New data presented at the 12th International Congress of Parkinson’s Disease and Movement Disorders prove that ropinirole is a highly effective molecule in managing Parkinson’s disease (PD). Results from the PREPARED study confirm that Requip-Modutab* (ropinirole prolonged release tablets) offers a highly effective and more simplified treatment regimen compared to ropinirole 3x daily, by providing continuous delivery of ropinirole day and night from a single daily dose1.

Professor Stocchi, lead trial investigator and Professor of Neurology, IRCCS San Raffaele, Rome, Italy commented: “For PD patients, continuous control of symptoms throughout the day and night is critical. Patients currently experience unpredictability in managing their disease on a daily basis. The results of the PREPARED study verify that Requip-Modutab is extremely effective in treating the complex, unpredictable nature of the disease. By using the Requip-Modutab treatment approach, patients are able to achieve clinically more significant outcomes compared with the intermittent delivery of ropinirole 3x daily. The improvement in symptom control provided by Requip-Modutab should significantly improve patients’ quality of life.”

The study compared two treatment approaches using once-daily Requip-Modutab and the ropinirole 3x daily formulation as adjunct therapy in patients with advanced PD. Patients using Requip-Modutab maintained a ≥20% reduction in ‘off’ time versus those taking ropinirole 3x daily (66% versus 51%) and were able to achieve a greater reduction in L-dopa dose compared with the 3x daily formulation. By using Requip-Modutab, patients are more easily able to access the full range of doses. Therefore the most clinically appropriate treatment dose can be reached more rapidly and simply than with ropinirole 3x daily. Whilst patients were able to reach higher doses with Requip-Modutab (mean dose of 18.6mg/day versus 8.9mg/day with ropinirole 3x daily), both treatment formulations were generally well tolerated.

Data from the study confirm that patients taking adjunctive Requip-Modutab demonstrate significant improvement on the CGI-I scale (54% versus 42% for ropinirole 3x daily) highlighting better patient outcomes with the Requip-Modutab treatment approach compared with intermittent delivery of ropinirole 3x daily.

In addition, a recent adherence survey suggests that therapies that offer simplified dosing regimens and provide less intermittent dosing during the day may reduce tablet burden, improve adherence and result in optimal symptom management2. Interim results from a pan-European survey revealed that 42% of PD patients (n= 1,026) needed to plan their day around the times they take their medication, highlighting an unmet need for simplified treatment regimens3.
vRequip-Modutab uses SkyePharma PLC’s (LSE: SKP) patented GEOMATRIX® technology. The new formulation has been developed to provide a continuous delivery of ropinirole over 24 hours, resulting in reduced fluctuations in plasma concentrations associated with ropinirole 3x daily. Requip-Modutab is the first and only oral non-ergot once daily dopamine agonist for the treatment of PD.

About GlaxoSmithKline

Ropinirole (ReQuip) was developed by and is marketed by GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies. For detailed company information, see GlaxoSmithKline’s website: http://www.gsk.com.

About SkyePharma PLC

Using it proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules. The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit http://www.skyepharma.com.

About The Prepared Study

The PREPARED study was a randomised, double-blind, double-dummy, parallel group study which compared treatment approaches using Requip-Modutab and ropinirole 3x daily as adjunct therapy over 24 weeks in patients with advanced PD. The primary endpoint was the percentage of patients maintaining a ≥20% reduction from baseline in ‘off’ time over two consecutive visits at week 24.

About The Adherence Study

The study assessed adherence among 250 PD patients taking ropinirole immediate release (IR) at least three times daily (TID), patient-reported drivers and consequences of non-adherence, and interest in a once daily formulation of ropinirole. The survey reported that patients were not adherent with their medications for a variety of reasons. Nonadherence resulted in breakthrough symptoms that affect quality of life.

Approval Status

Requip-Modutab has been approved and launched in 15 European countries (Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Slovak Republic, Slovenia, Sweden, Switzerland, UK).

*Requip-Modutab will also be known as Requip LP, Requip XL, Requip Depot, Requip Prolib and Requip prolonged release tablets.

References

1.Schapira HV et al.,editors. Abstract for the 12th International Congress of Parkinson’s Disease and Movement Disorders; 2008 22-26 June; Chicago, USA

2.Edin HM et al., editors. Abstract for the 12th International Congress of Parkinson’s Disease and Movement Disorders; 2008 22-26 June; Chicago, USA

3.EPDA. Real Life, Real PD Survey Interim Pan-European Results. 2007

SkyePharma PLC

View drug information on Requip.

GlaxoSmithKline announced the approval of Requip® XL™(ropinirole extended-release tablets) in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Itis the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson’s disease. The product should be available in U.S. pharmacies in mid-July 2008.

Patients with Parkinson’s disease may experience what is commonly known as “off” time when their medication wears off and their symptoms return. Symptoms such as slowness of movement, tremor, and rigidity can be problematic for these patients, causing simple activities and movement to become difficult. Results from a pivotal efficacy and safety trial showed that adding extended-release ropinirole to patients’ existing levodopa (l-dopa) therapy reduced the amount of “off” time experienced by patients with Parkinson’s disease by 2.1 hours per day on average, compared to baseline. Specifically, comparing the experience of the group treated with extended-release ropinirole versus the placebo group, the adjusted mean difference in the reduction of “off” time was -1.7 hours, which was statistically significant.

“Many patients require multiple doses of one or more medications to control their Parkinson’s symptoms, which makes taking their medicines correctly and at the right times challenging. In addition, patients with Parkinson’s disease may have trouble completing routine activities of daily living and self-care,” said clinical investigator Rajesh Pahwa, M.D., professor of Neurology and director of the Parkinson’s Disease and Movement Disorder Center at the University of Kansas Medical Center in Kansas City. “Requip XL provides continuous delivery of ropinirole over 24 hours to provide smoother blood levels without the peaks and troughs that multiple daily doses typically deliver. It is an important once-daily treatment option for patients with Parkinson’s disease.”

Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma PLC’s (LSE: SKP) patented GEOMATRIX™ technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Extended-release ropinirole offers physicians and patients a simple titration regimen; it also offers a convenient, once-daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day.

Clinical Study

FDA approval was based primarily on results from the EASE-PD (Efficacy And Safety Evaluation in Parkinson Disease) Adjunct Study, a multi-center, double-blind, placebo-controlled study conducted in patients with idiopathic Parkinson’s disease not adequately controlled with l-dopa. A total of 393 patients in the study were randomized to receive either extended-release ropinirole(n=202) or placebo (n=191) once daily for 24 weeks in addition to l-dopa. The study’s primary endpoint was the mean change from baseline at week 24 in awake time spent “off”, which was measured via patient diaries. Results from the study showed that extended-release ropinirole significantly reduced “off” time by an average of 2.1 hours per day from baseline, compared to a reduction of 0.4 hours per day for placebo.

Once-daily use of extended-release ropinirole was generally well tolerated in the study. The withdrawal rate due to adverse reactions was low and similar between groups (6 percent extended-release ropinirolevs. 5 percent placebo). The most common adverse reactions reported in patients taking extended-release ropinirole compared to placebo were dyskinesia (13 percent vs. 3 percent), nausea (11 percent vs. 4 percent), dizziness (8 percent vs. 3 percent), hallucination (7 percent vs. 3 percent), somnolence (7 percent vs. 4 percent), abdominal pain/discomfort (6 percent vs. 3 percent) and orthostatic hypotension (5 percent vs. 1 percent).

A Progressively Disabling Disease

Parkinson’s disease is a chronic, progressive, and often disabling neurological condition that eventually impairs the body’s ability to move and balance. Researchers have determined that Parkinson’s disease involves the degeneration of the cells in one of the brain areas responsible for motor control. Patients with Parkinson’s disease experience a reduction in dopamine, a key chemical in the brain that communicates messages about movement, resulting in the symptoms of Parkinson’s disease. These symptoms include tremor (involuntary shaking), rigidity (stiffness), akinesia (lack of movement or loss of spontaneous movement), bradykinesia (slower-than-normal voluntary movements), and problems with walking, balance and posture.

More than one million people in the United States have Parkinson’s disease. The average age of onset of Parkinson’s disease is about 60 years, but the disease can develop at an earlier age.

About Requip XL

Requip XL Tablets are indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson’s disease and are administered once daily. Prescription Requip XL is not for everyone. Requip XL may cause patients to fall asleep or feel very sleepy during normal activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand up. Patients should tell their doctor if they experience these effects or the following problems, or if they drink alcohol or are taking other medicines that make them drowsy. Side effects may include nausea, dizziness, drowsiness or sleepiness, headache, and sudden uncontrolled movements (dyskinesia). Increase or decrease in blood pressure and heart rate may occur. Hallucinations may occur at anytime during treatment. Patients should also tell their doctor if they experience new or increased gambling, sexual, or other intense urges while taking Requip XL. Requip XL may increase the side effects of l-dopa. Most patients were not bothered enough to stop taking Requip XL.

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension. The company has 12 approved products in the areas of oral, inhalation, and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies. For more information, visit http://www.skyepharma.com.

About GlaxoSmithKline

Requip XL was developed and is marketed by GlaxoSmithKline, one of the world’s leading research-based pharmaceutical and healthcare companies. More information on GlaxoSmithKline is available at the company’s Web site at http://www.gsk.com.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’s operations are described under ‘Risk Factors’ in the ‘Business Review’ in the company’s Annual Report on Form 20-F for 2007.

Editor’s Note: Requip XL is currently approved in Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, The Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and United Kingdom.

Requip ® XL™ will also be known as Requip ® LP, Requip-Modutab ® , and Requip ® Depot in Europe.

Requip ® XL™, Requip ® LP, Requip-Modutab ® , and Requip ® Depot are trademarks of the GlaxoSmithKline group of companies.

GEOMATRIX™ is a trademark of SkyePharma Plc.

View drug information on Requip.

Research released today provides evidence that a cure for Parkinson’s disease could lie just inside the nose of patients themselves.

The Griffith University study published in the journal Stem Cells found that adult stem cells harvested from the noses of Parkinson’s patients gave rise to dopamine-producing brain cells when transplanted into the brain of a rat.

The debilitating symptoms of Parkinson’s such as loss of muscle control are caused by degeneration of cells that produce the essential chemical dopamine in the brain.

Current drug therapies replace dopamine in the brain, but these often become less effective after prolonged use.

The discovery is the work of the National Centre for Adult Stem Cell Research, part of Griffith’s Eskitis Institute for Cell and Molecular Therapies.

Project leader Professor Alan Mackay-Sim said researchers simulated Parkinson’s symptoms in rats by creating lesions on one side of the brain similar to the damage Parkinson’s causes in the human brain.

“The lesions to one side of the brain made the rats run in circles,” he said.

“When stem cells from the nose of Parkinson’s patients were cultured and injected into the damaged area the rats re-aquired the ability to run in a straight line.

“All animals transplanted with the human cells had a dramatic reduction in the rate of rotation within just 3 weeks,” he said.

“This provided evidence the cells had differentiated to give rise to dopamine-producing neurons influenced by being in the environment of the brain. In-vitro tests also revealed the presence of dopamine.”

“Significantly, none of the transplants led to formation of tumours or teratomas in the host rats as has occurred after embryonic stem cell transplantation in a similar model.

He said like all stem cells, stem cells from the olfactory nerve in the nose are ‘na?ve’ having not yet differentiated into which sort of cells they will give rise to.

“They can still be influenced by the environment they are put into. In this case we transplanted them into the brain, where they were directed to give rise to dopamine producing brain cells.”

The advantage of using a patient’s own cells is that, unlike stem cells from a foreign embryo, they are not rejected by the patient’s immune system, so patients are free from a lifetime of potentially dangerous immuno-suppressant drug therapy.

This development follows Professor Mackay-Sim’s 2007 development of a world-first technique that demonstrated that olfactory adult stem cells can give rise to heart, nerve, liver and brain cells.

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Co-authors on the paper were Wayne Murrell, Andrew Wetzig, Michael Donnellan, Fran?ois Féron, Tom Burne, Adrian Meedeniya, James Kesby, John Bianco, Chris Perry, Peter Silburn.

The study was funded by the Australian National Health and Medical Research Council and the Australian Department of Health and Ageing.

Download the full article here at http://stemcells.alphamedpress.org/

Source: Jeannette Langan
Research Australia

Axxonis Pharma AG announces the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for Nenad(R) (lisuride transdermal patch as add-on therapy for Parkinson’s Disease and for Restless Legs Syndrome, and subcutaneous (sc) lisuride infusion for advanced Parkinson’s Disease)

Lisuride, the active principle of Nenad(R), is a potent dopamine agonist which in its parenteral forms (transdermal patch and sc infusion) has been developed to provide continuous dopaminergic stimulation (CDS). Experts expect from CDS a new quality of treatment of Parkinson’s Disease and RLS combined with ease of administration. All results obtained so far not only demonstrate strong efficacy but also a good general tolerability of Nenad(R) and an improved quality of life for those affected by these neurological conditions.

About Nenad(R)

Nenad(R) 10 cm squared and 20 cm squared transdermal patches, which release 2.5 microgram lisuride and 5.0 microgram lisuride per hour, respectively, have been developed as a new application form of the strong dopamine agonist lisuride in order to enhance efficacy and to improve tolerability. The Nenad(R) patch works by non-invasive transport of lisuride across the skin and provides continuous dopaminergic stimulation (CDS) over two days. For Parkinson’s Disease, one or two 20 cm squared patches are applied every other evening; for RLS, one or two 10 cm squared patches are applied every other morning. With these schedules, only one up-titration step is required in Parkinson’s Disease with a rapid onset of action (significant after only one week treatment) with a simultaneous reduction in early adverse events. In RLS, most patients respond satisfactorily to just one 10 cm squared patch or, in severe cases, two patches of 10 cm squared, with improvement also in day-time symptomatology.

Lisuride sc (Nenad(R) Powder for solution for sc infusion) was developed for the treatment of patients in an advanced stage of Parkinson’s Disease. The continuous application of this parenteral dopamine agonist using a small portable minipump provides stable individual drug levels and thereby achieves superior therapeutic results in treatment-resistant stages of Parkinson’s Disease complicated by motor fluctuations. Studies showed good therapeutic efficacy on “Off” (hypomobility) and “On” with troublesome dyskinesia (hypermobility).

Lisuride also has antifibrotic and antiproliferative effects as a strong antagonist of 5- HT (serotonin) 2B receptors and therefore is expected to cause no cardiac valvulopathy as is the case with some other dopamine agonists.

Information about Parkinson’s Disease

Parkinson’s Disease is a very frequent severe neurological illness of the higher age affecting about 2-3 out of 1.000 people. A cell decline in certain brain areas - the so-called “substantia nigra” - with reduction of the neurotransmitter dopamine is the basis for this disease and causes the typical motor symptoms of Parkinson’s Disease.

Information about RLS (Restless Legs Syndrome)

RLS is another neurological disease which occurs in up to 10 % of the population, and which in serious cases strongly interferes with patients’ sleep and quality of life on the subsequent day.

About Axxonis Pharma AG

Axxonis Pharma AG, Berlin, is a pharmaceutical company specialised on developing new products in neurodegenerative diseases.

To learn more about Axxonis, please visit the website at http://www.axxonis.com.

Forward-Looking Statements

This press release contains “forward-looking” statements related to our clinical development programm with Nenad(R). These forward-looking statements are based upon Axxonis’ current expectations. Forward-looking statements involve risks and uncertainties. Axxonis’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the ability of the company to successfully conduct the clinical trials, the uncertainty of the EMEA approval process and other regulatory requirements, the therapeutic and commercial value of the company’s products and issues relating to regulatory approval, manufacturing and commercialization, Axxonis expressly disclaims any obligation or undertaking to release publicity any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard there to.

Axxonis Pharma AG

The use of electrical impulses to stimulate weak or paralyzed muscles, called Functional Electrical Stimulation (FES), is often used to help stroke or multiple sclerosis patients to walk. In a pilot study published in Neuromodulation, Geraldine E. Mann of Salisbury Healthcare NHS Foundation Trust in England presents evidence that FES may also provide major benefits to people with Parkinson’s disease.

People suffering from Parkinson’s are prone to tripping and falling because they have difficulty picking up their feet consistently, as well as starting and maintaining walking. Although it has been widely observed that visual and auditory cues and cognitive strategies can improve walking ability in Parkinson’s sufferers, this study marks the first time that FES has been considered as an aid.

“Stimulation is triggered in FES by a footswitch usually placed in the heel of the shoe,” explains Mann. “As the heel rises stimulation starts, continues as the leg swings through and stops when the heel strikes the ground, continuing this cycle as the person walks.”

Mann and her team find significant evidence that FES can immediately reduce falls in people with Parkinson’s, as well as improving average stride length, speed of gait and distance walked.

The study also demonstrates a carryover or learning effect for improvements gained during FES use that continues even when stimulation has stopped.

While a larger study is required to support these findings, “they are interesting and deserve further investigation for the sake of people with Parkinson’s disease for whom there is little treatment other than medication to alleviate the problems they have with walking,” says Mann. “FES could make a big difference to their quality of life and provide therapists with an additional and much needed treatment modality.”

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This study is published in Neuromodulation.

Geraldine E. Mann MSc., MCSP is a Consultant Physiotherapist at Salisbury Healthcare NHS Foundation Trust, Salisbury District Hospital, in England.

Neuromodulation disseminates scientific and clinical information relevant to the field of neuromodulation. The journal’s sole purpose is to advance the basic and clinical science of the field of neuromodulation. It publishes original, scientific works, scientific reviews, abstracts of papers accepted for review at national and international congresses, and past and future news of events and activities of the society and its membership. Because the science of neuromodulation transcends many disciplines such as anesthesiology, angiology, cardiology, neurology, neuroscience, rehabilitation medicine, and vascular surgery, the information presented varies widely. For more information, please visit http://www.blackwell-synergy.com/loi/ner.

The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its journal Neuromodulation and chapter websites. For more information, please visit http://www.neuromodulation.com/.

Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley’s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit http://www.blackwellpublishing.com/ or http://interscience.wiley.com/.

Source: Sean Wagner
Wiley-Blackwell

A Binghamton University researcher will receive $1.33 million from the National Institutes of Health to support Parkinson’s research that will focus not only on the treatment of the disease but also on the side effects of treatment.

“Parkinson’s disease patients have trouble with movement,” said Christopher Bishop, assistant professor of psychology. “They move more slowly. They have rigidity in their limbs. They have balance problems and tremors.”

The cardinal symptoms are a result of a deficit of dopamine in the brain. Dopamine is a neurotransmitter that’s essential for movement; it also plays an important role in behavior, cognition and sleep. In Parkinson’s patients, neurons in the brain that make dopamine die. Scientists still aren’t sure why; genetic factors are believed to play only a small role.

This deficit of dopamine can be reversed with treatment using a compound called L-DOPA, which has been the gold standard in Parkinson’s treatment for about 50 years. The brain converts L-DOPA into dopamine, which is why it’s an effective replacement therapy for patients. For five to 10 years, this treatment works well. “The problem,” Bishop explained, “is that Parkinson’s is a progressive disease. You lose more and more of these neurons as time goes on, so therapeutically, doses of L-DOPA must increase.”

While that works for some people, many patients suffer troubling side effects as the dosage increases. “By year 10,” Bishop said, “as many as 90 percent of patients will start to suffer from motor fluctuations and something called L-DOPA-induced dyskinesia. So you go from a state of no treatment where you’re not moving well, to a state where the drug is working well and you’re moving fluidly, to a point where L-DOPA doses are very high and you’re producing these abnormal, involuntary movements.”

The excessive movements patients display aren’t a result of the Parkinson’s disease, but rather a symptom of the chronic L-DOPA. And patients can’t simply stop taking L-DOPA; if they do, they face a nearly “frozen” life with incredibly limited ability to move.

Bishop and his colleagues at Wayne State University’s medical school and the Veterans Administration hospital in Chicago hope to find a way to reduce dyskinesia and suppress these movements. There are very few treatments available, in part because how dyskinesia develops is still a mystery.

“We are beginning to believe that dyskinesia is actually the inability to suppress motor memories as a result of the drug’s stimulation,” Bishop said.

One possible treatment relates to glutamate, a neurotransmitter in the brain that can play a role in these memory processes, helping to lay down new pathways for motor memories. The five-year grant from the National Institute for Neurological Disorders and Stroke will allow Bishop and his team to study serotonin compounds that reduce glutamate following L-DOPA treatment. Bishop’s work has also been supported by the American Parkinson’s Disease Association.

According to Bishop, Parkinson’s is an increasingly urgent medical concern. Roughly 1 million people in the United States have Parkinson’s; 50,000 more Americans are diagnosed with the disease each year.

“That’s only going to increase as our population ages,” Bishop said. “This is not something that’s going away.

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Source: Gail Glover
Binghamton University

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, announced that in a pre-clinical study that was conducted with Tel Aviv University between February and May 2008, signs of impaired motor behavior in a rat model of Parkinson’s improved following transplantation of BrainStorm’s unique Neurotrophic Factor Cells (NTF).

“BrainStorm’s NTF cells are generated from adult human bone marrow derived stem cells, and indented for autologous transplantation in Parkinson’s patients. The cells produce and secrete neurotrophic factors, which are essential for the survival and outgrowth of neurons, and may become beneficial in neurodegenerative diseases,” explains Dr. Daniel Offen, Brainstorm Chief Scientist, and the study’s principal investigator.

In this study, Tel Aviv University scientists lesion the brains of lab rats by using the 6OHDA toxin, in order to mimic the motor dysfunction of parkinsonian patients. The rats were divided into three groups: one group was transplanted with BrainStorm NTF cells, another with undifferentiated mesenchymal stem cells and the third group was used as control.

The motor functions of the rats were repeatedly measured for 45 days, followed by histology. The results showed statistically significant improvement in NTF rats’ motor functions, in compared to the mesenchymal cell group and the controls. Moreover, the NTF cells increased the level of the neurotransmitter Dopamine (a low amount of which causes Parkinson). The researchers also detected, 45 days post-transplantation, viable transplanted cells which migrated toward the impaired portion of the affected brain. The Company believes that this is evidence of the integration ability of BrainStorm’s cells in the damaged brain. This is the second study completed using BrainStorm’s cells that produced similar results.

The findings of this study will be presented today by the Company’s chief scientist, Dr. Daniel Offen, at the Second International Stem Cell Meeting: “The Potency of Stem Cells” held from May 27-29, 2008 in Tel-Aviv in conjunction with the ILSI-Biomed Israel 2008 Conference.

Prof. Eldad Melamed, Chairman of the Company’s Scientific Advisory Board and the Company’s Chief Medical Advisor commented, “These exciting results provide validation of our previous scientific work. The study indicates that our cells show survival, integration and clinical efficacy. When considering the advantages of using adult stem cells, which are easy to harvest, autologous, do not create tumor problem and do not present the moral/ religious issues that are often discussed with embryonic stem cells, we remain optimistic that we will soon be able to embark on clinical trials in Parkinson’s disease.”

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is an emerging company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The NurOwn(TM) patent pending technology is based on discoveries made by the scientific team led by prominent neurologist Professor Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The Company’s initial focus is on Parkinson ALS and Spinal Cord Injury, although its technology has promise for treating several others diseases including MS, Huntington’s disease and stroke.

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, including BrainStorm’s ability to complete its equity financing transactions previously disclosed,. The potential risks and uncertainties include, among others, risks associated with BrainStorm Cell Therapeutics Inc.’s limited operating history, history of losses and expectation to incur losses for the foreseeable future; dependence on its license to Ramot’s technology; ability, together with its licensor, to adequately protect the NurOwn(TM) technology; dependence on key executives and on its scientific consultants; ability to identify, negotiate and successfully implement strategic partnering relationships; ability to complete clinical trials successfully and to obtain required regulatory approvals; competition with companies, some of which have greater resources and experience in developing and obtaining regulatory approval for treatments in BrainStorm Cell Therapeutics Inc.’s market; the limited public trading market for BrainStorm Cell Therapeutics Inc.’s stock which may never develop into an active market; and other factors detailed in BrainStorm Cell Therapeutics Inc.’s annual report on Form 10-KSB, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the Securities and Exchange Commission available at http://www.sec.gov/ or by request to the Company. The Company does not undertake any obligation to update forward-looking statements made by us.

BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced that Dr. Daniel Offen, the Company’s Chief Scientist, will present results of a most recent study in the Parkinson’s disease project, under the title: “Human Bone Marrow Stem Cells Induced To Secrete Neurotrophic Factors As A New Strategy For Autologous Cell Therapy In Neurodegenerative Diseases”, the lecture will be given at the Second International Stem Cell Meeting: “The Potency of Stem Cells” to be held from May 27-29, 2008 in Tel-Aviv in conjunction with the ILSI-Biomed Israel 2008 Conference.

Over the past few months, Dr. Offen and his team have conducted a study, using Brainstorm’s NTF cells, in which they were transplanted into rats model of Parkinson’s disease. The rats were examined to compare their motor function to the control group. The results will be presented at the conference.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is an emerging company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The NurOwn(TM) patent pending technology is based on discoveries made by the scientific team led by prominent neurologist Professor Eldad Melamed, Head of Neurology at Rabin Medical Center, and expert cell biologist Dr. Daniel Offen, Head of the Neuroscience Laboratory at the Felsenstein Medical Research Center of Tel-Aviv University. The technology allows for the differentiation of bone marrow-derived stem cells into functional neurons and astrocytes, as demonstrated in animal models. The Company holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The Company’s initial focus is on Parkinson ALS and Spinal Cord Injury, although its technology has promise for treating several others diseases including MS, Huntington’s disease and stroke.

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, including BrainStorm’s ability to complete its equity financing transactions previously disclosed,. The potential risks and uncertainties include, among others, risks associated with BrainStorm Cell Therapeutics Inc.’s limited operating history, history of losses and expectation to incur losses for the foreseeable future; dependence on its license to Ramot’s technology; ability, together with its licensor, to adequately protect the NurOwn(tm) technology; dependence on key executives and on its scientific consultants; ability to identify, negotiate and successfully implement strategic partnering relationships; ability to complete clinical trials successfully and to obtain required regulatory approvals; competition with companies, some of which have greater resources and experience in developing and obtaining regulatory approval for treatments in BrainStorm Cell Therapeutics Inc.’s market; the limited public trading market for BrainStorm Cell Therapeutics Inc.’s stock which may never develop into an active market; and other factors detailed in BrainStorm Cell Therapeutics Inc.’s annual report on Form 10-KSB, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the Securities and Exchange Commission available at http://www.sec.gov/ or by request to the Company. The Company does not undertake any obligation to update forward-looking statements made by us.

BrainStorm Cell Therapeutics Inc.

Laurent Attal, President and CEO, L’Oréal USA, and Dr. Ralph J. Cicerone, President, National Academy of Sciences have honored the 2008 recipients of the esteemed L’Oréal USA Fellowships For Women in Science at the American Museum of Natural History in New York City. These women were recognized for conducting innovative and breakthrough research across a range of disciplines, including neuroscience, oceanography, and aerospace engineering. Dr. Shirley Ann Jackson, President of Rensselaer Polytechnic Institute, was also honored with the L’Oréal USA For Women in Science Role Model Award, for raising awareness of the critical role that women play in the sciences.

The prestigious L’Oréal USA Fellowships For Women in Science, now in their fifth year, provide support to postdoctoral women scientists who are undertaking cutting-edge research with practical applications in today’s society. By researching such current pressing issues as Parkinson’s disease and the reduction of fuel consumption, these Fellows represent the next generation of women scientific role models, following in the footsteps of chemist and physicist Marie Curie, and Elizabeth Blackwell, who, in 1849, became the first woman to graduate from medical school. Awardees each receive $40,000 to be used toward independent scientific research. In addition, recognizing that funding is just one of several components necessary to help women build successful careers in the sciences, the L’Oréal USA Fellowships For Women in Science also offer professional development workshops for awardees, and help these Fellows build networks with accomplished women leaders in corporate, academic, governmental and scientific fields.

“Women scientists are making amazing progress, forging ahead and overcoming obstacles as they dispel the gender stereotype that women are not equipped to excel in the sciences,” said Laurent Attal. “L’Oréal USA is proud to help foster and recognize the success of women scientists at all levels. We believe the world needs science, and science needs women.”

The 2008 L’Oréal USA Fellows are:

• Dr. Sara Aton - University of Pennsylvania, Philadelphia, Pennsylvania - neuroscientist, researching how the sleeping brain consolidates learning and memory. Dr. Aton studies a key component in learning and memory: synaptic plasticity, which is the ability of a connection, or synapse, between two neurons to change in strength. She is performing the first study attempting such a large-scale recording of neurons within a synaptically-integrated network during plastic remodeling. Her findings will be a foundation for further research into understanding human development and how sleep affects cognition.

• Dr. Ania Bleszynski-Jayich - Yale University, New Haven, Connecticut - physicist, investigating the persistent current principle of quantum mechanics which, though predicted years ago in theory, has been challenging for scientists to test. Dr. Bleszynski-Jayich has developed an approach using new techniques: creating the extreme conditions necessary to accurately test the persistent current. She will conduct experiments testing the persistent current in normal rings using sensitive cantilevers for detection. The cantilevers sense the magnetic moment produced by the current, and Dr. Bleszynski-Jayich will both work to improve the sensitivity of the cantilever-based detector, and use it to perform systematic measurements of the persistent current.
• Dr. Laura Lapham - Florida State University, Tallahassee, Florida - chemical oceanographer, conducting research that may lead to new discoveries around the use of methane hydrates as a potential energy source. Dr. Lapham is working to determine how much methane is entrained as a hydrate, how stable these reservoirs are and how to harvest these deposits for fuel. The primary focus of her research is the development of instrumentation to regularly measure methane that has dissolved in sediments around the hydrates over time, which will allow researchers to better understand the role of hydrates in an abrupt climate change situation.
• Dr. Sridevi Vedula Sarma - Massachusetts Institute of Technology, Cambridge, Massachusetts - computational neuroscientist, using technology to improve the deep brain stimulation (DBS) technique to treat Parkinson’s disease. Dr. Sarma is employing engineering principles to automate the post-operative calibration process of DBS. Creating such an automated system would relieve patients of frequent physician visits, significantly cut medical costs and allow neurologists to treat more DBS patients. Concurrently, Dr. Sarma is developing a new dynamic feedback stimulation paradigm that will allow for low-powered DBS signals to be administered, eliminating the need for frequent battery replacement surgeries for patients.
• Dr. Sandra Ugrina - University of Maryland, College Park, Maryland - aerospace engineer, developing innovative techniques that help to improve the aerodynamic efficiency of materials and reduce fuel consumption. Dr. Ugrina studies active flow control, which involves the application of techniques to improve fluid quality control over an aerodynamic surface, such as an airplane wing. She is working to design smart material actuators that respond dynamically to external conditions and extend regions of laminar flow, or undisturbed fluid flow, over aerodynamic surfaces. Dr. Ugrina will implement control schemes using a fully integrated system design, helping to reduce drag and energy consumption, while increasing aerodynamic efficiency and reducing noise.

The Fellows were selected from a competitive pool of candidates by a jury of nine eminent scientists presided over by Dr. Cicerone. These Fellows have earned some of the highest honors in their fields and have been published in respected peer-reviewed journals such as the Journal of Neuroscience; Geochemistry, Geophysics, Geosystems; and the AIAA Journal.

“The L’Oréal USA Fellowships For Women in Science program is vital for supporting women scientists at the postdoctoral level, and for retaining women in the sciences,” said Dr. Cicerone. “We must engage the many intelligent young minds in our field. A diverse scientific community produces more cutting-edge research, which is essential to solving some of the world’s most complex problems.”

The awards ceremony was preceded by a panel discussion, which included Dr. Jackson; Dr. Elizabeth Blackburn, Morris Herzstein Professor of Biology and Physiology, University of California, San Francisco and 2008 L’ORéAL-UNESCO For Women in Science North American Laureate; Helen Greiner, Co-Founder and Chairman, iRobot Corporation; Danica McKellar, accomplished actress, mathematician and author; and Isha Himani Jain, 2008 Siemens Competition in Math, Science and Technology individual award winner. The panel was moderated by Dr. Emily Senay, Assistant Professor, Mount Sinai School of Medicine. The panel focused on dispelling the gender myths that undermine women’s potential in the sciences. Panelists discussed how they overcame challenges to achieve successful careers in their fields.

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ABOUT THE L’ORéAL USA FELLOWSHIPS FOR WOMEN IN SCIENCE

The L’Oréal USA Fellowships For Women in Science program is designed to recognize, reward and advance the role of women in scientific research. Each year, this annual awards program honors five American women at the beginning of their scientific careers. Recipients receive $40,000 each toward independent scientific research. Launched in 2003 as the U.S. component of the UNESCO-L’ORéAL International Fellowships program, the program aims to raise awareness of the contribution of women to the sciences, and to identify exceptional female researchers to serve as role models for young women and girls.

Since the L’ORéAL-UNESCO For Women in Science international program’s inception in 1998, 52 Laureates and 120 International Fellows have been recognized from around the world. National Fellowship programs have also been established in 35 countries and have awarded fellowship grants to more than 340 young women researchers.

ABOUT L’ORéAL

L’Oréal is a worldwide leader in the cosmetics industry, developing innovative products to meet the diverse needs of customers in 130 countries worldwide. Over 3,000 people work in the Group’s 16 research centers, located on three continents. Their findings are responsible for the registration of hundreds of patents annually. L’Oréal also devotes over 3% of sales annually to research and development - an investment unmatched anywhere else in the industry. Women represent 55% of L’Oréal’s research and development workforce. For more information, please visit: http://www.loreal.com/

Source: Vijay Jesrani
Edelman Public Relations

The current issue of Cell Transplantation (Vol. 17:4) features a number of publications by researchers seeking new ways to treat Parkinson’s disease (PD), a neurological disease characterized by muscle rigidity, tremor and slowed physical movements related to insufficient levels of dopamine (DA) in the basal ganglia of the brain, by using primate models to examine the potential therapy role of transplanted cells.

One research team looked at the ability of human neural progenitor cells (hNPCs) as a potential therapy when hNPCs were engineered to produce glial derived neurotrophic factor (GDNF) in the brain following hNPC transplants.

“Localized delivery is essential for aiming therapeutic molecules when treating neurodegenerative disorders,” said Maria Emborg, PhD, of the University of Wisconsin-Madison. “There are currently a number of clinical trials underway using direct gene therapy approaches to deliver potent trophic factors throughout the basal ganglia.”

Emborg and colleagues report that hNPCs genetically modified to over-express GDNF were able to survive transplant and produced GDNF for three months, and that functional recovery in test animals increased while no obvious negative side effects from the transplant procedure were observed.

An international team of researchers from the University of Kentucky Medical Center and the Shandong Provincial Hospital, Shangdong, PR of China, are studying the neurorestorative effects of the exogenous protein neurturin (NTN), another member of the GDNF family. They found that the protein may have beneficial effects on PD as their results showed some restorative influences after cell transplantation.

“Tissue distribution of trophic factor is a critical variable to achieve optimal effects on dopamine function and promote behavioral improvement,” said corresponding author Richard Grondin, PhD of the University of Kentucky. “The volume of GDNF distribution in the trophic factor recipients significantly correlated with motor function improvements. Tissue distribution may not have been optimal with NTN, but the overall effects of NTN on motor and dopaminergic function suggest potential therapeutic uses.”

According to Zhiming Zhang, M.D. corresponding author and colleagues from the University of Kentucky College of Medicine, the need is great for longitudinal noninvasive, highly sensitive imaging techniques to monitor treatment for PD. Their study reports on attempts at monitoring GDNF-induced functional changes in the basal ganglia using pharmacological MRI (phMRI) to measure response to dopamine. The aim is to eventually be able to visualize changes in the living brains of PD patients.

“Our hypothesis was that phMRI techniques combined with selective dopaminergic agents could monitor PD treatment,” said Zhang. “GDNF has been proven to halt or reverse progressive degeneration of the nigrostriatal DA system in models of PD. The ability to reliably monitor therapeutic effects would provide valuable information in assessing the progression of PD.”

In their study, Zhang, et al found that phMRI “showed its potential” by detecting functional changes before and after infusion with GDNF. These changes were also accompanied by improvements in motor function.

Transplantation of dopamine neurons as therapy for PD has been tested recently. Researchers sought to answer questions about where to place the transplanted neurons to gain the best environment for the optimal effect. One research team found that grafted dopamine neurons could “extend neurites toward a desired target over several millimeters through the brain in animal models…” which favors the prospect of “circuit reconstruction from grafted neurons placed at appropriate locations in the neural circuitry.”

According to corresponding author John Sladek, PhD of the University of Colorado School of Medicine, there have always been questions about the regenerative capacity of mammalian neurons. One point at issue was the need to provide a “neuronal microenvironment that would be more conducive for regulated neurological control of DA production and release by the grafted neurons,” said Sladek.

Test results suggested that substantia nigra grafts could send targeted DA neurons to a location where they could survive and extend neurites over longer distances.

“Survival of the grafts and extension of the axons is of importance because it positions the DA neurites to grow in a trajectory toward the striatum, using the striatal grafts as an attractant,” concluded Sladek.

“Taking these four papers together we can see that primate studies are helping to elucidate the likelihood of favorable outcomes following stem cell transplantation with respect to route of administration, possible modes of action and the ability to track the effects.” said Jeffrey Kordower, PhD of the Rush University Medical Center, Chicago and guest editor of this special meeting issue of Cell Transplantation.

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The editorial offices for Cell Transplantation are at the Center of Excellence for Aging and Brain Repair, College of Medicine, the University of South Florida and the Diabetes Research Institute, University of Miami Miller School of Medicine.

Source: Dr. Paul Sanberg
College of Medicine, the University of South Florida
Cell Transplantation Center of Excellence for Aging and Brain Repair