Category Archives: FDA Stem Cell Trials

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that important new data from clinical trials of several investigational and approved cancer medicines will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 31 to June 4, 2013, in Chicago. At the meeting, Genentech medicines will be highlighted in more than 275 abstracts, of which approximately one third were chosen for oral presentations. The collection of data at ASCO represents Genentechs breadth of research and includes: We need treatments that attack cancer cells in a variety of ways to continue to make a difference to the lives of people facing this disease, said Hal Barron, M.D., chief medical officer and head, Global Product Development. From harnessing a persons immune system to delivering chemotherapy directly to a cancer cell, we believe the new data from our pipeline presented at ASCO have the potential to markedly change how cancer is treated. Full session details of the 2013 Annual Meeting can be found through the ASCO iPlanner: https://www.iplanner.asco.org/am2013. Key Genentech Meeting Highlights Include: GA101: Unique Investigational Anti-CD20 Antibody The Phase III study CLL11, which is being … Continue reading →

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 →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Verastem, Inc., (VSTM) focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced the appointment of John Jack Green as Chief Financial Officer. Mr. Green was the former Chief Financial Officer of GTC Biotherapeutics and has held multiple senior finance roles in public and private biotechnology companies over the course of his career. Jack brings a great deal of experience in the financial management of biotechnology companies, said Henri Termeer, Lead Director of Verastem. On behalf of the entire board of directors, I welcome him and look forward to the contributions he will make. Cancer is an affliction that we all unfortunately have to face with our family and friends, said Mr. Green. Verastem has the potential to make a meaningful impact on many lives, and I am excited to join the team to help make these new therapeutic options a reality. Verastem has multiple programs in or entering clinical development in 2013. Verastem plans to initiate a potentially pivotal trial of lead FAK inhibitor, VS-6063, in mesothelioma midyear 2013. VS-6063 is currently being evaluated in a Phase 1/1b trial in combination with paclitaxel in patients with ovarian cancer. … Continue reading →

Studio City, CA (PRWEB) May 09, 2013 According to one nationally recognized health author/researcher, the enormous body of scientific evidence supporting turmeric's role in preventing and mediating against chronic disease is undeniable. During several years of authoring the Christian Wilde Stem Cell Research Report, exploring adult stem cell breakthroughs in FDA trials for families, the research very often revealed dramatic benefits from turmeric as well. Impressed with the degree and quality of the turmeric information, he changed the name of his Christian Wilde Stem Cell Research Report to, The Stem Cell and TURMERIC Research Report. http://abigon.com. Many of the peer journal reviewed landmark studies for catastrophic, chronic ailments have been conducted by world leading turmeric researcher, Ph.D., Bharat Aggarwal at MD Anderson Medical Center. Other researchers as well, at other university medical centers including Sloan-Kettering, UCLA, Duke, Johns Hopkins and the University of Maryland have continued to produce favorable study results for hundreds of chronic inflammatory conditions. http://www.abigon.com. India, China and Indonesia have used combinations of spices and herbs (as in the Enhanced Formula) to their health advantage for literally thousands of years. On many of his TV show episodes, Dr. Oz has acknowledged and praised Boswellia, Devils Claw and … Continue reading →

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) today reported financial results for the first quarter ended March 31, 2013. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development activities, progress with its antibody-drug conjugate (ADC) pipeline and technology and upcoming milestones. In 2013 we have continued to deliver on the ambitious goals we have set for ADCETRIS, our pipeline and our ADC technology, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. We and our collaborator, Millennium: The Takeda Oncology Company, are bringing ADCETRIS to patients in need through approvals to date in the United States, Canada, European Union and Switzerland. In addition, across both corporate and investigator-sponsored studies, there are currently more than 20 ongoing ADCETRIS clinical trials, including four phase 3 studies. Seattle Genetics is also advancing several additional ADCs, including two programs planned for phase 1 trial initiations during 2013, while our collaborators continue to advance more than a dozen ADCs in clinical development. Recent ADCETRIS Highlights Other Recent Highlights Upcoming Milestones First Quarter Financial Results Total revenues in the first quarter of 2013 were $57.3 million, compared to $48.2 million in the first quarter of 2012. First quarter 2013 revenues … Continue reading →

It takes courage to volunteer your own body to help try out an unproven medical treatment. IT began innocuously enough with a dry cough. But it was a stubborn cough that just wouldnt go away, despite being bombarded with a few rounds of antibiotics. So, the doctor advised English teacher S. Kamakshi to go for some blood tests to check for infectious diseases. But it wasnt an infection that turned out to be the culprit; it was something far more dreaded. A full blood count revealed that the then 44-year-old had an unusually high number of white blood cells floating around in her system. This immediately triggered an alarm, and she was sent off to the hospital to do a bone marrow aspiration a procedure where a needle is inserted into the pelvic or breast bone to obtain samples of bone marrow fluid in order to examine it under the microscope. That test confirmed her diagnosis; it was leukaemia, more specifically, chronic myeloid leukaemia (CML). Chromosome crossover Also known as chronic myelogenous leukaemia, this relatively rare condition is a cancer of the white blood cells that usually occurs in adults. Go here to see the original: Volunteering for clinical trials … Continue reading →

SEATTLE, May 2, 2013 /PRNewswire/ -- Cell Therapeutics, Inc.(CTI) (NASDAQ and MTA: CTIC) today reported financial results for the first quarter ended March 31, 2013. "In the first quarter, we generated initial commercial sales of PIXUVRI in countries in the European Union where there is market access pending the completion of the reimbursement process," said James Bianco, M.D., President and CEO of CTI. "Although it is early in the launch, we are pleased with the interest and receptivity of PIXUVRI by key lymphoma opinion leaders who treat patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) and who recognize the significant unmet need that exists for these patients. In addition, our Phase 3 PERSIST-1 clinical trial of pacritinib, an oral, once-daily JAK2/FLT3 inhibitor, in myelofibrosis continues to progress with the opening of additional sites and growing enrollment." First Quarter and Recent Highlights European Union (E.U.) Commercial Research and Development Corporate First Quarter 2013 Financial Results Total revenues for the first quarter of 2013 were $1.1 million. The revenues were solely attributable to net product sales of PIXUVRI. CTI sells PIXUVRI directly to health care providers and through a limited number of wholesale distributors in the E.U.CTI records product … Continue reading →

By Alexandra Sifferlin, TIME.com updated 9:06 AM EDT, Wed May 1, 2013 Hannah Warren, 2, recovers in a post-op room at the Children's Hospital of Illinois in Peoria. STORY HIGHLIGHTS (TIME.com) -- Hannah Warren was born without a trachea but now has one made from plastic fibers and a stew of her own stem cells. The 2-year-old Korean Canadian has spent every day of her life in intensive care, kept alive by a tube that substituted for the windpipe that was supposed to connect her mouth to her lungs. But nearly a month after her transplant, the toddler is mostly breathing on her own and is responding to doctors and nurses. The surgery, pioneered by Dr. Paolo Macchiarini, director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm, was only the sixth performed in the world, and Hannah was the youngest patient and first to receive the transplant in the United States. The procedure was approved by the FDA as an experimental operation for patients with very little hope of survival; being born without a trachea is fatal in 99% of cases. TIME.com: Stem cell therapies may cure chronic conditions Macchiarini performed the nine-hour operation … Continue reading →

By Alexandra Sifferlin, TIME.com updated 9:06 AM EDT, Wed May 1, 2013 Hannah Warren, 2, recovers in a post-op room at the Children's Hospital of Illinois in Peoria. STORY HIGHLIGHTS (TIME.com) -- Hannah Warren was born without a trachea but now has one made from plastic fibers and a stew of her own stem cells. The 2-year-old Korean Canadian has spent every day of her life in intensive care, kept alive by a tube that substituted for the windpipe that was supposed to connect her mouth to her lungs. But nearly a month after her transplant, the toddler is mostly breathing on her own and is responding to doctors and nurses. The surgery, pioneered by Dr. Paolo Macchiarini, director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm, was only the sixth performed in the world, and Hannah was the youngest patient and first to receive the transplant in the United States. The procedure was approved by the FDA as an experimental operation for patients with very little hope of survival; being born without a trachea is fatal in 99% of cases. TIME.com: Stem cell therapies may cure chronic conditions Macchiarini performed the nine-hour operation … Continue reading →

Jim Carlson / OSF Saint Francis Medical Center / handout / AP Darryl Warren and Lee Young-mi visit their 2-year-old daughter, Hannah Warren, in a post-op room at the Children's Hospital of Illinois in Peoria after having received a new windpipe in a landmark transplant operation on April 9, 2013. Hannah Warren was born without a trachea but now has one made from plastic fibers and a stew of her own stem cells. The 2-year-old Korean Canadian has spent every day of her life in intensive care, kept alive by a tube that substituted for the windpipe that was supposed to connect her mouth to her lungs. But nearly a month after her transplant, the toddler is mostly breathing on her own and is responding to doctors and nurses. The surgery, pioneered by Dr. Paolo Macchiarini, director of the Advanced Center for Translational Regenerative Medicine at the Karolinska Institute in Stockholm, was only the sixth performed in the world, and Hannah was the youngest patient and first to receive the transplant in the U.S. The procedure was approved by theFDAas anexperimental operation for patients with very little hope of survival; being born without a trachea is fatal in 99% of … Continue reading →