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First Patient Randomized in a Phase II Study Evaluating the Safety and Efficacy of Anakinra in the Treatment of Acute Gout

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

STOCKHOLM--(BUSINESS WIRE)--Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that the first patient has been randomized in the phase II study (anaGO) to evaluate efficacy and safety of Kineret® (anakinra) in the treatment of acute gout.

The purpose of the study is to evaluate pain relief in people with acute gout who cannot take or have not previously responded to non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine. The anaGO study is a randomized, double-blind, multicenter study being conducted in North America studying two dose levels of anakinra (s.c.) in comparison to intramuscular triamcinolone. In total 159 individuals are planned to be randomized in the study.

“There is a persistent and significant unmet medical need for resolving pain in people affected by acute gout, and there is a strong scientific rationale for investigating the safety and efficacy of anakinra in this disease. Therefore we are very excited to have the first patient randomized in this important Phase II study. We look forward to working with the study sites, and plan to complete enrollment by the second half of 2017,” says Milan Zdravkovic, Senior Vice President, Head of Research & Development at Sobi.

Read more: http://www.businesswire.com/news/home/20170111005068/en/Patient-Randomized-Phase-II-Study-Evaluating-Safety

Emergent Technologies’ Pure MHC Explores A New Collaboration With AbbVie Inc (NYSE:ABBV)

Source: https://marketexclusive.com/

AbbVie Inc (NYSE:ABBV) has sought a joint venture with its target discovery portfolio company, Emergent Technologies Inc, Pure MHC. The collaboration between the two will seek to identify a library of peptide targets that will necessitate further research across multiple tumor types.

AbbVie’s pipeline spans significant areas of medical need the likes of oncology, immunology, neuroscience and virology. This is why Chief Executive Officer at ETI and Pure MHC Thomas Harlan acknowledges, “We are excited to partner with AbbVie in the immuno-oncology space leveraging Pure MHC’s over 15 years of peptide target discovery with AbbVie’s deep clinical expertise to utilize these targets in new and improved therapies for the treatment of cancer.”

Combined efforts hope to accelerate the pace of innovation: Innovation has fully become the key driver of the world even in the simplest of tasks. Hence combined efforts are important according to AbbVie’s research and development and chief scientific officer Michael Severino. He emphasizes that the development of tomorrow’s therapies is dependent on today’s investment in leading technologies and scientific achievements. It will also facilitate an enhanced pace of innovation into new medicines for the next-generation of medical treatment.

Read more: https://marketexclusive.com/emergent-technologies-pure-mhc-explores-new-collaboration-abbvie-inc-nyseabbv/68396/

AbbVie Unveils 4 Global R&D Collaborations Focused on Advancing Next-Gen Science

Source: http://www.dddmag.com/

AbbVie, a global biopharmaceutical company, announced four new collaborations and investments with leading healthcare innovators to advance early-stage research in key therapeutic areas such as oncology and immunology. AbbVie is committed to investing in and developing transformational science and technologies to advance the next-generation of therapies across its robust pipeline in key therapeutic areas. With more than 50 compounds in clinical development, AbbVie's pipeline spans significant areas of medical need including oncology, immunology, neuroscience and virology.

"We can develop tomorrow's most important therapies by investing in today's leading technologies and scientific achievements," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Combining the strengths of AbbVie's discovery and development expertise and novel research from external partners will accelerate the pace of innovation into new medicines for the next-generation of medical treatment."

Read more: http://www.dddmag.com/news/2017/01/abbvie-unveils-4-global-r-d-collaborations-focused-advancing-next-gen-science

AbbVie Announces Four New Global Research Collaborations Focused on Advancing Next-Generation Science

Source: https://news.abbvie.com/

NORTH CHICAGO, Ill., Jan. 9, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced four new collaborations and investments with leading healthcare innovators to advance early-stage research in key therapeutic areas such as oncology and immunology. AbbVie is committed to investing in and developing transformational science and technologies to advance the next-generation of therapies across its robust pipeline in key therapeutic areas. With more than 50 compounds in clinical development, AbbVie's pipeline spans significant areas of medical need including oncology, immunology, neuroscience and virology.

"We can develop tomorrow's most important therapies by investing in today's leading technologies and scientific achievements," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Combining the strengths of AbbVie's discovery and development expertise and novel research from external partners will accelerate the pace of innovation into new medicines for the next-generation of medical treatment."

Read more: https://news.abbvie.com/news/abbvie-announces-four-new-global-research-collaborations-focused-on-advancing-next-generation-science.htm

Intarcia and Calibr Announce Collaboration and In-Licensing Deal Aimed at Delivering a Next Generation Combination Product for Diabetes and Obesity

Source: Intarcia Therapeutics, Inc. & reported by http://www.prnewswire.com/

BOSTON and SAN DIEGO, Jan. 9, 2017 /PRNewswire/ -- Intarcia Therapeutics, Inc. and the California Institute for Biomedical Research (Calibr) today announced a strategic research collaboration focused on the development of a novel peptide therapeutic leveraging Calibr's Stapled-Peptide Platform Technology. Intarcia plans to develop and administer this novel therapy in combination with Exenatide (a GLP-1 receptor agonist and active agent in Intarcia's ITCA 650 product), by leveraging its proprietary Medici Drug Delivery SystemTM.

Under the terms of the agreement, Calibr will receive an upfront grant of Intarcia equity, with additional shares vesting over key development milestones, as well as undisclosed cash payments on achievement of predetermined regulatory and sales milestones. In addition to the milestone payments, Calibr will be eligible to receive tiered royalties on product sales.

Kurt Graves, Chairman, President and CEO of Intarcia Therapeutics, commented: "We are committed to disruptive innovation leveraging our proprietary Medici Drug Delivery SystemTM and we now have several combination products in our pipeline that we believe we can uniquely optimize and deliver in a once- or twice-yearly mini-pump. We're excited to advance a combination program with Calibr that is targeting significant advances for patients suffering from type 2 diabetes and obesity."

Read more: http://www.prnewswire.com/news-releases/intarcia-and-calibr-announce-collaboration-and-in-licensing-deal-aimed-at-delivering-a-next-generation-combination-product-for-diabetes-and-obesity-300387513.html

Xenetic Biosciences Receives $3 Million Milestone Payment from Shire plc for PSA-Recombinant SHP656 in Development for Long-Acting Treatment for Hemophilia

Source: http://www.xeneticbio.com/

LEXINGTON, Mass.--(BUSINESS WIRE)-- Xenetic Biosciences, Inc. (NASDAQ: XBIO) (“Xenetic” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, announced today that Xenetic received a $3 million milestone payment from Shire plc (LSE: SHP, NASDAQ: SHPG) related to Shire’s advancing the Phase 1/2a clinical study for the PSA-Recombinant SHP656 or Factor VIII (“FVIII”) being developed as a long-acting therapeutic for the treatment of hemophilia. The stated goal of Shire is to introduce an innovative FVIII protein that can significantly prolong the circulating half-life of the FVIII protein, with the objective of providing a once weekly treatment or reaching higher trough activity levels for greater efficacy.

“We are thrilled with the progress that Shire has made developing the SHP656 program, which is currently in Phase 1/2a clinical trials for the treatment of hemophilia,” said Scott Maguire, Xenetic’s Chief Executive Officer. “We look forward to the continued development of SHP656 utilizing our proprietary PolyXen™ platform technology with the goal of having a once weekly or less frequent dosing, thereby making it the longest acting hemophilia A factor replacement treatment in development in the $9.3 billion global hemophilia market.”

Read more: http://www.xeneticbio.com/news-media/press-releases/detail/50/xenetic-biosciences-receives-3-million-milestone-payment

Synthetic Biologics’ SYN-004 (ribaxamase) Achieves Primary Endpoint in Phase 2b Trial for C. difficile Infection (CDI)

Source: Synthetic Biologics, Inc. & reported by http://www.prnewswire.com/

ROCKVILLE, Md., Jan. 5, 2017 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today announced positive topline data from its Phase 2b clinical trial for SYN-004 (ribaxamase), the Company's first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

The study, a randomized, double-blind, placebo controlled trial of 412 patients, met its primary endpoint of significantly reducing C. difficile Infection (CDI). Preliminary analysis of the data indicated seven confirmed cases of CDI in the placebo group compared to two cases in the ribaxamase treatment group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p-value=0.045) in CDI rates compared to patients receiving placebo. Adverse events reported during this trial were comparable between treatment and placebo arms.

Synthetic Biologics is also in the process of analyzing data from several exploratory endpoints that were designed to evaluate ribaxamase's ability to protect the gut microbiome from colonization by opportunistic bacteria such as C. difficile and other antibiotic-resistant pathogens. Preliminary analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients receiving ribaxamase compared to placebo (p-value=0.0002). With agreement from the FDA, the study included a secondary endpoint to assess ribaxamase's capacity to decrease the incidence of antibiotic-associated diarrhea from all causes. Preliminary analysis of the data suggested a trend towards such a reduction (p-value=0.13), which was due, for the most part, to the reduction of CDI.

Read more: http://www.prnewswire.com/news-releases/synthetic-biologics-syn-004-ribaxamase-achieves-primary-endpoint-in-phase-2b-trial-for-c-difficile-infection-cdi-300386140.html

Novaliq Announces Positive Topline Results of Phase 2 Clinical Trial Evaluating CyclASol® in Adults with Moderate to Severe Dry Eye Disease

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

HEIDELBERG, Germany--(BUSINESS WIRE)--Novaliq GmbH, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced positive Phase 2 results evaluating CyclASol®, a clear, preservative-free cyclosporine A solution, in 207 patients with moderate to severe dry eye disease (DED). CyclASol showed a consistent reduction in corneal fluorescein staining, the primary sign endpoint, with an early onset of action over the 4-month treatment period.

This Phase 2 randomized, double-masked, vehicle-controlled, multi-center U.S. study consisted of four treatment groups, including two CyclASol groups (0.05% and 0.1%), an open label active control, and a placebo (vehicle control) group. Both CyclASol groups showed a significant improvement in corneal staining compared with the vehicle over the 4-month treatment period. In particular, the central area of the cornea seems to benefit most, which is an important aspect for the visual function in dry eye patients. All treatment groups demonstrated improvement in symptoms, with CyclASol showing improvements over vehicle in subgroups. Data further indicates an early onset of action by reduction in corneal and conjunctival staining in as little as 14 days.

Read more: http://www.businesswire.com/news/home/20170105005211/en/Novaliq-Announces-Positive-Topline-Results-Phase-2

XTL Biopharmaceuticals’ Preclinical Studies of hCDR1 Demonstrate Therapeutic Potental In the Treatment of Sjögren’s Syndrome

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

RAANANA, Israel, Jan. 5, 2017 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases, today announced the Company intends to pursue Sjögren's syndrome as the second indication for its lead drug candidate hCDR1. Currently in development for the treatment of systemic lupus erythematosus (SLE), hCDR1 has been tested in over 400 patients, and is set to enter a global Phase 2 trial for SLE.

New in-vitro data from studies evaluating cells obtained from serum samples of patients with Sjögren's syndrome demonstrate that incubation with hCDR1 resulted in a significant reduction of gene expression of three cytokines considered to be pathogenic in Sjögren's syndrome. These data correspond to some of the in vitro data obtained in studies testing serum samples from patients with SLE.

Read more: http://www.prnewswire.com/news-releases/xtl-biopharmaceuticals-preclinical-studies-of-hcdr1-demonstrate-therapeutic-potental-in-the-treatment-of-sjogrens-syndrome-300386273.html

Halozyme Announces Phase 2 Study In Advanced Pancreas Cancer Meets Key Endpoints

Source: http://www.prnewswire.com/
SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase 2 randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.

Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the study, which completed enrollment in February 2016, showed a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm, and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm.

"These findings confirm our confidence in the development of PEGPH20 in this difficult to treat cancer," said Dr. Helen Torley, president and CEO. "We are pleased by the overall consistency of both the efficacy and safety data which are supportive of our ongoing Phase 3 clinical trial, HALO 301, currently underway at more than 160 sites worldwide."

Read more: http://www.prnewswire.com/news-releases/halozyme-announces-phase-2-study-in-advanced-pancreas-cancer-meets-key-endpoints-300386090.html


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