Archive for the ‘Gene Therapy Research’ Category
Live Cell Therapy | Stem Cell Malaysia – Video
Live Cell Therapy | Stem Cell Malaysia
stemcellmalaysia.com Live cell therapy is one form of stem cell therapy under the hierarchy of cell therapy, which is under regenerative medicine. Live cell therapy was made popular since 1931 by Dr Paul Niehans, who pioneered the therapy using injection. Oral or injection live cell therapy is far more superior than surgical implantation due to several advantages. Today, live cell therapy has been applied to disease treatment, beauty and health rejuvenation. For more information on stem cell therapy, please visit Stem Cell Malaysia at stemcellmalaysia.comFrom:stemcells2012Views:172 10ratingsTime:12:14More inScience Technology
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123Triad : fatgraftforumcom – Video
123Triad : fatgraftforumcom
123Triad is proud to design website for http://www.fatgraftforum.com Autologous fat grafting is rapidly becoming the standard in the field of Plastic Surgery and the demand for knowledge and advances in fat grafting have significantly increased. The International Fat Grafting Forum will present renowned physicians from all over the world to promote the advancement of fat grafting technology and techniques including the ongoing debate on stem cell therapy.From:123triadorgViews:2 0ratingsTime:00:36More inScience Technology
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123Triad : fatgraftforumcom - Video
Stem Cell Therapy (IMC) – Video
Stem Cell Therapy (IMC)
New Project 40From:OmarGonzalezMDViews:0 0ratingsTime:01:48More inScience Technology
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Stem Cell Therapy (IMC) - Video
MissouriCuresEvents_Oct2012_Dr.MarieCsete – Video
MissouriCuresEvents_Oct2012_Dr.MarieCsete
"The stem cell therapy race: roadblocks to the finish line", as presented by Dr. Marie Csete at The Danforth Center on behalf of Missouri Cures Education Foundation #39;s Speaker Series in October, 2012.From:MissouriCuresEventsViews:1 0ratingsTime:51:36More inNonprofits Activism
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MissouriCuresEvents_Oct2012_Dr.MarieCsete - Video
Sources Of Stem Cells | Stem Cell Malaysia – Video
Sources Of Stem Cells | Stem Cell Malaysia
stemcellmalaysia.com Sources of stem cells play a critical role in determining the outcome of stem cell therapy. Without a clear idea of the sources of stem cells, it is risky to be engaged in any form of stem cells treatment. The sources of stem cells include the type of animals, the location of the animals, and the parts of the animal. For more information on sources of stem cells, please visit Stem Cell Malaysia at stemcellmalaysia.comFrom:stemcells2012Views:207 9ratingsTime:04:13More inScience Technology
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Stem Cell Therapy (Cerebral Palsy) – Video
Stem Cell Therapy (Cerebral Palsy)
New Project 43From:OmarGonzalezMDViews:0 0ratingsTime:02:07More inScience Technology
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Stem Cell Therapy (Cerebral Palsy) - Video
Robert Toves Testimonial (Parkinson’s Disease) Stem Cell Therapy – Video
Robert Toves Testimonial (Parkinson #39;s Disease) Stem Cell Therapy
Robert Toves is a patient at Integra Medical Center, Mr.Toves suffers of Parkinson #39;s disease and has come to try Dr.Gonzalez method of stem cell therapy, just less than an hour after the stem cell therapy great results seem to show.From:OmarGonzalezMDViews:0 0ratingsTime:05:58More inScience Technology
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Robert Toves Testimonial (Parkinson's Disease) Stem Cell Therapy - Video
Emily Whitehead First Child Treated in Trial of T Cell Therapy for Acute Lymphoblastic Leukemia – Video
Emily Whitehead First Child Treated in Trial of T Cell Therapy for Acute Lymphoblastic Leukemia
In April 2012, 7-year-old cancer patient Emily (Emma) Whitehead became the first child to be enrolled in CTL019, a clinical trial for patients with B cell cancers such as acute lymphocytic leukemia (ALL), B cell non-Hodgkin lymphoma (NHL), and the adult disease chronic lymphocytic leukemia (CLL). Emily received this experimental treatment at The Children #39;s Hospital of Philadelphia in April 2012 after her cancer relapsed for the second time. Her cancer has been in remission since her treatment.From:ChildrensHospPhilaViews:6 0ratingsTime:06:45More inScience Technology
Cytomedix Announces Landmark Bright Cell Therapy Study in Peripheral Arterial Disease
GAITHERSBURG, MD--(Marketwire - Dec 6, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today the signing of an agreement with NIH to collaborate on a Phase 2 clinical study in patients with intermittent claudication (IC).IC is caused by peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles of the leg. The study is being funded by NHLBI/NIH and managed by the Cardiovascular Cell Therapy Research Network (CCTRN), which is also responsible for enrolling patients. The CCTRN is a network that includes seven centers in the United States with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases.
The Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.The primary endpoints of the study are safety and the change in peak walking time at 6 months compared to baseline.Additionally, changes in leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by magnetic resonance imaging (MRI) will be examined. These novel MRI techniques are incorporated into the study to assess perfusion, providing a unique set of data potentially supporting the angiogenic mechanism of Bright Cells.The clinical study has received Investigational New Drug approval from the U.S. Food and Drug Administration (FDA) and is expected to begin enrollment in Q1 2013 upon the Investigational Review Board approvals from the participating centers.
Martin P. Rosendale, Chief Executive Officer of Cytomedix, stated, "We are delighted that the CCTRN has chosen to collaborate with Cytomedix on this study.Our February acquisition of Aldagen and the Bright Cell technology has positioned us well to play a leading role in investigating promising clinical paths in regenerative medicine where there exists significant unmet medical need.We look forward to supplying a highly differentiated personalized cell therapy product to the participating CCTRN centers involved with this important PAD indication.Intermittent claudication is a serious consequence of arteriosclerosis which, if left untreated, will likely progress to pain at rest and possibly open wounds.Our experience with the AutoloGel product and the clinical treatment of lower extremity wounds resulting from CLI has provided us with a full appreciation of the difficult clinical outcomes associated with this compromised patient population.We are hopeful that improvements in lower leg blood flow will lead to increased peak walking time which has been accepted as an FDA approvable endpoint in pivotal Phase 3 trials in IC."
"This is the first randomized clinical trial to look at the benefits of autologous stem cell therapy in PAD patients with IC. It will collect important mechanistic and clinical information on the efficacy and safety of the direct injection of Bright Cells into these patients. It will also evaluate the utility of advanced imaging endpoints that could be used in the future to further understand the impact of novel therapies in this patient population," added Lem Moy, M.D., Ph.D., professor of biostatistics at the University of Texas School of Public Health, Houston, and co-author of the study protocol.
PAD is a major unmet medical need affecting approximately 8 to 10 million patients in the U.S. IC is a significant subset of the PAD population and is characterized by pain in the lower legs while in motion that resolves upon rest.Critical limb ischemia (CLI) is the advanced form of PAD, and is associated with poor clinical outcomes and increased morbidity.An important goal of medical intervention is to attempt to prevent the progression of patients from IC to CLI.This clinical studybuilds on the strong data showing increased blood flow and improved clinical status from Cytomedix's previous Phase 1/2 study of ALD-301 in CLI published last year ("A Randomized, Controlled Study of Autologous Therapy with Bone Marrow-Derived Aldehyde Dehydrogenase Bright Cells in Patients with Critical Limb Ischemia" Catheterization and Cardiovascular Interventions 2011).In the PACE study, ALD-301 will be delivered in the same manner, via direct, intramuscular injection in a grid pattern of the affected lower limb.Cytomedix will be responsible for manufacturing ALD-301 for the clinical trial and will have certain rights todata generated during the trial.
About ALD-301/ALDH Bright CellsALD-301 is a population of autologous pluripotent stem cells isolated from the patients' bone marrow using Cytomedix' proprietary Bright Cell technology.These adult stem cells express high levels of the enzyme ALDH, an indicator of biological activity in heterogeneous early stage stem cells.Preclinical research suggests that ALD-301 may promote the repair of ischemic tissue damage by producing signaling molecules that are involved in cell recruitment, cell adhesion, and angiogenesis.
About Cardiovascular Cell Therapy Research Network (CCTRN) and NHLBIThe CCTRN includes seven main stem cell centers in the United States with experience and expertise in clinical trials studying treatments for cardiovascular diseases.They are the Texas Heart Institute, the University of Florida at Gainesville, Minneapolis Heart Institute, Stanford University, University of Louisville, University of Miami and the Vascular and Cardiac Center for Adult Stem Cell Therapy in Indianapolis, Indiana.The CCTRN has successfully completed and published the results of three adult stem cell trials to date (TIME, LateTIME, and FOCUS).Further information on CCTRN is available at: cctrn.org.
The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available at: nhlbi.nih.gov.
About Cytomedix, Inc. Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel cPRP System, a blood processing device and disposable products used for the separation of blood and bone marrow into red cells, platelet poor plasma ("PPP") and PRP in surgical settings.On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com
Safe Harbor StatementStatements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.
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Cytomedix Announces Landmark Bright Cell Therapy Study in Peripheral Arterial Disease
Trillions for Global GeoEngeneering aka Chemtrails aka Aerosol Crimes – Video
Trillions for Global GeoEngeneering aka Chemtrails aka Aerosol Crimes
Petition petitions.whitehouse.gov Weather Modification, Inc. bull; 3802 #65279; 20th Street North, Fargo, ND 58102 bull; phone: 1-701-235-5500 bull; fax: #65279; 1-701-235-9717 Weather #65279; Modification, Inc http://www.weathermodification.com Investigating Chemtrails And What Is In Them http://www.stumbleupon.com Queensland went a lot further than that and recommended a very substantial long-term operational trial as well, which would have cost a great deal more than $10-million." http://www.abc.net.au August 1952 RAF in Britain conducted Operation Cumulus, which involved gliders spraying clouds with dry ice, salt or silver iodide. Within days North Devon received 250 times its normal August rainfall. Lynmouth was virtually washed away and 35 people were killed. http://www.theage.com.au June 2010 Australia announced a fast-start package of A$599 million for climate change. And climate change they did.. Inland tsunami #39;s, killing grandparents and kids, record breaking cyclones that made everyone #39;s hearts skip a beat, Ocean life washed ashore, birds dead in the street. http://www.climatechange.gov.au QLD State Government spending $17.6 million annually since 2007 aimed specifically at Geo-engineering CLOUD SEEDING programs. Since mid-January 2008 cloud seeding aircraft have made almost daily passes over the south east coast (Commonly known as CHEMTRAILS). Former Climate Change Minister Andrew McNamara said #39;there would be further flights in the next wet season. This project will focus on the Wivenhoe and Somerset dam catchments. Current ...From:TheKimrobViews:11 3ratingsTime:04:54More inNews Politics
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Trillions for Global GeoEngeneering aka Chemtrails aka Aerosol Crimes - Video
Zeitgeist
Zeitgeist Ancient Aliens : Chris White Interview
Chris White, prolific producer of countless painstakingly-researched "debunkumentaries", joins me to discuss his work on #39;Zeitgeist : The Movie #39;, the teachings of David Icke, The History Channel #39;s #39;Ancient Aliens #39; series, and his documentary #39;The New Age Its Relationship to the Antichrist. #39; ...is Jesus a myth? ... are we all the products of extra-terrestrial genetic engineering? Chris White explains. Source: themindrenewed.com Interview Notes: themindrenewed.com Podcast music: Antony Raijekov #39;s #39;Jazz U #39; freemusicarchive.org (CC BY-NC 2.5) creativecommons.orgFrom:TheMindRenewedDotComViews:1 0ratingsTime:01:13:36More inEducation
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Zeitgeist
Depths "Genetics of the Subconscious" Timeout – Video
Depths "Genetics of the Subconscious" Timeout
Wheeeeee~From:MalkyrianViews:19 2ratingsTime:01:46More inGaming
Touhou 11 SA – Extra ReimuA 967416080 (no deaths, perfect Koishi battle) – Video
Touhou 11 SA - Extra ReimuA 967416080 (no deaths, perfect Koishi battle)
What #39;s interesting is that this wasn #39;t even aiming for a perfect run; it was just a no-death run attempt. Although I took various scoring risks up until Youkai Polygraph, from Rorshach onwards I was ready to bomb. Well, until Subterranean Rose that is. Reaching 10000 graze is just a bonus on top of this. I #39;ve done it before, but only by bombing Koishi (ReimuA can get a decent amount from her spiral nonspells or Rorshach/Genetics). By the way circling around Koishi #39;s 5th nonspell seems easier than her 2nd despite them looking nearly the same. Though I still have yet to survive more than one circle. Why did I focus like that at the end? Not sure. I think it looks weird. Well, at least Reimu the Red Nose is in season. replays.gensokyo.orgFrom:KarisaMirisameViews:30 1ratingsTime:13:49More inGaming
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Touhou 11 SA - Extra ReimuA 967416080 (no deaths, perfect Koishi battle) - Video
Nobel Week Dialogue Parallel afternoon discussion panels Stream 2 – Video
Nobel Week Dialogue Parallel afternoon discussion panels Stream 2
14:30 - 15:45 2B: Genetics and Nurture: Understanding the Interactions Between Genetics and the Environment Moderator: Matt Ridley Panelists: Bruce Beutler John Dupré Mary-Claire King Helga Nowotny James WatsonFrom:thenobelprizeViews:139 2ratingsTime:02:30:36More inEducation
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Nobel Week Dialogue Parallel afternoon discussion panels Stream 2 - Video
My nephew dancing to Scream and shout! – Video
My nephew dancing to Scream and shout!
He cracks me up and is the light of my life. I could give a damn if his genetics are off. He is perfect in my eyes.From:klorissa marchettiViews:0 0ratingsTime:01:31More inPeople Blogs
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My nephew dancing to Scream and shout! - Video
Skewed X-Inactivation – Video
Skewed X-Inactivation
Project for Advanced Genetics, Fall 2012 Visual Teaching Aid Audrey Squire Erica Schindewolf No Copyright infringement intended Pictures and music taken from the internetFrom:aud712Views:8 1ratingsTime:03:38More inEducation
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Skewed X-Inactivation - Video
Dabs for farmer + Next Seeds…more importantly READ DESCRIPTION – Video
Dabs for farmer + Next Seeds...more importantly READ DESCRIPTION
Farmer is my friend and asked me to let you guys know about this situation since he is not able to let youtube know. Here is a link to Farmer #39;s facebook page where you can watch a video made by him regarding the situation. http://www.facebook.com Here is a link to Northwest Leaf. http://www.facebook.com Let them know what you think of the situation if it #39;s affecting you or the people you care about. They are making low blows now regardless of what has gone down since school of dank. From an outsiders point of view, Not the most professional way to handle this situation. It #39;s ok to take responsibility for your actions and say sorry. it turns into a whole other monster once you start lying and making excuses for your behavior. With that said, at this point, both sides are saying things out of anger we all know arguing over facebook is the most rediculous thing ever. Hopefully this issue ends in a somewhat civilized, professional, PRIVATE manner. Guess this rant isn #39;t helping 😉 Here is a comment from TGA i think sums up thier defense best, although i feel like this should be resolved in private, i #39;m doing my friend a favor and making this situation known like i said i would: "You don #39;t advertise for TGA Subcool genetics for free. We have money for our own ads... we don #39;t ride other peoples coat tails... we have our own wallet. We pay the state of California nearly 1K a month for taxes... so don #39;t pretend you were doing TGA favors, we never asked and we don #39;t need them. If you ran a TGA ...From:diavoloquasarViews:1 0ratingsTime:13:57More inHowto Style
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Dabs for farmer + Next Seeds...more importantly READ DESCRIPTION - Video
Lies-Finchel Story Ep 31 – Video
Lies-Finchel Story Ep 31
---In the car with Quinn, Brittany and Santana--- Santana:So what did you want to tell us? Quinn:Last night, well around two this morning Finn was screaming "No!" and "Please" I love you!" and "Don #39;t Leave me!" and then he woke up sweating, panting and tears streaming down his face. Santana:*laugh* Quinn:*chuckles*What? Brittany:I don #39;t get it. Santana:So he was just screaming and then woke up crying? Quinn:Yeah. I don #39;t get it. But something else happened last night just before he took Rachel home. Brittany:What did he do? Quinn:Rachel asked him who his social worker was and just before I answered he told me he had to go so I just left it. Santana:Maybe she was asking about something else. Quinn:You think? Brittany:Totally. Quinn:If you say so.*pulls up at school* All:*get out* ---Bell Rings--- Sam:*walks over*Hey.*kisses Quinn, sticks his arm out*May I escort my lady to her class. Quinn:You may. Quam:*walk away* Brittana:*walk to class* ---After school--- ---In Glee--- Everyone:*talking* Finchel:*making out* Mr Schue:*walks in*Finn, Rachel! Finchel:*stop and listen* Mr Schue:Okay, so does anyone have any songs they would like to sing? Rachel:I would. Mr Schue:Okay.*sits down* Rachel:Do I really have to say who this is for?*winks at Finn* *music starts* Does he tell he love you, When you least expect it? Does he flutter you heart, When he kisses your neck? No scientist, Or Biology, It #39;s obvious, When he #39;s holding me, It #39;s only natural, That I #39;m so effected. And my heart ...From:finchellover16Views:3 1ratingsTime:04:06More inEntertainment
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Lies-Finchel Story Ep 31 - Video
Songlian’s Madness: "Raise High" ‘s Paralyzed Denouement – Video
Songlian #39;s Madness: "Raise High" #39;s Paralyzed Denouement
The end of the Raise High story has Mistress 4 in a state of paralytic madness ("her mind #39;s not right"). A satisfying congruence perhaps with the Anglo-Gothic Bronte sisters #39; (Jane Eyre), except that the condition is imposed by circumstance and confinement, not genetics: nor is chaining nor hiding her away necessary. Is it a retrospective defence (earmuffing) against the agonized scream of Meishan #39;s deathcry (a real one, not from stagescript - for which nothing can prepare)? Or is it part of an unvanquished alliance?: In the end sequence, we see Songlian cranking away a victrola wherein is embedded the remembered (but now dead) voice: a classic formula for ghostliness (the record speaks but from "somewhere else"). But the price paid for this provocation/loyalty is a severe one: whether or not clinically so, Songlian is henceforth TREATED as insane (why else try to speak with another #39;s (a dead another #39;s) voice? From what has preceded, we should not be surprised to her the dead sing - in vengeance. But this is not vengeance, it is memory, almost childish memory. An indecisive end, but then the fate of the "House of Chen" is also, to say the least, uncertain.From:James PViews:0 0ratingsTime:06:10More inEducation
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Songlian's Madness: "Raise High" 's Paralyzed Denouement - Video
Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Data in CD30-Positive Non-Hodgkin Lymphomas and Other …
ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today summarized ADCETRIS (brentuximab vedotin) and CD30 expression data in non-Hodgkin lymphomas and other 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 encouraging interim data from a phase II clinical trial of ADCETRIS in non-Hodgkin lymphoma and long-term follow up from a pivotal clinical trial of ADCETRIS in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). In addition, investigators presented data describing the expression of CD30 in DLBCL and case studies on ADCETRIS in patients with systemic mastocytosis. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.
This collection of data from both corporate studies as well as investigator research into CD30 and the clinical role of ADCETRIS in non-Hodgkin lymphomas add to a growing body of evidence that ADCETRIS has potential in a broad array of CD30-positive malignancies, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The numerous data sets at ASH also reinforce our development strategy for the program and overall vision for ADCETRIS in the treatment of patients with significant unmet medical needs.
A Phase II Study of Brentuximab Vedotin in Patients with Relapsed or Refractory CD30-Positive Non-Hodgkin Lymphomas (Abstract #2746)
In an ongoing phase II clinical trial, patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas have been enrolled, including DLBCL and several other non-Hodgkin lymphoma subtypes. The trial is designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients. At the time of data analysis, 73 patients had been enrolled, including 44 with B-cell lymphoma and 29 with T-cell lymphoma. The median number of prior systemic therapies in both lymphoma classifications was two. Key findings include:
ADCETRIS is not approved for the treatment of the non-Hodgkin lymphoma subtypes described in this presentation.
Long-term Remissions Observed in an Ongoing Phase II Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (Abstract #2745)
A pivotal, single-arm clinical trial was conducted in 58 relapsed or refractory sALCL patients 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 two prior chemotherapy regimens.
Data highlights from long-term patient follow up in the pivotal trial were:
CD30 Expression in Diffuse Large B-Cell Lymphoma (Abstract #1558) and CD30 Expression in DLBCL and Its Relation to Important Clinical and Biological Disease Features (Abstract #1592)
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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Data in CD30-Positive Non-Hodgkin Lymphomas and Other ...
Seattle Genetics Reports Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line Mature T-Cell …
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 mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL). 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. ADCETRIS is not currently approved for use in the front-line treatment of MTCL.
In the phase I trial, newly diagnosed patients received six cycles of ADCETRIS every three weeks in combination with cyclophosphamide, doxorubicin and prednisone (CHP). This regimen removes vincristine (Oncovin) from CHOP, the standard treatment in this setting. Patients who achieved at least a partial remission after completing six cycles of combination therapy were eligible to receive continued single-agent ADCETRIS for up to ten additional 3-week cycles. The primary endpoints of the trial included defining maximum tolerated dose of ADCETRIS in combination with CHP and evaluating safety. The secondary endpoints were investigator assessment of response, progression-free survival and overall survival.
After completing combination therapy, 26 of 26 patients (100 percent) treated with ADCETRIS plus CHP had an objective response, including 23 patients (88 percent) with a complete remission. All 23 patients who achieved a complete remission demonstrated normalized glucose uptake by PET (positron emission tomography) evaluation.
The standard front-line regimen for patients with mature T-cell lymphomas is a combination chemotherapy regimen, CHOP, that has demonstrated complete remission rates of 39 to 53 percent, with a 5-year overall survival rate of less than 50 percent, said Michelle Fanale, M.D., Associate Professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. There is significant need to advance the treatment paradigm for newly diagnosed patients with these aggressive types of lymphoma. Data from this trial support further evaluation of ADCETRIS in the front-line treatment of patients with mature T-cell lymphomas.
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)
Data were reported from 26 previously untreated patients who received the combination regimen of ADCETRIS plus CHP. Nineteen patients had sALCL, and seven patients had a diagnosis of another mature T- or NK-cell lymphoma. The median age of patients was 56 years. Key findings, which were highlighted in an oral presentation by Dr. Fanale, include:
These data provide strong rationale for our planned phase III clinical trial to evaluate ADCETRIS plus CHP compared to CHOP in front-line patients with mature T-cell lymphomas, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. We are encouraged by the potential to introduce ADCETRIS into a novel regimen for these patients, with a goal of redefining front-line therapy from the standard therapeutic approach that has not seen an advance in decades.
A phase III clinical trial of ADCETRIS in CD30-positive MTCL patients is planned to compare progression-free survival in patients receiving ADCETRIS in combination with CHP (A+CHP) to patients receiving CHOP alone. The trial is expected to begin by late 2012 or early 2013.
About ADCETRIS
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Seattle Genetics Reports Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line Mature T-Cell ...
NATHAN KLEIN- FIRST MAN GENE THERAPY FOR PARKINSONS DISEASE – Video
NATHAN KLEIN- FIRST MAN GENE THERAPY FOR PARKINSONS DISEASE
FIRST MAN TO RECIEVE GROUND BREAKING GENE THERAPY FOR PARKINSONS DISEASEFrom:venture1webViews:12 0ratingsTime:03:27More inScience Technology
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NATHAN KLEIN- FIRST MAN GENE THERAPY FOR PARKINSONS DISEASE - Video
New Investigational Agent Targets Gene Signaling Pathways to Improve Therapeutic Response for Patients with Chronic …
ATLANTA, Dec.8, 2012 /PRNewswire-USNewswire/ -- The promising investigational targeted therapy ibrutinib and its mechanism of silencing gene communication pathways critical to the development of cancer may be an effective way to combat chronic lymphocytic leukemia (CLL), according to studies presented today at the 54th Annual Meeting of the American Society of Hematology (ASH).
CLL is a blood cancer that causes abnormal white blood cells called lymphocytes to accumulate in the blood, bone marrow, and in the lymph nodes or other organs, causing these organs to enlarge. Approximately 15,000 Americans are diagnosed with CLL every year; nearly 70 percent of those affected are 65 and older.[1], [2]For some patients with slower growing disease, physicians employ "watch and wait" strategies to minimize unnecessary treatment. However, patients with high-risk features such as rapidly progressing disease require prompt treatment to manage symptoms and reduce organ damage.
Ibrutinib is a specialized anti-cancer therapy that targets the Bruton's tyrosine kinase (BTK, an enzyme important in the development of CLL). As an inhibitor of BTK, ibrutinib selectively targets leukemia cells, promoting their death and preventing them from growing while leaving normal cells unharmed. Studies suggest this design allows the drug to more effectively treat the disease, with encouraging early results in harder-to-treat patient groups such as elderly untreated patients and those whose disease has become resistant to other therapies or those who have experienced disease recurrence after receiving other therapies. Two studies will present efficacy and safety results testing the compound alone and in combination with other currently used therapies for CLL.
"The evidence collected to date on ibrutinib demonstrates that it may have the potential to improve long-term prognosis for patients who are not sensitive to standard treatment," said Claire E. Dearden, MD, moderator of the press conference, Consultant Hematologist and Head of the CLL Unit at The Royal Marsden NHS Foundation Trust in London. "Equally important, the exciting efficacy and safety data that we are seeing for this drug in these studies underscore the significant progress we are making in our quest to better understand and attack the specific cellular targets responsible for CLL, particularly in these vulnerable patient populations."
This press conference will take place on Saturday, December 8, at 8:00 a.m. EST.
The Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Promotes High Response Rate, Durable Remissions, and is Tolerable in Treatment Naive (TN) and Relapsed or Refractory (RR) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Patients including Patients with High-Risk (HR) Disease: New and Updated Results of 116 Patients in Phase Ib/II Study [Abstract 189]
New research demonstrates that a novel investigational therapeutic agent called ibrutinib may be an effective and safe targeted treatment option for previously untreated, hard-to-treat, and relapsed patients with chronic lymphocytic leukemia (CLL).
Primary treatment for CLL includes a combined chemotherapy-based regimen with fludarabine and cyclophosphamide, along with the immune therapy rituximab. While rituximab is effective, it is generally not well tolerated among elderly patients. Treatment with this drug also compromises the immune system by attacking both cancerous and normal cells, putting patients at risk for a range of infections and increasing their risk of developing treatment-related acute myeloid leukemia.
To understand if ibrutinib may be effective for elderly CLL patients and to identify which patients might benefit most from the drug, researchers enrolled 116 CLL patient participants in several treatment cohorts: patients who were never treated (the treatment-naive group), those who had received two or more prior therapies (the relapsed/refractory group), those who had relapsed within two years of treatment (the high-risk group), and those over age 65. Two oral dosing regimens (420 mg or 840 mg daily) of ibrutinib were used. The primary goal of the study was to determine the safety of the low and high doses; secondary objectives included efficacy, measures of the intensity of the drug's effect in the body, and the long-term safety of administering this therapy continuously until relapse.
The study found that response to therapy was high across the cohorts, with largely manageable toxicities. Previously untreated elderly patients responded best to the agent, with 71 percent experiencing a complete or partial response at either treatment dose. The same response was observed in 67 percent of the relapsed patients and 50 percent of the high-risk patient cohort. After 22 months of follow-up, the disease had not progressed in 96 percent of previously untreated patients and 76 percent of relapsed and high-risk patients.
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