The Buccaneers signed Eric LeGrand on May 2. LeGrand's return to the field in October was voted by Sports Illustrated readers as the Best Moment of 2011.

AP

"I want to make sure Eric is a part of what we do, somehow. Eric's always going to be a part of my life." -- Tampa Bay coach Greg Schiano to me, upon being named coach of the Bucs in January, about the fate of Eric LeGrand, the former Rutgers defensive tackle who suffered a spinal-cord injury in a 2010 game.

When Greg Schiano told his kids they'd be moving to Florida, because he was going to become the coach of the NFL team in Tampa, one of them said: "What about Eric?''

What about Eric. It's something Schiano has been thinking about since the day LeGrand made a hard tackle against Army at the Meadowlands -- Oct. 16, 2010 -- and didn't get up. He broke two vertebrae and suffered a serious spinal cord injury, and his football career was over. Life would be challenging enough, never mind thinking about football.

LeGrand and Schiano got closer after the injury. A lot closer. "He was my coach before,'' LeGrand told me Sunday. "Now he's part of my family.''

How'd that happen?

"After I had the accident,'' LeGrand said, "I was laying in my hospital bed. My mom was with me every day. But she needed some relief at night, so about 11 o'clock, every other night, coach Schiano came into the room. I was so scared I couldn't sleep most of the time. But I'd look over and there he'd be. He'd talk to me, about everything. And if I'd doze off, I'd wake up and there he'd be, with his computer in his lap, doing the work he was supposed to be doing but he was seeing me instead. That happened every other night. We got close. He became a lot more than a coach to me.''

As LeGrand rehabbed and put the pieces of his life back together, he still thought about football. And he thought of it this spring. Had his career not been ended in the middle of his junior season, there's a chance he would have been picked on day two or three of this year's draft. LeGrand doesn't give in to pity much, but when he was watching the draft on TV late last month, he said at one point, "That could have been me.''

And so last Tuesday, when Schiano called to tell him something, football was still on LeGrand's mind. According to LeGrand, Schiano told him, "I want to offer you a contract. I want you to be our 90th man.''

Continue reading here:
Peter King: Schiano, Bucs honor LeGrand's perseverance with contract; mail

Recommendation and review posted by sam

DUBLIN--(BUSINESS WIRE)--

Dublin - Research and Markets (http://www.researchandmarkets.com/research/bx4hvt/acute_spinal_cord) has announced the addition of Global Markets Direct's new report "Acute Spinal Cord Injury - Pipeline Review, H1 2012" to their offering.

Global Markets Direct's, 'Acute Spinal Cord Injury - Pipeline Review, H1 2012', provides an overview of the Acute Spinal Cord Injury therapeutic pipeline. This report provides information on the therapeutic development for Acute Spinal Cord Injury, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Acute Spinal Cord Injury. 'Acute Spinal Cord Injury - Pipeline Review, H1 2012' is built using data and information sourced from Global Markets Direct's proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct's team.

Scope:

- A snapshot of the global therapeutic scenario for Acute Spinal Cord Injury.

- A review of the Acute Spinal Cord Injury products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.

- Coverage of products based on various stages of development ranging from discovery till registration stages.

- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.

- Coverage of the Acute Spinal Cord Injury pipeline on the basis of route of administration and molecule type.

- Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.

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Research and Markets: Acute Spinal Cord Injury - Pipeline Review, H1 2012

Recommendation and review posted by sam

Source: ISNA, Tehran

Iranian researchers managed to design and build a machine which helps the patients suffering Spinal Cord Injury (SCI) increase their movement abilities.

An Iranian faculty member of the University of Social Welfare and Rehabilitation Science, Amir Massoud Arab told ISNA that there is no treatment for the trauma and that rehabilitation plays a significant role in helping the patients to return to their previous condition to some extent.

Arab noted Functional Electrical Stimulation-Assisted Rowing Machine has been made inside the country by Iranian experts and would increase the movement activities of SCI sufferer. It aims to functionalize the rehabilitation objectives.

A Spinal Cord Injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease. Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.

Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.

Arab noted patients' lack of movements as well as their dependence on wheelchair is considered to be of major threats for the SCI sufferers and the designed machine would decrease their dependency and let them have more activities.

He said the advantages of rowing exercise comparing to other ones is that upper limbs would be involved in movement as well as the lower limbs which would help the operation of the patients' heart, adding the machine has been tested on a number of patients and the results were satisfying.

Iranian lecturer pointed out the machine possesses a fly wheel which is equipped with magnetic brakes with 9 resistance level, adding there is a chair equipped with a dorsal so that the patient do not have any problem while sitting on it.

Originally posted here:
Iran builds machine to help SCI patients' movements

Recommendation and review posted by sam

NEWARK, Calif., May 9, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced that Armin Curt, MD, FRCPC, Professor and Chairman, Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the Balgrist University Hospital and principal investigator for the Company's Phase I/II clinical trial in chronic spinal cord injury, will provide a progress report on the trial on Thursday, May 17 at the Interdependence 2012 Global SCI Conference. Interdependence 2012, which is being held in Vancouver, British Columbia on May 15-17, 2012, is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.

In addition, on Thursday, May 17, Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc., will make a presentation on neural stem cell transplantation in neurological disorders. Dr. Huhn will describe the scientific and preclinical rationale for the Company's extensive clinical development program which encompasses all three elements of the central nervous system -- spinal cord, brain, and eye. StemCells was the first company to receive authorizations from the US Food and Drug Administration and Swissmedic to conduct clinical trials to evaluate purified human neural stem cells as potential therapeutic agents.

The goal of Interdependence 2012 is to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research.

About the Spinal Cord Injury Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.

The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. For information on patient enrollment, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at stemcells.pz@balgrist.ch.

Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.

About Balgrist University Hospital

Balgrist University Hospital, University of Zurich is recognized worldwide as a highly specialized center of excellence providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions. The clinic owes its leading international reputation to its unique combination of specialized medical services. The hospital's carefully-balanced, interdisciplinary network brings together under one roof medical specialties including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology, and physical medicine. More information about Balgrist University Hospital is available at http://www.balgrist.ch.

Continued here:
StemCells, Inc. to Provide Progress Report on Spinal Cord Injury Trial at the Interdependence 2012 Global SCI ...

Recommendation and review posted by sam

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB:ACTC), a leader in the field of regenerative medicine, announced today first quarter financial results for the period ended March 31, 2012. The Company reported a loss from operations of $(5.4) million compared to a loss from operations of $(4.8) million in the 2011 first quarter.ACTreported a net loss of $(5.7) million or $(0.00) per share, compared to a loss in the same period in 2011 of $(3.3) million, or $(0.00) per share.

Net cash used in operations for the 2011 first quarter was $4.8 million, compared to net cash used in operations of $3.4 million in the same period in 2011. The Company ended the 2012 first quarter with cash and cash equivalents of $10.8 million, compared to $13.1 million as of December 31, 2011.

Highlights from the first quarter of 2012 included:

We are very pleased with our progress in the clinic so far, said Chairman and CEO Gary Rabin. We are encouraged by the results we have seen from the early patients treated in each of our indications, and look forward to completing the trials on schedule.

Conference call and Webcast

The Company will hold a conference call tomorrow at 9 a.m. eastern time to discuss the first quarter results and business outlook. Interested parties may access the call live by dialing (888) 264-3177 and using conference ID 72827188. This event will be streamed via webcast. The webcast will be available at http://us.meeting-stream.com/advancedcelltechnology050912. A replay of the call will also be available via the same link.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visitwww.advancedcell.com.

Forward-Looking Statements

See original here:
Advanced Cell Technology Announces 2012 First Quarter Results

Recommendation and review posted by sam

Newswise Timothy Cripe, MD, PhD, chief of Hematology/Oncology/Bone Marrow Transplantation at Nationwide Childrens Hospital, was recently appointed a member of the Cellular, Tissue and Gene Therapy Advisory Committee which reports to the Food and Drug Administration (FDA).

This committee provides guidance to the FDA in approving novel cellular, tissue and gene therapy therapeutics and devices. In recent years, the committee reviewed applications for the new cancer immunotherapy Sipuleucel-T (Provenge) and the first licensed cord blood product, HEMACORD. The committee is also charged with reviewing applications that use embryonic stem cells or other cellular therapies.

Such committees of the FDA are established to provide functions which support its mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act. The FDA has 32 Advisory Committees across all Centers which are subject to renewal at two-year intervals unless the committee charter states otherwise. They are advisory in nature with the FDA making final decisions.

Dr. Cripe recently came to Nationwide Childrens from Cincinnati Childrens Hospital Medical Center where he served as medical co-director in Clinical and Translational Research and was the founding director of the Comprehensive Musculoskeletal Tumor Program. During his stint at Cincinnati, he was a professor of Pediatrics and Director of Pilot and Collaborative Studies in the Center for Clinical and Translational Science and Training.

His clinical interests include gene and viral therapies for solid tumors in children, including brain tumors, neuroblastoma and bone and soft tissue sarcomas. Dr. Cripes current research focuses on developing and testing new, targeted therapies for pediatric solid tumors and translating those findings into clinical studies. He also investigates the use of viruses that selectively infect and kill cancer cells, studies their utility for killing cancer stem cells, and was among the first in the country to launch clinical trials of attenuated viruses in children.

Dr. Cripe is a magna cum laude graduate of Princeton University and completed his MD, PhD in genetics and pediatric residency training at the University of Iowa. He was a fellow in pediatric hematology/oncology at the Childrens Hospital and the Dana-Farber Cancer Institute in Boston, and at the Childrens Hospital and University of Colorado Health Sciences Center in Denver.

Following his subspecialty training, he was an assistant professor of Pediatrics at the University of Wisconsin Childrens Hospital and Comprehensive Cancer Center in Madison and was the pediatric medical director of the UW/American Red Cross Hemophilia Treatment Center.

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Dr. Timothy Cripe of Nationwide Children's Hospital Appointed to a Committee of the Food and Drug Administration

Recommendation and review posted by Bethany Smith

ALBANY, N.Y. (AP) -- Almost halfway through a $600 million state program supporting stem cell research, eight medical schools around New York are reporting progress on projects such as replicating liver cells and eradicating leukemia cells.

A new report from Associated Medical Schools of New York updates work at the institutions where hundreds of researchers are starting to unravel causes and potential treatments for conditions ranging from autism to heart disease and cancer. Stem cells are self-renewing and have the ability to develop into other types of cells.

The Mount Sinai School of Medicine reported finding a method to transform human skin cells into stem cells and turned differentiated human stem cells into heart cells. Those findings are expected to result in better understanding of how heart disease develops and allow initial testing of new treatments on stem cells before they are used on human subjects.

Dr. Ihor Lemischka, director of the Black Family Stem Cell Institute at Mount Sinai, said recreating heart cells in a dish from a patient with LEOPARD Syndrome, a disease caused by a genetic mutation, has opened ongoing avenues for researching the disease and screening potential drugs.

"It was a major achievement," Lemischka said. The initial work was reported in June 2010 in the journal Nature.

The shared research facility at Mount Sinai supports the work at 80 different labs, Lemischka said.

The Empire State Stem Cell Program was intended to fund projects in early stages, including those that initially have been unable to get federal or private funding. Grants have also been used for capital projects like renovating labs and establishing new stem cell centers.

The Albert Einstein College of Medicine reported replicating liver cells that could help reduce the need for liver transplants using live donors and cadavers.

Dr. Allen Spiegel said 12 new researchers have been hired with state funding at the Bronx school, which also lists anemia, brain disorders, heart disease and obesity among its stem cell research subjects.

"It offers tremendous potential for understanding the causes of and developing better treatments for diseases like cancer, type 1 diabetes and Parkinson's," he said.

Excerpt from:
NY medical schools chart progress with stem cells

Recommendation and review posted by Bethany Smith

LEUVEN, BELGIUM--(Marketwire -05/08/12)- TiGenix (TIG), a leader in the field of cell therapy, announced today that during the months of May and June the company will present at a number of key events in Europe and the U.S. geared at investor, industry, and academic audiences to highlight the commercial potential of ChondroCelect, the only approved cell therapy in Europe, and of the company's innovative proprietary allogeneic stem cell platform with programs in Phase I, II, and III for a range of inflammatory and autoimmune diseases.

May 15-16 BioEquity, Marriott Hotel, Frankfurt, Germany Presenter: Eduardo Bravo, CEO Date & time: Tuesday, May 15, 16:00-16:25 Room: Level 1, Room Gold 1

May 21-23 World Stem Cells and Regenerative Medicine Congress, Victoria Park Plaza, London, UK Presenter: Eduardo Bravo, CEO Date & time: Monday, May 21, 15:25 -15:50 Title: Cell Therapy & Regenerative Medicine - Progressing into phase III with an orphan indication

May 24 Knowledge for Growth, ICC Ghent, Belgium Presenter: Eduardo Bravo, CEO Time: 11:30 Keynote speech - Advanced therapies: this time it is for real

June 5-8 18th International Stem Cell Therapy Sociey Annual Meeting, Sheraton Seattle, WA, U.S. Presenter: Eduardo Bravo, CEO Date & time: June 7, 13:45-15:15 Title: Plenary Session 4 - Regenerative Medicine and Positioning for Commercial Success - Lessons from the commercial roll out of ChondroCelect in Europe

June 18-21 BIO International Convention, Boston Convention & Exhibition Center, MA, U.S. Presenter: Eduardo Bravo, CEO Date & time: June 20, 15:00-15:45 Title: Stem Cell Therapies...Fact or Fiction?

June 23 VFB Biotech Congres, Leuven, Belgium Location: Imec, Kapeldreef 75, Leuven Presenter: Gil Beyen, Chief Business Officer Time: 11am

June 23 Dag van de Biotechnologie, Leuven, Belgium Location: TiGenix headquarters, Leuven Event: Open day event throughout Flanders for all biotech companies & academic labs Time: 10am-5pm

About TiGenixTiGenix NV (TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit http://www.tigenix.com.

Forward-looking information This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

Continued here:
TiGenix : Presenting at Key Conferences - Spring 2012

Recommendation and review posted by Bethany Smith

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, reports the Chairman of its associate company, SG Austria, Dr. Walter Gunzburg, participated in multiple private meetings with leading Japanese biotech and pharmaceutical companies following the recent Annual Meeting of the Organisation for Oncology and Translational Research (OOTR), where he was a invited guest speaker.

The meetings took place immediately after his recent bench to bedside presentation of data from the clinical trials for the treatment of solid tumors using the companys cutting-edge living cell encapsulation technology. Nuvilex and SG Austria have been actively working to advance the value and use of the live cell encapsulation technology throughout North America and Europe, and are encouraged by the positive response in the Asia-Pacific Rim. Drs. Gunzburg and Salmons have been increasing the number of companies that know about this cutting-edge live cell encapsulation technology and their efforts have been paying off in terms of invitations for in-depth company meetings.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, Japan is well known as an important producer and consumer of advanced medical products and were excited to report there was keen interest in the use of live cell encapsulation. In addition, we are noting the living cell encapsulation technology is proving to be of great interest to a number of biotech companies developing cell therapies for the treatment of a wide variety of diseases.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Through substantial effort, aspects of our corporate activities alone and in concert with SG Austria are nearing completion, ultimately providing for a strong future together. Our companys clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.

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Nuvilex Announces Excitement Grows in Japan over Encapsulated Living Cell Technology Oncological Applications

Recommendation and review posted by Bethany Smith

07-05-2012 10:59 Here it is. The First Trailer for the Scientific Thriller Errors of The Human Body. Currently still seeking funds for post production through crowdfunding at

See the rest here:
Errors of The Human Body - Official Trailer - Video

Recommendation and review posted by Bethany Smith

07-05-2012 15:13 Dorothy Roberts, Professor at Northwestern University, discusses how emerging biotechnologies are reconfiguring, reforming and revising notions of race in potentially dangerous ways at the 2010 Tarrytown Meeting. The Tarrytown Meetings bring together people working to ensure that human biotechnologies and related emerging technologies support rather than undermine social justice, equality, human rights, ecological integrity and the common good. Find out more about the Tarrytown Meetings here: To find more videos, check out the Tarrytown Youtube channel: Presentation Excerpt: The expansion of genetic research and technologies has helped us cross a threshold into a new type of biopolitics concerned with our capacity to control and manipulate human life. As British sociologist Nicholas Rose has shown, so-called biological citizenship is grounded in the unprecedented authority wielded by individuals over their well-being at the molecular level. According to Rose, "our very biological life itself has entered the domain of decision and choice." Biological citizenship entails both individuals' autonomy over personal welfare and a biosociality that links people together around their common genetic traits. Genetic information enables individuals not only to manage their own health, but also to unite with others around their common health conditions, as revealed by DNA testing. Rose and others celebrate biocitizenship because it enhances ...

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Dorothy Roberts: Race and the New Biocitizen- Tarrytown 2010 - Video

Recommendation and review posted by Bethany Smith

07-05-2012 15:22 High-throughput technology and the data it generates is evolving and advancing basic science into clinical science and personalized medicine. But while currently available methods exist to rapidly and efficiently produce DNA, epigenetic, and RNA whole-genome profiles from individual tissue samples and cell lines, data analysis and deconvolution remain challenging. To address this issue, methods of knowledge-based functional analysis such as ontology enrichment, interactome, and causal networks have been developed. These analyses rely on databases designed to accommodate complex aspects of mammalian functionality, for example, coordinated expression of multiple genes to effect a single function, RNA splice variants, or protein isoforms. Webinar participants will discuss knowledge-based analytical methods, and how they can be used for functional analysis of OMICs datasets by cheminformatics and bioinformatics software tools such as network-generation algorithms, ontology enrichment, interactome calculations, and pathway modeling. The application of these analytical methods to advances in understanding breast tumor heterogeneity and the potential development of a targeted therapy based on this knowledge will also be discussed.

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Advancing Genomics into Personalized Medicine - Video

Recommendation and review posted by Bethany Smith

Public release date: 7-May-2012 [ | E-mail | Share ]

Contact: Emily Ng eng3@nshs.edu 516-562-2670 North Shore-Long Island Jewish (LIJ) Health System

Antipsychotic medications are increasingly prescribed in the US, but they can cause serious side effects including rapid weight gain, especially in children. In the first study of its kind, researchers at Zucker Hillside Hospital and the Feinstein Institute for Medical Research identified a gene that increases weight gain in those treated with commonly-used antipsychotic drugs. These findings were published in the May issue of Archives of General Psychiatry.

Second-generation antipsychotics (SGAs) were used as the treatment in this study. SGAs are commonly used to treat many psychotic and nonpsychotic disorders. However, it is important to note that these SGAs are associated with substantial weight gain, including the development of obesity and other cardiovascular risk factors. The weight gain side effect of SGAs is significant because it often results in a reduced life expectancy of up to 30 years in those who suffer from chronic and severe mental illnesses. The weight gain also prompts some to stop taking the medication, adversely impacting their quality of life.

In this genome-wide association study (GWAS), researchers first evaluated a group of pediatric patients in the US being treated for the first time with antipsychotics. They then replicated the result in three independent groups of patients who were in psychiatric hospitals in the United States and Germany or participating in European antipsychotic drug trials. The gene that was identified to increase weight gain, MC4R or melanocortin 4 receptor, has been previously identified as being linked to obesity and type 2 diabetes. In the new study, it was found that patients gained up to 20 pounds when on treatment.

"This study offers the prospect of being able to identify individuals who are at greatest risk for severe weight gain following antipsychotic treatment," said Anil Malhotra, MD, investigator at the Zucker Hillside Hospital Department of Psychiatry Research and Feinstein Institute for Medical Research. "We hope that those who are at risk could receive more intensive or alternative treatment that would reduce the potential for weight gain and we are currently conducting studies to identify such treatment."

Additional Details About the Study

Researchers conducted the first GWAS of SGA-induced weight gain in patients carefully monitored for medication adherence who were undergoing initial treatment with SGAs. To confirm results, they next assessed three independent replication cohorts: 1) a cohort of adult subjects undergoing their first treatment with a single SGA (clozapine), 2) a cohort of adult subjects treated with the same SGAs as in our discovery sample, and 3) a cohort of adult subjects in the first episode of schizophrenia and enrolled in a randomized clinical trial of antipsychotic drugs.

The discovery cohort consisted of 139 pediatric patients undergoing first exposure to SGAs. The 3 additional cohorts consisted of 73, 40, and 92 subjects. Patients in the discovery cohort were treated with SGAs for 12 weeks. Additional cohorts were treated for 6 and 12 weeks.

This GWAS yielded 20 single-nucleotide polymorphisms at a single locus exceeding a statistical threshold of P10-5. This locus, near the melanocortin 4 receptor (MC4R) gene, overlaps a region previously identified by large-scale GWAS of obesity in the general population. Effects were recessive, with minor allele homozygotes gaining extreme amounts of weight during the 12-week trial. These results were replicated in 3 additional cohorts, with rs489693 demonstrating consistent recessive effects; meta-analysis revealed a genome-wide significant effect. Moreover, consistent effects on related metabolic indices, including triglyceride, leptin, and insulin levels were observed.

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Researchers discover gene that leads to severe weight gain with antipsychotic treatment

Recommendation and review posted by Bethany Smith

ScienceDaily (May 7, 2012) Antipsychotic medications are increasingly prescribed in the US, but they can cause serious side effects including rapid weight gain, especially in children. In the first study of its kind, researchers at Zucker Hillside Hospital and the Feinstein Institute for Medical Research identified a gene that increases weight gain in those treated with commonly-used antipsychotic drugs.

These findings were published in the May issue of Archives of General Psychiatry.

Second-generation antipsychotics (SGAs) were used as the treatment in this study. SGAs are commonly used to treat many psychotic and nonpsychotic disorders. However, it is important to note that these SGAs are associated with substantial weight gain, including the development of obesity and other cardiovascular risk factors. The weight gain side effect of SGAs is significant because it often results in a reduced life expectancy of up to 30 years in those who suffer from chronic and severe mental illnesses. The weight gain also prompts some to stop taking the medication, adversely impacting their quality of life.

In this genome-wide association study (GWAS), researchers first evaluated a group of pediatric patients in the US being treated for the first time with antipsychotics. They then replicated the result in three independent groups of patients who were in psychiatric hospitals in the United States and Germany or participating in European antipsychotic drug trials. The gene that was identified to increase weight gain, MC4R or melanocortin 4 receptor, has been previously identified as being linked to obesity and type 2 diabetes. In the new study, it was found that patients gained up to 20 pounds when on treatment.

"This study offers the prospect of being able to identify individuals who are at greatest risk for severe weight gain following antipsychotic treatment," said Anil Malhotra, MD, investigator at the Zucker Hillside Hospital Department of Psychiatry Research and Feinstein Institute for Medical Research. "We hope that those who are at risk could receive more intensive or alternative treatment that would reduce the potential for weight gain and we are currently conducting studies to identify such treatment."

Additional Details About the Study

Researchers conducted the first GWAS of SGA-induced weight gain in patients carefully monitored for medication adherence who were undergoing initial treatment with SGAs. To confirm results, they next assessed three independent replication cohorts: 1) a cohort of adult subjects undergoing their first treatment with a single SGA (clozapine), 2) a cohort of adult subjects treated with the same SGAs as in our discovery sample, and 3) a cohort of adult subjects in the first episode of schizophrenia and enrolled in a randomized clinical trial of antipsychotic drugs. The discovery cohort consisted of 139 pediatric patients undergoing first exposure to SGAs. The 3 additional cohorts consisted of 73, 40, and 92 subjects. Patients in the discovery cohort were treated with SGAs for 12 weeks. Additional cohorts were treated for 6 and 12 weeks.

This GWAS yielded 20 single-nucleotide polymorphisms at a single locus exceeding a statistical threshold of P10-5. This locus, near the melanocortin 4 receptor (MC4R) gene, overlaps a region previously identified by large-scale GWAS of obesity in the general population. Effects were recessive, with minor allele homozygotes gaining extreme amounts of weight during the 12-week trial. These results were replicated in 3 additional cohorts, with rs489693 demonstrating consistent recessive effects; meta-analysis revealed a genome-wide significant effect. Moreover, consistent effects on related metabolic indices, including triglyceride, leptin, and insulin levels were observed.

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Continue reading here:
Gene that leads to severe weight gain with antipsychotic treatment discovered

Recommendation and review posted by Bethany Smith

$19 million collaboration fuelling groundbreaking discoveries

TORONTO, May 7, 2012 /CNW/ - Lawrence Tanenbaum, O.C., along with his wife Judy Tanenbaum, today joined the Honourable Brad Duguid Minister of Economic Development and Innovation, renowned researcher Dr. Jim Kennedy and Dr. Catherine Zahn, President and CEO, CAMH, to announce a $19 million collaboration and open the Tanenbaum Centre for Pharmacogenetics at the Centre for Addiction and Mental Health (CAMH).

This centre, a collaboration between Larry Tanenbaum, the Ontario Government and CAMH, has been established to support the groundbreaking research in the DNA laboratory of Dr. Kennedy and the clinic of Dr. Daniel Mueller to accelerate the time it takes to get genetic information to physicians and patients across Ontario. The Centre will be part of the Campbell Family Mental Health Research Institute at CAMH's College Street location.

"Pharmacogenetics" is an aspect of personalized medicine research that aims to help doctors understand in advance which individuals carry a genetic risk for serious side-effects from specific drugs. Genetic testing will also be helpful in determining who is more likely to respond to a given medication and if dose adjustments need to be considered. Similar work is being done in cancer and pain management, but CAMH is one of the world leaders in psychiatric applications of this research.

"Mistakes in drug treatment can result in devastating, even tragic side-effects. Still, inaccurate predictions of treatment for depression happen in about 30 per cent of cases and 11 per cent of all mental health patients are at serious genetic risk of suffering from inappropriate dosages of medication. The size of the problem is staggering, but the research in gene science that Dr. Kennedy and his team are doing can - and will - change that," said Mr. Tanenbaum, Chairman and CEO of the Kilmer Group, Chair of the Board, Maple Leaf Sports and Entertainment, and Governor of the NHL, NBA and Major League Soccer.

"We are honoured to be part of this collaboration because it holds the promise that one day soon drugs will be adapted to each person's genetic make-up. The faster these discoveries can get out of the lab, the sooner more effective and safe therapies will become available - changing and saving lives."

"Ontario's ongoing commitment to world-class research is one reason the province is home to more than 500 top neuroscientists," said Minister of Economic Development and Innovation Brad Duguid. "Our support of the new Tanenbaum Centre for Pharmacogenetics promises to improve medical care and quality of life for psychiatric patients and their families, save our health care system millions of dollars, while creating good jobs."

Most recently, Dr. Kennedy's lab has identified a new genetic risk factor for serious weight gain, a side-effect for 40 per cent of schizophrenia patients who receive a commonly used group of anti-psychotic drugs. Understanding in advance which individuals carry this genetic risk would help doctors know when to prescribe different drugs.

Along with establishing the Centre, the investment will move this and other genetic tests into medical practice through "lab-on-a-chip" technology currently in development. Clinical delivery of these tests is already available for CAMH patients, and extension to GTA-area physicians is expected to begin in 2014. Furthermore, the biotechnology development initiative within this program will create an increasing number of knowledge-based jobs in Ontario as the core genetics research expands.

For Dr. Kennedy, this investment sets in motion the potential to revolutionize psychiatry by scaling up testing and fueling the drive to find new genetic tests: "If we could prevent serious side effects such as movement disorders, sleep disturbance and increased risk of cardiovascular disease, I truly believe more people in need would stay on their medication and derive the long-term benefits of better mental health, living longer more productive and fuller lives with their families."

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New Tanenbaum Centre for Pharmacogenetics to accelerate gene-based personalized medicine in psychiatry

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Bangalore, May 8 : In technologically advanced world, there are numerous research and developments that take place to improve not only the standard of living but also to give a normal living.

One such development in the health field is the gene technology. With the advancement of this therapy, a patient is treated by its own cells, DNA, skin graft to cure the problem of the person.

Addressing a press conference here, Dr Sunita Agarwal, Medical Director, Gene Research Foundation, presented a case of city boy Naren (name changed) who was born dumb, deaf and blind from childhood due to genetic disorder.

Naren was diagnosed with the Usher's syndrome, a cognital error where he had no vision and was hearing and speech impaired. He underwent a surgery, Autologous Retinal Transplant, based on the concept of gene therapy.

The BCA graduate, however, after the therapy of three long years, has managed to get back his vision. "Since its a genetic disorder, the vision is never going to be normal like we all possess but through this therapy, we are atempting to give him a better clear vision if not in its entirety," said Dr Agarwal said.

The gene therapy is claimed to be one of its kind and it is said to be a breakthrough solution for the future of the medicinal world.

"Through this technology, diseases like blindness, diabetes, cancer, arthritis can be appreciably better within ten days of injection course," she added. (UNI)

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Gene technology: A new breakthrough research

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The Californian Right to Know campaign in support of labeling foods and ingredients produced using genetic engineering looks set for inclusion in the states November ballot, after it attracted nearly a million signatures. If enacted, what would the proposed law mean for food manufacturers?

The state has up to seven weeks to validate the 971,126 signatures. If they are validated, and voters approve the measure in November, food manufacturers could be required to label genetically modified (GM) foods and ingredients sold in California from July 1, 2014.

The California Right to Know Genetically Engineered Food Act would require such foods to be labeled in a clear and conspicuous manner, whether raw agricultural commodities or processed foods.

The bill reads that a food would deemed to be misbranded unless labeled: In the case of any processed food, in clear and conspicuous language on the front or back of the package of such food, with the words Partially Produced with Genetic Engineering or May be Partially Produced with Genetic Engineering

GMOs deemed unnatural

In addition, food labeled as natural would be deemed misbranded under the legislation if it contained genetically modified ingredients, in line with the precept of a swathe of lawsuits that have been brought against food companies in California. Currently the US Food and Drug Administration has no definition of the word natural.

The proposed legislation contains a number of exceptions, including allowances for unintentional presence of GM ingredients, and meat or milk from animals that may have eaten feed produced using genetic engineering. These would be exempt from labeling under the proposal, as is the case in European law.

Until July 2019, food products would also be exempt from labeling if a GM ingredient accounts for less than 0.5% of the foods total weight, and foods could contain up to ten such ingredients.

Industry opposition

Several major industry organizations and trade groups have set up a campaign opposing the proposition, including the California Retailers Association, Grocery Manufacturers Association, American Beverage Association, and California League of Food Processors, among others . Calling the coalition Californians Against the Costly Food Labeling Proposition, they claim that labeling GM foods and ingredients could increase food prices and mislead consumers into thinking their foods are unsafe.

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Californian GMO labeling: What would it mean for food companies?

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07-05-2012 12:34 Autism, just like any chronic health condition, is the result of genetic predispositions interacting with modifiable environmental factors. The key is to identify the contributing factors in each case. Some of the common factors include nutrient insufficiencies, toxin exposure, food allergies, intestinal yeast overgrowth, infections, and more. New functional medicine laboratory tests help to tailor the treatment in each case of autistic spectrum disorder. Personalized treatment based on this type of evaluation helps many patients with autism improve to varying degrees, sometimes a great deal. By Dr. Joseph Debé, Board Certified Nutritionist • • (516) 829-1515 Register for upcoming webinars at

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Autism - A Functional Medicine Approach to Treatment- a webinar presented on 12-15-2010 - Video

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ScienceDaily (May 7, 2012) The cells that slough off from a cancerous tumor into the bloodstream are a genetically diverse bunch, Stanford University School of Medicine researchers have found. Some have genes turned on that give them the potential to lodge themselves in new places, helping a cancer spread between organs. Others have completely different patterns of gene expression and might be more benign, or less likely to survive in a new tissue. Some cells may even express genes that could predict their response to a specific therapy. Even within one patient, the tumor cells that make it into circulating blood vary drastically.

The finding underscores how multiple types of treatment may be required to cure what appears outwardly as a single type of cancer, the researchers say. And it hints that the current cell-line models of human cancers, which showed patterns that differed from the tumor cells shed from human patients, need to be improved upon.

The new study, published May 7 in PLoS ONE, is the first to look at so-called circulating tumor cells one by one, rather than taking the average of many of the cells. And it's the first to show the extent of the genetic differences between such cells.

"Within a single blood draw from a single patient, we're seeing heterogeneous populations of circulating tumor cells," said senior study author Stefanie Jeffrey, MD, professor of surgery and chief of surgical oncology research.

For over a century, scientists have known that circulating tumor cells, or CTCs, are shed from tumors and move through the bloodstreams of cancer patients. And over the past five years, there's been a growing sense among many cancer researchers that these cells -- accessible by a quick blood draw -- could be the key to tracking tumors non-invasively. But separating CTCs from blood cells is hard; there can be as few as one or two CTCs in every milliliter of a person's blood, mixed among billions of other blood cells.

To make their latest discovery, Jeffrey, along with an interdisciplinary team of engineers, quantitative biologists, genome scientists and clinicians, relied on a technology they developed in 2008. Called the MagSweeper, it's a device that lets them isolate live CTCs with very high purity from patient blood samples, based on the presence of a particular protein -- EpCAM -- that's on the surface of cancer cells but not healthy blood cells.

With the goal of studying CTCs from breast cancer patients, the team first tested whether they could accurately detect the expression levels of 95 different genes in single cells from seven different cell-line models of breast cancer -- a proof of principle since they already knew the genetics of these tumors. These included four cell lines generally used by breast cancer researchers and pharmaceutical scientists worldwide and three cell lines specially generated from patients' primary tumors.

"Most researchers look at just a few genes or proteins at a time in CTCs, usually by adding fluorescent antibodies to their samples consisting of many cells," said Jeffrey. "We wanted to measure the expression of 95 genes at once and didn't want to pool our cells together, so that we could detect differences between individual tumor cells."

So once Jeffrey and her collaborators isolated CTCs using the MagSweeper, they turned to a different kind of technology: real-time PCR microfluidic chips, invented by a Stanford collaborator, Stephen Quake, PhD, professor of bioengineering. They purified genetic material from each CTC and used the high-throughput technology to measure the levels of all 95 genes at once. The results on the cell-line-derived cells were a success; the genes in the CTCs reflected the known properties of the cell-line models. So the team moved on to testing the 95 genes in CTCs from 50 human breast cancer patients -- 30 with cancer that had spread to other organs, 20 with only primary breast tumors.

"In the patients, we ended up with a subset of 31 genes that were most dominantly expressed," said Jeffrey. "And by looking at levels of those genes, we could see at least two distinct groups of circulating tumors cells." Depending on which genes they used to divide the CTCs into groups, there were as many as five groups, she said, each with different combinations of genes turned on and off. And if they'd chosen genes other than the 95 they'd picked, they likely would have seen different patterns of grouping. However, because the same individual CTCs tended to group together in multiple different analyses, these cells likely represent different types of spreading cancer cells.

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Not all tumor cells are equal: Huge genetic diversity found in cells shed by tumors

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Michael Pacanowski, PharmD, MPH; Shashi Amur, PhD; Issam Zineh, PharmD, MPH Author Affiliations: Genomics Group, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

Treatment of chronic hepatitis C (CHC) is a prototype for personalized medicine. Combination therapy with peginterferon alfa plus ribavirin was the standard of care for more than a decade. Greater understanding of the disease and determinants of treatment response have improved sustained virologic response (SVR) rates from less than 10% with interferon alfa in the 1990s to more than 80% with contemporary triple therapy regimens that include direct acting antivirals (DAAs) (Figure). Patient-specific factors such as viral genotype and early on-treatment responses are considered in therapeutic individualization. New approaches to search the human genome for predictors of drug response led to the discovery that single-nucleotide polymorphisms (SNPs) near the host IL28B gene are among the strongest predictors of response to peginterferon alfa and ribavirin. This Viewpoint discusses the evolution of CHC pharmacogenetics, its real-time incorporation into recent regulatory science evaluations, and its application in future drug development.

cDNA indicates complementary

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New Genetic Discoveries and Treatment for Hepatitis C [Viewpoint]

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Dell:

WHAT The team of parents, genetic and translational medicine scientists and pediatric oncologists trailblazing personalized medicine in the treatment of deadly pediatric cancers is convening in Austin to discuss the status of the worlds first personalized medicine clinical trial for pediatric cancer and plan next steps at the NMTRC Symposium 2012. Neuroblastoma affects 1 in 100,000 children and is responsible for 1 in 7 pediatric cancer deaths.

WHO Parents, advocates, oncologists from the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) and biomedical researchers from the Translational Genomics Research Institute (TGen), who are using high performance computing and cloud technology from Dell to identify targeted treatments based on the specific genetic vulnerabilities of each childs tumoran approach that could be used to treat all pediatric and adult cancers in the future.

WHY Personalized medicinetreatment based on the specific vulnerabilities of each tumor is overcoming longstanding barriers to treatment of pediatric cancer. There has been only one new treatment for pediatric cancer approved by the FDA since the 1980s, compared to 50 treatments approved for adult cancer in this same timeframe. As a result, pediatric oncologists use treatments designed for adults to treat children, with toxic side effects that are frequently as physically detrimental to the child as the cancer itself.

WHEN The following events will be available via live-stream: May 16 1-2 pm CT: Keynote: Molecular-Profiling for Optimized Precision Therapy, Dr. Timothy Triche, University of Southern California/ Childrens Hospital Los Angeles

2-4 pm CT: Panel Discussion: Kids Cloud: Access to Data Boundaries Dr. Melinda Merchant - National Cancer Institute Dr. Gary Marchant - Arizona State University Nancy Goodman - Kids V. Cancer Foundation Patrick Lacey - Friends of Will Foundation Andy Mikulak - Maxs Ring of Fire Foundation Dr. Giselle Sholler - Van Andel Institute Dr. Spyro Mousses - Translational Genomics Research Institute Dr. James Coffin - Dell

WHERE Participate and join the conversation via the #HealthCloud hashtag on Twitter. Tune in via Live-Stream here: http://www.fittotweet.com/live/nmtrc/.

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Innovators in Pediatric Cancer to Share Progress on Ground-Breaking Personalized Medicine Clinical Trial

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Public release date: 7-May-2012 [ | E-mail | Share ]

Contact: David Sampson ajpmedia@elsevier.com 215-239-3171 Elsevier Health Sciences

Philadelphia, PA, May 7, 2012 While active monitoring of serum prostate specific antigen (PSA) levels in men over 50 has greatly improved early detection of prostate cancer, prediction of clinical outcomes after diagnosis remains a major challenge. Researchers from the University of Pittsburgh School of Medicine have found that a genetic abnormality known as copy number variation (CNV) in prostate cancer tumors, as well as in the benign prostate tissues adjacent to the tumor and in the blood of patients with prostate cancer, can predict whether a patient will experience a relapse, and the nature of the relapse aggressive or indolent. Their report is published in the June issue of The American Journal of Pathology.

Copy number variations are large areas of the genome with either duplicated or missing sections of DNA. "Our analysis indicates that CNV occurred in both cancer and non-cancer tissues, and CNV of these tissues predicts prostate cancer progression," says lead investigator Jian-Hua Luo, MD, PhD, associate professor in the Divisions of Molecular and Cellular Pathology, and Anatomic Molecular Pathology, Department of Pathology, University of Pittsburgh School of Medicine. "Prediction models of prostate cancer relapse, or of the rate of PSA level increase after surgery, were generated from specific CNV patterns in tumor or benign prostate tissues adjacent to cancer samples."

To detect the abnormalities, scientists conducted a comprehensive genome analysis on 238 samples obtained from men undergoing radical prostatectomy: 104 prostate tumor samples, 85 blood samples from patients with prostate cancer, and 49 samples of benign prostate tissues adjacent to a tumor. A third of the samples were from patients exhibiting recurrence with a PSA level increasing at a rapid rate, doubling in less than four months (rapid increases are associated with lethal prostate cancer); a third from patients exhibiting recurrence with a PSA level increasing at a slow rate, doubling time greater than 15 months; and a third with no relapse more than five years after surgery. Three commercially available prostate cancer cell lines were also tested to validate the results.

Deletions of large segments of specific chromosomes occurred with high frequency, whereas amplification of other chromosomes occurred in only a subset of prostate cancer samples. Similar amplification and deletion of the same regions also occurred in benign prostate tissue samples adjacent to the cancer. Prostate cancer patients' blood was found to contain significant CNVs. Most were not unique and overlapped with those of prostate cancer samples.

Using gene-specific CNV from tumor, the model correctly predicted 73% of cases for relapse and 75% of cases for short PSA doubling time. The CNV model from tissue adjacent to the prostate tumor correctly predicted 67% of cases for relapse and 77% of cases for short PSA doubling time. Using median-size CNV from blood, the genome model correctly predicted 81% of the cases for relapse and 69% of the cases for short PSA doubling time.

Dr. Luo notes that there are several potential clinical applications using CNV tests. "For a patient diagnosed with prostate cancer, CNV analysis done on blood or normal tissues would eliminate the need for additional invasive procedures to decide a treatment mode. For a patient already having a radical prostatectomy, CNV analysis on the tumor or blood sample may help to decide whether additional treatment is warranted to prevent relapse. Despite some limitations, including the need for high quality genome DNA, CNV analysis on the genome of blood, normal prostate, or tumor tissues holds promise to become a more efficient and accurate way to predict the behavior of prostate cancer."

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Genetic abnormalities in benign or malignant tissues predict relapse of prostate cancer

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07-05-2012 15:43 Jonathan Kahn, Professor at Hamline University School of Law, frames how the relationship between genetics and society should be understood in an opening plenary at the 2010 Tarrytown Meeting. The Tarrytown Meetings bring together people working to ensure that human biotechnologies and related emerging technologies support rather than undermine social justice, equality, human rights, ecological integrity and the common good. Find out more about the Tarrytown Meetings here: To find more videos, check out the Tarrytown Youtube channel:

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Jonathan Kahn: Setting the Stage for Understanding Genetic Technologies- Tarrytown 2010 - Video

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

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (Nasdaq: SGEN - News), today announced the initiation of an international pivotal phase 3 clinical trial evaluating ADCETRIS (brentuximab vedotin) in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who received at least one prior systemic therapy. The global multi-center study with ADCETRIS, an antibody-drug conjugate (ADC) directed to CD30, will be conducted in the United States, Europe, Australia and Brazil. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) regarding the trial design. The study also received European Medicines Agency (EMA) scientific advice.

Millennium is pleased to announce the initiation of the pivotal trial of ADCETRIS in patients with relapsed CD30-expressing CTCL. We recognize this as a significant milestone in our efforts to explore the potential of this targeted therapy in other indications, said Karen Ferrante, MD, Chief Medical Officer, Millennium. Looking forward, this study may support the potential to supplement therapeutic options for patients, from traditional systemic chemotherapy to ADCETRIS, a targeted therapy.

Data from patients with cutaneous lesions observed in our pivotal trial in systemic anaplastic large cell lymphoma (sALCL) and interim data from investigator-sponsored trials in CTCL with ADCETRIS provide a strong rationale for initiating this phase 3 trial, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer, Seattle Genetics. CTCL is an important part of our development plan to broadly evaluate ADCETRIS in CD30-expressing malignancies. This trial complements many other ongoing and planned trials for patients in need, including two additional phase 3 trials for front-line Hodgkin lymphoma (HL) and front-line mature T-cell lymphomas expected to start by late 2012 or early 2013.

CD30 is a member of the tumor necrosis factor receptor (TNFR) family and is a characteristic cell surface receptor for activated T-cells and B-cells, including the malignant cells of HL and sALCL. According to published literature, up to 50 percent of CTCL patients lesions express CD30(1-3). Under a previously announced collaboration agreement with Ventana Medical Systems, Inc. (Ventana), Millennium and Seattle Genetics, Ventana is developing a molecular companion diagnostic test for use in this CTCL patient population.

Study design

The study is a randomized, open-label, phase 3 trial of ADCETRIS versus investigators choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF). The primary endpoint of the study is overall response rate (ORR), lasting at least 4 months, with ADCETRIS in patients with CD30-positive MF or pcALCL compared to that achieved with therapy in the control arm. The key secondary endpoints are complete response (CR), progression-free survival (PFS), and burden of symptoms. Approximately 124 patients will be enrolled in the pivotal trial.

For more information about the trial, please visit http://www.clinicaltrials.gov.

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.

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Millennium and Seattle Genetics Initiate Global Phase 3 Trial of ADCETRIS™ in Patients with CD30-Expressing Relapsed ...

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BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (Nasdaq:SGEN - News) today reported financial results for the first quarter ended March 31, 2012. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, ongoing and planned clinical development activities and upcoming milestones.

First quarter 2012 ADCETRIS net product sales were $34.5 million, an increase of 4 percent from $33.2 million in the fourth quarter of 2011. ADCETRIS gross product sales increased by 12 percent in the first quarter of 2012 compared to the fourth quarter of 2011, but this increase was offset by an expected increase in gross-to-net discount in the first quarter of 2012 driven by Public Health Services program discounts that became effective during January.

The commercialization of ADCETRIS continues to be strong, and we are pleased by the acceptance and utilization of ADCETRIS among oncologists and patients with relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Our long-term vision for ADCETRIS is to expand its use into earlier lines of HL and sALCL therapy and into other CD30-positive malignancies. To that end, we are conducting a robust clinical development program with ADCETRIS, including clinical studies to broadly assess CD30 expression in both hematologic malignancies and solid tumors, as well as to evaluate activity and tolerability of ADCETRIS in these patient populations. Initial data from these clinical studies will be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting and we have multiple late-stage trials that are already underway or are about to begin to further evaluate the broad potential of ADCETRIS. In addition, we and our collaborators are advancing a robust pipeline of clinical and preclinical ADC programs for a variety of cancers.

Recent ADCETRIS Highlights

Other Recent Highlights

Upcoming Milestones

The company is on track to achieve multiple near-term milestones for ADCETRIS and other pipeline programs, including:

First Quarter 2012 Financial Results

Revenues in the first quarter of 2012 were $48.2 million, compared to $12.2 million in the first quarter of 2011. First quarter 2012 revenues include ADCETRIS net product sales of $34.5 million. In addition, first quarter 2012 revenues reflect amounts earned under the companys ADCETRIS and ADC collaborations.

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Seattle Genetics Reports First Quarter 2012 Financial Results

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