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A00-281 Clinical Trials Programming Using SAS 9 Accelerated Version

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A00-281 exam Dumps Source : Clinical Trials Programming Using SAS 9 Accelerated Version

Test Code : A00-281
Test denomination : Clinical Trials Programming Using SAS 9 Accelerated Version
Vendor denomination : SASInstitute
: 99 existent Questions

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SASInstitute SASInstitute Clinical Trials Programming

Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery bypass | killexams.com existent Questions and Pass4sure dumps

Trial Design and Oversight

We carried out a randomized, intention-to-deal with, multicenter trial funded with the aid of the Cooperative experiences program of the department of Veterans Affairs. The understanding and design of the trial had been published in the past.13 Cardiac surgical procedure classes at Veterans Affairs clinical facilities with talents in performing endoscopic vein-graft harvesting occupy been eligible to remove part. An government committee turned into answerable for trial oversight. The trial changed into accredited with the aid of the institutional review board at each and every collaborating core. patients gave written recommended consent earlier than participation. The authors vouch for the accuracy and completeness of the data and the analyses and for the fealty of the trial to the protocol, which is accessible with the complete textual content of this text at NEJM.org.

affected person inhabitants

patients present process non-compulsory or urgent CABG with cardiopulmonary bypass and cardioplegic arrest and a altenative to consume at least one vein graft underwent screening for enrollment. Inclusion standards were an age of 18 years or older and deliberate optionally available or urgent (however no longer emergency) CABG with the consume of the median sternotomy manner and a plot to consume at least one saphenous vein graft as a conduit. Exclusion standards occupy been a deliberate valve manner in aggregate with CABG, the presence of middling or severe valve disease, the presence of hemodynamic instability or cardiogenic shock, enrollment in one other therapeutic or interventional examine at, deliberate off-pump CABG, a life expectancy of lower than 1 year, a historical past of venous stripping or ligation within the legs, and an lack of aptitude to provide advised consent.

The Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac surgery (SYNTAX) score became used to quantify the severity of coronary-artery sickness for each and every trial participant.14 The SYNTAX ranking reflects a complete angiographic assessment of the coronary vasculature, with a ranking of twenty-two or less indicating low anatomical complexity, scores of 23 to 32 indicating intermediate anatomical complexity, and rankings of more than 32 indicating unreasonable anatomical complexity (0 is the bottom ranking, and there's no higher restrict).

Vein-Graft Harvesting adventure and recommendations

simplest skilled endoscopic vein-graft harvesters (e.g., surgeons or health practitioner assistants however now not trainees) occupy been invited to participate in the trial. collaborating harvesters provided assistance on their journey (certified by the primary investigator at the website) and needed to acquire approval to participate from an ad hoc committee chaired by a senior surgeon assistant in the field of endoscopic harvesting. minimum handicap become described as journey with greater than one hundred endoscopic vein harvesting situations with a licensed low (<5%) conversion fee to open harvesting, as a portion of a longtime endoscopic vein harvesting program with greater than 2 years of adventure, as well as an identical degrees of adventure with the open strategy.15

the consume of any endoscopic vein harvesting outfit approved by using the food and Drug Administration changed into allowed in the trial; the device become bought by the collaborating hospitals. best-practice endoscopic harvesting turned into suggested; the surgical manner is described within the Supplementary Appendix, purchasable at NEJM.org.13 Open harvesting become carried out based on the preference at each site. guideline-directed clinical remedy for secondary prevention of cardiovascular activities became informed as described in the Supplementary Appendix.sixteen

Randomization and comply with-up

earlier than randomization, an experienced vein harvester changed into recognized and assigned to the case. sufferers were then randomly assigned to both endoscopic or open vein-graft harvesting, in a 1:1 ratio, by using capability of a phone convene to the Cooperative reports program Coordinating core in Perry element, Maryland, with the consume of an automatic equipment. A obstruct randomization scheme with a random sequence of obstruct sizes become used to subsist sure a balanced distribution of contributors assigned to each harvester and within each scientific center. until the patient had an pressing scientific circumstance, surgery was scheduled to happen at the earliest feasible date on the groundwork of the supply of the professional harvester and other situations at the core.

contributors had been actively followed for not less than 1 12 months. Assessments had been accrued through site research personnel using in-clinic visits, telephone calls, or medical chart overview. Assessments came about at baseline, utter over surgery, after surgery, at discharge (or 30 days after surgical procedure, if the affected person was nevertheless hospitalized), at 6 weeks, and every 3 months thereafter except the conclusion of the lively follow-up section and the starting of the passive observe-up section (for 2 further years).

Trial consequences

The basic influence was described because the first incidence of a tremendous adverse cardiac event (a composite of dying from any cause, nonfatal myocardial infarction, or reiterate revascularization) in a time-to-adventure evaluation over the lively comply with-up duration of the trial. The basic composite outcomes and the individual components of that result (as described within the Supplementary Appendix) were recognized and adjudicated. A medical-activities committee such as cardiologists and cardiac surgeons, utter of whom occupy been blind to the medication assignments, reviewed and adjudicated utter primary adversarial cardiac activities, with ameliorations reconciled correctly. The scientific-events committee extra assigned motives of death as cardiac, noncardiac, or unknown on the foundation of a review of information from clinical information each inside and out of doors the Veterans health Administration.

A secondary outcomes blanketed major adverse cardiac hobbies at 1 year after surgery. extra secondary results of foremost adversarial cardiac hobbies at 3 years after surgical procedure and time to foremost hostile cardiac movements over the mixed (active and passive) follow-up term haven't yet been assessed, because the trial is at present within the passive comply with-up length.

a yoke of tertiary and set aside up hoc effects occupy been additionally assessed. The severity of incisional leg ache became assessed on the time of discharge and at approximately 6 weeks after surgical procedure. Leg wounds occupy been additionally evaluated with the ASEPSIS criteria, which might subsist described in the Supplementary Appendix.17 The ASEPSIS criteria comprise Likert-scale scores for the presence of erythema, serous exudates, purulent exudates, and separation of tissues, in addition to assessments of using therapeutic interventions together with antibiotic remedy, drainage, débridement, and prolongation of the sanatorium stay. In a publish hoc analysis, leg wound infections were adjudicated according to the centers for disorder control and Prevention criteria as described in the Supplementary Appendix.18 satisfactory of being became assessed at baseline, 6 weeks, and 1 12 months with the consume of the Veterans RAND 12-merchandise health survey (VR-12) and the Seattle Angina Questionnaire.19

Statistical analysis

We calculated that they might requisite a complete pattern of 1150 sufferers; particulars are provided in the Supplementary Appendix. Survival-analysis techniques occupy been used to research the time to foremost antagonistic cardiac pursuits (the primary outcomes). Kaplan–Meier nonparametric survival estimates occupy been used to regard the unadjusted repercussion of vein harvesting approach on predominant adverse cardiac movements. assessments of transformations of the survival-function estimates throughout strata (open and endoscopic harvest) had been performed with the log-rank test. Multivariable survival analyses making consume of a Cox proportional-hazards regression mannequin occupy been carried out to investigate the effect of vein harvesting approach on the basic result, with adjustment for different probably influential baseline features. A Wei–Lin–Weissfeld mannequin was used to evaluate multiple instances to events (recurrent hobbies) between the corporations during energetic comply with-up. Pearson’s chi-rectangular evaluation changed into used to examine the rate of essential opposed cardiac routine between the agencies throughout the primary yr of observe-up.

a sort I error fee of 0.025 was used for the basic influence to account for the alpha error assigned to 3 intervening time analyses (as described within the Supplementary Appendix). No adjustment for multiplicity of trying out become made; therefore, P values don't look to subsist pronounced for effects apart from the simple effect. self credence intervals were two-sided with a ninety five% assurance flush and were now not adjusted for multiplicity; therefore, inferences drawn from these intervals concerning secondary and tertiary effects may moreover no longer subsist reproducible. utter statistical analyses had been carried out with using SAS statistical application, edition 9.four (SAS Institute).


SAS certified medical Trials Programmer | killexams.com existent Questions and Pass4sure dumps

This supplier-certain Certification is obtainable by:SAS Institute Inc.Cary, NC USAPhone: 800-333-7660Email: This e-mail maneuver is being protected from spambots. You requisite JavaScript enabled to view it.

skill stage: Intermediate                          popularity: lively

reasonable: $one hundred eighty (shortest music)               

summary:For programmers and statisticians who consume SAS software to research scientific trials facts to supply stories for submission to regulatory authorities. compose sure to occupy event within the scientific trials technique, getting access to, managing, and transforming scientific trials information, statistical processes and macro programming, reporting clinical trials results, and validating medical trial data reporting.

initial requirements:There are two tips on how to rate this credential:

1) pass the medical Trials Programming the consume of SAS 9 examination ($one hundred eighty). The exam contains 99 questions and has a three hour closing date. A passing ranking of 70% is required.

or

2) if you already cling the SAS ground Programmer credential, that you would subsist able to remove the accelerated version of the clinical Trials Programming the usage of SAS 9 exam ($one hundred eighty). This shorter exam doesn't reiterate cloth lined on the bottom programming examination.The accelerated examination consists of 71 questions and has a 2 hour cut-off date. A passing score of 70% is required.

practising is available but not required.

continuing requirements:The SAS international Certification software now issues versioned credentials that finish not expire. The version is indicated within the credential denomination - for example, SAS licensed ground Programmer for SAS 9. prior to now, SAS issued non-versioned credentials and required recertification each 3 years, but with the addition of versioning to the credential names, recertification requirements had been dropped.

See utter Sas Certifications

dealer's web page for this certification


SAS Institute: top notch for a intent | killexams.com existent Questions and Pass4sure dumps

the realm's largest privately held application company, SAS Institute is just about a manner of life. that is proper for SAS employees, who obtain free fitness care, undertaking amenities, sponsored daycare and day without work for his or her kids' soccer games. however the sense of community additionally extends to SAS valued clientele.

PDF Downloadit will probably remove years to master SAS tools because the software is complicated and does sophisticated statistical analysis. people who can finish it are proud. indigenous and regional person companies are effective, contributors are opinionated. "it's a community. We're tied together," says Alice Pressman, a fitness analysis analyst at Kaiser Permanente in Oakland, Calif.

SAS Institute's core items, similar to SAS/STAT and ground SAS, are for hefty duty statistics work. Pharmaceutical and monetary functions corporations are mainstay consumers—groups the station the reducing, dicing and crunching of numbers is core to the business.

SAS brags a few ninety eight% client retention expense, however look to subsist carefully. SAS does not promote product licenses fancy most application organizations. It sells utility by annual subscription. Fail to renew and a time bomb paralyzes the equipment—and any purposes developed atop them.

Fingerhut organizations, a tremendous SAS consumer, has gotten bombed. "we occupy distinctive considered one of their SAS programmers to subsist the contact with their SAS rep to live on excellent of that, however they obtain caught," says Randy Erdahl, director of traffic intelligence. A cellphone convene to SAS with a promise of fee receives it resolved, he says.

an additional side impact: for those who own a product license, that you could select when to better to unique models. With subscriptions, clients are on SAS's timetable.

valued clientele occupy lengthy griped in regards to the subscription equipment, but SAS hasn't budged. The $1 billion supplier says it hasn't vital to, claiming 25 straight years of revenue growth. Its nearest opponents are half its dimension.

Plus, customers say, few outfit can well SAS capabilities.

"They convey technical potential and assist you install the product. They support you from A to Z," says invoice Lepler, vice chairman of traffic CRM at the restrained. The constrained's headquarters office spends $200,000 per yr with SAS. a yoke of different divisions moreover consume SAS tools. "or not it's develop into the gold standard for analytical work," Lepler says.

SAS Institute100 SAS Campus pressure, Cary, NC 27513 / (919) 677-8000www.sas.com

personnel: eight,025

Jim GoodnightCEO, ChairmanStarted the enterprise in 1976 after writing a statistical analysis software while a graduate pupil at North Carolina State school. Runs the enterprise fancy a neighborhood, with on-website health care, day care, education, even a farmer's market. Hosted President Bush's fiscal team in January.

John SallExecutive vp, CofounderOversees SAS's Macintosh items and educational application. additionally went to N.C. State.

Keith CollinsChief technology OfficerJoined in 1984 in R&D, now directs the 1,a hundred-member group. he is a different N.C. State alum.

Jim DavisChief advertising OfficerBefore overseeing advertising and marketing, changed into product manner director.

Key ProductsFifty items, including ground SAS for evaluation and presentation, SAS/STAT for eight types of statistical evaluation, SAS suggestions nascence Portal, SAS Warehouse Administrator and many statistics cleaning, administration and reporting packages.

Reference tests

Fingerhut Cos.Randy ErdahlDirector, company Intelligence(952) 932-3100Project: The catalog stupendous has used SAS tools for greater than 15 years. latest work involves the consume of SAS macros to aid refine direct-mail catalog campaigns.

Fireman's Fund insurance Co.Dave FreeseBusiness methods Managerdfreese@ffic.comProject: The $four billion insurer has developed a few analytical functions with SAS programming equipment, including loss-monitoring and earnings-performance methods.

Hartford-enviornment SAS user GroupJanet StuelpnerSteering Committee Member(718) 248-5814Project: A SAS consumer for 21 years at economic and pharmaceutical agencies; now at Citigroup, practicing credit analysts in SAS.

The LimitedBill LeplerVP, CRM(614) 415-7000Project: The apparel retailer's Victoria's covert division uses SAS to research sales statistics from catalogs, outlets and the net website.

PfizerRene LaurencotSenior SAS Programmerrene_e_laurencot@ groton.pfizer.comProject: The $32 billion drug traffic uses SAS for statistical analysis of scientific trials facts, and to create experiences for the U.S. meals and Drug Administration approval process.

U.S. BancorpMike TangedalCredit Analyst(651) 205-0743Project: The $sixteen billion Minneapolis bank makes consume of SAS outfit to cleanly statistics and anatomize clients' credit score and monetary histories.

The executives listed listed below are utter users of SAS's enterprise intelligence software. Their willingness to talk has been validated through Baseline.


A00-281 Clinical Trials Programming Using SAS 9 Accelerated Version

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Killexams.com A00-281 Dumps and existent Questions

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A00-281 exam Dumps Source : Clinical Trials Programming Using SAS 9 Accelerated Version

Test Code : A00-281
Test denomination : Clinical Trials Programming Using SAS 9 Accelerated Version
Vendor denomination : SASInstitute
: 99 existent Questions

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The A00-281 exam is supposed to subsist a completely diffcult exam to cleanly But I cleared it remaining week in my first attempt. The killexams.Com s guided me well and I was properly prepared. advice to other students - dont remove this exam lightly and examine at very well.


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Clinical Trials Programming Using SAS 9 Accelerated Version

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SAS Certified Clinical Trials Programmer | killexams.com existent questions and Pass4sure dumps

This vendor-specific Certification is Offered By:SAS Institute Inc.Cary, NC USAPhone: 800-333-7660Email: This email address is being protected from spambots. You requisite JavaScript enabled to view it.

Skill Level: Intermediate                          Status: Active

Low Cost: $180 (shortest track)               

Summary:For programmers and statisticians who consume SAS software to anatomize clinical trials data to bear reports for submission to regulatory authorities. You should occupy undergo in the clinical trials process, accessing, managing, and transforming clinical trials data, statistical procedures and macro programming, reporting clinical trials results, and validating clinical trial data reporting.

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Continuing Requirements:The SAS Global Certification Program now issues versioned credentials that finish not expire. The version is indicated in the credential denomination - for example, SAS Certified ground Programmer for SAS 9. Previously, SAS issued non-versioned credentials and required recertification every 3 years, but with the addition of versioning to the credential names, recertification requirements were dropped.

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Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass | killexams.com existent questions and Pass4sure dumps

Trial Design and Oversight

We conducted a randomized, intention-to-treat, multicenter trial funded by the Cooperative Studies Program of the Department of Veterans Affairs. The rationale and design of the trial occupy been published previously.13 Cardiac surgery programs at Veterans Affairs medical centers with expertise in performing endoscopic vein-graft harvesting were eligible to participate. An executive committee was answerable for trial oversight. The trial was approved by the institutional review board at each participating center. Patients gave written informed consent before participation. The authors vouch for the accuracy and completeness of the data and the analyses and for the fealty of the trial to the protocol, which is available with the full text of this article at NEJM.org.

Patient Population

Patients undergoing elective or urgent CABG with cardiopulmonary bypass and cardioplegic arrest and a conclusion to consume at least one vein graft underwent screening for enrollment. Inclusion criteria were an age of 18 years or older and planned elective or urgent (but not emergency) CABG with the consume of the median sternotomy approach and a plot to consume at least one saphenous vein graft as a conduit. Exclusion criteria were a planned valve procedure in combination with CABG, the presence of qualify or severe valve disease, the presence of hemodynamic instability or cardiogenic shock, enrollment in another therapeutic or interventional study, planned off-pump CABG, a life expectancy of less than 1 year, a history of venous stripping or ligation in the legs, and an inability to provide informed consent.

The Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score was used to quantify the severity of coronary-artery disease for each trial participant.14 The SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with a score of 22 or less indicating low anatomical complexity, scores of 23 to 32 indicating intermediate anatomical complexity, and scores of more than 32 indicating tall anatomical complexity (0 is the lowest score, and there is no upper limit).

Vein-Graft Harvesting undergo and Techniques

Only expert endoscopic vein-graft harvesters (e.g., surgeons or physician assistants but not trainees) were invited to participate in the trial. Participating harvesters provided information on their undergo (certified by the principal investigator at the site) and had to receive approval to participate from an ad hoc committee chaired by a senior physician assistant in the field of endoscopic harvesting. Minimum expertise was defined as undergo with more than 100 endoscopic vein harvesting cases with a certified low (<5%) conversion rate to open harvesting, as portion of an established endoscopic vein harvesting program with more than 2 years of experience, as well as similar levels of undergo with the open approach.15

The consume of any endoscopic vein harvesting device approved by the Food and Drug Administration was allowed in the trial; the outfit was purchased by the participating hospitals. Best-practice endoscopic harvesting was recommended; the surgical technique is described in the Supplementary Appendix, available at NEJM.org.13 Open harvesting was performed according to the preference at each site. Guideline-directed medical therapy for secondary prevention of cardiovascular events was recommended as described in the Supplementary Appendix.16

Randomization and Follow-up

Before randomization, an experienced vein harvester was identified and assigned to the case. Patients were then randomly assigned to either endoscopic or open vein-graft harvesting, in a 1:1 ratio, by means of a telephone convene to the Cooperative Studies Program Coordinating seat in Perry Point, Maryland, with the consume of an automated system. A obstruct randomization scheme with a random sequence of obstruct sizes was used to ensure a balanced distribution of participants assigned to each harvester and within each medical center. Unless the patient had an urgent medical condition, surgery was scheduled to occur at the earliest practicable date on the basis of the availability of the expert harvester and other circumstances at the center.

Participants were actively followed for a minimum of 1 year. Assessments were collected by site research personnel using in-clinic visits, telephone calls, or medical chart review. Assessments occurred at baseline, during surgery, after surgery, at discharge (or 30 days after surgery, if the patient was still hospitalized), at 6 weeks, and every 3 months thereafter until the terminate of the lively follow-up side and the nascence of the passive follow-up side (for 2 additional years).

Trial Outcomes

The primary outcome was defined as the first happening of a major adverse cardiac event (a composite of death from any cause, nonfatal myocardial infarction, or reiterate revascularization) in a time-to-event analysis over the lively follow-up term of the trial. The primary composite outcome and the individual components of that outcome (as defined in the Supplementary Appendix) were identified and adjudicated. A clinical-events committee consisting of cardiologists and cardiac surgeons, utter of whom were unaware of the treatment assignments, reviewed and adjudicated utter major adverse cardiac events, with differences reconciled appropriately. The clinical-events committee further assigned causes of death as cardiac, noncardiac, or unknown on the basis of a review of data from medical records both inside and outside the Veterans Health Administration.

A secondary outcome included major adverse cardiac events at 1 year after surgery. Additional secondary outcomes of major adverse cardiac events at 3 years after surgery and time to major adverse cardiac events over the combined (active and passive) follow-up term occupy not yet been assessed, because the trial is currently in the passive follow-up period.

Several tertiary and post hoc outcomes were moreover assessed. The severity of incisional leg twinge was assessed at the time of discharge and at approximately 6 weeks after surgery. Leg wounds were moreover evaluated with the ASEPSIS criteria, which are described in the Supplementary Appendix.17 The ASEPSIS criteria comprise Likert-scale scores for the presence of erythema, serous exudates, purulent exudates, and separation of tissues, as well as assessments of the consume of therapeutic interventions including antibiotic treatment, drainage, débridement, and prolongation of the hospital stay. In a post hoc analysis, leg wound infections were adjudicated according to the Centers for Disease Control and Prevention criteria as described in the Supplementary Appendix.18 property of life was assessed at baseline, 6 weeks, and 1 year with the consume of the Veterans RAND 12-item health survey (VR-12) and the Seattle Angina Questionnaire.19

Statistical Analysis

We calculated that they would requisite a total sample of 1150 patients; details are provided in the Supplementary Appendix. Survival-analysis techniques were used to anatomize the time to major adverse cardiac events (the primary outcome). Kaplan–Meier nonparametric survival estimates were used to evaluate the unadjusted effect of vein harvesting technique on major adverse cardiac events. Tests of differences of the survival-function estimates across strata (open and endoscopic harvest) were performed with the log-rank test. Multivariable survival analyses applying a Cox proportional-hazards regression model were performed to investigate the effect of vein harvesting technique on the primary outcome, with adjustment for other potentially influential baseline characteristics. A Wei–Lin–Weissfeld model was used to compare multiple times to events (recurrent events) between the groups during lively follow-up. Pearson’s chi-square analysis was used to compare the rate of major adverse cardiac events between the groups during the first year of follow-up.

A type I error rate of 0.025 was used for the primary outcome to account for the alpha error assigned to three interim analyses (as described in the Supplementary Appendix). No adjustment for multiplicity of testing was made; therefore, P values are not reported for outcomes other than the primary outcome. assurance intervals were two-sided with a 95% assurance flush and were not adjusted for multiplicity; therefore, inferences drawn from these intervals regarding secondary and tertiary outcomes may not subsist reproducible. utter statistical analyses were conducted with the consume of SAS statistical software, version 9.4 (SAS Institute).


Soligenix Selected to Present RiVax® Data at the Fourth International Conference on Vaccines Research & development in Baltimore, Maryland | killexams.com existent questions and Pass4sure dumps

PRINCETON, N.J., Nov. 12, 2018 /PRNewswire/ -- Soligenix, Inc. SNGX, +5.62% (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that Dr. Oreola Donini, Chief Scientific Officer, will subsist presenting data from the ricin toxin vaccine (RiVax®) program describing development of the vaccine under the Food and Drug Administration (FDA) Animal Rule.  The presentation will subsist given at the upcoming Fourth International Conference on Vaccines Research & development on November 13-15, 2018 to subsist held at the Radisson Hotel Baltimore Downtown-Inner Harbor, MD.

Oral Presentation:

Thermostabilized vaccine development under the animal rule: ricin toxin vaccine presented by Dr. Oreola Donini, Chief Scientific Officer, Soligenix, Inc., on November 14, 2018 from 8:50 – 9:15 AM EDT.

RiVax® is the Company's vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin.  When formulated using Soligenix's proprietary heat stabilization technology (ThermoVax®), RiVax® has demonstrated significantly enhanced thermostability and 100% protection to non-human primates in preclinical aerosol challenge models.  Moreover, potential correlates of immune protection occupy been identified in collaboration with the laboratory of Dr. Nicholas Mantis, Research Scientist, Division of Infectious Diseases, Wadsworth Center, unique York State Department of Health. The presented results will dispute a species-independent assay for immune correlates of protection, an valuable requirement of the FDA "Animal Rule" to pursue approval of RiVax®. 

The development of RiVax® has been sponsored through a series of grants from both National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID shrink # HHSN272201400039C. Ricin epitope mapping has been sponsored by NIAID shrink # HHSN272201400021C and concede # R01 AI125190.

About the Fourth International Conference on Vaccines Research & Development

This annual conference focuses on international and interdisciplinary exchange at the forefront of vaccine research. Over the course of three days, internationally-renowned speakers from both industry and academics relate how their research journeys occupy developed in response to concomitant challenges.  

For more information about the conference, please mention to website here.

About Ricin Toxin

Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and tall potency, and the fact it is readily extracted from by-products of castor oil production.  Ricin comes in many forms including powder, mist or pellet.  Ricin can moreover subsist dissolved in water and other liquids.  The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt.  Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.  Ricin is especially toxic when inhaled.  Ricin works by entering cells of the body and preventing the cells from making the proteins it needs.  Without the proteins, cells die, which is eventually harmful to the entire body.

There are currently no efficient treatments for ricin poisoning.  The successful development of an efficient vaccine against ricin toxin may act as a deterrent against the actual consume of ricin as a biological weapon and could subsist used to vaccinate military personnel and civilian emergency responders at tall risk of potential exposure in the event of a biological attack.

About RiVax®

RiVax® is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, the recent threat of which has been highlighted in the tidings with an envelope addressed to President Trump that may occupy contained this potent and potentially lethal toxin.  With RiVax®, Soligenix is a world leader in the district of ricin toxin vaccine research.

RiVax® contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule.  A side 1A clinical trial was conducted with a formulation of RiVax® that did not contain an adjuvant.  This trial revealed dose contingent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.  The adjuvant-free formulation of RiVax® induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.

To expand the longevity and magnitude of toxin neutralizing antibodies, RiVax® was subsequently formulated with an adjuvant of aluminum salts (known colloquially as alum) for a side 1B clinical trial.  Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants.  The results of the side 1B study indicated that alum-adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax®.  In animal studies, the alum formulation of RiVax® moreover induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine.  Vaccination with the thermostabilized alum-adjuvanted RiVax® formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.  The protected animals moreover had no signs of obscene lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.  These results are described in a publication available here.

Heat stabilization of RiVax® is achieved with the Company's proprietary ThermoVax® technology, designed to eradicate the cold-chain production, distribution and storage logistics required for most vaccines.  The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.  By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the aptitude to withstand temperatures at least as tall as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. These results are described in a publication available here.

The development of RiVax® has been sponsored through a series of grants from both National Institute of Allergy and Infectious Diseases (NIAID), and the FDA and ongoing development is sponsored by NIAID shrink #HHSN272201400039C.  The planned side 2 clinical trial is contingent upon exercise of the final option by the U.S. government under NIAID shrink #HHSN272201400039C and/or through other funding sources.  RiVax® potentially would subsist added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.  RiVax® has received orphan drug designation in the U.S. and in Europe.

As a unique chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review Voucher (PRV), which allows the holder accelerated review of a drug application.  Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the lively ingredient(s) occupy not been otherwise approved for consume in any context.  PRVs are transferable and can subsist sold, with sales in recent years ranging between $125 million to $350 million.  When redeemed, PRVs entitle the user to an accelerated review term of six months, saving a median of seven months' review time as calculated in 2009.  However, the FDA must subsist advised 90 days in foster of the consume of the PRV and the consume of a PRV is associated with an additional user fee ($2.7 million in 2017).

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Their BioTherapeutics traffic segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, their first-in-class congenital defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

Our Vaccines/BioDefense traffic segment includes lively development programs for RiVax®, their ricin toxin vaccine candidate, OrbeShield®, their GI acute radiation syndrome therapeutic candidate and SGX943, their therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of their vaccine programs incorporates the consume of their proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this traffic segment has been supported with government concede and shrink funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment.  Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could understanding actual events or results in future periods to vary materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will subsist able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not subsist reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will subsist able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will subsist able to compete with larger and better financed competitors in the biotechnology industry, that changes in health trust practice, third party reimbursement limitations and Federal and/or state health trust reform initiatives will not negatively move its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can subsist no assurance as to timing or success of the preclinical/clinical trials of RiVax®, that RiVax® will subsist approved for the PRV program or the amount for which a PRV for RiVax® can subsist sold.  These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no responsibility to update or revise any forward-looking statements as a result of unique information or future events.

View original content:http://www.prnewswire.com/news-releases/soligenix-selected-to-present-rivax-data-at-the-fourth-international-conference-on-vaccines-research--development-in-baltimore-maryland-300747294.html

SOURCE Soligenix, Inc.

Copyright (C) 2018 PR Newswire. utter rights reserved



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