International Stem Cell Corp., "Regenerative Medicine Company with a Twist"
SNNLive spoke with Simon Craw, Ph.D. from International Stem Cell Corporation (ISCO:OTCQB) at the 5th Annual LD Micro Conference 2012 in Los Angeles, CA. For more information: http://www.internationalstemcell.com

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International Stem Cell Corp., "Regenerative Medicine Company with a Twist" - Video

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Stem Cell Therapy for Stroke
He is a known case of CVA since July 2010, leading to left sided hemiplegia with speech involvement. On MRI Brain, it was seen to be right MCA infarct. He was managed conservatively and has been undergoing regular rehabilitation since then. Neurologically, he is hypertonic and hyperreflexic. On examination: he has left sided paraesthesia (abnormal sensation). He has near normal left lower extremities voluntary control, but poor voluntary control of left hand, but fair control over left (proximal) upper extremities mainly shoulder and elbow. He has near normal cognition and speech. He has affected fine motor control and gross balance while walking. He has hemiplegic gait. Functionally, he is independent in most ADL and mobility. After Stem Cell Therapy 1) Now grasp of left hand has improved. Can hold glass with minimal assistance and drink water. Earlier could not hold glass. 2) Now uses his left hand more in activities -- drinking water. Earlier it was not possible to drink water and use left hand but now he can. 3) Stiffness in left upper limb reduced. 4) Can now sleep on left side also. Earlier would pain a lot. 5) Now he doesn #39;t require help while putting his pant hooks/buttons (but only in certain pants, which are not tight). Stem Cell Therapy done at NeuroGen Brain and Spine Institute Surana Sethia Hospital Sion-Trombay Rd, Suman Ngr Opp Corporate Park, Chembur, Mumbai -- 71. Tel : 022 - 25283706, 022 - 25281610, Mob : +91 9920 200 400 http://www.neurogen.in www ...

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Stem Cell Therapy for Stroke - Video

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Stem Cell Therapy for Spinal Cord Injury c5 - c6
He has history of fall in the swimming pool ,leading to fracture and compression of C4 over C5 and Quadriplegia with complete bowel bladder incontinence . He was operated for C5 corpectomy spiral stabilization. He is on regular rehabilitation since then. Neurologically, he is hypertonic hyperreflexic On examination, he has partial sensory recovery till D1, but complete loss below D1 .He has grade 0 muscle power in bilateral lower extremity wrist below, but grade 3++ muscle power in bilateral shoulders. He has no bowel bladder control is on condom catheter for same on ASIA impairment scale he scores #39;A #39; Functionally, he is dependent for all ADL will chair bound for mobility. On FIM he scores 73 After Stem Cell Therapy 1) Trunk balance has improved in sitting and standing. 2) Touch sensation has improved (10%). 3) Now while standing and exercising, can feel stress coming on joint (proprioception). 4) Spasticity, flexor spasms in lower limb increased. 5) Left thumb movement has started. 6) FIM -- no change. 7) Now spasticity grade 2 to 3. 8) Walking in parallel bars better. Can turn and find it easier than before. Stem Cell Therapy done at NeuroGen Brain and Spine Institute Surana Sethia Hospital Sion-Trombay Rd, Suman Ngr Opp Corporate Park, Chembur, Mumbai -- 71. Tel : 022 - 25283706, 022 - 25281610, Mob : +91 9920 200 400 http://www.neurogen.in http://www.stemcellsmumbai.com

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Stem Cell Therapy for Moderate Mental Retardation with Behavioural Issues
She is a known case of Mental Retardation with history of full term normal delivery, but mother had malaria during pregnancy. She had delayed motor milestones but achieved. She had delay mainly in speech. So she was tested and diagnosed to have MR. Gradually, she developed abnormal behavior and hyperactivity. Neurologically, she has near normal tone, reflexes and muscle power. On examination: She is hyperactive. She has poor social interaction and poor social skills. She has poor attention span. She has aggressive behavior. She is unable to read and write, but goes to a special school. She is unable to follow commands and has delayed speech. She needs assistance in all ADL. After Stem Cell Therapy OT assessment: 1) Hyperactivity has reduced by 30-40%. Now she can sit at one place if activity is of interest for 1-2 hours. She has calmed down a lot. 2) Attention and concentration has improved. Now she follows commands or instructions given. Does not need repetitions. 3) Concepts have improved, recognizes objects, matching colours, alphabets, numbers. 4) Speech is clearer and responses are relevant to questions asked. She sometimes still has repetitive speech or speaks sentences not appropriate to the present situations. 5) Aggressive behaviours have decreased. Initially the first month after SCT -- she showed increased aggressiveness towards younger brother. She would beat her brother for no reason. That slowly reduced. Now rarely does it (only when very angry). 6 ...

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Stem Cell Therapy for Cerebral Palsy
She is a known case of CP with history of full term normal delivery, with birth weight approximately 2.4 kg. But gradually as she grew parents noticed she had delayed motor milestones, so she was tested and diagnosed to have CP. Cause for it was suspected to be maternal TORCH infection during pregnancy. She has been on regular rehabilitation and has also had Botox injections twice. Neurologically, she is hypertonic and hyperreflexic. On examination: she has poor voluntary control of bilateral lower extremities, but near normal upper extremities voluntary control. But her grip is slightly poor. She has slurred speech and near normal bowel bladder control. She has fair oromotor control. Functionally, she needs assistance in all ADL and mobility. She is able to walk with AFOs for short distances. On WeeFIM she scores 57. After Stem Cell Therapy OT assessment: 1) Now able to walk with walker. Shifts weights of pelvis. 2) Stamina has increased. Exercise tolerance has increased. 3) Trunk balance has improved. 4) Now stepping is better, now lifts leg while stepping. 5) Standing without holding for about 50 counts. 6) Fear of falling has reduced. 7) Tightness in LL has reduced. 8) Catching ball is better. 9) Back extensor has improved. 10) Can come on bed without support of wall to get a thrust. 11) FIM improved from 60 to 65 secondary to bathing, dressing. 12) Now uses a potty seat over commode, sits independently. Assessment by Speech Therapist: 1) Loudness has improved. 2 ...

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Stem Cell Therapy for Cerebral Palsy - Video

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Stem Cell Therapy for Left Hemiplegia Stroke
He is a case of right MCA infarct with left hemiplegia since 2009. He was treated conservatively and is able to walk independently, but not able to use left upper extremity. Neurologically, he is hypertonic and hyperreflexic on the left side. On examination: he has grade 3 voluntary control in left lower extremity and walks with aid of a stick. He has hemiplegic gait. Left upper limb voluntary control is poor with spaticity grade 3 in shoulder. On Modified Ashworth Scale spasticity on left side is grade 4. He has normal speech and bowel /bladder control. After Stem Cell Therapy 1) Spasticity has reduced in all muscle of left UE and LE. 2) He can raise his left shoulder upto 100° of range which he couldn #39;t do before. 3) Previously, he used to stretch his left hand only in the morning but now he can do the same throughout the day. 4) He can climb stairs without any support. 5) Balance while standing, walking and stair climbing has improved. 6) Now he can maintain tandem stance for 20 sec without losing balance. 7) He can do marching with leg in standing which he couldn #39;t do before. 8) VC grading : elbow 3 knee 4 Stem Cell Therapy done at NeuroGen Brain and Spine Institute Surana Sethia Hospital Sion-Trombay Rd, Suman Ngr Opp Corporate Park, Chembur, Mumbai -- 71. Tel : 022 - 25283706, 022 - 25281610, Mob : +91 9920 200 400 http://www.neurogen.in http://www.stemcellsmumbai.com

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A new study published this month in the journal Human Gene Therapy has shown that a modified protein from the HIV virus itself could someday be used to prevent AIDS.

This is like fighting fire with fire, said David Harrich, co-author of the study and an associate professor at the Queensland Institute of Medical Researchs (QIMR) Molecular Virology Laboratory. If this research continues down its strong path, and bear in mind there are a many hurdles to clear, were looking at a cure for AIDS.

Harrich runs the only research laboratory in Queensland that works with the HIV virus. The protein he and his colleagues discovered, named Nullbasic, was formed by mutating an existing HIV protein over many generations. The researchers are confident enough in their findings that animal trials are set to begin this year.

Patients infected with the HIV virus currently take large doses of expensive drugs to subdue the virus. Nullbasic treatments wouldnt eliminate HIV from patients bodies but, according to Harrich, it could significantly reduce the cost of treatment for HIV.

I have never seen anything like it. The modified protein works every time, said Harrich. You would still be infected with HIV, its not a cure for the virus. But the virus would stay latent, it wouldnt wake up, so it wouldnt develop into AIDS. With a treatment like this, you would maintain a healthy immune system.

Harrich has been studying HIV since the early 1980s, when the very first cases of AIDS began to be diagnosed. He began as a research assistant at the University of California, Los Angeles (UCLA).

Ive come close to giving up in the past, said Harrich. But today Im so encouraged. I feel very fortunate because not a lot of scientists are able to stay in the same game long enough to see these sorts of developments.

The video below was released by QIMR. It features Harrich discussing his teams Nullbasic findings.

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Potential AIDS Cure Could Make HIV Dormant

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Washington, January 27 (ANI): An Indian origin scientist and his team analyzed the genomes of 14 family members who were affected by malignant melanoma and found an identical mutation in the gene for telomerase, an enzyme often called 'immortality enzyme', in all persons studied.

Telomerase protects the ends of chromosomes from being lost in the process of cell division and, thus, prevents that the cell ages and dies. The inherited gene mutation leads to the formation of a binding site for protein factors in the controlling region of the telomerase gene, causing it to become overactive. As a result, mutated cells overproduce telomerase and hence become virtually immortal.

This spectacular finding of the family analysis prompted the scientists to also look for mutated telomerase genes in non-inherited (sporadic) melanoma, which is much more common than the familial variant.

In most of the tissue samples of melanomas of all stages they found alterations in the telomerase gene switch, which the researchers clearly identified as typical consequences of sun exposure. Even though these mutations were not identical to those found in the melanoma family, they had the same effect: overactive telomerase.

"We don't believe that the telomerase gene in melanoma is mutated by pure chance, but that it is a so-called driver mutation that drives carcinogenesis," said Prof. Dr. Rajiv Kumar of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) who conducted the study together with Prof. Dr. Dirk Schadendorf from Essen University Hospital.

This is also confirmed by the surprising incidence of this alteration: The telomerase gene is the most frequently mutated gene in melanoma.

"This is something we hadn't expected, because malignant melanoma has been genetically analyzed thoroughly. But this mutation always seems to have been overlooked," said Kumar.

Kumar, Dirk Schadendorf and their teams are hoping that the alterations in the telomerase gene may be a starting point for developing novel treatment methods for malignant melanoma. (ANI)

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Familial gene mutation immortalizes deadly skin cancer

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My Father, My Hero- (a painful 2min puke session)
My 70 yr old father just about throws up his internal organs for a incredibly painful two minutes straight. After drinking a fifth of SoCo, i convinced him that smoking a blunt with me would be the proper thing to do. After all, hanging out with the old man is a rare thing these days- so I thought, what the hell , right ? Having last smoked in 1969 , this video shows a direct result of the wonders of modern pharmaceutical science. A "crash course" in genetic engineering, if you will, and in manipulation of the genetic makeup of the cannabis seed. So, in closing, this is what happens when you introduce your dad to my friend Jack Herer. I encourage others to do the same.

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My Father, My Hero- (a painful 2min puke session) - Video

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Genes1
The latest in genetic engineering

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Genes1 - Video

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Genes2
The latest in genetic engineering

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Washington, January 27 (ANI): Researchers at Washington University in St. Louis have found new genetic differences in hearts with disease.

The finding might explain gender differences in heart disease and ultimately lead to personalized treatment of various heart ailments.

Generally, men are more susceptible to developing atrial fibrillation, an irregular, rapid heartbeat that may lead to stroke, while women are more likely to develop long-QT syndrome, a rhythm disorder that can cause rapid heartbeats and sudden cardiac death.

While prior studies have clearly established differences in the development of heart disease between men and women, very few studies had looked at the molecular mechanisms behind those differences in human hearts.

Igor Efimov, PhD, the Lucy and Stanley Lopata Distinguished Professor of Biomedical Engineering in the School of Engineering and Applied Science at Washington University in St. Louis, and a former doctoral student, Christina Ambrosi, PhD, analyzed 34 human hearts looking for genetic differences.

The team took advantage of the unique opportunity at the university to obtain failing human hearts at the time of transplantation from Barnes-Jewish Hospital and non-failing hearts unsuitable for transplantation from Mid-America Transplant Services, a St. Louis-based organ procurement service.

The team screened for 89 major genes in electrophysiology, ion channel subunits, calcium handling proteins and transcription factors important in cardiac conduction and in the development of arrhythmia and the left atria and ventricles in human hearts.

"What was striking in this study is that we expected very large gender differences in expression of genes in the ventricles, but we did not find such differences. Unexpectedly, we found huge gender differences in the atria," said Efimov, also a professor of medicine, of radiology and of cell biology and physiology at Washington University School of Medicine.

The results showed that women with failing hearts have a weaker system of gene expression than men - males showed overall higher expression levels of nearly all of the 89 genes than women.

Women showed particularly lower atrial expression levels of several important genes encoding for potassium channels, including Kv4.3, KChIP2, Kv1.5 and Kir3.1. In fact, the atria of women with heart disease had less than half of the KChIP2 mRNA than atria in men.

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Genes provide clues to differences in heart disease between men and women

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LONDON--(BUSINESS WIRE)--

Inventages (a global healthcare venture capital fund backed by Nestl) announced today that they are working with SAP AG to integrate a comprehensive and mechanism-based approach to disease management with best-in-class IT frameworks to develop the next generation of personalized medicine companies.

Personalized medicine uses genetic and non-genetic information, such as environmental factors, to individualize the prevention, diagnosis, and treatment of disease. However to date, these solutions have typically been fragmented and incomplete, only addressing a subset of influencing factors. The personalized medicine solutions of the future will be holistic; integrating a patients genomic information, medical history, environmental and lifestyle factors. This holistic approach to managing disease will require the integration of multiple data sources and the structuring and analysis of large data volumes. This capability will be a key differentiator in ensuring the success and longevity of a personalized medicine solution.

This collaboration between a global healthcare venture capital fund and one of the worlds leading IT companies aims to provide emerging healthcare companies with both capital and extensive expertise and resources. The collaboration plans to leverage Inventages experience in developing highly efficacious clinically validated products and SAPs expertise in building and operating complex IT platforms and ecosystems.

Inventages has been looking at personalized medicine for several years and consequently we recognize that the future of disease management needs to be holistic; all of the factors that influence a patients health need to be considered. Inventages and SAP are aligned in their vision to advance personalized medicine through the use of information technology. This collaboration plans to provide our companies with access to SAPs unique capabilities and resources in mobile, cloud and big data processing, said Dr Gunnar Weikert, Chairman and Managing Partner of Inventages.

We are excited about this opportunity to collaborate with Inventages and Nestl, and combine our complementary capabilities in healthcare and IT, said Dr. Stefan Sigg, senior vice president, SAP HANA, SAP AG. Inventages and Nestl bring deep unbiased expertise in healthcare technology development including the design and running of clinical trials, as well as navigation of the complex regulatory and reimbursement environments. We are confident that this collaboration will help to identify and develop innovative healthcare solutions with the goal of improving peoples lives.

About Inventages

# # #

SAP and all SAP logos are trademarks or registered trademarks of SAP AG in Germany and in several other countries.

All other product and service names mentioned are the trademarks of their respective companies.

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Inventages Announce They Are Working with SAP to Develop the Next Generation of Personalized Medicine Companies

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Washington, Jan 28 (IANS) Even though healthy men and women have similarly structured hearts, the US researchers have discovered genetic differences in diseased hearts.

The new genetic differences found by researchers from Washington University in St. Louis in diseased hearts could pave the way to personalised treatment of various heart ailments.

Generally, men are more susceptible to developing atrial fibrillation, an irregular, rapid heartbeat that may lead to stroke, while women are more likely to develop long-QT syndrome, a rhythm disorder that can cause rapid heartbeats and sudden cardiac death, the journal Public Library of Science ONE reports.

Igor Efimov, professor of biomedical engineering at the Washington University School of Engineering & Applied Science, and former doctoral student Christina Ambrosi analysed 34 human hearts, looking for genetic differences that might explain gender differences in heart disease, according to a Washington statement.

The team screened for 89 major genes in electrophysiology, ion channel subunits, calcium handling proteins and transcription factors important in cardiac conduction and in the development of arrhythmia (irregular heartbeats) and the left atria (upper chambers) and ventricles (lower chambers) in human hearts.

"What was striking in this study is that we expected very large gender differences in expression of genes in the ventricles, but we did not find such differences," says Efimov, also professor of medicine, radiology and cell biology and physiology at Washington School of Medicine.

"Unexpectedly, we found huge gender differences in the atria," the professir said.

The results showed that women with failing hearts have a weaker system of gene expression than men -- males showed overall higher expression levels of nearly all of the 89 genes than women.

"When women have the highest levels of estrogen, they are least vulnerable to arrhythmia -- women are protected by estrogen," Efimov says. "But after menopause, women develop atrial fibrillation at the same rate as men. We don't understand this and need to study this in humans."

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Genetic disparity marks male, female hearts

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Chapters 5 and 6 Genetics Part 1r audio

By: Jeanne Calvert

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Chapters 5 and 6 Genetics Part 1r audio - Video

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Dihybrid Cross Review
This video reviews the basics with Dihybrid Crosses in Genetics and offers students two different ways to solve these types of problems.

By: Charles Filipek

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Dihybrid Cross Review - Video

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Incomplete Dominance Review
This video reviews the basics of Incomplete Dominance in Genetics and includes sample problems.

By: Charles Filipek

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Incomplete Dominance Review - Video

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Co-Dominance Review
The video reviews Co-Dominance in Genetics and includes sample problems.

By: Charles Filipek

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Co-Dominance Review - Video

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Getting Rid Cellulite Up Front Reviews of Getting Rid of Cellulite
http://www.com-release.com Click on The Link If you #39;re ready for getting rid of cellulite Precisely what is more, make sure you dramatically reduced your intake of rather-simple carb supply sugar combined with choose complex carbohydrate supply including nutritional fibre. The vitality founded upon complex carbohydrate food becomes discharged more slowly in your body, continues to keep you full for prolonged allowing it to plus improve bowel motion. Consider that constipation leads to immensely to the event involving cellulite. So that you should eat a great deal of vegetables and fruit, grain and furthermore dried beans. A diet plan is really a time period thankful method to get rid of cellulite and the entire body unwanted fat. Numerous people express doing exercises plus diets is more than rated , nor accomplish the task. I #39;m sure that the majority of individuals which proclaim the following make " up " standard excuses with a loss in perseverance and also your self willpower. Getting yourself into descent shape continually demands tasks, and also to remain very happy to try to get hold of what you look for. A number of us that are taking part in incorrect factors to reduce pounds. You will discover differing plenty solutions obtainable, along with some are definitely more well suited for pre-determined most people than the others. Discover a good diet plan or alternatively fitness program which fits your life-style which will then aid you in getting rid of cellulite and also ...

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Getting Rid Cellulite Up Front Reviews of Getting Rid of Cellulite - Video

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Genetics 1
Wolverine Tutors discusses the basis of genetics, such as genes, alleles, chromosomes, and other topics. *I do not own any of the images or video in this video.

By: Manoj Kowshik

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Genetics 1 - Video

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Cancer Awareness
Cancer Awareness. http://www.CancerUncensored.com. Welcome to today #39;s issue of cancer uncensored. Hi, I #39;m Chris, and I am the author of cancer uncensored, a step-by-step guide to cancer prevention, early detection and cancer survival. In today #39;s video,I want to present you with an overview of cancer. I #39;m going to briefly talk about what cancer is, what triggers it, what the symptoms are, how you can actively avoid it. We will also go over current treatment methods and alternative medicine. I will also show you where you should go to get the most up-to-date news and breakthroughs. Before we get stuck in, I would like to address two points Firstly, most people are afraid of cancer. I can fully understand that, as my wife has cancer, but as a society, we must not let the fear of the disease prevent us from taking steps to understand it, as that way we can actively prevent it. One in three of us will be diagnosed with cancer within our lifetimes, and yet 85% of cancer is preventable! This video, and my book, cancer uncensored, will tell you how. So take in as much of this data as you can, because it could save your life. Secondly, you need to realise that cancer isn #39;t fully understood. We have a number of very solid theories, and plenty of study data, but if cancer was fully understood, we might be closer to a cure. To quote Thomas Edison, "The doctor of the future will no longer treat the human frame with drugs, but rather will cure and prevent disease with nutrition." But as ...

By: CancerUncensored

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Cancer Awareness - Video

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Cancer Help - Help With Cancer
Cancer Help. http://www.CancerUncensored.com. Welcome to today #39;s issue of cancer uncensored. Hi, I #39;m Chris, and I am the author of cancer uncensored, a step-by-step guide to cancer prevention, early detection and cancer survival. In today #39;s video,I want to give you an overview of cancer. I am going to briefly talk about exactly what cancer is, what triggers it, what the symptoms are, how you can actively prevent it. We will also cover current treatment procedures and alternative treatment. I will also let you know where you can go to obtain the most up-to-date news and breakthroughs. Before we get stuck in, I ought to address two points Firstly, people are afraid of cancer. I can understand that, as my wife has recently been diagnosed with cancer, but as a society, we mustn #39;t allow the fear of the disease prevent us from taking steps to understand it, because that way we can actively prevent it. One in three of us will be diagnosed with cancer during our lifetimes, and yet 85% of cancer is avoidable! This video, and my book, cancer uncensored, can tell you how. So take in as much of this data as you can, because it could save your life. Secondly, you need to realise that cancer is not entirely understood. We have quite a few very solid theories, and plenty of study data, but if cancer was fully understood, we might be even closer to a cure. To quote Thomas Edison, "The doctor of the future will no longer treat the human frame with drugs, but rather will cure and prevent disease ...

By: CancerUncensored

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Cancer Help - Help With Cancer - Video

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Seattle Genetics Inc. ( SGEN ) and Takeda Pharmaceutical Company Limited ( TKPYY ) recently announced the commencement of a global phase III study (ECHELON-2) on their oncology treatment, Adcetris (brentuximab vedotin). Adcetris (brentuximab vedotin) plus chemotherapy will be evaluated for the front-line treatment of CD30-positive mature T-cell lymphoma (MTCL) including in patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas.

We note that study is being conducted under the U.S. Food and Drug Administration's (FDA) Special Protocol Assessment (SPA) program. Seattle Genetics said that the European Medicines Agency (EMA) also provided scientific advice for the study. The randomized, double-blind, controlled study will enroll roughly 300 patients and will be conducted in North America, Europe and Asia.

Seattle Genetics and Takeda had presented encouraging phase I data on Adcetris at the American Society of Hematology (ASH) annual meeting in Dec 2012. Adcetris is currently approved in the US for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT and the treatment of sALCL in treatment-experienced patients. Adcetris is approved in the EU as well.

Our Take

We are positive on Seattle Genetics' efforts to expand Adcetris' label. Approval in the front-line setting will boost Adcetris' sales signifcantly. Adcetris net revenue in the third quarter of 2012 was $33.7 million and for the nine months ending Sep 30, 2012 was $102.8 million.

Seattle Genetics carries a Zacks Rank #3 (Hold). Right now Agenus Inc. ( AGEN ), Valeant Pharmaceuticals International, Inc. ( VRX ) and Targacept, Inc. ( TRGT ) look more attractive with a Zacks Rank #1 (Strong Buy).

AGENUS INC (AGEN): Free Stock Analysis Report

SEATTLE GENETIC (SGEN): Free Stock Analysis Report

(TKPYY): ETF Research Reports

TARGACEPT INC (TRGT): Free Stock Analysis Report

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SGEN/Takeda's Adcetris Progresses - Analyst Blog

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

Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas. The trial, also known as ECHELON-2, is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and also received scientific advice from the European Medicines Agency (EMA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for use in the front-line treatment of MTCL.

The standard of care for newly diagnosed MTCL, a chemotherapy regimen called CHOP, has not changed in more than three decades, and there is a significant need to identify enhanced treatment options for these patients, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. Recent phase I data from 26 patients presented at the ASH annual meeting showed that adding ADCETRIS to CHP resulted in compelling antitumor activity, with 100 percent of the patients experiencing a response, and a manageable safety profile. Our goal with this phase III trial is to redefine the standard of care for front-line treatment of MTCL.

This is the third global phase III trial with ADCETRIS to be initiated in the past nine months, said Karen Ferrante, M.D., Chief Medical Officer, Millennium. This trial represents another major achievement in our aspiration to bring important new therapies to patients with CD30-expressing malignancies by evaluating ADCETRIS in the front-line setting.

The ECHELON-2 study is a randomized, double-blind, placebo-controlled multi-center global phase III trial designed to investigate ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (A+CHP) versus cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) as front-line therapy in patients with CD30-expressing MTCL. The primary endpoint is progression-free survival (PFS) per independent review facility assessment using the Revised Response Criteria for malignant lymphoma (Cheson, 2007). Secondary endpoints include overall survival (OS), complete remission (CR) rate and safety. The trial will be conducted in North America, Europe and Asia and is expected to enroll approximately 300 patients (approximately 150 patients per treatment arm). A molecular companion diagnostic test will be used in this trial to identify eligible patients based on CD30 expression. The companion diagnostic test is being developed under a previously announced collaboration agreement with Ventana Medical Systems, Inc. (Ventana), Millennium and Seattle Genetics.

At the recent 54th American Society of Hematology (ASH) Annual Meeting and Exposition held December 8-11, 2012 in Atlanta, GA, encouraging phase I data were presented from an abstract titled Brentuximab Vedotin Administered Concurrently with Multi-Agent Chemotherapy as Front-line Treatment of ALCL and Other CD30-Positive Mature T-Cell and NK-Cell Lymphomas (Abstract #60). The clinical trial was conducted to evaluate ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed MTCL patients, including patients with sALCL. Data were reported from 26 previously untreated patients who received the combination regimen of ADCETRIS plus CHP.

After completing a combination regimen of ADCETRIS plus CHP, 26 of 26 patients (100 percent) treated with ADCETRIS plus CHP had an objective response, including 23 patients (88 percent) with a complete remission. The most common treatment-emergent adverse events of any grade regardless of relationship occurring in more than 30 percent of patients were nausea (62 percent), peripheral sensory neuropathy (62 percent), diarrhea (58 percent), fatigue (54 percent) and alopecia (46 percent). The most common Grade 3 or 4 treatment-emergent adverse events regardless of relationship included Grade 3 febrile neutropenia, peripheral sensory neuropathy, nausea and dyspnea and Grade 4 nausea and diarrhea. The abstract can be found at http://www.hematology.org.

More information about the ECHELON-2 phase III trial of ADCETRIS in front-line CD30-expressing MTCL, including enrolling centers, will be available by visiting 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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Seattle Genetics and Millennium Initiate Global Phase III Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Front ...

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* Save my soul * - Stargate Atlantis -
I have only one word, as John Sheppard! hahahaha .. Between side effects of gene therapy on the wraith, and fratricidal wars of the nation wraith.

By: ManofMysteria

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* Save my soul * - Stargate Atlantis - - Video

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