CRUCELL/AERAS START TURBERCULOSIS VACCINE CLINICAL TRIAL.Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CRXL; Swiss Exchange: CRX) has started the phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of the AdVac-based tuberculosis vaccine it is developing in partnership with The AERAS Global TB Vaccine Foundation. The clinical trial will be an open-label study that will test the vaccine in a dose-escalation trial involving 24 healthy volunteers. The Phase I trial will be funded and managed by Aeras through a Contract Research Organization (CRO), PRA PRA - PRAgmatics. The language used by COPS for specification of code generators. ["Metalanguages of the Compiler Production System COPS", J. Borowiec, in GI Fachgesprach "Compiler-Compiler", ed W. Henhapl, Tech Hochs Darmstadt 1978, pp. 122-159]. Clinical Pharmacology Center in Lenexa, Kansas, USA. The main parameters under examination will be safety, tolerability and immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. . "We are very proud to join with Aeras in applying our AdVac technology to the vital task of finding new TB vaccines," said Crucell's Chief Scientific Officer, Dr Jaap Goudsmit. Dr. Jerald C. Sadoff, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Aeras, added: "The start of this Phase I trial is important to our overall goal of developing a new vaccine to help eliminate the current TB pandemic." The second-generation Ad35 vector applied in the Crucell-Aeras TB program is extremely suitable for vaccine production on PER.C6 cell culture at scale. The production scale potential of the PER.C6 cell line has been demonstrated in an unprecedented successful bioreactor bioreactor a container in which living organisms carry out a biological reaction. run of 20,000 liters. Such highly productive systems are particularly important in the case of poverty-related diseases such as HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , malaria and TB, when 10-100 millions of doses need to be manufactured while keeping costs relatively low. About tuberculosis Tuberculosis is the world's second deadliest infectious disease behind AIDS, with 8 to 9 million new cases discovered each year. According to the World Health Organization (WHO), nearly 2 million people die from TB each year. One third of the world's population has been infected with the TB bacillus and current treatment takes 6-9 months. Failure to comply with drug treatment breeds drug resistance, which is rising dangerously in many parts of the world. The current TB vaccine is over 80 years old and has limited effect in childhood and no protection against TB for adolescents and adults. About AdVac technology and Ad35 AdVac technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and re-emerging infectious diseases, and in biodefense. The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a "vehicle" called a vector, which then delivers the immunogenic im·mu·no·gen·ic adj. Producing an immune response. immunogenic producing immunity; evoking an immune response. material directly to the immune system. Most vectors are based on an adenovirus adenovirus Any of a group of spheroidal viruses, made up of DNA wrapped in a protein coat, that cause sore throat and fever in humans, hepatitis in dogs, and several diseases in fowl, mice, cattle, pigs, and monkeys. , such as the virus that causes the common cold. The AdVac technology is specifically designed to manage the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5. AdVac technology is based on adenovirus vectors that do not regularly occur in the human population, such as Ad35. In contrast to the AdVac vectors, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines. All vaccine candidates based on AdVac are produced using Crucell's PER.C6 production technology. About PER.C6 technology Crucell's PER.C6 technology is a cell line developed for the large-scale manufacture of biopharmaceutical products including vaccines. The production scale potential of the PER.C6 cell line has been demonstrated in an unprecedented successful bioreactor run of 20,000 liters. Compared to conventional production technologies, the strengths of the PER.C6 technology lie in its excellent safety profile, scalability and productivity under serum-free culture conditions. These characteristics, combined with its ability to support the growth of both human and animal viruses, make PER.C6 technology the biopharmaceutical production technology of choice for Crucell's current and potential pharmaceutical and biotechnology partners. About Aeras The Aeras Global TB Vaccine Foundation is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are distributed to all who need them around the world. Dr Sadoff has overseen FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. licensure of five vaccines and worked on the research and development of numerous other vaccine candidates while at Merck and the Walter Reed Army Institute of Research This article is about the U.S. Army medical research institute (not the hospital). Otherwise, see Walter Reed (disambiguation). The Walter Reed Army Institute of Research (WRAIR) is the largest biomedical research facility administered by the U.S. . Aeras is primarily funded by the Bill and Melinda Gates Foundation Bill and Melinda Gates Foundation, philanthropic institution founded in 1994 by Microsoft chairman Bill Gates and his wife, Melinda, to improve the lives of the poor throughout the world, primarily through grants for projects relating to global health care, , and also receives important support from the Government of Denmark Denmark is a constitutional monarchy with a representative democracy based on a unicameral parliamentary system. The affairs of Government are decided by a Cabinet of Ministers, which is led by a Prime Minister. , the U.S. Centers for Disease Control, and the U.S. National Institutes of Health. Aeras is based in Rockville, Maryland where it recently opened a $10 million state-of-the-art manufacturing and laboratory facility. For more information, visit http://www.aeras.org. About Crucell Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases, and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine and the only aluminum-free hepatitis A vaccine Hepatitis A Vaccine, Avaxim, is a vaccine against the Hepatitis A virus. The vaccine protects against the virus in more than 95% of cases and provides protection from the virus for ten years. on the market. The company has a broad development pipeline, with several Crucell products based on its unique PER.C6 production technology. The company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM 1. DSM - Data Structure Manager. An object-oriented language by J.E. Rumbaugh and M.E. Loomis of GE, similar to C++. It is used in implementation of CAD/CAE software. DSM is written in DSM and C and produces C as output. Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, Spain, Italy, Korea and the US. The company employs about 900 people. For more information, visit http://www.crucell.com or call 212/926-1733. |
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