{"id":2082,"date":"2009-05-16T13:36:57","date_gmt":"2009-05-16T13:36:57","guid":{"rendered":"https:\/\/www.progeriaresearch.org\/?p=2082"},"modified":"2020-12-10T16:44:57","modified_gmt":"2020-12-10T21:44:57","slug":"moving-ahead-at-lightening-speed-as-the-progeria-triple-drug-trial-begins","status":"publish","type":"post","link":"https:\/\/www.progeriaresearch.org\/id\/2009\/05\/16\/moving-ahead-at-lightening-speed-as-the-progeria-triple-drug-trial-begins\/","title":{"rendered":"Bergerak Maju dengan Kecepatan Kilat saat Uji Coba Tiga Obat Progeria Dimulai!"},"content":{"rendered":"

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Hayley dari Inggris dan Michiel dari Belgia tersenyum lebar saat berpose dengan piala mereka karena berhasil menyelesaikan uji klinis obat Progeria pertama pada hari Jumat, 14 Agustus 2009. Mereka juga, bersama saudara perempuan Michiel, Amber (kanan), menyelesaikan kunjungan pertama mereka untuk uji coba tiga obat minggu itu.<\/em><\/strong><\/p>\n

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Yayasan Penelitian Progeria dan Rumah Sakit Anak Boston kembali bermitra untuk menyelenggarakan uji klinis kedua bagi anak-anak penderita Progeria. Uji klinis yang menarik dan jauh lebih besar ini melibatkan 45 anak dari 24 negara, yang berbicara dalam 17 bahasa berbeda!\u00a0<\/strong><\/p>\n

Ringkasan<\/strong>: Para peneliti telah mengidentifikasi dua obat tambahan yang, bila digunakan dalam kombinasi dengan obat FTI yang saat ini sedang diuji, dapat memberikan pengobatan yang lebih efektif untuk anak-anak penderita Progeria dibandingkan dengan FTI saja.<\/p>\n

Dasar Ilmiah untuk Pengobatan<\/strong><\/div>\n
Progeria disebabkan oleh protein abnormal bernama progerin. Tim peneliti Progeria di Rumah Sakit Anak Boston akan menambahkan dua obat, yang disebut pravastatin dan zoledronat, ke dalam pengobatan FTI saat ini.<\/div>\n
\u00a0<\/div>\n
Strategi:<\/em><\/strong> Ketiga obat tersebut akan menargetkan titik-titik berbeda di sepanjang jalur yang mengarah pada produksi progerin penyebab penyakit. Dalam studi laboratorium menarik yang dipresentasikan oleh Dr. Carlos Lopez-Otin dari Spanyol pada Lokakarya Ilmiah Yayasan Penelitian Progeria 2007, kedua obat baru tersebut memperbaiki penyakit pada sel Progeria dan memperpanjang umur pada model tikus Progeria.<\/div>\n
\u00a0<\/strong><\/div>\n
Sasaran:<\/em><\/strong> Jika ketiga obat yang diberikan dalam uji coba ini dapat secara efektif memblokir ikatan kelompok farnesyl ini, maka progerin dapat "dilumpuhkan" dan Progeria dapat ditingkatkan. Kami berharap bahwa obat-obatan tersebut akan bekerja sebagai mitra, untuk saling melengkapi sehingga protein progerin lebih terpengaruh dengan menggabungkan ketiga obat tersebut daripada menggunakan satu obat saja.<\/div>\n
\u00a0<\/div>\n
Siapa Saja yang Terdaftar dalam Uji Coba Tiga Obat?<\/strong><\/div>\n
Uji Kelayakan:<\/strong>\u00a0Tim tersebut telah melakukan uji coba mini untuk 5 anak penderita Progeria. Uji coba "kelayakan" yang singkat dan berlangsung selama satu bulan ini menanyakan apakah kombinasi tiga obat tersebut dapat ditoleransi dengan baik, sebelum memulai uji coba internasional yang lebih besar. Efek sampingnya dapat diterima, dan tim tersebut telah melanjutkan ke uji coba kemanjuran yang lebih besar.<\/div>\n
Uji Khasiat:<\/strong> Pada bulan Januari 2010, uji coba tiga dosis tersebut telah mendaftarkan 45 anak secara penuh. Ini termasuk anak-anak yang berpartisipasi dalam uji coba FTI saja, 5 anak dalam uji coba kelayakan, dan anak-anak lain yang terlalu muda untuk berpartisipasi dalam uji coba pertama atau anak-anak yang telah kami temukan selama 2 tahun terakhir. Anak-anak yang terdaftar dalam uji coba FTI saja memiliki kesempatan untuk mendaftar dalam uji coba tiga dosis saat mereka datang untuk uji coba pertama tersebut. Hal ini memungkinkan anak-anak untuk terus mengonsumsi FTI tanpa ada dosis yang terlewat.<\/div>\n
\u00a0<\/strong><\/div>\n
Hubungan Pengobatan\/Progeria<\/strong><\/div>\n
Bagaimana kita beralih dari penemuan gen ke terapi obat untuk anak-anak penderita Progeria? Menemukan gen untuk Progeria adalah kuncinya. Gen ini disebut LMNA<\/em>, dan biasanya mengkodekan protein yang disebut prelamin A (protein ini diproses lebih lanjut dan menjadi lamin A). Anak-anak dengan Progeria memiliki mutasi pada LMNA<\/em> yang menyebabkan produksi prelamin A abnormal yang disebut "progerin." Penelitian dasar selama bertahun-tahun tentang prelamin A dan lamin A memberi kami kemampuan untuk memahami bahwa obat yang diberikan dalam uji coba ini dapat memengaruhi penyakit pada Progeria. Selama enam tahun terakhir, penelitian telah difokuskan pada pengujian obat ini secara sistematis pada sel Progeria dan tikus Progeria.<\/div>\n
\u00a0<\/div>\n
Tim Uji Klinis<\/strong><\/div>\n
Sejak Mei 2007, tim yang beranggotakan 28 orang telah merawat anak-anak penderita Progeria dari seluruh dunia. Anggota tim memiliki keahlian tidak hanya dalam Progeria, tetapi juga dalam tiga obat yang diberikan dalam uji coba ini.<\/div>\n
\u00a0<\/strong><\/div>\n
Sekilas tentang Obat Uji Coba<\/strong><\/div>\n
Obat Pravastatin<\/strong> (dipasarkan sebagai Pravachol atau Selektine) adalah anggota golongan obat statin. Obat ini biasanya digunakan untuk menurunkan kolesterol dan mencegah penyakit kardiovaskular.<\/div>\n
Asam zoledronat <\/strong>adalah bifosfonat, <\/strong>Biasanya digunakan sebagai obat tulang untuk memperbaiki osteoporosis, dan untuk mencegah patah tulang pada orang yang menderita beberapa jenis kanker.<\/div>\n
Obat Lonafarnib<\/strong> adalah sebuah FTI<\/strong> (Inhibitor farnesyltransferase), obat yang dapat membalikkan kelainan pada sel Progeria di laboratorium, dan telah memperbaiki penyakit pada tikus Progeria.<\/div>\n
Ketiga obat tersebut memblokir produksi molekul farnesyl yang dibutuhkan progerin untuk menciptakan penyakit pada Progeria.<\/em><\/div>\n
\u00a0<\/strong><\/div>\n
Waktu<\/strong><\/div>\n
Pasien akan melakukan perjalanan ke Boston untuk menjalani pengujian dan pemeriksaan yang berlangsung selama 4-7 hari, setiap 6 bulan selama jangka waktu 2 tahun. Untuk uji coba FTI saja, kunjungan ke Boston dilakukan setiap empat bulan.<\/div>\n
\u00a0<\/strong><\/div>\n
Biaya<\/strong>
Tentu saja, uji klinis sebesar ini mahal untuk dikelola, dan hanya ada sedikit sumber dukungan untuk penelitian penyakit langka. Namun pada bulan Oktober 2009, Institut Jantung, Paru-paru, dan Darah Nasional NIH memberikan hibah bergengsi "Grand Opportunities" kepada tim uji tiga kali lipat yang akan menanggung sebagian besar biaya. Kami sangat gembira telah memperoleh dukungan luar biasa ini dari NIH.<\/div>\n
\n

Akan tetapi, hibah tersebut tidak mencakup semua biaya persidangan. PRF masih perlu mengumpulkan sekitar $150.000 untuk beberapa biaya yang tidak ditanggung oleh hibah tersebut.<\/p>\n

klik disini<\/a> untuk menyumbang ke uji coba tiga obat dan membantu menjadikan TUJUAN pengobatan dan penyembuhan menjadi KENYATAAN!
<\/strong><\/p>\n<\/div>\n

* <\/em>\u201cPengobatan gabungan dengan statin dan aminobifosfonat memperpanjang umur pada model tikus penuaan dini manusia\u201d,<\/strong> oleh Ignacio Varela, Sandrine Pereira, Alejandro P. Ugalde, Claire L. Navarro, Mar\u00c4\u00b1a F. Suarez, Pierre Cau, Juan Cadinanos, Fernando G. Osorio, Nicolas Foray, Juan Cobo, Felix de Carlos, Nicolas Levy, Jose MP Freije dan Carlos Lopez-Ot\u00c4\u00b1n. Obat Alami, <\/em>2008. 14(7): hal. 767-72.<\/em><\/div>\n
\u00a0<\/em>
<\/em>T<\/strong>Generasi baru anak-anak yang dibantu PRF\u2026<\/strong><\/div>\n
Pada bulan Maret 2009, lima anak berusia 2-3 tahun berpartisipasi dalam studi kelayakan selama satu bulan untuk menentukan apakah efek samping dari ketiga obat yang dikonsumsi bersamaan dapat ditoleransi. Hasilnya positif, membuka jalan bagi Uji Coba Tiga Obat selama dua tahun untuk mengikutsertakan hingga 45 anak penderita Progeria.\u00a0Salut untuk keluarga-keluarga yang luar biasa ini!<\/strong><\/div>\n
\u00a0<\/strong><\/div>\n
Berikut ini adalah pernyataan beberapa dari mereka:<\/strong><\/div>\n

\"\"\u201c<\/em>SEMUA ORANG sangat luar biasa. Bagi kami, kalian SEMUA adalah UPACARA KARYA TUHAN dan kami MENGHARGAI semua yang kalian lakukan untuk malaikat kecil ini. Keluarga kami sangat gembira dan penuh dengan berbagai macam emosi atas perjalanan Adalia ke Boston akhir pekan ini. Saya bahkan tidak dapat mulai mengetik kata-kata untuk menggambarkan perasaan kami.<\/em>".<\/em><\/p>\n

<\/em><\/p>\n

\"\"\u201cObat baru untuk Zach ini memberi kami harapan baru bahwa jantungnya akan lebih kuat, senyumnya akan lebih cerah, dan hidupnya akan lebih panjang. Uji coba obat baru ini adalah jawaban atas doa kami. Terima kasih kepada semua orang yang terlibat dengan PRF yang telah mewujudkannya\u2026 para dokter, peneliti, dan staf. Kalian adalah pahlawan kami!\u201d<\/em><\/div>\n
\u00a0<\/div>\n
\n
\"\"

Cam dan ayahnya belajar cara mencampur obat FTI dengan pemanis.<\/p><\/div><\/p>\n

\u201cAtas nama Cam dan keluarga kami, terima kasih banyak kepada semua orang di PRF atas semua yang telah Anda lakukan! Kami akan tersesat dalam dunia yang penuh kebingungan dan kesedihan tanpa Anda. Sebaliknya, kami hidup di dunia yang penuh harapan dan tujuan. Terima kasih sekali lagi! Dengan penuh cinta dan rasa hormat,\u201d<\/em><\/p>\n<\/div>\n

\u00a0<\/div>\n<\/div>\n

[\/et_pb_teks][\/et_pb_kolom][\/et_pb_baris][\/et_pb_bagian]<\/p>","protected":false},"excerpt":{"rendered":"

[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d3.22\u2033][et_pb_row _builder_version=\u201d3.25\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d3.25\u2033 custom_padding=\u201d|||\u201d custom_padding__hover=\u201d|||\u201d][et_pb_image src=\u201dhttps:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2009\/05\/HayleyMichielAmber-Aug09.jpg\u201d title_text=\u201dHayleyMichielAmber-Aug09\u2033 _builder_version=\u201d4.6.5\u2033 _module_preset=\u201ddefault\u201d hover_enabled=\u201d0\u2033 align=\u201dcenter\u201d sticky_enabled=\u201d0\u2033 custom_margin=\u201d||-4px|||\u201d][\/et_pb_image][et_pb_text admin_label=\u201dcaption HM\u201d _builder_version=\u201d4.6.5\u2033 _module_preset=\u201ddefault\u201d text_font_size=\u201d12px\u201d] Hayley dari Inggris dan Michiel dari Belgia tersenyum lebar saat berpose dengan piala mereka karena telah menyelesaikan Uji klinis obat Progeria pertama kali dilakukan pada hari Jumat, 14 Agustus 2009. Mereka juga, [\u2026]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"

[vc_custom_heading text=\"Moving Ahead at Lightening Speed as The Progeria Triple Drug Trial Begins!\" font_container=\"tag:h1|text_align:left\" use_theme_fonts=\"yes\"]<\/p>

[caption id=\"attachment_2083\" align=\"alignleft\" width=\"200\"]\"\" Hayley from England and Michiel from Belgium are all smiles as they pose with their trophies for completing the first-ever Progeria clinical drug trial on Friday, August 14, 2009. They also, along with Michiel\u2019s sister Amber (right), completed their first visit for the triple drug trial that week.[\/caption]

The Progeria Research Foundation and Children\u2019s Hospital Boston are once again partnering to conduct a second clinical trial for children with Progeria. This exciting and much larger trial includes 45 children from 24 countries, speaking 17 different languages!\u00a0<\/strong><\/p>

Summary<\/strong>: Researchers have identified two additional drugs that, when used in combination with the current FTI drug being tested, may provide an even more effective treatment for children with Progeria than FTI\u2019s alone.<\/p>

Scientific Basis for Treatment<\/strong><\/div>
Progeria is caused by an abnormal protein named progerin.\u00a0The Progeria research team at Children\u2019s Hospital Boston will add two drugs, called pravastatin and zoledronate, to the current treatment with FTI.<\/div>
\u00a0<\/div>
Strategy:<\/em><\/strong> All three drugs will target different points along the pathway leading to production of the disease-causing progerin.\u00a0In exciting laboratory studies presented by Dr. Carlos Lopez-Otin of Spain at the 2007 Progeria Research Foundation Scientific Workshop, the two new drugs improved disease in Progeria cells and extended lifespan in mouse models of Progeria.<\/div>
\u00a0<\/strong><\/div>
Goal:<\/em><\/strong> If the three drugs administered in this trial can effectively block this farnesyl group attachment, then progerin may be \u201cparalyzed\u201d and Progeria may be improved.\u00a0We hope that the drugs will work as partners, to complement each other so that the progerin protein is affected more by combining the three drugs than using any one drug alone.<\/div>
\u00a0<\/div>
Who is Enrolled in the Triple Drug Trial?<\/strong><\/div>
The Feasibility Trial:<\/strong>\u00a0The team has already conducted a mini-trial for 5 children with Progeria.\u00a0The short, one month \u201cfeasibility\u201d trial, asked whether the three-drug combination would be well-tolerated, prior to embarking on a larger international trial.\u00a0Side effects were acceptable, and the team has moved ahead to the larger efficacy trial.<\/div>
The Efficacy Trial:<\/strong> In Janaury 2010, the triple trial beamce fully enrolled with 45 children. This includes children participating in the FTI-only trial, the 5 in the feasibility trial, and other children that were either too young to participate in the first trial or children that we\u2019ve discovered over the past 2 years. Children enrolled in the FTI-only trial had the opportunity to enroll in the triple trial when they arrived for that first trial.\u00a0This allowed the children to continue taking FTI without any missed doses.<\/div>
\u00a0<\/strong><\/div>
The Treatment\/Progeria Relationship<\/strong><\/div>
How did we get from gene discovery to drug therapy for children with Progeria?\u00a0Finding the gene for Progeria was the key. This gene is called LMNA<\/em>, and it normally encodes a protein called prelamin A (this protein is further processed and becomes lamin A). Children with Progeria have a mutation in LMNA<\/em> which leads to the production of an abnormal form of prelamin A called \u201cprogerin.\u201d \u00a0Many years\u2019 worth of basic research on prelamin A and lamin A gave us the ability to understand that the drugs administered in this trial may affect disease in Progeria. \u00a0Over the past six years, research has focused on systematically testing these drugs on Progeria cells and Progeria mice.<\/div>
\u00a0<\/div>
The Clinical Trial Team<\/strong><\/div>
Since May 2007, a 28-member team has treated children with Progeria from around the globe.\u00a0Members of the team have expertise not only in Progeria, but also in the three drugs administered in this trial.<\/div>
\u00a0<\/strong><\/div>
Trial Medications at a Glance<\/strong><\/div>
Pravastatin<\/strong> (marketed as Pravachol or Selektine) is a member of the drug class of statins.\u00a0It is usually used for lowering cholesterol and preventing cardiovascular disease.<\/div>
Zoledronic acid <\/strong>is a bisphosphonate, <\/strong>usually used as a bone drug for improving osteoporosis, and to prevent skeletal fractures in people suffering from some forms of cancer.<\/div>
Lonafarnib<\/strong> is an FTI<\/strong> (Farnesyltransferase inhibitor), a drug that can reverse an abnormality in Progeria cells in the laboratory, and has improved disease in Progeria mice.<\/div>
All 3 drugs block the production of the farnesyl molecule that is needed for progerin to create disease in Progeria.<\/em><\/div>
\u00a0<\/strong><\/div>
Timing<\/strong><\/div>
Patients are traveling to Boston for testing and examinations lasting 4-7 days, every 6 months for a period of 2 years. For the FTI-only trial, Boston visits occurred every four months.<\/div>
\u00a0<\/strong><\/div>
Cost<\/strong>
Of course, a clinical trial of this magnitude is expensive to manage, and there are precious few sources of support for rare disease research.\u00a0 But in October 2009, the NIH's National Heart, Lung, and Blood Institute awarded the triple trial team a prestigious \"Grand Opportunities\" grant that will cover many of the costs.\u00a0 We are thrilled to have earned this extraordinary support from NIH.<\/div>

However, the grant doesn't cover all of the trial expenses.\u00a0 PRF still needs to raise about $150,000 for some costs not covered by the grant.<\/p>

Click here<\/a> to donate to the triple drug trial and help make the GOAL of treatment and cure a REALITY!
<\/strong><\/p><\/div>

* <\/em>\u201cCombined treatment with statins and aminobisphosphonates extends longevity in a mouse model of human premature aging\u201d,<\/strong> by Ignacio Varela, Sandrine Pereira, Alejandro P. Ugalde, Claire L. Navarro, Mar\u00c4\u00b1a F. Suarez, Pierre Cau, Juan Cadinanos, Fernando G. Osorio, Nicolas Foray, Juan Cobo, Felix de Carlos, Nicolas Levy, Jose MP Freije and Carlos Lopez-Ot\u00c4\u00b1n. Nature Medicine, <\/em>2008. 14(7): p. 767-72.<\/em><\/div>
\u00a0<\/em>
<\/em>T<\/strong>he new generation of children PRF is helping\u2026<\/strong><\/div>
In March, 2009, five children, ages 2-3, participated in a one-month feasibility study to determine if the side effects of the three drugs taken together were tolerable.\u00a0The results were positive, paving the way for the full, two-year, Triple Drug Trial to enroll up to 45 children with Progeria.\u00a0Hats off to these amazing families!<\/strong><\/div>
\u00a0<\/strong><\/div>
Here is what some of them had to say:<\/strong><\/div>

\"\"\u201c<\/em>EVERYONE has been so wonderful.\u00a0 To us you are ALL GOD SENT and we APPRECIATE all that you do for these little angels.\u00a0 Our family is so overwhelmed with excitement and all sorts of emotions with Adalia\u2019s trip to Boston this weekend, I can\u2019t even begin to type the words of how we are feeling<\/em>\u201d.<\/em><\/p><\/div>

\"\"\u201cThis new medication for Zach gives us a renewed hope that his heart will be stronger, his smile will be brighter and his life will be longer.\u00a0 This new drug trial is an answer to our prayers. \u00a0 Thank you to everyone involved with PRF who made this happen...the doctors, the researchers and the staff.\u00a0 You are our heroes!\u201d<\/em><\/div>
\u00a0<\/div>
\u00a0<\/div>
\u00a0<\/div>
\u00a0<\/div>
[caption id=\"attachment_2086\" align=\"alignright\" width=\"150\"]\"\" Cam and his dad learn how to mix the FTI drug with a sweetener.[\/caption]

\u201cOn behalf of Cam and our family, thank you all at PRF so much for all you have done!\u00a0 We would have been lost in a world of confusion and grief without you.\u00a0 Instead, we live in a world of hope and purpose.\u00a0 Thank you again and again!\u00a0\u00a0With much love and respect,\u201d<\/em><\/p><\/div>

\u00a0<\/div><\/div>","_et_gb_content_width":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[2],"tags":[],"class_list":["post-2082","post","type-post","status-publish","format-standard","hentry","category-news"],"yoast_head":"\nMoving Ahead at Lightening Speed as The Progeria Triple Drug Trial Begins! - The Progeria Research Foundation<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.progeriaresearch.org\/id\/2009\/05\/16\/moving-ahead-at-lightening-speed-as-the-progeria-triple-drug-trial-begins\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Moving Ahead at Lightening Speed as The Progeria Triple Drug Trial Begins! - The Progeria Research Foundation\" \/>\n<meta property=\"og:description\" content=\"[et_pb_section fb_built=”1″ _builder_version=”3.22″][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/www.progeriaresearch.org\/wp-content\/uploads\/2009\/05\/HayleyMichielAmber-Aug09.jpg” title_text=”HayleyMichielAmber-Aug09″ _builder_version=”4.6.5″ _module_preset=”default” hover_enabled=”0″ align=”center” sticky_enabled=”0″ custom_margin=”||-4px|||”][\/et_pb_image][et_pb_text admin_label=”caption HM” _builder_version=”4.6.5″ _module_preset=”default” text_font_size=”12px”] Hayley from England and Michiel from Belgium are all smiles as they pose with their trophies for completing the first-ever Progeria clinical drug trial on Friday, August 14, 2009. 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