Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
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Health Highlights: May 18, 2012
Health Highlights: May 18, 2012
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Mary Ann Liebert releases BioResearch Open Access journal
The inaugural issue of BioResearch Open Access, a new bimonthly peer-reviewed open access journal, was released today by Mary Ann Liebert, Inc., publishers. The Journal provides a new rapid-publication forum for a broad range of scientific topics including but not limited to molecular and cellular biology, tissue engineering and biomaterials, regenerative medicine, stem cells, gene therapy, systems biology, genetics, biochemistry, virology, microbiology, and neuroscience. The first issue is available on the BioResearch Open Access website at http://www.liebertpub.com/biores.
The premier issue includes research papers and a brief report from the U.S., U.K., Germany, and Korea on diverse topics such as tissue engineering, stem cells, HIV, and genetics. Forthcoming papers for the second issue include genetics, xenotransplantation, nuclear transfer, and cardiac research.
The Journal is under the leadership of Editor-in-Chief Jane Taylor, PhD, Senior Research Fellow, MRC Centre for Regenerative Medicine, University of Edinburgh, and seasoned journal editors as Section Editors, including James M. Wilson, MD, PhD, University of Pennsylvania; Antonios G. Mikos, PhD, Rice University; Professor Sir Ian Wilmut, OBE FRS FRSE, University of Edinburgh; Peter C. Johnson, MD, Scintellix, LLC, Raleigh, NC; Aubrey D.N.J. de Grey, PhD, SENS Foundation, Cambridge, UK; Alan J. Russell, PhD, Carnegie Mellon University; Thomas Hope, PhD, Northwestern University; Ganes C. Sen, PhD, Cleveland Clinic Foundation; Bruce A. Sullenger, PhD, Duke University Medical Center; Graham C. Parker, PhD, Wayne State University School of Medicine; Carol Shoshkes Reiss, PhD, New York University; Stephen C. Ekker, PhD, Mayo Clinic, Rochester, MN; John B. West, MD, PhD, University of California, San Diego; David L. Woodland, PhD, Chief Scientific Officer, Keystone Symposia on Molecular and Cellular Biology; Stephen Higgs, PhD, Kansas State University; Eugene Kolker, PhD, Seattle Children’s Hospital; and Domenico Grasso, PhD, PE, DEE, University of Vermont.
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Mary Ann Liebert releases BioResearch Open Access journal
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Stem Cells for Spinal Cord Injury: Some Patients Have Long-Term Improvement
Thirty Percent of Patients Show Improved Functioning after Stem Cell Therapy
Philadelphia, Pa. (May 17, 2012) One of the first long-term studies of stem cell treatment for spinal cord injury shows significant functional and other improvements in three out of ten patients, reports a study in the May issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
The results support the safety of mesenchymal stem cells (MSCs) derived from the patient’s own bone marrow, showing “continuous and gradual motor improvement” in at least some patients with disability caused by spinal cord injury. The lead author of the new study was Dr. Sang Ryong Jeon of University of Ulsan College of Medicine, Seoul, South Korea.
Evidence of Improved Function after MSC Treatment for Spinal Cord Injury The researchers performed MSC transplantation in ten patients with permanent motor (movement) deficits or paralysis (paraplegia or quadriplegia) after spinal cord injury. Mesenchymal stem cells are a type of “multipotent” cell that can be cultured from adult bone marrow and induced to develop into many different types of cells.
The cultured MSCs were injected directly into the injured spinal cord and the surrounding (intradural) space. Additional cells were injected after another four and eight weeks. The results were assessed by measuring improvement in the patients’ ability to move their arms and hands and to perform key activities of daily living. Imaging scans and tests of muscle activity were performed as well.
During the first six months after MSC transplantation, six of the ten patients showed improvement in motor power of the arms and hands. Of these, three patients had gradual improvement in the ability to perform daily activitiesfor example, preparing meals and typing on a keyboard.
These three patients also showed significant changes on MRI scans of the spinal cord, including evidence of healing around the injured area of the spine. They also had improvement in electrophysiologic studies of muscle electrical activity.
No Long-Term Safety Problems of MSC Transplant None of the ten patients had any permanent complications related to MSC transplantation. This helps to alleviate concerns that MSC injection could lead to later problems like the development of tumors or calcifications.
Previous studies have shown promising results with MSC transplantation in animals and humans with spinal cord injury. Mesenchymal cells have some important potential advantages for stem cell therapy, as they are a relatively easily accessible source of the patient’s own cells. The ten patients treated by Dr. Jeon and colleagues represent the first attempt at direct spinal injection of MSCs for the treatment of spinal cord injury in humans.
Following up on a previous study reporting initial improvement in six patients, the new paper describes continued improvementincluding meaningful gains in the ability to perform everyday functional tasksin three patients. Dr. Jeon and colleagues note that all three patients with progressive improvement had some “residual neurological function.” They write, “Therefore, MSC treatment is more likely to enhance the remaining neurological function rather than rengeneration.” They call for further studies to understand the mechanism of improvement after MSC treatment and to clarify which patients with spinal cord injury are most likely to benefit.
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Stem Cells for Spinal Cord Injury: Some Patients Have Long-Term Improvement
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Ilika plc – Trading Update
Ilika (LSE: IKA.L – news) plc
(“Ilika”)
Trading Update
Ilika (AIM: IKA), the advanced cleantech materials discovery company, announces substantial growth in joint development and contract research revenues in the financial year ended 30 April 2012.
Total (Other OTC: TTFNF.PK – news) revenues (including other grant income) increased to approximately 2.3 million, 21% ahead of the previous year’s total revenues (2011: 1.90m).Turnover from operations increased to approximately 2.0 million, 30% ahead of the previous year (2011: 1.54m).
Earnings before Interest, tax, depreciation, amortisation and share based payment charge improved slightly compared with last year’s reported loss of 1.81 million and losses before tax for the year improved compared with last year’s reported loss of 3.15m.
Cash balances total 5.3m at 30 April 2012, reflecting the placing announced on 4 April 2012 which raised 4.6m after expenses.
All 2012 figures are unaudited.
Commenting on these results, Graeme Purdy, Ilika’s Chief Executive, said: “We are pleased with the significant progress made in the development of products with our partners. Specific examples include:
1) One of our manufacturing partners, Sigma Aldrich (NasdaqGS: SIAL – news) , has been successful in manufacturing gram scale quantities of hydrogen storage materials based on our patented formulation and is undertaking pre-marketing activities to gauge commercial demand.
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Ilika plc – Trading Update
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Suzanne Somers 'Feeling Back To Her Old Self Again' Following Breast Augmentation
AndersonCooper.com
By Radar Staff
Suzanne Somers says she’s feeling back to her old self again following a breast augmentation using her own stem cells, after cancer surgery to remove a malignant tumour left her with uneven breasts.
“I have a hard time keeping my clothes on now,” the 65-year-old bombshell told Anderson Cooper on Thursday. “It’s so great to have two breasts.”
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The Three’s Company star said she sought the services of Japanese surgeon Dr. Kotora Yoshimura, who championed the procedure eight years ago.
“At the time when they took my breasts I didn’t want implants, I didn’t want a foreign object in my body, I didn’t want to do what they call a tram flap, which is where they cut a woman from side to side, at her hip take a muscle and blood vessel and move it up here, there’s no feeling,” she said. “I heard about a doctor in Japan, at the University of Tokyo, who had successfully regrown the breasts of over 400 Japanese women who had lost their breasts to cancer.”
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Somers explained the complicated ins-and-outs of the procedure.
“They took fat from my stomach, whipped out my stem cells, separated them, cleaned them and discarded the weak ones. They took the strong ones put them in a small amount of that fat they took from me, [injected] the concoction into this breast and ‘Poof!’ They made it the size of the other one, it has feeling, it’s soft, there are no scars.
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Suzanne Somers 'Feeling Back To Her Old Self Again' Following Breast Augmentation
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Health Canada approves Osiris’ Prochymal to treat acute GvHD in children
Osiris Therapeutics Inc. (NASDAQ: OSIR) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the world’s first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.
“I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope,” said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. “As a result of Health Canada’s comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920′s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”
Prochymal was authorized under Health Canada’s Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.
“Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.”
Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal’s safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.
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Health Canada approves Osiris’ Prochymal to treat acute GvHD in children
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Eisai Oncology to Present New Research on Product Portfolio and Pipeline at ASCO Annual Meeting
Hatfield, England (ots/PRNewswire) Eisai announced today that 12 abstracts highlighting new study results will be presented during the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, USA, from 1-5 June 2012.
These studies highlight Eisais current product portfolio and oncology pipeline, reinforcing the companys commitment to patients and their families affected by cancer.
Our human health care mission is to help address unmet medical needs and increase benefits to patients and their families, said Takashi Owa, Ph.D., Chief Scientific Officer, Eisai Product Creation Systems. Our portfolio of oncology compounds and therapies underscores our commitment to this important mission.
The following Eisai abstracts are accepted for presentation at this years ASCO meeting:
Notes to Editors
Eisai in Oncology
Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisais human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.
Halaven(R) (eribulin)
Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane.[1] Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.
Lenvatinib (E7080)
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Eisai Oncology to Present New Research on Product Portfolio and Pipeline at ASCO Annual Meeting
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Cardio3 BioSciences Has Been Selected to Present C3BS-CQR-1 Trial Data in Late Breaking Clinical Trial Session at …
MONT-SAINT-GUIBERT, Belgium, May 18, 2012 /PRNewswire/ —
The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces that the final results of its Phase II clinical trial of C3BS-CQR-1 is will be presented at the late breaking clinical trial session at the European Society of Cardiology 2012 Heart Failure Congress in Belgrade, Serbia taking place on May 19-22.
Andr Terzic, M.D., Ph.D, Director at Center of Regenerative Medicine, Mayo Clinic, the co-lead investigator on the trial, will present new final follow up data on the Company’s stem cell therapy for heart failure, C3BS-CQR-1, which is based on “Cardiopoiesis” proprietary technology. The presentation will be held on Sunday, May 20th in Belgrade, Serbia.
Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: “Being selected to present the final follow-up data in the late breaking clinical trial session at this prestigious cardiology congress highlights the quality of our technology and reiterates our belief in C3BS-CQR-1 as a potential treatment for patients with heart failure, a condition with a significant unmet medical need. We look forward to advancing the product into Phase III.”
About Cardio3 BioSciences
Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.
The Company’s lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3 BioSciences has also developed C-Cath, the next-generation injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.
C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities. As a result, of these factors investors and prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or review any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information contact:
Cardio3 BioSciences: http://www.c3bs.com Dr Christian Homsy, CEOTel : +32-10-39-41-00 Anne Portzenheim, Communication Manager aportzenheim@c3bs.com
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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London
MARLBOROUGH, Mass.–(BUSINESS WIRE)–
Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.
Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).
ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.
About SMD, Dry AMD and Degenerative Diseases of the Retina
Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit www.advancedcell.com.
Forward-Looking Statements
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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London
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Canada approves stem cell therapy
Osiris Therapeutics Inc says Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.
Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.
Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient’s body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.
The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.
Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company’s chief executive, said in an interview that could take three to four years.
Some investment analysts have been skeptical about Prochymal’s future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.
Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD — those who have more or less failed all other therapies — Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.
In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.
The Canadian authorities approved the drug on the basis of that data, the company said.
FDA SUBMISSION THIS YEAR
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