Monthly Archives: February 2012

Health Canada reviewing MS drug Gilenya, linked to 11 deaths outside Canada

Posted: Published on February 28th, 2012

TORONTO - Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths. There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya. Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role. Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya. Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated. At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect. But Health Canada says it felt the drug's benefits outweighed its risks. Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks and another a disturbance of the heart rhythm. The seven other deaths are unexplained, including one … Continue reading →

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Safety of MS pill Gilenya reviewed after deaths

Posted: Published on February 28th, 2012

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths. There have been no reports of deaths in Canada of people taking the Novartis drug, which is sold under the brand name Gilenya. Gilenya, also called fingolimod, is taken once a day for people with the relapsing-remitting form of MS. (Novartis) Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role. Both the U.S. Food and Drug Administration and the European Medicines Agency had earlier announced that they were undertaking reviews of Gilenya. Gilenya is used for treatment of relapsing-remitting MS to reduce the frequency of attacks and to delay physical disability; it is generally recommended when other MS treatments have not been effective or cannot be tolerated. At the time the drug was authorized, it was known that certain types of heart rhythm disturbances can be seen with Gilenya use and the Canadian labelling contains several warnings to this effect. But Health Canada says it felt the drug's benefits outweighed its risks. Of the 11 reported deaths, four involved serious heart-related events — three were heart attacks … Continue reading →

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Scientists urged to share data on stem cells research

Posted: Published on February 28th, 2012

By Noimot Olayiwola Staff Reporter Researchers and scientists in the field of both embryonic and adult stem cells research in the Middle East were yesterday urged to be more open to collaboration and networking among themselves in order to build on their already acquired and existing strengths for the betterment of the future use of stem cells in curing genetic diseases in the region. Stem cells are ‘unspecialised’ cells that are able to divide and produce copies of themselves and having the potential to differentiate, that is, to produce other cell types in the body. Speaking on how to further expand the scope of stem cell research in the region during a panel discussion yesterday at the ongoing Qatar International Conference on Stem Cell Science and Policy, Weill Cornell Medical College in Qatar’s Dr Jeremie Arash Rafii Tabrizi said there was the need for the region’s researchers in the field of stem cells to know each other and come together to network and form collaborations. “I believe that each and everyone in the field within this region has built some sort of strength while conducting their individual researches, so I will suggest that we all come together to put heads … Continue reading →

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Stem cell fertility treatments could be risky for older women

Posted: Published on February 28th, 2012

Harvard scientists are challenging traditional medical logic that dictates that women are born with a finite amount of eggs.  The scientists said they have discovered the ovaries of young women harbor rare stem cells that are in fact capable of producing new eggs. If properly harnessed, those stem cells may someday lead to new treatments for women suffering from infertility due to cancer or other diseases – or for those who are simply getting older, according to the researchers.  Lead researcher Jonathan Tilly of Harvard's Massachusetts General Hospital has co-founded a company, OvaScience Inc., to try to develop the findings into fertility treatments. The idea that women are born with all the egg cells – called oocytes – they’ll ever have has been called into question by past research, which found egg-producing stem cells in adult mice. In this latest study, Harvard researchers, in collaboration with Japanese scientists, used donated frozen ovaries from 20 year olds and ‘fished out’ the purported stem cells.   The researchers inserted a gene into the stem cells, which caused them to glow green.  If the cells produced eggs, those would glow green, too. The researchers first watched through a microscope as new eggs grew … Continue reading →

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New Stem Cell Research Could End the Hard Stop of Female Fertility

Posted: Published on February 28th, 2012

A long-held belief about women and fertility is that each woman has a set amount of eggs in her lifetime and that when those eggs are depleted at menopause, so are her chances at having a biological child. However, research out of Massachusetts General Hospital questioning that view. Using stem cells taken from human ovaries, scientists have produced early-stage eggs, which brings up all sorts of questions about possible new methods for treating infertility. Nicholas Wade, writing in the New York Times, adds, "The ability to isolate stem cells from which eggs could be cultivated would help not only with fertility but also with biologists’ understanding of how drugs and nutrition affect the egg cells." RELATED: Gecko Foot Glue; When Alcohol Is a Health Food Jonathan Tilly, the director of Mass General's Vincent Center for Reproductive Biology and leader of the new research, had reported in 2004 that ovarian stem cells in mice could create new eggs "similar to how stem cells in male testes produce sperm throughout a man’s life." His new study attempted to prove this with humans. Researchers took healthy ovaries from patients having sex reassignment surgery, and injected stem cells from the ovaries into human ovarian tissue grafted … Continue reading →

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Bad breath being used in Stem Cell research

Posted: Published on February 28th, 2012

SALT LAKE CITY — Researchers may have found a use for the chemical that causes the stench in bad breath, stink bombs, and flatulence. This smelly substance known as Hydrogen Sulphide has been used in helping to convert stem cells from human teeth into liver cells. The scientists conducting the investigation and research in the Journal of Breath Research claim that the gas increased the purity of the stem cells. The goal is that the liver cells produced from the stem cells could be used for repair if the organ was damaged. Hydrogen Sulphide is produced by bacteria, and is toxic in large amounts. A group in China has reportedly tested the gas on rats to enhance the survival of mesenchymal stem cells taken from the bone marrow. Researchers from the Nippon Dental University were investigating stem cells from dental pulp — the material in the middle of the tooth. The dental pulp was taken from patients undergoing a routine tooth extraction. Dr. Ken Yaegaki, the lead author of the study, told the BBC why the dental pulp was so effective. "High purity means there are less 'wrong cells' that are being differentiated to other tissues, or remaining as stem … Continue reading →

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Story on human genetic origins is one of EurekAlert!s most-visited releases in 2011

Posted: Published on February 28th, 2012

Public release date: 27-Feb-2012 [ | E-mail | Share ] Contact: Jennifer Santisi jsantisi@aaas.org 202-326-6213 American Association for the Advancement of Science A striking discovery in the study of human genetics was the focus of the most-visited press release posted on EurekAlert! in 2011. Researchers found that part of the non-African human X chromosome came from Neanderthals, confirming that they interbred with early human populations. Breakthroughs in mathematics, physics, chemistry, and medicine, along with discoveries in zoology, psychology, and astrobiology, were also featured in the 10 releases most often viewed by EurekAlert! readers in 2011. Website statistics collected over the course of the year identified the year's 10 most-visited news releases. The No. 1 most-visited press release garnered over 102,000 views. The (love) connection between early humans and Neanderthals described in 2011's most-visited news release Researchers from the University of Montreal and the CHU Sainte-Justine Research Center answered a nearly 10-year-old question concerning the origin of a part of the human X chromosome that shows characteristics different from the rest of the chromosome. Using the Neanderthal genome, which was sequenced in 2010, to compare with the human genome, researchers found a match. The mysterious piece of the human X chromosome's … Continue reading →

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Ultragenyx Granted Orphan Drug Designation for UX003 for the Treatment of Mucopolysaccharidosis Type 7 (MPS 7)

Posted: Published on February 28th, 2012

NOVATO, Calif., Feb. 28, 2012 /PRNewswire/ -- Ultragenyx Pharmaceutical Inc., a biotechnology company focused on developing treatments for rare and ultra-rare genetic disorders, today announced that the FDA Office of Orphan Products Development has granted orphan drug designation for UX003 for the treatment of MPS 7.  MPS 7 is an extremely rare autosomal recessive lysosomal storage disorder characterized by a deficiency of the lysosomal enzyme Beta-glucuronidase, required for the degradation of the glycosaminoglycans dermatan sulfate (DS) and heparan sulfate (HS).  UX003 is a recombinant human Beta-glucuronidase intended as an enzyme replacement therapy for the treatment of MPS 7.  MPS 7 was originally described in 1973 by William Sly, MD, St. Louis University School of Medicine, and is also known as Sly Syndrome. Ultragenyx in-licensed the MPS 7 program from St. Louis University.  su "Obtaining orphan drug designation for UX003 is a significant achievement for Ultragenyx that adds value to our development pipeline and attests to the importance of this product candidate in filling an unmet medical need," said Emil D. Kakkis, MD, PhD, Chief Executive Officer of Ultragenyx. "We look forward to continuing to collaborate with Dr. Sly and colleagues at St. Louis University to advance this urgently needed therapy … Continue reading →

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‘Scope for innovation in genetic medicine’

Posted: Published on February 28th, 2012

There is a tremendous opportunity in genetic medicine for innovation and for new players to make significant contributions, because it is still experimental, noted biologist and Nobel Laureate Dr David Baltimore said yesterday. “Today, it is mainly the province of biotechnology companies and universities, not big pharmaceutical companies,” he observed in a keynote presentation at the Qatar International Conference on Stem Cell Science and Policy 2012. There are new genetic tools available – though they are still experimental - to treat diseases which involve adding, subtracting or modifying genes in the cells of the body. “However, they are powerful tools and I am confident they will be an important part of the medicine of the future,” he said. Speaking on ‘The hematopoietic stem cell (HSC) as a target for therapy against cancer and Aids,’ Dr Baltimore explained that HSCs are one of the few cell types routinely used for bone marrow transplant. The HSCs are easily accessible, retroviruses can be used to carry genes into these stem cells, the genes are then expressed in all of cells that derive from the HSC and can correct inherited defects and bring genes that perform therapy under a programme called engineering immunity. “Though … Continue reading →

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Bioheart Announces University of Miami as Clinical Site for ANGEL Trial of LipiCell(TM)

Posted: Published on February 28th, 2012

SUNRISE, Fla., Feb. 28, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced that the company will conduct the ANGEL trial using adipose (fat) derived stem cell technology or LipiCell(TM) at the University of Miami Miller School of Medicine. Bioheart recently applied to the FDA to begin trials using adipose derived stem cells in patients with chronic ischemic cardiomyopathy. "Dr. Joshua Hare and the University of Miami are world leaders in the field of stem cell research," said Mike Tomas, President and CEO of Bioheart. "We look forward to working with these acclaimed experts and bringing the LipiCell(TM) technology to patients in the U.S." The clinical protocol of the ANGEL trial is designed to assess the safety and cardiovascular effects of intramyocardial implantation of autologous adipose derived stem cells (LipiCell(TM)) in patients with chronic ischemic cardiomyopathy. Joshua Hare, MD, Director of the Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine is the principle investigator of the clinical program. The Interdisciplinary Stem Cell Institute was established to capitalize on pioneering work in the use of adult stem cells for the repair of malfunctioning human organs. The goal of the Institute is to find new treatments for heart … Continue reading →

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