Stem Cells in Ophthalmology An Update AstraZeneca Joins the Fray

As reported by The Guardian (UK), AstraZeneca and University College London (UCL) have announced a research partnership, to develop medicines that use stem cells to repair damaged eyesight in people with diabetes.

Under the three-year partnership, funded by the drugmaker, researchers from AstraZeneca will team up with scientists at the UCL Institute of Ophthalmology to work on new medicines that use the regenerative capacity of stem cells. They hope to come up with a compound in three to five years, which could then undergo clinical development and possibly be on the market in 10 years' time.

Dr Marcus Fruttiger of the UCL Institute of Ophthalmology, who is leading the project, said: "These tools could be used either to manufacture transplantable material or to directly stimulate new cell growth in the eye to help restore or improve the vision of those with diabetic retinopathy (DR)."

AstraZeneca's U.S. rival Pfizer also has a partnership with Professor Pete Coffey of the UCL Institute of Ophthalmology, aimed at another eye condition, macular degeneration. Coffey said: "It's great that 'Big Pharma' is considering regenerative medicines as a serious possibility." He added: "This is British science being developed into a commercial entity with the pharmaceutical industry. It's a good example why the government shouldn't cut funding for biomedical research."

While this is the first time that AstraZeneca has worked on medicine for retinopathy, diabetes has been an area of focus. The company has a new diabetes treatment on the market called Onglyza, which was developed with Bristol-Myers Squibb, and the companies are developing a second diabetes drug that could be submitted to regulators for approval later this year.

Diabetic retinopathy (DR) is now the most common cause of vision impairment or blindness among western people of working age.

* The majority of patients with type-1 diabetes, which occurs when the body produces no insulin and often develops during the teenage years, will suffer eyesight problems and about 20%-30% will become blind;

* Moreover, at least 50% of patients with type-2 diabetes - the far more common type of diabetes, which occurs when the body produces too little insulin or when cells in the body do not react properly to insulin - will also develop retinopathy over time;

* With the rapid spread of type-2 diabetes, which is linked to obesity, the need for a retinopathy treatment will grow as more than 438 M people are expected to suffer from diabetes by 2030;

* A study published this year by Oxford University predicted that eight out of 10 men and almost 7 to 10 women will be overweight or obese by 2020;

* It forecast a 98% rise in obesity-related diabetes by 2050.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com

To read about the other companies involved in developing stem cells for use in ophthalmology, along with an extensive description of what stem cells are all about, and where they are being used in ophthalmology, please see: A Primer on the Use of Stem Cells in Ophthalmology.

Stem Cells in Ophthalmology Update 15 Wills Eye Joins ACT’s Clinical Trials for Dry AMD Using Embryonic Stem Cell derived RPE

Advanced Cell Technology announced yesterday that the Wills Eye Institute in Philadelphia had received institutional review board (IRB) approval to become a site for the Phase I/II clinical trial for dry age-related macular degeneration (Dry AMD) using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. Wills will join UCLA’s Jules Stein Eye Institute and Moorfields Eye Hospital in London as sites participating in the clinical trials for Dry AMD, under ACT’s National Clinical Trials protocols.

"The participation of Wills Eye Institute in this trial will significantly enhance our clinical program," said Robert Lanza, M.D., ACT's chief scientific officer. "Wills Eye Institute is the oldest eye-care facility in the United States and is consistently ranked as one of the best ophthalmology hospitals in the country by the U.S. News & World Report. We are looking forward to working with Dr. Regillo and his team to address the unmet medical needs of degenerative diseases of the retina. With this latest approval, the company continues to assemble a clinical team that includes the best eye hospitals and surgeons in the world in our effort to find an effective therapy for this devastating eye disease."

The Phase I/II trial for dry AMD is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format. Which patients will be enrolled at the Wills Eye Institute will be determined in the near future.

"Degenerative diseases of the retina often lead to a significant visual impairment," said Carl Regillo, M.D., director of clinical retina research at Wills Eye Institute and professor of ophthalmology at Thomas Jefferson University. "Replacing lost or damaged cells with functional and healthy cells may provide a treatment option that could slow vision loss, and perhaps even reverse the effects of disease. We are looking forward to collaborating with ACT to evaluate the potential of the stem cell-derived RPE cells for debilitating diseases such as Stargardt's macular dystrophy and dry AMD."

Dry AMD, or "central geographic atrophy," is the "dry" form of advanced age-related macular degeneration. Dry AMD occurs when the light-sensitive cells (photoreceptors) in the macula slowly break down, gradually blurring central vision in the affected eye. Over time, as less of the macula functions, central vision is gradually lost in the affected eye, often progressing to blindness. The loss of photoreceptors is a direct result of a preceding degeneration of the retinal pigment epithelial (RPE) layer of cells just below the retina. As many as 30 million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority suffering from the "dry" form of AMD -- which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

"We are honored to have the opportunity to work with one of the foremost eye care centers in the world", said Gary Rabin, chairman and chief executive officer of ACT. "This clinical trial represents the culmination of years of innovation and hard work by ACT's scientific team. The whole world is focused on our trials, most especially patients suffering from dry AMD and other forms of macular degeneration. Wills Eye Institute has a strong tradition of innovation and discovery, and we are excited at their participation in bringing this cutting-edge technology through the clinic."

Additional details about these studies, for which the Jules Stein Institute at the University of California, Los Angeles and Moorfields Eye Hospital in London have also received IRB approval, can be found at ClinicalTrials.gov Identifier: NCT01344993.

Editors Note: As noted in the above quote from Dr. Regillo, it can be speculated that Wills Eye will soon join both Jules Stein and Moorfields in also treating Stargardt’s disease, under ACT’s National Clinical Trials NCT01345006 and NCT01469832.

It should also be noted that Wills Eye is also one of the clinical sites participating in the Centecor (J&J) clinical study of Dry AMD using adult stem cells from umbilical cord blood, NTC01226628.

Breaking News – as of January 19th, Wills Eye had been added to ACT’s clinical protocol for treating Dry AMD with embryonic stem cell-derived RPE cells, and was actively recruiting patients.

About Wills Eye Institute

Wills Eye Institute is a global leader in ophthalmology, established in 1832 as the nation's first hospital specializing in eye care. U.S. News & World Report has consistently ranked Wills Eye as one of America's top three ophthalmology centers since the survey began in 1990. Wills Eye is a premier training site for all levels of medical education. Its resident and post-graduate training programs are among the most competitive in the country. One of the core strengths of Wills is the close connection between innovative research and advanced patient care. Wills provides the full range of primary and subspecialty eye care for improving and preserving sight, including cataract, cornea, retina, emergency care, glaucoma, neuro-ophthalmology, ocular oncology, oculoplastics, pathology, pediatric ophthalmology and ocular genetics, refractive surgery and retina. Ocular Services include the Wills Laser Correction Center, Low Vision Service, and Diagnostic Center. Its 24/7 Emergency Service is the only one of its kind in the region. Wills Eye also has a network of nine multi-specialty, ambulatory surgery centers throughout the tri-state area. To learn more, please visit www.willseye.org .

Jill Satterfield Joins Yoga for Healthy Aging!

by Nina

Jill Satterfield by Jamey Lord

I’m excited to announce that I’ve invited Jill Satterfield to join our staff and she has accepted. That means you’ll be hearing from her regularly from now on, probably once a month. And from now on, she’ll write under the name “Jill” and be listed on our About Us page. She already has a page Jill's Workshops and Classes with her classes and workshop information on it as well as Guided Meditations by Jill with some of her guided meditations.

I invited Jill to join us both because we’re big fans of her writing (my favorites include Spiritual Sanity and When Red Flags Should Be Raised) and because she has some expertise in areas that we don’t due to her knowledge of Buddhism well as yoga. Besides being a very experienced, long-time teacher of mindfulness and embodiment practices, she also has a lot of knowledge about helping people with chronic illness and pain, something she has had personal experience with this. And she is currently training to be a hospital chaplain (which I hope she’ll write about sometime). 

The funny thing is that I got to know Jill because of Facebook! After she moved to Berkeley, she posted a photo of a quirky shop near my house. I commented on her post that I lived nearby, which lead to personal messages and then a get-together for tea. Kind of like a blind date only for friendship! We’ve been friends and colleagues ever since, always talking about “work” issues as well as personal ones. I especially appreciate the intellectual discussions we have about differences and similarities between yoga and Buddhism, which has led me to new insights. And some of her posts came out of discussions we had when we got together as friends because I said, "You need to write about that!"

To find out about Jill, see her website: vajrayoga.com. Here are all the posts that Jill has done for us so far:  

Practicing Titration in Difficult Times  

Mindfulness of Sensation 

Checking In: A Guided Meditation  

The Kindness Practice 

Attached to My Face 

Spiritual Sanity  

When Red Flags Should Be Raised 

No Control: Watching Your Breath in Asana

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