All posts in News

Source: Novo Nordisk & reported by http://www.prnewswire.com/
MUNICH, September 16, 2016 /PRNewswire/ -- Novo Nordisk today announced that semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, significantly reduced the risk of the primary composite endpoint of time to first occurrence of either cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 26% vs placebo, when added to standard of care in 3,297 adults with type 2 diabetes at high CV risk.[1] These results were based on an accumulation of first major adverse CV events (MACE) in 254 people.
The main results from SUSTAIN 6 were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016[2] and also published in the New England Journal of Medicine.
Furthermore, there was a significant 39% decrease in non-fatal stroke and a non-significant 26% decrease in non-fatal myocardial infarction and a neutral outcome (2% decrease) in CV death after only two years of treatment.
"The reduction in cardiovascular events observed with semaglutide in SUSTAIN 6 is notable given the small study population and the short trial duration," said Dr Steven Marso, SUSTAIN 6 investigator and the lead author for the New England Journal of Medicine publication of SUSTAIN 6. "These findings are clinically relevant, as cardiovascular disease is the leading cause of death in people with type 2 diabetes and new treatment options that can also reduce the risk of cardiovascular events are needed."
Read more: http://www.prnewswire.com/news-releases/semaglutide-reduced-major-cardiovascular-events-by-26-in-adults-with-type-2-diabetes-at-high-cardiovascular-risk-593658161.html

Source: http://www.streetinsider.com/
Galena Biopharma, Inc. (Nasdaq: GALE) announced that preclinical data from the Company’s NeuVax (nelipepimut-S) program is being presented today at the Progress in Vaccination Against Cancer (PIVAC) Conference in Winchester, UK. NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein, which is expressed in ovarian and pancreatic cancers as well as in breast cancer.

The poster, entitled, “Preclinical study on the efficacy of NeuVax peptide vaccine against human Her2+/ HLA-A2.1+ ovarian and pancreatic cancer,” demonstrated the results of HLA-A2 transgenic mice that were immunized with NeuVax (E75) mixed with recombinant mouse GM-CSF (NeuVax mice). As control, a group of mice received GM-CSF alone (control mice). CD8+ T cells purified from the spleens of HLA-A2 transgenic immunized mice were adoptively transferred to NSG (NOD/SCID/IL2Rγnull) mice bearing human ovarian or pancreatic tumors which were HER2+, HLA-A2+.

Administration of the NeuVax vaccination resulted in a specific, delayed-type hypersensitivity (DTH) reaction and in the induction of E75 specific CD8+ T cells that express PD-1 (programmed T-cell death protein). Both ovarian and pancreatic tumor growth rate was significantly reduced in NSG mice that received the CD8+ T cells from NeuVax-immunized mice compared to those receiving CD8+ T cells from control mice. Additionally, PD-1 was identified on activated CD8+ T cells.

Read more: http://www.streetinsider.com/Corporate+News/Galena+Biopharma+(GALE)+Announces+Presentation+of+Significant+NeuVax+Preclinical+Data+at+PIVAC+Conference/12026975.html

Source: Novo Nordisk & reported by http://www.prnewswire.co.uk/
MUNICH, September 13, 2016 /PRNewswire/ -- Novo Nordisk today announced that semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, significantly improved glycaemic control compared to placebo, as add-on to basal insulin alone or in combination with metformin, in adults with a mean type 2 diabetes duration of 13 years. Results from SUSTAIN 5 were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016.

The 30-week trial showed that, from a mean baseline HbA1c of 8.4%, adults treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significant and superior HbA1c reductions of 1.4% and 1.8%, respectively, vs 0.1% reduction with placebo. In addition, more adults treated with 0.5 mg and 1.0 mg semaglutide achieved HbA1c targets compared with placebo: HbA1c <7% (61% and 79% vs 11%) and ≤6.5% (41% and 61% vs 5%). Adults with type 2 diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved superior weight loss vs placebo (3.7 kg and 6.4 kg vs 1.4 kg) from a mean baseline body weight of 91.7 kg. Read more: http://www.prnewswire.co.uk/news-releases/semaglutide-demonstrated-superior-hba1c-reduction-vs-placebo-as-add-on-to-basal-insulin-alone-or-with-metformin-in-adults-with-type-2-diabetes-593219281.html

Source: Stealth BioTherapeutics & reported by http://www.prnewswire.com/
BOSTON, Sept. 12, 2016 /PRNewswire/ -- Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing investigational drugs to treat mitochondrial dysfunction, today announced the initiation of a longitudinal extension trial for evaluating elamipretide in primary mitochondrial disease. The study, MMPOWER-2, will be limited to patients who completed the initial MMPOWER Phase 2 study. Positive data from MMPOWER were announced in June 2016 showing statistically significant improvement in distance walked in six minutes.

"Patients with rare primary mitochondrial diseases have no FDA-approved treatment options to address their needs," said Stealth Chief Executive Officer Reenie McCarthy. "We're committed to helping fill these significant gaps in care through our study of elamipretide. Following the promising results from our Phase 2 MMPOWER study, we're happy to announce the initiation of MMPOWER-2, which will help us better understand the effects of longer treatment with elamipretide for these patients, who often face severe challenges completing even simple daily activities."

MMPOWER-2 is a randomized, double-blind, placebo-controlled crossover study to evaluate the safety, tolerability and efficacy of four weeks' treatment with once-daily subcutaneous injections of elamipretide in patients with genetically confirmed mitochondrial disease. All patients in this study have previously completed the MMPOWER study.
Read more: http://www.prnewswire.com/news-releases/stealth-biotherapeutics-initiates-phase-2-study-of-elamipretide-in-primary-mitochondrial-disease-300325810.html

Source: http://www.businesswire.com/
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Circle Pharma, Inc., today announced that it will apply its computational design and synthetic chemistry platform to design and create a physical screening library of novel macrocyclic peptides. Once completed, the library is initially expected to comprise several hundred macrocycles that will be designed to potentially disrupt bioactive conformations commonly found in protein-protein interactions known to drive disease processes, and will deploy backbone scaffolds screened in silico for intrinsic cell permeability characteristics. In addition, the design of the library will permit the simple creation of derivative libraries tailored to specific features of a therapeutic target class.

Pfizer Inc. (NYSE:PFE) has entered into an agreement with Circle under which Pfizer will provide support for the library build, and Circle has granted Pfizer non-exclusive rights to screen the library against certain targets. The rights granted to Pfizer exclude specified targets for which Circle has reserved exclusive rights to screen the library.

“This physical library will complement Circle’s target-specific computational design toolkit,” said David J. Earp, J.D., Ph.D., Circle’s President and CEO. “We expect to use the library for our internal pipeline discovery work, and we will make it available to all of our collaboration partners in drug discovery.”

Read more: http://www.businesswire.com/news/home/20160912005024/en/

Source: http://www.alz-pharma.com/
Lyon, France, September 12, 2016: Alizé Pharma III SAS, an Alizé Pharma group company specialized in the development of biopharmaceuticals to treat metabolic disorders and rare diseases, today announces it will present preclinical results from its I-HBD1 program in osteoporosis during the Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Atlanta on September 16-19, 2016.

Alizé’s I-HBD1 program focuses on a new peptide derived from a physiological protein, IGFBP-2 (Insulin-like Growth Factor Binding Protein-2), as a new bone anabolic agent. Scientific work led by Dr David Clemmons from the University of North Carolina at Chapel Hill (USA) and Dr Clifford Rosen from the University of Maine (USA) has established that IGFBP2 plays a key physiological role in the differentiation of osteoblasts, the cells responsible for bone formation. I-HBD1, a short peptide fragment derived from IGFBP-2, replicates the anabolic effects of IGFBP-2 on bone. It is intended to be developed as a new therapeutic approach for osteoporosis and some rare metabolic diseases associated with impaired bone formation.

Alizé Pharma III is conducting the I-HBD1 project in collaboration with New Paradigm Therapeutics, a spin-off company from the University of North Carolina at Chapel Hill founded by Dr. David Clemmons.

Read more: http://www.alz-pharma.com/actualite/alize-pharma-iii-presents-preclinical-results-from-its-i-hbd1-program-at-the-annual-meeting-of-the-american-society-for-bone-and-mineral-research

Source: Avelas Bioscienes, Inc. & reported by http://www.prnewswire.com/
SAN DIEGO, Sept. 8, 2016 /PRNewswire/ -- Avelas Biosciences, Inc., a clinical stage oncology-focused company dedicated to improving cancer patient care from diagnosis through treatment, today announced the completion of patient enrollment in its Phase 1b clinical trial for AVB-620, a surgical marker, in women with primary, non-recurrent breast cancer undergoing surgery. Avelas will announce data from the trial at a future medical meeting.

"I'm pleased to announce that we have completed enrollment in our Phase 1b trial of AVB-620 in women with primary, non-recurrent breast cancer undergoing surgery," said Carmine N. Stengone, president and chief executive officer of Avelas Biosciences. "I believe that AVB-620 could contribute materially and positively to the diagnosis and treatment of this highly prevalent disease and look forward to sharing the results from this program in the coming months."

AVB-620 Phase 1b Clinical Program: Fifteen patients were enrolled in the initial dose-escalation portion of the Phase 1b trial, the purpose of which was to evaluate safety and pharmacokinetics and to determine the dose for additional imaging analysis in the second stage of the study. Interim analysis showed no toxicity issues and identified a preferred dose to take forward into the expansion phase of the trial. A total of 12 additional patients have been enrolled in the dose-expansion stage of the trial, where the focus remains on safety, pharmacokinetics, and the timing of imaging after AVB-620 administration. The company expects to announce data from its completed Phase 1b trial later this year.

Read more: http://www.prnewswire.com/news-releases/avelas-biosciences-completes-patient-enrollment-for-avb-620-phase-1b-clinical-trial-300324345.html