Monthly Archives: September 2012

CAMBRIDGE, Mass. & BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the completion of patient enrollment in a phase III clinical trial of ADCETRIS (brentuximab vedotin) for post-transplant Hodgkin lymphoma (HL) patients. The phase III trial, also known as the AETHERA trial, is evaluating ADCETRIS versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.

We are pleased to complete the enrollment of this important phase III trial, evaluating the use of ADCETRIS for Hodgkin lymphoma patients who are at high risk of residual disease following an ASCT, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. The AETHERA trial is designed to provide the medical community with valuable insight into the potential for ADCETRIS to consolidate responses in Hodgkin lymphoma patients following a transplant, and will be the first data on the use of ADCETRIS in a maintenance-type setting. We anticipate data from this trial will be available in late 2013 or early 2014.

Completing enrollment of the AETHERA trial in the post-transplant Hodgkin lymphoma patient population at high risk for residual disease is a significant milestone for our ADCETRIS clinical development program, said Karen Ferrante, M.D., Chief Medical Officer, Millennium. We look forward to continuing to work with our partner Seattle Genetics to determine the potential benefit of this targeted treatment in other CD30-expressing tumors.

The AETHERA trial is a randomized, double-blind, placebo-controlled phase III study, comparing progression-free survival in 329 post-ASCT patients receiving ADCETRIS to those receiving placebo. Patients must be at high risk for residual HL, defined as those with a history of refractory HL, those who relapse or progress within one year from receiving front-line chemotherapy and/or those who have disease outside of the lymph nodes at the time of pre-ASCT relapse. Secondary endpoints of the trial include overall survival, safety and tolerability. Patients receive ADCETRIS every three weeks for up to approximately one year. This international multi-center trial is being conducted in the United States, Europe and Russia.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency (EMA) in June 2011. In July 2012, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for the conditional approval of ADCETRIS, supporting an approval decision in the European Union.

Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

More:
Seattle Genetics and Millennium Complete Enrollment in Phase III AETHERA Trial of ADCETRIS® for Post-Transplant ...

STOCKHOLM, September 24, 2012 /PRNewswire/ --

As our knowledge of genetics and genomics steadily expands and the potential applications of this understanding multiply, it becomes more and more urgent to address the societal implications of these developments. At a unique gathering in Stockholm on 9 December 2012, Nobel Laureates, prominent scientists, key policy makers and opinion leaders will review the current and future prospects for areas such as personalised medicine, genetically modified organisms and human evolution. With the theme of"The Genetic Revolution and its Impact on Society", this free public conference calledNobel Week Dialogue, will be devoted to reviewing the past 50 years of progress in genetics and genomics and looking towards current and future trends.

Key Topics and Participants

What have the last 50 years of progress in genetics taught us about what to expect in the future?

Can healthcare systems adapt to take advantage of the potential of personalized medicine?

How well do we understand how to manipulate gene expression and what are the consequences of this understanding?

These are some of the questions which will be discussed in a series of thought-provoking sessions and working groups. Participating Nobel Laureates include Bruce Beutler (2011), Steven Chu (1997), Joseph Goldstein (1985), Craig Mello (2006), Daniel McFadden (2000), Christiane Nsslein-Volhard (1995) and James Watson (1962). The 2012 Nobel Laureates will also be invited to attend.

Bruce Beutler, 2011 Nobel Laureate in Medicine says, "The information required to make a complex organism, such as a living person, resides within a few picograms of DNA in the nucleus of every cell. And much of what befalls us as individuals, for better or worse, is at least strongly influenced, if not foretold outright, by this subtle essence. A bit over 50 years ago, we began to understand how the information carried in DNA might be interpreted. Our understanding has grown quite sophisticated, and particularly in recent years, our ability to access DNA sequence has grown enormously. It is a good moment to count our gains, to explain them as best we can, and to consider what new barriers must be overcome."

Helga Nowotny, President of the European Research Council says, "The question before us is how to share the spectacular developments in the life sciences with wider society. Sharing is more than communicating. It means creating common ground that, even if contested, can also reassure and create trust. One often neglected instrument to achieve common ground is the law. It functions to stabilize relations between humans and their mutual expectations, although the objects to be mediated are biological entities or assemblages.I am glad to see that the upcoming event will provide an opportunity to discuss the social and legal issues around genetics."

Some of the experts include Mary-Claire King, President of the American Society of Human Genetics, Eric Lander, founder of the Broad Institute of Harvard and MIT, John Dupr, Director of the ESRC Centre for Genomics in Society and Janet Woodcock, Director of the Center for Drug Evaluation and Research at the Food and Drug Administration. For a complete list of participants, see: http://www.nobelweekdialogue.org/participants/

See the original post:
Nobel Laureates and Experts Gather to Discuss Genetics and Society

It was a summer trip Hobe Sounds Grant Casto wont likely soon forget.

Casto, 17, traveled to Nuremberg, Germany, in late June to present a research paper in the study of genetics. He participated in the European Human Genetics Conference, attending with his grandfather, Richard J. Crout, an associate dean of research and a professor of dentistry and medicine at West Virginia University schools of dentistry and medicine

Going to a different country and seeing all these people from different countries come together to share their work that they found on genetics, I learned a lot about different diseases and all these new genetic disorders theyre finding, said Casto. He meet students and instructors from several nations at the event.

During the conference, Casto presented a research paper on the effects of genetics on dental health, such as cavities. Casto, whose parents work in dental care, said growing up in a family of medical professionals helped to spark his interest in science and medicine.

Ive liked science ever since I was young, he said. My long-term goal is to be an endodontist like my dad.

This fall, Casto has shifted his concentration back to his studies as a junior at the Clark Advanced Learning Center, a public charter high school on Southeast Salerno Road in Stuart where he is a junior. He currently maintains 3.8 grade-point while taking an academic curriculum that concentrates on science and college-level courses at Indian River State College. Casto said he hopes to attend West Virginia University and enroll in dental school while also pursuing a Ph.D in genetics.

Besides his studies, he has performed in years past with a local youth symphony, playing various instruments. He also volunteers at the Boys and Girls Club of Martin County. Casto said that the volunteer work is part of program through his school in which students help to organize events for children at the club, including holiday activities.

(I enjoy) seeing the kids happy, he said of his volunteer experiences.

What are your hobbies?

Music. I like pets. I like to take care of them. I have a parakeet, a blue-tounged skink, a leopard geck.

Continued here:
Love of science lifts Hobe Sound teen to genetics conference in Germany