Задаксин /Zadaxin/ е имуномодулатор, който се приема заедно с пегилиран интерферон.
Ето малко информация от страницата на HCVAdvocate.org:
Hepatitis C Treatments in Current Clinical Development
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ZADAXIN® (thymalfasin or thymosin alpha 1) - Immunomodulator
Производители: SciClone/Sigma-Tau
Фаза на клинично изпитане: III
Детайли:
Boosts the immune system. Patients in a phase III study of Zadaxin used in combination with interferon and ribavirin showed only a modest improvement in treatment outcome and liver histology. Final results from the complete study released in May 2006 found that Zadaxin in combination with pegylated interferon failed to produce significant results over pegylated interferon alone. On December 28, 2006 SciClone and its European partner Sigma-Tau announced that full patient enrollment is complete for its phase 3 clinical trial evaluating the use of ZADAXIN® in combination with pegylated interferon alpha and ribavirin to treat patients infected with the hepatitis C virus. This trial is being conducted by Sigma-Tau in Europe and has enrolled a total of 553 patients. Data from this trial are expected to be publicly announced by year-end 2008.
Последна промяна: May 23, 2008
Информация за лекарството:
About ZADAXIN® | SciClone Pharmaceuticals InternationalЕто още няколко новини, свързани с клиничните изпитания за ефективността на лекарството при лечение на хроничен хепатит C:
от 2002 година:
ZADAXIN Shows Direct Antiviral Effects On Cells Infected With Hepatitis B and HIVот 2004 година:
SciClone Pharmaceuticals (SCLN) Reports Data: 41% Of Hepatitis C Non-Responder Patients Test HCV RNA Negative After 24 Weeks Of ZADAXIN Triple TherapySciClone's ZADAXIN Shows Promise in Triple Therapy Trial for Hepatitis C Non-Responder Patients; Endpoint Data Presented at World's Largest Meeting of Liver Specialists American Association of the Study of Liver Disease (AASLD)от 2005 година:
SciClone Announces Zadaxin Hepatitis C Triple Therapy Poster Presentationот юли 2008 година:
Difficult Obstacles for SciCloneТова е цялата новина от юли 2008 година:
Difficult Obstacles for SciClone
http://www.fool.com
By Brian Lawler
With all the new technologies and discoveries, some drugmakers are undoubtedly going to be left in the dust. SciClone Pharmaceuticals (Nasdaq: SCLN), with its lead drug Zadaxin, might be one such drugmaker.
On Thursday, SciClone announced that patients in a large phase 3 trial testing Zadaxin as a treatment for hepatitis C had completed dosing and that top-line clinical trial data would be announced in the fourth quarter.
Zadaxin has been tested for a range of indications including hepatitis B, melanoma, and hepatitis C. In February, SciClone released "blinded" data from one point in this phase 3 study showing that 31% of patients who had failed with other hepatitis C therapies had no detectable levels of the virus in their bloodstream at the end of 48 weeks in the trial.
The most commonly used hepatitis C standard-of-care drugs from Schering-Plough (NYSE: SGP) and Roche have cured up to 16% of patients in clinical testing. The catch with comparing the Zadaxin phase 3 data with this data is that the interim look at the Zadaxin trial contains both placebo and drug-treated patients -- that's what "blinded" means -- so the high response rate could theoretically be mostly placebo patients (or vice-versa, if you are a SciClone optimist). Also, this 31% response rate was at the end of treatment, so we'll need to wait for the full results to see where the long-term hepatitis C cure rates from this study will fall.
There are other potential issues for Zadaxin as well. But the bigger problem is that even in a perfect-case scenario -- it makes it onto the market at this point (despite significant hurdles) -- data from other compounds like Vertex Pharmaceuticals' (Nasdaq: VRTX) protease inhibitor telaprevir show them to be extremely effective in similar patients. So they may be ahead in the race to be the next hepatitis C drug onto the market. Being second on market and potentially inferior to the competition is not a winning recipe for commercial success with a drug.
Zadaxin is already approved for marketing in hepatitis B in China, which is undoubtedly the Wild West of pharmaceuticals, so who knows how Zadaxin will fare over there. But its potential as a treatment for hepatitis C in the U.S. and European Union looks rough at this point because of formidable competition.
На страницата на
SciClone Pharmaceuticals International можеш да прочетеш в кои държави Задаксин е одобрен за лечение. Тук ще ги цитирам:
Product: ZADAXIN (thymosin alpha 1) - Approvals
Одобрен за лечение на хроничен хепатит B в следните държави:
Argentina, Azerbaijan, Bahrain, Brunei, Cambodia, China, Dominican Republic, Hong Kong, India, Indonesia, Kuwait, Kyrgyzstan, Laos, Malaysia, Maldives, Malta, Mexico, Pakistan, Peru, Philippines, Singapore, Sri Lanka, Thailand, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, Vietnam
Одобрен за лечение на хроничен хепатит C в следните държави:
Argentina, Dominican Republic, Mexico Peru, Philippines, Singapore, Sri Lanka, Thailand, Ukraine
Одобрен като имуностимулант в следните държави:
Brazil, Georgia, Myanmar, Peru
Както виждаш, това лекарство не е официално одобрено за лечение в Русия, и е в процес на тестване в Европа и то единствено като лекарство за лечение на хроничен хепатит C.
От другите новини обаче виждаш, че като цяло не дава осезаемо по-добри резултати и при конкуренцията на значително по-добре представящи се в клиничните изпитания лекарства /като VX-950/ няма големи шансове да се наложи сериозно на пазара.
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