Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, disclosed interim results from the RELY-ABLE trial, a long-term extension of the RE-LY study. During more than two years of randomized follow-up, key safety outcomes such as major bleeding, total bleeding and life-threatening bleeding were similar to the results of the dabigatran 110-mg and 150-mg arms of the pivotal RE-LY trial that evaluated Pradaxa (dabigatran etexilate mesylate) capsules in

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

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

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.

Cytori Therapeutics Inc., of San Diego, said two independent investigator-sponsored and funded cell therapy clinical trials in Japan have been approved. One study will investigate Cytori's cell therapy as a treatment for ischemic heart failure and the other for cirrhosis of the liver. In each study, patients will receive an injection of Cytori's cell therapy, which consists of the patient's own adipose-derived stem and regenerative cells (ADRCs) processed using Cytori's Celution system. The

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

Aeterna Zentaris Inc., of Quebec City, said its ghrelin agonist, AEZS-130, showed potential as an oral diagnostic test for adult growth hormone deficiency, and that its accuracy is comparable to currently available tests. The study and its results were presented at the International Congress of the Growth Hormone Research and Insulin-like Growth Factor Society in Munich, Germany. Curis Inc., of Lexington, Mass., achieved the first two development milestones related to its agreement with the

Chiesi Group, of Parma, Italy, said it completed a Phase I trial of inhaled PDE4 inhibitor CHF 6001 that showed the drug was well tolerated up to the highest doses administered, in single and multiple dose parts of the study. Based on those data, two Phase IIa studies are ongoing in patients with asthma and chronic obstructive pulmonary disease. Pfizer Inc., of New York, said it completed a study to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg twice daily compared to

Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported preliminary results from a study showing treatment with melt-in-the-mouth desmopressin, an orally disintegrating tablet, reduced period limb movements (PLMS) in children with nocturnal enuresis (bedwetting). The anti-diuretic effect of desmopressin melt correlated strongly with reduced PLMS, with 90 percent of children in the study experiencing reduced PLMS. Data were presented at the Joint Congress of the International Children's

Arena Pharmaceuticals Inc., of San Diego, said it started dosing in a Phase I trial of APD811, an oral drug candidate designed to target the prostacyclin receptor for the treatment of pulmonary arterial hypertension. The dose-titration study is planned to enroll up to 30 healthy adult volunteers and will evaluate safety, tolerability and pharmacokinetics of multiple ascending doses. Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the

Pfizer Inc., of New York, disclosed top-line Phase III data from an open-label long-term safety study of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, noncancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release

Cytori Therapeutics Inc., of San Diego, began a Phase I/II trial (ATHENA) of its cell therapy for refractory heart failure resulting from myocardial ischemia. The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S. who will be randomized to cell therapy or inactive placebo injection. All patients will have adipose tissue removed. The tissue is used for processing into adipose-derived stem and regenerative cells. Euthymics Bioscience Inc

Pierre Fabre Dermatolgie Laboratories, of Castres, France, a subsidiary of Pierre Fabre Laboratories, reported Phase III data showing that propranolol oral solution in infantile hemangioma resulted in complete or nearly complete resolution of the hemangioma for a sizeable majority of the infants who were treated, compared to an almost complete lack of effect from placebo. The company said it expects to submit for the drug's use in children in both the U.S. and Europe. Teva Pharmaceutical