Crucell HIV Vaccine: Promising Preliminary Results Phase I Study
Presented by Dr Dan Barouch at AIDS
(Thomson Reuters ONE) - Leiden, The Netherlands (October 21, 2009) - Dutch biopharma companyCrucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) todayannounced that preliminary results of the Phase I study of its HIVvaccine were presented at La Conférence AIDS Vaccine 2009 in Paris,France. The presentation was given by Dr Dan H. Barouch, MD, PhD,Associate Professor of Medicine, Division of Vaccine Research,Department of Medicine at the Beth Israel Deaconess Medical Center(BIDMC) in Boston, USA. The preliminary results of the Phase I studyshow that this HIV candidate vaccine is safe and immunogenic.In April 2008, Crucell announced the start of a Phase I clinicalstudy of the novel recombinant HIV vaccine. The vaccine is based onits AdVac® and PER.C6® technologies, using adenovirus serotype 26(rAd26) as vector and is jointly developed by Crucell and the BIDMC,funded by a grant from the US National Institute of Allergy andInfectious Diseases, part of the National Institutes of Health. TherAd26 vector is specifically designed to avoid the pre-existingimmunity to the more commonly used adenovirus serotype 5 (Ad5). ThePhase I clinical study is being conducted at the Brigham and Women'sHospital in Boston, USA and involves 48 healthy volunteers. Boostvaccinations are ongoing."The vaccine is designed to overcome the pre-existing immunity inhumans against the most commonly used recombinant vaccine vector,adenovirus serotype 5. These encouraging preliminary results arepaving the way for the further development of this vaccine vector forHIV and other pathogens." says Dr Barouch.About AdVac® technologyAdVac® technology is a vaccine technology developed by Crucell and isconsidered to play an important role in the fight against emergingand re-emerging infectious diseases, and in biodefense. Thetechnology supports the practice of inserting genetic material fromthe disease-causing virus or parasite into a 'vehicle' called avector, which then delivers the immunogenic material directly to theimmune system. Most vectors are based on an adenovirus, such as thevirus that causes the common cold. The AdVac® technology isspecifically designed to manage the problem of pre-existing immunityin humans against the most commonly used recombinant vaccine vector,adenovirus serotype 5 (Ad5), without compromising large-scaleproduction capabilities or the immunogenic properties of Ad5. AdVac®technology is based on adenoviruses that do not regularly occur inthe human population, such as Ad35. In contrast to for instance Ad35antibodies, antibodies to Ad5 are widespread among people of all agesand are known to lower the immune response to Ad5-based vaccines,thereby impairing the efficacy of these vaccines. All vaccinecandidates based on AdVac® are produced using Crucell's PER.C6®production technology.About PER.C6® technologyCrucell's PER.C6® technology is a cell line developed for thelarge-scale manufacture of biopharmaceutical products such asrecombinant proteins including monoclonal antibodies. The strengthsof the PER.C6® technology lie in its safety profile, scalability andproductivity under serum-free culture conditions.About Beth Israel Deaconess Medical CenterBIDMC is a patient care, teaching and research affiliate of HarvardMedical School, and consistently ranks in the top four in NationalInstitutes of Health funding among independent hospitals nationwide.BIDMC is clinically affiliated with the Joslin Diabetes Center and isa research partner of Dana-Farber/Harvard Cancer Care Center. Formore information, visit www.bidmc.harvard.edu.About Brigham and Women's HospitalBWH is a 747-bed non-profit teaching affiliate of Harvard MedicalSchool and a founding member of Partners HealthCare, an integratedhealth care delivery network. BWH is committed to excellence inpatient care with expertise in virtually every speciality of medicineand surgery. The BWH medical pre-eminence dates back to 1832, andtoday that rich history in clinical care is coupled with its nationalleadership in quality improvement and patient safety initiatives andits dedication to educating and training the next generation ofhealth care professionals. Through investigation and discoveryconducted at its Biomedical Research Institute (BRI), BWH is aninternational leader in basic, clinical and translational research onhuman disease, involving more than 860 physician-investigators andrenowned biomedical scientists and faculty supported by more than$416 M in funding. BWH is also home to major landmark epidemiologicpopulation studies, including the Nurses' and Physicians' HealthStudies and the Women's Health Initiative. For more information aboutBWH, please visit www.brighamandwomen's.org.About CrucellCrucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is aglobal biopharmaceutical company focused on research development,production and marketing of vaccines, proteins and antibodies thatprevent and/or treat infectious diseases. Its vaccines are sold inpublic and private markets worldwide. Crucell's core portfolioincludes a vaccine against hepatitis B, a fully-liquid vaccineagainst five important childhood diseases and a virosome-adjuvantedvaccine against influenza. Crucell also markets travel vaccines, suchas the only oral anti-typhoid vaccine, an oral cholera vaccine andthe only aluminum-free hepatitis A vaccine on the market. The Companyhas a broad development pipeline, with several product candidatesbased on its unique PER.C6® production technology. The Companylicenses its PER.C6® technology and other technologies to thebiopharmaceutical industry. Important partners and licensees includeDSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck &Co. Crucell is headquartered in Leiden, the Netherlands, withsubsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S.The Company employs over 1000 people. For more information, pleasevisit www.crucell.com.Forward-looking statementsThis press release contains forward-looking statements that involveinherent risks and uncertainties. We have identified certainimportant factors that may cause actual results to differ materiallyfrom those contained in such forward-looking statements. Forinformation relating to these factors please refer to our Form 20-F,as filed with the U.S. Securities and Exchange Commission on April22, 2009, in the section entitled 'Risk Factors'. The Companyprepares its financial statements under International FinancialReporting Standards (IFRS).For further information please contact:Crucell N.V.Oya YavuzVice PresidentCorporate Communications & Investor RelationsTel. +31-(0)71-519 7064ir(at)crucell.comwww.crucell.comhttp://hugin.info/132631/R/1348705/324681.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 21.10.2009 - 12:30 Uhr
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