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NeuroPhage Reports Beneficial Effects of its Drug Candidate in a Pre-clinical Study of Parkinson's Disease Funded by …

Posted: Published on October 18th, 2012

CAMBRIDGE, Mass., Oct.17, 2012 /PRNewswire/ --NeuroPhage Pharmaceuticals, Inc. announced today positive data with NPT001 in an alpha-synuclein pre-clinical model for Parkinson's disease (PD). The study was funded by The Michael J. Fox Foundation (MJFF). NPT001 is a first-in-class drug candidate with potential disease-modifying activity that disrupts and clears a variety of amyloid aggregates in the brain. In addition to reducing beta amyloid and tau aggregates in Alzheimer's disease (AD) preclinical studies, the new study demonstrates that NPT001 disrupts alpha-synuclein fibrils which are thought to play a critical role in PD. The study was conducted in collaboration with Dr. Eliezer Masliah at the University of California San Diego (UCSD) and demonstrated that a single NPT001 treatment produced significant reductions in neuropathology along with improved motor performance in the PD model. Specifically, NPT001 significantly reduced alpha-synuclein deposits in the brain and restored dopamine-producing cells to normal function. Deficits in dopamine production are responsible for many of the behavioral dysfunctions in PD. In addition, NPT001 was well-tolerated and produced no observable adverse effects. The data will be presented at the upcoming 2013 ADPD meeting in Florence, Italy. "The effects produced by NPT001 are robust and impressive, and the treatment improved the critical functions … Continue reading →

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Calgarians head to international concussion conference

Posted: Published on October 18th, 2012

A group of University of Calgary researchers are off to Switzerland for an International Conference on Concussions to share ideas on new detection and treatment methods for the brain injury. Kathryn Schneider is a physiotherapist at the U of Cs Sport Injury Prevention Research Centre. She says concussions are not just about focusing on the brain anymore. Often times individuals, following concussions, report symptoms of dizziness and of blurred vision. So it's something that may help us to then learn more about what happens following a concussion, Schneider said. Schneider will join the U of Cs Dr. Willem Meeuwisse at the meeting in Zurich. Meeuwisse says a lot has changed in the four years since the last conference. At that time the only remedy for a concussion was rest. The problem is for the 30 per cent of people that are not better right away, what do you do with them? Is it more rest, or is it something you can actually intervene or do? Meeuwisse said. Meeuwisse says they're getting closer to answering those questions. The latest information on concussions will be released in a report in April. More: Calgarians head to international concussion conference … Continue reading →

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New advance could help soldiers, athletes, others rebound from traumatic brain injuries

Posted: Published on October 18th, 2012

A potential new treatment for traumatic brain injury (TBI), which affects thousands of soldiers, auto accident victims, athletes and others each year, has shown promise in laboratory research, scientists are reporting. TBI can occur in individuals who experience a violent blow to the head that makes the brain collide with the inside of the skull, a gunshot injury or exposure to a nearby explosion. The report on TBI, which currently cannot be treated and may result in permanent brain damage or death, appears in the journal ACS Nano. Thomas Kent, James Tour and colleagues explain that TBI disrupts the supply of oxygen-rich blood to the brain. With the brain so oxygen-needyaccounting for only 2 percent of a person's weight, but claiming 20 percent of the body's oxygen supplyeven a mild injury, such as a concussion, can have serious consequences. Reduced blood flow and resuscitation result in a build-up of free-radicals, which can kill brain cells. Despite years of far-ranging efforts, no effective treatment has emerged for TBI. That's why the scientists tried a new approach, based on nanoparticles so small that 1000 would fit across the width of a human hair. They describe development and successful laboratory tests of nanoparticles, … Continue reading →

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Canadian study tracks MS patients after ‘liberation treatment’ – 09/10/2012 – Video

Posted: Published on October 18th, 2012

12-10-2012 13:48 Canadian study that tracked 80 multiple sclerosis patients who underwent the controversial "liberation treatment" outside of the country suggests that about half of them saw their symptoms improve after the procedure. Researchers in British Columbia surveyed 80 people over the phone one year after they received the controversial treatment, which involves opening up blocked veins to improve blood flow from the brain. "The picture that seems to be coming out is that about half of the patients feel some improvements in MS symptoms. The degree of improvements ranges from mild to significant," Dr. Anthony Traboulsee, medical director of the UBC Hospital MS Clinic, told CTV News. "And about half the patients feel exactly the same as before the procedure or worse." About 11 per cent of surveyed patients reported complications around the time they received the liberation treatment. Another 13.8 per cent experienced troubles up to one month afterward. Pain and bleeding were among the complications experienced. One patient suffered a stroke after the procedure while another one reported symptoms similar to those of a heart attack. Nine patients had difficulties related to the procedure itself. One reported insufficient anesthetic and said they woke up near the end … Continue reading →

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New Method Harvests Stem Cells From Cadavers

Posted: Published on October 18th, 2012

October 17, 2012 Michael Harper for redOrbit.com Your Universe Online Stem cell research, as promising as it may be, has always run into some controversial matters of ethics. As such, research into these stem cells and their relatively untapped potential could be hampered by these legal and political roadblocks. Now new research has discovered a method of harvesting pockets of cells from the scalps and brain linings of recently deceased humans then repurposing them as stem cells. With this new method, stem cells could only be a trip to the morgue away. Armed with these stem cells, scientists could develop new cell therapies as well as gain a better understanding of developmental disorders such as autism, bipolar disorder and schizophrenia. The trouble now, according to Ronald D.G. McKay of the National Institute of Neurological Disorders and Stroke, is knowing which stem cells come from embryos and which come from adult, mature human cells. Speaking with ABC News, McKay explained that there are big differences between the stem cells and so far scientists dont know enough about the two to accurately distinguish them. Fred H. Gage of the Salk Institute in LaJolla, California, who led the research, agrees. We cant look … Continue reading →

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Casey Analyst Forecasts Explosive Biotech Growth

Posted: Published on October 18th, 2012

Submitted by The Life Sciences Report as part of our contributors program . This interview was conducted by The Life Sciences Report (10/11/12) The myth of technology, whether for smartphones or cancer treatments, is that the next big thing appears suddenly and magically. Casey Research Analyst Alex Daley sets the record straight in this exclusive interview with The Life Sciences Report . While the science of genetic medicine has accelerated the process of turning magical thinking into practical medicine, Daley cautions investors in biotech and medical device companies to be patient, and names companies with innovative technologies poised for explosive growth. The Life Sciences Report: At Casey Research's "Navigating the Politicized Economy" summit, you talked about the difference between the speed of science and the speed of technology, and how quickly the time to market and cost of products in the life sciences space is decreasing. Can you provide some examples? Alex Daley: Many technologies, like the touch-screen tablets and smartphones that now dominate the market, seem to come out of nowhere, perpetuating the myth of technology as almost magical. But you only have to look as far as the as-yet-unfulfilled promises of recent years to see the slow development … Continue reading →

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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell …

Posted: Published on October 18th, 2012

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM). "There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner. Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for … Continue reading →

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FDA issues warning letter to local stem cell company

Posted: Published on October 18th, 2012

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug. In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA. "Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday. The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The new warning letter reiterates those problems and asks for more information about them. David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA. In a … Continue reading →

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FDA issues warning to local stem cell company

Posted: Published on October 18th, 2012

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug. In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA. "Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday. The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The new warning letter reiterates those problems and asks for more information about them. David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA. In a … Continue reading →

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FDA issues warning to Sugar Land stem cell company

Posted: Published on October 18th, 2012

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug. In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA. "Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday. The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests. The new warning letter reiterates those problems and asks for more information about them. David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA. In a … Continue reading →

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