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Phase III Data Leads Intercell AG to Shelve Late Stage Travelers Diarrhea Vaccine Patch Stock Down 4. AM ESTVIENNA and GAITHERSBURG, Md., Dec. ![]() PRNewswire/ - -Travelers' Diarrhea vaccine candidate failed to meet efficacy endpoints to protect against enterotoxigenic E. The pivotal studies confirm that the vaccine candidate induces reproducible levels of protective antibodies against the LT toxin resulting in a meaningful reduction of LT specific ETEC episodes, following transcutaneous immunization. The projected year end loss for 2. EUR 4. 0m since milestone payments in connection with the Travelers' Diarrhea program are not expected to be received, and the Company expects to impair all or a substantial part of its respective intangible assets. Intercell has taken the decision not to pursue further clinical development of its Travelers' Diarrhea vaccine candidate Intercell will reduce R& D expenses by approximately 4. Management is focusing the Company's R& D strategy and resources on the other projects in its well- balanced clinical stage portfolio, especially the successful and highly attractive nosocomial programs including the investigational vaccines against Pseudomonas and C. The decision was made following the receipt of results of its randomized and placebo- controlled Phase III study (ELT3. Europe to Mexico and Guatemala as well as the pilot efficacy Phase II trial (ELT2. Europe to India. Both trials were successfully conducted according to study design, met statistical targets of enrollment, participation follow- up, subject and site compliance, and produced a firm preliminary conclusion. The vaccine was generally well tolerated and the safety profile was consistent with that observed in earlier studies. In an earlier randomized double blind placebo- controlled Phase II field trial (ELT2. TD vaccine candidate showed excellent immunogenicity and reduced the risk of clinically significant diarrheal episodes in U. S. The Phase III trial was intended to confirm the efficacy of the investigational TD Vaccine Patch for prevention of moderate to severe diarrhea in a similar field setting. The trials' primary endpoints, reduction of incidence of all types of enterotoxigenic E. Thus, in the ELT3. ETEC and no apparent effect on the frequency of all- cause moderate to severe diarrhea was observed. ![]() However, a statistically significant reduction of duration of all- cause diarrheal episodes and total number of unformed stools was observed, confirming observations from a previous Phase II study. In study ELT3. 01, the vaccine protected most against LT positive ETEC (up to 6. However, the study was not powered to demonstrate a statistically significant efficacy against individual ETEC types. Furthermore the incidence of LT positive ETEC in both trials was lower than expected, compared to previous trials and published data. The current trials have confirmed the previous Phase II observation of a consistent induction of protective levels of antibodies against the LT- toxin following transcutaneous immunization and using the Company's proprietary delivery technology. This clearly supports and validates patch- based vaccination as a suitable route of immunization for future potential product candidates. Intercell is carrying out further analysis of the trial results. However, subject to this analysis and further consultation with its partner, the Company remains committed to expanding the development of the use of patch technology for existing or novel vaccines as well as the development of the investigational Vaccine Enhancement Patch (VEP) system for vaccination against Avian H5. N1 Influenza. Following the successful progression of the S. Hospital- acquired infections represent a major health need and Intercell is well positioned with its portfolio to help address this medical need. Intangible assets pertaining to the TD vaccine program and other patch programs represented a book value of EUR 1. September 3. 0, 2. Intercell expects to impair all or a substantial part of these assets following an impairment analysis triggered by the study results.
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Educational Leadership: Building a Community for Learning: Teaching Students to Be Peer Mediators. September 1. 99. 2 . Johnson, Bruce Dudley and Robert Burnett. While traditional discipline procedures—from expulsion to scolding—teach students to depend on authority figures to resolve conflicts, the Peacemaker Program teaches children how to mediate disputes and negotiate solutions themselves. External Rewards/Punishments. Competencies for Self- Regulation. Traditional discipline programs require an adult to monitor student behavior, determine whether it is or is not within the bounds of acceptability, and force students to terminate inappropriate actions.
![]() Peer Mediation Program 1. INTRODUCTION The Los Angeles Mission College Peer Mediation Program is a voluntary program available to all faculty and staff to assist in. Peer Mediation Program: A Parent’s Guide to. Conflict Resolution & Peer Mediation. What is peer mediation? The Mediation Center of Savannah. Cutting the Emotional and Financial Costs of Disputes. Peer Mediators is a complete school curriculum to help students constructively address. When the infractions are minor, teachers often arbitrate (“The pencil belongs to Mary. Jane, be quiet and sit down.”) or cajole students to end hostilities (“Let's forgive and forget. Shake hands and be friends.”). If such strategies don't work, students may be sent to the principal's office for a stern but cursory lecture about the value of getting along; a threat that, if the conflict continues, more drastic action will ensue; and a final admonition to “go and fight no more.” If that does not work, time- out rooms might be tried. Eventually, some students are expelled from school. Peer Mediation Programs ElementaryPeer Mediation Program For Elementary SchoolSuch programs teach students that adults or authority figures are needed to resolve conflicts. The programs cost instructional and administrative time and work only as long as students are under surveillance. This approach does not empower students. While adults may become more skillful in controlling students, students do not learn the procedures, skills, and attitudes required to resolve conflicts constructively in their personal lives at home, in school, at work, and in the community. At the other end of the continuum are programs aimed at teaching students self- responsibility and self- regulation. Self- regulation is the ability to act in socially approved ways in the absence of external monitors. Quick Guide to Implementing a Peer Mediation Program by Richard Cohen Peer Mediation: A form of conflict resolution in which trained student leaders. It is the ability to initiate and cease activities according to situational demands. Self- regulation is a central and significant hallmark of cognitive and social development. To regulate their behavior, students must monitor their own behavior, assess situations, make judgments as to which behaviors are appropriate, and master the procedures and skills required to engage in desired behavior. In interaction with other people, students have to monitor, modify, refine, and change how they behave in order to act appropriately and competently. If students are to learn how to regulate their behavior, they must have opportunities to (1) make decisions regarding how to behave and (2) follow through on the decisions made. Allowing students to be joint architects in matters affecting them promotes feelings of control and autonomy. Students who know how to manage their conflicts constructively and regulate their own behavior have a developmental advantage over those who do not. Ideally, students will be given the responsibility for regulating their own and their classmates' behavior so that teachers can concentrate on instruction rather than control. Empowering Students To Be Peacemakers. In order to decide which type of discipline program will work best, it helps to know what types of discipline problems are occurring. Typically, most discipline problems involve either conflicts among students, conflicts between students and teachers, or conflicts between students and standards of acceptable conduct. By training students to manage conflicts constructively, a discipline program can empower students to solve their own problems and regulate their own and their classmates' behavior. Although such programs have been suggested for years (Johnson 1. For the past two years we have implemented a peer mediation program at Highlands Elementary School in Edina School District, Edina, Minnesota. In 3. 0 minutes of training per day for 3. The curriculum Teaching Students to be Peacemakers (Johnson and Johnson 1. Step 1: Negotiation. The first step in the Peacemaker Program is to teach all students to negotiate constructive resolutions to their conflicts. The negotiation procedure and skills need to be over- learned so that they are available for use when emotions run high and feelings of fear and anger are intense. To negotiate solutions, students need to define their conflict, exchange positions and proposals, view the situation from both perspectives, invent options for mutual gain, and reach a wise agreement. Students are taught the following procedure (Johnson and Johnson 1. State what you want: “I want to use the book now.”State how you feel: “I'm frustrated.”State the reasons for your wants and feelings: “You have been using the book for the past hour. If I don't get to use the book soon, my report will not be done on time. It's frustrating to have to wait so long.”Summarize your understanding of what the other person wants, how the other person feels, and the reasons underlying both. Invent three optional plans to resolve the conflict. Choose one plan and shake hands. Students need to learn the negotiation procedure and become skillful in its use in relatively easy situations before they can be expected to use it to resolve real conflicts. Mediation is easier, and more effective, when students have previously been trained in the negotiation procedure. Step 2: Conflict Mediation. The second step is to teach all students how to mediate constructive resolutions of their classmates' conflicts. Mediation is the utilization of the services of another person to help settle a dispute. The purpose of mediation is to help classmates negotiate a constructive resolution to their conflicts. Mediation is usually contrasted with arbitration. Arbitration is the submission of a dispute to a disinterested third party (such as a teacher or principal), who makes a final and binding judgment as to how the conflict will be resolved. Following is the mediation procedure the students are taught (Johnson and Johnson 1. Introduction: When mediating a conflict, the class mediator first introduces him- or herself. The mediator asks students if they want to solve the problem and does not proceed until both answer “yes.”Guidelines: The mediator explains: “Mediation is voluntary. My role is to help you find a solution to your conflict that is acceptable to both of you.”“I am neutral. I will not take sides or attempt to decide who is right or wrong. I will help you decide how to solve the conflict.”“Each person will have the chance to state his or her view of the conflict without interruption.”Rules: The rules students must agree to are: Solve the problem. Do not resort to name calling. Do not interrupt. Be as honest as you can. If you agree to a solution, you must do what you have agreed to do. Anything said in mediation is confidential. Step 3: The Peacemaker Program. After students are introduced to negotiation and mediation skills, the teacher selects two class members to serve as official mediators each day. Any conflicts students cannot resolve themselves are referred to the class mediators. The mediators wear official T- shirts, patrol the playground and lunchroom, and are available to mediate all conflicts. The role of class mediator is rotated throughout the class so that each student serves as a class mediator an equal amount of time. Mediating classmates' conflicts is perhaps the most dramatic way of teaching students the need for the skillful use of each step of the negotiation procedure. Refresher lessons are taught once or twice a week. The processes of negotiation and mediation allow students to practice joint decision making within a structure that emphasizes a solution/settlement that is acceptable to all parties involved and is, therefore, fair. Students are given the power to decide the outcome (within the constraints of the school policy and the law). Negotiation and mediation are self- empowering. They enable students to make decisions about issues and conflicts that affect their own lives rather than having a decision imposed on them by teachers and administrators. Results at Highlands Elementary. At Highlands Elementary School we initially gathered data on the need for a Peacemaker Program. We found that even in a suburban, middle- class school such as Highlands, most students were involved in conflicts daily. The conflicts reported (in terms of frequency) were put- downs and teasing, playground conflicts, access or possession conflicts, physical aggression and fights, academic work conflicts, and turn- taking problems. Before training, students often referred the majority of their conflicts to the teacher. One of the teachers stated in her log, “Before training, students viewed conflict as fights that always resulted in a winner and a loser. To avoid such an unpleasant situation, they usually placed the responsibility for resolving conflicts on me, the teacher.”If students did not bring the conflict to the teacher, they typically used destructive strategies (such as repeating their request and trying to force the other person to give in) that would escalate the conflict. Negotiating an agreement that both students liked was never an option. Students had no idea how to do so. From these findings, we concluded that students were not being taught negotiation procedures and skills in the home or community at large and, therefore, that all students needed to be trained in how to manage conflicts constructively. Once it was established that conflict training was needed, the question investigated was whether or not the Peacemaker Program worked. Conflict training works if it: reduces the number of student- student conflicts referred to teachers and the principal,results in students mastering the negotiation and mediation procedures and skills taught, andresults in students using these procedures and skills in settings other than the classroom. Manuals - Peer Mediators. Manuals. The Peer Mediators core curriculum includes a set of comprehensive, customizable manuals designed to guide you through the implementation and administration of the Peer Mediators program. The resources include the following manuals: Program Implementation Guide. The Peer Mediators Implementation Guide provides an overview of the key questions to consider, resources to identify, and strategies to put in place as you develop your Peer Mediators program. Regardless whether you are setting up a program from scratch, already have some of the suggested mechanisms in place, or are building upon a currently existing program, this guide serves as an accessible, instructive quality assurance resource for your program. The Peer Mediators Trainer. It provides the trainer valuable training tips including information about curriculum delivery, training logistics, the trainer. The training curriculum itself is presented in twelve modules. The first three modules are designed to introduce students to each other, to conflict, and to the peer mediation process. Modules 4- 1. 2 are focused on very specific skill sets within peer mediation. These modules are designed for a 1. For your convenience, an overview of each module's training objectives is included in Appendix A of the Manual. The Peer Mediators Student Workbook is a collection of all of the handouts corresponding to each training module. We encourage the trainer to customize the training activities that best suit your group, and to add in any additional worksheets or pages that s/he feels would assist students in the learning process. To help ensure constructive conflict programming is accessible to all schools and students, free electronic versions of these resources are available! You may request your free digital copies using the form below. Note: Once downloaded, please refrain from embedding or hosting the Peer Mediator curriculum on other websites. If you are interested in further sharing these resources with your networks, please feel free to link directly to this page or Peer. Mediators. org. Thank you. Printed Manuals & DVD Purchases. For those who may be interested, professionally bound copies of these manuals may also be available depending on current stock. Each Peer Mediators curriculum set includes one copy each of the Program Implementation Guide, Trainer's Manual, and Student Workbook, a DVD of all the Peer Mediators training videos, and a CD containing electronic versions of the three manuals. Curriculum sets may be ordered for $5. Orders inquiries, including bulk pricing options and pre- purchase invoice requests, are accepted via email. |
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December 2016
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