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NicOx : Garufi ... e la Rivoluzione Pharma (3 lettori)
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Netzach
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AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma QUEBEC CITY, Aug. 3 /CNW Telbec/ - AEterna Zentaris Inc. (NASDAQ: AEZS,TSX: AEZ), ("the Company") a global biopharmaceutical company focused onendocrine therapy and oncology, today announced that Keryx Biopharmaceuticals,Inc. (Nasdaq: KERX), its partner and licensee for perifosine in the NorthAmerican market, has reached an agreement with the U.S. Food and DrugAdministration (FDA) regarding a Special Protocol Assessment (SPA) on thedesign of a Phase 3 trial for the Company's PI3K/Akt pathway inhibitorcompound, perifosine (KRX-0401), in relapsed or relapsed/refractory multiplemyeloma patients previously treated with bortezomib (VELCADE(R)). The SPAprovides agreement that the Phase 3 study design adequately addressesobjectives in support of a regulatory submission. The study, entitled, "APhase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Addedto the Combination of Bortezomib and Dexamethasone in Multiple MyelomaPatients Previously Treated with Bortezomib", will be a double-blind,placebo-controlled study comparing the efficacy and safety of perifosine vs.placebo when combined with bortezomib and dexamethasone. The trial, powered at90%, will enroll approximately 400 patients with relapsed orrelapsed/refractory multiple myeloma. The primary endpoint is progression-freesurvival and secondary endpoints include overall response rate, overallsurvival and safety. Juergen Engel, Ph. D., President and Chief Executive Officer of AEternaZentaris commented, "We are very pleased and excited about perifosine movingforward into a Phase 3 trial. This represents a major milestone in ouroncology drug development strategy which could hold great promise for patientswith multiple myeloma." About the Phase 3 Trial Design The Phase 3 trial is a randomized (1:1), double-blind trial comparing theefficacy and safety of perifosine to placebo when combined with bortezomib anddexamethasone in approximately 400 patients with relapsed orrelapsed/refractory multiple myeloma. Patients must have been previouslytreated with both bortezomib (VELCADE(R)) and an immunomodulatory agent(REVLIMID(R) or THALIDOMID(R)) and previously treated with one to four priorlines of therapy. The primary endpoint is progression-free survival andsecondary endpoints include overall response rate, overall survival andsafety. About Multiple Myeloma Multiple myeloma, a cancer of the plasma cell, is an incurable buttreatable disease. Multiple myeloma is the second most-common hematologiccancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths.According to the American Cancer Society, in 2009, there will be an estimated20,580 new cases of multiple myeloma and an estimated 10,500 deaths frommultiple myeloma in the United States. To date, several FDA approved therapiesexist for the treatment of multiple myeloma. Despite this progress, patientscontinue to relapse, become refractory to prior treatments and eventually diefrom their disease. Thus, new therapies are needed to treat these patients andextend their survival. About Perifosine Perifosine is a novel, first-in-class, oral anti-cancer agent thatmodulates several key signal transduction pathways, including Akt, MAPK, andJNK that have been shown to be critical for the survival of cancer cells.Perifosine has demonstrated single agent anti-tumor activity in Phase 1 andPhase 2 studies and is currently being studied as a single agent and incombination with several forms of anti-cancer treatments for various forms ofcancer. Most recently, positive results were reported for the single agent useof perifosine in patients with advanced metastatic renal cancer and incombination with capecitabine for advanced metastatic colon cancer(placebo-controlled), as well as for perifosine in combination with bortezomib+/- dexamethasone in relapsed and refractory myeloma. About Special Protocol Assessments The Special Protocol Assessment (SPA) process is a procedure by which theFDA provides official evaluation and written guidance on the design and sizeof proposed protocols that are intended to form the basis for a new drugapplication. Final marketing approval depends on the results of efficacy, the adverseevent profile and an evaluation of the benefit/risk of treatment demonstratedin the Phase 3 trial. The SPA agreement may only be changed through a writtenagreement between the sponsor and the FDA, or if the FDA becomes aware of asubstantial scientific issue essential to product efficacy or safety. For moreinformation on the Special Protocol Assessment process, please visit:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf About AEterna Zentaris Inc. AEterna Zentaris Inc. is a global biopharmaceutical company focused onendocrine therapy and oncology, with proven expertise in drug discovery,development and commercialization. News releases and additional informationare available at www.aezsinc.com. Forward-Looking Statements This press release contains forward-looking statements made pursuant tothe safe harbor provisions of the U.S. Securities Litigation Reform Act of1995. Forward-looking statements involve known and unknown risks anduncertainties, which could cause the Company's actual results to differmaterially from those in the forward-looking statements. Such risks anduncertainties include, among others, the availability of funds and resourcesto pursue R&D projects, the successful and timely completion of clinicalstudies, the ability of the Company to take advantage of businessopportunities in the pharmaceutical industry, uncertainties related to theregulatory process and general changes in economic conditions. Investorsshould consult the Company's quarterly and annual filings with the Canadianand U.S. securities commissions for additional information on risks anduncertainties relating to the forward-looking statements. Investors arecautioned not to rely on these forward-looking statements. The Company doesnot undertake to update these forward-looking statements. We disclaim anyobligation to update any such factors or to publicly announce the result ofany revisions to any of the forward-looking statements contained herein toreflect future results, events or developments except if we are requested by agovernmental authority or applicable law.For further information: Investor Relations: Ginette Vallières, InvestorRelations Coordinator, (418) 652-8525 ext. 265, [email protected]; MediaRelations: Paul Burroughs, Director of Communications, (418) 652-8525 ext.406, [EMAIL="[email protected]"][email protected][/EMAIL] senti questa musichetta qui oggi
keryx in forte salita e vaiiiiiiiiiiiiiiiiii
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,,, anche qui ,,,, BASTAVA solo aspettare
Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma
Intanto tiriamo le reti piene di pesci qui<<poi la baleniera di nicox riempirà la stiva
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Intanto tiriamo le reti piene di pesci qui<<poia la baleniera di nicox riempirà la stiva
uehhhhh ,,, DUTUR ,,,, QUI si rimane in pochetti, pochetti
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E esattamente quello che ho sempre affermatouehhhhh ,,, DUTUR ,,,, QUI si rimane in pochetti, pochetti
Ueh quando vieni da ste parti lumbardacqua+
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E esattamente quello che ho sempre affermato
agosto ultrapreso
,,,,, vediamo a settembre organizza una convention nitrica
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