Daily News 24 / 02 / 2017

L’Europe aujourd’hui et demain: discours du Président Juncker

Le Président Juncker a prononcé un discours hier à l’Institut d’études européennes de l’Université catholique de Louvain-la-Neuve intitulé ‘l’Europe aujourd’hui et demain’. Le constat que le Président Juncker tire de l’histoire de l’intégration européenne est que “l’Europe n’est pas une évidence. L’Europe fut et l’Europe restera un choix.” En parlant du futur de l’Europe, le Président Juncker a affirmé que l’heure n’est pas à la redivision mais au rassemblement. Le président a cité plusieurs scénarios qui pourraient caractériser ce rassemblement et a plaidé à ce qu’une réponse soit apportée à la question de savoir s’il ne faudrait pas que ceux en Europe qui veulent avancer plus rapidement puissent le faire. Le discours complet est disponible en ligne. (Pour plus d’informations: Natasha Bertaud – Tel.: +32 229 67456)

WTO confirms Russian pork ban is illegal

The WTO’s Appellate Body confirmed that Russia’s import ban from 2014 on live pigs, pork and other pig products from the EU violates international trade rules. The ruling concerns a ban imposed by Russia because of the outbreak of African Swine Fever in areas in the EU close to the border with Belarus. In August 2016, a WTO panel acknowledged that the Russian measures are not based on the relevant international standards and violate WTO rules. The ruling confirms this finding, thereby sending another strong signal to Russia and all WTO Members on their obligation to respect international standards and, in particular, the principle of regionalisation, which would allow trade from individual areas of a country which are recognised as pest or disease-free, independent of the health status in the rest of the country. The EU has one of the world’s most efficient animal health and food safety systems, including high detection levels and stringent risk management rules. EU products from disease-free areas are safe, and there is no need for any country to maintain unjustified import restrictions. The EU calls on Russia to withdraw its unjustified measures and allow EU companies to resume normal business with their Russian partners. More information is available here. (For more information: Daniel Rosario – Tel.: + 32 229 56185; Enrico Brivio – Tel.: + 32 229 56172; Axel Fougner – Tel.: +32 229 57276)

EU proposes €105 million in humanitarian assistance for Africa’s Lake Chad region

The European Commission plans to mobilise a total of €105 million in humanitarian support to populations in the Lake Chad region in Africa in 2017. Commissioner for Humanitarian Aid and Crisis Management Christos Stylianides made the announcement today during an international conference in Oslo, Norway aimed at addressing the pressing humanitarian situation in the region. “With the crisis in the Lake Chad region growing at an extremely alarming rate, the EU is stepping up its response. Today I announced the EU’s allocation of €105 million in humanitarian aid for the crisis. These funds will help meet the life-saving needs of the affected populations and scale up our response. The conditions for delivering assistance remain particularly difficult. It is essential to ensure quick and safe access to people who need lifesaving assistance.” saidCommissioner Stylianides.Read the full press release here. (For more information: Carlos Martín Ruiz de Gordejuela – Tel.: + 32 229 65322; Daniel Puglisi – Tel.: +32 229 69140)

New Commission app for tracking invasive alien animals and plants in the EU

The European Commission’s Joint Research Centre (JRC) has developed an online application that will help citizens identify and share information about 37 Invasive Alien Speciesin Europe. ‘Invasive Alien Species Europe’, which contains detailed information about and photos of those animals and plants, makes it possible for citizens to use their phones’ navigation system and cameras to capture images of them. By sending the exact location of a sighting and a photo via the app, users contribute to crowdsourcing the maps showing where invasive aliens species occur, and help to build the European Alien Species Information Network. Tibor Navracsics, Commissioner for Education, Culture, Youth and Sport, responsible for the JRC, said: “The beauty of this app is that it turns its users into citizen-scientists, helping to monitor invasive alien species that threaten biodiversity in the EU. The information collected will enrich existing insights into invasive alien species. In this way we also foster citizens’ awareness of the problems caused by invasive alien species in Europe.” The list for instance includes the American grey squirrel, which transfers a poxyvirus that is lethal to native red squirrels and leads to their local extinction, the raccoon, which can harbour and spread diseases affecting humans as well as farmed and wild animals, and the signal crayfish that carries the crayfish plague fungus and leads to the extinction of native crayfish. A small proportion of alien species become invasive and seriously disturb ecosystems, causing damage worth millions of euros in the EU every year. The application is free and can be downloaded for android and iOS. (For more information: Nathalie Vandystadt – Tel.: +32 229 67083; Joseph Waldstein – Tel.: +32 229 56184)

 

Mergers: Commission clears acquisition of Harman by Samsung

The European Commission has approved, under the EU Merger Regulation, the acquisition of Harman International Industries, Incorporated of the US, by Samsung Electronics Co., Ltd. of South Korea. Harman designs and engineers software products and solutions for automakers, consumers and enterprises worldwide. Samsung is a global electronics company active in consumer electronics, information technology and mobile communications and device solutions. The activities of the parties overlap in several product areas, such as, headphones, audio home systems, speakers and DVD recorders. Some of Samsung’s memory integrated circuits (DRAMs and NANDs) are also destined for the automotive industry and used in Harman’s automotive products. The Commission concluded that the proposed acquisition would raise no competition concerns because of the relatively low market shares and the existence of many strong competitors in the product markets concerned, including alternative suppliers of DRAMs and NANDs and alternative customers of these products. The transaction was examined under the simplified merger review procedure. More information is available on the Commission’s competition website, in the public case register under the case number M.8318. (For more information: Ricardo Cardoso – Tel.: +32 229 80100; Maria Tsoni – Tel.: +32 229 90526; Yizhou Ren – Tel.: +32 229 94889)

ANNOUNCEMENTS

 

Vice-President Ansip to call for vision, speed and cooperation on 5G at the Mobile World Congress

Vice-President for the Digital Single Market Andrus Ansip participates in the Mobile World Congress in Barcelona on Monday 27 and Tuesday 28 February, the world’s largest event for the international mobile community, gathering policymakers, industry leaders and experts (see Vice-President Ansip’s blog post ahead of the event). On Tuesday at 11:00 am CET he will deliver a keynote speech asking Europe and its international partners to work together to deploy the next generation of communication networks, 5G. Common standards and spectrum coordination – both at global and European levels – are paramount for all sectors, from transport to healthcare, to fully benefit from first-class connectivity across borders. During the event, Vice-President Ansip will meet Spanish Minister of Energy, Tourism and Digital Agenda Álvaro Nadal, Brazilian Minister of Science, Technology, Innovation and Communications Gilberto Kassab as well as the Chairman of the US Federal Communications Commission Ajit Pai. He will also meet CEOs of European telecoms companies, participates in a roundtable on connected and automated driving and contributes to the GSMA Trans-Atlantic dialogue on the future of the digital economy. Vice-President Ansip will visit a series of stands, including the Graphene experience zone which showcases the latest achievements of the EU-funded Graphene Flagship and innovation based on this revolutionary material (see Vice-President Ansip’s recent blog post on the European Future and Emerging Technology Flagships). During these visits, he will have bilateral meetings with the senior management of Ericsson, Nokia and AT&T. More details on Vice-President Ansip’s programme at the Mobile World Congress 2017 can be found in his agenda and in the Commission’s weekly calendar. Photo and video coverage will be available on EbS, his speech will be published here and webstreamed here. Regular updates will be posted on @Ansip_EU. See also this new factsheet on the main achievements so far under the Digital Single Market strategy.(For more information: Nathalie Vandystadt – Tel.: +32 229 67083; Inga Höglund – Tel.: +32 229 50698)

La Commission européenne présente au Salon de l’Agriculture à Paris pour célébrer l’agriculture française

Le Salon international de l’Agriculture ouvre demain ses portes à Paris pour une quinzaine de jours. Ce rendez-vous incontournable est l’occasion de prendre le pouls du secteur agricole français et européen et de célébrer ses réussites, sans occulter les défis et difficultés auxquels font face les agriculteurs français. Cette année, deux Commissaires européens visiteront le Salon de l’agriculture: Pierre Moscovici, Commissaire aux affaires économiques et financières, à la fiscalité et à l’Union douanière le lundi 27 février, et Phil Hogan, Commissaire à l’agriculture, le jeudi 2 mars. A cette occasion, les Commissaires s’entretiendront avec les représentants des éleveurs et producteurs agricoles en France. La Commission européenne sera présente tout au long de la durée du Salon avec un stand d’information pour renseigner le public sur la Politique Agricole Commune (PAC). C’est d’ailleurs au stand de la Commission que le Commissaire Hogan remettra le mercredi 1er mars les prix du Concours général agricole aux jeunes agriculteurs.A son arrivée à Paris le 1er mars, le Commissaire Hogan rencontrera le Premier ministre français, Bernard Cazeneuve, et le ministre de l’agriculture, Stéphane le Foll. La France reste le premier pays bénéficiaire de la Politique Agricole Commune. Plus d’informations sur la PAC en France sont disponibles en ligne. (Pour plus d’informations: Daniel Rosario – Tel: +32 229 56 185; Annika Breidthardt – Tel.: +32 229 56153; Clemence Robin – Tel.: +32 229 52509)

Commissioner Vella travels to Indonesia for World Ocean Summit

Commissioner Karmenu Vella, responsible for fisheries and maritime affairs, is attending the World Ocean Summit in Bali, Indonesia this week. Speaking at the session ‘the ocean economy – a whale of an opportunity?’ yesterday, he stressed the potential for sustainable ocean-based growth, for instance in emerging technologies like ocean energy, and laid out the EU’s international ocean governance agenda. “Blue economic growth is neither automatic nor inevitable. If our oceans are in bad shape, the blue economy cannot thrive. That is why, last November, the European Union proposed 50 actions to create the conditions for a sustainable blue economy around the world. We are creating a healthy investment environment for a healthy and productive marine environment,” Commissioner Vella said. On the margins of the Summit, he discussed ocean governance and the potential of the blue economy with Ms Susi Pudjiastuti, Minister for Maritime Affairs and Fisheries of Indonesia, Mr John Maneniaru, Minister for Fisheries and Marine Resources of the Solomon Islands, Mr Peter Thomson, President of the 71st United Nations General Assembly (UNPGA), and business leaders. Today, in the closing session, he will also draw attention to the fourth Our Ocean Conference, a high-level international event aimed at generating commitments for concrete and measurable actions for healthy, sustainable oceans worldwide. This year’s edition will be hosted by the EU in Malta on 5-6 October. For more information see here. (For more information: Enrico Brivio – Tel.: + 32 229 56172; Aikaterini Apostola – Tel.: +32 229 87624)

 

Calendar

The Commissioners’ weekly activities

Upcoming events of the European Commission (ex-Top News)

Wounded Warrior Project Veterans Connect with Community at Vets 4 Vets Gathering

JACKSONVILLE, Fla., Feb. 24, 2017 /PRNewswire-USNewswire/ — Wounded Warrior Project® (WWP) veterans recently joined roughly 200 of their brothers and sisters in arms at Jacksonville Veterans Memorial Arena, where they networked with several veterans service organizations at the quarterly Vets 4 Vets event. Such a large gathering of peers let WWP warriors experience what is possible at events that get them out of the house and socially connected with fellow service members.

Warriors listened to guest speakers from Canine Companions for Independence®, United Service Organizations, Dignity Memorial®, Veterans of Foreign Wars Post 8255, and more. Other organizations such as Mission 22, Reboot Combat Recovery, and Florida Fallen Heroes set up informational tables. The wide selection of beneficial resources made the event particularly attractive to Navy veteran April Imani Smith.

“I am always looking for ways to connect with other veterans and organizations geared toward helping service members,” she said. “Sometimes I’m nervous about meeting new people, but it didn’t take long for me to get to know some other warriors. So it was nervousness and excitement all in one.”

These connection activities support the recovery needs of warriors by reintroducing them to the bonds experienced during military service. In a WWP survey of the injured warriors it serves, more than half of survey respondents (51.7 percent) talked with fellow veterans to address their mental health issues.

Warriors learned about helpful programs and services provided by WWP and other veterans service organizations. WWP assists injured veterans with mental health, physical health and wellness, career and benefits counseling, and connecting with other warriors and their communities. Generous donors make it possible for wounded warriors to take part in outreach activities and benefit from program resources at no cost to them.

“Wounded Warrior Project is always very welcoming and accommodating to me and my family,” April said. “It has opened me up to opportunities I would not have experienced on my own.”

To learn more about how WWP’s programs and services connect, serve, and empower wounded warriors, visit http://newsroom.woundedwarriorproject.org/.

About Wounded Warrior Project
Wounded Warrior Project® (WWP) connects, serves, and empowers wounded warriors. Read more at http://newsroom.woundedwarriorproject.org/about-us.

SOURCE Wounded Warrior Project

Wounded Warrior Project and Stack-Up Connect Veterans Through Gaming

PITTSBURGH, Feb. 24, 2017 /PRNewswire-USNewswire/ — Video game night made a triumphant return to the Pittsburgh Wounded Warrior Project® (WWP) office, providing injured veterans with a night of friendly competition, food, and fellowship. Stack-Up, a charity organization that brings veterans and civilian supporters together through a shared love of video gaming, co-hosted the event with WWP. While video gaming often carries the stereotype of being an anti-social activity, it’s the opposite for one Marine Corps veteran.

“I love going to Wounded Warrior Project events because they give me a chance to connect with other veterans,” said wounded warrior George Powell. “The game nights have been my favorite by far. With the way these gatherings are set up, anyone can jump in and out of the different game sessions. It makes it comfortable and easy to meet everyone.”

For George, gaming not only offers a chance to connect with warriors at WWP’s office but also outside of it – online, whenever he wants to. In a WWP survey of the injured warriors it serves, more than half of survey respondents (51.7 percent) talked with fellow veterans to address their mental health issues, including post-traumatic stress disorder (PTSD).

“Video games have always been a big thing in my life; I played them growing up,” George said. “And they continued to be a big part of my life after leaving the military. I have PTSD, and there are days where the anxiety is pretty intense. I don’t get out as often as I would like. Gaming helps me stay connected with the outside world and my friends on those days when I feel that way. I can get online, connect with a friend, and talk about how I’m feeling. There’s no judgment, and while I’m doing that, I can also have fun in the process.”

For many veterans, the experiences they had in the military were some of the best of their lives, filled with camaraderie, meaning, and direction. It can be difficult knowing how to recreate those feelings. WWP and Stack-Up have hosted several game nights at WWP offices to provide bonding opportunities that extend beyond a single gathering.

To read more about this event, visit:

About Wounded Warrior Project
Wounded Warrior Project® (WWP) connects, serves, and empowers wounded warriors. Read more at http://newsroom.woundedwarriorproject.org/about-us.

SOURCE Wounded Warrior Project

Delpor Awarded NIH Grant for 3-month Olanzapine Implant for the Treatment of Schizophrenia

Delpor’s Drug Delivery Subcutaneous Implant Device

The lack of a 3-month olanzapine formulation, creates a tremendous unmet need within this patient population. Our goal is to move beyond the 4-week limit of the current formulation while substantially improving the safety profile of the product

Delpor, Inc. (Delpor), a biotechnology company focused on drug delivery, today announced the awarding of a $224K grant from the National Institute of Mental Health (NIMH) for the further advancement of the company’s 3-month olanzapine product (DLP-119). The product is based on Delpor’s PROZOR technology and is expected to deliver therapeutic levels of olanzapine for a period of 3 months.
“We are honored and thankful to receive this award which will provide valuable resources to further advance our olanzapine implant program.” said Tassos Nicolaou, President and CEO of Delpor.

Olanzapine is one of the most widely prescribed antipsychotic drugs with sales over $4 billion before its patent expired in 2011. Long-acting antipsychotics provide substantial benefits to patients and caregivers by improving medication adherence. Currently, the only available long acting formulation of olanzapine is Zyprexa® Relprevv™, a 2-4 week depot injection. Zyprexa® Relprevv™ carries the risk of post-injection delirium/sedation syndrome (PDSS), a serious condition which includes heavy sedation, coma, and delirium after injection. Patients need to be observed for at least 3 hours post-injection in a registered facility with ready access to emergency response services, and be accompanied from the facility to their destination.

Tassos Nicolaou continued: “The lack of a 3-month olanzapine formulation, creates a tremendous unmet need within this patient population. Our goal is to move beyond the 4-week limit of the current formulation while substantially improving the safety profile of the product, including eliminating the risk of PDSS, allowing for withdrawal of the medication if needed, and delivering the medication in more favorable pharmacokinetic profile.”

About Delpor, Inc.
Delpor develops the next generation Drug Delivery Systems that improve the clinical and commercial value of drugs and biopharmaceuticals. The company’s technologies enable the sustained release of drugs through a small non-mechanical subcutaneous implant device. The device is implanted during a 10 minute, simple, in-office, procedure using local anesthetic and without the need for any surgical sutures. Delpor’s device can deliver small & large molecules within a predefined therapeutic window over several months while maintaining zero-order release pharmacokinetics. Delpor is focusing on the delivery of biologics and antipsychotics in order to improve medication adherence, safety and convenience. The company’s lead products include 3-6 month formulations of Exenatide and Risperidone. Additional information about the company can be found at http://www.delpor.com.

About DLP-119
Delpor’s DLP-119 is a matchstick-sized titanium reservoir loaded with a unique formulation of olanzapine and implanted during a simple, 10 minute, in-office procedure with local anesthesia. The product is designed to provide a constant therapeutic dose of olanzapine each day for a total period of 3 months. Additional features include reversibility, immediate onset of action, and no accumulation.

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment and other risks the Company may identify from time to time in the future.

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Gym Source Announces New Store in Wilmington, DE

Gym Source

We carry a wide variety of brands so shoppers can actually try out strength equipment, treadmills, ellipticals and lots of fitness accessories.” said Tom Richards, Director of Marketing at Gym Source.

Gym Source, America’s leading retailer of premium residential and commercial fitness equipment, announces the grand opening of a new showroom in Wilmington, DE.

“We are elated to be opening this new showroom,” explains Tom Richard, Director of Marketing at Gym Source. “Our goal is a personalized shopping experience for each customer who walks in the door. Gym Source fitness experts can match the client’s space and budget with their individual fitness goal. We carry a wide variety of brands so shoppers can actually try out strength equipment, treadmills, ellipticals and lots of fitness accessories.”

“We think the first state, Delaware, should have the first and best in specialty fitness equipment.” said Richard Miller, Gym Source’s founder and CEO. “The newest store location in Wilmington means that Gym Source can provide even more fitness fans with the best in fitness equipment and service.”

The Wilmington store is located at 3901 Concord Pike, Wilmington, DE 19803.

Gym Source is celebrating its newest location with a Grand Opening Sale through February 28th.

To learn more about the new Gym Source showroom in Wilmington, visit https://www.gymsource.com/store-locator/wilmington-delaware or connect with an equipment expert at 302-434-4400.

About Gym Source:
Gym Source is the nation’s oldest and largest specialty distributor of fitness equipment. The company has 36 retail locations from Florida to New Hampshire and serves customers in all 50 states and 47 countries. Gym Source offers a full range of fitness products including treadmills, strength training equipment and ellipticals both for commercial and home use. The company takes great pride in its reputation as America’s #1 fitness equipment expert and its exceptional post-sale delivery and customer service. Gym Source has made over 2 million fitness equipment deliveries to its nearly 400,000 customers.

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Wounded Warrior Project Connects Veteran to Job That Needs Brains

NEW YORK, Feb. 24, 2017 /PRNewswire-USNewswire/ — A good day at work for Army veteran Danny Benitez is all about brains. Not learning something new, not just making smart decisions – actual, physical, brains. Danny works with researchers at a hospital in New York. For the past 30 years, doctors there have studied brains to find links to post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), Parkinson’s disease, Alzheimer’s disease, and dementia.

That’s where Danny comes in; he responds to referrals and screens the individuals to see if they would be a fit. Then he has the unenviable task of approaching family right after the death of a loved one.

“It can be especially difficult when there is a sudden death or someone younger dies,” Danny said. “Many families are willing to help, though, because the research can confirm diseases and help surviving family be aware.”

The research hits close to home for Danny, who served seven years in the Army.

“I deal with PTSD, and there is no cure, but there are ways to combat it.”

The nature of this job keeps Danny on the go, which he said helps. He also works from home a couple of days a week, keeping him better connected with family.

When Danny left the military, he had to transition from a familiar role to the unknown. He worked a couple of jobs but didn’t find the right fit.

“After being unemployed for so long, you become doubtful for your future.”

Then Danny saw an advertisement for Wounded Warrior Project® (WWP); he signed up and found hope. Danny started looking at job listings in the weekly email newsletter and connected with WWP’s career counseling.

“Wounded Warrior Project helped direct me to new career options. They translated my military experience into a civilian resume. They then prepared me for job interviews.”

Danny’s role is to find suitable brains and approach families to approve the research, but sometimes there is more to his job.

“All organ donations are time-sensitive. So there have been times when I have to go collect the brain after someone has extracted it.”

Read how WWP connects, serves, and empowers warriors across the country at http://newsroom.woundedwarriorproject.org.

About Wounded Warrior Project
Wounded Warrior Project® (WWP) connects, serves, and empowers wounded warriors. Read more at http://newsroom.woundedwarriorproject.org/about-us.

 

SOURCE Wounded Warrior Project

Wounded Warrior Project Connects Veteran to Job That Needs Brains

NEW YORK, Feb. 24, 2017 /PRNewswire-USNewswire/ — A good day at work for Army veteran Danny Benitez is all about brains. Not learning something new, not just making smart decisions – actual, physical, brains. Danny works with researchers at a hospital in New York. For the past 30 years, doctors there have studied brains to find links to post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), Parkinson’s disease, Alzheimer’s disease, and dementia.

That’s where Danny comes in; he responds to referrals and screens the individuals to see if they would be a fit. Then he has the unenviable task of approaching family right after the death of a loved one.

“It can be especially difficult when there is a sudden death or someone younger dies,” Danny said. “Many families are willing to help, though, because the research can confirm diseases and help surviving family be aware.”

The research hits close to home for Danny, who served seven years in the Army.

“I deal with PTSD, and there is no cure, but there are ways to combat it.”

The nature of this job keeps Danny on the go, which he said helps. He also works from home a couple of days a week, keeping him better connected with family.

When Danny left the military, he had to transition from a familiar role to the unknown. He worked a couple of jobs but didn’t find the right fit.

“After being unemployed for so long, you become doubtful for your future.”

Then Danny saw an advertisement for Wounded Warrior Project® (WWP); he signed up and found hope. Danny started looking at job listings in the weekly email newsletter and connected with WWP’s career counseling.

“Wounded Warrior Project helped direct me to new career options. They translated my military experience into a civilian resume. They then prepared me for job interviews.”

Danny’s role is to find suitable brains and approach families to approve the research, but sometimes there is more to his job.

“All organ donations are time-sensitive. So there have been times when I have to go collect the brain after someone has extracted it.”

Read how WWP connects, serves, and empowers warriors across the country at http://newsroom.woundedwarriorproject.org.

About Wounded Warrior Project
Wounded Warrior Project® (WWP) connects, serves, and empowers wounded warriors. Read more at http://newsroom.woundedwarriorproject.org/about-us.

 

SOURCE Wounded Warrior Project

La Comisión Europea aprueba REVLIMID® (lenalidomida) como terapia de mantenimiento en pacientes con Mieloma Múltiple de nuevo diagnóstico tras recibir un Trasplante Autólogo de Progenitores Hematopoyéticos

BOUDRY, Suiza–(BUSINESS WIRE)–La compañía biotecnológica Celgene ha anunciado hoy que la Comisión Europea ha aprobado REVLIMID® (lenalidomida) como terapia de mantenimiento para el tratamiento de pacientes adultos con Mieloma Múltiple de nuevo diagnóstico que han sido sometidos previamente a un Trasplante Autólogo de Progenitores Hematopoyéticos (TAPH). La aprobación de esta nueva indicación por parte de la Agencia Europea convierte a lenalidomida en el primer y único tratamiento de mantenimiento disponible en Europa, demostrando un beneficio en la supervivencia para este grupo de pacientes.

La autorización de comercialización de lenalidomida ha sido actualizada con esta nueva indicación, ampliando y reforzando las indicaciones actuales en las que lenalidomida se emplea como terapia de combinación para el tratamiento de pacientes con Mieloma Múltiple de nuevo diagnóstico no candidatos a trasplante o que han recibido al menos una terapia previa.

En este sentido, el Dr. Juan José Lahuerta, jefe de Sección del Servicio de Hematología del Hospital 12 de Octubre de Madrid, aclara que, “como ya lo fue con la aprobación de lenalidomida en pacientes no candidatos a trasplante, la aprobación de esta nueva indicación es una gran noticia para los pacientes candidatos a trasplante. Esta aprobación europea nos acerca un poco más a su uso en la práctica clínica. Los datos demuestran una eficacia superior clara de esta estrategia en comparación con la estrategia actual de observar y esperar sin ninguna intervención”.

El Mieloma Múltiple es un tipo de cáncer de la sangre, recurrente y grave, que se caracteriza por la proliferación tumoral y la supresión del sistema inmune1. Se considera una enfermedad rara y potencialmente mortal: cada año se diagnostican 39.000 nuevos casos en Europa y causa la muerte de cerca de 24.000 personas2. La edad media del diagnóstico oscila entre los 65 y 70 años en Europa3; y los pacientes menores de 65 años, con buen estado de salud y en buena condición física, suelen ser considerados candidatos al TAPH3.

Para los pacientes recién diagnosticados con Mieloma Múltiple y candidatos a TAPH, los objetivos clave del tratamiento son retrasar la progresión de la enfermedad y, en última instancia, lograr un control a largo plazo sobre el Mieloma Múltiple4. Estos pacientes suelen recibir terapia de inducción y dosis altas de quimioterapia con melfalán seguido del TAPH. Esta estrategia de tratamiento ha sido el estándar terapéutico vigente durante más de 20 años5. Teniendo en cuenta que más de la mitad de los pacientes recaen entre 2 y 3 años después del TAPH6,7, la aprobación de esta nueva terapia de mantenimiento tras un TAPH representa un avance importante para este grupo de pacientes ya que retrasa la progresión de la enfermedad.

Al respecto, el Dr. Jesús San Miguel, director de Medicina Clínica y Traslacional de la Universidad de Navarra, en Pamplona, explica que “los resultados del meta-análisis, incluyendo tres grandes estudios de mantenimiento junto a los datos más recientes del grupo inglés, han consolidado la utilidad de lenalidomida con el fin de prolongar de manera muy significativa la supervivencia libre de progresión y la supervivencia global de los pacientes con mieloma múltiple sometidos a trasplante”.

La decisión de aprobación de Agencia Europea se basa en los resultados de dos grandes ensayos liderados por los grupos cooperativos, CALGB 1001048 e IFM 2005-029:

  • El CALGB 100104 es un ensayo fase III, controlado, doble ciego y multicéntrico, en el que han participado 460 pacientes con Mieloma Múltiple de nuevo diagnóstico sometidos al TAPH, aleatorizados a recibir posteriormente tratamiento continuo diario con lenalidomida o placebo hasta la recaída o intolerancia.
  • El IFM 2005-02 es un ensayo internacional fase III, controlado, doble ciego y multicéntrico, en el que han participado 614 pacientes con Mieloma Múltiple de nuevo diagnóstico, que fueron aleatorizados a recibir 2 meses de tratamiento de consolidación post TAPH con lenalidomida en monoterapia, seguido de un tratamiento continuo diario con lenalidomida o placebo hasta la recaída o intolerancia.

En ambos ensayos fase III, el objetivo primario de eficacia en el estudio fue la supervivencia libre de progresión (SLP) desde el momento del TAPH hasta la fecha de progresión de la enfermedad o la muerte. El tratamiento con lenalidomida como terapia de mantenimiento tras un TAPH reduce el riesgo de progresión de la enfermedad o muerte de los pacientes con Mieloma Múltiple. En ambos ensayos se abrió el doble ciego en base a que lenalidomida había alcanzado los límites preespecificados que demostraban su superioridad frente al comparador. Datos actualizados de la SLP, a fecha de 1 de febrero de 2016, muestran igualmente una ventaja en este parámetro:

  • CALGB 100104: tras 81,6 meses de seguimiento, la mediana de SLP fue de 56,9 meses (95% Intervalo de Confianza (IC) 41,9; 71,7) en el brazo de lenalidomida frente a los 29,4 meses (95% IC 20,7; 35,5) en el brazo de placebo. (HR=0,61: 95% IC 0,48; 0,76; p<0,001)
  • IFM 2005-02: la mediana de SLP tras 96,7 meses de seguimiento fue de 44,4 meses (95% IC 39,6; 52,0) en el brazo de lenalidomida frente a los 23,8 meses (95% IC 21,2; 27,3) en el brazo de placebo (HR=0,57; 95% IC 0,47; 0,68; p<0,001)

Los estudios individuales no tenían como prioridad analizar la supervivencia global (SG). Un análisis descriptivo de los datos del ensayo CALGB 100104, a fecha de 1 de febrero de 2016, mostró que la mediana de SG fue de 111,0 meses (IC 95%, 101,8; no estimable) para los pacientes que recibieron lenalidomida frente a 84,2 (IC del 95% 71,0; 102,7) en el grupo de placebo (HR = 0,61; IC del 95%: 0,46; 0,81; p <0,001). En el estudio IFM 2005-02, la mediana de SG fue de 105,9 meses (IC 95%, 88,8; no estimable) con lenalidomida y de 88,1 (IC 95%: 80,7; 108,4) en el grupo de placebo (HR = 0,90; IC del 95% 0,72; 1,13; p = 0,355).

Por su parte, el Dr. Joan Blade, del Servicio de Hematología del Hospital Clinic de Barcelona, puntualiza que “esta nueva indicación de lenalidomida como terapia de mantenimiento post-trasplante en pacientes con mieloma múltiple de nuevo diagnóstico, supone un gran avance para este grupo de pacientes, ya que consigue prolongar la supervivencia”.

Estos ensayos mostraron un perfil de seguridad de lenalidomida similar al observado en otros ensayos en pacientes con Mieloma Múltiple de nuevo diagnóstico no candidatos a TAPH y en los estudios post autorización en pacientes con Mieloma Múltiple en recaída o refractario. Los efectos adversos hematológicos más frecuentes observados fueron neutropenia y trombocitopenia. Dentro de los no hematológicos, los más comunes fueron infecciones. En ambos ensayos se observó un aumento de incidencia de segundas neoplasias primarias en el brazo de lenalidomida. No obstante, la opinión positiva del CHMP confirma una relación beneficio-riesgo de lenalidomida positiva para esta nueva indicación.

En palabras de Tuomo Pätsi, presidente de Celgene Europa, Oriente Medio y África (EMEA), “estamos orgullosos de poner a disposición de los pacientes con Mieloma Múltiple esta indicación tan importante ya que, hasta ahora, no contaban con ningún tratamiento autorizado para el tratamiento de mantenimiento tras un TAPH. Esta última aprobación subraya la importancia de lenalidomida en el tratamiento del Mieloma Múltiple, extendiendo su uso a otros aspectos básicos de esta enfermedad, y pone de relieve nuestro compromiso con los pacientes con Mieloma Múltiple. Por ello, continuamos invirtiendo en investigación y desarrollo de nuevas terapias que contribuyan a mejorar el curso del Mieloma Múltiple, así como de otras muchas, actualmente sin cura”.

La decisión de la Agencia Europea para el uso de lenalidomida como terapia de mantenimiento para pacientes adultos con Mieloma Múltiple de nuevo diagnóstico tras un TAPH se basa en la opinión positiva del Comité de Medicamentos de Uso Humano (CHMP) de la Agencia Europea de Medicamentos (EMA), recibida el pasado mes de enero.

El 22 de febrero, la Agencia Americana del Medicamento (FDA, por sus siglas en inglés) aprobó la comercialización de esta nueva indicación de lenalidomida en Estados Unidos como terapia de mantenimiento para el tratamiento de pacientes con Mieloma Múltiple que han sido sometidos previamente a un TAPH.

Sobre CALGB 100104

El CALGB 100104 es un ensayo fase III, aleatorizado, controlado, doble ciego y multicéntrico, realizado en 47 centros de Estados Unidos. 460 pacientes con Mieloma Múltiple de nuevo diagnóstico – de entre 18 y 70 años de edad – que lograron al menos una enfermedad estable 100 días después de someterse al TAPH, fueron aleatorizados a recibir terapia de mantenimiento con lenalidomida (a dosis de 10 mg/día durante 3 meses y posteriormente 15 mg/día) o placebo hasta la progresión de la enfermedad, la aparición de efectos adversos intolerables o muerte.

Sobre IFM 2005-02

El IFM 2005-02 es un ensayo fase III controlado, doble ciego y multicéntrico con placebo llevado a cabo en 77 centros repartidos a lo largo de 3 países europeos. Se incluyeron 614 pacientes menores de 65 años con Mieloma Múltiple de nuevo diagnóstico, sin signos de progresión de la enfermedad en un plazo de 6 meses tras haber sido sometidos al TAPH. Todos los pacientes recibieron 2 ciclos de consolidación con lenalidomida en monoterapia a dosis de 25 mg/día durante 21 días en ciclos de 28 días. Tras la consolidación, fueron aleatorizados a recibir lenalidomida a dosis de 10 mg/día durante 3 meses, y posteriormente 15 mg/día, o placebo hasta la progresión de la enfermedad, la aparición de efectos adversos intolerables o muerte.

Sobre lenalidomida

Lenalidomida está autorizado en combinación con dexametasona en Europa, Estados Unidos, Japón y en otros 25 países para el tratamiento de pacientes adultos con Mieloma Múltiple que no han sido tratados previamente para esta enfermedad y que no son candidatos a trasplante. Lenadidomida también está aprobado en combinación con dexametasona para el tratamiento de pacientes con Mieloma Múltiple que han recibido al menos un tratamiento previo en casi 70 países, entre ellos Europa, América, Oriente Medio y Asia; así como en combinación con dexametasona para el tratamiento de los pacientes cuya enfermedad ha progresado después de una terapia en Australia y Nueva Zelanda.

Lenalidomida en monoterapia está indicado para el tratamiento de pacientes adultos con anemia dependiente de transfusiones debida a síndromes mielodisplásicos (SMD) de riesgo bajo o intermedio-1 asociados a una anomalía citogenética de deleción 5q aislada cuando otras opciones terapéuticas son insuficientes o inadecuadas.

Además, lenalidomida está aprobado en Europa y Estados Unidos para el tratamiento de pacientes con linfoma de células mano (LCM) que han sufrido una recaída o cuya enfermedad ha progresado después de dos terapias previas, una de las cuales incluyó bortezomib. En Suiza, lenalidomida está indicado para el tratamiento de pacientes con LMC recidivante o refractario después de un tratamiento previo que incluía bortezomib y quimioterapia con rituximab.

Lenalidomida no está indicado ni recomendado para el tratamiento de pacientes con leucemia linfocítica crónica (LLC) fuera del ámbito de un ensayo clínico.

Sobre Celgene

Celgene es una compañía biotecnológica multinacional dedicada al desarrollo de importantes tratamientos para personas con enfermedades graves o debilitantes, en las cuales existen escasas o nulas opciones terapéuticas, o en las que los tratamientos actuales no son suficientes.

La compañía centra sus esfuerzos en el desarrollo de medicamentos que puedan marcar una gran diferencia en la vida del paciente, incluyendo las enfermedades raras o debilitantes como el mieloma múltiple, síndromes mielodisplásicos, linfomas, tumores sólidos y enfermedades inmuno-inflamatorias.

En 2013, cerca de 200.000 personas en todo el mundo fueron tratadas con medicamentos desarrollados por Celgene. En la actualidad, la compañía sigue trabajando en medicamentos innovadores a través de ensayos clínicos que se están realizando en Europa con un total de 18 compuestos indicados en enfermedades huérfanas y con más de 45 indicaciones en otras patologías. Celgene invierte más del 30% de sus ingresos en I+D, el doble de la media del sector, y mantiene su compromiso para cambiar el curso de estas enfermedades.

Referencias

1 Palumbo A, et al. N Engl J Med. 2011;364:1046–1060.

2 Ferlay J, et al. Eur J Cancer. 2013;49:1374–1403

3 Moreau P, et al. Ann Oncol. 2013; 24 (Suppl 6): vi133-vi137

4 Stewart AK, et al. Blood. 2009;114:5436-5443.

5 Bird JM, et al. Br J Haematol. 2011;154:32-75

6 Attal M, et al. Blood. 2006 Nov 15;108(10):3289-94

7 Child JA, et al. N Engl J Med. 2003; 348:1875-1883

8 McCarthy PL, et al. N Engl J Med. 2012;366(19):1770-1781. CALGB is the cooperative group Cancer and Leukemia Group B (now known as Alliance).

9 Attal M, et al. N Engl J Med. 2012;366(19):1782-1791. IFM is the cooperative group Intergroupe Francophone du Myélome.

ProfNet Experts Available on Post-Election Stress, Retirement, Video-Game Addiction, More

NEW YORK, Feb. 24, 2017 /PRNewswire/ — Below are experts from the ProfNet network who are available to discuss timely issues in your coverage area.

You can also submit a query to the hundreds of thousands of experts in our network – it’s easy and free! Just fill out the query form to get started: http://prn.to/queryform

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MEDIA JOBS

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EXPERT ALERTS:

Post-Election Stress Disorder a National Health Crisis
Kiran Dintyala, MD, MPH
Founder, President
Stress Free Revolution
Post-Election Stress Disorder is affecting millions of Americans and is becoming a national health crisis, says Dr. Dintyala. According to several independent surveys, 90% of those reporting election-related stress thought this election was worse than any other; Internet searches for “presidential election” were associated with searches for depression and anxiety; 57% report the current political climate to be stressful; 65% of Clinton supporters say their stress levels have increased since the election; crisis and suicide prevention hotline calls surged following the election. In addition to feelings of insecurity, severe chronic stress often leads to physical symptoms, poor relationships, and depression.
Says Dr. Dintyala (aka “Dr. Calm”): “It’s no secret that the majority of people who didn’t vote for Donald Trump are having trouble accepting his administration. In fact, many Americans are seeking medical help for the anxiety they are experiencing due to the change of occupant at 1600 Pennsylvania Avenue. I have seen patients with Post-Election Stress Disorder, including some with previously well-controlled blood pressure who are coming in with alarmingly high numbers. I’m calling this ‘Trumpertension,’ a substantial increase in blood pressure unrelated to diet, sodium intake or exercise that is solely attributable to worries over what a Trump presidency may mean for your future and America’s. I find myself sharing tips to stay calm amidst the seemingly endless flow of unsettling news and ways to remain positive and hopeful, no matter who’s in the Oval Office.”
Dr. Dintyala, a Palm Springs-based internal medicine physician, recently published “Seven Keys to Surviving the Trump Presidency” to offer tips for remaining calm, positive, and hopeful despite concerns for the country. Dintyala is a Board Certified Internal Medicine Physician who holds a master’s in public health. He is also a Diplomate of the American Board of Integrative and Holistic Medicine. Dr. Dintyala is a keynote speaker who hosts seminars and retreats to help people learn to reduce stress and find peace of mind and experience more joy.
Websites: www.stressfreerevolution.com and www.trumpertension.com
Contact: Penny Sansevieri, authorservices@amarketingexpert.com

Running a Lifecare Retirement Community
Robert E. Caulfield
President/CEO
Jefferson’s Ferry Life Plan Retirement Community
“Running a lifecare retirement community well requires looking beyond the numbers. It’s about connecting with the people and understanding their needs.”
Caulfield is available to discuss successful aging, senior living options, continuing care retirement communities (CCRC), and finance for CCRCs. Caulfield knows how to establish a CCRC from the ground up with a long history of working with senior care. He is a CPA, and current and active member of the LeadingAge-NY CCRC Cabinet, co-Chair of CCRC Cabinet, Regulation 140 Workgroup. He’s actively involved in LeadingAge-NY advocacy initiatives, including meeting annually with state legislators to bring about regulatory changes that will have a positive impact on seniors. He is based in S. Setauket, N.Y.
Website: www.jeffersonsferry.org
Contact: Kathleen Caputi, kcaputi@epoch5.com

Is Fake News Making You Sick?
Carol Kershaw
Licensed Mental Health Clinician
Fake news is everywhere, and worse than the misinformation, the stress of it could be making you sick, says Kershaw. According to several surveys, there were 10+ million fake news Facebook engagements in 2016; fake 2016 election news fooled American adults 75% of the time; 52% of Americans found the recent election a very high or significant source of stress, especially those on social media (54% vs 45%), where the bulk of fake news is shared; and at least 78% of people report at least one physical symptom of stress. So who do you trust? Kershaw says our brains can only take so much of this stress before showing signs of post-traumatic stress: “We live in a world of information overload. Add to this reality the fact that the country is seriously divided politically and that more people are frightened about their immediate and long-term security, physically, economically, and emotionally than for generations. When you hit overload, your brain has the reaction of fight, flight, freeze, or faint. The reaction is useful if you are about to be attacked or a tornado rages in your direction, but few of the problems you may have can be solved by your fight, flight, freeze, or faint response.”
Wade has been in private practice for 35 years and recently co-authored “The Worry-Free Mind” with her husband and colleague, Bill Wade. A guide to inoculating yourself against stress and worry, “The Worry-Free Mind” is backed by the latest research, and features simple, practical tools to reduce worry and improve our state of mind. Additionally, Kershaw and Wade run workshops and retreats that focus on empowering clients to live their best possible lives. Kershaw is available to discuss the very real mental and physical health problems of fake news and how to move forward.
Website: www.drscarolandbill.com
Contact: Penny Sansevieri, authorservices@amarketingexpert.com

The Cost of Changing a Youth’s Life
Katherine Irwin, Ph.D.
Professor of Sociology
University of Hawaii Manoa
“For the past 30 years, America has been the most incarcerating nation in the world. And while President Obama and his attorney general led the charge to start decreasing our prison population, many in the U.S. continue to cling to punishment as a solution to social problems, with public schools being one among many institutions that continue to mete out harsh disciplinary actions for rule violators. In an era of tough-on-crime solutions to youth crime, some community leaders are taking a different approach by supporting, counseling, and mentoring young people. Not only are these approaches more effective in helping kids graduate from school, get along better with adults, and avoid getting into trouble, but they also cost less than punitive alternatives like detention and incarceration.”
Finding humane and effective ways to curb interpersonal violence, especially youth violence, isn’t easy. That’s why so few lives are changed. As the child of an incarcerated father, Dr. Irwin certainly has skin in the game as she seeks ways for individuals to engage positively in conventional society. Her work has focused on the inequalities that underscore youth violence today, especially among Pacific Islander Teens, who face racism, sexism, poverty, and political neglect in the context of two hundred years of American colonial control in the Pacific. She’d love to work with you on an article that includes some of the following ideas: why black and brown lives need to matter; addicted to punishment: tales from the school-to-prison pipeline; the real cost behind curbing teen violence. Despite the gravity of the situation she sees, Irwin has a message of hope. The teens in her study display remarkable resilience and ability to overcome numerous hardships – from trauma to socio-political inequalities: Their suspension rate went from 16% to 0, and their school absences were more than 33% lower than a control group. And the cost is minimal: less than $160/year for each child, compared with the nearly $200,000 cost of incarceration for a single bed in Hawaii’s youth correctional facility. She recently co-authored ” JACKED UP AND UNJUST: Pacific Islander Teens Confront Violent Legacies” with Karen Umemoto, and has published numerous academic journal articles regarding youth violence prevention, ethnographic methods, inequalities and delinquency, and youth culture. She is dedicated to building culturally respectful, gender responsive, and non-punitive delinquency prevention programs for public school students.
Bio: www.socialsciences.hawaii.edu/profile/index.cfm?email=kirwin@hawaii.edu
Contact: Penny Sansevieri, authorservices@amarketingexpert.com

Video-Game Addiction as Mental Disorder
Dr. Frieda Birnbaum
Research Psychologist, Psychoanalyst
“Video games today can be especially addictive because of how much stimulation they provide to the brain. This type of stimulation maybe difficult or impossible to attain in waking reality without enduring considerable effort. Video game addiction appears to parallel pornography addiction in our culture. Anyone with an addition to video games — or electronics, for that matter — should seek counseling. They don’t have to go cold turkey, but they should have a healthy balance on how often they play video games and use electronic devices. People who are addicted to video games should try another game from time to time called “life” — the graphics are amazing, it’s 3D interactive, and when you acquire enough experience, you get promoted to the next level of evolution and increase your happiness along the way.”
Based in the New York metro area, Dr. Birnbaum is author of ” Life Begins at 60: A New View on Motherhood, Marriage, and Reinventing Ourselves.” She’s an expert on depression, women’s issues, and attaining happiness.
Contact: Ryan McCormick, ryan@goldmanmccormick.com

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TearLab Announces 1-for-10 Reverse Split of Common Stock

SAN DIEGO, Feb. 24, 2017 (GLOBE NEWSWIRE) — TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) today announced that it will effect a 1-for-10 reverse stock split previously approved by the Company’s stockholders at a special meeting held on February 23, 2017. The 1-for-10 reverse stock split will be effective as of the close of business on Friday, February 24, 2017, and the Company’s common stock will begin trading on a split-adjusted basis on Monday, February 27, 2017 on both the Nasdaq Capital Market (Nasdaq) and the Toronto Stock Exchange (TSX).
The reverse stock split is intended to increase the price per share of the Company’s common stock to allow the Company to demonstrate compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq.  The trading symbol will remain TEAR on the Nasdaq and TLB on the TSX.  Proportional adjustments will be made to the conversion and exercise prices of the Company’s outstanding warrants, convertible preferred stock and stock options, and to the number of shares issued and issuable under the Company’s equity compensation plans. The number of authorized shares of the Company’s common stock will be reduced to 9,500,000 shares.Information for StockholdersUpon the effectiveness of the reverse stock split, each ten shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.001 per share. The Company will not issue any fractional shares in connection with the reverse stock split.  Instead, a cash payment will automatically be made in lieu of any fractional shares.  The reverse stock split will not modify the rights or preferences of the common stock.The Company’s transfer agent, Computershare Trust Company, N.A. (“Computershare”), will act as its exchange agent for the reverse stock split.  Computershare will provide stockholders of record holding certificates representing pre-split shares of the Company’s common stock as of the effective date a letter of transmittal providing instructions for the exchange of shares.  Registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split.For questions about the exchange of pre-split shares, please contact Computershare at (800) 546-5141, within the United States, United States territories and Canada.  For assistance outside the United States, United States territories and Canada, please call +1 (781) 575-2765.Additional information pertaining to the reverse split, including on how to exchange shares, is contained in the Company’s proxy statement filed with the U.S. Securities and Exchange Commission on January 3, 2017.
About TearLab CorporationTearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System.  TearLab Corporation’s common shares trade on the NASDAQ Capital Market under the symbol ‘TEAR’ and on the Toronto Stock Exchange under the symbol ‘TLB’.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include, among others, statements concerning whether the reverse stock split will increase the price of our common shares and whether we will be able to maintain our Nasdaq Capital Market Listing.  These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 9, 2016, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed with the SEC on November 9, 2016. We do not undertake to update any forward-looking statements except as required by law.Investor Contact:
The Ruth Group
Lee Roth
Tel: 646-536-7012
lroth@theruthgroup.com