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Kala Pharmaceuticals to Present Clinical Data for KPI-012, its Mesenchymal Stem Cell Secretome Product, for the Treatment of PCED at the 2022 ARVO…

Posted: May 2, 2022 at 1:54 am

-- Data Demonstrate Rapid and Complete Wound Healing, with Six of Eight (75%) Patients Achieving Complete Healing within Four Weeks; All Remained Healed Through End of Follow-Up ---- All Patients with Pain at Baseline Reported Zero Pain by Week 3 ---- KPI-012 was Well-Tolerated with No Significant Safety Issues Observed ---- On Track to Submit Investigational New Drug Application (IND) and Initiate Phase 2/3 Trial in 4Q 2022 --

ARLINGTON, Mass., May 01, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported clinical data from a Phase 1b trial of KPI-012, its novel, cell-free secretome therapy for the treatment of severe ocular diseases driven by impaired healing. As previously disclosed, treatment with KPI-012 was well tolerated and resulted in significant improvements in patients with various persistent corneal epithelial defect (PCED) etiologies, with complete healing of the PCED in six of eight evaluable patients. The data will be presented on Tuesday, May 3 in a poster session at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

The clinical activity observed to date with KPI-012 is encouraging, said Valeria Snchez-Huerta, M.D. FACS, Medical Director at Asociacin para Evitar la Ceguera en Mxico (Association to Prevent Blindness in Mexico) and an investigator in the Phase 1b trial. PCED is a disease of impaired corneal healing which, if left untreated, can lead to infection, corneal perforation and irreversible vision loss. Achieving rapid and complete wound healing, as well as a reduction in PCED-related pain, and an improvement in visual acuity and corneal opacity, in patients with a range of underlying etiologies is remarkable, particularly after such a short treatment duration. Based on these early data, I believe KPI-012 could become the first treatment to address PCED across all etiologies and I look forward to further evaluating its potential in later-stage studies.

PCED, which is defined as a persistent non-healing corneal defect or wound that is refractory to conventional treatments, is a rare disease with an estimated incidence in the United States of 100,000 cases per year. PCED can have various etiologies, including neurotrophic keratitis, surgical epithelial debridement, microbial/viral keratitis, corneal transplant, limbal stem cell deficiency and mechanical and chemical trauma and can lead to corneal ulceration, perforation, stromal scarring, secondary infections and significant vision loss.

Healing after corneal injury follows a highly coordinated process involving growth factors, cell signaling, proliferation, migration and extracellular matrix remodeling. In patients with PCED, there is an imbalance of key biomolecules, including growth factors and cytokines, which results in significant inflammation, impaired innervation and disruption of the protective corneal epithelial and stromal layers. KPI-012 was designed specifically to address this imbalance: it is a novel, human bone marrow-derived mesenchymal stem cell (MSC) secretome containing numerous human biomolecules, including protease inhibitors, matrix proteins, growth factors and neurotrophic factors, that provide a multifactorial mechanism of action to address impaired corneal healing across numerous etiologies.

We are pleased to present these exciting data from the first KPI-012 clinical trial, said Kim Brazzell, Ph.D., Head of Research and Development and Chief Medical Officer at Kala Pharmaceuticals. These data, which served as the foundation for our acquisition of Combangio last year, highlight the potential of KPI-012 to deliver a novel approach to treating PCED, as well as other rare front and back of the eye diseases. Our goal remains to advance KPI-012 into a Phase 2/3 trial for PCED later this year, as we aim to deliver new and better options to people living with severe ocular surface diseases.

The poster presentation is now available on the Kala Pharmaceuticals website at https://investors.kalarx.com/presentations.

Highlights from the ARVO Presentation

The single-arm, prospective, open-label Phase 1b clinical trial enrolled 12 patients, including three who were enrolled in a safety lead-in cohort and nine enrolled in an efficacy cohort. Within the efficacy cohort, patients presented with PCED of various etiologies and durations ranging from 15 to 871 days. Patients were treated with twice daily KPI-012 for up to four weeks, with follow-up occurring at two, four and 12 weeks after their last dose of therapy. The key efficacy endpoint was complete healing of the corneal defects evaluated by corneal staining. Other efficacy endpoints included reduction in defect size, visual acuity, and corneal opacity. Safety measures included tolerability/pain, intraocular pressure and adverse events.

Eight patients were evaluable for efficacy assessment; one participant was ineligible due to a non-treatment related adverse event. Improvement was seen in seven of the eight evaluable patients, with six of the eight achieving complete healing by the end of Week 4, including four patients who were healed by the end of Week 1 and one patient who was healed by the end of Week 2. All six healed patients remained healed through the end of the follow-up period. In addition, improvement in PCED lesion size was observed in both patients who did not experience full wound healing. Across all eight patients, the mean improvement in lesion size from baseline to end of treatment was -16.23 mm. KPI-012 was well-tolerated in the trial.

Clinical Development Plans

Kala plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) and, subject to regulatory clearance, initiate a Phase 2/3 clinical trial of KPI-012 in PCED patients in the fourth quarter of 2022. Kala believes this trial could serve as the first of two required pivotal trials. The FDA has granted KPI-012 Orphan Designation for the treatment of PCED and the Company believes it could also meet the criteria for fast-track and breakthrough designations.

In addition, Kala believes the multifactorial mechanism of action of KPI-012 also makes it a platform technology and is evaluating KPI-012 for potential expansion toindicationsfor rarefront of the eye diseases, such as limbal stem cell deficiency and Sjogrens Syndrome, as well as select rareback of the eye diseases, such as retinitis pigmentosa and optic neuritis.

About Kala Pharmaceuticals, Inc.

Kala is a commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYmucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS(loteprednol etabonate ophthalmic suspension) 0.25% and INVELTYS(loteprednol etabonate ophthalmic suspension) 1%. The Company also has a pipeline of development programs including a clinical-stage secretome product candidate, KPI-012, initially targeting persistent corneal epithelial defects (PCED) and multiple proprietary new chemical entity (NCE) preclinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. For more information on Kala, please visitwww.kalarx.com.

Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about Kalas future expectations, plans and prospects, including but not limited to statements about Kalas expectations with respect to KPI-012, the future development or commercialization of KPI-012, conduct and timelines of clinical trials, Kalas plans to progress its pipeline of preclinical development programs targeted to address front and back of the eye diseases, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of Kalas Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings Kala makes with the Securities and Exchange Commission. These forward-looking statements represent the Companys views as of the date of this release and should not be relied upon as representing the Kalas views as of any date subsequent to the date hereof. Kala does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Contacts:

Jill Steierjill.steier@kalarx.com 781-996-5252

Hannah Deresiewiczhannah.deresiewicz@sternir.com 212-362-1200

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Vale man with MS needs 50,000 for treatment in Mexico – Evesham Journal

Posted: May 2, 2022 at 1:54 am

A Vale man is in need of 50,000 for vital medical care in Mexico.

James Monks, 29, was diagnosed with multiple sclerosis following a wakeboarding accident last year.

In the months since he has been in steady decline, prompting his friends to launch a fundraiser to pay for stem cell therapy.

Alistair Taylor, a friend of James since their schooldays at Prince Henrys High School, has been delighted with the generosity shown thus far.

He said: Were practically joined by the hip so when he became unwell, I just had to do something.

We launched the Go Fund Me page at about 4.30pm on Wednesday and in less than three days weve raised more than 27,000.

Its been overwhelming, especially to see some of the names donating. There are people we went to school with and people we havent seen in years donating.

Theres been an awful lot of bad news recently so its so great to see people coming together and trying to help James.

James was diagnosed with MS following a wakeboarding accident last year. Before his diagnosis, friends described him as "the picture of health"

Alistair is hoping to raise 50,000 which would pay for James to go to Mexico to receive stem cell therapy.

The procedure would see James immune system wiped out by chemotherapy and rebuilt via stem cell transplant.

James is currently in discussions with medical consultants and is hoping to fly over in July.

Alistair added: Though there are no guarantees with MS, this therapy is James best chance at stopping the disease and giving James his life back.

MS is a time-sensitive disease and given his quick deterioration, the lottery of waiting to see how bad his condition gets leaves us no option but to seek this treatment abroad.

James Monks, with his partner Hazel Jenkins

Before diagnosis, James friends described him as the picture of health and he had been caring for his grandmother with dementia in Harvington.

He had also been helping his father, who has Parkinson's Disease, and his mother, who is battling breast cancer, all alongside his job.

Alistair believes this stress, coupled with a wakeboarding crash in August 2021, was the perfect storm to trigger the dormant MS in his system.

He added: James is a person who has always been generous with his time and always been the first to help others in need.

Now it is his time to be supported.

To donate, visit James Go Fund Me page here.

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Long-Term Axi-Cel Data ‘May Be Suggestive of a Cure’ in Patients With Large B-Cell Lymphoma – Curetoday.com

Posted: May 2, 2022 at 1:54 am

Long-term clinical trial data continues to support the use of axi-cel (axicabtagene ciloleucel) in treating patients with relapsed/refractory large B-cell lymphoma (LBCL), according to data presented at the 2022 Tandem Meeting.

Researchers presented five-year data from the phase 2 ZUMA-1 clinical trial, including the one- and two-year event-free survival findings.

In this updated five-year analysis, axi-cel induced long-term (overall survival) ... among treated patients, according to Dr. Caron A. Jacobson, the medical director of the Immune Effector Cell Therapy Program and senior physician at Dana-Farber Cancer Institute and an assistant professor of medicine at Harvard Medical School. She continued, Between the four- and five-year analysis, the time to next therapy curve remains stable and 92% of patients remained alive without a need for subsequent therapy, which may be suggestive of a cure in these patients.

Investigators reported a five-year overall survival rate of 42.6% following treatment with axi-cel. In the population of patients who experienced a complete response, the five-year overall survival rate was 64.4% and the median overall survival was not reached. Additionally, 63% of complete responders were alive at the five-year data cut off. At the four-year data cutoff, one patient died at month 63 and one experienced progressive disease at month 54.

To be considered for treatment, patients were required to have LBCL, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma. Patients were also required to have not responded to their last chemotherapeutic treatment or have relapsed 12 months or less following autologous stem cell transplant, which is a stem cell transplant using the patients own healthy cells. Treatment with a previous anti-CD20 monoclonal antibody and anthracycline was also necessary.

Those who underwent treatment received a conditioning regimen of cyclophosphamide and fludarabine for three days to get them ready for the main line of treatment. This was followed by axi-cel.

The main goal of the study was overall response rate with first response assessment four weeks following infusion. Key secondary end points included overall survival, safety and translational evaluations.

A total of 111 patients were enrolled on the study, eight of whom did not undergo treatment for one of the follow reasons: side effects (four patients), no measurable disease (two patients), death due to disease progression (one patient), and manufacturing failure (one patient); this left 103 patients to undergo conditioning. Of these patients, two were not treated due to side effects and death, respectively.

The data cutoff was Aug. 11, 2021 and the median follow-up was 63.1 months.

Additional findings from the trial highlighted a median time to next anticancer therapy of 8.7 months following infusion. A total of 34% of patients were alive at cutoff with no subsequent therapy or retreatment with axi-cel. Two patients who had prior progression underwent new anticancer therapy.

The five-year overall survival rates among those who had or had not experienced an event-free survival at month 12 were 5.3% vs 90.9%, respectively.

Events were classified as instances when the cancer recurred or became worse.

The median overall survival was 8.3 months among those who experienced an event and was not reached in those who did not experience an event. Additionally, the five-year overall survival rates among those who did or did not have an event at month 24 were 11.3% and 92.3%, respectively. Moreover, the median overall survival in both respective groups was 9.2 months and not reached.

Investigators also determined that early CAR-T cell expansion was associated with ongoing response at 60 months. The median peak CAR T levels appeared to be numerically higher in those who had an ongoing response at month 60 and lower in those who relapsed or did not respond to treatment. Similarly, another trend was observed in those who experienced CAR-T cell expansion by area under the curve from day 0 to 28.

A total of 58% of patients had died by the cutoff date. No new safety signals had been observed as of the five-year data cutoff, including serious side effects or secondary malignancies related to treatment.

Patients most commonly died due to progressive disease (45 patients), side effects (four patients), secondary malignancies (one patient) or other reasons (nine patients).

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Billy Connolly donates painting to Glasgow woman diagnosed with cancer five times – Glasgow Times

Posted: May 2, 2022 at 1:54 am

Sir Billy Connolly has donated his own painting to help a woman who has been diagnosed with cancer five times.

The Big Yin gifted the limited edition hand signed piece to help Stace OBrien finally be cured after a brutal 10 yearbattle with the cruel illness.

It comes as the 38-year-old, from Glasgow, suffers from Li-Fraumeni syndrome, a genetic condition increasing her chances of getting cancer.

Stace has been battling cancer for ten years

She is left in severe pain everyday and feels 100-years-old after doctors found cancer in her bones, breasts, lymph nodes, and sarcoma in her leg.

Stace hopes to travel to London for stem cell treatment which she believes could finally cure her, but it will cost around 30,000.

Now Scots comedy legend Billy Connolly has stepped in to help her on her way to recovery by giving her a wind swept and interesting yellow painting which she plans to auction.

It comes after his team reached out saying: We would gladly donate one of Billy Connollys hand-signed limited editions for you to sell, to help raise money for Staces treatment.

Stace will sell the painting to pay for treatment

Stace told the Glasgow Times: It is so nice having a Sir Billy Connolly painting in the house that he gave to me.

Ive hung it on the wall just now so I can enjoy it until it sells, it is so amazing.

I need to get it auctioned soon so I can get a treatment that may work and be painless.

It will cost 30,000 but would mean the world to me as Im so sickly now I just want to be able to do the things I used to do.

Im really struggling with severe pain, I am in agony.

"I feel so broken. I dont know anyone else who has survived cancer five times but Im hoping I will.

Stace spends a lot of time in hospital

Stace was first diagnosed with osteosarcoma bone cancer after suffering a burning pain in her hip which was revealed to be a tumour in January 2012.

She underwent gruelling chemotherapy and thought she was in remission for five years before finding a lump in her breast in February 2019.

She also underwent a double mastectomy and reconstruction surgery to tackle the illness but tragedy struck again in December 2019 when doctors found Lymph Node cancer.

Stace needs stem cell treatment that costs 30,000

Stace was then diagnosed with Sarcoma in her leg in February 2021 and underwent four surgeries to tackle it.

Then last October she was diagnosed with the cruel illness for the fifth time, as doctors found her breast cancer had spread to her chest wall, behind her heart and liver.

Now this year doctors have tragically found more cancer in her bones but Stace is determined to keep fighting.

Miraculously her cancer is now starting to shrink as she undergoes Exemestane, zoladex and phesgo treatment on the NHS.

But the aggressive treatment has left her in excruciating pain and in tears everyday leaving her desperate to get the stem Dendritic cell therapy could target her illnesses pain free.

Dendritic cells help the immune system recognise and attack abnormal cells, such as cancer cells. To make the vaccine, scientists grow dendritic cells alongside cancer cells in the lab.

The vaccine then stimulates your immune system to attack the cancer.

It comes after previous attempts to cure her condition left her infertile, temporarily blind, numb in her limbs and struggling to swallow.

Stace in 2012 around the time she was first diagnosed

Stace said: Im happy the new drug is helping but Im in so much pain in my bones and joints I cry most days.

Its so painful Im really not well with it although I got my results through and the cancer is shrinking which is a miracle.

Im even up every night taking pain medication at 3am but its just getting worse.

Ive been totally devastated by the treatments for my cancer, the effects of treatment can start to compromise my life so badly.

A gofundme page has also been set up for Stace by her friends and family who are desperate to see her fight off the cancer.

The fundraiser has brought in more than 9,000 at the time of publishing and hopes to hit a 35,000 target soon.

The page reads: Stace has been a close friend for over 30 years to many of us.

We have come together to support her in receiving this life saving treatment.

We will passing over any donations received directly to Stace so that she can arrange this as soon as possible.

Lets aim to give this amazing, beautiful person the support and love she deserves.

Stace added: Im actually desperate for the doctors to stop this pain no matter what it takes.

"Im so touched by my friends doing all this and wanting me to live.

If we get more money from the fundraising then I will use it to start a support centre to help young newly diagnosed women learn how to cope with it.

I really missed a place like this and think there is a real need for it.

You can donate to help pay for Stace's care here.

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Sure Signs You Have Diabetes, Say Physicians Eat This Not That – Eat This, Not That

Posted: April 19, 2022 at 2:44 am

According to the Centers for Disease Control and Prevention, "37.3 million Americansabout 1 in 10have diabetes. About 1 in 5 people with diabetes don't know they have it." While diabetes is manageable, if left untreated, diabetes can become a serious condition that can result in blindness, nerve damage, heart disease, kidney failure and amputations. Keeping diabetes in check is key to living a healthy life. Eat This, Not That! Health talked with experts who explain what the risk factors are for diabetes, how to help get it under control and what symptoms to watch out for. Read onand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

Dr. Bayo Curry-Winchell, Urgent Care Medical Director and Physician, Carbon Health, and Saint Mary's Hospital says, "If you need to use the restroom more than usual for example (waking up in the middle of the night) and it's not associated with increased fluid intake this could be a sign of diabetes. When your body has an elevated amount of glucose the kidneys respond by increasing urination to help remove the excess glucose."

"If you start to experience numbness, sharp pains, tingling in your hands, arms, legs or feet often referred to as neuropathy, this can be a sign of diabetes. This is caused by an increase in blood sugar (glucose) which affects the amount of blood flowing to your organs and muscles affecting nerves throughout the body," Dr. Curry-Winchell explains.

Dr. Curry-Winchell states, "Unfortunately, elevated blood sugar does not mean more energy. The body is not able to use the excess sugar, instead you feel tired and "run down" even after a good night's rest."

Dr. Curry-Winchell shares, "Diabetes can affect many aspects of your daily life. The disease has the potential to cause harm or damage to several organs such as the eyes, brain, heart, kidneys, and skin. When diabetes is not under control, it can be disruptive to your life and impact your ability to perform personal and professional activities."

RELATED: Habits Secretly Increasing Your Pancreatic Cancer Risk, Say Physicians

According to Dr. Curry-Winchell, "The reason is multifaceted and involves a decrease in physical activity and increased consumption of high calorie foods which leads to weight gain ultimately increasing your risks for developing diabetes. The pandemic has also played a role. For almost two years people were asked to stay home which led to less exercise, isolation and adopting unhealthy coping skills with food or sedentary hobbies."6254a4d1642c605c54bf1cab17d50f1e

Dr. Nisha Jayani, a board-certified endocrinologist with Paloma Health shares, "Being overweight and being physically inactive are two major risk factors for type 2 diabetes. By eating better and getting regular exercise, you can help to prevent type 2 diabetes.You should avoid eating processed meats, white rice, and sugar-sweetened beverages. Instead, load up on nutrient-dense goodness like leafy green veggies, fruits rich in anthocyanins, quality dairy products, nuts, and legumes."

RELATED: Doing This After Age 60 is "Unhealthy," Say Physicians

Dr. Jayani states, "Eating a Mediterranean-style diet, a diet rich in fish, vegetables, fruits, whole grains, beans, nuts and seeds, and olive oil, can be beneficial for the long-term prevention of diabetes." Dr. Jayani adds, "Aerobic exercises like walking, swimming, or riding your bike can help decrease your blood glucose levels. I recommend 30 minutes of moderate aerobic activity a few days a week to help prevent diabetes in the long term."

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Sure Signs You Have Diabetes, Say Physicians Eat This Not That - Eat This, Not That

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2 symptoms of high blood sugar in the mouth that may indicate diabetes – NationalWorld

Posted: April 19, 2022 at 2:44 am

Almost four million people in the UK have diabetes, but thousands of cases are still undiagnosed.

Figures from the Diabetes and Wellness Foundation estimates that 1,000,000 adults have type 2 diabetes but do not know it.

Type 2 diabetes is far more common than Type 1, and accounts for around 90% of all adult cases in the UK.

The lifelong condition is caused by problems with the production of insulin in the body and is often linked to being overweight or inactive, or having a family history of type 2 diabetes.

It causes the level of glucose in the blood to become too high and can lead to a variety of serious health conditions, such as heart disease or a stroke.

Many people have the condition without realising as symptoms do not necessarily make you feel unwell, making the disease difficult to spot.

However, there are a few telltale signs to look for that could be a warning sign of type 2 diabetes.

What are the symptoms?

Two common symptoms of high blood sugar - also known as hyperglycaemia - can be evident in the mouth. These include a dry mouth and a breath that smells fruity, according to the NHS.

Other symptoms that could be a sign of type 2 diabetes include:

Symptoms of hyperglycaemia in people with diabetes tend to develop slowly over a few days or weeks, and in some cases symptoms will not appear until blood sugar levels are very high.

Hyperglycaemia symptoms can also be caused by undiagnosed diabetes, so the NHS advises seeing a GP if this applies to you.

What can cause high blood sugar?

A variety of factors can trigger an increase in blood sugar level in people with diabetes. Typically this can include:

How is it treated?

Most people will need medicine to control their type 2 diabetes. This will help to keep blood sugar levels as normal as possible to prevent further health problems and may need to be taken for the rest of your life.

A healthy diet and keeping active can also help to manage your blood sugar levels.

The NHS recommends eating a wide range of foods, including fruit, vegetables and starchy foods like pasta, and keeping sugar, fat and salt to a minimum. Around 2.5 hours of physical activity is also advised per week.

There is evidence that eating a low-calorie diet (800 to 1,200 calories a day) on a short-term basis (around 12 weeks) can help with symptoms of type 2 diabetes, and some people have found that their symptoms go into remission.

However, a low-calorie diet is not safe or suitable for everyone with type 2 diabetes, such as those who need to take insulin, so it is important to seek medical advice before going on this type of diet.

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American Diabetes Association Honors Two Outstanding CU Anschutz Researchers – University of Colorado Anschutz Medical Campus

Posted: April 19, 2022 at 2:44 am

In 1986, Jill Norris had a Bachelor of Arts degree in biology in hand and pondered what to do next. She decided to pursue a doctorate in epidemiology and applied to a few schools. An invitation from a renowned figure in the field not only cemented her decision but also set her on a lifelong professional path to an elite position among her peers and now, international recognition.

Norris hadnt anticipated the door that opened. She was still mulling her doctoral choices when the late Dr. Ronald LaPorte, an epidemiologist at the University of Pittsburgh, urged Norris to join his program. LaPortes studies focused on type 1 diabetes, the autoimmune disease that destroys the bodys ability to produce the glucose-regulating hormone insulin. LaPorte needed investigative allies and told Norris he had a position for her, should she choose to accept.

Norris didnt know much about type 1 diabetes, but took LaPorte up on his offer anyway.

I liked him so much and loved his group, she recalls. I walked into a wonderful situation where I learned the story behind type 1 diabetes and so many things about it that I hadnt even been aware of.

Norris embarked initially on a project to study the protective effects of breastfeeding against type 1 diabetes. It set the stage for a career dedicated to probing the mysteries of autoimmune diseases not only diabetes, but also rheumatoid arthritis, celiac disease, multiple sclerosis and lupus. Her contributions include extensive funded research, hundreds of published peer-reviewed papers, wide-ranging committee work, and a long commitment to mentoring students. She has chaired the Department of Epidemiology in the Colorado School of Public Health since 2011.

The early days in Pittsburgh set her course. From the very beginning, my work was on nutrition and type 1 diabetes. Amazingly, Ive never strayed too far from that, Norris said.

A little more than three decades after she received her doctorate in Epidemiology from Pitt, Norriss unflagging work on type 1 and type 2 diabetes has earned a notable honor. She is the 2022 recipient of the American Diabetes Associations Kelly West Award for Outstanding Achievement in Epidemiology, which recognizes significant contributions to the field of diabetes epidemiology.

ADA Award Winner Reusch, MD, Makes the Most of CU Anschutz Collaborations

Jane E.B. Reusch, MD, professor of medicine, bioengineering and biochemistry in the Division of Endocrinology, Metabolism and Diabetes at the University of Colorado School of Medicine and associate director of the Ludeman Family Center for Womens Health Research at the University of Colorado Anschutz Medical Campus, is the recipient of the2022 Albert Renold Award from the American Diabetes Association (ADA). She is based in the division of endocrinology, metabolism and diabetes at CU Anschutz and the endocrine section at the Rocky Mountain Regional VA Medical Center.

This award is presented to an individual whose career is distinguished by outstanding achievements in the training and mentorship of diabetes research scientists and in the development of communities of scientists to enhance diabetes research.

Reusch started her career in as a physician scientist doing cell biology research on the nuclear aspects of insulin resistance and how that affects diabetes and its complications. Propelled by a desire to help patients, including her father, who suffered from the disease, Reusch partnered with Judy Regensteiner, PhD, director of the Ludeman Family Center for Womens Health Research, to understand how diabetes leads to impairments in functional exercise capacity.

Functional exercise capacity is measured by exercising as hard as you can. People with type 1 or type 2 diabetes already have about a 20% defect in their maximal exercise capacity. Maximal exercise capacity is the most potent predictor of life expectancy, so it is serious that it is impaired in people with otherwise uncomplicated diabetes. Reusch and Regenstiener identified that insulin resistance, blood-flow abnormalities, cardiac dysfunction and skeletal muscle dysfunction collude to give diabetes patients lower functional exercise capacity.

She also collaborates with researchers at the Childrens Hospital such as Kristen Nadeau, MD, MS, who won the Outstanding Scientific Achievement Award from the ADA in 2021, the Center for Bioengineering and the Barbara Davis Center for Diabetes.

Reusch said CU Anschutz is the place where you should be doing diabetes research. We have a great collaborative environment, brilliant scientists and a growing infrastructure to support innovation.

Reusch also mentors students, post-doctoral fellows, and junior, mid-level and senior faculty. One of the first graduate students she worked with was a trainee of Jill Norris, PhD, MPH, at the Colorado School of Public Health.

She is dedicated to training the next generation of scientists and to the strengthening the clinical-translational workforce. At the core of her world-class NIH, VA and ADA-funded translational diabetes research program is the mission to recruit, train and retain new translational scientists to the diabetes workforce, particularly focused on womens health and sex as a biological variable.

I love the opportunity to be a doctor, to be an educator and to ask questions and contribute to discovery in research, Reusch said. I have the world's best job, so of course I want other people to have it too.

- Kiley Kudrna

Norris will discuss her work, which includes not only her pioneering studies into the genetic and environmental links with type 1 diabetes and other autoimmune diseases, but also mentoring and volunteering, at the ADAs 82nd Scientific Sessions in New Orleans June 3-7.

That effort spans decades of contributions to long-term studies of diabetes. These include, among many others, nearly 30 years of service with the NIH-funded Diabetes AutoImmunity Study in the Young (DAISY), working with her colleague Dr. Marian Rewers, executive director of the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus. The aim: explore the ways that a persons genetics and environment may combine to drive type 1 diabetes.

In addition, Norris is a longtime investigator on The Environmental Determinants of Diabetes in the Young (TEDDY) Study (also NIH-funded, with the Barbara Davis Center one of six study sites). She has co-chaired its Diet Committee since 2002.

The TEDDY initiative is responsible for screening well over 400,000 kids with type 1 diabetes in the United States and Europe. It identifies newborns at genetic risk for the disease and follows them for 15 years in the hopes of deciphering the causes of type 1 diabetes and how they might be addressed with strategies like modifying diet.

For example, some studies suggest that low levels of vitamin D and omega 3 fatty acids may increase the risk of type 1 diabetes. More work is needed, but the studies open the possibility of targeted dietary interventions aimed at those who would most benefit, Norris said.

In a summary of her research, Norris underscored her strong belief that genetics predisposes individuals to type 1 diabetes and other autoimmune disorders, such as celiac disease, but also that they dont predetermine outcomes.

It has become clear that without considering both the genetic and environmental risk factors of diseases, we may never come to a complete understanding of their etiology and potentially, their public health impact, she wrote.

Asked to elaborate on the point, she said, I like to think that we can work within a persons genetic predisposition to decrease the burden of the presence of the disease.

Norris cautioned, however, that the genetic-environmental connection is complicated and much effort remains to untangle it. For example, some studies indicate that the potentially protective power of foods rich in vitamin D, omega 3 fatty acids and other biomarkers may hinge not only on eating more of them but also on an individuals genetic ability to turn them into something that has protective influence. What turns one person on and another not, in effect, is a big question to be answered.

The TEDDY study therefore points to the importance of finding the kids whose genetic makeup make them the best candidates for interventions, informing them of the reasons to make changes in their diets and lifestyles, and making sure those changes fit in the fabric of their everyday lives, Norris said.

My goal would be to create diets that are attainable and sustainable, she said. We dont want diets where people totally eliminate one thing. You want to give people options. Its not all about one good thing or one bad thing.

Going forward, Norris said she also anticipates further research aimed at preventing autoimmune diseases from occurring. That requires not only broad screening to identify at-risk individuals but also having safe interventions at the ready for those who need them, she said.

In Norriss view, the Kelly West honor puts her name among the many epidemiologists who helped to spur her career and whose friendship and collegiality she values.

When I look at the long list of winners before me, many of them were my mentors and many others are current colleagues and friends, she said. To be part of that fabulous community means so much to me.

Her connection with LaPorte illustrates the depths of her roots in that community. LaPorte, Norriss original entre to epidemiology and Type 1 diabetes research, was one of the original Kelly West Award recipients in 1988. He also was instrumental in driving development of type 1 diabetes registries around the world, including one established in Pittsburghs Allegheny County.

His work, as well as that of Jan Dorman, LaPortes wife and Norriss co-mentor while at Pittsburgh, dovetailed nicely with Norriss budding career when she moved to Colorado in 1990 to take a position as assistant professor in the Department of Preventive Medicine and Biometrics Section of Epidemiology and Community Health in the University of Colorado School of Medicine. She worked with Dr. Richard Hamman, a fellow epidemiologist who was to become the founding Dean of the Colorado School of Public Health in 2008. In 1984, Hamman had also launched a type 1 diabetes registry to identify and collect data on all children in Colorado diagnosed with the disease.

Hamman and his colleagues published the influential San Luis Valley Diabetes Study of residents in two deeply rooted southern Colorado communities. The study concluded that type 1 diabetes was a major chronic disease problem for persons of Hispanic ethnicity in the San Luis Valley.

Norris worked with Hamman and Dr. Julie Marshall, now Professor Emeritus in the Department of Epidemiology at ColoradoSPH, studying the genetic and environmental epidemiology of type 2 diabetes among families in the San Luis Valley. In her work, she relied on the population from Hammans San Luis Valley Diabetes Study and studied their family members in a community-run research clinic Hamman established.

I have a soft spot for the San Luis Valley, said Norris, recalling how her studies deepened her appreciation for its people, whose descendants have spread far beyond its geographical bounds. I learned there how to conduct research, not just outside our front door.

The experience in the San Luis Valley also placed Norris as one of many foundational pillars in the Rocky Mountain Prevention Research Center, launched in 1998 by Hamman and Marshall and now directed by Dr. Jenn Leiferman, professor and Chair in ColoradoSPHs Department of Community & Behavioral Health which continues to maintain strong ties in southern Colorado.

Having gained so much knowledge from others, Norris is intent on extending the same commitment to fellow contributors to epidemiology.

Mentoring is incredibly important to me, she said. Mentoring can take many forms. It can be students but it can also be your fellow faculty. A number of students that I have worked with in the past have grown and while they may not be working on diabetes, they have developed other exciting and important areas of research. I cant imagine being at an institution that didnt emphasize teaching.

Guest contributor: Tyler Smith for the Colorado School of Public Health

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The Global Diabetes Compact: a promising first year – World Health Organization

Posted: April 19, 2022 at 2:44 am

One year ago today, WHO, together with the Government of Canada, launched the Global Diabetes Compact an ambitious new initiative to galvanize efforts around the world to both reduce the risk of diabetes, and ensure that all people diagnosed with diabetes have access to equitable, comprehensive, affordable and quality treatment and care.

Those responsible for the conception of the Compact were under no illusions about the immensity of the challenge.

The fact that 100 years after the discovery of insulin, a life-saver for many people with diabetes, the treatment was still out of reach for millions of people who needed it, was a clear signal that business as usual was no longeran option, said Dr Bente Mikkelsen, Director of the Department of Noncommunicable Diseases at the World Health Organization. The enthusiasm that we saw among political leaders at the highest levels for the Global Diabetes Compact showedus that the motivation for a radical scale-up of efforts was widely supported.

A World Health Assembly Resolution: an important milestone

The critical nature of scaling-up efforts to prevent and treat diabetes was made clear by the adoption by WHO Member States of a historic resolution on diabetes at the World Health Assembly in May. The Resolution recommends the integration of prevention and treatment of diabetes into primary health services, the development of pathways for a substantial increasein access to insulin, the promotion of convergence and harmonization of regulatory requirements for diabetes medicines and technologies and improved diabetes monitoring and surveillance. Furthermore, it asks WHO to advise Member States on how to ensurethe uninterrupted treatment of people living with diabetes in humanitarian emergencies. This important milestone provides a global mandate for diabetes efforts for the next decade.

Meanwhile work was underway to ensure that WHO had access to leading experts to provide technical advice on matters relating to WHOs work on diabetes. The result was the establishment of a Technical Advisory Group on Diabetes in August. The Group,chaired by Professor Amanda Adler, Professor of Diabetic Medicine and Health Policy at Oxford University, met for the first time in September 2021.

The importance of engaging a broader community beyond technical experts was very clear when the Compact was established, and in November, the first Global Diabetes Compact Forum was held. With more than 50 participants from nongovernmental organizations, academic institutions, philanthropicfoundations and business associations, the Forum provided an opportunity for the exchange of information on ongoing and future activities and the sharing of ideas on future endeavours that could be organized collectively for greater impact.

Learning from people with lived experience

Hearing from and learning from people living with diabetes will help ensure that work undertaken through the Compact is focused on areas where action is most needed. Focus groups hosted by WHO brought together more than 50 individuals with lived experienceearly in the year for an exchange of knowledge and information to help direct WHOs diabetes efforts. The event featured the expertise and passion of people with lived experience from over 20 countries, from Africa to the Americas to Asia, including Australia, Bosnia and Herzegovina, Brazil, Canada, Costa Rica, Ghana, India, Indonesia, Kenya, Mexico, Netherlands, Nigeria, occupied Palestinian territory, South Africa, Sweden, Tunisia, and the United States of America.During the event, facilitated by people with lived experience from Australia, Bosnia and Herzogovina, Costa Rica, India, Mexico and the UnitedStates of America. Insights were shared on access to and the affordability of diabetes care, medicine and technologies; diabetes risk reduction and education; mental health and the stigma associated with diabetes; and research and innovation.

New report recommends key actions for better accessibility of insulin

Anew reportpublished by WHO in the lead-up to World Diabetes Day in November highlighted the alarming state of global access to insulin and diabetes care, findingthat high prices, low availability of human insulin, few producers dominating the insulin market and weak health systems are the main barriers to universal access.

Recommendations made in the report for addressing these issues included boosting human insulin production, introducing pooled procurement mechanisms to bring down prices and improving transparency in price-setting. As part of efforts to address theseand other issues relating to the insulin market, WHO has embarked on dialogues with the private sector on medicines and technologies for diabetes care, the last of which was held in September 2021. While these early discussions have served as a basis for setting out goals and potential activitiesto reach them, WHO will continue to encourage and ask the private sector for commitments and contributions with the aim of dramatically improving access to insulin and health technologies in low- and middle-income countries, as well as in humanitarianemergencies.

Making a difference at country level

The establishment of the Compact and its associated coordination activities have given added impetus to diabetes efforts within ministries of health around the world.

WHO regional and country office staff have used the opportunity to support countries in their efforts, providing technical guidance and support for advocacy efforts.

World Diabetes Day in November, when there is focused attention from media and the public health community on the topic, provided an opportunity to highlight new and ongoing initiatives.

In a special ceremony at UN City in Copenhagen the day after World Diabetes Day, the World Diabetes Foundation signed an agreement granting WHO more than US$ 900 000 for a 3-year project in support of efforts for the prevention and control of noncommunicable diseases in primary care in Kyrgyzstan and Uzbekistan. The main beneficiaries of this project will be people with diabetesand their families and carers, particularly those most in need.

Also in November, at a national conference in Ljubljana, Slovenia presented its National Programme of Diabetes Control and Management 20202030. Detailed action plans will be developed every two years, with reporting required at the end of each period.

In Africa, WHO has been working hard to integrate diabetes into primary care, using the WHO Package of Essential Noncommunicable disease interventions (PEN) toolkit. Seven countries Burkina Faso, Mali, Niger, Senegal, Uganda, United Republic of Tanzania and Zimbabwe are implementing the HEARTS package. In Mali, the training of health-care workers on managing diabetes is underway. There are ongoing projects with partners such as the International Diabetes Federation, Africa Region and Sant Diabte.

In South-East Asia, WHOs technical guidance on diagnosis and management of type 2 diabetes, HEARTS-D, was adapted into an online training module for use by programme managers responsible for planning diabetes services and facility managers andprimarycare staffinvolved in clinical care.

Also in South-East Asia, donations of insulin were provided to Bhutan, Maldives, Nepal, Sri Lanka and Timor-Leste during 2021. While donations are not a sustainable solution to meeting population needs for diabetes medicines, they have enabled countriesto meet at least some of their needs during a year when supply continued to be disrupted by the COVID-19 pandemic.

Looking ahead

Reflecting on the year since the launch of the Compact and looking ahead, Dr Bente Mikkelsen said: In the past twelve months we have established the foundations that will enable us to collectively work towards the goals of the Global Diabetes Compact.But this is just the start. We look forward to building on the achievements of this first year with our partners around the world to make a real difference to the lives of people with diabetes. They are counting on us.

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Improving outcomes for children and adolescents living with Type 1 diabetes is the goal of a collaboration between UBMD Pediatrics and Cecelia Health…

Posted: April 19, 2022 at 2:44 am

Dr. Lucy Mastrandrea (left) and Dr. Kathleen Bethin (right).Photo credit: Jacobs School of Medicine and Biomedical Sciences.

Program funded by a $1.4 million grant from The Leona M. and Harry B. Helmsley Charitable Trust will focus on expanding access to virtual diabetes care.

NEW YORK, NY APRIL 19, 2022 The majority of children living with Type 1 diabetes in the United States are not meeting their hemoglobin A1c (HbA1c) goals, a measure of how much sugar is in the blood, and a leading indicator of both short- and long-term disease state complications. Current research indicates that this trend is particularly prevalent in underserved communities lacking access to appropriate health resources.

Now, pediatric endocrinologists at UBMD Pediatrics and the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo have launched a collaboration to provide remote care management and physiological monitoring for children living with Type 1 diabetes. The team will be evaluating the financial viability of providing these services as well as their impact on diabetes-related outcomes.

A $1.43 million grant awarded to UBMD Pediatrics from The Leona M. and Harry B. Helmsley Charitable Trust is making this program possible.

Despite recognition of the benefits of remote care programs that deliver support in-between physician visits, most primary care and specialty providers lack the financial resources to deploy them effectively. Moreover, the COVID-19 pandemic has exacerbated outcome gaps among underserved communities primarily due to limited access to remote care services and community-based resources.

By working with Cecelia Health, a virtual-first health care provider, UBMD Pediatrics will be supplementing the in-person patient care it provides with care from an experienced remote diabetes and chronic care management team. Cecelia Health provides patients with a spectrum of support in managing their diabetes to ease the daily burden, help improve health outcomes, and free up care resources for providers.

A key goal of the program is to explore how improving access to remote support and the internet to better manage chronic conditions will improve outcomes. In particular, the program will examine whether access to fully supported cellular-enabled tablets and remote support enables patients to take full advantage of their existing diabetes technologies, such as continuous glucose monitors and insulin pumps. In return, this should improve HbA1c levels and reduce hospital admissions for diabetic ketoacidosis, a life-threatening condition which develops when the body doesn't have enough insulin to allow blood sugar into cells for use as energy.

Using telehealth to improve care of youth with Type 1 diabetes is at the forefront of clinical care, said Lucy Mastrandrea, MD, PhD, Associate Professor and Chief of the Division of Pediatric Endocrinology/Diabetes at the Jacobs School and UBMD Pediatrics. We expect to show that utilizing certified diabetes care and education specialists to deliver virtual support and education to our patients and families is financially sustainable. We are also taking this further by studying the clinical outcomes of patients with limited internet access who are provided tablets with cellular service and full technical support.

Our Division of Pediatric Endocrinology/Diabetes cares for about 1,000 patients with diabetes, said Kathleen Bethin, MD, PhD, principal investigator of the study and Clinical Professor of Pediatrics at the Jacobs School. We have many years of experience with both basic and clinical research to improve the lives of our patients.

Cecelia Health has worked with several university and hospital diabetes specialty clinics during the COVID-19 pandemic.

During the first year of the COVID-19 pandemic, and thanks to the support of the Helmsley Charitable Trust, we were fortunate to leverage the expertise of Cecelia Health and its team of certified diabetes care and education specialists to provide telehealth support services to our diabetes patients who were unable to be seen in-person on a regular interval, said Bethin, also a member of UBMD Pediatrics Division of Endocrinology/Diabetes.

Additionally, the researchers are interested to see how video care support along with improved ability to share data from pumps and blood glucose devices compares to phone-only support.

We are thrilled to be collaborating with UBMD Pediatrics on this important initiative, said Arnold Saperstein, MD, FACP, Chief Medical Officer at Cecelia Health. It affords us the opportunity to highlight both the clinical and financial value of our remote care model for chronic conditions in partnership with established clinical practices.

The grant will support this collaboration for three years.

Dedication to discovery, patient care, and advancing science is what defines renowned academic medical centers like ours, said Steven E. Lipshultz, MD, A. Conger Goodyear Professor and Chair of Pediatrics in the Jacobs School. UBMD Pediatrics is proud to join forces with the Helmsley Charitable Trust and Cecelia Health to transform the lives of the patients we serve by translating innovation in the lab to improve outcomes at the bedside and in the community, elevating care in an equitable and inclusive way for all patients.

The Helmsley Charitable Trust, the funder of this project, is one of the largest private foundation funders of Type 1 diabetes in the nation.

Telehealth has the unparalleled ability to meet patients where they are, but for these services to be used, they must be reimbursed properly said Sean Sullivan, PhD, Program Officer for the Helmsley Charitable Trusts Type 1 Diabetes Program. This innovative work aligns with our goal at Helmsley to better understand the impact and viability of programs that can expand access to quality care for all people with Type 1 diabetes, regardless of their zip code.

To learn more about how to support children with Type 1 diabetes through medical discovery and advances at the Jacobs School visit http://www.buffalo.edu/campaign.html or contact Kathy M. Swenson, Senior Director of Advancement at kswenson@buffalo.edu or by calling 716.829.5052.

About Cecelia Health

Cecelia Health is a virtual-first provider organization delivering integrated care to patients across all chronic disease risk profiles. We address critical care gaps, reduce variability in care, and improve medication and device adherence. Our virtual specialty care solution delivers the optimal mix of clinical interventions with digital touchpoints. We offer a comprehensive suite of synchronous and asynchronous disease management capabilities including remote clinical support, device training, remote patient monitoring, and telemedicine delivered via a national network of specialty providers. We complement our virtual care capabilities with robust data and analytics that deliver meaningful insights to our partners.

Cecelia Health Media Contact: Misty Greficz.

About UBMD Pediatrics

UBMD Pediatricsis one of 18 practice plans within UBMD Physicians Group, the single largest medical group in Western New York.We provide premier primary and specialty health care to infants, children, adolescents, and young adults throughout Western New York and beyond. Our doctors make up the academic teaching faculty within the Department of Pediatrics at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo and are also the physicians at Oishei Childrens Hospital.For more information, please visit UBMDPediatrics.com.

About the Helmsley Charitable Trust

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $3 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes Program is one of the largest private foundation funders of T1D in the nation focused on understanding the disease, developing better treatments, and improving care and access in the U.S and low- and middle- income countries. For more information on Helmsley and its programs, visit helmsleytrust.org.

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Improving outcomes for children and adolescents living with Type 1 diabetes is the goal of a collaboration between UBMD Pediatrics and Cecelia Health...

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Vacuum Lancing Technology Enters the UAE, Making Virtually Painless Glucose Checks a Possibility for Emiratis Living With Diabetes – PR Web

Posted: April 19, 2022 at 2:43 am

TUALATIN, Ore. (PRWEB) April 18, 2022

Genteel LLC, one of the largest Bioscience & Health Technology companies in the Pacific Northwest, is improving health outcomes for diabetics far beyond the US. The vacuum lancing device manufacturer announces another international distribution partnership, this time in the United Arab Emirates with DiapointME.

Genteel manufactures the only vacuum lancing device FDA-cleared for use anywhere on the body. With blood sample readings from palms matching those of sensitive fingertips, Genteel significantly reduces pain associated with blood glucose monitoring.

Genteel LLC is proud to announce that their technology is now available to a population in great need of improved diabetes management. According to statistics from the International Diabetes Federation, the UAE holds one of the highest prevalence of diabetes globally. Nearly half of the adult population with type 2 diabetes mellitus are still undiagnosed and untreated.

DiapointME, headquartered in Dubai, is a space for diabetes advocacy, education, and products. As an authorized distributor of the Genteel lancing device, they have joined the Genteel mission of providing relief from discomfort and fear through comfortable glucose checks. Vice President of Sales and Marketing, Mark Berkovich, commented on the deal saying, I am absolutely thrilled to bring the Genteel solution to more people. Through the pursuit of less pain, we are improving patient adherence, and ultimately health outcomes for those who need it most

About Genteel

Genteel LLC is the leader in premium painless vacuum blood draw lancing devices. With over 27 worldwide patents granted in its technology, their unique and gentle device has helped tens of thousands of people living with diabetes give their fingers a break. Learn more about Genteel here.

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Vacuum Lancing Technology Enters the UAE, Making Virtually Painless Glucose Checks a Possibility for Emiratis Living With Diabetes - PR Web

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