Medical Reports: Defeating Diabetes

People with diabetes face a daily and lifelong struggle, but there’s promising news. Researchers right here in Miami say they’re working on defeating diabetes for good. 7′s Lynn Martinez has the story.

WSVN — At age 16, Cyndi Smart knew something wasn’t right.

Cyndi Smart, Has Type-1 Diabetes: “I was waking up between five and six times a night. I was so thirsty I couldn’t even lick my lips. My tongue was completely dry.”

Then came the news that changed her life forever: Cyndi had Type-1 Diabetes.

Cyndi Smart: “I would have to be monitored every single minute of every single day of my life.”

Her body doesn’t produce insulin, so she had to check her blood sugar every day and give herself insulin shots.

Cyndi Smart: “I was on four shots a day, before every meal and before I went to bed.”

She is not alone.

Robert Pearlman, Pres. of the Diabetes Research Institute Foundation: “The numbers approach 26 million people, about a third of whom are walking around undiagnosed.”

But those with the most severe cases, like Cyndi, also suffer from something called hypoglycemic unawareness.

Robert Pearlman, Pres. of the Diabetes Research Institute Foundation: “They’re not aware that they’re going low in their blood sugars and they pass out. They can’t operate a car, they can’t hold a job.”

She says it became a nightmare.

Cyndi Smart: “It changes your whole life. You have these brief moments of your life that are missing.”

But now there’s hope at the Diabetes Research Institute, thanks to an experimental procedure called an islet cell transplant.

Dr. Camillo Ricordi, who pioneered the research, says insulin-producing cells are taken from a donor’s pancreas and transplanted into the patient.

Dr. Camillo Ricordi, Dir. of the Diabetes Research Institute & Cell Transplant: “The transplant is very simple. It’s like a blood transfusion.”

The cells are extracted through a Ricordi chamber he invented.

Researchers are hoping it will one day lead to a cure.

Dr. Camillo Ricordi, Dir. of the Diabetes Research Institute & Cell Transplant: “We always work like it could happen within the next three to five years.”

Cyndi had the transplant.

She still has diabetes, but it’s a lot more manageable.

Now, she can eat what she wants and checks her blood sugar a lot less often.

Cyndi Smart: “I come and go as I please. I know there’s not going to be any low sugar, so I have my whole life back.”

Lynn Martinez: “Researchers say the problem is, there’s a limited number of donor cells available, and there’s a long waiting list for the procedure.”

For more information about the Diabetes Research Institute and Foundation:
Diabetes Research Institute
www.DiabetesResearch.org
Tel: (800) 321-3437

For information about insulin pump therapy and more:
Animas Corporation
www.Animas.com
Tel: (877) YES-PUMP (1-877-937-7867)

LifeScan
www.LifeScan.com
Tel: (800) 227-8862

Diabetic Tester That Talks to iPhones and Doctors

While consumer technology advances by leaps and bounds, the devices patients use to manage diseases often seem stuck in the past. A glaring example is the glucometer, the instrument diabetics use to measure the sugar in their blood—information they use to adjust their diet, exercise and medication.

These meters, which analyze drops of blood drawn from fingertips, typically resemble crude PDAs from 10 or 15 years ago. They offer little feedback and can’t connect to the Internet to show results to caregivers. Most diabetics who use them log their readings on paper, which they hand doctors weeks or months later.

But that is beginning to change. Next week, a small start-up will introduce a new diabetes meter it says is the first with wireless technology that instantly transmits a patient’s readings to a private online database, which can be accessed by the patient or—with permission—by a doctor, caregiver or family member. This system charts the results to highlight trends and spot problems, and can be accessed via a Web browser or an iPhone app. It automatically transmits relevant feedback—such as whether your readings seem high or low—and allows doctors to respond.

I’ve been testing this new meter and service, which is called Telcare and comes from a Bethesda, Md., company of the same name. As a Type 2 diabetic myself, I found the Telcare meter a refreshing change, and a significant step toward bringing consumer medical devices closer to the world of modern technology.

Despite some drawbacks, including a high price, I recommend the Telcare be considered by diabetics who want a better substitute for paper logs, or would benefit from real-time sharing of their readings.

However, as with any medical decision, I urge people to consult their doctors before switching meters. Also, I evaluated this product as a consumer technology. I am not a physician or diabetes expert. While I found the Telcare meter convenient and accurate for me, your situation might differ.

The Telcare device works much like a traditional meter. You insert a test strip into a slot on the meter, then prick your finger with a lancing device to get a drop of blood, touch the strip to the drop, and wait for the reading to appear.

The difference is the meter immediately sends results to its online database, where you or your doctor can find it via the password-protected website or iPhone app. This transmission is achieved via a built-in cellular modem, which doesn’t involve any cellphone, carrier contract or fee.

That cellular connection is used to send you messages about your readings, if necessary. In this first version, the patient can’t reply to doctors’ messages from the meter, but that’s planned for the future.

Telcare typically uses T-Mobile’s network, but, if that’s not available, the meter will automatically shift to whatever compatible connection it finds. If no connection is available, it will save the results and you can transmit them manually when you’re back in range.

Because it automatically logs results and allows real-time sharing, I believe diabetics who use this new system will be less likely to skip readings, or to fudge the numbers, especially if they allow doctors and other caregivers to see the results instantly. And that could mean an improvement in their health.

While it’s a leap ahead of typical diabetes meters, the Telcare meter isn’t exactly cutting edge. It looks like a thick, old cellphone, though it’s light. Unlike most other glucose meters, it has a large color screen that allows it to display informative graphics and messages.

One drawback is the price. While many diabetes meters cost well under $50, or are free (the money is in the test strips), the Telcare meter costs $150 for a starter kit that includes the meter, a wall charger, a case and accessories. The cost drops to $100 if you subscribe to a one-year supply of test strips. The strips cost $56 for a container of 50, or $36 with the subscription. Insurance may reduce these costs.

Another drawback is battery life. Traditional meters use removable batteries that can last months. The Telcare has a sealed battery and must be recharged frequently, like a cellphone. The company says if you turn it off between readings, a battery charge should last for 200 to 300 tests. If you leave it on, it will go to sleep between tests and need to be recharged every two or three days. In my tests, doing three readings a day for four days, I didn’t need to recharge it, but I turned it off when not in use.

Also, many diabetics carry around their meters, and the Telcare is larger than any traditional meter I’ve seen, though it fits in a pocket or small purse.

Finally, the meter and strips will, at first, be available only from the company, though it’s hoping to sell them in drugstores soon.

In my tests, the meter was easy to use and gave me helpful messages, such as whether I was in my prescribed range, or what my daily averages were. A Telcare official posing as my doctor sent me test messages reacting to my readings.

I can’t judge the accuracy of the Telcare, but it has been cleared by the Food and Drug Administration, and the company says it meets or exceeds FDA standards for accuracy. Its readings seemed right to me.

I found the website and iPhone app worked well, giving me constantly updated and detailed lists, graphs and pie charts that showed me where I stood over short and long periods. These can be printed out or turned into documents for email. You can also enter notes for any reading and the meter asks you to indicate whether a reading was, say, after or before a meal or physical activity. Using the website, you can adjust your preferred range of glucose readings to fit your doctor’s advice. And the iPhone app allows manual entries, if you use another meter.

I did find some bugs, all of which the company pledges will be fixed before next week’s launch. In one case, when a reading produced a clearly erroneous number (something that can happen with every meter I’ve used) the Telcare failed to offer advice on what to do. Two subsequent readings were correct, however, and the company says such errors are rare.

In another case, I found I could alter a reading on the iPhone after transmission.

Telcare isn’t the only company trying to drag the glucose meter into the modern era. Entra Health Systems has a meter called MyGlucoHealth that transmits readings via Bluetooth to a cellphone for transmission to an online portal. And Sanofi and AgaMatrix offer a diabetic-testing attachment for the iPhone called the iBGStar, which isn’t yet available in the U.S., but is sold in some other countries. It can email results.

But the Telcare device is a leap ahead of nearly all glucose meters. If you’re a diabetic, or care for one, it’s worth a look.

Poor sleep worsens health in youth with type 1 diabetes

Young people with type 1 diabetes mellitus (T1DM) may have difficulty getting a good night’s sleep, resulting in difficulty controlling blood sugar and decreased performance in school, according to a study published in the January issue of SLEEP.

Forrest MacCormack, for USA TODAY

Nicholas Rudd, age 10, demonstrates how he would give himself an insulin shot using the door of a refrigerator to pop up his arm to be able to inject insulin in the proper place.

Michelle M. Perfect, Ph.D., of the University of Arizona in Tucson, and colleagues used home-based polysomnography, actigraphy, and questionnaires to track the sleep health of 50 patients, aged 10 to 16 years, with T1DM; results were compared with a control group without diabetes matched for sex, age, and body mass index. The level of glucose control was simultaneously assessed using continuous glucose monitors and hemoglobin A1C values.

The researchers found that, overall, young patients with T1DM spent about 21 minutes (or 5 percent) less time per seven-hour night in deep sleep than individuals without diabetes. Even those with mild sleep difficulties experienced more hyperglycemia and emotional and behavioral difficulties, reduced diabetes-related quality of life, lower grades, depression, sleep-wake behavior problems, poor sleep quality, sleepiness, and lower math scores. Patients with sleep apnea had associated higher blood sugar levels. As sleep is a potentially modifiable behavior, the authors suggest that improving clinician awareness of potential sleep problems could help these children and adolescents improve their quality of life.

“Overall, this study supports the need to inquire about sleepiness and sleep habits as part of the clinical care of youth with T1DM. Clinicians and school-based professionals need to be aware that reports of daytime sleepiness, disrupted sleep, or poor sleep habits, may affect patients’ daytime functioning, including the possibility of interfering with their diabetes self-care, quality of life, and school performance,” the authors write.

Johnson & Johnson (Lifescan) donated all One Touch Ultra Meters and a portion of the strips used in the study; several authors disclosed financial ties to the pharmaceutical and medical device industries.

FDA clears Abbott’s Freestyle for use with Insulet’s OmniPod

The FDA granted 510(k) clearance to Abbott’s Freestyle glucose test strip for use with Insulet’s OmniPod insulin management system.

The FDA granted 510(k) clearance to Abbott’s (NYSE:ABT) Freestyle glucose test strip for use with Insulet’s (NSDQ:PODD) OmniPod insulin pump.

“The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod,” Insulet confirmed in an email to MassDevice. “The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week.”

It’s good news for Bedford, Mass.-based Insulet, as Abbott’s Freestyle is one of the most popular test strips on the market.

Insulet is awaiting word from the federal watchdog agency on its 510(k) application for the next-generation OmniPod it says will help reduce production costs by more than a third.

The latest version of the system is ⅓ smaller, 25 percent lighter and “expected to reduce our cost of production by about a third, driving significant gross margin improvement,” CEO Duane DeSisto said in May 2011. “We are confident that the easy-to-use design of our tubeless insulin pump will raise the bar for the industry again and improve our competitive position in the marketplace.”

Last November, Insulet reported wider third-quarter losses than expected and lowered its full-year sales guidance, despite logging a 75.2 percent addition to the top line.

Diabetes in pregnancy, poverty linked to ADHD

So-called gestational diabetes typically develops during the second or third trimester of pregnancy.

Babies born to poor mothers with pregnancy-related diabetes have an extra-high risk of developing attention-deficit/hyperactivity disorder, a new study suggests.

So-called gestational diabetes typically develops during the second or third trimester of pregnancy, especially in women who are overweight before getting pregnant, eat an unhealthy diet and don’t exercise. It affects between two and 10 percent of pregnant women, according to national data, and rates are rising alongside type II diabetes in the general public.

While the new study doesn’t prove that moms’ gestational diabetes leads to ADHD in kids, it’s likely that diabetes-related changes in the blood shared by mother and fetus could affect how babies’ brains develop, researchers said.

“There seems to be more research going in the direction that… the brains of children with ADHD are different,” said Ginette Dionne, who has studied gestational diabetes and language development at Laval University in Quebec but wasn’t involved in the new study.

“Gestational diabetes may not be a specific cause (of ADHD), but may be one of the factors that affects brain development,” she added.

Researchers from the Mount Sinai School of Medicine in New York led by Dr. Yoko Nomura recruited 212 preschoolers for their study, two-thirds of whom were at risk for ADHD, based on teacher and parent reports.

According to interviews with their moms, 21 had been diagnosed with gestational diabetes while pregnant.

The researchers found that at ages three to four, kids whose mothers had had gestational diabetes scored worse on tests of language, memory and IQ than those with diabetes-free moms. And at age six, they had more communication and attention problems.

The effect seemed to be most pronounced in kids born to moms with gestational diabetes who were also poor. Those kids were 14 times more likely to meet the criteria for an ADHD diagnosis at age six, compared to kids of moms who were middle class or well-off and hadn’t had gestational diabetes.

Babies of women who’d had gestational diabetes but weren’t poor, or were poor but diabetes-free, were not at increased risk of ADHD, the researchers report in the Archives of Pediatrics & Adolescent Medicine.

In cases of gestational diabetes, babies get exposed to extra glucose in the blood that passes through the placenta, researchers said. Diabetes could also affect the amount of oxygen or iron in that blood.

Something about the altered blood, or the way the baby’s body responds to it, may interfere with brain development.

“Really right now we have no idea what the specific culprit is,” Dionne told Reuters Health.

“What the cumulative data is showing is there is something happening to the brain development of babies of these mothers that have gestational diabetes, and it doesn’t seem to affect all babies equally.”

Environment after birth also appears to play a role — kids who grow up in disadvantaged families might not be able to bounce back from early developmental issues, according to experts.

“If you have a subtle problem, if you have better medical care, better food, better intellectual stimuli, you might be able to fix it,” Nomura told Reuters Health.

“But if you’re born into a harsher, more adverse environment, maybe that tiny little problem acts as a bigger hindrance developmentally.”

Researchers agreed that the findings reinforce the importance for women who are planning to become pregnant of getting their weight under control and improving their diet to lower their chances of developing gestational diabetes.

“It is equally important not to frighten pregnant women because (gestational diabetes) is relatively common,” said Asher Ornoy, who studies the effects of gestational diabetes at the Hebrew University of Jerusalem, Israel, in an email to Reuters Health.

“Hence preventive measures — early diagnosis, good nutrition in pregnancy, avoiding overweight… are very important.”

Pure Play Diabetes Technology Companies Offer Little To No Value For Investor

The first blood glucose meter came to market in doctors’ offices in 1965. Within a minute of placing a drop of blood on a paper strip, a color reading was produced. The doctor compared this color to a color chart and came up with the blood glucose reading. The first digital readout came in 1970 with in home meters being produced starting in 1975. From 1975 until 2005, there were not too many updates to the at home blood glucose monitor: the device grew to be more accurate and smaller over time. Additionally meters are now available that enable physicians to download the readings onto their computers instead of patients having to write it down in a log. Enter the continuous glucose monitor in 2005.

The continuous glucose monitor is a device that that tracks blood glucose readings in real time. Typically attached to the stomach is a needle to draw minute amounts of blood. This links up to an electronic device that stores the data. The simple argument as to why this technology will be a breakthrough is because patients, mostly Type 1 Diabetics, will be able to monitor the highs and lows of their glucose levels, theoretically enabling them to better manage their condition. There are several reasons that the potential market for this device might be less than industry insiders and investors have come to believe. First, the patient has to feel that it is important enough to them to monitor their condition full time that they are willing to have these items attached to their body. Additionally, the patient still has to calibrate the device twice a day with a reading from a traditional glucometer. Also, insurance companies are on the fence about whether or not to cover the device. While commercial insurance companies have largely come around, there has been no national decision by Medicare and it is unlikely that Medicaid will ever take it up. That being said, CGM claims many Type 1 diabetes patients as fans. Many people swear by it and perhaps that’s what has driven up the valuation of the only pure play public company with a device currently on the market, Dexcom (DXCM). Though far from its $25 high in 2005 at $9 currently, the company’s market capitalization is 20% higher at $600 million now then it was in 2005 as a result of a tripling in the company’s shares outstanding. The company has an accumulated deficit of over $400 million. While I don’t think Dexcom is a bad company, it has become clear over the years that to get an increase in sales, the company has to spend incrementally more money. Though sales have increased from $2 million in 2006 to about $69 million in 2011, net loss has stayed about the same at around $45 million. The company has to spend a large amount of money to market its product because its primary competitor is Medtronic (MDT), a company with a great amount of resources. Medtronic has the only fully integrated product in the United States that combines an insulin pump with continuous glucose monitoring, making DXCM’s sale a difficult one. As a result, we think DXCM’s 8.5x Price/Sales multiple is not warranted without further evidence that the market is larger than current sales levels reflect.

* Numbers In Millions

The next big pure play in the diabetes technology market is Insulet (PODD), the maker of the OmniPod, the lightest insulin pump on the market. The clear competitive advantage that it has is being the only wireless pump in the United States. Type 1 diabetics have caught on to this product as well over the past few years. Similarly to Dexcom, while sales increased from $4 million in 2006 to about $135 million in 2011, net loss increased from $32 million to $64 million in the same respective period. A big part of this spend has gone into increasing awareness of the product and attempting to effectively compete with Medtronic. We think that while Insulet will continue to gain market share until Medtronic develops a tubeless pod system, sales will likely not accelerate further until the company receives FDA approval for a product that integrates the insulin pump with CGM, like Medtronic has on the market. While the stock topped out at $27 in 2007, market capitalization is at its high with the share count nearly tripling over the past four years. One particularly questionable move that the company made earlier in 2011 was the acquisition of Neighborhood Diabetes, a diabetes products supplier. Our thoughts are that the company made this large and non-core acquisition to thwart off any potential acquisition attempts. While the company was a pure play insulin pump company, a large med tech might have been interested in purchasing it. PODD trades at 8x price/insulin pump sales, similar to DXCM, compared to 2x sales for the average med-tech company. Additionally, over the past 6 months, executives have sold over 120,000 shares.

In conclusion, while we favor the fact that these products make the lives of diabetics easier in some cases, we do not think the current valuations are supported by fundamentals or realistic expectations for future demand. Medtronic, one of the largest Med-Tech companies in the world, currently dominates the space and companies including Johnson & Johnson (JNJ) & Roche (RHHBY.PK) are increasing their presence within the space. We think that the barriers to entry are somewhat low given that the IP for both products is based on established technology. We recommend investors stay away from the space until valuations rationalize considerably.

Diabetes Care Thwarted by Unstable Health Insurance: Study

Disease management requires continuous coverage for preventive screenings, experts say

FRIDAY, Jan. 6 (HealthDay News) — Diabetes patients require continuous health coverage to ensure they receive recommended care, a new study concludes.

For the study, U.S. researchers analyzed data from nearly 3,400 diabetes patients who received medical care between 2005 and 2007 at 50 federally qualified health centers in Oregon. At these centers, free or reduced-cost care is provided to low-income patients whether they have insurance or not.

Of the patients in the study, 52 percent had continuous health insurance coverage (most often provided by Medicaid), 21 percent had interrupted coverage during the three-year period, and 27 percent had no coverage. Patients with private insurance were not included in the study.

The researchers looked at whether the patients received four health services recommended at least once a year for diabetes patients: a lipid test for high cholesterol; a flu vaccine; a blood sugar level test; and a urine test that can detect kidney damage.

Among patients with continuous insurance, 48 percent received at least three lipid-screening tests during the three-year study, 25 percent received three or more flu shots, 72 percent received three or more blood glucose screenings, and 19 percent underwent three or more screenings for kidney damage.

Patients with interrupted or no coverage received far fewer of these preventive health services, the investigators found.

“Our study shows that patients need continuous health insurance coverage in order to ensure adequate preventive care, even when that care is provided at a reduced cost,” study author Rachel Gold, an investigator with the Kaiser Permanente Center for Health Research in Portland, Ore., said in a Kaiser Permanente news release.

While services at the clinics are free, some of the diagnostic tests require a small co-payment that is usually covered by Medicaid. Patients who lose Medicaid coverage often delay getting the tests because they can’t afford the co-payment, the researchers noted.

The study, funded in part by the U.S. National Institutes of Health, is published online and in the January-February issue of the Journal of the American Board of Family Medicine.

More information

The American Diabetes Association has more about living with diabetes.

Copyright © 2011 HealthDay. All rights reserved.

Diabetes in Lab Mice Reversed with Natural Compound

 

The International Diabetes Federation has released data (this week) that indicates the number of people living with diabetes around the world will likely rise from 366 million to 552 million by 2030 if urgent action is not taken. In marking World Diabetes Day this week, the World Health Organization focused attention on India and other developing countries that bear the brunt of the global diabetes epidemic – even as new research offers hope that a cure for the most common form of the disease – Type 2 diabetes – might not be far off.

Many public monuments in New Delhi were illuminated with blue lights on Monday to mark World Diabetes Day. There was good reason for the special notice. India has the world’s largest number of diabetics – more than 50 million people and that number is expected to climb to 61 million over the next two decades.

“We want to disseminate the message to the public all over India and also to the world that you (should) beware of diabetes,” said Anup Mishra, chairman of the Fortis Center for Diabetes in India.

The International Diabetes Federation predicts that at least one in 10 people in the world could have diabetes by 2030.  This most common of human disorders is caused mainly by poor diet, excess body weight and physical inactivity.  It not only reduces the quality of life but is also a risk factor for heart disease, stroke and dementia.

A team of researchers in the United States reported recently that it was able to cure Type 2 diabetes in mice. In a study conducted at Washington University School of Medicine in St. Louis,Missouri, the researchers treated mice with a naturally-occurring substance known by its chemical acronym, NMN.

“The bottom line is, NMN has remarkable effects on Type 2 diabetes, at  least in mice,” said Professor Shin-ichiro Imai. He explains the results in mice hold promise because the metabolic processes that NMN influences in mice are likely to be the same in the human body.

“We fed mice a high-fat diet where 40 percent of the calories came from fat – a fatty, nasty diet which the mice liked and eventually they came up (down) with serious Type 2 diabetes. And that’s the model we used to examine the effects of NMN and it works really well.”

The study shows that aging and eating a high-fat diet reduce production of NMN in the body, leading to abnormal metabolic conditions – including diabetes.

The researchers are collaborating with a Japanese company to come up with a grade of the compound that can be used in human trials.

“It will probably take a couple of years, but we are planning to launch a human pilot trial,” said Imai.

The hope is that one day, it will be possible for people to take the compound like a daily vitamin as a way to treat or even prevent Type 2 diabetes.

Antibody Could Reverse Diabetes

New approach treats more than symptoms

The most common form of diabetes, type 2, occurs when the pancreas doesn’t produce enough insulin, which regulates sugar in the blood. The excess sugar can affect the heart and blood vessels, eyes and other organs.

Scientists in California have developed a new approach to treating diabetes which might be able to reverse the disease and not just treat the symptoms.

The World Health Organization estimates that more than one-third of a billion people worldwide have diabetes. The most common form of the disease, type 2 diabetes, is on the rise. It’s usually the result of excess weight and lack of physical exercise.

The pancreas doesn’t produce enough insulin, which regulates sugar in the blood. The excess sugar can affect the heart and blood vessels, eyes, and other organs.

Treatment includes losing weight and exercising. Some patients take insulin or other medicines.

At the California biotechnology company Genentech, researchers have been investigating a growth factor protein called FGF21, which is involved in controlling blood sugar.

Junichiro Sonoda says previous studies have shown that when FGF21 is injected into laboratory mice and monkeys, it has a variety of beneficial effects. “Well, the animals lose weight, and cholesterol, which increases cardiovascular risk, now goes down. And there’s a good cholesterol called HDL, which level goes up with FGF21 treatment.”

Efforts to get the same effect in humans have been stymied by the fact that the effect lasts only a few hours. “So that means, to get the beneficial effect you have to inject a lot of it and many times during the day.”

So the Japanese-born researcher and his colleagues tried a different approach. They developed antibodies that mimic FGF21 by attaching to the same receptors in the pancreas and elsewhere, and they tested it on mice.

“The blood glucose level got normalized. And we kept monitoring blood glucose after a single injection of this antibody, and it took almost 40 days for the blood glucose level to come back to a ‘normal’ diabetic level,” Sonoda said.

That kind of long-lasting effect is one of the things that drug developers look for.  “This could become the very first class of drug that could reverse the disease instead of just treat the symptoms of disease. That would be a huge benefit for patients.”

Junichiro Sonoda says further work is needed on this potential antibody-based treatment for diabetes before moving on to human testing. A paper describing the research is published in  Science Translational Medicine.

JDRF to Support ViaCyte’s Development o Innovative Encapsulated Beta Cell Replacement Therapy for Diabetes

 

 

 

 

 

 

 

Contact: Joana Casas, 212-479-7560; mcasas@jdrf.org

–Goal of new JDRF research is to restore insulin production in people with type 1 diabetes–

New York, NY, December 13, 2011 — JDRF announced today its support of a pioneering diabetes research program that is developing a first-of-its-kind cell therapy for type 1 diabetes (T1D) and other forms of insulin-dependent diabetes. The therapy is a combination product that packages immature cells made from human embryonic stem cells (hESCs) that over time develop into mature pancreatic hormone producing cells (pro-islet) including insulin-producing cells. The research is an important step toward producing an unlimited source of insulin-producing cells that could serve as replacements for those destroyed in both T1D and insulin-dependent type 2 diabetes. The diabetes program is being funded by JDRF, the largest charitable funder of T1D research in the world, the California Institute for Regenerative Medicine (CIRM), and ViaCyte, a San Diego, California-based biotechnology company focused on diabetes.

Ongoing research of this combination product in rodents has demonstrated that within two to three months of implantation, the immature human pancreatic hormone cells mature into functional pancreatic hormone producing cells, including functional insulin producing cells that can regulate blood glucose.

Existing cell therapies such as islet and pancreas transplantation have the potential to cure T1D by restoring normal islet function and normalizing blood glucose levels in people with T1D. Because the number of cadaveric human donors for pancreatic islets is limited, ViaCyte’s program will provide a replenishable supply of functional insulin-producing cells. Furthermore, packaging the cells in a device (“encapsulation”) creates a physical barrier around the cells and has the potential to protect the transplanted cells from immune rejection, and may eliminate the need for chronic immunosuppressive drugs. The ultimate goal of this partnership is to help patients with T1D restore their ability to regulate blood glucose, thereby reducing or eliminating the need for constant self-management and administration of insulin.

The three-year series of preclinical studies being co-funded by JDRF will help ViaCyte prepare the information necessary to apply for regulatory approvals to study the system for safety and efficacy in people with T1D.

“Encapsulation research is one of JDRF’s priorities because of the profound possibilities it holds for many avenues of research for type 1 diabetes,” said Julia Greenstein, JDRF’s assistant vice president for Cure therapies. “We’re excited about partnering with ViaCyte to explore the use of encapsulated stem cell-based replacement. This type of innovative therapy could revolutionize the way people live with type 1 diabetes, and may also reduce the risk of dangerous complications that often result from extreme high and low blood sugars.”

“We are thrilled to be partnering with JDRF, the leader in the field of support for diabetes research,” said Allan Robins, Ph.D., acting CEO from ViaCyte. “ViaCyte’s goal is to create a product that will free people with diabetes from insulin dependence for the long-term, and we believe this therapy has the potential to transform lives.”

“At CIRM, we have long had the goal of leveraging the financial and intellectual capital of California with other funds and talent from around the state and around the world, and the decision by JDRF is a clear example of how these partnerships can enhance the opportunities to get to the end goal of a therapy for patients,” said Alan Trounson, president of CIRM. “We are proud to have JDRF as a partner in working with ViaCyte and their scientific team to bring a potentially life-changing therapy for people with diabetes to the clinic.”

 

About T1D

In T1D, a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. People with T1D need to test their blood sugar and give themselves insulin (with injections or an insulin pump) multiple times every day, and carefully balance insulin doses with eating and daily activities throughout the day and night. However, insulin is not a cure for diabetes, and even with that intensive care, a significant portion of the day is still spent with either high or low blood sugar, placing people with T1D at risk for devastating complications such as heart attack, stroke, blindness, and amputation.

About JDRF

JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.6 billion to T1D research. More than 80 percent of JDRF’s expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. For more information, please visit www.jdrf.org.

About ViaCyte

ViaCyte is a preclinical cell therapy company focused on diabetes. The Company’s technology is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. ViaCyte’s goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications. ViaCyte is a private company headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine.

This news release may contain forward-looking statements made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995.