All posts in Peptide News from Biotech and Pharma

Source: http://www.businesswire.com/

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ra Pharmaceuticals announced today that it has launched a Phase 1 study of its synthetic peptide C5 inhibitor, RA101495. The Phase 1 trial is a randomized, double-blind study designed to test the safety of single, escalating doses of RA101495 and to establish the pharmacokinetics and pharmacodynamics after subcutaneous administration in healthy volunteers.

“This study is the first step in the clinical development of RA101495 and will allow us to determine a dose suitable for treating patients with a range of complement-mediated disorders including our lead indication, paroxysmal nocturnal hemoglobinuria (PNH), a rare acquired hematologic syndrome in which red blood cells are destroyed by the complement system,” said Debasish Roychowdhury, M.D., Acting Chief Medical Officer of Ra Pharmaceuticals. “In this study we will be monitoring both safety as well as complement inhibitory activity in plasma samples from treated subjects. The data being presented at ASH highlights the novel mechanism of action and the in vivo pharmacokinetics and pharmacodynamics of RA101495. Our in vivo studies have demonstrated that RA101495 can potently and durably suppress complement activity, which is known to be a critical factor in the treatment of PNH”, added Dr. Roychowdhury.

Read more: http://www.businesswire.com/news/home/20151202005317/en/Ra-Pharmaceuticals-Announces-Initiation-First-in-Human-Clinical-Trial

Source: RegeneRx Biopharmaceuticals, Inc. and reported by http://www.prnewswire.com/

ROCKVILLE, Md., Dec. 4, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the Chinese State Intellectual Property Office (SIPO) has issued a patent for a key peptide fragment of Thymosin beta 4 (TB4) to RegeneRx. The patent claims are directed to both composition of matter and methods of use, including suppressing inflammation, stimulating cell migration, protecting tissue from cytotoxicity, inhibiting apoptosis, inhibiting tissue damage caused by UV radiation, and stimulating elastin, among others.  The patent expiry is expected to be in 2029.

"This is one of two biologically active peptide fragments of TB4 that we are interested in because, as demonstrated in a number of animal models, we believe they have properties potentially useful in medical and cosmeceutical product candidates.  We are pleased that we received this patent in China, which has significant market potential for such products," stated Dr. Allan L. Goldstein, Emeritus Professor and Chairman of the Department of Biochemistry and Molecular Medicine at The George Washington University School of Medicine and RegeneRx's chief scientific advisor.

Read more: http://www.prnewswire.com/news-releases/regenerx-receives-chinese-patent-for-key-tb4-peptide-fragment-300188201.html

Source: http://www.prnewswire.com/

ZUG, Switzerland and NEW YORK, Nov. 30, 2015 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on innovative products to treat cancers and central nervous system (CNS) diseases, today announced that positive data from the Company's clinical studies of its WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) and acute myeloid leukemia (AML) were reported at the International WT1 Conference, held in Kyoto, Japan, earlier this month. Clinically meaningful prolonged survival was demonstrated in both patient groups. A median overall survival of 52.5 months was achieved in a Phase 2 trial of the WT1 vaccine in adult patients with AML. Similarly, in a previous Phase 1 AML study, the WT1 vaccine resulted in a median overall survival of more than 5 years. When combined, the results from the Phase 1 and Phase 2 studies demonstrated a 2-year overall survival in adult AML patients of 79%. Historical 2-year overall survival results in similar patient populations range from 30% to 45%.

Additionally, a randomized, double-blind, placebo-controlled Phase 2 study in MPM patients at Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center showed a median overall survival of 21.4 months for WT1 vaccine-treated patients versus 16.6 months overall survival for patients in the placebo control arm at a recently updated review. The WT1 cancer vaccine also resulted in a median progression-free survival of 11.4 months, double that of the control arm, 5.7 months, in patients with MPM. In both the AML and MPM trials, SELLAS's WT1 vaccine demonstrated a favorable safety and tolerability profile. These and other clinical data were reported at the International WT1 Conference in an oral presentation, titled "Clinical Development of a Multivalent WT1 Peptide Vaccine for Leukemias and Solid Tumors," delivered by David A. Scheinberg, M.D., Ph.D., an inventor of the WT1 vaccine and Chairman of the Molecular Pharmacology Program and of the Center for Experimental Therapeutics at Memorial Sloan Kettering Cancer Center (MSK).

Read more: http://www.prnewswire.com/news-releases/sellas-life-sciences-reports-positive-wt1-cancer-vaccine-clinical-results-in-mesothelioma-and-acute-myeloid-leukemia-aml-patients-at-the-annual-international-wt1-conference-300185027.html

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PARIS, Sept. 29, 2015 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus (T2DM).

"The FDA filing notification for lixisenatide is an important milestone for Sanofi," said Pierre Chancel, Senior Vice President, Head of Global Diabetes at Sanofi. "Sanofi's integrated portfolio of marketed products provides treatment, monitoring and support at every stage of the diabetes journey. Lixisenatide is a critical element of this portfolio, and we look forward to working with the FDA during the review process with the goal of bringing lixisenatide to patients in the U.S."

The NDA submission for lixisenatide is based on results from the GetGoal clinical program and includes findings from the recently-completed ELIXA study, the first completed long-term CV outcomes study of a GLP-1 receptor agonist. The GetGoal Phase III clinical program enrolled more than 5,000 patients worldwide, evaluating the safety and efficacy of lixisenatide, including its treatment effect on HbA_1c, post-prandial glucose and body weight in adults with T2DM. The ELIXA trial evaluated the cardiovascular safety of lixisenatide versus standard of care in more than 6,000 adults with T2DM and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event).

Read more: http://www.prnewswire.com/news-releases/sanofi-new-drug-application-for-lixisenatide-accepted-for-review-by-fda-300150622.html

Source: http://www.businesswire.com/

JERUSALEM & LONDON--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Heptares Therapeutics (“Heptares”), a wholly owned subsidiary of Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announce that they have entered into a licensing and drug-discovery agreement under which Teva will receive exclusive global rights to develop, manufacture and commercialize novel, small-molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares for the treatment of migraine.

Under the terms of the agreement, Heptares will receive an upfront payment of $10 million, research funding, and is eligible to receive additional research, development and commercialization milestone payments of up to $400 million. In addition, Heptares will be eligible to receive royalties on net sales of products resulting from the alliance.

“We are delighted to begin this partnership with Heptares, which through its industry-leading, structure-based design approach has generated novel CGRP antagonists with significant promise for treating migraine,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. “CGRP antagonism represents an exciting opportunity to treat migraine. We believe small-molecule CGRP antagonists offer further opportunities that are highly complementary to our promising candidate, TEV-48125, an anti-CGRP antibody.”

Read more: http://www.businesswire.com/news/home/20151125005141/en/Teva-Heptares-Enter-Agreement-Discover-Develop-Small-Molecule

Source: http://www.businesswire.com/

MONTREAL--(BUSINESS WIRE)--Angiochem, a biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier (BBB) announced positive clinical results with ANG1005, a novel paclitaxel-peptide drug conjugate, in breast cancer patients with leptomeningeal carcinomatosis (LC), a metastatic cancer that spreads rapidly to the membranes of the brain and spinal cord. Interim data from this ongoing Phase 2 study were presented at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) at San Antonio, Texas. Based on these results, Angiochem is developing a multi-study Phase 3 clinical program to evaluate ANG1005 in breast cancer patients with or without LC.

In a poster titled “ANG1005, a Novel Brain-penetrant Peptide-taxane Conjugate, for the Treatment of CNS Metastases from Breast Cancer,” Angiochem researchers and collaborators at Northwestern University and other clinical centers reported interim Phase 2 study results demonstrating that breast cancer patients with brain metastases treated with ANG1005, including a subset of patients with LC, achieved encouraging responses. Of the 21 heavily pre-treated patients with LC, 5 patients (24%) achieved a partial response (PR) and 11 patients (52%) had stable disease (SD) as best intracranial response. The Kaplan-Meier estimates of survival in patients with LC treated with ANG1005 predict a median survival (95% CI) of 38.4 weeks as compared to 4-6 weeks if left untreated or 12-24 weeks with conventional chemotherapy. In addition, ANG1005 demonstrated intracranial and extracranial antitumor activity in patients with various other subtypes of breast cancer including patients previously treated with paclitaxel. ANG1005 was shown to be generally safe and well-tolerated, and demonstrated an adverse event profile consistent with conventional taxane therapy at both dose levels studied (550mg/m² and 600mg/m²).

Read more: http://www.businesswire.com/news/home/20151120005128/en/Angiochem-Reports-Positive-Clinical-Data-ANG1005-Breast

Source: http://www.businesswire.com/

Ipsen (Euronext: IPN, ADR: IPSEY), a global specialty driven pharmaceutical Group, and Interprotein Corporation (Interprotein), a Japanese R&D focused biotechnology company, today announced that they have signed a research collaboration and an option agreement to develop and commercialize new therapeutic peptides intended for serious medical conditions in endocrinology, such as Cushing’s disease.

Under the terms of the agreement, Ipsen will combine its expertise in design and development of therapeutic peptides targeting specific receptors with Interprotein’s Protein-Protein Interaction (PPI) and helix-loop-helix-peptide (HLHP) technologies.

“We are very excited to be involved in Ipsen’s innovative drug discovery program for this rare disease. We are particularly proud that our technological platform has been selected to advance Ipsen’s target molecules. This agreement fits our strategy to partner on PPI targeted Drug Discovery activities," said Masato Hosoda, Chief Executive Officer at Interprotein.

Read more: http://www.businesswire.com/news/home/20151118006712/en/Ipsen-Interprotein-enter-research-collaboration-peptides-endocrinology

Source: http://www.fiercebiotech.com/

PRINCETON, N.J.--(BUSINESS WIRE)--Derma Sciences, Inc. (Nasdaq: DSCI), a tissue regeneration company focused on advanced wound and burn care, announces the termination of its Phase 3 clinical trials with aclerastide (DSC127) for diabetic foot ulcer healing. This action is based on futility determinations conducted by the Data Monitoring Committee (DMC) for the planned, pre-specified interim analyses regarding the primary efficacy endpoint of confirmed complete wound closure of the target ulcer within 12 weeks of the start of treatment. The decision to end the studies followed the recommendation by the DMC to stop enrollment in the studies. The DMC also reported that there were no safety concerns attributed to aclerastide.

"We are very disappointed with the findings of the analyses of the DMC, but are grateful for the support and commitment from the participating patients and the study investigators," said Edward J. Quilty, chairman and chief executive officer of Derma Sciences. "We have stopped further enrollment and initiated an orderly termination of the aclerastide trials and program, which we believe will be substantially complete by year end. We are also halting all development work with DSC127 in scar reduction and radiation dermatitis."

Read more: http://www.fiercebiotech.com/press-releases/derma-sciences-announces-results-futility-analyses-phase-3-clinical-trials

Source: Eiger BioPharmaceuticals, Inc. and reported by http://www.prnewswire.com/

PALO ALTO, Calif., Nov. 12, 2015 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. today announced that it has acquired an exclusive license to a targeted therapeutic for treating post-bariatric surgical hypoglycemia.  Gastric bypass procedures are widely performed and are increasing for medically complicated obesity, including Type 2 diabetes.  The technology was invented by Tracey McLaughlin, MD, Associate Professor of Medicine at Stanford University Medical Center in the Division of Endocrinology.

As the use of bariatric surgical procedures increases worldwide, a new post-surgical complication, hyperinsulinemic hypoglycemia, is increasingly reported.  This disorder leads to frequent symptomatic hypoglycemia, often resulting in glucose concentrations low enough to cause seizures, altered mental status, loss of consciousness, cognitive dysfunction, disability and death.  Quality of life can be severely diminished, and many patients cannot care for themselves or others, work, drive, or be left alone.  There is no approved treatment for this condition, and severe cases have been surgically managed with near-total to total pancreatectomy, which results in insulin-dependent diabetes and is associated with up to a 6% surgical mortality risk.

"Research suggests that elevated glucagon-like-peptide (GLP-1) may play an important role in hyperinsulinemic hypoglycemia in post-bariatric surgery patients.  Surgically-altered nutrient transit causes enhanced secretion of GLP-1 leading to elevated insulin secretion.  This effect may play a primary role in the early resolution of Type 2 diabetes after surgery," said Joanne Quan, MD, Chief Medical Officer at Eiger.  "An exaggeration of this same effect in some patients results in severe debilitating hypoglycemia. Stanford Researchers have now demonstrated in multiple clinical studies in patients that pharmacologic blockade of the GLP-1 receptor with Exendin (9-39) prevents hypoglycemia and improves symptoms.  Exendin (9-39) may represent the first targeted medical treatment for patients with post-bariatric surgical hypoglycemia."

Read more: http://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-announces-acquisition-of-exclusive-license-to-program-for-treatment-of-post-bariatric-hypoglycemia-from-stanford-university-300177006.html

Source: Morphotek, Inc. and reported by http://www.prnewswire.com/

EXTON, Pa., Nov. 9, 2015 /PRNewswire/ -- Morphotek^®, Inc., a subsidiary of Eisai Inc., announced today that it has entered into a license agreement with Blaze Bioscience, Inc. of Seattle, WA, a privately held biotechnology company developing Tumor Paint technology.  Under the agreement, Morphotek provides to Blaze an exclusive, worldwide, royalty-bearing license to develop, license, and once approved, commercialize a potential tumor-targeting chlorotoxin derivative linked to a near-infrared diagnostic agent, which may help visualize cancer cells during surgery.

The tumor-targeting chlorotoxin derivative was originally isolated from scorpion venom. The chlorotoxin peptide was identified and pursued experimentally based on its ability to bind and suppress growth of activated epithelial cells. Subsequent studies have found that chlorotoxin peptides and engineered variants may bind and potentially be internalized by malignant cells via the annexin A2 complex. A completed Phase 2 clinical trial of radio-labelled chlorotoxin peptide evaluated overall survival in patients with recurrent glioma.

Read more: http://www.prnewswire.com/news-releases/morphotek-inc-announces-a-license-agreement-with-blaze-bioscience-inc-for-the-development-of-novel-oncology-imaging-technology-300172565.html