Archive for the ‘Gene Therapy Research’ Category

Genetic Engineering Awareness
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Ramble: Simelweis Taboo
I just don #39;t understand narrowmindedness. I don #39;t understand the stubborn refusal to face reality with integrity. I don #39;t understand cowardice. We each have only one life. Why squander it on timidity, prejudice and just so stories? Video referenced: "Taboos of Science" scishow youtu.be " Published on Jul 30, 2012 Hank discusses some of the taboos which have plagued scientific inquiry in the past and a few that still exist today. Like SciShow? http://www.facebook.com Follow SciShow: http://www.twitter.com References: dft.ba This video contains the following sounds from Freesound.org: "grim fart.wav" by Walter_Odington "Toilet Flush.wav" by tweeterdj science, scishow, taboo, society, culture, research, study, ignaz semmelweis, germ theory, disease, louis pasteur, antiseptic, social norms, semmelweis reflex, dean radin, noetic science, stem cell, chimaera, human cloning, clone, dolly, sheep, ethics, religion, panayiotis zavos, synthetic biology, genetic engineering, biology, genetics, mental health, gender identity, gender dysphoria, sexual orientation, physics, archaeology, human remains, spirituality, consciousness, poop, toilet, sanitation"From:rriverstone1Views:20 2ratingsTime:15:28More inPeople Blogs

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GEARS - Genetic Engineering at Rutgers Society
Biology Undergraduates discuss their research projects, their findings, and experiences conducting research at Rutgers.From:RutgersViews:7 0ratingsTime:06:34More inEducation

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Washington, December 10 (ANI): A new study has suggested that just as human DNA varies from person to person, so too does the massive collection of microbial DNA in the intestine.

The research was conducted by researchers at Washington University School of Medicine in St. Louis and the European Molecular Biology Laboratory in Heidelberg, Germany.

It is the first to catalog the genetic variation of microbes that live in the gut, where they extract nutrients from food, synthesize vitamins, protect against infections, and produce compounds that naturally reduce inflammation.

The widespread genetic diversity uncovered by the scientists can help them understand how our microbial genes work together with our human genes to keep us healthy or, in some cases, to cause disease.

"Surprisingly, each of us can be identified by the collective DNA of our gut microbes," said corresponding author George Weinstock, PhD, associate director of The Genome Institute at Washington University.

"That collection is individualized, completely analogous to our human genome. Differences in the way individuals respond to various drugs or the way they use specific nutrients can be traced to the genetic variation in our microbial genes as well as in our human genes," he stated.

The researchers analyzed the microbial DNA in 252 stool samples from 207 individuals living in the United States and Europe.

All the subjects had participated in one of two recent high-profile initiatives to catalog the diverse species of microbes that live in and on the body. Neither of those studies - the Human Microbiome Project, funded by the National Institutes of Health, and the Metagenomics of the Human Intestinal Tract (MetaHIT) project, funded by the European Commission - looked at the genetic variation of the microbial genomes in the body.

For the new study, the researchers zeroed in on 101 species of microbes commonly found in the intestine, identifying more than 10 million single-letter changes in the collective DNA of those microbes. They also found numerous other DNA alterations, including insertions, deletions and structural changes.

In 43 subjects for whom the researchers had two stool samples collected at least a month apart (most were collected six months to a year after the initial sample), the researchers found very little variability in the microbial DNA over time, although the species of microbes in the intestine fluctuated.

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Gut microbes identified as new genetic fingerprint

MELVILLE, N.Y.--(BUSINESS WIRE)--

Population Diagnostics, Inc. (PDx), a private company with a novel approach for systematically uncovering the genetic causes of disease as well as the genetic basis of drug efficacy and safety, together with collaborators from The Hospital for Sick Children (SickKids) in Toronto, reported today in the journal G3 (GenesGenomesGenetics) the discovery of a collection of gene variants for autism spectrum disorder. These variants confer clinical utility and will enable a new generation of early detection diagnostic tests that will be highly sought after by the patient community. The newly discovered variants will also provide insights into the emerging field of drug discovery for autism.

Our collaboration with Population Diagnostics has been very fruitful, said the primary investigator, Dr. Stephen Scherer at The Hospital for Sick Children. We set out to understand microarray platform differences in copy number variant (CNV) detection but because of PDxs technical contribution, which delineates benign variants from those that are pathogenic, we were able to effectively interpret the genome at a higher resolution than obtained with previously utilized microarrays. This focused our attention on smaller variants associated with autism. Not only were we able to confirm variants in genes that we and others have previously discovered using alternate methods, but more importantly, we are pleased that an abundance of novel variants have been uncovered. We intend to report on additional discoveries in future publications that are based on an even finer-scale interpretation of the data in this joint project.

In addition to discovering sixteen novel genes associated with autism (many implicated in neurodevelopment), this study highlights the general importance of analyzing genomes specifically for CNVs, which is a type of genetic variant that can disrupt, delete, or generate multiple copies of a gene. However, the analytical tools that detect CNVs differ significantly in their output. For example, 64% of the CNVs observed in this study using a high resolution platform specifically designed to detect CNVs were missed in a prior CNV study that used SNP microarrays, which are not optimized for CNV detection because they were originally designed to detect another class of variants called single nucleotide polymorphisms (SNPs). Many SNP-based studies did not yield sufficient medically useful information and the SNP microarray data were subsequently mined for the presence of CNVs, which is a suboptimal strategy. The size of CNVs that can be detected is a key difference, and in this study the researchers found that 75% of the CNVs missed by SNP microarrays were small and these afford a greater opportunity to pinpoint single genes involved in autism. A more refined analysis of the autism patients used in the present study is underway and is revealing additional small CNVs in novel autism genes as well as novel variants in previously known autism genes.

Population Diagnostics holds two US patents (7,702,468 and 7,957,913) that describe a method of comparison of CNVs in subjects with a given condition to those present in a cohort comprised of healthy individuals. By eliminating benign and irrelevant CNVs in such a comparison, one is quickly led to genes that are pathogenic, which can then be interrogated using higher resolution genetic analysis techniques such as sequencing. In addition to disease gene discovery, PDxs methods can also reveal genetic biomarkers applicable for patient stratification (optimization of clinical trials), such as genetically differentiating a drug responder from a non-responder (efficacy) or identifying individuals most likely to experience a serious adverse event to a given drug.

The discoveries reported in this study underscore that the genetic landscape for autism involves numerous genes containing many low frequency genetic variants with large effect, said Dr. Peggy Eis, Chief Technology Officer at Population Diagnostics. Collectively, these newly discovered genes from our collaboration with SickKids, along with novel genes from our finer-scale analysis that will be reported in a future paper, represent a significant portion of the unexplained genetic contribution to autism and greatly expand our understanding of the underlying genetic causes of autism. We are excited about the opportunity to accelerate their clinical use in diagnostic tests, as potential drug targets and as genetic biomarkers in therapeutics development.

The US CDC estimates 1 in 88 children have autism. Genetics is believed to be the major causal factor, with up to 90% of cases having a genetic contribution. Rare gene variants are usually sufficient to cause autism by themselves. There is no single cause or type of autism. The average age of diagnosis is 4.5 years via observational methods and it is clear that the earlier the diagnosis the better the treatment outcome through early intervention modalities. With knowledge of the various genetic causes, a genetic test can be performed immediately after the birth of a child and provide the maximum opportunity for treatment. There are ~4 million live births in the US per year and 45,000 of these newborns will develop autism.

About Population Diagnostics, Inc.

Population Diagnostics, Inc. (PDx, http://www.populationdiagnostics.com) is applying its discoveries in human genetics to the development of DNA-based diagnostics and personalized medicine tests. PDxs technology, which reveals the genetic causes of complex diseases such as autism, Parkinsons, Alzheimers, and food allergies, enables development of early detection diagnostic tests that predict pre-symptomatically why some individuals will suffer from debilitating diseases while others will not. When applied to drug discovery, the technology enables pharmaceutical companies to develop targeted therapies and companion diagnostics. Its novel technology and exclusive products places PDx in a prime position to (i) transform how physicians diagnose and manage disease in their patients and (ii) enable pharmaceutical companies to expand the number of available therapies and market drugs with higher efficacy and safety.

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Population Diagnostics, Inc. and The Hospital for Sick Children Discover Novel Genetic Variants Associated with Autism ...

Being a little bit Godly - The Hidden
Just playing a bit of the Hidden What the hell is going on you ask? Storyline In the early 1950s human genetics experimentation was taking its first, tentative steps. Amongst many other black projects, a team of British scientists working at an Infinitum Research experimental station stumbled across some remarkable phenomena involving DNA manipulation. This led to deeper research with dangerously unpredictable results, often leading to human patients losing their lives in irresponsible and immoral experiments. Time passed on, and by the mid 1990s the failure rate of the experiments had been reduced from 75% to a mere 15%, enough for Infinitum to move onto the next stage: Biological Light Refraction. The British team were hoping to unravel the possibilities of light manipulation to create the perfect covert military agent. Early into the new millennium, due to a gross miscalculation, a series of tests on Subject 617 led to a massive synaptic trauma leaving the patient with multiple genetic anomalies. The subject was left in constant pain and with unstable DNA. The subject escaped captivity, killing anyone that got in its way. The IRIS (Infinitum Research Interception Squad) team have been deployed to return the subject to a maximum security Infinitum Research facility for further study and dissection. The entire project was considered a failure: all funding ceased and development was discontinued while all records and traces of the experiments were destroyed. Infinitum ...From:MultiAwesomeness96Views:4 1ratingsTime:04:44More inGaming

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Genetics Project : Traits
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Genetics Review UCO Fall 2012 Part 1
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Archive Genetics Pt. 6
Day 54 of FlowerFrom:GODLUNGSViews:132 24ratingsTime:04:01More inEntertainment

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Bone marrow transplants: Genetics linked to heart failure after chemotherapy | City of Hope Research
Saro Armenian, DO, MPH, medical director, Pediatric Survivorship Clinic at City of Hope discusses his recent study demonstrating that genetics may explain why some bone marrow transplant survivors develop congestive heart failure after receiving chemotherapy called anthracyclines. The findings will enable physicians to better screen at-risk patients and potentially prevent this lethal complication. ###################### Learn more about Saro Armenian, DO, MPH - http://www.cityofhope.org CONNECT WITH CITY OF HOPE http://www.facebook.com http://www.twitter.com http://www.causes.com and more at http://www.cityofhope.org ABOUT CITY OF HOPE City of Hope is a leading medical research, treatment and education center dedicated to preventing, treating and curing cancer, diabetes, HIV/AIDS and other life-threatening diseases. Our mission is to quickly turn research ideas into cures that help save patients #39; lives all over the world. Learn more at http://www.cityofhope.org.From:cityofhopeonlineViews:12 0ratingsTime:02:00More inEducation

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Genetics Review UCO Fall 2012 Part 2
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Amgen Purchases Company in Iceland
The biotech manufacturer, which has a facility in West Greenwich, has agreed to buy Decode Genetics, a gen-hunting company in Iceland.From:WPRIViews:0 0ratingsTime:00:25More inNews Politics

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Max Cooper feat. Braids - Automaton (D/R/U/G/S Mxcpr Remix)
Conditions One EP loz; Fields #887396917491 loz; Released:10.12.2012 soundcloud.com braidsmusic.com soundcloud.com http://www.beatport.com Buy it: http://www.beatport.com Release Info: Rising UK electronica star Max Cooper has collaborated with Canada?s intellectual art-rockers BRAIDS on a two-part EP named CONDITIONS ONE. The human condition is a well-examined idea ? but as an ex-genetics researcher with a PhD, Cooper takes a somewhat aslant look at humanity with the two collaborations. ?Pleasures,? he says, ?is just that ? an attempt to write something purely pleasurable and beautiful. But Automaton is darker ? an attempt to show how humans are essentially deterministic, trapped in a set of predictable reactions to their environment, their upbringing, their lives?. All three members of BRAIDS sing, and the tracks on the CONDITIONS EP combine vocal lines, melodies and individual vocal sounds from every song on BRAIDS? most recent album, Native Speaker ? both as ?proper vocals?, and or ethereal, pure sound.From:SteepedInMystery1Views:0 0ratingsTime:06:38More inMusic

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TRENTON, N.J. (AP) Biotech pioneer Amgen Inc., in a bid for a big edge in using people's genetic information to find better ways to attack diseases, is buying human genetics research and analytics leader deCODE Genetics for $415 million.

Amgen, the world's largest biotech company by revenue, and deCODE, based in Reykjavik, Iceland, announced the all-cash deal Monday.

DeCODE, founded in 1996, has discovered genetic risk factors for dozens of diseases, ranging from cardiovascular disease to cancer.

Probably its key asset and the reason for the deal is deCODE's huge database of the genetic and medical information of Iceland's population. That data can help researchers find links between genetic variations and characteristics that increase a person's risk of getting a particular disease and also affect patients' response to a drug.

"DeCODE Genetics has built a world-class capability in the study of the genetics of human disease. This capability will enhance our efforts to identify and validate human disease targets," Amgen CEO Robert Bradway said in a statement.

"This fits perfectly with our objective to pursue rapid development of relevant molecules that reach the right disease targets while avoiding investments in programs based on less well-validated targets," Bradway added.

That's important because the vast majority of experimental drugs, after years of expensive testing, eventually turn out not to work well or to have dangerous side effects. Drugmakers worldwide are trying to find ways to make their drug-development process more efficient to avoid spending tens of millions of dollars testing drugs that end up failing.

UBS Securities analyst Matthew Roden wrote in a note to investors that Amgen management stressed to him that being able to more efficiently identify and confirm targets for future development would help the company spot promising candidates, as well as likely failures, earlier.

"It is not surprising that Amgen is building out this R&D capability," given that some of its key experimental drugs were identified based on human genetics work, Roden wrote.

He has a "Buy" rating for Amgen and a 12-month share price target of $96, higher than its shares have ever been and significantly above its $89.95 peak over the last year. Roden noted Amgen will use off-shore cash for the deal and will not issue debt to cover it.

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Amgen buying deCODE Genetics for $415 million

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today summarized ADCETRIS (brentuximab vedotin) data in relapsed Hodgkin lymphoma (HL) and other CD30-positive malignancies from multiple presentations at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. Highlights include compelling survival data from long-term follow up in a pivotal clinical trial of ADCETRIS in relapsed or refractory HL and a retrospective comparison of overall survival among patients treated with ADCETRIS to those not treated with ADCETRIS following an autologous stem cell transplant (ASCT). In addition, data describe the activity and tolerability of ADCETRIS in the salvage HL setting from an investigator-sponsored trial and in relapsed patients age 60 or over with CD30-positive malignancies, including HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.

"There are more than a dozen data presentations at ASH evaluating the use of ADCETRIS in CD30-positive malignancies and we are very encouraged by both the broad application across multiple hematologic disease areas as well as the encouraging activity associated with ADCETRIS, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The extensive investigator and corporate data presentations at ASH clearly demonstrate the important role ADCETRIS plays in the treatment of relapsed HL and systemic anaplastic large cell lymphoma and the promise of the role it potentially will play in additional future indications.

Long-term Survival Analysis of an Ongoing Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #3689)

A pivotal, single-arm trial was conducted in 102 relapsed or refractory HL patients after ASCT to assess efficacy and safety of single-agent ADCETRIS. In addition, the trial was designed to determine duration of response, progression-free survival and overall survival. Enrolled patients had received a median of more than three prior chemotherapy regimens.

Data highlights from the long-term survival analysis in the pivotal trial were:

Overall Survival Benefit for Patients with Relapsed Hodgkin Lymphoma Treated with Brentuximab Vedotin After Autologous Stem Cell Transplant (Abstract #3701)

An independent retrospective comparison conducted by MD Anderson Cancer Center evaluated overall survival in 102 relapsed HL patients treated with ADCETRIS in a pivotal clinical trial compared to data from 756 relapsed HL patients treated at six international centers (Horning et al., 2008). The authors compared median overall survival, starting at the time of receiving an ASCT, among ADCETRIS treated patients to patients not treated with ADCETRIS. Key findings, which were highlighted in a presentation by Dr. Meghan Karuturi from MD Anderson Cancer Center, included:

Brentuximab Vedotin as a First Line Salvage Therapy in Relapsed/Refractory HL (Abstract #3699)

An investigator-sponsored trial was conducted to evaluate ADCETRIS as a salvage therapy for HL. Fourteen patients were evaluated for response and safety and all had relapsed or refractory HL after initial therapy with the chemotherapy regimens ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, Adriamycin, cyclophosphamide, Oncovin, procarbazine hydrochloride, prednisone) or a combination of chemotherapy with or without consolidative radiation treatment. Patients were treated with ADCETRIS every three weeks for a maximum of four cycles. Data were presented by Dr. Robert Chen from City of Hope National Medical Center in Duarte, CA.

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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Data in Relapsed Hodgkin Lymphoma and Other CD30-Positive ...

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today presented preclinical data from SGN-CD33A, an antibody-drug conjugate (ADC) in development for the treatment of acute myeloid leukemia (AML), at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. SGN-CD33A is a novel CD33-directed ADC utilizing Seattle Genetics next generation technology. The CD33 antibody is attached to a highly potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer via a proprietary site-specific conjugate technology to a monoclonal antibody with engineered cysteines (EC-mAb). Seattle Genetics expects to advance SGN-CD33A into a phase I clinical trial in 2013.

Our SGN-CD33A program showcases our next generation ADC technology, including our latest highly potent cell-killing agent and our new engineered antibody technology, said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. Of approximately 30 ADCs in development, more than 50 percent utilize Seattle Genetics technology. Through our continued innovation we are leading the development of novel ADCs, and believe that ADCs can transform the way cancer is treated.

ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

PBDs are a class of DNA-crosslinking agents that are significantly more potent than systemic chemotherapeutic drugs. Seattle Genetics has been working with PBDs since 2008 under an exclusive licensing arrangement with Spirogen Ltd. Over the past four years, Seattle Genetics has selected and optimized specific PBD molecules combined with novel linkers for use in ADCs, and has conducted process development and scale-up activities to create robust synthetic GMP manufacturing processes for these PBD drug-linkers.

SGN-CD33A: A Novel CD33-Directed Antibody-Drug Conjugate, Utilizing Pyrrolobenzodiazepine Dimers, Demonstrates Preclinical Antitumor Activity Against Multi-Drug Resistant Human AML (Abstract #3589)

Key findings from the preclinical evaluation of SGN-CD33A included:

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The U.S. Food and Drug Administration granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the initiation of future clinical trials with SGN-CD33A. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to generate the appropriate data and information to support an investigational new drug submission to the FDA. More information about the risks and uncertainties faced by Seattle Genetics is contained in the companys 10-Q for the quarter ended September 30, 2012 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Seattle Genetics Highlights Next Generation Antibody-Drug Conjugate SGN-CD33A at ASH Annual Meeting

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that results from two ongoing investigator-sponsored phase II clinical trials of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in the treatment of CTCL.

Brentuximab Vedotin Demonstrates Significant Clinical Activity in Relapsed or Refractory Mycosis Fungoides with Variable CD30 Expression (Abstract #797)

The ongoing phase II clinical trial is enrolling CTCL patients with mycosis fungoides (MF) or Sezary syndrome. Twenty patients have been enrolled to date with a median of six prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response and safety. The study was led by principle investigator Dr. Youn H. Kim from Stanford University School of Medicine in Stanford, CA, and was presented in an oral session. Key findings include:

Results of a Phase II Trial of Brentuximab Vedotin (SGN-35) for CD30+ Cutaneous T-Cell Lymphomas and Lymphoproliferative Disorders (Abstract #3688)

Data were presented from a phase II investigator-sponsored trial evaluating the use of ADCETRIS in CD30-positive CTCL patients, including lymphomatoid papulosis (LyP), primary cutaneous anaplastic large cell lymphoma (pcALCL) or MF. The ongoing study is being conducted by Dr. Madeleine Duvic from The University of Texas MD Anderson Cancer Center in Houston, TX. Among 54 patients enrolled to date, 46 patients were evaluable at the time of analysis. The primary endpoint of the trial is to evaluate the safety and efficacy of ADCETRIS in CD30-positive CTCL. The key findings include:

Seattle Genetics and Millennium: The Takeda Oncology Company have initiated the ALCANZA trial, a randomized phase III clinical trial of ADCETRIS for relapsed CD30-positive CTCL patients. The trial is assessing ADCETRIS versus investigators choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with pcALCL or MF. The primary endpoint of the study is overall response rate lasting at least four months. Approximately 124 patients will be enrolled in the pivotal trial. The ALCANZA trial is being conducted under a Special Protocol Assessment agreement from the U.S. Food and Drug Administration (FDA). The study also received European Medicines Agency scientific advice.

About CTCL

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of non-Hodgkin lymphomas that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. Progression from limited skin involvement is variable and may be accompanied by tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. According to published literature, up to 50 percent of CTCL patients lesions express CD30.

About ADCETRIS

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Seattle Genetics Announces Data from Investigator-Sponsored Trials of ADCETRIS® (Brentuximab Vedotin) in Cutaneous T ...

ATLANTA--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed advanced stage Hodgkin lymphoma (HL) patients. The data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for use in the front-line treatment of HL.

In the phase I trial, newly diagnosed patients received ADCETRIS concomitantly with either ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or AVD, which removes bleomycin from the regimen. At the end of front-line therapy, 24 of 25 patients (96 percent) treated with ADCETRIS plus AVD and 21 of 22 (95 percent) patients treated with ADCETRIS plus ABVD had a complete remission. None of the patients treated in the ADCETRIS plus AVD cohort experienced pulmonary toxicity, compared with an expected rate of pulmonary toxicity caused by ABVD alone of 10-25 percent. The trial was designed to establish the safety profile and maximum tolerated dose when adding ADCETRIS to ABVD or AVD. Antitumor activity was assessed as a secondary endpoint.

"For over 30 years, the standard of care for front-line HL has been a chemotherapy regimen called ABVD that has demonstrated a complete remission rate of 70 to 80 percent and is associated with considerable life-threatening toxicities. There is a significant need to identify better treatment options for patients in the front-line HL setting, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Our goal is to redefine front-line treatment of HL with the addition of ADCETRIS, and the encouraging results of this phase I trial clearly support this goal and provide rationale for the ongoing ADCETRIS phase III trial in this setting."

Front-line Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma (Abstract #798)

In this open-label, multicenter trial, cohorts of patients received an escalating dose of ADCETRIS (0.6 milligrams per kilogram (mg/kg), 0.9 mg/kg, 1.2 mg/kg) every two weeks concomitantly with ABVD or a dose of 1.2 mg/kg every two weeks concomitantly with AVD.

Fifty-one patients were enrolled in the phase I study and 47 were evaluable for response at trial completion. The 47 evaluable patients included 25 in the ADCETRIS plus AVD cohort and 22 in the ADCETRIS plus ABVD cohorts. All patients were previously untreated and 45 percent had Stage IV HL. The median age of patients across all cohorts of the trial was 33 years. Key findings, which were highlighted in an oral presentation by Dr. Stephen Ansell, Professor of Medicine, Division of Hematology, from the Mayo Clinic, included:

For decades researchers have strived to improve our front-line HL treatment strategy by enhancing the activity of traditional chemotherapy regimens while reducing the significant toxicities and long-term side effects of such regimens, said Stephen Ansell,M.D., Ph.D., Professor of Medicine, Division of Hematology, Mayo Clinic. There is a significant need to identify better treatment options for patients in the front-line setting. With a complete response rate of 96 percent and a manageable safety profile, data from this trial support further evaluation of ADCETRIS administered concomitantly with AVD in previously untreated HL patients to potentially improve the current standard of care.

Seattle Genetics and Millennium: The Takeda Oncology Company have initiated a phase III clinical trial in advanced stage front-line HL patients. The randomized trial is comparing progression-free survival in patients receiving ADCETRIS in combination with AVD to patients receiving ABVD alone. For more information about the trial visit http://www.seattlegenetics.com or http://www.clinicaltrials.gov.

About ADCETRIS

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Seattle Genetics Reports Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line Hodgkin Lymphoma at ...

Seattle Genetics Inc. plans to proceed with a late-stage study of a possible additional use for its lymphatic cancer treatment Adcetris after releasing results from a small, early-stage test.

The Bothell, Wash., company said Sunday 23 of 26 patients with an aggressive form of non-Hodgkin lymphoma who received Adcetris combined with chemotherapy achieved complete remission, which means they had no trace of the cancer after the treatment was completed.

CEO Clay B. Siegall said in a statement the data offers a "strong rationale" for late-stage testing that will compare Adcetris combined with chemotherapy to the standard chemotherapy treatment for the disease. The company plans to start the trial by early next year.

Seattle Genetics announced the results at the American Society of Hematology's annual meeting in Atlanta.

Adcetris is Seattle Genetics' only marketed product. It is already approved to treat two types of lymphoma. The company also is seeking approval to market the drug as a treatment for mycosis fungoides, a type of non-Hodgkin lymphoma that starts in the skin.

Last month, the Food and Drug Administration gave the treatment orphan drug status for that indication. That means that if Adcetris is approved as a treatment for that disease, the FDA won't approve similar products for seven years.

Orphan drug status is given to treatments for disease that affect fewer than 200,000 Americans.

Shares of Seattle Genetics fell 14 cents to $25.40 in Monday morning trading, while the Nasdaq exchange rose less than 1 percent. The company's shares are still up about 52 percent since closing 2011 at $16.72.

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Seattle Genetics to test possible new Adcetris use

AMSTERDAM, December 11, 2012 /PRNewswire/ --

uniQure B.V., a leader in the field of human gene therapy, today announced the start of its Phase I clinical trial in acute intermittent porphyria (AIP) with the treatment of the first patient. The study is conducted under the aegis of the AIPGENE consortium, a pan-European collaboration funded in part by the European Commission's Seventh Framework Program with the aim to develop a gene therapy for the treatment of AIP, a rare and devastating disease caused by mutations in the porphobilinogen deaminase gene (PBGD). AIP can be life-threatening and the long-term effects include irreversible nerve damage, liver cancer and kidney failure. uniQure was granted orphan drug designation for the treatment of AIP in 2009 from the European Medicines Agency.

"The start of the AIP Phase I study marks the first of four programs that will enter clinical trials over the next 12 months," says Jrn Aldag, CEO of uniQure. "After AIP we expect clinical trials to be initiated in Parkinson's disease, hemophilia B, and Sanfilippo B. After many years of building and developing our capabilities and competencies, and the approval in November of Glybera for LPLD as the first gene therapy in the Western world, we are highly motivated to expedite the clinical development of our other advanced gene therapies."

About the AIP Phase I study

The Phase I will enroll eight patients with severe AIP at two centers: the Clinical University of Navarra, Pamplona, Spain, and the 12 de Octubre University Hospital,, Madrid, Spain. The study's primary objective is the assessment of safety and determination of the maximum tolerated dose. Secondary objectives include tolerability of treatment, pharmacokinetics, changes in the levels of surrogate markers of activity including porphobilinogen (PBG) and delta-aminolevulinic acid (ALA), and assessment of symptom control, neuro-psychological changes and quality of life. All patients will be followed for one year, and the interim results of the Phase I are expected in Q3 2013.

About acute intermittent porphyria

Acute Intermittent porphyria (AIP) is a rare genetic disease which is caused by mutations in the porphobilinogen deaminase (PBGD) gene; one of the enzymes of the heme biosynthesis pathway. Mutations in this gene cause insufficient activity of the protein resulting in partially disruption of heme synthesis. This in turn leads to accumulation of toxic intermediates (ALA and PBG) giving rise to a wide variety of problems including acute, severe abdominal pains, psychiatric and neurological disorders, and muscular weakness. Acute porphyric attacks can be life-threatening and the long-term consequences include irreversible nerve damage, liver cancer and kidney failure. Currently, the only curative therapy is liver transplantation and thus, new curative options are urgently needed. Severe AIP patients are suffering poor quality of life with palliative treatments for the different symptoms including glucose or heme infusions for metabolic replacement and inhibition of toxic metabolic production.

About AIPGENE

AIPGENE is a European Commission Framework Programme 7-funded consortium (Grant Agreement number 261506) which was put together with the aim to develop the orphan gene therapy drug AAV5-AAT-PBGD (AMT-021) for the treatment of Acute Intermittent porphyria (AIP). The consortium's objective is to contribute to alleviating the negative impact of this disease on the quality of life of the patients and their families. Overall coordinator of the project is the Centre for Applied Medical Research (CIMA) at the University of Navarra, Pamplona, Spain. Apart from uniQure, other members of the consortium are the Clinical University of Navarra, Pamplona, Spain; Karolinska University Hospital, Stockholm, Sweden; German Cancer Research Center (NCT-DKFZ), Heidelberg, Germany; DIGNA Biotech, Pamplona, Spain; Servicio Madrileno de Salud, Madrid, Spain.

About uniQure

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uniQure Initiates Phase I in Acute Intermittent Porphyria

STAMFORD, Conn.--(BUSINESS WIRE)--

Alliance for Cancer Gene Therapy (ACGT), the nations only non-profit organization dedicated exclusively to funding cell and gene therapy research for cancer, is excited to play a major role in the recent leukemia study pioneered by scientists at the Perelman School of Medicine at the University of Pennsylvania. ACGT was the initial funding arm for the study using immune-mediated gene therapy for leukemia and lymphoma. This study illustrates the successful and sustained demonstration of how gene therapy uses the bodys own T-cells and turns them into weapons aimed directly at cancer.

Initial ACGT grants were awarded in 2004 to Dr. Carl June of the Abramson Family Cancer Research Institute at the University of Pennsylvania, and to Dr. Michel Sadelain, of Memorial Sloan-Kettering Cancer Center, Gene Therapy & Gene Expression Laboratory in New York City. Preliminary results were issued by Dr. Carl June and the University of Pennsylvania in August 2011, with additional results released this week and presented by Dr. Carl June at the American Society of Hematologys Annual Meeting and Exposition being held in Atlanta, Georgia.

The clinical trial participants, all of whom had advanced cancers, included ten adult patients with chronic lymphocytic leukemia, were treated at the Hospital of the University of Pennsylvania (HUP) and two children with acute lymphoblastic leukemia were treated at the Childrens Hospital of Philadelphia (CHOP). Two of the first three patients treated with the protocol at HUP whose cases were detailed in The New England Journal of Medicine and Science Translational Medicine in August 2011 remain healthy and in full remission more than two years after their treatment, with the engineered cells still circulating in their bodies. Currently, nine out of 12 of the participants show their disease in remission.

The discovery of successful cancer gene therapy treatments are what my husband and I hoped for when we founded ACGT a decade ago, noted Barbara Netter, president and co-founder of the Alliance for Cancer Gene Therapy. We knew it would be an uphill battle. ACGT was the only organization willing to take the risk when others were not. With federal funds decreasing, and the realization that pharmaceutical companies will not participate in the research phase until marketable and mass-produced treatments are created, we seized the chance to make a difference. My late husband Edward Netter (1932-2011), was a true visionary in the field of medical research. He would be so thrilled by the progress ACGT has made possible.

ACGT is currently funding 17 clinical trials in cancer cell and gene therapy targeting numerous types of cancers. Since its inception, ACGT has awarded more than $23 million in grants to 39 investigators to treat 11 different types of cancer. In 2012, ACGT also awarded a $500,000 grant to a clinical translational study on pancreatic cancer and has great expectations for its outcome. In ACGTs 2011 grant cycle, 87 scientists from throughout the U.S. responded with grant applications for ACGTs Young Investigator Grants, making 2011 one of the most sought-after funding year in ACGT history. The ACGT funded clinical studies are already showing promise, especially in the treatment of leukemia, lung, melanoma and prostate cancers.

It is so exciting that the pathfinder role ACGT played by provided the seed money for the University of Pennsylvania trial has led to these stunning successes for leukemia treatment, said Dr. Savio Woo, chairman of ACGTs Scientific Advisory Council, and founding Chair of the Department of Gene and Cell Medicine at Mt. Sinai School of Medicine in New York City.

Woo noted that 100 percent of all funds donated to ACGT go directly toward funding innovative cancer gene therapy research grants. ACGTs Scientific Advisory Council, which comprises some of the best scientific minds and thought leaders with major U.S. medical institutions, oversee all phases of the ACGT grant process. Through this rigorous review, ACGT is able to identify and fund studies with the most potential for positive and innovative outcomes for treating cancer using cell and gene therapy.

The University of Pennsylvanias initial study was funded primarily by ACGT. The most recent clinical trial was also supported by ACGT, the Leukemia & Lymphoma Society (Dr. June is the leader of one of the LLSs grants), and the National Institutes of Health. In addition, Novartis announced this summer that it would fund additional research at the University of Pennsylvania to further study the immunotherapies and has acquired exclusive rights to market the treatment.

Alliance for Cancer Gene Therapy (ACGT) is the nations only non-profit dedicated exclusively to cell and gene cancer therapy research. One hundred percent of all contributions to ACGT go directly to research and fund grants with leading scientists in the U.S., representing such institutions as Harvard Medical School, Johns Hopkins University School of Medicine, Mayo Clinic, St. Judes Childrens Hospital, Duke University, The Salk Institute, University of Pennsylvania, Memorial Sloan-Kettering, Stanford University, Dana Farber Cancer Center, University of California San Diego, University of Pittsburgh, and the University of Chicago. A rigorous grant review by Scientific Advisory Council ensures the most promising projects are rewarded. To learn more about the leukemia study at the University of Pennsylvania, and about the Alliance for Cancer Gene Therapy (ACGT), visit http://www.acgtfoundation.org or call 203.358.8000.

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Alliance for Cancer Gene Therapy Funds Promising Leukemia Study – Patients in Remission More Than Two Years after Gene ...

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