Category Archives: Diseases

ReNeuron Group (Berlin: RQE.BE - news) plc

("ReNeuron" or the "Company")

ReNeuron receives DSMB clearance to progress to higher dose in stem cell clinical trial in stroke patients

First (OTC BB: FSTC.OB - news) patient treated in this higher dose cohort

Guildford, UK, 14 August 2012: ReNeuron Group plc (AIM: RENE) today provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, taking place in Scotland, ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

The Company is pleased to report that the independent Data Safety Monitoring Board (DSMB) for the clinical trial has recommended that the trial advances to the evaluation of a higher dose of ReN001 in the third of four dose cohorts to be treated in the study. In arriving at this recommendation, the DSMB reviewed safety data from the first two dose cohorts of six patients treated with ReN001. Of these patients, two are through 18 month follow-up, one is through 12 month follow-up, one is through 9 month follow-up, one is through 6 month follow-up and one is through three month follow-up. No cell-related adverse events or adverse immune-related responses have been reported in any of the patients treated to date.

The Company is also pleased to report that the first patient in this third dose cohort of three patients has now been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising.

The primary aim of the PISCES study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.

In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at Glasgow at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan (EUREX: FMJP.EX - news) . Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

The PISCES study is the world's first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. The trial is being conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board.

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ReNeuron Group plc - Stroke Trial Update

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies and CNS therapeutics, announced that Rasheda Ali Walsh, daughter of the legendary Muhammad Ali, visited the Companys laboratories as well as its cleanrooms at Hadassah Medical Center, where she received a briefing on the companys clinical trial conducted there. Ms. Ali Walsh, an internationally known advocate for promoting research and awareness of neurodegenerative diseases, is a member of the Advisory Board of BrainStorm.

BrainStorms President, Mr. Chaim Lebovits, and CEO Dr. Adrian Harel accompanied Ms. Ali Walsh for a meeting with Prof. Dimitrios Karussis, Principal Investigator of the Companys ongoing Phase I/II clinical trial at Hadassah, and Prof. Tamir Ben-Hur, Head of the Neurology Department. The group discussed the latest innovative treatments for neurodegenerative diseases and BrainStorms leading role in this area.

Having heard so much about the recent positive interim safety report and the outstanding progress being made by BrainStorm at Hadassah, I felt the need to actually meet the team in person, commented Ms. Ali. The amazing work being done here gives a ray of hope to patients and families worldwide that autologous stem cell transplants may be the answer theyve been waiting for to overcome neurodegenerative diseases.

According to Dr. Adrian Harel, BrainStorms CEO, The support and encouragement by world-renowned individuals like Rasheda Ali is important for increasing awareness of the need for a cure for debilitating neurodegenerative diseases. We are hopeful that this awareness will lead to more widespread efforts by governments and health organizations worldwide to fund research in this area and provide assistance to patients and their families.

About BrainStorm Cell Therapeutics, Inc. BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of adult stem cell therapeutic products derived from autologous bone marrow cells and intended for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel-Aviv University. For more information, visit the companys website at http://www.brainstorm-cell.com.

Safe Harbor Statement Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as may, should, would, could, will, expect, likely, believe, plan, estimate, predict, potential, and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorms forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or managements beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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Rasheda Ali, Daughter of Legendary Muhammad Ali and Advisory Board Member of BrainStorm, Visits Company Laboratories ...

Ravel, a horse competing at the 2012 London Olympics, underwent stem cell therapy treatment that helped heal a possibly career-ending injury to one of his legs, according to the Helen Woodward Animal Center in California.

Ravel, a regular client of Rodrigo Vazquez of Equine Surgical Services at the center, is believed to be the first Olympian to benefit from a stem cell-based treatment. Ravel is now the highest scoring horse on Team USA at the Olympics.

"Ravel is a high-impact athlete," Vazquez said. "He runs the same risks as any other athlete in a high performance sport and he gets hurt like any other athlete too. But he is something special. He works hard and he's focused and he thrives in his sport. He just didn't want to quit."

The 15-year-old equine athlete, owned by Akiko Yamazaki, was united with his rider Steffen Peters in late 2006. Since then, the team has made history, with Ravel excelling in dressage, which is one of three Olympic equestrian disciplines. It involves riding and training a horse in a manner that develops obedience, flexibility and balance.

Ravel and Peters were the highest placing American pair at the 2008 Beijing Olympics, and have won numerous competitions over the years, including the prestigious Rolex/FEI World Cup in dressage.

Before these victories, Ravel sustained the leg injury. Jessica Gercke, a spokesperson for the Helen Woodward Animal Center, told Discovery News that staff working with competitive horses like Ravel do not wish to reveal detailed information about medical conditions and treatments, since that might affect the perceptions of judges or others.

Vazquez, however, did share that regular check-ups, vaccinations, dentistry and the "emergency treatment with a new technology based on stem cell therapy" helped to heal Ravel after an eight-month break in training.

Adult stem cells can reproduce and differentiate into different types of cells. They continue to be a focus of study for scientists hoping to treat a number of diseases in humans and non-human animals. In horses, to repair cartilage and tendon tissues, scientists have been looking into stem cells derived from bone.

"Bone derived cells in horses are most often obtained from an aspirate (material drawn by suction) of either the hip or sternum with apparent minimal discomfort" to the horse, according to David Frisbie, an associate professor at the Colorado State University College of Veterinary Medicine. "The procedure typically takes less than 15 minutes and can be done standing under light sedation."

Results of clinical studies on horses suggest that stem cell treatment can improve healing rates, overall outcomes, and decrease re-injury rates almost by half. Further studies are needed, however, to better determine dosage and timing specifics.

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Olympic Horse Used Stem Cell Therapy

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For many Southern California high school students, summer is synonymous with surf, sand and sun. But, for some of Los Angeles' top math and science students, the lure of the beach and traditional summer fun fizzles fast when compared to microscopes, slide kits and real-life stem cell research.

Armed with little more than protective gear and enthusiasm, 20 overachieving teenagers have been clocking 40-hour weeks in the lab at USC's Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research.

Among them is 17-year-old Brian Tom of Lincoln Heights.

Its fascinating because stem cells have all this potential to heal these degenerative diseases like Multiple Sclerosis and Alzheimer's," says Tom, a senior at Bravo Medical Magnet in Los Angeles. "It's amazing how you can create multiple tissues from one cell."

Stem cells offer promise as a treatment or cure for many diseases because they can be can induced to morph into other cell types such as brain, muscle or skin cells. Stem cells can also divide without limit, which gives them the potential to repair and replace damaged tissue.

You can just imagine the possibilities," says Sophie McAllister, a 17-year-old senior at Harvard-Westlake School in Los Angeles. McAllister works with a USC mentor on cardiac cell regeneration.

Two programs, one goal

McAllister and nine other students are in a program that's privately funded by two donors with ties to USC. Meanwhile, Tom and his summer school classmates are studying under a statewide program funded by the California Institute of Regenerative Medicine (CIRM), a voter-created agency that funds stem cell research throughout California.

CIRM has invested $1.7 million in nine high school summer programs statewide for three years.

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Summer school students help scientists advance stem cell research at USC

CARLSBAD, CA--(Marketwire -08/09/12)- International Stem Cell Corporation (ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based biotechnology company focused on therapeutic and research products, today announced financial results for the three and six months ended June 30, 2012.

Three and Six Months Ended June 30, 2012

Revenue for the three months ended June 30, 2012 totaled $1.06 million compared to $1.11 million for the three months ended June 30, 2011. The decrease in revenue was due largely to lower sales generated from Lifeline Cell Technology (LCT). LCT and Lifeline Skin Care (LSC) each accounted for approximately 50% total revenue in the three months ended June 30, 2012 compared to 52% and 48%, respectively, in the corresponding periods the prior year. Revenue for the six months ended June 30, 2012 was $2.13 million compared to $2.63 million for the corresponding period in 2011. The decrease in revenue was due principally to fewer sales generated from LSC, partially offset by LCT's higher sales generated from larger distributors. For the six months ended June 30, 2012, LSC generated $1.07 million or 50% of total revenue, compared to $1.66 million or 63% of total revenue for the corresponding period in 2011. For the six months ended June 30, 2012, LCT generated $1.06 million or 50% of total revenue, compared to $0.97 million or 37% of total revenue for same period in 2011.

Research and development expenses (R&D) were $0.87 million for the three months ended June 30, 2012, representing a decrease of approximately 23% compared to the corresponding period in 2011. The decrease was due primarily to lower consulting expenses associated with various research projects, lower stock-based compensation expense, lower laboratory-related expenses, and lower personnel-related spending. The decrease was partially offset by higher stem cell line research and testing expenses. R&D expenses were $1.80 million for the six months ended June 30, 2012, compared to $2.13 million for the same period in 2011. The 15% decrease was due primarily to lower consulting expenses associated with various research projects, lower stock-based compensation expense, lower laboratory-related expenses, and reduced travel expenses, partially offset by higher stem cell line research and testing expenses and higher personnel-related spending associated with higher headcount and increased research activities.

The Company continues to invest in its sales and marketing initiatives. Marketing expenses for the three months ended June 30, 2012 were $0.55 million, an increase of 58% from the same period in 2011. The increase was primarily driven by investments in marketing and promotion, advertising, higher shipping and logistic expenses, additions of sales and customer service staff, higher consulting expense and higher commission paid to various strategic partners. The increase was partially offset by a reduction in commission paid to a consultant who promoted, marketed, and sold skin care products through various proprietary mailings and employee stock-based compensation. For the six months ended June 30, 2012, marketing expenses amounted to $1.04 million, reflecting an increase of $0.38 million or 57%, as compared to $0.66 million for the corresponding period in 2011. The substantial increase was primarily driven by increased investments in marketing support, promotion, and advertising, higher consulting expense, higher shipping and logistic expenses, higher personnel-related expenses resulting from higher headcount in the sales and marketing of the skin care products, and higher commission paid to various strategic partners. The increase was partially offset by a reduction in sales commission paid to a consultant who promoted, marketed, and sold skin care products through various proprietary mailings and lower employee stock-based compensation.

General and administrative expenses for the three months ended June 30, 2012 were $1.76 million, down 18% compared to the same period in 2011, as a result of ongoing operational efficiency initiatives. The decrease resulted largely from lower employee stock-based compensation, reduced employee-related spending resulting from lower headcount, lower professional accounting fees, and lower corporate support expenses. The decrease was partially offset by higher legal fees relating to our corporate activities, and higher consulting expense. General and administrative expenses for the six months ended June 30, 2012 were $3.79 million, reflecting a decrease of $0.58 million or 13%, compared to $4.37 million for the same period in 2011. The decrease was primarily attributable to lower employee stock-based compensation, the absence of stock-based compensation incurred for services provided by a consultant, reduced employee-related spending resulting from lower headcount, and lower corporate support expenses. The decrease was partially offset by an increase in legal fees relating to our corporate expenses, higher consulting expense, and higher professional accounting fees related to Sarbanes-Oxley compliance efforts.

Cash and cash equivalents totaled $4.29 million at June 30, 2012 compared to $1.34 million as of December 31, 2011, due primarily to two financing transactions totaling approximately $6.9 million completed in the first six months of 2012 partially offset by normal business operations.

"We have made solid progress across our entire organization in the first half of this year," stated Dr. Andrey Semechkin, ISCO's CEO and Co-Chairman, "and I'm pleased to see that the operational efficiencies we implemented in the second quarter are resulting in lower administrative expenses. Going forward we will continue to look for further opportunities to improve our organization effectiveness and reduce expenses. As you may have read in my shareholder letter, following a detailed analysis of our research priorities, we concentrated our resources on the most promising therapeutic programs and this has already resulted in exciting achievements and progressed our programs closer to clinical development."

Q2 2012 Highlights:

Conference Call and Webcast Details:

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International Stem Cell Corp Announces Second Quarter 2012 Financial Results

DALLAS and GERMANTOWN, Md., Aug. 2, 2012 (GLOBE NEWSWIRE) -- BioLife Cell Bank, Inc., the leader in cryogenic storage of adipose (fat) tissue and adult mesenchymal stem and regenerative cells, and Intrexon Corporation, a synthetic biology company that utilizes its proprietary products to provide control over cellular function, announced today the formation of a global exclusive research collaboration. Under the collaboration, BioLife, with its extensive physician network and stem cell experience coupled with Intrexon's innovative technology, will strive to produce new treatments for Spinal Muscular Atrophy (SMA).

"With the tremendous potential of this collaboration, we are more than excited for the SMA community," said John A. Carbona, Chief Executive Officer of BioLife. "Intrexon's impressive suite of technologies will give researchers access to unprecedented resources including new techniques and processes which could rapidly propel us toward the development of new treatments and products to help treat children with SMA."

Carbona continued, "I am happy to help realize the dream of our founders, Dr. David G. Genecov and John D. Harkey Jr., to make a positive and sustainable impact in health care. We're elated by our new collaboration with Intrexon and will undertake immediately the establishment of relationships with the world's leading scientists in SMA research such as: Dr. Arthur Burgess of Ohio State, Dr. Brian Kaspar of Nationwide Children's Hospital, Dr. Charlotte Sumner of Johns Hopkins, Dr. Chris Lorson at the University of Missouri, and Dr. Kathy Swaboda at the University of Utah. BioLife, through its ongoing relationships with Intrexon and these dedicated individuals, hopes for great strides toward lessening the impact of this terrible disease, if not curing it completely--which, of course, is our ultimate goal."

Thomas D. Reed, Ph.D., Founder and Chief Science Officer of Intrexon, said, "Intrexon's mission is to invent, acquire, and integrate the diverse technology platforms required to modulate cellular behavior through genome re-engineering. We are dedicated to building the molecular toolbox and scientific expertise needed to empower clinicians to treat previously intractable diseases. SMA is a devastating genetic disorder that requires a gene rescue paradigm. Intrexon looks forward to working with BioLife and their growing network of clinical specialists to define, explore, and develop several different cell therapy approaches for treating SMA."

Under the collaboration, Intrexon, acting through its Human Therapeutics Division, will be applying its technologies to the discovery of autologous, genetically-modified stem cell therapeutics. BioLife will be supplying the collaboration with stem cells and clinical expertise. BioLife also will be responsible for conducting preclinical and clinical development of candidate SMA therapeutic products that may be advanced out of the collaboration, as well as for aspects of manufacturing and regulatory approval.

About Spinal Muscular Atrophy

Spinal Muscular Atrophy (SMA) is an autosomal-recessive genetic disorder characterized by progressive weakness of the lower motor neurons. SMA is caused by a genetic defect in the SMN1 gene which codes SMN, a protein necessary for survival of motor neurons. SMA kills more infants than any other genetic disease in today's world.

About BioLife

As part of their core business, BioLife Cell Bank, Inc. offers individuals a way to safely store their adipose (fat) tissue and/or their adipose-derived stem and regenerative cells--giving patients and physicians easy, multi-use access to cells and tissue for future cosmetic, reconstructive, and regenerative therapies. Tissue is extracted via liposuction and sent to BioLife in a collection kit (validated to E.T.L. standards). Tissue is processed using proprietary technology and Cytori Therapeutics' (CYTX) products. Tissue is cryogenically preserved, and may be stored indefinitely. BioLife is registered with the FDA as a processing bank and complies with FDA regulations and guidance including current Good Tissue Practice (cGTP). BioLife is based in Dallas, Texas, at Forest Park Medical Center. For more information: http://www.biolifecellbank.com.

About Intrexon Corporation

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BioLife Cell Bank and Intrexon Establish Worldwide Exclusive Collaboration for Spinal Muscular Atrophy (SMA)