Автор Тема:  Датска фирма разработи революционно лечение за хепатит  (Прочетена 5352 пъти)

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Неактивен ediarti

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  • Вид лечение: Нуклеозиден аналог
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  • Статус: Хроничен хепатит B
Лекарство, което се справя с хепатит C по напълно нов начин, се е оказало много ефективно при шимпанзетата и е работело няколко седмици след прекратяване на лечението, предаде Ройтерс.

Има надежди, че лекарството на датската компания Santaris Pharma AS, носещо експериментално означение SPC3649, може да замени по-токсичните лекарства като част от коктейл за борба с хепатит C, смята Робърт Ланфорд от Югозападната фондация за биомедицински изследвания в Сан Антонио, Тексас. „Докато се провеждаше проучването, бяхме впечатление колко добре работи лекарството“, обясни той. Ланфорд, който няма да финансови връзки с датската компания, редовно провежда тестове на нови средства за лечение на хепатит C върху шимпанзета, които са единствените животни освен хората, податливи на вируса. Този вид хепатит се пренася по кръвен път и уврежда черния дроб, като причинява хронични проблеми, цироза, рак и смърт. Това е най-често срещаната причина за болести на черния дроб по цял свят, която засяга около 3,2 милиона души в САЩ и 170 милиона души по света. Обичайното лечение включва 48 седмици с Интерферон и антивирусния препарат Рибавирин. Комбинацията работи само при около половината пациенти, а някои развиват толкова тежки странични ефекти, че трябва да спрат лечението. Новият препарат е насочен към генетичния материал в микро-РНК, който вирусът използва, за да се репродуцира. Лекарството на Santaris блокира този процес. При две шимпанзета, които са получили по-голяма доза препарат, е имало намаление на нивата на вируса с 350% за 12 седмици. Предвид липсата на токсични ефекти при шимпанзетата, компанията е започнала клинични изследвания върху доброволци.

http://news.v2.bgnes.com/view/789757

Неактивен anita

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    • ХепАктив - сдружение за борба с хепатита
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  • Статус: Хроничен хепатит C
Добра новина, но не се знае дали ще стигне до пазара и кога.
Толкова много лекарства се разработват но така и не достигат до производство.


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Неактивен Радослав Русинов

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Много обичам сензационните новини за нови лекарства, които лекуват цироза и какво ли още не и за които научаваме от разни български сайтове за новини като този, които понякога дори и не могат да преведат както трябва това, което са прочели. И най-важното, никога не цитират източниците си.
Затова сега се разрових и първото нещо, което открих е, че тази новина е от 29 май 2008 година. Това за пореден път показва колко са в час нашите журналисти. Попадат на думичката "Ground-breaking" и решават, че това е сензационна новина. Иначе за какво да проверяват откога е новината, голяма работа че е на година и половина  :pardon:

Ето я и самата новина:
Цитат
Santaris Pharma Begins Human Clinical Testing of the World’s First Medicine Targeted at a Human microRNA
http://www.businesswire.com

SPC3649 (LNA-antimiR-122) being developed as a potential new therapy for Hepatitis C virus (HCV) infection

Ground-breaking Phase I volunteer study made possible through the success of Locked Nucleic Acid (LNA) chemistry


COPENHAGEN, Denmark--(BUSINESS WIRE)--Santaris Pharma, the Danish biopharmaceutical company, announced today that it has commenced a Phase I human volunteer trial of the world’s first microRNA medicine to be tested in man - SPC3649 (LNA-antimiRTM-122). The study is being conducted by PhaseOneTrials A/S, Copenhagen, and will include a maximum of 48 healthy male volunteers. The Company also announced that the first cohort of healthy volunteers in the study have completed treatment satisfactorily. SPC3649 is being developed by Santaris Pharma as a potential new approach to the treatment for Hepatitis C infection. Phase II studies in hepatitis patients will follow.

SPC3649 specifically targets microRNA-122, a small, liver-expressed, regulatory ribonucleic acid (RNA) that has recently been shown to facilitate human Hepatitis C virus replication in liver cells. Keith McCullagh, President & CEO, Santaris Pharma, said:

“The mechanism of action of this drug represents a potential breakthrough in medical science. The ability to switch off the functions of particular microRNAs may enable clinicians to modulate entire networks of genes associated with disease or ill-health. Santaris Pharma scientists recently published the results of successful microRNA silencing with SPC3649 in non-human primates.1 We are excited now to be able to evaluate the drug’s efficacy and safety in human subjects. If successful, such trials may lead to the development of a new approach to the treatment of Hepatitis C and more generally, contribute to the development of a major new class of therapeutic agents.”

The Phase I “First-In-Man” clinical trial is a placebo-controlled, double-blind, randomised, single dose, dose-escalating safety study of SPC3649 in a total of 48 healthy male volunteers. The volunteers are divided into six groups with eight persons in each. In each group six persons will receive SPC3649 and two will receive placebo (non-effective substance). Each volunteer will receive a single two hour intravenously infusion with either SPC3649 or placebo. SPC3649 will be administered at six escalating dose levels and each volunteer will be followed for three months.

About Santaris Pharma
Santaris Pharma is a Danish clinical stage biopharmaceutical company. The Company was formed in 2003 and has the exclusive rights to LNA technology, a 3rd generation antisense chemistry used to develop new classes of RNA medicines, called RNA antagonists. Santaris Pharma’s messengerRNA antagonists and microRNA antagonists are being developed to silence mRNAs and microRNAs associated with various diseases, including cancer, metabolic disorders and viral infections. Santaris Pharma completed a Euro 40m second round of equity financing in May 2006 and a Euro 20m third round of equity financing in December 2007. Santaris Pharma has a global alliance with Enzon Pharmaceuticals of New Jersey to develop and co-commercialise a series of Santaris Pharma RNA antagonists for the treatment of cancer and a worldwide strategic alliance with GlaxoSmithKline for the discovery, development and commercialization of novel medicines against viral diseases.

About Santaris Pharma’s Locked Nucleic Acid technology
LNA is the first true conformational analogue of RNA (ribonucleic acid). The ribose sugar in LNA is ‘locked’ in the three-dimensional shape of RNA by virtue of its rigid bicyclic structure. The result is that when incorporated into oligonucleotides, LNA conveys dramatically enhanced binding affinity to complementary RNA sequences. Drug molecules with multiple LNA substitutions therefore have truly unprecedented potencies. The greater potency of LNA in binding complementary RNA sequences means that LNA oligonucleotide drugs can be made significantly shorter than previous antisense or siRNA drugs. These shorter RNA antagonist drugs are taken up efficiently by cells and tissues, thereby overcoming many of the delivery problems of RNAi to date. As LNA drugs are resistant to degradation when given systemically, have long tissue half lives, and are taken up readily by many tissues they have greater potency than other oligonucleotide chemistries.

About microRNAs
MicroRNAs are a newly discovered class of small regulatory molecules which control many biological processes in cells. In addition, microRNAs are implicated in many diseases, such as cancer, viral infections, cardiovascular disease and neurological disorders and, therefore, represent a new class of targets for therapeutic intervention. Santaris Pharma’s unique LNA technology enables development of short, synthetic RNA-binding molecules that can effectively antagonize disease-causing microRNAs and, thus may yield patient benefits unobtainable by other therapeutic approaches.

About SPC3649:
SPC3649 is the first of the new class of microRNA antagonists based on Santaris Pharma’s proprietary LNA technology. SPC3649 targets the liver specific microRNA122. SPC3649 works by blocking microRNA-122 in liver cells leading to a rapid loss of Hepatitis C virus replication. Another effect of the drug is to enhance the metabolism of cholesterol and fats.

About Hepatitis C (HCV):
There is a huge need to develop effective therapeutics for the treatment of HCV. 170 million people world-wide are chronically infected with the disease. 75-80% of newly infected patients develop chronically HCV infection which leads to severe morbidity and mortality caused by cirrhosis, cancer and liver failure. Six different types (genotypes) of HCV have so far been identified. The standard therapy, which is a combination therapy (pegylated interferon and ribavirin) is often poorly tolerated by the patients. This treatment is furthermore only efficient in 50 % of the cases against the most frequent HCV genotype (1).

About PhaseOneTrials
PhaseOneTrials A/S is a Danish Contract Research Organization (CRO) that conducts highly specialized clinical phase I trials and early phase II trials of new drug candidates. PhaseOneTrials has extensive experience planning and conducting ”First-in-Man” trials for both classical pharmaceutical and new biological drugs having worked with recombinant peptide hormones, enzymes and growth factors. The location at a university hospital, proximity to their intensive care unit and collaboration with distinguished specialists all mean that the Company easily meet the increasing government safety requirements for such trials.

1 See reference: Elmen, J, Lindow, M. et al., (2008) “LNA-mediated microRNA silencing in non-human primates.” Nature, VOL 452, April 17, pages 896-899, 2008

Contacts
Santaris Pharma
Randi Krogsgaard, +45 4517 9879
Cell +45 2048 8384
Director, Corporate Communications
rmk@santaris.com

А иначе на 5 май 2009 година е завършила фаза I на клиничните изпитвания, която се е провела върху 48 здрави мъже (в това число са и тези, които са били в плацебо групата):
Цитат
Hepatitis C Treatments in Current Clinical Development
...
SPC3649 (LNA-antimiRTM-122)

Comments: On May 29, 2008 Santaris announced that it was commencing a study of SPC3649 in up to 48 healthy male volunteers who will receive SPC3659 or placebo. The trial is a placebo-controlled, double-blind, randomized, single dose, dose-escalating safety study. After establishing the safety and tolerability of the drug the next step would be to study the drug in HCV patients. MicroRNA drugs are a new class of drugs and this trial is the first to test a microRNA in humans. It was announced that the phase I trial was completed in May 2009. (May 5, 2009)
...
Целта на изпитването до този момент е да се провери безопасността на лекарството и едва след това то ще бъде тествано върху хора с хроничен хепатит C.

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Нямам възможност да отговарям своевременно на постове и лични съобщения.
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Неактивен Neval

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Здравейте на всички!
Страхотна новина,нищо че идва при нас след година и половина.  :smile:Най-важното в случая е,че действа безотказно върху най-близката до нас "клонка"- шимпанзето.Направете справка колко бързо в еволюционен план ще дойде "тази гъша х..." до нас. :laugh:А можеше и да е много по-лошо-ако действаше върху рибите,например.Голямо чакане щеше да пада.. :laugh: :bye2:

Неактивен Радослав Русинов

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След като на второ място във форума се появи информация за същата новина, но публикувана в друг сайт, проверих дали наистина тези дни не е изтекла някаква новина за лекарството SPC3649.
И се оказа, че наистина има излязла такава новина на 4-ти декември в Лос Анджелис Таймс:
Experimental drug is combating hepatitis C in chimps, researchers say
Ето и най-важната част от новината според мен:
Цитат
Experimental drug is combating hepatitis C in chimps, researchers say
...
Lanford and his colleagues injected SPC3649 intravenously into four chimpanzees chronically infected with hepatitis C for 12 weeks, followed by 17 weeks of observation. In the two animals receiving the highest dose, there was a 350-fold drop in the virus level. "That's a very good drop," Lanford said. "Some antivirals will do that initially, but then resistance becomes a problem."

Virus levels remained low through most of the observation period, and there was never the strong viral rebound that is characteristic of developing resistance.

The only side effect of the treatment was a 45% drop in levels of low-density lipoprotein, the so-called bad cholesterol. One of the normal functions of miR-122 is to regulate cholesterol production. A reduction in bad cholesterol is "a clearly beneficial outcome," Lanford said.
...
Излиза, че 2 от тестваните 4 шимпанзета са имали намаление на вирусния товар от 350 пъти. Шимпанзетата са били наблюдавани 17 седмици след 12-седмичното лечение с това лекарство, като за този период са запазили ниския вирусен товар през по-голямата част от времето. Не знам какво имат предвид под "по-голямата част от времето", но не ми звучи като че са запазили ниския вирусен товар докрая на 17-те седмици наблюдение.
Никой не споменава за отрицателен ПСР, нито за SVR. което би трябвало да е основната им цел в крайна сметка. Ако лекарството сваля вирусния товар, то искам да разбера доколко го сваля и за какъв период от време той остава толкова нисък.

Ето и информацията за тези проучвания, публикувани на сайта на www.hcvadvocate.org:
Цитат
New Hepatitis C Treatment Shows Promise

http://health.usnews.com
By Jennifer Thomas
HealthDay Reporter

Drug prevented virus from replicating in the livers of primates

THURSDAY, Dec. 3 (HealthDay News) -- A new drug to treat hepatitis C has shown promise in a primate study.

The drug, called SPC3649, uses a new strategy to prevent the hepatitis C virus from replicating. Unlike other antivirals that target the virus itself, the new DNA-based drug targets a small RNA molecule in the liver that hepatitis C needs to replicate, the researchers explained.

By inhibiting the molecule, SPC3649 reduced hepatitis C virus levels in the liver and in the bloodstream in chimpanzees that received the highest dose by 350-fold.

Importantly, the virus showed no signs of resistance to SPC3649, developed by the Denmark-based company Santaris Pharma A/S. And levels of the virus remained low several months after the chimps had ended treatment, raising the possibility that the medicine would only need to be taken temporarily, the researchers added.

"It is a conceptually new approach. Instead of directly targeting the virus, the drug targeted a liver-specific molecule necessary for replication," said study author Robert Lanford, a scientist at the Southwest Foundation for Biomedical Research in San Antonio, Texas. "If we take that away from the virus, it can't replicate anymore."

Viruses replicate inside cells. Like small factories, they require all of the "machinery" inside the cell to accomplish this, explained Lanford. "The beauty of this drug is it takes away the host factor that the virus needs to replicate, and the virus cannot gain a mutation that allows it to be resistant to it."

The study appears in the Dec. 3 online edition of Science.

Hepatitis C, which is spread by contact with the blood of someone who is infected, infects the liver. About 70 percent to 80 percent of those with the virus have no symptoms initially, according to the U.S. Centers for Disease Control and Prevention. But over time, between 60 percent and 70 percent will develop chronic liver disease. Eventually, the virus can cause enough damage to the liver to lead to the formation of scar tissue, and eventually cirrhosis. The virus can also cause liver cancer.

There are about 170 million people infected with hepatitis C worldwide, according to background information in the study. Many don't know they have it.

The standard treatment is a two-drug cocktail of interferon, which makes the immune system more effective in eradicating the virus, and ribavirin, an antiviral, which cures about half of those infected, said Dr. Bruce Bacon, director of the division of gastroenterology and hepatology at Saint Louis University and co-director of the Saint Louis University Liver Center.

However, the side effects can be grueling, including flu-like symptoms, fatigue, depression and low white blood cell counts. Some patients have to be on the drugs for about six months, while some need about a year of treatment to kick the infection, Bacon said.

For those who don't respond to the two-drug cocktail, there are few options, Lanford said. Blacks are more likely to be among those in whom the treatments do not work, possibly due to genetic factors, Lanford noted.

SPC3649 may one day replace interferon, or be combined with the other drugs to augment it, Lanford said. Some evidence indicates it may work in those who don't respond to interferon. In the study, researchers gave four infected chimps SPC3649 intravenously for 12 weeks.

While the findings are exciting, the study involved only four chimps and there's a long way to go before this drug is ready for humans, Bacon said.

"What they have shown is successful reduction in the virus and no clear evidence of resistance, which are two of the major principals that need to be achieved with new therapies," Bacon said. "But what they have to prove now is whether this is a durable response. If you take the drug away, does the patient relapse."

Secondly, better treatments for hepatitis C are on the horizon. Phase 3 trials for two new protease inhibitors are wrapping up. The drugs have the potential to increase the cure rate to 70 percent to 80 percent when added to the two-drug interferon/ribavirin cocktail, Bacon said.

"The bar over which new discoveries much leap is that they have to have a better cure rate than the 70 or 80 percent we are going to see inside of two years," Bacon noted.

Phase 1 clinical trials for SPC3649 in people without hepatitis C are underway, Lanford said. Phase 2 trials in patients with hepatitis C should begin next year.

В горната новина има и изказани мнения за изнесената информация, които искам да цитирам отделно:
Цитат
While the findings are exciting, the study involved only four chimps and there's a long way to go before this drug is ready for humans, Bacon said.

"What they have shown is successful reduction in the virus and no clear evidence of resistance, which are two of the major principals that need to be achieved with new therapies," Bacon said. "But what they have to prove now is whether this is a durable response. If you take the drug away, does the patient relapse."
Общо взето, учените са побързали да се похвалят, преди наистина да има малко повече информация за ефекта на лекарството върху вируса в по-дългосрочен план, и преди да е изпробвано върху повече шимпанзета, или върху хора.

Все пак, явно съм избързал с оценката за журналиста, превел статията, за което се извинявам  :oops:

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Нямам възможност да отговарям своевременно на постове и лични съобщения.
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