Merck and Co. Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma. Based on data for 85 of 132 patients enrolled in the study to date, 43 patients (51 percent) showed an objective antitumor response and eight patients (9 percent) showed a complete response at or after the 12-week assessment. Of 27 patients previously treated with ipilimumab (Yervoy, Bristol
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
Advanced Cell Technology Inc., of Santa Monica, Calif., said it has treated 13 patients thus far in its three ongoing trials for dry age-related macular degeneration and Stargardt's disease using human embryonic stem cell-derived retinal pigment epithelial cells. The first two trials began in July 2011. The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the UK. Across the various clinical trial sites, with regular patient
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
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
Amgen Inc., of Thousand Oaks, Calif., reported results from the LAPLACE-TIMI 57 and MENDEL Phase II studies testing AMG 145 in hypercholesterolemic patients with or without statins, respectively, showing that treatment with the PCSK9-directed antibody resulted in a statistically significant reduction in low-density lipoprotein cholesterol (LDL-C). All six dose regimens of AMG 145 significantly decreased LDL-C, measured by preparative ultracentrifugation, from baseline vs. placebo at week 12 in
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
Advaxis Inc., of Princeton, N.J., presented updated data at the Society for Immunotherapy of Cancer meeting in North Bethesda, Md., from its ongoing 110-patient Phase II trial testing ADXS-HPV vs. ADXS-HPV plus cisplatin in India in women with recurrent/refractory cervical cancer who have failed previous cytotoxic therapy. As of Oct. 22, landmark survival at six months, nine months, 12 months and 18 months was 65 percent, 44 percent, 33 percent and 17 percent, respectively, with no apparent
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.
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.
Astex Pharmaceuticals Inc., of Dublin, Calif., said it started an open-label Phase II trial testing Hsp90 inhibitor AT13387 in anaplastic lymphoma kinase-positive non-small-cell lung cancer (NSCLC) patients or other potentially Xalkori- (crizotinib, Pfizer Inc.) sensitive NSCLC patients who have been receiving Xalkori. The study will test AT13387 as both a single agent and in combination with Xalkori. The study will consist of three parts: The primary objective of Part A is to determine safety
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
Merck and Co. Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma. Based on data for 85 of 132 patients enrolled in the study to date, 43 patients (51 percent) showed an objective antitumor response and eight patients (9 percent) showed a complete response at or after the 12-week assessment. Of 27 patients previously treated with ipilimumab (Yervoy, Bristol