A Phase 2 Study of the Safety and Effectiveness of SANGUINATE™ in the Treatment of Vaso-Occlusive Crises in the Ambulatory Setting: A Placebo-Controlled, Single-Dose, Single-Blind Study in Adults With Sickle Cell Disease

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

Start Date01 Nov 2016

Sponsor / Collaborator

Prolong Pharmaceuticals LLC

NCT02672540 / CompletedPhase 2

A Phase II, Multicenter, Single-Blind, Randomized Study of the Safety and Effectiveness of SANGUINATE™ Versus Normal Saline in Adult Sickle Cell Disease Patients With Vaso-Occlusive Crisis (VOC)

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis who are admitted to the hospital for treatment.

Start Date01 Jul 2016

Sponsor / Collaborator

Prolong Pharmaceuticals LLC

NCT02754999 / CompletedPhase 1

An Open-label Phase 1 Safety Study of SANGUINATE™ Infusion in Patients With Acute Severe Anemia Who Are Unable to Receive Red Blood Cell Transfusion

In this open-label study, eligible and consenting adult patients admitted to the hospital for critical care that have acute severe anemia, defined as a blood hemoglobin level ≤ 5 g/dL, but who are unwilling or unable to receive red blood cell (RBC) transfusion, will receive one or more infusions of SANGUINATE as are deemed necessary by the Investigator for survival of the acute anemic episode.

Start Date01 Mar 2016

Sponsor / Collaborator

Prolong Pharmaceuticals LLC

100 Clinical Results associated with Pegylated bovine carboxyhemoglobin

100 Translational Medicine associated with Pegylated bovine carboxyhemoglobin

100 Patents (Medical) associated with Pegylated bovine carboxyhemoglobin

125

Literatures (Medical) associated with Pegylated bovine carboxyhemoglobin

01 Jul 2024·JOURNAL OF CLINICAL IMMUNOLOGY

Treatment with Elapegademase Restores Immunity in Infants with Adenosine Deaminase Deficient Severe Combined Immunodeficiency

Article

Author: Mousallem, Talal ; Buckley, Rebecca H ; Hall, Geoffrey ; Tarrant, Teresa K ; Hicks, Elizabeth Daly ; Bali, Pawan ; Sleasman, John W ; Hershfield, Michael S

Abstract:

Purpose:

Patients with adenosine deaminase 1 deficient severe combined immunodeficiency (ADA-SCID) are initially treated with enzyme replacement therapy (ERT) with polyethylene glycol-modified (PEGylated) ADA while awaiting definitive treatment with hematopoietic stem cell transplant (HSCT) or gene therapy. Beginning in 1990, ERT was performed with PEGylated bovine intestinal ADA (ADAGEN®). In 2019, a PEGylated recombinant bovine ADA (Revcovi®) replaced ADAGEN following studies in older patients previously treated with ADAGEN for many years. There are limited longitudinal data on ERT-naïve newborns treated with Revcovi.

Methods:

We report our clinical experience with Revcovi as initial bridge therapy in three newly diagnosed infants with ADA-SCID, along with comprehensive biochemical and immunologic data.

Results:

Revcovi was initiated at twice weekly dosing (0.2 mg/kg intramuscularly), and monitored by following plasma ADA activity and the concentration of total deoxyadenosine nucleotides (dAXP) in erythrocytes. All patients rapidly achieved a biochemically effective level of plasma ADA activity, and red cell dAXP were eliminated within 2–3 months. Two patients reconstituted B-cells and NK-cells within the first month of ERT, followed by naive T-cells one month later. The third patient reconstituted all lymphocyte subsets within the first month of ERT. One patient experienced declining lymphocyte counts with improvement following Revcovi dose escalation. Two patients developed early, self-resolving thrombocytosis, but no thromboembolic events occurred.

Conclusion:

Revcovi was safe and effective as initial therapy to restore immune function in these newly diagnosed infants with ADA-SCID, however, time course and degree of reconstitution varied. Revcovi dose may need to be optimized based on immune reconstitution, clinical status, and biochemical data.

01 Jun 2024·Nanomedicine-Nanotechnology Biology and Medicine

Riboflavin-targeted polymers improve tolerance of paclitaxel while maintaining therapeutic efficacy

Article

Author: Baier, Jasmin ; Rix, Anne ; Rama, Elena ; Darguzyte, Milita ; Hermann, Juliane ; Khedri, Mohammad ; Rezvantalab, Sima ; Kiessling, Fabian ; Jankowski, Joachim

Active targeting can enhance precision and efficacy of drug delivery systems (DDS) against cancers. Riboflavin (RF) is a promising ligand for active targeting due to its biocompatibility and high riboflavin-receptor expression in cancers. In this study, RF-targeted 4-arm polyethylene glycol (PEG) stars conjugated with Paclitaxel (PTX), named PEG PTX RF, were evaluated as a targeted DDS. In vitro, PEG PTX RF exhibited higher toxicity against tumor cells compared to the non-targeted counterpart (PEG PTX), while free PTX displayed the highest acute toxicity. In vivo, all treatments were similarly effective, but PEG PTX RF-treated tumors showed fewer proliferating cells, pointing to sustained therapy effects. Moreover, PTX-treated animals' body and liver weights were significantly reduced, whereas both remained stable in PEG PTX and PEG PTX RF-treated animals. Overall, our targeted and non-targeted DDS reduced PTX's adverse effects, with RF targeting promoted drug uptake in cancer cells for sustained therapeutic effect.

01 Apr 2024·Journal of comparative effectiveness research

PEG hydrogel sealant versus fibrin glue in posterior fossa surgery: an economic comparison across five European countries

Article

Author: Deppo, Lisa Da ; Horaczek, Jörn-Andre ; Torres, Rafael Torrejon ; Talamonti, Giuseppe ; Carter, Marissa J

News (Medical) associated with Pegylated bovine carboxyhemoglobin

04 Apr 2023

·www.businesswire.com

Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023" report has been added to ResearchAndMarkets.com's offering. The Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 report provides comprehensive understanding and unprecedented access to the joint venture deals and agreements entered into by the worlds leading life science companies. This report provides details of the latest joint venture agreements announced in the pharmaceutical, biotechnology and diagnostic sectors. Fully up to date, the report provides details of joint venture agreements from 2016. There is an increasing willingness for parties to enter joint venture deals; such deals enable both parties to benefit from the upside of a big product win, whereas traditional licensing deals forfeit upside for near term upfront, milestone and royalty payments. Joint venture partnering allow the parties to securitize value and reduce risk, but keep a part of the potential upside should the product reach the market. Event if the licensor does not commercialize the project they can either sell those rights to the licensee partner or another partner for an amount higher than would have been achieved at an earlier stage licensing deal. Another reason for joint venture deals is the joint origin of a project. Drug development projects often require various scientific and technological novelties that stem from different companies. If both companies contributed to the origination of the project, then both have from the beginning a stake in the project. The report provides a detailed understanding and analysis of how and why companies enter joint venture deals. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all joint venture deals announced since 2016 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual joint venture contract documents as submitted to the Securities Exchange Commission by companies and their partners. Contract documents provide the answers to numerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability to derive value from the deal. The initial chapters of this report provide an orientation of joint venture dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an analysis of the trends in joint venture as well as a discussion on the merits of the type of deal. Chapter 3 provides an overview of the structure of joint venture deals. The chapter includes numerous case studies to enable understanding of joint venture deals. Chapter 4 provides a review of the leading Joint venture deals since 2016. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database. Chapter 5 provides a comprehensive listing of the top 25 most active Joint venture dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand. Chapter 6 provides a comprehensive and detailed review of Joint venture deals organized by company A-Z, therapy, technology and industry type signed and announced since 2016 where a contract document is available. Contract documents provide an indepth insight into the actual deal terms agreed between the parties with respect to the Joint venture deal. The appendices to the report includes a comprehensive listing of all Joint venture deals announced since 2016. Each listing is organized as an appendix by company A-Z, stage of development at signing, therapeutic area and industry type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends and activities in Joint venture dealmaking since 2016. In conclusion, this report provides everything a prospective dealmaker needs to know about Joint venture alliances. Key benefits Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 provides the reader with the following key benefits: In-depth understanding of joint venture partnering deal trends since 2016, with real life case studies Comprehensive listing of all joint venture deals since 2016, together with deal terms, value and press release Comprehensive access to actual joint venture contracts entered into by the world's life science companies Insight into the terms included in a joint venture agreement, together with real world clause examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies Report scope Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 is intended to provide the reader with an in-depth understanding of the joint venture trends and structure of deals entered into by leading life science companies worldwide. Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 includes: Trends in joint venture dealmaking in the biopharma industry since 2016 Case studies of real-life joint venture deals Comprehensive listing of joint venture deals since 2016 Access to joint venture contract documents The leading joint venture deals by value since 2016 Most active joint venture dealmakers since 2016 The leading joint venture partnering resources In Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 available deals and contracts are listed by: Company A-Z Headline value Therapeutic area Technology type Each deal title links via Weblink to an online version of the actual deal record and where available, contract document, providing easy access to each contract document on demand. The Global Joint Venture Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016-2023 report provides comprehensive access to available contract documents for joint venture deals. Companies Mentioned 3SBio 1717 Life Science Ventures A*STAR Agency for Science Technology and Research A*STAR Institute of Microelectronics (IME) A*STAR' Institute of Molecular and Cell Biology A2A Pharmaceuticals AAP Implantate AG Abbott Laboratories Abbvie Abilita Bio ABIVAX Abzena Accellix Accuray Acnos Pharma Adept Neuro Adisseo Advanced Prenatal Therapeutics Advanced Technologies Solutions Aequus Pharmaceuticals Agilis Biotherapeutics AgonOx AirWare Labs Aitbiotech Akers Biosciences AKESOgen Aleafia Health Aleva Neurotherapeutics Allied-Bristol Life Sciences Allied Minds Ally Bridge Group Altus Formulation Alzheimer's Association Alzheimer's Research UK Amarantus BioSciences Amendia American Diabetes Association AmerisourceBergen Amunix Amyris AnaBios Anokion Antitope Antoxerene Apax Partners Aphria Arbele Arbutus ARCH Personalized Medicine Initiative Aridis Pharmaceuticals Aruvant Sciences Arvinas Ascendance Biotechnology Ascendis Pharma Asklepios Biopharmaceutical Aslan Pharma Astellas Pharma AstraZeneca ATAI Life Sciences Athenex ATL Technology Atomwise Atrapos Therapeutics Atropos Therapeutics Auramedi Farmaceutica Autobio Diagnostics AUT Roche Diagnostics Laboratory AUT University Auxly Cannabis Group Avacta Avactis Biosciences Avalon GloboCare Avivagen Avvinity Therapeutics Axis Therapeutics Bain Capital Baxter International Bayer Baylor College of Medicine Baylor Miraca Genetics Laboratories B Braun B Braun CeGaT Beckley Canopy Therapeutics Beckley Foundation Becton Dickinson BeiGene Beijing Genomics Institute (BGI) Beijing Leadman Biochemistry Berry Genomics Betaliq BevCanna BGI Tech Solutions BHB Therapeutics Bill and Melinda Gates Foundation Bio-Techne BioAmber Biodist Biodyne USA BioFields Biogen Biohealth Innovation BioHeart BioLife Solutions BioLight BiolineRX biologistex CCM BioMed X Innovation Center Biomerics BioMotiv BioPharma Services Blackstone Blockshine Technology Bloomage BioTechnology Bloom Burton BLP Management Blueberries Medical Boehringer Ingelheim Breakthrough Diagnostics Brigham and Women's Hospital Bristol-Myers Squibb Broad Institute Buchang Pharmaceutical Buck Institute for Age Research Bukwang Pharmaceuticals Button Capital Calysta Energy Cancer Research Technology Cannabics Pharmaceuticals Cannabis Biocare Cannabis Therapeutics CannAmerica Brands CannaRoyalty Canopy Health Innovations Capna Intellectual Capnia Cardio3 Biosciences Asia Holdings Casebia Therapeutics Catapult Therapy TCR CB2 Therapeutics CBDerma Technology CBDistribution Cedar Gate Technologies CeGaT Cell Therapy Catapult Celyad Centauri Therapeutics Centene Center for Genetic Engineering and Biotechnology (Cuba) Centre for Commercialization of Regenerative Medicine (CCRM) Centro de Inmunolgia Molecular Cerevel Therapeutics Cesca Therapeutics Chan Soon-Shiong Institute of Molecular Medicine ChemAxon Children's Medical Research Institute Chimera Biotec China-Israel Biological Technology China-Singapore Guangzhou Knowledge City China Isotope And Radiation Chinese Academy of Science Chinese Future Industry Investment Fund Chongqing PSK-Health Sci-tech Development Cincinnati Children's Hospital Medical Center City of Hope CJ CheilJedang ClearPath Cloaked Therapeutics Co-Diagnostics Cohen Veterans Bioscience Cold Spring Harbor Colibri Heart Valve Collagen Solutions Plc Columbus Venture Partners Concentrics Research Consortium AI Corestone Biosciences Cornerstone Animal Health Corning Covenant Animal Health Partners Cre8ive CRISPR Therapeutics CureCell Cyclica CytoBioscience Cytotheryx Cytovant Sciences Daewoong Pharmaceutical Dance Biopharm Dasman Diabetes Institute David Snow Deerfield Management DemeRx Demetra Denka Denka-KEW Genomics DepYmed DIAN Diagnostics Diavax Biosciences Dixi Dizal Pharmaceutical DolCas-Tenshi Bioceuticals DolCas Biotech Dona Blanca Dongbao Dr. Walter Bell Duke-NUS Graduate Medical School Singapore Eastar Industries Eastern Capital Easton Pharmaceuticals eCardio Diagnostics Eddingpharm Eden BioCell Elanix Biotechnologies Elevar Therapeutics Eli Lilly EMD Millipore EMD Serono Emergence Therapeutics EmoCellix Emory University Emosis Enigma Diagnostics Enova Illumination Entheogenix Biosciences ERS Genomics Evotec ExCellThera Exemplar Genetics Facebook Faes Farma Faxian Therapeutics Fedecore Fedora Pharmaceuticals FerGene Ferring Pharmaceuticals FJ Pharma Flexpoint Ford Flow Pharma Fonterra Food and Drug Administration (FDA) FORMA Therapeutics Fortress Biotech Fosun Pharmaceutical FoxBio Fox Chase Cancer Center Fraunhofer Institute for Microelectronic Circuits and Systems Frazier Healthcare Ventures Fresenius Kabi Pharmaceuticals Frontage Laboratories FSD Pharma Futura Medical Fuzionaire Diagnostics Fuzionaire Radioisotope Technologies G-treeBNT Galectin Sciences Galectin Therapeutics Galvani Bioelectronics Gauss Surgical Genentech Gene Therapy Research Institution Genetic Technologies Genevant Sciences Genome Institute of Singapore Genomix Scientific Gentag GeoVax German Research Center for Artificial Intelligence Gerresheimer GHO Capital Ginkgo BioWorks GlaxoSmithKline For more information about this report visit https://www.researchandmarkets.com/r/laae8e About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

09 Feb 2023

·www.biospace.com

Prolong Pharmaceuticals Announces Presentation of Phase 1 Data from HEMERA-1 Clinical Study of PP-007 in Patients with Acute Ischemic Stroke at the Late-Breaking Science Session, ISC 2023

Novel Biotherapeutic Product Focused on The Treatment of Acute Ischemic Stroke SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)-- Prolong Pharmaceuticals, a clinical stage biopharmaceutical company, today announced that preliminary data from the recently completed Phase 1 clinical study of PP-007 (HEMERA-1) in acute ischemic stroke (AIS) patients will be presented in the Late-Breaking Science session during ISC 2023 in Dallas, TX and in the forthcoming PAIRS conference in Dubai. PP-007 (PEGylated carboxyhemoglobin, bovine) is a novel investigational biopharmaceutical product that improves microvascular perfusion while promoting transfer of oxygen to oxygen-deprived (hypoxic) cells and tissues. PP-007 has been shown in several non-clinical stroke models to improve collateral circulation, specifically delivering oxygen to hypoxic regions of the brain following a large vessel occlusion reducing neuronal death and improving neurological outcomes. HEMERA-1 is the first clinical trial of PP-007 in AIS. Dr. Italo Linfante, Medical Director of Interventional Neuroradiology at Miami Neuroscience Institute, Baptist Health South Florida, and Principal Investigator of the study, stated, “The evaluation of PP-007 in AIS large vessel occlusion patients receiving a mechanical thrombectomy exhibited acceptable safety and tolerability. PP-007’s multi-modal mechanism of action includes (1) increased blood flow and vasodilation of collateral circulation, (2) targeted delivery of oxygen in ischemic areas for 24 hours, and (3) plasma expansion. This unique molecule has the potential to improve neurological scores and outcomes in AIS patients, and this foundational safety study warrants the expanded clinical evaluation of PP-007 in AIS.” The following are the details of the presentations: ISC, Dallas, TX: Session A21; Late-Breaking Science Oral Abstracts; Title: Hemera 1 Carboxyhemoglobin Oxygen Delivery for Revascularization in Acute Stroke: Phase 1 clinical Trial–Thursday, February 9, 2:00-3:00 PM; Room C155/C156; Presenter: Dr. Italo Linfante, USA PAIRS, Dubai, UAE: Session 5; Title: Hemera 1 Carboxyhemoglobin Oxygen Delivery for Revascularization in Acute Stroke: Phase 1 clinical Trial; Sunday, February 12, 15:00-16:00 Hrs, Hall C; Presenter: Dr. Italo Linfante, USA Prolong Corporate Statement “This study represents a key milestone in the clinical development of PP-007 that builds upon our strong preclinical and clinical evidence for treating conditions of ischemia/hypoxia. We are extremely grateful to the study participants and the clinical research teams leading this important trial through such a challenging time with ongoing COVID-19,” stated Ronald Jubin, Ph.D., Vice President of Early Development at Prolong. About the HEMERA-1 Study (carboxyHEMoglobin oxygEn delivery for Revascularization in Acute stroke) The HEMERA-1 study is a randomized, Phase 1, blinded, contemporaneously controlled, single dose study of the safety, tolerability, and pharmacokinetics of PP-007 in acute ischemic stroke patients. The study is ongoing at multiple Stroke Centers in the United States. Outcomes measures and key eligibility criteria are described on (NCT04677777). About PP-007 PP-007 (previously known as SANGUINATE®) is a clinical stage biopharmaceutical product. In addition to numerous published non-clinical studies of ischemia/hypoxia and anemia, over 270 individuals in 12 clinical trials have received single or multiple dose treatments in prior studies of PP-007 including healthy volunteers, subarachnoid hemorrhage, severe life-threatening anemia and other diseases or conditions with an underlying ischemia/hypoxia component, such as beta thalassemia and sickle cell disease. About Prolong Pharmaceuticals Headquartered in South Plainfield, New Jersey, Prolong Pharmaceuticals, LLC is developing PP-007 as a treatment for acute ischemic stroke to lessen the debilitating comorbidities associated with reduced quality of life, increased medical cost and significant mortality. For more information visit: . View source version on businesswire.com: Contacts Ronald Jubin, Ph.D. Vice President, Early Development Prolong Pharmaceuticals Ph: (908) 315-5762 rjubin@prolongpharma.com Source: Prolong Pharmaceuticals View this news release online at:

Phase 1Clinical Result

100 Deals associated with Pegylated bovine carboxyhemoglobin

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Indication	Highest Phase	Country/Location	Organization	Date
Brain Death	Phase 3	US	Prolong Pharmaceuticals LLC	01 Aug 2015
Delayed renal graft function	Phase 3	US	Prolong Pharmaceuticals LLC	01 Aug 2015
Delayed Graft Function	Phase 3	-	Prolong Pharmaceuticals LLC	-
Delayed Graft Function	Phase 3	-	Enzon Pharmaceuticals, Inc.	-
Vaso-occlusive crisis	Phase 2	CO	Prolong Pharmaceuticals LLC	01 Jul 2016
Vaso-occlusive crisis	Phase 2	DO	Prolong Pharmaceuticals LLC	01 Jul 2016
Vaso-occlusive crisis	Phase 2	HN	Prolong Pharmaceuticals LLC	01 Jul 2016
Vaso-occlusive crisis	Phase 2	PA	Prolong Pharmaceuticals LLC	01 Jul 2016
Leg Ulcer	Phase 2	DO	Prolong Pharmaceuticals LLC	01 Mar 2016
Leg Ulcer	Phase 2	PA	Prolong Pharmaceuticals LLC	01 Mar 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02411708 (ASH2017) Manual	Phase 2	Vaso-occlusive crisis	-	PEG-COHb 320 mg/kg	moblmdfpoa(hbtjeetpsj) = eanlgxarlt blagvkpmgo (theknfxxrf ) View more	Positive	07 Dec 2017
				placebo	moblmdfpoa(hbtjeetpsj) = szmcptzzzh blagvkpmgo (theknfxxrf )
ISC2017	Not Applicable	-	-	SanguinateTM	bxzeeichpa(keiexxqufj) = lzmlgtqspa glwflgczoc (tmspzwjlzf )	-	01 Feb 2017
				Vehicle (Lactated Ringer’s)	bxzeeichpa(keiexxqufj) = egsnidjiem glwflgczoc (tmspzwjlzf )
ISC2017	Not Applicable	Subarachnoid Hemorrhage	12	Sanguinate 160mg/kg	pircqhbhyv(sjwcghmmpo) = uicigtkjwh pmnzwpziic (ylmnymwrlh ) View more	-	01 Feb 2017
				Sanguinate 240mg/kg	pircqhbhyv(sjwcghmmpo) = lbtrkjtztl pmnzwpziic (ylmnymwrlh ) View more
NCT01848925 (Pubmed) Manual	Phase 1	Anemia, Sickle Cell	24	SANGUINATE	fdlqarllcj(fstayjwpfe) = Musculoskeletal related events were the most common. Transient troponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity ghvqfznund (lgnodazszd )	Positive	01 Jan 2017
ASCO2015	Not Applicable	Anemia	5	PEG-HbCO	aswkqusctq(vajidrdjjw) = orzormpwpl avvaqwzgsg (mpybzpryab )	Positive	20 May 2015

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