Healthpoint Biotherapeutics, of Fort Worth, Texas, said that the results for its Phase IIb trial investigating the efficacy of HP802-247 in venous leg ulcers are published in The Lancet. The trial, which enrolled 228 subjects, was designed to determine the potential effectiveness of two cell concentrations and two dosing frequencies of HP802-247, when combined with standard care, compared to control plus standard care, in healing venous leg ulcers over a 12-week treatment period. HP802-247, the
Advanced Cell Technology Inc., of Marlborough, Mass., treated its fourth patient, or the first in a second cohort, in a Phase I/II trial for dry, age-related macular degeneration with its human embryonic stem cell-derived retinal pigment epithelial cells. The procedure was carried out at the Willis Eye Institute in Philadelphia. BioDelivery Sciences International Inc., of Raleigh, N.C., and Endo Health Solutions, of Chadds Ford, Pa., began a Phase III trial of BEMA Buprenorphine for chronic
Acetylon Pharmaceuticals Inc., of Boston, said it initiated enrollment in a Phase Ib trial of lead candidate rocilinostat (ACY-1215) in combination with Revlimid (lenalidomide, Celgene Corp.) and dexamethasone for the treatment of relapsed and relapsed/refractory multiple myeloma. Rocilinostat is an oral Class II histone deacetylase inhibitor selective for the intracellular enzyme HDAC6. The primary outcome is to establish the optimal dose of rocilinostat over a 28-day treatment cycle. Acetylon
Pfizer Inc., of New York, reported top-line results from the Phase III ORAL Start study of JAK inhibitor tofacitinib in moderate to severe active rheumatoid arthritis (RA). Data showed that the drug met the primary endpoints at both the 5-mg and 10-mg twice-daily doses. Tofacitinib was found to be superior to methotrexate, with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Share Score, and in reducing signs and
GenSpera Inc., of San Antonio, Texas, said the FDA cleared the firm to start a Phase II trial of lead compound G-202 in prostate cancer patients who have failed prior hormonal therapy. The trial is expected to recruit up to 40 patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer. GenSpera's platform combines plant-derived cytotoxin thapsigargin with a prodrug delivery system designed to release the drug only within the tumor. Lixte Biotechnology Holdings Inc., of
Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said results of analyses show that Onglyza (saxagliptin) 5 mg demonstrated improvements across key measures of blood sugar control compared to placebo in adults with Type II diabetes who are at high risk for cardiovascular disease. The results, from a pooled, post hoc assessment of five, 24-week Phase III studies involving 1,681 patients, showed that patients taking Onglyza 5 mg demonstrated glycemic improvements compared to
Advanced Cell Technology Inc., of Marlborough, Mass., treated its final patient of the first cohort in a Phase I/II trial of retinal pigment epithelial cells derived from embryonic stem cells for Stargardt's macular dystrophy. The cells were delivered by sub-retinal transplantation. The primary endpoint of the study is safety and tolerability at 12 months following the procedure. Immatics biotechnologies GmbH, of Tübingen, Germany, published data from two clinical trials of IMA901, a cancer
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a Phase III trial of ponatinib, a pan-Bcr-Abl inhibitor, in adults with newly diagnosed chronic myeloid leukemia (CML). The study, dubbed EPIC (Evaluation of Ponatinib vs. Imatinib in Chronic Myeloid Leukemia) is designed to support regulatory approval of the drug in treatment-native CML patients by assessing its efficacy against Gleevec (imatinib, Novartis AG), with a primary endpoint of major molecular response (MMR) rate at 12
Apogenix GmbH, of Heidelberg, Germany, said its Phase II trial of lead compound APG101 in recurrent glioblastoma met and exceeded expectations, which was to increase the percentage of patients reaching progression-free survival for six months by 100 percent. A total of 84 patients were treated either with a combination of APG101 plus radiotherapy (APG101+RT group) or radiotherapy alone (RT group) in the randomized controlled study. In addition, the company said all the important secondary
Sanofi Pasteur, the vaccines division of Paris-based Sanofi SA, said its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, generating antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand. Large-scale Phase III trials with 31,000 participants are under way in 10 countries of Asia and Latin America.
Actinium Pharmaceuticals Inc., of Newark, N.J., made a regulatory milestone payment to Abbott, of Abbott Park, Ill., following the launch of Actinium's Phase I/II trial of Actimab-A in acute myeloid leukemia. The candidate is a construct developed using Lintuzumab, the monoclonal antibody licensed from Abbott Biotherapeutics, and Actinium's technology to deliver high doses of alpha irradiation directly to cancer cells while largely sparing healthy tissue. Under terms of the Abbott license
Amarin Corp. plc, of Dublin, Ireland, said results from its pivotal Phase III trial (ANCHOR) are now available electronically through The American Journal of Cardiology, scheduled for print publication in October 2012. The publication describes previously reported results showing that the product, AMR101, met all primary and secondary endpoints. The 12-week, placebo-controlled, randomized, double-blind, 12-week study evaluated AMR101 for high triglycerides in patients with mixed dyslipidemia
Kowa Pharmaceuticals America Inc., of Montgomery, Ala., and Eli Lilly and Co., of Indianapolis, released results from a pharmacokinetic study exploring potential drug interaction between cholesterol medication Livalo (pitavastatin) 4 mg and protease inhibitor combo Prezista/Norvir (darunavir, Tibotec Pharmaceuticals Ltd./ritonavir, Abbott) 800 mg/100 mg in healthy volunteers. The study found that, when co-administered, the blood levels for Livalo and each of the protease inhibitors were not
Bristol-Myers Squibb Co., of New York, said its candidate for liver cancer, brivanib, did not meet its primary overall survival objective based on a noninferiority statistical design in the Phase III BRISK-FL trial. The randomized, double-blind, multicenter trial enrolled patients with advanced hepatocellular carcinoma who had not received prior systemic treatment. Other ongoing trials of brivanib will continue.
GlaxoSmithKline plc, of London, said it began a Phase III trial of its herpes zoster vaccine candidate for the prevention of shingles in immunocompromised patients. The vaccine contains the QS-21 Stimulon 1 adjuvant by Agenus Inc., of Lexington, Mass. The randomized, placebo-controlled trial has enrolled more than 1,400 patients.
AMAG Pharmaceuticals Inc., of Lexington, Mass., reported preliminary results from the second Phase III study testing Feraheme (ferumoxytol) in patients with iron deficiency anemia regardless of the underlying cause. Feraheme demonstrated superiority on all primary efficacy endpoints, with patients in the Feraheme group achieving a statistically significant mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of 0.1 g/dL in patients in the placebo group. The trial
AstraZeneca plc, of London, said it plans to conduct the EUCLID study, a global trial involving 11,500 patients with peripheral artery disease (PAD), to test Brilinta (ticagrelor) as a monotherapy, compared to Plavix (clopidogrel, Sanofi SA and Bristol-Myers Squibb Co.). EUCLID is designed to evaluate cardiovascular event rate and safety in PAD patients. Grifols SA, of Barcelona, Spain, said it plans to start a safety trial of an inhaled formulation of alpha1-proteinase inhibitor later this
Medgenics Inc., of Misgav, Israel, said it launched a Phase IIa trial in Israel testing Epodure Biopumps in anemia in patients with end-stage renal disease on dialysis. The study will evaluate the ability of the biopumps, which deliver sustained doses of erythropoietin (EPO), to replace most or all injections of EPO or other erythropoiesis-stimulating agents while maintaining blood hemoglobin levels within the desired range. Medgenics anticipates beginning a larger Phase IIb trial in dialysis
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported positive results from a Phase I trial of ALN-TTR02 in TTR-mediated amyloidosis. The randomized, single-blind, placebo-controlled study in 17 healthy volunteers showed that there was a 94 percent knockdown of serum TTR levels, which was highly statistically significant (p < 0.00001). ALN-TTR02 was found to be generally safe and well tolerated, which was the primary objective of the study. Shares of Alnylam (NASDAQ:ALNY) jumped $6.64, or
Eli Lilly and Co., of Indianapolis, reported negative results from study H8Y-MC-HBBM investigating pomaglumetad methionil, also known as mGlu2/3, in patients with acute exacerbations of schizophrenia. The drug did not separate from placebo in the primary efficacy endpoint in either the overall or predefined genetic subpopulation at the two doses investigated.
Healthpoint Biotherapeutics, of Fort Worth, Texas, said that the results for its Phase IIb trial investigating the efficacy of HP802-247 in venous leg ulcers are published in The Lancet. The trial, which enrolled 228 subjects, was designed to determine the potential effectiveness of two cell concentrations and two dosing frequencies of HP802-247, when combined with standard care, compared to control plus standard care, in healing venous leg ulcers over a 12-week treatment period. HP802-247, the