‫تجربة LIMES المعشاة ذات الشواهد حول بالون سيروليموس المطلي في BTK تأخذ الخطوة الأولى: بدأ تسجيل المرضى

Concept Medical Inc. ، وهي شركة رائدة في تطوير منصات أجهزة توصيل الأدوية للتدخل الوعائي، أعلنت عن بدء تجربة LIMES .

مونستر، ألمانيا, 30 يوليو / تموز 2022 /PRNewswire/ — قامت LIMES (تجربة معشاة ذات شواهد متعددة المراكز لتقييم سلامة وفعالية بالون SeroLIMus المغلف بالأدوية مقابل رأب الوعاء القياسي لعلاج الانسداد تحت الرضفة في المرضى الذين يعانون من مرض السكري الشرياني) بتسجيل 15 مريضًا، وهو أمر مشجع حيث تتطلع الشركة إلى تحقيق قفزة في علاج مرض الشريان المحيطي (PAD).

Study team at the University Hospital Münster Germany -LIMES RCT - First Patient Enrolled!

بدأت LIMES من قبل المستشفيات الجامعية جينا ولايبزيغ في ألمانيا وبقيادة الباحث الرئيسي ( PI ) الأستاذ الدكتور أولف تيشغرابر إلى جانب الباحث الرئيسي المشارك البروفيسور توماس زيلر والبروفيسور ديرك شاينرت، وهي تجربة مستقبلية متعددة المراكز وعشوائية الشواهد ( RCT ) تم تصميمها وتهدف إلى تقييم Magic Touch – PTA 0.014 “و 0.018” ( Concept Medical Inc ) مقابل POBA (Plain Old Balloon Angioplasty) في مقارنة وجهًا لوجه (1: 1). بدأت التجربة مع تسجيل مريض المؤشر في 31 مارس 2022 من قبل الأستاذ الدكتور ناسان ماليار في مستشفى جامعة مونستر في ألمانيا.

من المقرر أن يسجل LIMES RCT 230 مريضًا، عشوائيًا في 1: 1 موضة ( Magic Touch-PTA: POBA ) في 19 مركزًا حاليًا في جميع أنحاء ألمانيا والنمسا. سيشمل عدد المرضى الذين يعانون من نقص تروية الأطراف الحرجة المزمنة الموثقة ( CLI ) في الطرف المستهدف المعرف باسم فئة رذرفورد السريرية (RCC) 4 أو 5 أو 6 الذين تتراوح أعمارهم بين ≥18 عامًا. تقيم الدراسة المرضى الذين لديهم قطر وعاء مرجعي (RVD) ≥2 و ≤4.0 مم وانسداد كلي (تضيق بنسبة 100%) للآفة المستهدفة. لا يوجد حد أدنى لطول الآفة المطلوبة، ولا يوجد حد لطول الآفة ولا يوجد قيود على عدد الأجهزة المستخدمة. ستكون المتابعة لكل زيارة داخلية في 30 يومًا و 6 و 12 و 24 و 36 شهرًا.

سيقيس RCT فعالية البالونات المغلفة بال Sirolimus في بيئة معقدة ( CLTI ) من قطاع PAD (الموجود أسفل الجزء P3 من الشريان المأبضي إلى مفصل tibiotalar ) مقابل المعيار الحالي للرعاية، مما يجعل التجربة مهمة وواحدة نتطلع إليها. نقاط النهاية الأولية للدراسة هي مركب إنقاذ الأطراف والمباح الأولي خلال 6 أشهر. إضافة إلى أهمية التجارب العشوائية المضبوطة، فإن نقطة نهاية السلامة الثانوية الرئيسية هي مركب من أحداث الأطراف الضائرة الرئيسية ( MALE ) والوفاة المحيطة بالجراحة ( POD ) في 30 يومًا. سيقوم مختبر أساسي أعمى بتقييم المباح في 6 و 12 و 24 شهرًا عن طريق الموجات فوق الصوتية المزدوجة وتصوير الأوعية الدموية الكمي ( QVA ) في حالة وجود أي TLR .Concept Medical Logo

يوضح البروفيسور أولف تيشغرابر نقطة حول سبب قيمة RCT من حيث تدخل DCB في الانسداد تحت المأبضي، “تتعامل إعادة التوعي BTK مع منطقة الأوعية الدموية الأكثر تحديًا في المرضى جدًا. سيحل LIMES السؤال عما إذا كان رأب الأوعية بالبالون sirolimus لديه القدرة على أن يصبح المعيار المستقبلي للرعاية في تدخلات BTK “ ، بعد عرضه الأخير في LINC 2022 .

يلفت RCT انتباه واهتمام المجتمع بالنظر إلى مجموعة المرضى المعقدة التي سيشملها، واستخدام البالون المغلف بالـ Sirolimus ، والذي يثبت بالفعل جدارته في SFA ضد POBA و Paclitaxel في العديد من التجارب العشوائية المضبوطة. Magic Touch PTA هو sirolimus DCB الوحيد المتاح تجاريًا ل PAD ، والذي تم منحه أيضًا تسمية Breakthrough Device Designation . باكليتاكسيل يثير الأفكار الثانية بسبب مخاوف السلامة التي أثارتها إدارة الأغذية والعقاقير الأمريكية في العلاج المحيطي، Sirolimus هو الأكثر طلبًا واحتمالًا محتملًا للبديل التالي في علاج PAD . من المؤكد أن تقييم البالون المطلي بالـ Sirolimus في هذا الإعداد المعقد سيضيف وزنًا وقيمة إلى بالون Magic Touch PTA Sirolimus المطلي كمستقبل للتدخل المحيطي.

نبذة عن MagicTouch PTA

Magic Touch PTA هو أول بالون مغطى بالدواء، حيث أُسند إلى “تصميم جهاز الاختراق” من قبل إدارة الغذاء والدواء الأمريكية ( FDA) ، لعلاج أضرار أسفل الركبة في الشرايين المحيطية. MagicTouch PTA عبارة عن بالون مطلي بطبقة sirolimus معتمد من الاتحاد الأوروبي ويتم تسويقه تجاريًا، وقد تم تطويره باستخدام تقنية النانولوت الخاصة وهي منصة تكنولوجيا توصيل الأدوية الخاصة ببالون MagicTouch PTA ، وهي مصممة لتوصيل جزيئات شبه ميكرون من sirolimus للوصول إلى أعمق طبقات جدران الأوعية.

نبذة عن شركة Concept Medical Inc (CMI)

يقع المقر الرئيسي لشركة Concept Medical Inc (CMI) في تامبا بولاية فلوريدا ولديها مكاتب تشغيلية في هولندا وسنغافورة والبرازيل ووحدات تصنيع في الهند. تتخصص الشركة في تطوير أنظمة توصيل الأدوية ولديها منصات تقنية فريدة وحاصلة على براءة اختراع يمكن نشرها لتوصيل أي دواء / عامل صيدلاني عبر الأسطح اللمعية للأوعية الدموية.

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FTX Exchange FZE Receives Dubai’s First Virtual Asset Service Provider MVP Licence from the Virtual Assets Regulatory Authority

DUBAI, United Arab Emirates, July 29, 2022 /PRNewswire/ — FTX Exchange FZE, today announced that it has received approval to enter Dubai’s ‘Minimum Viable Product’ (MVP) programme for Virtual Assets under the world’s only specialist regime for this sector operated by the Virtual Asset Regulatory Authority (VARA). As a subsidiary of FTX Europe, FTX Exchange FZE (FTX) becomes the first Virtual Asset Service Provider (VASP) to receive this MVP licence to operate its Virtual Asset (VA) Exchange and Clearing House services in Dubai, United Arab Emirates.

FTX MENA

Earlier this year, FTX became the first fully regulated Exchange to receive a provisional licence and ready itself to trial complex crypto derivatives dedicated to professional institutional investors in the UAE. Having successfully concluded VARA’s rigorous regulatory evaluation, it has now been fully approved to transition to an operational MVP licence, enabling the Company’s VA Exchange to deploy regulated crypto derivatives products, and trading services to Qualified Institutional Investors across the region. In addition, the VARA MVP Licence also grants FTX permission to act as a Clearing House, operate an NFT Marketplace, and provide Custodial Services under tightly prescribed parameters for specific class of consumers – assuring strong guardrails for market protection and economic security.

H.E. Helal Saeed Almarri, Director General of Dubai World Trade Centre Authority that houses VARA said, “We are pleased to onboard FTX as the first VASP to enter the operational phase of the VARA MVP Programme. VARA’s operating model, based on our unique test-scale-adapt principle designed for secure and sustainable growth, is reflective of Dubai’s commitment to creating a globally interoperable model for the ‘future economy’. The MVP Phase, exclusive to select, responsible international players like FTX, will allow VARA to prudently structure guidelines and risk mitigation levers for secure commercial operations. We look forward to FTX’s active participation in this next stage of collaborative global VA innovation”.

FTX CEO, Sam Bankman-Fried, commented on the news, “The approval for FTX to receive the first MVP VASP licence from Dubai’s prudential supervision regime to fully operate our exchange is a tremendous honor and landmark achievement for our team. Our mission is to lead the way in growing the digital asset industry in countries and jurisdictions that possess a robust digital asset framework.”

With VARA’s letter of approval, FTX FZE Exchange will operate under a model which has rigorous regulatory oversight and mandatory FATF compliance controls that are in line with the requirements of Tier 1 international financial markets.

Patrick Gruhn, Head of FTX Europe, adds, “Over the last several months, we at FTX Europe have been working alongside regulators to secure the first official VASP-MVP licence to operate in the UAE region. The approval from Dubai’s VARA is yet another milestone for FTX Europe, and we look forward to expanding our presence within the Dubai, UAE and MENA regions as a result.”

Mohammad Hans Dastmaltchi, Chairman of the Board of FTX Exchange FZE, adds, “We are honored to be the inaugural MVP licence holder of the esteemed VARA Ecosystem. We are grateful and obliged to have our operating licence. This would not have been possible without the progressive business environment in Dubai, the thorough and trustworthy regulatory guidelines provided by VARA, and the outstanding support from their team. We are motivated and committed to being a constructive and responsible participant in the VARA ecosystem and looking forward to growing and strengthening our regional office in Dubai”.

About FTX Exchange FZE

FTX Exchange FZE is a subsidiary of FTX Europe and the Middle East division of FTX, a cryptocurrency exchange built by traders, for traders.  Through FTX Exchange FZE, users in the Middle East will soon be able to access FTX’s innovative products, including industry-leading derivatives, options and volatility products, tokenized stocks, and other services and products.

About FTX.COM

FTX is a cryptocurrency exchange built by traders, for traders. It offers innovative products, including industry-leading derivatives, options and volatility products, tokenized stocks, prediction markets, leveraged tokens and an OTC desk. FTX strives to be an intuitive yet powerful platform for all kinds of users, and to be the most innovative exchange in the industry.

To learn more about FTX.COM, please visit: https://ftx.com

FTX.COM is not available to US residents or residents of other prohibited jurisdictions, as set out in its Terms of Service.

About VARA

Dubai Virtual Assets Regulatory Authority [VARA] is the world’s first specialised regulator for the Virtual Assets sector. Established in March 2022, following the effect of Law No.4 of 2022, VARA is responsible by decree for licensing and regulating the Virtual Asset sector in the Emirate of Dubai and its free zone territories [excluding DIFC], and oversees all licensing requirements and applications for authorisation of Virtual Asset activities under UAE law. VARA plays a central role in creating Dubai’s advanced legal framework to protect investors and establish international standards for Virtual Asset industry governance, while supporting the vision for a borderless economy.

Media Contact
Jay Morakis
M Group Strategic Communications (on behalf of FTX)
+1 646 859 5951
ftx@mgroupsc.com

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Sudanese political forces to announce new prime minister within two weeks: al-Faki

The Forces of the revolution will announce constitutional arrangements and a civilian prime minister within two weeks, said Mohamed al-Faki a former member of the Sovereign Council and prominent FFC leader.

On July 4, the army commander in chief and head of the Sovereign Council called on the political forces to form a civilian-led transitional government, announcing their withdrawal from the political dialogue.

In addition, Abdel Fattah al Burhan said they would dissolve the Sovereign Council and replace it with a high military body for security and defence issues with some additional powers related to its competencies.

“The forces of the revolution will announce, within two weeks, new constitutional arrangements and a civilian prime minister, to put the military before the fait accompli,” said al-Faki in an interview with the Sudan Tribune on Saturday.

He underscored that the Prime Minister would be given broad powers to form his government without pressing him to appoint any of his cabinet members, provided that he consult with the “forces of the revolution”.

Al-Faki said the forces involved in the appointment are the Forces for Freedom and Change, armed movements that signed the Juba peace agreement SRF and NC, resistance committees and other anti-coup civilian entities.

He further disclosed they are now mulling over several candidates before picking one of them as prime minister.

The designated prime minister will be accountable to the Transitional Parliament for the performance of the government. Also, he expected the abolition of the Sovereignty Council in the new constitutional declaration that the FFC intend to submit its draft to the revolution forces for consultation.

Al-Faki’s statements come as several local media report that the ruling military-led Sovereign Council are about to announce a new prime minister, nine months after the military coup carried out by Army Commander-in-Chief al-Burhan on October 25, 2021.

Possible differences

During the interview, al-Faki spoke about possible disagreements with the military component, signatory groups and the Sudanese Communist Party.

He first stressed the need to reach an agreement with the military component about the role and powers of the security and defence council where the military leaders will take part.

He pointed out that it must be chaired by the Prime Minister or the civilian head of the Sovereign Council if a consensus has been reached over him.

Yasir Arman SPLM-N Agar Deputy Chairman and FFC leadership member disclosed earlier this month after al-Burhan statements that the military component informed the dialogue’s facilitation panel they would keep some sovereign tasks related to the foreign policy and central bank.

He further spoke about the signatory groups including the National Consensus (NC) coalition of Minni Minnawi and Gibril Ibrahim and the Sudanese Revolutionary Front (SRF) as they reject the idea of not taking part in the government.

“The disagreement between us and the armed movements will be over their demand to participate in the government as politicians, while the street’s demand is an independent government (of technocrats).”

But armed groups point to the Juba Peace agreement saying that 25% of the cabinet member should represent the armed groups under the signed deal.

However, Minni Minnawi, SLM leader, posted a tweet on Saturday speaking about great hopes to strike a deal in the coming days on the new prime minister.

“My hope and those with me that we will reach clear understandings in the coming days,” he wrote.

With regard to the Sudanese Communist Party, al-Faki said they are moving in a different direction but they can participate in the ongoing consultations about the prime minister.

The SCP recently announced the formation of a new coalition to overthrow the coup government and cancel the Juba peace agreement.

“The disagreement now is over power, but we all agree on the independence of the judiciary and citizenship and other issues. So, this dispute must be overcome with the participation of all in the selection of the prime minister”. emphasized al-Faki.

Source: Sudan Tribune

Al-Hilu’s SPLM-N has nothing to do with Blue Nile tribal violence

The SPLM-N led by Abdel-Aziz al-Hilu rejected accusations made by the Governor of the Blue Nile Region about the group’s involvement in the recent tribal violence in the area.

Speaking on Thursday to Sudan Tribune, Ahmed Alomda the Blue Nile Governor said that foreign parties and the SPLM-N al-Hilu were involved in the inter-communal attacks that took place in the region, earlier this month.

“The Movement has nothing to do with the ongoing conflict between the ethnic components in any part of the country,” Mohamed Youssif al-Mustafa, an SPLM-N Hilu leadership member told Sudan Tribune in response to Alomda.

Youssif further accused Malik Agar the leader of the signatory SPLM-N, members of “the coup council” and the governor of causing troubles in the Blue Nile region.

“They are the ones who stir up strife, impoverish the poor, steal other people’s bounties, and create injustice everywhere,” he added.

Al-Mustafa called on the governor of the Blue Nile to show courage and disclose the names of those involved in the eruption of the conflict in the Blue Nile.

On July 14, a bloody conflict erupted between Funj and Hausa tribes in several areas of the southeastern part of Sudan after the latter’s demand to establish a chiefdom in the region.

Over 79 people were killed and 199 others injured, according to the Federal Ministry of Health.

The Attorney General formed a committee to investigate the inter-communal violence in the area where the government fought the SPLM-N for long years.

However, the armed group split into two factions in 2017, one in the Blue Nile led by Agar and the second in South Kordofan under the leadership of al-Hilu with supporters in the first.

Source: Sudan Tribune

136 people killed over land in S. Kordofan, West Darfur: group

At least 136 people died as a result of inter-tribal attacks in West Darfur, South Kordofan and Abyei areas of Sudan in June alone, a New York-based human rights organization said in a report.

The African Center for Justice and Peace Studies (ACJPS) said it was deeply concerned over the “continued” inter-tribal clashes occurring in Sudan.

The attacks, it stressed, has resulted into several deaths as well as injuries.

According to ACJPS, conflicts over land in Abyei area, West Darfur and South Kordofan in June 2022 also led to the displacement of 5,000 people.

“The conflicts are often related to border demarcation, gold mining areas, agricultural land, and animal pathways among others,” says the report.

As part of its recommendation, however, ACJPS urged Sudanese authorities to carry out an independent and impartial investigations into the circumstances of the killings, injuries and hold perpetrators accountable.

“Authorities must also to put in place a legislation that addresses land ownership in conflict and mineral rich areas. We also call upon the communities to respect customary land ownership laws,” it stressed.

Further calls were also made for authorities of Sudan and South Sudan to agree and take immediate measures in resolving land conflicts in Abyei.

Inter-tribal land disputes in Sudan have taken place mainly in conflict areas where people were forced to leave their homes and settle somewhere else.

There are also reports that the discovery of minerals in some states have also triggered these conflicts in the recent year, while the withdrawal of the United Nations-African Union hybrid peacekeeping mission (UNAMID) in December 2020 worsened the situation having left a security vaccum.

Source: Sudan Tribune

‘Inauguration of Judicial Reforms Committee key milestone in peace implementation’-RJMEC

The Reconstituted Joint Monitoring and Evaluation Commission (RJMEC) has lauded the inauguration of the ad-hoc Judicial Reforms Committee (JRC) of the Republic of South Sudan saying it is another key milestone in the implementation of the Revitalized Peace Agreement.

Speaking at the official inauguration of the Committee in Juba on Thursday, July 28, 2022, RJMEC Interim Chairperson Maj. Gen. Charles Tai Gituai, said as a committee mandated to study and recommend appropriate judicial reforms to the transitional government, the work of the JRC will lay a firm foundation for the future of the Judiciary in the country.

“The Judiciary is an important third arm of government and an effective, independent, and impartial judiciary is sine quo non for lasting peace, stability, and democratization,” he said. “Despite the slow pace and delays in the implementation of the Peace Agreement generally, the launch of the JRC today is very timely. It comes on the heels of the enactment of the Constitution Making Process Bill by the Parliament and the ongoing National Constitutional Amendment Committee review of the National Elections Ac.”

“It also comes at a time when the RTGoNU is developing a roadmap for the implementation of all critical pending tasks towards credible elections at the end of the Transitional Period,” he added.

Gen. Gituai said he strongly believes that the RTGoNU will factor the work of the JRC into the roadmap and that they will be accorded sufficient time to execute their tasks.

“The JRC report and recommendations will be taken on board by the RTGoNU to ensure that the judiciary is reformed before the end of the Transitional Period,” he said. “We must all lend our support politically, technically, and of course financially for the JRC to do its work within the stipulated timelines.”

“I believe that the key reforms that will be recommended by the JRC, will get prioritized by the Revitalized Transitional National Legislative Assembly,” he added.

The JRC is chaired by Justice James Ogoola of Uganda and deputized by Justice Joyce Alouch of Kenya.

Relatedly, RJMEC praised the start of the review of the National Elections Act 2012 of South Sudan, one of the key legislations assigned to the National Constitutional Amendment Committee (NCAC), terming it as an important step for the successful conclusion of the Transitional Period of the peace agreement.

Speaking at the opening of the experts meeting on the electoral laws in Juba on Thursday, RJMEC Chief of Staff, Amb. Berhanu Kebede, said the review of the South Sudan National Elections Act is a demonstration that the Revitalized Peace Agreement is indeed on the right path to making a difference in the governance of the country.

“The conduct of credible, peaceful, free, fair, and democratic elections is the only endpoint of the Transition under the Revitalized Peace Agreement, and the review and amendment of the elections laws and the eventual reconstitution of the election commission are two key pre-requisites,” he added.

Chapter 1, Article 1.20.3 of the agreement provides that the National Elections Act 2012 be amended to conform to the terms of the Revitalized Peace Agreement.

“We trust that the experts assembled here today, parties and the various stakeholders to be engaged by the NCAC in this review process, will draft an election law that not only conforms to the Agreement but one that will ensure the conduct of a democratic, peaceful, free and fair elections and referenda in South Sudan,” he said.

According to RJMEC, the review and amendment of the electoral law will involve a participatory process, which includes convening expert and stakeholder forums, whose views will define the scope of the amendment to the electoral law.

Source: Radio Tamazuj

Security situation in Ikotos returns to normal as schools, shops reopen

The situation in Ikotos town in Eastern Equatoria State has returned to normal, with schools, businesses, and other social amenities reopening after fear griped the area last week following clashes between the army and civilians.

Ikotos County authorities also revealed plans to hold a public rally to placate the town’s population who had fled their homes but are now back, to create confidence.

Adamu Samuel, the head teacher of the AIC Luther Secondary School, told Radio Tamazuj that schools had resumed operations after a week’s closure and that the situation had stabilized.

“Right now the situation is normal and I am talking from my office. All the schools are operating now, only that the number of children is not up to date because the rest of the children and their parents fled because of the incident which happened,” he said. “The children are coming back and will resume their classes. It was scary and the teachers also had to protect the children because of the random shooting from crossfire.”

“The school closure lasted one full week,” he added.

A local trader, Ekwang John, said they opened their shops at the direction of the commissioner.

“People have reopened because the commissioner and organized forces here asked us to open shops. The situation was not good and some people have not returned. Maybe if the governor comes, it will help,” he said. “For now, the situation is quite normal now. These people still have wounds in their hearts so the two warring groups should be sat down to resolve the matter.”

Joseph Loholong Jenisio, the commissioner of Ikotos County, said calm had returned to the area and confirmed that schools and markets have reopened.

“The schools and markets are open and all the institutions are functioning. This is because we announced that everybody should come back,” he said. “The situation is calm and this is why people have started living freely and cultivating seriously. We are here to control the treats we are still preparing to conduct a rally.”

Ihisa Marta, a resident of Hai Askal in Ikotos town, said there is relative calm in the town but urged the government to protect civilians and mitigate further tensions.

“The situation has improved somehow compared to the past. You can see children are now moving to school and the market has now reopened,” she said. “The situation has returned to normal and people are now moving freely without any fear. Many people have returned and children are playing freely.”

“We need a strong government to come to protect civilians,” she added.

A resident of the Lokudaru, who only identified himself as Koki, said that although there is a semblance of normalcy, many civilians are still in neighboring countries. He also demanded better civil-military relations in the area.

“We have returned home and we are living peacefully but some people are still running. Some continue to go to the camp, others are going to Torit,” he said. “What made us return is because forces were deployed. It was not a good life before because the civilians and the army wanted to fight.”

“Our top officials should come and talk to people, especially the civilians to find out what their problems are so that everybody will share their opinion,” he advised.

The state information minister, Patrick Oting Cyprian, also said the county is currently enjoying relative peace and stability.

“Calm has returned in Ikotos and people are doing very well. As we are talking, there is supposed to be a rally in Ikotos by the commissioner to talk to the communities of Ikotos about the general situations,” he said.

Source: Radio Tamazuj