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Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA

Posted: Published on May 15th, 2013

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The FDA is expected to take action on the application by September 14, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL. Our goal is to broaden the ADCETRIS U.S. labeling claims to provide both patients and physicians the opportunity to incorporate ADCETRIS into additional HL and sALCL treatment settings, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The FDAs acceptance of our sBLA submission is an important step towards making ADCETRIS available in the retreatment and extended duration setting, and we look forward to the regulatory outcome. The sBLA is based on results from a phase 2 clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients … Continue reading

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American CryoStem Partners with Rutgers for Novel Wound Care Product

Posted: Published on May 15th, 2013

Regenerative medicine is constantly discovering new inroads to potential therapies utilizing adult stem cells for a variety of life threatening or debilitating conditions and diseases. Progress has accelerated in the past few years, fueled in part by President Obamas 2009 Executive Order 13505 that removed barriers in responsible research which has opened doors to examination of new ways of thinking. It has also aided in the emergence of research in the area of adipose (fat)-based stem cell therapy, which could prove to be a major breakthrough in regenerative medicine. Not only has early research at Johns Hopkins suggested the possibility of superior efficacy with Adipose-Derived Stem Cells, or ADSCs, in the treatment of glioblastoma (a severe form of brain cancer), but ADSCs are easily harvested, meaning that they could become a standard as the most reliable and abundant source of stem cells for research, cultures and therapeutic processes. Akin to institutions like Harvards Dana-Farber and University of Texas MD Anderson being recognized as two of the worlds leading cancer research centers, certain institutions have become established as pioneering experts in stem cell research. Johns Hopkins and Rutgers University sit amongst the leaders in this arena. This bodes very well for … Continue reading

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Milestone in medical human 'cloning'

Posted: Published on May 15th, 2013

15 May 2013 Last updated at 14:02 ET By James Gallagher Health and science reporter, BBC News Human cloning has been used to produce early embryos, marking a "significant step" for medicine, say US scientists. The cloned embryos were used as a source of stem cells, which can make new heart muscle, bone, brain tissue or any other type of cell in the body. The study, published in the journal Cell, used methods like those that produced Dolly the sheep in the UK. However, researchers say other sources of stem cells may be easier, cheaper and less controversial. Opponents say it is unethical to experiment on human embryos and have called for a ban. Stem cells are one of the great hopes for medicine. Being able to create new tissue might be able to heal the damage caused by a heart attack or repair a severed spinal cord. There are already trials taking place using stem cells taken from donated embryos to restore people's sight. However, these donated cells do not match the patient so they would be rejected by the body. Cloning bypasses this problem. The technique used - somatic cell nuclear transfer - has been well-known since Dolly … Continue reading

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Nobel Prize Rockets Stem Cell Program to New Heights

Posted: Published on May 15th, 2013

Shinya Yamanaka, MD, PhD Stem cell science blasted across front pages worldwide when Shinya Yamanaka, MD, PhD, won the 2012 Nobel Prize in Physiology or Medicine. The UCSF professor and senior investigator at the UCSF-affiliated Gladstone Institutes received the award for discovering how to transform ordinary adult skin cells into cells that, like embryonic stem cells, are pluripotent capable of becoming any cell in the human body. The news bringing UCSF's total of Nobel laureates to five brought fresh attention to something UCSF long ago sensed and seized: the promise of regeneration medicine for repairing or replacing damaged cells, tissues, and even whole organs. Gail Martin, PhD More than three decades ago, UCSF researcher Gail Martin, PhD, co-discovered embryonic stem cells in mice, coining the term. The cells were discovered separately and simultaneously by University of Cambridge investigators Martin Evans, PhD, and Matthew Kaufman, PhD. Embryonic stem cells brought hope to billions, giving scientists new avenues for understanding and treating some of the worlds most complex health conditions heart disease, diabetes, epilepsy, multiple sclerosis, Parkinsons disease, spinal cord injury, and many more. Despite the cells tremendous promise, political pressure to stop embryonic stem cell research began to brew. In a … Continue reading

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Scientists create human stem cells through cloning

Posted: Published on May 15th, 2013

NEW YORK- After more than 15 years of failures by scientists around the world and one outright fraud, biologists have finally created human stem cells by the same technique that produced Dolly the cloned sheep in 1996: They transplanted genetic material from an adult cell into an egg whose own DNA had been removed. The result is a harvest of human embryonic stem cells, the seemingly magic cells capable of morphing into any of the 200-plus kinds that make up a person. The feat, reported on Wednesday in the journal Cell, could re-ignite the field of stem-cell medicine, which has been hobbled by technical challenges as well as ethical issues. Until now, the most natural sources of human stem cells have been human embryos, whose use in research poses ethical quandaries. The technique announced on Wednesday, by scientists at Oregon Health & Science University and the Oregon National Primate Research Center, uses unfertilized human eggs. Eliminating the need for human embryos could boost attempts to use stem cells and their progeny to replace cells damaged or destroyed in heart disease, Parkinson's disease, multiple sclerosis, spinal cord injuries and other devastating conditions. But the achievement could also revive fears of reproductive … Continue reading

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Scientists Convert Human Skin Cells Into Embryonic Stem Cells

Posted: Published on May 15th, 2013

Dr. Shoukhrat Mitalipov, Ph.D., researches in the lab at the Oregon Health & Science University. For the first time, a team of scientists say they have successfully converted human skin cells into embryonic stem cells, a move that could help quiet the ethical debate surrounding stem cell research. Researchers at Oregon Health & Science University say they were able to implant the nucleus from a skin cell into a donated human egg cell with its nucleus removed, creating an embryo-like cell that has the genetic makeup of the patient who donated the skin cell. [RELATED: Scientists Can Turn Stem Cells Into Brain Cells] Since 2007, scientists have had successes with the procedure using monkeys and other mammals but not with human subjects. "Every species is a little different biologically," says Shoukrat Mitalipov, lead author of the study, which was published Wednesday in Cell. "We've been using a good model in primates, but we've now finally been able to optimize it in humans." The embryonic stem cells created by Mitalipov can be differentiated into many types of human cell, including nerve cells, liver cells and heart cells. Scientists have suggested that stem cells may one day be used to treat brain … Continue reading

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At actress's Geneva jewel auction, $3M for 1 gem

Posted: Published on May 15th, 2013

GENEVA (AP) Sotheby's auctioned off $78 million in jewels Tuesday night, fetching just under $3 million for a fancy yellow diamond belonging to actress Gina Lollobrigida that was once owned by a shah of Persia and she hoped would now bring more support for stem cell research. The auction house said the diamond was a highlight in a collection of 23 jewels that the 85-year-old actress, who starred opposite Humphrey Bogart, Frank Sinatra and other top actors in the 1950s and 1960s, was selling partly to fund an international hospital for stem cell treatment. Jewelry, watches and other luxury items are sold every spring by the big auction houses at Geneva's elegant lakefront hotels seemingly a world away from some European countries whose economies are shrinking as their governments enact often tough budget austerity measures to get a handle on their debts. The 74.53-carat fancy yellow diamond that was sold off once belonged to Ahmad Shah Qajar, the shah of Persia from 1909 to 1925 and the last ruler of the Qajar dynasty. Its sale for $2,985,750 set both an auction record and a record price per carat an eye-popping $40,061 per carat for a fancy yellow diamond, according to … Continue reading

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Human Cloning Breakthrough Hailed By Scientists

Posted: Published on May 15th, 2013

A "milestone" breakthrough in human cloning has been revealed by scientists, who successfully used skin to generate embryonic cells. Scientists in the United States said that could mean avoid using fertilised human embryos for stem cell therapies, stressing they had no interest in creating cloned humans, but the development is sure to spark renewed debate on the ethics of cloning human cells. The "Brave New World" process the scientists have developed could also be used as a starting point for cloning humans. Human embryonic stem cells are normally derived from "unwanted" fertilised human embryos left over from IVF treatment, which raises ethical concerns. It is the first time scientists have managed to create human embryos through cloning developed enough to provide stem cells. In the new study, reported in the journal Cell, scientists transferred nuclei from human skin cells into human egg cells. The scientists used caffeine to keep the eggs stable during the procedure after it was shown to be effective in monkeys. "The importance of the egg donor is again illustrated in this paper. Only high quality human eggs had the potential to reprogram somatic cells. It is remarkable that adding caffeine was the key that resulted in … Continue reading

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Cloning fears as scientists create human embryos from SKIN in stem cell 'milestone'

Posted: Published on May 15th, 2013

Breakthrough could have major implications for stem cell treatments First time scientists have managed to create human embryos through cloning developed enough to provide stem cells Raises possibility of babies being cloned in the lab by rogue scientists By Fiona Macrae Science Correspondent PUBLISHED: 11:00 EST, 15 May 2013 | UPDATED: 13:59 EST, 15 May 2013 Scientists have cloned human embryos from slivers of skin and extracted precious stem cells from them. The world first brings closer hopes that customised stem cells can be used to treat and even cure diseases from Alzheimers and Parkinsons to multiple sclerosis and paralysis. However, it also raises the spectre of babies being cloned in the lab, with grieving couples paying for a duplicate child to be made for them. Scroll down for video A donor egg held by pipette prior to nuclear extraction at the start of the radical new process The same somatic cell nuclear transfer (SCNT) technique was employed by researchers at the Roslin Institute in Edinburgh to produce Dolly the Sheep, the first mammal to be cloned from an adult cell. During SCNT, a donor cell nucleus is transferred to an egg cell whose own nuclear DNA has been removed. … Continue reading

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OncoMed Pharmaceuticals Initiates Phase 1b/2 Clinical Trial of Anti-Cancer Stem Cell Therapeutic OMP-59R5 (Anti-Notch2 …

Posted: Published on May 15th, 2013

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced clinical progress with its Anti-Notch2/3 (OMP-59R5) product candidate, which will trigger an $8 million milestone payment from the companys strategic collaborator GlaxoSmithKline (GSK). OncoMed has initiated a Phase 1b/2 clinical trial in its anti-Notch2/3 antibody (OMP-59R5) program. In the Phase 1b/2 PINNACLE trial (Phase 1b/2 INvestigation of anti-Notch Antibody therapy with Cisplatin and etoposide in small cell Lung carcinoma Efficacy and safety), Anti-Notch2/3 is being tested in combination with cisplatin and etoposide in first-line extensive-stage SCLC patients. Following a Phase 1b dose escalation and expansion phase, a randomized Phase 2 clinical trial will proceed in these patients to compare the efficacy of standard-of-care cisplatin and etoposide either with Anti-Notch2/3 or with placebo. The primary endpoint of the Phase 2 part of the trial will be progression-free survival (PFS) in the Anti-Notch2/3 arm compared to a placebo arm in patients who have a particular biomarker. Key secondary and exploratory endpoints include overall survival, response rate, and safety. Enrollment of patients in both the U.S. and Europe is planned. Dr. Robert Jotte, Developmental Co-Chair for US Oncology Lung … Continue reading

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