in congestive heart failure patients. The first cohort of five patients will be completed and analyzed to help establish a safety profile and preliminary efficacy. Cellceutix Corp., of Beverly, Mass., said it has recruited the

AstraZeneca plc, of London, said it started a Phase III study, dubbed FALCON, to compare fulvestrant to Arimidex (anastrozole) in hormone therapy-naïve postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer. The study is expected to involve 450 women and will evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg.

Biogen Idec Inc., of Weston, Mass., reported in its third-quarter earnings call that it will not proceed with a planned Phase IIa rheumatoid arthritis (RA) study of its Syk inhibitor partnered with Portola Pharmaceuticals Inc., of South San Francisco. Biogen said the compound did not meet the "stringent target product profile to be competitive in this specific market." The companies, which entered the potential $553.5 million Syk collaboration last year, will continue exploratory work in

Daiichi Sankyo Co. Ltd., of Tokyo, said it completed patient enrollment in the Hokusai-VTE Phase III study testing once-daily oral Factor Xa inhibitor edoxaban for the treatment and prevention of recurrence of venous thromboembolism in patients who have had an acute symptomatic deep vein thrombosis, pulmonary embolism or both.

Teva Pharmaceutical Industries Ltd., of Jerusalem, said its women's health subsidiary reported Phase III findings showing that Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an extended-regimen oral contraceptive, showed the product is efficacious for the prevention of pregnancy and has a safety profile similar to those of other oral contraceptives. Data were presented at the American Society of Reproductive Medicine meeting in San Diego.

Abbott, of Abbott Park, Ill., said results from a post-hoc subanalysis of the 52-week Humira (adalimumab) ULTRA 2 study showed clinically meaningful rates of mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis who failed, were intolerant or had contraindications to certain other medications and achieved a response to Humira induction therapy at eight weeks. Of the 494 patients included in the analysis and who responded at eight weeks, significantly more

Agenus Inc., of Lexington, Mass., said it started a Phase II study of HerpV, a recombinant off-the-shelf therapeutic vaccine candidate, containing the company's QS-21 Stimulon adjuvant, for treating genital herpes in herpes simplex virus 2-positive subjects. The study will enroll 75 patients who have a history of frequent disease recurrences and will test the efficacy of the vaccine as measured by effect on genital viral shedding. Celgene Corp., of Summit, N.J., said its Celgene International