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
Allon Therapeutics Inc., of Vancouver, British Columbia, said patient treatment has been completed in the multinational pivotal Phase II/III trial with davunetide as a potential treatment for progressive supranuclear palsy, a rapidly progressing and fatal degenerative brain disease. Allon is on track to release top-line data from the trial in the second half of December. AtheroNova Inc., of Irvine, Calif., said its Russian licensing partner, OOO CardioNova, formally submitted an
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.
Achillion Pharmaceuticals Inc., of New Haven, Conn., said that it completed a drug-drug interaction study of sovaprevir and ACH-3102 in 24 healthy volunteers, showing no interaction and that the compounds were safe and well tolerated. The drugs are being developed for hepatitis C virus. The company also reported additional proof-of-concept data from a Phase Ib trial of ACH-2684, for hepatitis C virus. In chronic genotype 1 patients, there was a mean maximum 3.67 log10 reduction in HCV RNA
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
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
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
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.
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