Biometrics: Clinical

Showing posts with label Clinical. Show all posts

Regulus Announces Key Goals Under its 'Clinical Map Initiative' for 2015

LA JOLLA, Calif., Jan. 8, 2015 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced key goals for 2015 under its 'Clinical Map Initiative' to advance its microRNA therapeutics portfolio and biomarkers platform.

"Regulus enters 2015 with the scientific and financial strength to realize the transformative potential of microRNAs. As such, we've set aggressive goals for the year focused on creating a clear path to value for what we believe to be our greatest opportunities," said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus. "Under our 'Clinical Map Initiative', we are focusing our near term efforts on accelerating RG-101 for HCV with a Phase II dual-track clinical development strategy, while advancing our overall therapeutics pipeline and aligning our biomarker efforts to streamline our clinical development decisions."

Key Goals Under Regulus' 'Clinical Map Initiative' for 2015

'Clinical Map' of RG-101 for HCV Defined: Dual-Track Strategy Accelerates Phase II Development; Multiple Data Read-Outs in 2015. Following the favorable interim results reported in October 2014 from its ongoing clinical study, Regulus has accelerated development of RG-101, a wholly-owned, GalNAc-conjugated anti-miR targeting microRNA-122 ("miR-122") for the treatment of HCV. Regulus is pursuing a Phase II dual-track development strategy (i) to investigate RG-101 in combination with oral agents to potentially shorten treatment durations, optimize clinical outcomes and potentially improve responses in certain underserved HCV patient populations; and (ii) to investigate RG-101 further as a single agent to determine whether HCV viral cures are achievable with monotherapy treatment (single or multiple doses of RG-101). In the near term, Regulus expects to file both a Clinical Trial Application and an Investigational New Drug application for RG-101 with the goal to initiate the above described studies in Europe and the United States in the second quarter of 2015. Multiple Data Read-Outs for RG-101 in 2015. In early February 2015, Regulus expects to report new results from part IV of its ongoing clinical study of RG-101: viral load reduction and interim safety from the 4 mg/kg dose cohort (16 total HCV patients; 14 receiving a single administration of RG-101, 2 receiving placebo), as well as extended follow up results from the 2 mg/kg cohort. In the second quarter of 2015, Regulus expects to report full results from the ongoing study at a medical meeting. In the fourth quarter of 2015, Regulus plans to report viral load reduction and safety data from the Phase II program, as described above. 'Clinical Map' of RG-012 for Alport Syndrome Emerging; Near Term Focus on ATHENA Enrollment, Phase I Study to Initiate in 1H 2015. RG-012 is a single-stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21") for the treatment of renal dysfunction in Alport syndrome patients. Alport syndrome is a life-threatening, genetic kidney disease driven by mutations in specific collagen. By inhibiting miR-21, which is highly overexpressed in animal models of Alport syndrome, RG-012 is intended to act by reducing the severity of fibrosis, which then may reduce the rate of decline of renal function in Alport syndrome patients. Near Term Efforts Focused on ATHENA. Regulus plans to focus its near term efforts on enrolling up to 120 Alport syndrome patients in its global ATHENA natural history of disease study, which is designed to characterize the natural decline of renal function (as measured by established renal markers) in Alport syndrome patients over time. The data from ATHENA should provide the clinical basis for the design of a Phase II proof-of-concept study to monitor the therapeutic effect of RG-012 on the decline in renal function in patients with Alport syndrome. The ATHENA study is being conducted at thirteen clinical sites worldwide, with multiple active sites in the United States, France and Germany, and additional sites anticipated to be active in Australia, Canada and other countries in Europe. In addition to enrolling patients in ATHENA, Regulus plans to initiate a Phase I study in the first half of 2015 to evaluate the safety and tolerability of RG-012 in healthy volunteers."2015 will be an important year for the advancement of our clinical portfolio, with key data read outs on the horizon for RG-101 and other programs," said Paul Grint, M.D., Chief Medical Officer of Regulus. "While aggressively moving forward with RG-101 this year, we also aim to expand our clinical pipeline to include opportunities in oncology and orphan diseases, such as Alport syndrome, where we believe we can build significant value for the portfolio."

microRNA Therapeutics Portfolio and Regulus microMarkersSM Goals for 2015
Advance microRNA Therapeutics Pipeline; Nominate At Least One Candidate for Clinical Development in 2015. Regulus continues to pursue several undisclosed microRNA targets, namely for oncology and orphan disease indications. In addition to its internal research efforts, Regulus aims to advance certain programs with its strategic alliance partners, microRNA-103/107 for the treatment of metabolic diseases and microRNA-19 for oncology indications with AstraZeneca, microRNA-221 and miR-21 for hepatocellular carcinoma and miR-21 for renal fibrosis (RG-012) with Sanofi. In 2015, Regulus expects to nominate at least one additional microRNA candidate for clinical development, either independently or with a partner.
Expand Regulus microMarkersSM Work to Support 'Clinical Map' of RG-101, RG-012 and Partners' Programs. Regulus' microMarkersSM division utilizes a highly reproducible, proprietary technology platform to extract, profile, and analyze microRNAs from small volumes of different bodily fluids to differentiate disease from healthy patient samples and to identify microRNAs as potential biomarkers for disease. Regulus microMarkersSM has profiled over 3,000 clinical samples in a wide variety of disease states and has formed a research collaboration with Biogen Idec, an additional large pharmaceutical partner (undisclosed), and multiple academic research institutions. To support the 'Clinical Map' of RG-101, Regulus microMarkersSM plans to profile serum samples from the healthy volunteers and HCV patients in the ongoing clinical study of RG-101 to identify potential microRNA signatures, which may aide in accurately predicting a patient's response to RG-101 therapy. Regulus microMarkersSM believes that it has identified a microRNA signature in urine that may discriminate mutant mice from wild type mice early in disease progression in a kidney fibrosis model. These findings suggest that profiling microRNAs in urine may be a useful biomarker approach to support the 'Clinical Map' of RG-012. As part of the ongoing ATHENA study, Regulus microMarkersSM plans to profile urine and blood samples from the Alport syndrome patients to potentially identify a clinically useful microRNA signature. To support its collaborators and academic research partners, Regulus microMarkersSM aims to utilize its robust technology platform to profile and analyze microRNAs in different bodily fluids including plasma, serum, whole blood, urine and cerebrospinal fluid. As part of its ongoing collaboration with Biogen Idec, Regulus microMarkersSM will profile whole blood samples of patients treated with a Biogen Idec multiple sclerosis therapy to identify potential microRNA signatures. "Regulus aims to pursue opportunities both internally and with our strategic partners where we can apply our oligonucleotide drug discovery and development expertise to validated microRNA targets," said Neil W. Gibson, Ph.D., Chief Scientific Officer of Regulus. "Specifically in 2015, our goal is to nominate at least one additional microRNA candidate for clinical development and expand our biomarkers work to support our clinical pipeline and our collaborators' programs."

About Regulus

Regulus Therapeutics Inc. (NASDAQ: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkersSM biomarkers platform and a rich intellectual property estate to retain its domain dominant leadership in the microRNA field. Under its 'Clinical Map Initiative', Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy. Regulus is also advancing several programs toward clinical development in orphan disease indications, oncology and fibrosis. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi and a research collaboration with Biogen Idec focused on microRNA biomarkers. Regulus maintains its corporate headquarters in La Jolla, CA. For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to its 'Clinical Map Initiative' goals, including development and other activities related to RG-101 and RG-012 and with respect to the nomination of at least one microRNA candidate for clinical development in 2015), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans (including Regulus' expected future activities in 2015), technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SOURCE Regulus Therapeutics Inc.

New Clinical Informatics Curriculum Prepares Future Pathologists

NORTHFIELD, Ill., July 9, 2014 /PRNewswire-USNewswire/ -- The widespread adoption of the electronic health record (EHR), spurred in large part by meaningful use and related federal programs, is changing the way health care providers interact with laboratory information. Now, more than ever, pathologists need to be well-versed in the field of clinical informatics in order to deliver high quality and cost-effective patient care.

To address the educational needs of pathologists in this evolving health care landscape, the College of American Pathologists (CAP), the Association of Pathology Chairs (APC), and the Association for Pathology Informatics (API), announced today the launch of a new graduate medical education clinical informatics curriculum—Pathology Informatics Essentials for Residents (PIER)—at the APC annual meeting.

"The CAP is proud to collaborate with APC and API on this important education initiative to help train pathology residents in clinical informatics," said CAP President Gene N. Herbek, MD, FCAP. "Today's health care environment calls for pathologists with competencies in clinical informatics to manage technology advances for the diagnostic management of patient care. PIER addresses this education and workforce need."

Jointly developed by the three organizations, PIER presents informatics topics identified by leading experts in the field. It offers key training elements for residency program directors and faculty to implement informatics training, while meeting the milestone requirements outlined by the Accreditation Council for Graduate Medical Education (ACGME). Interested residency programs can find details about PIER on the APC's website at apcprods.org/PIER.

"Training pathology residents in clinical informatics is 'a must' to build the skills required now and in the future," said APC President-Elect Donald S. Karcher, MD, one of the leaders overseeing the development of PIER and chairman of the Department of Pathology at George Washington University in Washington, D.C. "We designed PIER with the residency programs in mind and have created a flexible curriculum, which can be integrated throughout residency training."

Theory and Practice
PIER is designed for all pathology residents—those specializing in anatomic or clinical pathology or both. The curriculum exposes residents to information technology in pathology as they participate in their anatomic and/or clinical pathology rotations and residency activities related to management; quality assurance and control; and regulatory and accreditation issues; as well as the daily flow of information into and out of the laboratory and the proper utilization of that information. Each topic includes key outcomes mapped to pathology informatics ACGME milestone levels.

"PIER serves as a research-based instructional resource," said Liron Pantanowitz, MD, API immediate past president, co-leader of the working group developing PIER, and director of the Pathology Informatics Fellowship Program and associate director of the Pathology Informatics Division at the University of Pittsburgh in Pennsylvania. "We plan to update PIER as technology advances to ensure residents receive the most current knowledge in this field."

The three organizations designed PIER to help residency programs prepare their residents for the future of the specialty.

"Information management will continue to play a crucial role in pathology," said Walter Henricks, MD, FCAP, medical director of Pathology Informatics at the Cleveland Clinic in Ohio, and co-leader of the PIER working group. "By developing PIER, we are empowering pathologists in clinical informatics with the knowledge and skill sets necessary to meet the demands of the current and future health care environment."

About the College of American Pathologists
As the leading organization with more than 18,000 board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP's Laboratory Improvement Programs, initiated 65 years ago, currently has customers in more than 100 countries, accrediting 7,600 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about the CAP at cap.org. Follow CAP on Twitter: @pathologists.

About the Association of Pathology Chairs
The Association of Pathology Chairs (APC) serves as the voice of academic pathology. The APC exists to provide leadership and advocacy for this dynamic discipline and to enable academic departments to meet the demands of their three missions—medical education, research, and practice. The APC provides education, training, information resources, and networking opportunities for chairs, residency program directors, medical student educators, department administrators, and graduate program coordinators.

About the Association for Pathology Informatics
The mission of the Association for Pathology Informatics (API) is to promote the field of pathology informatics as an academic and clinical subspecialty of pathology. API provides a leadership role in the promotion of data standards relating to both pathology research and service pathology to encourage effective reporting and integration of pathology data. API has over 350 members comprised of physicians, researchers, residents, fellows, technical staff, and individual members covered under our Corporate, Non-Profit, and Teaching Institutional memberships. API was originally organized in 2000 as a part of Universities Associated for Research and Education in Pathology, a 501(c)(3) organization that subsequently dissolved in 2002. In September 2009, API was incorporated in the Commonwealth of Pennsylvania, and received approval of status as a 501(c)(3) not-for-profit organization. In March 2013, API signed an MOU with the American Society for Clinical Pathology to collaborate on education and advocacy. In addition, ASCP manages API's membership services.

SOURCE College of American Pathologists

OptiScan Biomedical Enrolls First Patient in Pivotal U.S. Clinical Study of OptiScanner® 5000

HAYWARD, Calif., April 28, 2014 /PRNewswire/ -- OptiScan Biomedical Corporation, a developer of innovative continuous monitoring systems for use in the intensive care unit (ICU), today announced the enrollment of the first patient in a pivotal, multi-center Investigational Device Exemption (IDE) clinical study of the OptiScanner® 5000. The OptiScanner 5000 is the company's first-of-its-kind automated, bedside glucose monitoring system that provides physicians with critical information to manage patient glucose levels in the ICU.

The pivotal trial, known as the MANAGE IDE Study (Manual vs. Automated moNitoring Accuracy of GlucosE IDE), is expected to enroll 200 patients at up to 10 sites, most of which will be located in the U.S. The study's initial three clinical sites include: Washington University School of Medicine in St. Louis, MO; Tufts University School of Medicine in Boston, MA; and Saint Luke's Mid-America Heart Institute in Kansas City, MO. If successful, the MANAGE IDE study will serve as the basis for an application for approval in the U.S.

The OptiScanner 5000 represents a significant advancement in the delivery of care to ICU patients by automating the measurement of patients' plasma glucose, as opposed to current manual measurement of glucose in whole blood. It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 60 percent of ICU patients suffer from "stress hyperglycemia" or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain glycemic control.

"The initiation of this pivotal study of the OptiScanner 5000 represents a key milestone for OptiScan as we continue our efforts to bring the paradigm-shifting potential of this platform to critically ill patients and those ICU physicians responsible for their care," said Peter Rule, chairman and chief executive officer of OptiScan Biomedical. "There is an acute need for breakthrough technologies that enable the automated, real-time monitoring of blood glucose in ICU patients in order to combat both the hyperglycemia and hypoglycemia that further complicate their already challenging health conditions. Our extensive clinical research to date demonstrates the OptiScanner 5000's ability to safely and effectively meet these needs and we are eager to see the MANAGE IDE trial further corroborate those findings."

This pivotal MANAGE IDE study follows OptiScan's previously completed MANAGE I and MANAGE II trials, which were conducted at two world class European research centers and evaluated the OptiScanner 5000 in very sick ICU patients. Taken together, these studies represent the most comprehensive clinical validation program conducted to date with a continuous blood monitoring platform in the critical care setting. Results from these studies demonstrated the ability of the OptiScanner 5000 to combine accurate blood glucose measurement with the convenience of continuous, real-time bedside monitoring.

Based on previous studies, the OptiScanner 5000 has received CE Mark certification for use in the European Union, allowing it to be sold and marketed in the 30 countries that make up the European Economic Area (EEA). OptiScan has initiated commercial efforts in the EU in 2014.

About the OptiScanner® 5000

The OptiScanner® 5000 is a first-of-its-kind automated, bedside glucose monitoring system that provides physicians with information on glucose levels in the ICU. Through automated monitoring of a patient's glucose values in plasma (as opposed to whole blood), the OptiScanner has alarms to alert clinicians to the existence of hyperglycemia (values that are too high) and hypoglycemia (values that are too low). It is estimated that between 60-80% of all ICU patients suffer from elevated glucose values, requiring insulin delivery and frequent glucose monitoring.

About OptiScan Biomedical

OptiScan Biomedical is the world leader in developing innovative continuous monitoring systems for use in hospital intensive care units (ICU). The company has developed the OptiScanner® 5000, a first-of-its-kind automated, bedside glucose monitoring system that provides accurate, automated monitoring of patients' glucose levels measured in plasma, as opposed to whole blood. The system prominently displays glucose level trend data updated every 15 minutes to help manage patients' glucose levels within an optimum target range.

The company is currently developing a next-generation OptiScanner product. The OptiScanner 6000 will expand the glucose monitoring capability of the platform technology to include monitoring of two leading measures of cardiac output and oxygenation (hemoglobin and ScvO2) in the same single blood sample, thereby providing additional information about the condition of a critically ill patient.

For more information visit: www.optiscancorp.com

Vida Strategic Partners (On behalf of OptiScan)

Patrick Nugent, Chief Financial Officer

SOURCE OptiScan Biomedical Corporation

RELATED LINKS
http://www.optiscancorp.com/

reade more...

Theorem Clinical Research Joins MedNet Solutions' iMedNet Partner Program

MINNETONKA, Minn., April 29, 2014 /PRNewswire/ -- MedNet Solutions, a global life sciences technology company specializing in eClinical technology systems, is pleased to welcome Theorem Clinical Research into the iMedNet Partner Program. Theorem, one of the industry's leading contract research organizations, provides comprehensive clinical research and development services to customers around the world.

"The partnership with MedNet supports Theorem's commitment to serve as a leader in CRO services to the medical device and diagnostic community. Theorem looks to extend the experience and quality that ensure our customers' medical device product success," said Lee Spurgin, PhD, Senior Vice President and General Manager for Medical Device & Diagnostic Development at Theorem.

"MedNet is extremely pleased to be partnering with Theorem, an innovative and highly respected CRO with a truly global presence," noted John M. (Rob) Robertson, President and CEO of MedNet Solutions. "Our significant technical experience in the medical device arena meshes perfectly with Theorem's deep therapeutic and device research expertise. We're looking forward to working closely with Theorem for many years to come."

Stay in touch with MedNet:

About Theorem Clinical Research

Theorem Clinical Research Inc. is a leading midsized provider of comprehensive clinical research and development services with offices in more than 30 countries and a customer base comprised of some of the world's top pharmaceutical, biotech and medical device companies. As a forerunner in medical device and drug-device combination trials with notable capabilities in pharmaceuticals and biologics, Theorem offers deep expertise in a broad range of therapeutic areas and in all phases of development. With some of the industry's top scientists and most advanced clinical analytics capabilities, Theorem ensures smooth-running, successful trials. For the full-service, right-size global research partner, don't think twice. THINK THEOREM. For more information, please visit www.theoremclinical.com.

About MedNet Solutions

MedNet Solutions is a leading healthcare technology company specializing in electronic data capture (EDC) and clinical trial management systems (CTMS) designed for the global life sciences market. MedNet delivers proven, flexible and easy-to-use web-based eClinical solutions that effectively support clinical studies, registries and investigator initiated trials of all types and sizes. Since 2001, MedNet has successfully supported pharmaceutical, medical device, biotechnology and Contract Research Organizations (CROs) on clinical research conducted around the world. These companies trust MedNet to consistently deliver the technology innovation, experience and reliability they need for success. For more information, please visit www.mednetstudy.com.

MedNet Contact Information
Dirk H. Nelson
Director of Marketing
MedNet Solutions
110 Cheshire Lane, Suite 300
Minnetonka, MN 55305
USA
763.258.2735
contact@mednetstudy.com

Theorem Contact Information
Lea Studer
308.237.5567
lea@scorrmarketing.com

SOURCE MedNet Solutions

RELATED LINKS
http://www.mednetstudy.com

reade more...

Tute Genomics Selected by Affiliated Genetics for Clinical Genome Interpretation

PROVO, Utah, March 28, 2014 /PRNewswire-iReach/ -- Tute Genomics has been selected as the next-generation sequencing (NGS) analytics pipeline for Utah-based Affiliated Genetics, Inc (AGI). AGI performs a wide variety of diagnostic services, including pharmacogenetic testing, and CLIA-certified sequencing of gene panels and whole exomes for clinicians and researchers. The Tute Genomics platform allows AGI to rapidly interpret next-generation sequencing data, including automated and customizable clinical reporting.

(Photo: http://photos.prnewswire.com/prnh/20140328/MN92681)

"Partnering with Tute Genomics has enabled us to automate our genome analytics pipeline, making the time from sequencing to interpretable results faster than ever." says Jeff Ward, President of Affiliated Genetics. The secure Tute Genomics platform annotates every genetic variant with public and proprietary data sources and scoring mechanisms. Tute also uses machine-intelligence to assign a summary score to each variant, known as the Tute score, to enable more robust variant and biomarker discovery. Tute has also recently launched a number of features including case-control and family-based analyses, custom gene panel support, and now automated clinical reporting. "A clinical report is generated for every genome and gene panel uploaded to the Tute system for manual review and approval," announced Dr. Kai Wang, President of Tute Genomics. "Ultimately, this provides a human manageable list of prioritized variants on each genome and automates the process of querying a genome for ACMG reportable incidental findings, along with indication-related findings, such as cancer somatic variants and inherited disease mutations."

According to Tute Genomics CEO, Reid Robison, MD MBA, "This pipeline that we've set up with AGI represents a big leap forward towards individualized, genomic medicine. With data streaming directly from their sequencers, we have streamlined the interpretation pipeline, allowing users to visualize and interpret human genomes with just a few clicks." Tute will be demonstrating clinical reporting and advanced analytics features at the ACMG 2014 Annual Meeting in Nashville, TN on March 27 to 28, 2014 at Booth 532. Please see www.acmgmeeting.net for more details.

About Affiliated Genetics:

Founded in 1994, Affiliated Genetics, Inc. is a privately held corporation providing dozens of medical DNA testing applications, a full range of genomic services, and DNA-based, human identity testing. Located in Salt Lake City, UT, Affiliated Genetics provides DNA testing for numerous federal, state, and local agencies, universities, commercial laboratories, and private clients. Accredited by CAP, CLIA, and AABB, Affiliated Genetics is frequently the molecular genetics laboratory performing tests for other branded services. Our laboratory provides state-of-the-art testing and outstanding customer service through a highly trained staff of scientists, technicians and customer service representatives.

About Tute Genomics:

Tute Genomics is a cloud-based clinical genome interpretation platform that enables researchers and clinicians to utilize human genetic data for scientific discovery and individualized treatment. Tute is built on the expertise that developed ANNOVAR, the most widely used genome annotation & interpretation technology with over 600 scientific publications. Tute provides robust & scalable genome analysis that incorporates proprietary machine-learning algorithms to assist researchers and clinicians with gene and biomarker discovery. To learn more please visit www.tutegenomics.com.

Media Contact: Mary Brown, Tute Genomics, (858) 779-4363, mary@tutegenomics.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Tute Genomics

RELATED LINKS
http://www.tutegenomics.com

reade more...

MedNet To Showcase The iMedNet Partner Program At Partnerships in Clinical Trials 2014

MINNETONKA, Minn., March 26, 2014 /PRNewswire/ -- MedNet Solutions, a global life sciences technology company specializing in clinical study management systems, will once again be participating in the Partnerships in Clinical Trials conference. This year's event will be held March 30 – April 2 in Las Vegas, Nevada. Attendees are encouraged to visit MedNet's booth to see iMedNet EDC – an incredibly flexible and user friendly SaaS-based eClinical technology platform – and learn about the iMedNet Partner Program, created specifically to support the success of Clinical Research Organizations (CROs) and other healthcare consultants.

Key benefits of the iMedNet Partner Program include:

Predictable and Affordable Pricing Plus special partners-only discountsFull Sales and Marketing Support From sales training to prospective customer referralsiMedNet Advisory Forum Membership Ensuring partners' eClinical needs are fully addressed"This year's Partnerships conference will be an exciting one," noted John M. (Rob) Robertson, President and CEO of MedNet Solutions. "We'll have representatives on site to provide interested individuals with iMedNet demonstrations as well as more details about our iMedNet Partner Program. Since interest in our technology solutions and wrap-around support programs is growing rapidly, we anticipate a busy, but very productive few days."

Stay in touch with MedNet:

About MedNet Solutions
MedNet Solutions is a leading healthcare technology company specializing in electronic data capture (EDC) and clinical trial management systems (CTMS) designed for the global life sciences market. MedNet delivers proven, flexible and easy-to-use web-based eClinical solutions that effectively support clinical studies, registries and investigator initiated trials of all types and sizes. Since 2001, MedNet has successfully supported pharmaceutical, medical device, biotechnology and Contract Research Organizations (CROs) on clinical research conducted around the world. These companies trust MedNet to consistently deliver the technology innovation, experience and reliability they need for success. For more information, please visit www.mednetstudy.com.

Contact Information:
Dirk H. Nelson
Director of Marketing
110 Cheshire Lane, Suite 300
Minnetonka, MN 55305
USA
(763) 258-2735

SOURCE MedNet Solutions

RELATED LINKS
http://www.mednetstudy.com

reade more...

SourceMedical Announces Hiring of Clinical Expert for ASC Division

Ann Geier has been named VP-Clinical Informatics by Source Medical Solutions, Inc. (PRNewsFoto/SourceMedical)jwplayer.key="2kY/GKwZ2uQZmDlQ9VYArfZt2b4+KhHX3+DM4zisgtE=";BIRMINGHAM, Ala., Dec. 10, 2013 /PRNewswire-iReach/ -- Source Medical Solutions, Inc., the nation's leading provider of specialized software and billing services to outpatient surgery centers and specialty hospitals, announced today it has hired Ann Geier to the position of Vice President-Clinical Informatics within its Surgery division. In this role, Ms. Geier will provide product development insight that draws upon her 30-plus years of experience in the ASC industry.

(Photo: http://photos.prnewswire.com/prnh/20131210/MN30283)

Over the course of her career, Ms. Geier has been responsible for total financial and clinical operations in nationally based management companies and freestanding surgery centers. A recognized presenter and thought leader, she teaches in the AORN Ambulatory Boot Camp and speaks at national meetings on topics such as Supply Chain Management, Human Resources, Case Costing, QAPI, Credentialing and Peer Review, and Staffing. Ms. Geier's clinical background is the operating room, where she has been a scrub nurse, circulator, educator, and director. She has served on the ASC Quality Collaborations Expert Group since its inception in 2006.

"I've worked with Ann for several years, and because of my respect for her operational and clinical skills, I am confident that she will bring valuable expertise to SourceMedical," says Patrick Doyle, SourceMedical's EVP-Sales and Marketing.

"The addition of Ann Geier to our leadership team is another demonstration of our commitment to delivering the best products and services to the ASC market," says Ralph Riccardi, CEO of SourceMedical. "Her understanding of the challenges faced by administrators and owners, and the input she will provide as we deliver solutions, are fully aligned with our strategic vision."

"I am delighted to join the SourceMedical team, with its deep commitment to solutions that help surgery centers run more efficiently and enable a higher quality of patient care," Ms. Geier says.

***

About SourceMedical

SourceMedical is the largest provider of outpatient information solutions and revenue cycle management services for ambulatory surgery centers, specialty hospitals, and rehabilitation clinics nationwide. With 30 years of real-world experience, more than 5,000 satisfied customers, and the confidence of more than 250 consultants and management companies, SourceMedical offers the broadest range of solutions and enhancements available to the industry. The company's unique end-to-end systems improve operational efficiency and cash flow while enabling healthcare facilities to capture, exchange, and analyze data to deliver a higher standard of patient care. For more information, please visit www.sourcemed.net.

###

Press contact information:

Kathleen M. Joyce

kathleen.joyce@sourcemed.net or 203-284-7596

Media Contact: Kathleen Joyce, SourceMedical, 203-284-7596, kathleen.joyce@sourcemed.net

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE SourceMedical

SourceMedical Announces Hiring of Clinical Expert for ASC Division

(Photo: http://photos.prnewswire.com/prnh/20131210/MN30283)

"I am delighted to join the SourceMedical team, with its deep commitment to solutions that help surgery centers run more efficiently and enable a higher quality of patient care," Ms. Geier says.

***

About SourceMedical

###

Press contact information:

Kathleen M. Joyce

kathleen.joyce@sourcemed.net or 203-284-7596

Media Contact: Kathleen Joyce, SourceMedical, 203-284-7596, kathleen.joyce@sourcemed.net

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE SourceMedical

Baxter Completes Enrollment In Phase III Clinical Trial Of BAX 855, Extended Half-life Recombinant FVIII For Hemophilia A

DEERFIELD, Ill., Nov. 13, 2013 /PRNewswire/ -- Baxter International Inc. today announced it has completed enrollment in its Phase III clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) treatment for hemophilia A. The ongoing trial is aimed at assessing the efficacy of the compound in reducing annualized bleed rates (ABR) in both prophylaxis and on-demand treatment schedules, and will also evaluate its safety and pharmacokinetic profile.

BAX 855 was designed based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product with 10 years of real-world experience. The BAX 855 molecule was modified with PEGylation technology designed to extend its duration of activity in the body.

"The BAX 855 development program is a priority for Baxter as we evaluate the potential to provide an efficacious and safe treatment with an extended half-life for patients with hemophilia," said Anders Ullman, M.D., Ph.D., vice president of global research and development in Baxter's BioScience business. "We are focused first and foremost on strategies to address optimal efficacy and minimize patients' bleeding episodes, while at the same time delivering on the convenience of less frequent dosing for this population with severe disease."

The Phase II/III multi-center, open-label study called PROLONG-ATE is evaluating BAX 855 among 146 adult patients with previously-treated severe hemophilia A. Patients participating in PROLONG-ATE receive treatment twice weekly (45 IU/kg) and are followed for six months. The primary endpoint of the study is the annualized bleed rate (ABR) during the treatment period. The study is also evaluating the safety and immunogenicity of the compound when administered on either prophylaxis and on-demand treatment regimens. Other outcome measures include number of infusions needed to treat bleeding episodes, time intervals between these episodes, pharmacokinetics and patient reported outcomes. To date, no inhibitors or safety issues have been reported in the study.

Based upon the results of the study, the company expects to complete the trial and file for regulatory approval late in 2014. Baxter is also initiating a continuation study for all patients who complete the pivotal Phase II/III study, and expects to initiate a study of BAX 855 among pediatric patients in 2014.

The treatment protocol is based on the results of a Phase I trial of BAX 855, assessing its safety, tolerability and pharmacokinetics. That trial found that the half-life (measuring the duration of activity of the drug in the body) of the investigational compound was approximately 1.5-fold higher compared to ADVATE. An extended half-life was achieved in all patients in the study using BAX 855, no patients developed inhibitors to either the base molecule, BAX 855 or to PEG, and no patients had allergic reactions. No treatment-related or serious adverse events were reported, and no patients withdrew from the study due to adverse events.

BAX 855 is built from the same native FVIII protein used in the production of ADVATE, and employs proprietary PEGylation technology from Nektar Therapeutics (NASDAQ: NKTR) designed to extend the duration of activity of proteins. PEGylation technology has been widely used in various approved treatments.

About ADVATE

ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] is indicated for the control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A. ADVATE is not indicated for the treatment of von Willebrand disease.

ADVATE has a demonstrated efficacy profile and a low rate of inhibitor development. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.

ADVATE is approved in 60 countries worldwide including the United States, Canada, 27 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Croatia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.

Detailed Important Risk Information for ADVATE

ADVATE is contraindicated in patients with known anaphylaxis to mouse or hamster protein or other constituents of the product.

Allergic-type hypersensitivity reactions, including anaphylaxis, are possible and have been reported with ADVATE. Symptoms have manifested as dizziness, paresthesias, rash, flushing, face swelling, urticaria, dyspnea, and pruritus. Discontinue use if hypersensitivity symptoms occur and administer appropriate emergency treatment.

Carefully monitor patients treated with AHF products for the development of FVIII inhibitors by appropriate clinical observations and laboratory tests. Inhibitors have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs).

If expected plasma FVIII levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures FVIII inhibitor concentration.

The serious adverse reactions seen with ADVATE are hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to FVIII.

The most common adverse reactions observed in clinical trials (frequency greater than or equal to 10 percent of subjects) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia, and limb injury.

Please see full prescribing information for ADVATE at: http://www.baxter.com/downloads/healthcare_professionals/products/ADVATE_PI.pdf

About Hemophilia A

Hemophilia is a rare genetic[1] blood clotting disorder and the most severe forms of the disease primarily affect males.[2] People living with hemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood.[3] Two of the most common forms of hemophilia are A and B. In people with hemophilia A, clotting factor VIII is not present in sufficient amounts or is absent. Without enough FVIII, people with hemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal.[4] According to the World Federation of Hemophilia, it is estimated that more than 400,000 people in the world have hemophilia. [5] All races and economic groups are affected equally.[6]

About Baxter in Hemophilia

Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work focuses on optimizing hemophilia care and improving the lives of people worldwide living with bleeding disorders.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

This release includes forward-looking statements concerning BAX 855 and related clinical studies, including expectations with regard to regulatory filings. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical results; changes in laws and regulations; product quality or supply or patient safety issues; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Media Contact
Brian Kyhos
(224) 948-5353, media@baxter.com

Investor Contact
Mary Kay Ladone, (224) 948-3371

[1] How do you get hemophilia? World Federation of Hemophilia. Accessed on: June 3, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=644
[2] Frequently Asked Questions About Hemophilia. World Federation of Hemophilia. Accessed on: June 3, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=637
[3] What is Hemophilia? World Federation of Hemophilia. Accessed on: June 3, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=646
[4] Lee, C. A. Hemophilia Care in the Modern World, in Current and Future Issues in Hemophilia Care (eds E.-C. Rodriguez-Merchan and L. A. Valentino), 2011.
[5] Treatment. World Federation of Hemophilia. Accessed on June 3, 2013. Available at: http://www.wfh.org/en/page.aspx?pid=642
[6] What is Hemophilia? Hemophilia Federation of America. Accessed on June 3, 2013. Available at: http://www.hemophiliafed.org/bleeding-disorders/hemophilia/

SOURCE Nektar Therapeutics

Pages

.