StemCells, Inc. Announces Preclinical Results Showing Its Proprietary Human Neural Stem Cells Can Prevent Vision Loss

StemCells, Inc. (NASDAQ:STEM) reported today that its proprietary HuCNS-SC® product candidate (purified human neural stem cells), when transplanted into a well-established animal model, can protect the retina from progressive degeneration. Retinal degeneration leads to loss of vision in diseases such as age-related macular degeneration and retinitis pigmentosa. This promising study was conducted by Dr. Raymond Lund, a researcher and professor at the Casey Eye Institute at Oregon Health & Science University (OHSU) and his research team. Dr. Lund will present the study results at a seminar sponsored by the Foundation Fighting Blindness on Saturday, November 1, 2008. The seminar is scheduled to begin at 9:00 a.m. and will be held at the University of California – San Francisco, Cole Hall (Medical Sciences Building on Parnassus Campus) in San Francisco, California.

“This study confirms the results of previously published academic studies evaluating neural stem cell transplantation into the retina and provides us with the rationale to pursue clinical testing of HuCNS-SC cells for retinal disorders,” said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. “We are already conducting additional preclinical studies and a pre-IND meeting has been scheduled with the FDA for December of this year to determine the pathway to a successful IND filing.”

In this preclinical study, Dr. Lund and his co-investigator at OHSU, Dr. Peter Francis, transplanted HuCNS-SC cells into the Royal College of Surgeons (RCS) rat, a well established animal model of retinal degeneration. In the RCS model, a genetic mutation causes dysfunction of the retinal pigmented cells. Dysfunction in these cells, whose normal function is to support photoreceptors in the eye, causes progressive loss of the photoreceptors and degeneration of the retina, and ultimately, loss of visual function. Photoreceptor loss in the RCS rat begins as early as three weeks of age and by 24 weeks all photoreceptors are typically lost. In the study, the researchers transplanted HuCNS-SC cells into one eye of 21-day-old RCS rats while keeping the opposite eye as the control. Animals were evaluated starting at day 40 (19 days post transplant) and then at routine intervals up to 150 days post transplant. The evaluations showed that the HuCNS-SC cells survived the transplants and engrafted, and the eyes transplanted with the cells showed preservation of the photoreceptors and stabilization of visual function.

“The HuCNS-SC cell has proven to have very robust survival, preserving vision in our rat model at time points beyond six months,” commented Dr. Lund. “These data are very encouraging and suggest cell-based therapies for retinal degeneration can be a viable treatment approach.”

Dr. Francis, a retina specialist and researcher, added, “I am excited by our burgeoning collaboration with StemCells. The results of the early preclinical studies support the potential for these cells to treat retinal degenerative disease. I am especially excited by the fact that the cell is currently being tested in a clinical trial for Batten disease, a disorder of the central nervous system, which should make the transition from the laboratory to clinical use in retinal disease that much easier.”

Dr. Lund received his PhD in Anatomy from University College London, after which he joined the faculty and received tenure within two years. Shortly thereafter, he moved to the United States, joining the faculty at Stanford University. Throughout his career, Dr. Lund has held several impressive academic positions including Chair of the Anatomy Department at the Medical University of South Carolina, Chair of the Neurobiology and Anatomy Department at the University of Pittsburgh, chair of the Anatomy Department at the University of Cambridge in England, the Duke Elder Professorship at the Institute of Ophthalmology in London, and the Calvin and JeNeal Hatch Chair of Ophthalmology at the Moran Eye Center at the University of Utah. In 2005, he was appointed Vice Chair of research at the Moran Eye Center in Utah. In 2007, Dr. Lund was recruited to join the faculty of the Oregon Retinal Degeneration Center at the Casey Eye Institute.

Throughout his career, Dr. Lund’s research has centered on the response of the central nervous system to injury and mechanisms of rescue and repair. Focusing on the retina and its connections with the brain, he pioneered eye transplants in mammals in the late 1970s. Currently, he is investigating the use of cell-based therapies for photoreceptor degeneration in animal models of human disease.

Dr. Francis is an ophthalmologist and retina specialist at the Casey Eye Institute, and an Associate Professor, Oregon Health & Science University. Dr. Francis received his MD from University of Southampton, Southampton, England, and his PhD in molecular genetics at the Institute of Ophthalmology in London. He co-directs the Casey Macular Degeneration and Oregon Retinal Degeneration Centers. His clinical and research interests have focused on age-related macular degeneration and inherited retinal disorders.

About Retinal Degeneration

The retina is a thin layer of neural cells that lines the back of the eye and is responsible for converting external light into neural signal processed by the brain. The loss of function in retinal cells leads to an impairment or loss of vision. The macula, one of the most critical parts of the retina, is responsible for processing detailed vision. The most common forms of retinal degeneration are age-related macular degeneration and retinitis pigmentosa. In the United States, age-related macular degeneration affects over 1.7 million people in the over-65 population and is the leading cause of blindness in that group. Retinitis pigmentosa is a class of hereditary diseases that also leads to progressive degeneration of retinal cells. In the United States, the most common types of retinitis pigmentosa affect approximately 65,000 people. Preventative measures for both age-related macular degeneration and retinitis pigmentosa have limited impact on the disease and current treatments are not curative.

About HuCNS-SC Cells

StemCells’ lead product candidate, HuCNS-SC cells, is a purified composition of normal human neural stem cells that are expanded and stored as banks of cells. The Company’s preclinical research has shown that HuCNS-SC cells can be directly transplanted; they engraft, migrate, differentiate into neurons and glial cells; and they survive for as long as one year with no sign of tumor formation or adverse effects. These findings show that HuCNS-SC cells, when transplanted, act like normal stem cells, suggesting the possibility of a continual replenishment of normal human neural cells.

About StemCells, Inc.

StemCells, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of cell-based therapeutics to treat diseases of the central nervous system and liver. The Company’s product development programs seek to repair or repopulate CNS and liver tissue that has been damaged or lost as a result of disease or injury. StemCells has pioneered the discovery and development of HuCNS-SC® cells, its highly purified, expandable population of human neural stem cells. StemCells has completed enrollment and dosing of a six patient Phase I clinical trial of its proprietary HuCNS-SC product candidate as a treatment for neuronal ceroid lipofuscinosis (NCL) and expects the trial to be completed in January 2009. NCL, which is often referred to as Batten disease, is a rare and fatal neurodegenerative disease that affects infants and young children. StemCells owns or has exclusive rights to more than 50 issued or allowed U.S. patents and more than 150 granted or allowed non-U.S. patents. Further information about the Company is available on its web site at: stemcellsinc.

About OHSU and Casey Eye Institute

Oregon Health & Science University is Oregon’s only health and research university and the state’s only academic health center. OHSU is Portland’s largest employer and the fourth largest in Oregon (excluding government), with more than 12,400 employees. OHSU’s size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.

The Casey Eye Institute, named after the founders of United Parcel Service, opened on the OHSU Marquam Hill Campus in 1991. The Casey Eye Institute is an academic regional eye center dedicated to preventing blindness through research, and to bringing advanced technology to the Pacific Northwest through continuing education of physicians. Casey is the seventh and final regional eye research center in the nation sponsored by Research to Prevent Blindness, the world’s leading voluntary organization in support of eye research. ohsucasey

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. (the “Company”) and its ability to conduct clinical trials as well as its research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in NCL or in future clinical trials of proposed therapies for other diseases or conditions despite the novel and unproven nature of the Company’s technologies; uncertainties regarding the Company’s ability to obtain the increased capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty regarding the validity and enforceability of the Company’s patents; uncertainty as to whether HuCNS-SC and any products that may be generated in the future in the Company’s cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company’s manufacturing capabilities given its increasing preclinical and clinical commitments; uncertainties as to whether the Company will achieve revenues from product sales or become profitable; and other factors that are described under the heading “Risk Factors” in Item 1A of Part II of the Company’s Annual Report on Form 10-K.

Oregon Health & Science University

Will Individuals With Alzheimer’s Disease Benefit From Cataract Surgery?

A multi-institutional team of researchers, led by the Mandel School of Applied Social Sciences at Case Western Reserve University, will begin a five-year, $2.9 million National Institutes of Health-funded study. They will examine the lives of patients with both cataracts and Alzheimer’s disease (AD) to document how restored vision improves everyday life for people with dementia.

“This project addresses a major social justice issue in the disparity in vision care of persons diagnosed with Alzheimer’s disease,” said Grover “Cleve” Gilmore, dean of the Case Western Reserve Mandel School and principal investigator of the study.

Gilmore will lead faculty from the departments of Ophthalmology and Visual Sciences and Neurology at the Case Western Reserve University School of Medicine and physicians from the Eye Institute and Neurological Institute at University Hospitals and the Division of Ophthalmology at MetroHealth Medical Center.

In 20 years of research, Gilmore has found people with dementia lose their ability to see objects in medium- and low-contrast environments, but boosting the contrast of objects improves their ability to move around their homes; eat better; read; and do other simple, everyday tasks.

Cataracts cloud and blur the vision in the eye causing AD patients additional problems. If untreated, the cataracts lead to blindness, but sight can be restored with surgery to remove the cataract.

Co-investigator Jonathan Lass, M.D., the Charles I Thomas Professor and chair of the department of ophthalmology and visual sciences at the Case Western Reserve School of Medicine and director of the Eye Institute at University Hospitals, says, surprisingly, a preliminary study has shown 10 percent of patients over 65 who have an eye exam have some memory impairment along with cataracts. Most people start to show signs of cataracts in their early 60s.

“This research is important because we are a visual world,” said Thomas Steinemann, M.D., professor of ophthalmology at the School of Medicine and ophthalmologist in the ophthalmology division at Metrohealth Medical Center.

Steinemann said he has observed improvements in AD patients following cataract surgery. Some who were combative before surgery are more cooperative following it. And even though they still are cognitively impaired to some degree, Steinemann said improved vision may even help AD patients recognize family members.

“Ultimately, if you can’t perceive something, it is hard to remember it,” says Alan Lerner, associate professor of neurology at the Case Western Reserve School of Medicine and director of the Memory and Cognition Center in University Hospital’s Neurological Institute. “If the vision is blurry, then your memory may be more faulty than necessary. The cataract removal may offer benefits of improved quality of life which is a major aim in AD therapeutics overall.”

“This grant demonstrates that the NIH recognizes a major disparity in healthcare for individuals with Alzheimer’s disease and cataracts,” said Gilmore. “We hope to provide evidence that AD patients also benefit from cataract surgery.”

In the randomized controlled NIH-funded study, half of the 210 patients will receive cataract surgery and the other half will have surgery delayed for six months. The researchers will follow the progress of the two groups. During this time, the primary caregivers associated with these patients also will supply information about the patient’s quality of life and activity levels by answering surveys and other measures.

In addition to finding scientific evidence that cataract surgery helps AD patients, the researchers hope to identify a warning sign of AD. They will test changes in the thickness of the retina, a part of the eye that is an extension of the brain. Using a technology called optical coherence tomography (OCT), they will track changes in the retinal thickness of these patients over six months to determine if there is a connection with AD.

By using the technology, Gilmore says they hope to find an indicator of the onset of AD and prompt referrals to neurologist for early interventions and medicines to delay memory loss.

In addition to Gilmore, Lass, Lerner and Steinemann, Julie Belkin, M.D., assistant professor of ophthalmology at the Case Western Reserve School of Medicine and of the Eye Institute at University Hospitals, will work with the co-investigators.

Source:
Susan Griffith
Case Western Reserve University

Early Detection For Glaucoma Sufferers, UK

Lincolnshire residents at risk from an eye disease that is a major cause of blindness can now take advantage of state-of-the-art equipment at David Burghardt Vision Care for early detection of glaucoma.

Glaucoma is one of the main causes of severe vision loss and can affect anyone, especially those with a family history of the condition, shortsightedness or blood pressure problems.

The new Heidelberg Retinal Tomograph (HRT 3) at leading optometrist David Burghardt Vision Care in Nettleham detects signs of the progressive disease up to eight years earlier than conventional techniques.

The revolutionary instrument uses a high-resolution laser scanner to make a 3D precision measurement of the optic nerve head at the back of the eye where the damage occurs.

During the examination, which takes a few seconds, it measures up to 28 million individual points which are then analysed through a computer system to assess the optic nerve head’s condition.

With such early detection glaucoma can be prevented from developing and causing permanent harm to the eye, including complete blindness.

David Burghardt is one of only three practitioners in Lincolnshire to offer this early high-tech glaucoma detection, which is not widely available even in hospital clinics.

Many of David’s glaucoma assessments are carried out as a result of referrals from doctors or other optometrists, but anyone can book an appointment if they are concerned about glaucoma.

David said: “By offering this new service to our patients we are hoping to detect any signs of glaucoma much earlier than we could before through more traditional methods.

“If caught early enough it can be treated simply with eye drops to prevent any further damage. I would recommend that people take glaucoma seriously and get checked regularly for the disease.”

For more information on David Burghardt Vision Care or to book a glaucoma assessment, visit davidburghardt.

Notes

– The Heidelberg Retinal Tomograph (HRT 3) is produced by Heidelberg Engineering.

– David Burghardt Vision Care first opened in Lincoln in 1984 and the practice relocated to Nettleham in 1989. David Burghardt also practises at Vision Care No8 off Bailgate in Lincoln.

– David Burghardt has an impressive list of specialist qualifications to his name, including a Diploma in Contact Lens Practice and a Diploma in Therapeutics.

– The award-winning David Burghardt Vision Care was shortlisted in two categories in The Optician Awards: Independent Practice of the Year and Software Practice of the Year. The practice was also awarded the Rodenstock Impression ILT Lens Practice of the Year in 2006 and still holds this title.

– David Burghardt is one of only two practitioners in the Lincoln area to offer orthokeratology – the use of rigid gas-permeable contact lenses, normally worn only at night, to improve vision through the reshaping of the cornea.

– David Burghardt Vision Care also offers pre- and post-laser care, including assessment for laser treatment, as well as a large selection of quality spectacle frames and sunglasses.

David Burghardt Vision Care

More Evidence On Benefits Of High Blood Pressure Drugs In Diabetic Eye Disease

Scientists in Massachusetts are reporting new evidence that certain high blood pressure drugs may be useful in preventing and treating diabetic retinopathy, the leading cause of vision loss in people with diabetes. The study, the largest to date on proteins in the retina, could lead to new ways to prevent or treat the sight-threatening disease, they say. The findings are in ACS’ Journal of Proteome Research, a monthly publication.

Edward Feener and colleagues point out that diabetic retinopathy is a common complication of diabetes, which affects millions of people worldwide. It involves damage to blood vessels in the retina, the light sensitive tissue in the back of the eye. Previous studies suggested that drugs used to treat high blood pressure, including ACE inhibitors and angiotensin receptor blockers (ARBs), may help prevent the condition.

The scientists analyzed proteins from the retinas laboratory mice with normal blood pressure and diabetes and compared them to those of non-diabetic mice. They identified 65 abnormal proteins in the diabetic mice out of more than 1,700 proteins in the study. Treatment with the ARB medication, candesartan, prevented the abnormal changes in more than 70 percent of the proteins.

Article: “Angiotensin AT1 receptor antagonism ameliorates murine retinal proteome changes induced by diabetes” pubs.acs/doi/full/10.1021/pr9006415

Source: Michael Bernstein

American Chemical Society

American Academy Of Ophthalmology-MEACO Joint Meeting 2010 Scientific Program Highlights

Results of clinical research on new presbyopia treatments now available in Europe – and possibly available soon in the United States – were reported in the Scientific Program of the 2010 Joint Meeting of the American Academy of Ophthalmology (AAO) and Middle East-Africa Council of Ophthalmology (MEACO). The AAO-MEACO meeting is the world’s largest, most comprehensive ophthalmic education conference and is in session October 16 through 19 at McCormick Place, Chicago.

Presbyopia is Inevitable, but Blurry Vision is Not

From age 40 onward our eyes’ lenses gradually lose the ability to focus on close-up objects, a condition called presbyopia. By our 50s or 60s, almost everyone experiences blurry near vision, although distance vision often remains good. More than 60 million people in the United States are presbyotic, as are more than 400 million worldwide. Reading glasses are one solution, but many people are interested in glasses-free vision correction. Options now available include a form of LASIK that improves near vision in one eye, called monovision, and intraocular lenses (IOLs) that replace the eyes’ natural lenses. Within a few years, several new presbyopia treatments described in today’s Scientific Program will likely be available in the U.S.

A Corneal Lens Implant with Built-In Vision Correction

Ioannis G Pallikaris, MD, University Hospital of Crete, Greece, reported on a new type of micro-lens, the Flexivue, that was implanted in the corneas of 15 patients, who were followed for 12 months post-surgery. In a procedure lasting about 10 minutes, an extremely thin lens was inserted into the cornea (the clear outer structure) of the patient’s non-dominant eye through a tiny pocket made with a highly precise femtosecond laser. The specific vision-correcting prescription for each patient was incorporated in the outer area of the lens. After lens insertion, the pocket self-sealed and held the lens in place. On average, treated eye near vision improved from 20/100 to 20/25 without glasses, and distance vision decreased from 20/20 to 20/40. Vision remained stable in both eyes post-surgery in all patients through the follow-up period.

“This corneal lens implant appears to be a safe, effective way to correct presbyopia in people aged 45 to 60,” said Dr. Pallikaris. “Ninety-eight percent of patients were satisfied with their vision; 69 percent reported ‘excellent’ and 30 percent ‘good’ near vision in our survey. Ninety-two percent said they no longer used glasses.”

He said there were no surgery-related complications, but about 15 percent of patients reported glare and/or halos around lights, and some had reduced contrast sensitivity. Distance vision in the implanted eye is less influenced and remains better than it would be when a LASIK monovision procedure corrects for near vision; Dr. Pallikaris called this advantage “smart monovision.” Another key advantage is that, unlike LASIK and related refractive surgical procedures, the effects of corneal lens implants can be reversed by lens removal. Dr. Pallikaris was one of the pioneers of LASIK in the early 1990s.

He stressed that proper patient selection is crucial to Flexivue implant success: the candidate should have worn reading glasses for at least one year; patients would be disqualified if they have certain types of astigmatism, lens opacity (cataract) or several other conditions.

Financial disclosure: Dr. Pallikaris states that he is chair of the medical advisory board of Presbia, maker of Flexivue.

Corneal Inlay “Pinhole” Optics Sharpens Near Vision

Corneal inlays work by changing the eye’s depth of focus. Clinical trials are underway in the U.S., and the inlay is commercially available in Europe and Asia. Daniel S Durrie, MD, reported on three years of clinical trial results for 153 patients implanted with either a 5- or 10-micron-thick AcuFocus lens. Both near and distance vision were slightly better in the 5-micron group. Both groups showed improvement in near vision, on average 20/25 in the 10 micron group and 20/20 in the 5 micron group. Distance vision was preserved in the implanted eye.

The procedure involves making a corneal flap as in LASIK, placing a small, donut-shaped inlay in the center of the cornea in the non-dominant eye, then replacing the flap. With the inlay’s small-aperture (“pinhole”) optics, peripheral light coming into the eye is blocked while central rays are unaffected, resulting in improved near vision. Distance vision is mostly unaffected, but patients may notice a slight difference when they compare their two eyes. Like corneal lenses, inlays’ effects can be reversed by removal.

“Results for AcuFocus have remained stable for three years of follow up, and we’ve seen dramatic improvements in corneal inlays in the past seven years of clinical study,” Dr. Durrie said.

Financial disclosure: Dr. Durrie states that he is a clinical investigator for AcuFocus.

Reshaping the Cornea without Breaking the Surface

Perhaps the most surprising cornea-based correction technique among the newcomers is INTRACOR. This technology applies femtosecond laser energy pulses inside the cornea, in the stromal cell layer just under the surface. Unlike LASIK and related surgeries, no tissue is removed. Instead, the pulses cause a biomechanical change in the cornea that shifts its center slightly forward. This improves near vision while maintaining distance vision. Small interior incisions may also be made to correct small degrees of near- or farsightedness. The procedure, done in the non-dominant eye, takes less than half a minute.

Mike P Holzer, MD, University of Heidelberg, Germany, presented two year follow-up data on INTRACOR presbyopia correction in 25 patients. Participants showed significant gains in near vision without glasses and maintained good distance vision. Patient satisfaction was high. INTRACOR has generated strong interest in Europe, Asia and South America and is gathering momentum in the U.S.

“The procedure is painless, and because no tissue is removed, the risk of infection is extremely low and the body does not need to mount a strong healing response,” Prof. Holzer said. “The cornea is not weakened, as it can be with other types of refractive surgery. Patients’ vision improved within hours of the procedure and remained stable over the follow-up period,” he added.

Financial disclosure: Prof. Holzer states that he receives consulting fees from Technolas Perfect Vision GmbH.

Source:
Mary Wade
American Academy of Ophthalmology

New Study Outlines Steps To Improve Eye Care For Those With Dementia, UK

Recently published guidelines (1) relating to sight tests among people with dementia go some of the way to addressing the specific needs of this group. However, there is still a long way to go in terms of improving the provision of eye care services and optimising the visual health of this group, says a new study published today by Thomas Pocklington Trust (2).

The study (3) – The development of professional guidelines for the eye examination of people with dementia – was presented at the first ever national “Dementia and Sight Loss conference” in London (1st December) – a forum where 100 dementia and sight loss professionals met to discuss ways to tackle the challenge of concurrent dementia and sight loss (4).

The study, by researchers at the University of Bradford Schools of Optometry and Health Studies (3), reviewed procedures for sight tests and eye examinations among those with dementia. It found that policy and practice were hampered by a serious lack of basic research into concurrent dementia and sight loss and prompted recommendations which could lead to improved procedures, tools and techniques.

“Our study shows that professionals are working without the support of solid information,” said Ron Bramley, Chief Executive, Thomas Pocklington Trust. “The implications of having both dementia and sight loss are under- researched and too often ignored but we believe that discussions at today’s national conference will help to change that.”

An estimated 750,000 people in the UK live with dementia and over the next few decades this figure is set to increase. Of these, at least 100,000 will also have sight loss. People with dementia are potentially more at risk of visual impairment than people without dementia. Their visual acuity, contrast sensitivity and colour vision can be impaired, as well as their spatial awareness and perception of depth. Since their ability to cope with this sight loss is reduced by dementia, it has a far greater impact on their cognitive performance, mobility and daily living activities.

Despite this, few people with dementia appear to have access to regular eye tests. Promoting the fact that some optometrists make home visits could be vital, suggest the researchers, as is clear communication of the findings, not just to the person tested but to their family and/or professional carers.

More research is needed to help professionals choose the right testing and eye care for people with dementia. Determining which actions give the best results and when, specifically, people with dementia most benefit from them would be invaluable.

Recommendations prompted by the study outline seven steps towards improving policy and practice:

– Conduct a systematic study of the availability and uptake of sight tests among people with dementia.

– Set up a website for people with dementia and their carers with information on how dementia affects eye health, and the importance of eye examinations.

– Develop education and training for optometrists and care home staff.

– Compile a list of optometrists experienced in providing eye care for people with dementia.

– Develop a template for recording the results of eye examinations in people with dementia – something which can be endorsed by professional bodies and made available to care homes.

– Measure the effectiveness of eye care, such as sight tests and cataract removals, on the quality of life of people with dementia.

– Research clinical testing methods so that guidelines can be strengthened. Measuring contrast sensitivity, for example, in someone with dementia could be vital as an inability to judge contrasts can make daily tasks impossible.

Ron Bramley said: “The steps set out in this study show ways to meet the eye health needs of people with dementia that are both thorough and tailored to the individual. These steps could revolutionise the eye care of people with both dementia and sight loss.”

Notes:

1. College of Optometrists – here. Published August 2010

2. Thomas Pocklington Trust is a charity which aims to improve the quality of life of people with sight loss. It is a leading provider of housing, care and support services for people with sight loss in the UK, and is a major research and development body.

3. The findings of the study are included as part of a Thomas Pocklington Trust Research Discussion Paper number 8 – “Improving the provision of vision and eye health care to people with dementia” available from 1st Dec. here. The study was conducted by by Dr. Declan McKeefry (School of Optometry & Vision Science) and Dr. Ruth Bartlett (Division of Dementia Studies) from the University of Bradford.

4. The first national Dementia and Sight Loss Conference will be chaired by Baroness Sally Greengross.

5. The Conference is one initiative of the Dementia and Sight Loss Interest Group (DaSLIG) an alliance of the charities Royal National Institute of Blind People (RNIB), Alzheimer’s Society, Thomas Pocklington Trust and Arup (an independent firm including designers, planners and engineers). This special interest group leads work to raise awareness of joint dementia and sight loss and is part of VISION 2020 UK. For more information about DaSLIG visit the microsite here.

Source:

Thomas Pocklington Trust

Acuity Pharmaceuticals Reports Positive Initial Phase II Results For Bevasiranib (Cand5) In Wet AMD

Acuity
Pharmaceuticals, an ophthalmic pharmaceutical company, today announced that
its lead clinical compound bevasiranib sodium, formerly known as Cand5,
appeared safe and showed clinical evidence of efficacy in the first results
from the Phase II C.A.R.E.(TM) trial for the treatment of wet AMD.
Bevasiranib is a first-in-class small interfering RNA (siRNA) therapeutic
designed to turn off or silence the gene that produces VEGF, the growth
factor believed largely responsible for wet age-related macular
degeneration (wet AMD), a leading cause of adult blindness. The findings
are being presented today at the annual meeting of the American Society of
Gene Therapy in Baltimore, Maryland.

“As a clinician I am encouraged by these initial results, which show a
trend toward dose dependent efficacy without discernable adverse effects in
these AMD patients with serious progressive disease,” said Lawrence
Singerman M.D., founder and executive secretary of the Macula Society,
clinical professor of ophthalmology at Case University and a principle
investigator for the study at its Cleveland site. “Bevasiranib and its
unique mechanism has the strong potential to be useful as a maintenance
therapy, first using a VEGF antagonist to ‘mop-up’ existing VEGF and then
using bevasiranib to stop further production in the eye, and it may also be
an effective new therapy for wet AMD on its own.”

Top-line Phase II results presented at the conference show bevasiranib
to be safe and well tolerated, with a dose related effect evident across
multiple endpoints including near vision, lesion size (CNV) and time to
rescue. Clinical data will be presented at the meeting of the American
Society of Retinal Specialists in September.

“These positive findings of safety and efficacy continue Acuity’s
leadership in developing gene silencing therapies for diseases of the eye,
and represent the first-ever clinical proof-of-concept for an siRNA-based
therapy,” said Dale Pfost, Ph.D., president and CEO of Acuity. “Overall
these positive initial results give us the foundation we need to take
bevasiranib into Phase III clinical trials, which we expect to begin next
year.”

The Acuity Cand5 Anti-VEGF RNAi Evaluation, or C.A.R.E. study, was a
randomized, double-masked trial that included three dose levels of
bevasiranib (Cand5) tested in 129 patients at 28 sites nationwide. The
study focused on patients with serious disease, including those who had
rapidly degenerating retinal lesions or had failed previous treatments and
it excluded patients with slow-growing occult lesions. Bevasiranib
demonstrated signs of efficacy at all dose levels.

“It is noteworthy that the groundbreaking C.A.R.E. trial was designed
and executed with the highest scientific standards and Acuity delivered
positive results from 28 clinical sites in just nine months from the
initiation of the trial,” said Jason Slakter, M.D., macular disease
specialist at the Vitreous Retina Macula Consultants of New York and
clinical professor of ophthalmology at N.Y.U. School of Medicine. “The
novel mechanism of bevasiranib has the potential to provide important
benefits in the treatment of wet AMD now reaching critical levels as our
population grows older, and I look forward to working with Acuity
researchers on the Phase III trials for bevasiranib that are now being
planned.”

Bevasiranib uses RNA interference (RNAi) to silence genes that promote
the overgrowth of blood vessels that lead to vision loss in wet AMD. This
shuts down the production of vascular endothelial growth factor (VEGF),
which has been shown to be the central stimulus in the development of wet
AMD. Bevasiranib is administered directly into the eye and does not affect
the patient systemically, an important safety consideration. The Phase III
clinical trial will further examine efficacy parameters, as well as dosing
and dose scheduling regimens.

About Wet AMD

Wet age-related macular degeneration (wet AMD) is the number one cause
of irreversible vision loss in the developed world, and its incidence is
growing rapidly. Advanced age is the main risk factor for wet AMD, and it
is expected to become an increasingly common condition as the population
grows older. An estimated 1.65 million Americans have wet AMD today and an
estimated 11 million people worldwide will have AMD by 2013. Existing
treatments for wet AMD are of limited efficacy and fail to halt disease
progression in many patients. In the search for more effective treatments,
researchers are targeting vascular endothelial growth factor (VEGF), which
has been shown to be a key cause of the excess growth of blood vessels that
results in loss of vision.

About Acuity Pharmaceuticals

Founded in 2002, Acuity Pharmaceuticals is an ophthalmic pharmaceutical
company applying proprietary technologies to the treatment and prevention
of ophthalmic diseases. Acuity’s lead clinical compound, bevasiranib, a
small- interfering RNA (siRNA) therapeutic targeting VEGF, is in clinical
trials for two of the leading causes of adult vision loss. Acuity recently
completed a Phase II trial of bevasiranib in age-related macular
degeneration and is currently conducting a Phase II trial for diabetic
macular edema. Acuity is applying its drug development expertise to a
growing pipeline of novel agents for ophthalmic conditions. In support of
these programs, Acuity is also developing proprietary technologies for
ocular drug delivery. For more information, see the company’s website at
.

Acuity Pharmaceuticals
acuitypharma

Improved Options For Prosthetics And Treatments After Injury Offered By Brain-Machine Interfaces

Two experimental brain-machine technologies – deep brain stimulation coupled with physical therapy and a thought-controlled computer system – may offer new therapies for people with stroke and brain injuries, new human research shows. In addition, an animal study shows a new artificial retina may restore vision better than existing prosthetics. The findings were announced at Neuroscience 2010, the annual meeting of the Society for Neuroscience and the world’s largest source of emerging news on brain science and health.

Brain-machine interface is an emerging field of neuroscience that aims to translate basic neuroscience research on how the brain packages and processes information to develop devices that help people regain functions lost to disease or injury.
The new findings show that:
Researchers have developed a faster, more accurate way to control cursors with thoughts alone. This scientific advance gives “real-time” feedback of brain activity and may provide more therapeutic options to people with brain injuries or syndromes that limit communication abilities (Anna Rose Childress, PhD, abstract 887.27).
Brain stimulation and physical therapy restores the use of paralyzed limbs – at least temporarily – in people recovering from a stroke. Few people recover completely after a stroke, and the new method may help in developing therapies to increase range of motion in affected limbs (Satoko Koganemaru, MD, PhD, abstract 898.5).
Scientists have constructed an artificial retina that incorporates the signals the eye normally sends to the brain. The new prosthetic may be capable of reproducing normal vision more effectively than existing technologies (Sheila Nirenberg, PhD, abstract 20.1).

“Harnessing the brain’s ability to process, decode, and utilize information has untold therapeutic possibilities,” said press conference moderator Miguel A. Nicolelis, MD, PhD, of Duke University and an expert in neurotechnology and brain-computer interfaces. “Today’s research advances clearly demonstrate neuroscience’s ability to expand our understanding of how the brain works, and translate that knowledge into better treatments, therapies, and technologies.”

This research was supported by national funding agencies, such as the National Institutes of Health, as well as private and philanthropic organizations.

Source:
Kat Snodgrass
Society for Neuroscience

Genes That Cause Blindness Produced By Corneal Oedema Identified For The First Time

UGR News Scientists of the University of Granada (Spain) and the San Cecilio Teaching Hospital (Granada) have determined for the first time the causes for the blindness produced by corneal oedema and have identified the genes which cause it. The research group of Tissue Engineering of the UGR and the San Cecilio University Hospital, who has recently constructed the first complete artificial cornea, has established in a research work which has just been published in the journal Experimental Eye Research new findings related to blindness caused by corneal oedema originated by the alteration of the cell barrier of corneal endothelium. When the endothelial cell barrier is unharmed, the cornea remains dehydrated and transparent.

An oedema is a swelling caused by the accumulation of liquid in the tissues of the human body, including the cornea. The researchers of Granada have proved that the alteration of the mechanisms that regulate the volume of endothelial cells and their content in ions is the cause for which the endothelial barrier stops being effective in the control of corneal transparency.

Ion concentration

The research work has experimentally established the volume and concentration of ions in cells when they make up the endothelial barrier and when they stop forming it. If, due to a traumatism, cataract surgery, ageing, etc., the barrier of endothelial cells breaks, dispersed cells increase their volume and content in ions, potassium and chlorine. The goal of these changes is to repair the endothelial barrier, prevent corneal oedema and, therefore, the loss of transparency and the resulting blindness. The research carried out in the University of Granada has also determined the genes involved in the control of such a process.

Such recent findings suggest new treatments for corneal oedema. The scientists explain that maybe in the not too distant future it will be possible to use eye drops which provide the ions involved or even the possibility of modifying the affected genes by means of gene therapy, which could mend or palliate some of these alterations.

The work was published in the month of May in the renowned journal Experimental Eye Research.

The authors of the work are Professors Miguel Alaminos, Miguel Gonz??lez Andrades, Jos?� Ignacio Mu?�oz ??vila, Ingrid Garz??n, M?? Carmen S??nchez Quevedo and Antonio Campos.

Source: Antonio Campos Mu?�oz

Universidad de Granada

American Academy Of Ophthalmology Appoints International Advisors

Dennis S.C. Lam, MD, of Hong Kong and Stefan Seregard, MD, of Sweden have been appointed to serve a one-year term on the American Academy of Ophthalmology’s (AAO) Board of Trustees.

The International Advisor position on the AAO Board was established in 2010 to bring a global perspective to the board’s decision making and policy setting. Each advisor serves a one year term and represents one of the five major geographic world regions. In 2011, the new appointees will represent two of the remaining three regions.

“The AAO has a substantial number of international members,” said David W. Parke II, MD, executive vice president and CEO of the AAO. “At the same time, we have expanded upon and strengthened our relationships with national and supranational ophthalmic societies worldwide. We are very fortunate to add the insight of strong leaders like Dr. Lam and Dr. Seregard to our board of trustees and will look to them for guidance regarding our participation in the international ophthalmic community.”

Dr. Lam is the chairman of the department of ophthalmology and visual sciences at the Chinese University of Hong Kong. He is the secretary-general and CEO of the Asia-Pacific Academy of Ophthalmology (APAO), and served as president and organizing committee chairman of the 2008 World Ophthalmology Congress (held in Hong Kong).

Dr. Seregard is professor of ophthalmology, Karolinska Institutet, and chairman, department of vitreoretinal diseases, at St. Erik’s Eye Hospital in Stockholm. He currently serves as secretary general of the European Ophthalmological Society and president of the Swedish Ophthalmological Society.

Source
American Academy of Ophthalmology