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ALS
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Joi, 18 Decembrie 2008 22:24 |
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Source: Business Journal
Neuralstem Inc. has filed its first application to test its stem cell technology in humans in an effort to treat the incurable Lou Gehrig’s Disease.
If federal regulators approve the application early next year, the Rockville company plans to launch the trials in the first half of 2009 at Emory University, though a University of Michigan Medical School neurology professor will oversee the overall testing.
The company has raised more than $1.7 million in a stock offering to help pay for the trials. The fundraising, which elicited $2 million in gross proceeds and closed on Wednesday, entailed the sale of 1.6 million shares at a price of $1.25 per share, a nearly 43 percent discount from Wednesday’s closing price of $2.18.
In its first phase of clinical studies, Neuralstem (AMEX: CUR) has proposed testing whether its use of fetal stem cells and method of injecting them into a patient’s spinal cord, a process it recently licensed in from the Cleveland Clinic at Emory University, are safe and possible in humans. The company also hopes to see how effective the combination are in slowing the degenerative process that results in paralysis and eventual death in Lou Gehrig’s Disease, officially known as amyotrophic lateral sclerosis, or ALS.
In a study published in the journal Transplantation, the company and Johns Hopkins University researcher collaborators showed that the stem cells extended the life of rats ridden with Lou Gehrig’s Disease.
Six to nine months after starting the U.S. trial, Neuralstem has said it plans to launch another in Taiwan, where the company signed an agreement with the China Medical University and Hospital of Taiwan.
It’s a key starting point for the small company, housed in Rockville’s Maryland Technology Development Center incubator, which has been developing the fetal stem cell technology for the past 13 years. It’s working on injecting fetal cells, a less politically charged option than embryonic stem cells, to replace dead or damaged nerve cells to help turn around such neurological disorders as ischemic spastic paraplegia and Huntington’s Disease.
“The filing of this IND is an important event for Neuralstem,” said CEO Richard Garr. “But it marks only the beginning of a process which includes working together with the FDA to approve the first human ALS stem cell trial; refining our understanding of how to optimize delivery of our cells into patients; and ultimately delivering a new treatment for patients with this currently incurable disease.”
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ALS
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Marţi, 02 Decembrie 2008 23:39 |
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Source: UK sys-con
ROCKVILLE, Md., Dec. 2 /PRNewswire-FirstCall/ -- Neuralstem Inc. (NYSE Alternext US: CUR) announced today that it has entered into a collaboration with the China Medical University & Hospital of Taiwan, to advance development of Neuralstem's human spinal cord neural stem cell therapies. The collaboration will focus on Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) with Dr. Shinn-Zong Lin, MD, PhD as principle investigator.
"We are pleased to have established this collaboration in Taiwan," said Richard Garr, Neuralstem President & CEO. "The goal is to qualify our existing cGMP spinal cord cells into a human trial program to treat ALS in Taiwan. We would expect the Taiwan trial to follow the U.S. trial by about 6 to 9 months. As we prepare to submit an IND to treat ALS with our stem cells in the U.S. this fall, we continue to look for strategic relationships in both Europe and Asia that will allow us to move the cells into humans. Taiwan is a substantial and important market in Asia, and China Medical University is the National leader in innovative neurological research and treatments. We are very pleased to be adding them as another partner as we build out our worldwide network of neurosurgical centers capable of conducting clinical trials, and ultimately delivering our cell therapies."
About Neuralstem
Neuralstem's patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia.
Major Central Nervous System diseases targeted by the Company with research programs currently underway include: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury and ALS. The company's cells have extended the life of rats with ALS (Lou Gehrig's disease) as reported the journal TRANSPLANTATION, in collaboration with Johns Hopkins University researchers, and also reversed paralysis in rats with Ischemic Spastic Paraplegia, as reported in NEUROSCIENCE on June 29, 2007, in collaboration with researchers at University of California San Diego. The Company expects to file its first IND (Investigational New Drug) application with the FDA for ALS in the fall.
Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward- looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10- KSB for the year ended December 31, 2007 and the quarterly report on form 10-Q for the period ended September 30, 2008.
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ALS
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Marţi, 29 Iulie 2008 19:40 |
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Source: Earth Times
Bi-coastal collaboration aimed at applying stem cell technology to an 'orphan disease' in a unique translational research setting
CAMBRIDGE, Mass. and IRVINE, Calif., July 29 /PRNewswire-USNewswire/ -- ALS Therapy Development Institute (ALS TDI) and California Stem Cell, Inc. (CSC) announced today a new collaboration aimed at advancing any potential application of stem cells in treating ALS - amyotrophic lateral sclerosis, commonly known as Lou Gehrig's diseases. The new set of experiments will begin in August 2008 and continue through the end of 2009. This effort is the latest in the two groups' on-going partnership to understand how stem cells, and their derivatives, may be used as part of a therapeutic strategy to treat or cure the fatal neurodegenerative disease.
"It is no mystery to us in the ALS community that stem cells ought to be looked at and considered by researchers. The work we are doing together with California Stem Cell will help to make sure that we are leaving no stone unturned in our mission to discover and develop an effective treatment that will slow or stop ALS," said Sean Scott, president of ALS TDI.
ALS is a neurodegenerative disease resulting in progressive paralysis and is considered fatal. The disease strikes typically without an identifiable cause, indiscriminately affecting a new family every 90 minutes in the U.S. That incidence rate is similar to that of multiple sclerosis, but the typical survival prognosis given to a new ALS patient is only 2-5 years from their date of diagnosis. Currently, there is no known cure for ALS and only one FDA-approved drug, with marginal efficacy, for treating the disease.
"ALS TDI is a natural partner. Their expertise in preclinical research focused on ALS is unparalleled. With ALS TDI we have access to a dedicated and passionate group of experts that can help to fully understand how stem cell derived products may play a role in a potential therapeutic for this horrible disease," said Chris Airriess, chief operating officer for California Stem Cell, Inc.
California Stem Cell recently presented the findings from the two groups' previous collaboration during the International Society for Stem Cell Research annual meeting June 11th in Philadelphia.
In that experiment, the two groups worked together to design and execute experiments aimed at transplanting high purity motor neurons developed and manufactured by CSC, into the spinal cords of mice with neuronal loss at ALS TDI.
The collaborations between ALS TDI and CSC are funded in part through a major, three-year, $18 million funding and scientific partnership ALS TDI entered into at the beginning of 2007 with the Muscular Dystrophy Association (MDA) and its Augie's Quest Initiative.
About the ALS Therapy Development Institute
The ALS Therapy Development Institute (ALS TDI) (www.als.net), based in Cambridge, Mass., operates the world's largest research and development program focused exclusively on ALS. At ALS TDI, a staff of over 30 scientists and research technicians work on behalf of ALS patients to discover and advance novel therapeutics for treating and ultimately curing ALS. The nonprofit biotechnology institute excels in identifying novel disease targets, discovering compounds that may act against these targets, and screening potential treatments for clinical development.
About Augie's Quest
Fitness pioneer Augie Nieto started Augie's Quest (www.augiesquest.org) in conjunction with MDA's ALS Division. Nieto is co-founder and former president of Life Fitness of Chicago, and chairman of Octane Fitness. He and his wife, Lynne, serve as co-chairpersons of MDA's ALS Division. Nieto received a diagnosis of ALS in March 2005.
About MDA
MDA (www.mda.org) is the world's largest provider of ALS services and funder of ALS research. Over the years, it has expended almost $210 million in this effort. It operates 225 neuromuscular disease clinics across the country and 38 ALS-specific research and care centers.
CONTACT: Robert Goldstein of ALS TDI, +1-617-441-7295,
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; or Chris Airriess of California Stem Cell, +1-949-534-9149,
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ALS
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Marţi, 15 Iulie 2008 19:59 |
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Source: Pilot & Today
Steamboat Springs — As they reached mile 1,450 of a 2,600-mile, cross-country bike tour Wednesday, three friends pulled into Concordia Lutheran Church to spend the night.
It was a familiar stopping point — with no sleeping bags, no tents and only one change of clothes, the spartan travelers have recently found refuge in a network of churches across the nation.
Mark Price, 22, and 23-year-olds Jon Lugar and Nic Huffman hit Steamboat Springs in about the middle of their cycling trip from Indianapolis to San Francisco. Recent graduates from Anderson University in Indiana, they are traveling as cheaply as possible as they pedal to raise money for ALS, also known as Lou Gehrig’s disease.
After a friend’s grandfather died from the progressive, non-treatable disease, the three friends decided to raise money for ALS research before they hit the road. They said they ran into bureaucratic pitfalls in an attempt to gain corporate sponsorship, but they did manage to raise nearly $1,000 from individual sponsors before they began riding on June 15, and they hope to raise more after the ride is finished July 31.
At first, they tried to use only Church of God churches to rest during the night, because their college is affiliated with the church. However, the trio soon expanded to all denominations. Their strategy has paid off, as they have had to sleep in hotels only twice during the trip.
Steamboat Springs also provided the trio their first chance to speak with a person afflicted with ALS. They said they had met many people who had lost friends or family to the disease, but Steamboat’s Larry Stevenson put ALS in a new perspective.
“Larry’s the first person we have come across who has the disease, instead of people with a family member who died from it,” Huffman said. “We appreciated the chance to talk to him.”
Stevenson, who was diagnosed with ALS in 1998 and has been in a wheelchair for the past three years, met with the men briefly and thanked them for their fundraising efforts. Before he contracted the disease, Stevenson was an owner of Alpine Insurance.
Stevenson said he was happy the trio was raising money for the disease. He said that although gene therapy and stem cell research have shown progress in finding a treatment for ALS, a cure has not yet been discovered.
Kansas tough
Price began marking out the trip’s route early in 2008. The path has taken them through small towns in Indiana, Ohio, Illinois, Missouri, Kansas and now Colorado.
Huffman said the most difficult segment of the trip surprised them.
“Northeastern Kansas was easily the most difficult,” he said. “It was very hilly, and I wasn’t expecting that.”
The three agreed that the mountains of Colorado were easier in comparison because there was beautiful scenery to distract them as they rode.
“We didn’t expect any town this big to be in the middle of the mountains,” Price said. Steamboat was the third largest town they have passed through along the ride, behind only Denver and Quincy, Ill.
They have stopped for only one day, when they joined a friend to watch a Colorado Rockies baseball game July 4. They also will stop on the Nevada and California border for an extra day at Lake Tahoe for some cliff diving but are on an otherwise tight schedule. They plan to arrive in San Francisco on Aug. 1 and have a plane ticket booked to return home Aug. 8. On Aug. 11, Price will begin medical school at Ohio State University. Huffman will begin as a track coach at Anderson shortly after that.
They are traveling from at least 26 to more than 100 miles a day. They plan to follow U.S. Highway 40 through the remainder of Colorado, ride to Salt Lake City and then break south through Northern Nevada on their way to the coast.
“We plan to get to the ocean and say ‘Well, that’s as far as we can go,’” Huffman said.
— To reach Zach Fridell, call 871-4208
or e-mail
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