‫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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Spain and Brazil report first monkeypox-related deaths outside Africa

Spain reported its first monkeypox-related death on Friday, in what is thought to be Europe’s first death from the disease and only the second outside Africa in the current outbreak.

Brazil reported earlier on Friday the first monkeypox-related death outside the African continent in the current wave of the disease.

According to a World Health Organization (WHO) report from July 22, only five deaths had been reported worldwide, all in the African region.

The WHO last Saturday declared the rapidly spreading outbreak a global health emergency, its highest level of alert.

In its latest report, the Spanish Health Ministry said 4,298 cases had been confirmed in the country. Of the 3,750 patients it had information on, it said 120 had been hospitalised – accounting for 3.2 per cent – and one had died, without providing further details.

A spokesperson for the Health Ministry declined to give further details on the deceased person.

In Brazil, a 41-year-old man died of monkeypox, local authorities said on Friday.

The man, who local media said had serious immune system problems, died in Belo Horizonte, the capital of the southeastern Minas Gerais state, on Thursday.

He “was receiving hospital treatment for other serious conditions,” the state health ministry said in a statement.

Brazil’s health ministry has recorded close to 1,000 monkeypox cases, mostly in Sao Paulo and Rio de Janeiro states, which are also in the country’s southeast.

The first case was detected on June 10 in a man who had travelled to Europe.

Early signs of the disease include a high fever, swollen lymph glands and a chickenpox-like rash.

The WHO last Saturday declared the monkeypox outbreak a global health emergency.

According to the WHO, more than 18,000 cases have been detected throughout the world outside Africa since the beginning of May.

It has been detected in 78 countries with 70 per cent of cases found in Europe and 25 per cent in the Americas, WHO chief Tedros Adhanom Ghebreyesus said on Wednesday.

Source: NAM NEWS NETWORK

Pope Says He’ll Slow Down or Retire

ABOARD THE PAPAL PLANE —

Pope Francis acknowledged Saturday that he can no longer travel like he used to because of his strained knee ligaments, saying his weeklong Canadian pilgrimage was “a bit of a test” that showed he needs to slow down and one day possibly retire.

Speaking to reporters while traveling home from northern Nunavut, the 85-year-old Francis stressed that he hadn’t thought about resigning but said “the door is open” and there was nothing wrong with a pope stepping down.

“It’s not strange. It’s not a catastrophe. You can change the pope,” he said while sitting in an airplane wheelchair during a 45-minute news conference.

Francis said that while he hadn’t considered resigning until now, he realizes he has to at least slow down.

“I think at my age and with these limitations, I have to save (my energy) to be able to serve the church, or on the contrary, think about the possibility of stepping aside,” he said.

Francis was peppered with questions about the future of his pontificate following the first trip in which he used a wheelchair, walker and cane to get around, sharply limiting his program and ability to mingle with crowds.

He strained his right knee ligaments earlier this year, and continuing laser and magnetic therapy forced him to cancel a trip to Africa that was scheduled for the first week of July.

The Canada trip was difficult, and featured several moments when Francis was clearly in pain as he maneuvered getting up and down from chairs.

At the end of his six-day tour, he appeared in good spirits and energetic, despite a long day traveling to the edge of the Arctic on Friday to again apologize to Indigenous peoples for the injustices they suffered in Canada’s church-run residential schools.

Francis ruled out having surgery on his knee, saying it would not necessarily help and noting “there are still traces” from the effects of having undergone more than six hours of anesthesia in July 2021 to remove 33 centimeters of his large intestine.

“I’ll try to continue to do the trips and be close to people because I think it’s a way of servicing, being close. But more than this, I can’t say,” he said Saturday.

In other comments aboard the papal plane, Francis:

• Agreed that the attempt to eliminate Indigenous culture in Canada through a church-run residential school system amounted to a cultural “genocide.” Francis said he didn’t use the term during his Canada trip because it didn’t come to mind. Canada’s Truth and Reconciliation Commission determined in 2015 that the forced removal of Indigenous children from their homes and placement in church-run residential schools to assimilate them into Christian, Canadian constituted a “cultural genocide.” “It’s true I didn’t use the word because it didn’t come to mind, but I described genocide, no?” Francis said. “I apologized, I asked forgiveness for this work, which was genocide.”

• Suggested he was not opposed to a development of Catholic doctrine on the use of contraception. Church teaching prohibits artificial contraception. Francis noted that a Vatican think tank recently published the acts of a congress where a modification to the church’s absolute “no” was discussed. He stressed that doctrine can develop over time and that it was the job of theologians to pursue such developments, with the pope ultimately deciding. Francis noted that church teaching on atomic weapons was modified during his pontificate to consider not only the use but the mere possession of atomic weapons as immoral and to consider the death penalty immoral in all cases.

• Confirmed he hoped to travel to Kazakhstan in mid-September for an interfaith conference where he might meet with Russian Orthodox Patriarch Kirill, who has justified the war in Ukraine. Francis also said he wants to go to Kyiv, Ukraine’s capital, though no trip has yet been confirmed. He said he hoped to reschedule the trip to South Sudan he canceled because of his knee problems. He said the Congo leg of that trip would probably have to be put off until next year because of the rainy season.

Source: Voice of America

Action on Monkeypox Accelerates in US as Outbreak Expands

Two of the hardest-hit U.S. regions have raised the alert level over the monkeypox outbreak.

San Francisco declared a public health emergency Thursday. The city accounts for 281 of California’s nearly 800 cases. The declaration gives health officials access to additional resources to deal with the outbreak.

New York, with nearly 1,400 cases statewide, made a similar declaration Thursday.

Worldwide, more than 21,000 cases have been reported in 78 countries, nearly all of them outside West and Central Africa, where the virus is endemic. The World Health Organization (WHO) raised the threat level to its highest ranking last weekend.

The U.S. case count is nearing 5,000, according to the U.S. Centers for Disease Control and Prevention (CDC).

The federal government has not declared an emergency but announced plans Thursday to distribute nearly 800,000 additional doses of monkeypox vaccine.

U.S. health officials said they had already distributed 340,000 doses, but many jurisdictions have reported that they have had to turn away patients because of short supplies.

Here are some answers to frequently asked questions.

Who gets monkeypox, and how?

The outbreak has been concentrated among men who have sex with men, though anyone can get monkeypox.

The virus spreads through contact with the rash that infected patients develop. It can also pass through bodily fluids, respiratory droplets after prolonged face-to-face contact or contaminated clothing, bedding or towels.

Men who have sex with men should have fewer sex partners in order to curb the spread, WHO chief Tedros Adhanom Ghebreyesus said Wednesday.

“This is an outbreak that can be stopped,” Tedros said. “The best way to do that is to reduce the risk of exposure.”

However, he added, intolerance of homosexuality would not help.

“Stigma and discrimination can be as dangerous as any virus, and can fuel the outbreak,” Tedros said.

What are the symptoms? Is it fatal?

The disease causes fever, headache, muscle pain, fatigue and swollen lymph nodes, followed by a rash, usually on the face, palms and soles of the feet. About a third of cases also develop a rash on the genitals.

The strain of monkeypox responsible for the global outbreak is rarely fatal but can be extremely painful, according to the CDC. About 10% of cases have been hospitalized “to manage the pain caused by the disease,” Tedros said.

Five deaths have been reported — three in Nigeria and two in the Central African Republic.

What about vaccines and treatments?

About 16 million doses of vaccine are available worldwide, but most will take several months to be packaged and distributed, according to the WHO, which is recommending vaccination only for people at high risk, including people exposed to an infected person, health workers and people with multiple sex partners.

People vaccinated against smallpox likely have some protection against monkeypox, which is a related virus. Smallpox vaccination ended after the disease was declared eradicated in 1980.

Several antiviral medications have been approved.

How unusual is this outbreak?

The current outbreak is the first time this many cases have occurred in such widely dispersed areas outside the endemic countries in West and Central Africa.

Europe accounts for two-thirds of the cases. Nearly one-fifth are in the United States.

WHO’s advisory committee did not agree on the magnitude of the threat at its meeting last Saturday, but Tedros made the decision to declare a “public health emergency of international concern,” the agency’s highest threat assessment.

Source: Voice of America

UN Agency Calls for More Protection for African Refugees and Migrants

GENEVA —

The UN refugee agency, UNHCR, Friday called for more to be done to protect African refugees and migrants from traffickers on their way from the Sahel and the Horn of Africa toward North Africa and Europe.

UNHCR spokeswoman Shabia Mantoo says traffickers take advantage of African refugees fleeing persecution and violence and of migrants fleeing poverty and climate shocks, subjecting them to appalling abuse.

“Some of them are left to die in the desert. Others suffer repeated sexual and gender-based violence, kidnapped for ransom, torture and many other forms of physical and psychological abuse,” said Mantoo. “So, the human trafficking issue is widespread and is incredibly alarming.”

The report issued by the UNHCR and the Mixed Migration Center at the Danish Refugee Council, is based on information from 12 countries, from Burkina Faso and Cameroon to Somalia and Sudan.

Mantoo tells VOA human traffickers and smugglers use technology and online platforms to advertise their services to unsuspecting victims. She says traffickers employ the internet to identify, groom and recruit victims, including children.

She says the UNHCR is urging governments and the private sector to work together to crack down on the use of the Internet by traffickers.

“These same digital technologies can be leveraged to actually counter the issue and counter trafficking by helping empower communities with trustworthy information, to better protect themselves and also be aware of the risks that they might face on these journeys …to ensure that there are protection services available for the people who are taking these precarious and perilous journeys, to prevent and end the human trafficking and smuggling rings,” said Mantoo.

The report provides tailored information for refugees and migrants on services available on different routes. The UNHCR is calling for the creation of shelters and safe places, better access to legal services, and specialized services for children and female survivors of trafficking and gender-based violence.

UNHCR officials stress the importance of identifying critical locations to serve as so-called last stops – places where refugees and migrants can get information about the dangers that lie ahead before they embark on journeys across the Sahara.

Source: Voice of America