StemCell Therapy

Glaucoma refers to the group of conditions characterized by optic nerve damage, visual field loss, and secondary to retinal ganglion cell damage, which may lead to death. According to the International Agency for the Prevention of Blindness: 2016, glaucoma is second leading cause of blindness and leading cause of irreversible blindness worldwide. The most common types of glaucoma are Primary Open Angle Glaucoma (POAG) and Primary Angle Closure Glaucoma (PACG). Moreover, PACG is most common in South-East Asian population while POAG is most common in white Caucasians and individuals of African origin. PACG is associated with a high risk of blindness as compared to POAG.

Glaucoma is a group of eye diseases which result in damage to the optic nerve and cause vision loss. The most common type is open-angle (wide angle, chronic simple) glaucoma, in which the drainage angle for fluid within the eye remains open, with less common types including closed-angle (narrow angle, acute congestive) glaucoma and normal-tension glaucoma. Open-angle glaucoma develops slowly over time and there is no pain. Peripheral vision may begin to decrease, followed by central vision, resulting in blindness if not treated. Closed-angle glaucoma can present gradually or suddenly. The sudden presentation may involve severe eye pain, blurred vision, mid-dilated pupil, redness of the eye, and nausea. Vision loss from glaucoma, once it has occurred, is permanent. Eyes affected by glaucoma are referred to as being glaucomatous.

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Risk factors for glaucoma include increasing age, high pressure in the eye, a family history of glaucoma, and use of steroid medication. For eye pressures, a value of greater than 21 mmHg or 2.8 kPa is often used, with higher pressures leading to a greater risk. However, some may have high eye pressure for years and never develop damage. Conversely, optic nerve damage may occur with normal pressure, known as normal-tension glaucoma. The mechanism of open-angle glaucoma is believed to be slow exit of aqueous humor through the trabecular meshwork, while in closed-angle glaucoma the iris blocks the trabecular meshwork. Diagnosis is by a dilated eye examination.Often, the optic nerve shows an abnormal amount of cupping.

If treated early, it is possible to slow or stop the progression of disease with medication, laser treatment, or surgery. The goal of these treatments is to decrease eye pressure. A number of different classes of glaucoma medication are available. Laser treatments may be effective in both open-angle and closed-angle glaucoma. A number of types of glaucoma surgeries may be used in people who do not respond sufficiently to other measures. Treatment of closed-angle glaucoma is a medical emergency.

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Night blindness, also known as nyctalopia, is a type of vision impairment that makes it difficult to read or see in dim light or at night. It is not a disease itself, but rather a symptom of an underlying medical condition. Although the name suggests blindness during the night, it usually means difficulty in reading or driving in a dusky environment, which can happen any time during the day.

Difficulty to see in a dark room is usually normal but in nyctalopia, it is more strenuous. It can even prevent you from pointing out the stars in the night sky. Night blindness may make it difficult to recognize faces or locate obstacles in a dimly-lit room. Your vision could also take longer than usual to adjust to the transition from darkness to bright light.

Causes of night blindness

Night blindness may be caused by a variety of underlying causes including the following:

Treatment for night blindness

It is important to know the exact cause of the condition for an appropriate intervention to be planned. The treatment for nyctalopia may vary from simply getting a new pair of prescription glasses or switching glaucoma medications to surgery if the cause is cataracts.

A proper balance diet may also be advised if the condition is caused due to a dietary imbalance. Vitamin and mineral requirements may be fulfilled by supplementation, depending on your doctors recommendation. If a retinal disease is discovered, the treatment will be carried out by an ophthalmologist depending on the type and severity of the condition.

Unfortunately, treatment of genetic conditions such as retinitis pigmentosa and Usher syndrome that cause nyctalopia are yet to be developed.

Prevention and precautions

There is no way to prevent night blindness when it is caused by genetic conditions or birth defects. However, in the case of other causes, you can take the following measures to reduce the risk of developing the condition:

For more information, read our article on Night Blindness.

Health articles on News18 are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

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Nyctalopia: All You Need to Know About Night Blindness - News18

PETALUMA, Calif., Dec. 15, 2020 /PRNewswire/ --RetinalGeniXTM Technologies, Inc. https://retinalgenix.com/ announced today the engagement of Amato and Partnersto provide Investor Relations services. RetinalGeniXTM Technologies is a private California-based medical technology company focused on prevention of blindness through mass medical retinal screening and patient home monitoring.

RetinalGeniX is moving forward with a strategic investor relations plan that will be supported by Amato and Partners. Amato and Partners is an independent Investor Relations firm headquartered in New York City. The firm has a strong and well-recognized brand in the U.S. capital markets. The Amato team has over 40 years of experience developing and executing investor relations programs and a proven track record of achieving results both for private and public companies.

"Amato and Partners provides experienced advice and established Wall Street relationships that will cultivate company visibility with market participants including equity research analysts, investment banks and appropriate potential investors," said Jerry Katzman, M.D., RetinalGeniX's chief executive officer. "We very much look forward to working together."

About RetinalGeniX Technologies, Inc. RetinalGeniX Technologies, Inc. is a privately held emerging medical device company focused on preventing blindness through a cost-effective Mass Retinal Screening Device and a Patient Real-Time Home Monitoring Imaging & Physician Alert System. (A) The Mass Retinal Screening device provides retinal imaging that captures a 200 FOV without pupil dilation and detects the earliest stages of diabetic retinopathy to prevent blindness. This device requires submission to the FDA's 510(k) approval process. (B) RetinalGeniX's second product is RetinalCam, the first in-home, self-monitoring device providing real-time ocular and retinal imaging and streams video to the physician. The technology enables high-risk individuals to send their physician digitized retinal images and streaming video easily from their home. This second device does not require submission to the FDA's 510(k) approval.

Safe Harbor Statement This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the Mass Retinal Screening Device and a Patient Real-Time Home Monitoring Imaging & Physician Alert Systemand other information that is not historical information. When used herein, words such as "anticipate", "being", "will", "plan", "may", "continue", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon RetinalGeniX's current expectations and various assumptions. Voltron believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. RetinalGenix may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions. Consequently, forward-looking statements should be regarded solely as RetinalGeniX's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. RetinalGenix cannot guarantee future results, events, levels of activity, performance or achievements. Voltron does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contact:Jerry Katzman, M.D.Chief Executive Officer(415) 578-9583[emailprotected]

SOURCE RetinalGeniX Technologies, Inc.

https://retinalgenix.com/

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RetinalGeniX Has Engaged New York Investor Relations Firm Amato and Partners, LLC - PRNewswire

Many neurodegenerative conditions, from glaucoma to Alzheimers disease, are characterized by injury to axons the long, slender projections that conduct electrical impulses from one nerve cell to another, facilitating cellular communications. Injury to axons often leads to neuronal impairment and cell death.

Researchers know that inhibiting an enzyme called dual leucine zipper kinase (DLK) appears to robustly protect neurons in a wide range of neurodegenerative diseases models, but DLK also inhibits axonal regeneration. Until now, there have been no effective methods to modify genes to improve both the long-term survival of neurons and promote regeneration.

In a paper published December 14, 2020 in PNAS, a multi-university team led by researchers at University of California San Diego School of Medicine and Shiley Eye Institute at UC San Diego Health identified another family of enzymes called germinal cell kinase four kinases (GCK-IV kinases) whose inhibition is robustly neuroprotective, while also permitting axon regeneration, making it an attractive therapeutic approach for treating at some neurodegenerative diseases.

We basically figured out that there are a set of genes that, when inhibited, allow optic nerve cells to survive and regenerate, said senior author Derek Welsbie, MD, PhD, associate professor of ophthalmology in the Viterbi Family Department of Ophthalmology at Shiley Eye Institute.

Example of retinal ganglion cells with axons and dendrites in the retina of a healthy eye.

Prior to this work, the field knew how to get these cells to survive, but not regenerate. Conversely, there are ways to promote regeneration, but then the survival was rather modest. Of course, for a successful strategy of vision restoration, you need both and this is a step in that direction.

The researchers conducted a series of screens after first creating retinal ganglion cells (RGC) from human stem cells. RGCs are a type of neuron located near the inner surface of the retina of the eye. They receive visual information from photoreceptors and collectively help transmit that information to the brain.

The first screen involved testing a group of well-studied chemicals to assess their ability to increase the survival of RGCs; the second to measure the ability of chemicals to promote regeneration.

We then used a machine-learning technique to understand why certain compounds were active while others were not and it identified these key genes, said Welsbie.

The discovery that these genes improved RGC survival was not surprising, he said. However, you would have predicted that they (like DLK) would have blocked regeneration when inhibited, not promote regeneration. That was definitely a surprise. It highlights one of the advantages of discovery-based science using high-throughput screening: By testing many agents at once, we can find identify overlooked genes that might not have been thought to play a role.

Welsbie and colleagues focused their work on RGCs because they are interested in optic neuropathies, such as glaucoma. Most people think only about glaucoma in terms of eye pressure, Welsbie said. But eye pressure is only part of the problem. At its core, glaucoma is a neurodegenerative disease characterized by progressive loss of RGCs and their axons, leading to measurable structural and functional damage to the optic nerve, visual impairment and blindness.

The U.S. Centers for Disease Control and Prevention estimate 3 million Americans have glaucoma. It is the second leading cause of blindness worldwide.

Welsbie cautioned that its not yet known whether these findings extend to other neuron types, but he noted that the work suggests strong therapeutic possibilities.

Co-authors include: Amit K. Patel, Risa M. Broyer, Cassidy D. Lee, Tianlun Lu, Mai T. Vu, Karl J. Wahlin and Robert N. Weinreb, all at UC San Diego; Mikaela J. Louie, Anna La Torre and Yang Hu, UC Davis; Hassan Al-Ali, John L. Bixby and Vance P. Lemmon, University of Miami; Katherine L. Mitchell and Vinod Jaskula-Ranga and Donald J. Zack, Johns Hopkins University; Xin Duan, UC San Francisco; Santiago Vilar, Truvitech, Miami.

Funding for this research came, in part, from the National Institutes of Health (grant 1RO1EY029342), Research to Prevent Blindness, E. Matilda Ziegler Foundation, Brightfocus Foundation, Fight for Sight Foundation, the Glaucoma Research Foundation Catalyst for the Cure and the Tushinsky family.

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Researchers Discover Clue to How to Protect Neurons and Encourage Their Growth - UC San Diego Health

Jos-Alain Sahel was on a rare vacation in Portugal in the spring of 2018 when his phone rang with grim news: The gene therapy he had worked on for a decade, a potential cure for a rare form of blindness, had failed in a pivotal trial.

In the first minute, I was very disappointed, Sahel says. I said, well OK, its not working.

A failed trial in drug development is crushing but not unexpected, a tradeoff of doing business in biology. You examine the full data, go back to the drawing board and either abandon the effort or tweak and try again. Sahel, founder of four companies and the longtime head of the Vision Institute of Paris, was used to the process. But this time, when the full data came, he was bewildered.

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They thought their gene therapy failed. Instead, it spawned a medical mystery - Endpoints News

Of all the hardships on Little House on the Prairie, this Mary Ingalls (Melissa Sue Anderson) going blind was one of the saddest. When it comes to how the real Mary Ingalls went bind, though, the story is still a little bit muddled.

Heres what we know about the differences between Mary Ingalls blindness in the television series, the novel, and real life.

Shes the eldest of the Ingalls girls. Although shes smart and beautiful, Mary doesnt have it easy. On the television series, Little House on the Prairie, Mary Ingalls falls deathly ill in a two-part episode, needing surgery (To Live With Fear.)

As she got older, this character had dreams of becoming a teacher. After studying for hours by candlelight for the state teachers exam, and complaining that her eyes are tired, Mary gets a shocking piece of news shes going blind.

She completely loses her sight in the two-part episode, Ill Be Waving as You Drive Away. The reason for this, Charles Ingalls is told, is her scarlet fever. After that, Mary Ingalls attends a school for the blind, where she meets her husband, a teacher named Adam.

According to Little House on the Prairies website, though, in real life, Mary Ingalls never married or taught at this school. The reason for her blindness, however, may also different from the television series.

RELATED: Little House on the Prairie: Melissa Gilberts Grandfather Helped Create This Television Comedy Classic

In real life, Mary Ingalls went blind at the age of 14, her parents then sending her to the Iowa School for the Blind. The characters blindness was somewhat delayed in the television series, according to one website, for fear it would limit storyline options.

Even the reason behind Mary Ingalls blindness mightve been altered in different tellings of her story. One scientific journal states that the reason behind permanent blindness caused by scarlet fever is uncertain. It could be a postinfectious autoimmune phenomenon. Its more likely, however, that Mary Ingalls went blind for another reason.

CNN reports that Wilder wrote letters to her daughter, Rose, making reference to some sort of spinal sickness. The letter also mentions that Mary saw a specialist in Chicago who said the nerves of her eyes were paralyzed and there was no hope.

RELATED: Little House On The Prairie: What Is Melissa Gilberts Net Worth and What Is She Working On Now?

Similar to the television series, in the Little House on the Prairie novel, the author tweaks Mary Ingalls illness, making it scarlet fever. This change could be because of the common illnesses of the time period.

According to CNN, it could be because Wilder and her editors thought scarlet fever would be more relatable to her readers. Scarlet fever is mentioned in other books from the period, including Little Women and Frankenstein.

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'Little House on the Prairie:' Here's the Reason Why the Real Mary Ingalls Went Blind - Showbiz Cheat Sheet

News Release

Tuesday, December 15, 2020

NIH study finds that some patients need both treatments for long-term improvements in vision

Surgical and injectable drug approaches are equally effective for treatment of bleeding inside the eye from proliferative diabetic retinopathy (PDR), according to a National Eye Institute (NEI)-supported clinical study from the DRCR Retina Network (DRCR.net). A consequence of diabetes, PDR involves the growth of new, abnormal blood vessels in the light-sensing retina. These blood vessels are prone to bleeding into the gel-like vitreous that fills the eye, causing vision loss. NEI is part of the National Institutes of Health.

Researchers compared anti-vascular endothelial growth factor (VEGF) eye injections versus removal of blood via vitrectomy surgery and laser photocoagulation. Both treatments improved central vision for the majority of participants, although approximately one-third of the participants needed both anti-VEGF injections and surgery. The findings will help guide treatment for people with bleeding in the eye from PDR. The results were published in the Journal of the American Medical Association.

This clinical trial was an opportunity to compare two commonly used treatments for vitreous hemorrhage from proliferative diabetic retinopathy head-to-head. The results provide useful guidance for clinicians who are managing patients with this condition, said Adam Glassman, Jaeb Center for Health Research, director of the DRCR.net coordinating center.

Vitrectomy surgically removes the blood from inside the eye. To prevent more blood vessels from forming, vitrectomy is usually paired with a laser treatment (laser photocoagulation). This treatment often restores central vision, but the laser treatment may reduce peripheral vision. More recently, NEI-supported trials found that anti-VEGF injections into the eye help control PDR and other diabetic eye complications. These drug treatments decrease the growth of blood vessels in the eye and prevent rebleeds while the blood in the vitreous is being absorbed.

Over the past 15 years, the DRCR Retina Network has performed trials that have helped set the standard of care for diabetic eye disease, said Jennifer Sun, M.D., Harvard University, Cambridge, Massachusetts, chair of Diabetes Initiatives for the Network. There have been major advances in surgical technology and technique since the initial studies that evaluated surgical treatment of PDR. This latest DRCR Retina Network study lets us understand how outcomes in the modern era of retinal surgery compare to treatment with intraocular anti-VEGF injections for vitreous hemorrhage from PDR.

In this new clinical study, the DRCR Retina Network team compared these two standard treatments to see if either was more effective in improving visual acuity over two years. Of 205 participants, 100 were assigned an anti-VEGF drug, aflibercept (brand name Eylea), and 105 were assigned prompt vitrectomy and laser photocoagulation. The researchers tracked best corrected visual acuity over two years. At four weeks, visual acuity in the surgery group was significantly higher than the anti-VEGF group, but by 24 weeks, the visual acuity in the anti-VEGF group had caught up to the surgery group. Visual acuity was similar between the two groups out to two years. Approximately one in three participants in each group eventually received both types of treatments to help control their PDR during that time.

This is a very common disease for patients with diabetes particularly after living with diabetes over several decades. For patients who are experiencing visual loss from bleeding due to PDR, these strategies are both excellent treatments and can improve and then preserve visual acuity over six months to two years, said Sun. But there are some subtleties to this study that will help clinicians tailor their treatment plans for an individual patient.

For people with severe bleeds or who need to improve their vision quickly, surgery results in more rapid improvement, Sun said. But for people who cannot receive surgery or prefer to avoid surgery if possible, anti-VEGF treatment still leads to equivalent visual outcomes over the long term.

About a third of our study participants ended up needing both treatments, said Glassman, so we think its critical that people continue to follow up with their clinicians after starting treatment for PDR, because they may need to adjust their treatment along the way to get the best outcome.

An estimated 30 million Americans have diabetes. Blood vessel abnormalities, including the growth of new blood vessels, are common in people with diabetes. PDR can lead to retinal tissue death, permanent vision loss, and eventually blindness in some patients. Prior to the development of surgical and laser treatments to remove blood and regress abnormal blood vessel growth, PDR was a leading cause of blindness in the United States.

The Clinicaltrials.gov identifier for this study is NCT02858076. The study was supported by NEI and the National Institute of Diabetes and Digestive and Kidney Diseases through a cooperative agreement (EY14231). Regeneron provided aflibercept for the study and funds to DRCR.net to defray the studys clinical site costs.

NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visithttps://www.nei.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Antoszyk AN, Glassman AR, Beaulieu WT, Jampol LM, Jhaveri CD, Punjabi OS, Salehi-Had H, Wells JA III, Maguire MG, Stockdale CR, Martin DF, and Sun JK, for the Diabetic Retinopathy Clinical Research Network. Effect of Intravitreous Aflibercept Versus Vitrectomy with Panretinal Photocoagulation on Visual Acuity in Patients with Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. Dec 15, 2020

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Surgical and drug treatment options lead to similar outcomes for diabetic eye disease - National Institutes of Health

In a development that could restore sight to thousands of people with an inheritable condition calledLeber's Hereditary Optic Neuropathy (LHON), scientists have been able to improve vision in both eyes in a majority of patients even though only one eye was actually treated.

The treatment is an experimental type of gene therapy, where tailored genetic material is injected to counteract genes that are defective or malfunctioning. With LHON, a m.11778G>A mutation in the MT-ND4 gene is the target.

In a phase 3 clinical trial, 37 patients were treated with a modified viral vector rAAV2/2-ND4 in one eye only, leading to an average vision improvement of 15 letters on the standard ETDRS chart you might have spotted at an optician's clinic.

"We expected vision to improve in the eyes treated with the gene therapy vector only," says neuro-ophthalmologist Patrick Yu-Wai-Man, from the University of Cambridge.

"Rather unexpectedly, both eyes improved for 78 percent of patients in the trial following the same trajectory over two years of follow-up."

The eyes that didn't get the gene therapy were given a sham treatment instead, and while the improvement wasn't as great, it was still substantial. Those in the earlier stages of LHON typically saw a bigger improvement in their vision from the treatment.

LHON is the most common form of mitochondrial blindness transmitted from a mother to her children and attacks the retinal ganglion cells, damaging the optic nerves. Around 1 in 30,000 people are thought to be affected, usually men in their 20s or 30s.

The replacement MT-ND4 gene treatment seems to rescue the retinal ganglion cells from their fate, causing results that can be "life-changing" according to the researchers. Normally less than 20 percent of those affected get their sight back.

"As someone who treats these young patients, I get very frustrated about the lack of effective therapies," says ophthalmologist Jos-Alain Sahel, from the University of Pittsburgh.

"These patients rapidly lose vision in the course of a few weeks to a couple of months. Our study provides a big hope for treating this blinding disease in young adults."

While scientists know what causes the loss of vision, finding a way to stop it has proved difficult. LHON is a good candidate for gene therapy though, because it has a clear starting stage and genetic targets that are relatively straightforward to hit.

What's not clear yet is why and how the gene therapy is spreading from one eye to the other. Follow-up experiments in macaque monkeys, which have vision systems similar to humans, suggested the injected viral vector can spread to other tissue via some means of interocular diffusion, but more research is going to be needed to understand the mechanisms at work.

Gene therapy is now being used to tackle a wide range of diseases and health issues, including those inherited from parents. Many other eye problems are in the sights of researchers too, and advances in one area can quickly help research in another something that the team behind the current study is excited about.

"Our approach isn't just limited to vision restoration," says Sahel. "Other mitochondrial diseases could be treated using the same technology."

The research has been published in Science Translational Medicine.

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Experimental Therapy Injected in One Eye Unexpectedly Improves Vision in The Other - ScienceAlert

Lineage Cell Therapeuticsis a clinical-stage biotechnology company developing novel, off the shelf cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell therapy platform and in-house development and manufacturing capabilities. Their lead program features the manufacture and transplant of retinal pigment epithelium cells for the treatment of dry age-related macular degeneration, one of the leading causes of blindness. The therapy recently completed enrolment in a Phase 1/2a clinical trial.Here we share a Q&A with CEO Brian Culley. In this interview, Brian discusses age-related macular degeneration and retinal pigment epithelium transplant therapy.Q: What is age-related macular degeneration and what is the current treatment landscape?A: Age-related macular degeneration (AMD) is a leading cause of blindness in adults over the age of 50. Progression of the disease occurs as a result of the death of specialized retina cells in the area of the macula, which gradually leads to a decrease or complete loss of vision, particularly affecting the central vision, which is needed to use a cell phone, recognize faces, drive a car, etc. The causes of AMD are multifactorial and include age, genetics, smoking, and environmental influences. There are two forms of AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases, while wet AMD is the less common, accounting for approximately 10-15% of cases.Wet AMD, or neovascular macular degeneration, occurs due to an abnormal growth of blood vessels beneath the macula, resulting in spots in the visual field or straight lines appearing wavy to the patient. Unlike dry AMD, which develops slowly, wet AMD can rapidly progress and cause a loss of central vision. There are a number of effective U.S. Food and Drug Administration (FDA) approved treatment options available for wet AMD. These treatments are designed to stop the development or growth of blood vessels and are known as antiangiogenic or "anti-vascular endothelial growth factor (VEGF) therapies. Anti-VEGF therapies can slow the progression of wet AMD and in some cases improve the patients vision.

In the early to intermediate stages of dry AMD development, retinal cells have died off and as a result, yellow deposits of metabolic waste products known as drusen begin to accumulate in the back of the eye. Drusen can vary in size and number and are considered a natural part of the eyes aging process. However, in dry AMD, the retinal pigment epithelium (RPE) cells are dysfunctional or dying and unable to clear the metabolic waste. Over time, the disease will inevitably progress, sometimes into advanced dry AMD with geographic atrophy (GA), meaning total and irreversible loss of cells in an area. There are currently no FDA or European Medicines Agency approved treatment options for dry AMD. This is likely because dead cells cannot be restored. Humans lack the ability to regenerate retinal tissue and replace lost retina cells which has led to a presumption that progression of GA may someday be slowed or halted but cannot be reversed.Q: Could you tell us about the allogeneic RPE cell replacement therapy Lineage is developing for the treatment of dry AMD with GA?A: One of the most promising potential therapies for advanced dry AMD with GA is cell replacement therapy, because cell therapy means transplanting cells which cannot be generated any other way. Most traditional approaches seek to slow or halt a disease process, but cannot reverse it. Cellular therapies are often aimed at regenerating or replacing absent cells and/or improving bodily functions. Therefore, cellular therapies may be shown to have broader or more suitable applicability than pharmaceuticals in the treatment of advanced dry AMD and other serious diseases. The benefits to the patient include drusen reduction, photoreceptor recovery and preserved or improved sight. At Lineage Cell Therapeutics we are exploring these potential benefits through the clinical development of an RPE cell replacement therapy called OpRegen. OpRegen is a formulation of allogeneic RPE cells, designed to ultimately be used as an off-the-shelf or thaw-and-inject treatment for advanced dry AMD with GA. That means were generating the cells outside of the body from established cell lines. The hypothesis of this therapy is that newly transplanted, healthy RPE cells may replace the patients dead RPE and support dysfunctional or dying RPE that would otherwise continue to progress to death. This is similar to a bone marrow transplant, except it is happening in the eye. The objective of OpRegen therapy is to slow, halt or even reverse the progression of dry AMD with GA. OpRegen is currently in a Phase 1/2a dose escalation safety and efficacy clinical study of a single injection of transplanted cells in patients with advanced dry AMD with GA. The primary objective of the study is to evaluate the safety and tolerability of OpRegen, while secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters, such as visual acuity and reading speed.We recently reported evidencefrom a patient with atrophic end-stage disease, who received a transplant of allogeneic RPE cells and showed substantial restoration of retinal tissue within the area of GA. Specifically, the area of GA assessed at 9 months was approximately 25% smaller than the patients pre-treatment baseline and it grew approximately 50% slower than its historical rate during the subsequent six months. This patients area of GA remained below baseline for 23 months and counting. Lineage is not aware of any other company or academic lab which has shown such a dramatic reversal of the disease in a human. These unprecedented findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging.To our knowledge, this is the first time any experimental treatment for dry AMD has demonstrated a reduction, rather than expansion, of an area of atrophy over a clinically meaningful time period.This finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients.Q: What are the manufacturing capabilities at Lineage, and could you touch on the purity of the RPE cells?A: As we aim to pioneer a new branch of medicine, based on transplanting specific cell types into the body, relying on our competitive advantage of differentiating an unlimited supply of pluripotent stem cells into specialized cell types like retinal cells. Lineage has extensive experience directing the lineage of pluripotent cells into terminally differentiated, specialized cell types and scaling them up in preparation for commercialization. OpRegen cells are greater than 99% pure RPE cells manufactured from a pluripotent cell line that is NIH approved and established 20 plus years ago. The cells have undergone extensive characterization and karyotyping, and there are no genetic modifications made to the RPE cells. Commercial scale-up has already been achieved, with a current production scale of around 5 billion cells per 3-liter bioreactor, or the equivalent of greater than 2,500 clinical doses per batch. Further scale-up can be performed in larger or additional (i.e. parallel) reactors.

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Cell Replacement Therapy A Promising Treatment for Age-Related Macular Degeneration - Technology Networks

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On Tuesday, Novartis announced the first interpretable results from its Phase III KESTREL study of humanized single-chain antibody fragment (scFv) Beovu, demonstrating significant improvement in central subfield thickness in Diabetic Macular Edema (DME).

DME occurs when consistently high blood sugar levels cause damage to small blood vessels in the eye, resulting in an accumulation of leaked fluid, or edema, in the macula, a pigmented area near the center of the eye crucial for the human brain to process light and register a sharp, detailed picture. DME is the leading cause of blindness among young adults in developing nations, 40% of whom have either type 1 or type 2 diabetes.

Beovu (brolucizumab, RTH258), is the most clinically advanced humanized scFv and is currently approved in more than 50 countries, including the U.S. and the EU for the treatment of wet AMD (macular degeneration), a condition that causes blurred vision or a blind spot in the visual field.

According to Suying Dang et al in the journal Hybridoma, single-chain variable fragment of antibody (scFv Ab) provides many advantages over monoclonal antibodies, especially for therapeutic purposes, including enhanced tissue penetration due to their small size and abrogated immunogenicity.

In the KESTREL study, Beovu met the primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at the one-year mark and demonstrated significant improvement at the 6 mg does in the change of central subfield thickness (CST) from baseline between weeks 40 and 52.

The results affirm the positive topline results Novartis announced in September from its pivotal KITE Phase III study of Beovu with DME.

Central subfield thickness [CST] is a key indicator of fluid in the retina, which is an indicator for active disease. For many DME patients, frequent anti-VEGF injections are needed to reduce the fluid in the eye and control the disease. The data from KITE and KESTREL suggest Beovu may have the potential to provide DME patients with better disease management through extended dosing intervals resulting in less overall injections, Dirk Sauer, Global Development Unit Head Opthalmology, told BioSpace.

Beovu also met its secondary endpoint, as more than half of participants in the 6 mg arm were maintained on a three-month dosing interval through year one, after the loading phase. Overall, the study showed that Beovu was well-tolerated.

Novartis is interested in determining whether the same level of efficacy can be achieved with an extended dosing interval. The Phase III KITE and KESTREL trials were designed to show non-inferiority in change from baseline in best-corrected visual acuity. The studies looked at Beovu 6 mg on a flexible dosing regimen, allowing for three and two-month dosing intervals versus aflibercept 2 mg on a two-month dosing interval. More than half of Beovu patients in the 6 mg arm were maintained on a three-month dosing interval through year one, following the loading phase, Sauer said. These data suggest Beovu may have the potential to provide DME patients with better disease management through extended dosing intervals, which could ultimately lead to better treatment adherence.

Sauer also stated that Novartis intends to submit the data from both KITE and KESTREL to health authorities in H1, 2021 and looks forward to working with regulators worldwide to make Beovu available to DME patients in need.

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Novartis' KESTREL Study Reaffirms Positive Results of Beovu in DME - BioSpace

Photo by Brandon Kopp

From an email:

Washington National Cathedral will toll its bells 300 times on Tuesday, Dec. 15 starting at 5 p.m. ET, in memory of the 300,000 Americans who have died of COVID-19.

The Very Rev. Randolph Marshall Hollerith, the Cathedrals dean, also released this statement:

We have reached the point in America where the death toll from COVID-19 for just one day was the equivalent of 16 fully loaded 737 jets falling from the sky.

Think about that. We would never allow that kind of disaster to take place day after day in this country, and we certainly would never allow such tragedy to become normal or expected. And yet, the climbing death toll from this pandemic seems disturbingly routine. How awful that is.

As the Cathedral marks 300,000 lives lost to COVID-19, I have grown weary of tolling this bell. I dont want to toll this bell any more. I dont want to lose any more lives. I dont want us to think this is normal, or that it is just the price we must pay for living in a free society. God forgive us if we find ourselves tolling this bell again at 400,000 lives lost.

The Christian faith teaches that each person is a beloved child of God, and that my well-being is deeply connected to your well-being. We are not lone individuals free from responsibility; rather, we are dependent upon one another for our very lives and commanded to love our neighbors as ourselves.

There are simple things we can do wear a mask, keep our distance, adjust our holiday plans to show our mutual respect and concern for one another. Yes, we are tired from the confines and struggles of this pandemic, and yes, its been a long nine months. But now, more than ever, we have to protect each other because there has been far too much death. A vaccine is coming and we will get through these difficult days, but we will only succeed if we do it together.

Lord, in your mercy, heal us from this disease. Remove the blindness from our eyes that keeps us from seeing your face in our neighbor. Soften our hearts, give us strength to endure and the will to act for the common good.

Lord, in your mercy, hear our prayer.

Originally posted here:
Washington National Cathedral will toll its bells 300 times starting at 5 pm "in memory of the 300000 Americans who have died of COVID-19."...

DUBLIN, Dec. 14, 2020 /PRNewswire/ -- The "Vision Care: Global Markets" report has been added to ResearchAndMarkets.com's offering.

The current report provides a detailed analysis of the vision care devices market. This report will highlight the current and future market potential of vision care devices along and provide a detailed analysis of the competitive landscape. The report covers market projections for 2025 along with current market estimates. Epidemiology trends of major eye disorders, drivers, restraints, and opportunities will also be covered in the current report along with company profiles of the key market players.

The report segments the market for vision care devices based on device, distribution channel, and geography. Based on device type, the market is broadly segmented into eyeglasses, contact lenses, intraocular lenses (IOLs), and artificial tears. Eyeglasses are further segmented into a single vision, bifocal and progressive. Contact lenses are further segmented into spherical lenses, toric lenses, multifocal contact lenses, and others. For market estimates, data will be provided for 2019 as the base year, with estimates for 2020 and forecast values for 2025.

By geography, the market has been segmented into North America, Europe, the Asia-Pacific region, Latin America, and the Middle East and Africa. Detailed analysis of major countries such as the U.S., Canada, Germany, the U.K., Italy, France, Spain, Japan, China, India, Australia, Brazil, and Mexico will be covered in the regional segments.

The Report Includes:

Market growth is attributed to factors such as the growing prevalence of blindness and vision impairment, a rise in the world's geriatric population, and growing collaborations between vision care companies and technology companies for the advent of technologically advanced products to address current unmet needs.

According to the IAPB, nearly 1.1 billion people are considered to be affected by some form of vision loss: 43 million people are categorized as blind, about 553 million people are estimated to suffer from some form of moderate to severe visual impairment (MVSI), about 258 million people experience mild vision impairment and about 510 million suffer from near vision impairment. In addition, at least 1 billion more people need ongoing access to eye care services. High prevalence and the increasing burden of vision impairment is likely to drive the vision care market during the forecast period.

Reasons for Doing This Study:

Visual impairment is a global health concern that has a negative impact on both physical and mental wellbeing. Preventive blindness, a common vision disorder, represents a major challenge to the global healthcare system. Visual impairment is associated with loss of global productivity and high disability-adjusted life years (DALYs) and is responsible for significant healthcare spending. According to the International Agency for the Prevention of Blindness (IAPB), in 2020, nearly 1.1 billion people were considered to be affected by some form of vision loss; 43 million people are categorized as blind, about 553 million people are estimated to suffer from some form of Moderate and Severe Vision Impairment MSVI, about 258 million people experience mild vision impairment and about 510 million suffer from near vision impairment. In addition, at least 1 billion more people need ongoing access to eye care services.

Globally, the leading causes of vision impairment are uncorrected refractive errors and cataracts. Refractory disorders, particularly myopia, are one of the common ailments seen across all age groups. The incidence of refractory disorders is estimated to have doubled in the last decade compared to past generations, with the rise driven by rapid changes in lifestyles, genetic disorders, and malnutrition. Refractory disorders, although increasingly prevalent, can be treated and are considered preventable ailments if addressed quickly.

Market growth has been spurred by the introduction of technologically advanced products and the rise in the global visually impaired population. This report is designed to provide the reader with a background on vision care products, an analysis of the current factors influencing the market, and the tools to make decisions regarding expansion and penetration in this market.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Clinical Overview

Chapter 4 Epidemiological Insights

Chapter 5 Supply Chain Overview

Chapter 6 Vision Care Market Dynamics

Chapter 7 Impact of COVID-19 Pandemic on the Vision Care Market

Chapter 8 Market Breakdown by Product Type

Chapter 9 Market Breakdown by Region

Chapter 10 Competitive Landscape

Chapter 11 Company Profiles

Chapter 12 Appendix: Acronyms

For more information about this report visit https://www.researchandmarkets.com/r/k467nz

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

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Insights on the Vision Care Global Market to 2025 - Increase in Uptake of a New Generation of Contacts Lenses is Driving Growth - PRNewswire

New York, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell and Gene Therapy Global Market Report 2020-30: COVID-19 Growth and Change" - https://www.reportlinker.com/p05996809/?utm_source=GNW

The global cell and gene therapy market is expected to decline from $6.68 billion in 2019 to $6.92 billion in 2020 at a compound annual growth rate (CAGR) of 3.61%. The slow growth is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $13.23 billion in 2023 at a CAGR of 24.10%.

The cell and gene therapy market consists of sales of cell and gene therapies by entities (organizations, sole traders and partnerships) that develop cell and gene therapies. Cell therapy refers to the transfer of intact, live cells that are originated from autologous or allogenic sources and gene therapy refers to the introduction, removal, or change in the genome for treating diseases. The market consists of revenue generated by the companies developing cell and gene therapy products by the sales of these products.

North America was the largest region in the cell and gene therapy market in 2019. It is also expected to be the fastest-growing region in the forecast period.

In December 2019, Roche, a Swiss multinational healthcare company, acquired Spark Therapeutics for $4.3 billion. The acquisition supports the commitment of Roche to bring transformational therapies and innovative approaches to people with serious illnesses. Spark Therapeutics will continue to work within the Roche Group as an independent company. Spark Therapeutics, headquartered in Philadelphia, is a fully integrated commercial company involved in the discovery, production, and distribution of gene therapies for genetic disorders including blindness, hemophilia, lysosomal storage, and neurodegenerative diseases.

The cell and gene therapy market covered in this report is segmented by product into cell therapy; gene therapy and by application into oncology; dermatology; musculoskeletal; others.

Limited reimbursements preventing patients from receiving treatments are expected to limit the growth of cell and gene therapy (CGT market. In 2019, Trinity Life Sciences, a life sciences solution provider, researched national and large regional commercial health insurance plans in the US. It found that the confluence of increasing price, patient volume and number of CGTs on the market is likely to change the reimbursement model for CGTs and impact payer budgets by 5-10%. Payers realize that financing needs to be generated for cost management due to the uncertainty surrounding reimbursement of ancillary costs. Limited reimbursements and uncertain insurance plans are preventing patients from receiving high-cost CGT, which is expected to limit market growth.

Chimeric antigen receptor (CAR) T-cell therapy is shaping the cell and gene therapy (CGT) market. (CAR) T-cell therapy is a combination of cell and gene therapy in which T cells are collected from the patients blood and are genetically engineered to produce modified receptors at their surface, known as chimeric antigen receptors (CARs). These modified T cells with special structures (receptors) are reinfused into the patient. Then, the modified receptors of T cell help in targeting the surface antigen of the cancer cell that ultimately results in the killing of tumor cells in patients. In 2020, the US-FDA approved Bristol-Myers Squibbs two CAR-T cell therapies to treat lymphoma and multiple myeloma and is set to be launched. Currently, FDA approved CAR-T cell therapy treatments like Tisagenlecleucel for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and Axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Steady investment and consolidation in cell and gene therapies contributed to the growth of the cell and gene therapy (CGT) market. After recognizing the potential of the CGT market, 16 out of the 20 largest biopharma companies by revenue, added CGT products to their portfolio. For instance, Merck invested $109 million in viral vector and gene therapy manufacturing in April 2020. Moreover, 12% of industrial clinical pipeline products and at least 16% of preclinical pipeline products consist of CGT. Steady investment and consolidation in CGT production capacity led to an increase in production capacity and also contributed to the growth of the market.Read the full report: https://www.reportlinker.com/p05996809/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cell and Gene Therapy Global Market Report 2020-30: COVID-19 Growth and Change - GlobeNewswire

Joceline Colvert was diagnosed with relapsing remitting Multiple Sclerosis in her early 20s and says she spent the first eight years researching and managing her condition while trying to mention it as little as possible to others and completing her Sound Production degree.

I spent most of my late 20s and early 30s finding ways to manage relapses, the symptoms of which have included whole body numbness, loss of the use of both hands, right eye blindness, vertigo and double vision, she said. Thankfully these symptoms did resolve however left scarring on my nerves. This results in reduced vision in my formerly blind eye and hands that dont function very well with repetitive tasks.

This semi-denial worked for me until about 2010 when I started to become a bit limpy which I did my best to hide. After a couple of memorable falls and fractures I decided to face up to being slightly rickety and got a hiking pole that I used occasionally in public. Since then Ive needed to get used to being visibly disabled, and switch between two hiking poles for very short distances and a wheelchair everywhere else.

Joceline, who lives with her husband and her five beloved cats and dogs, says she is not eligible for Haematopoietic Stem Cell Transplantation (HSCT), on the NHS which is the first treatment I have ever got excited about and believe could work. It could be truly life-changing.

As a result she is trying to raise money to fund the treatment herself.

HSCT is a procedure that aims to reset the faulty immune system which, in my case, is attacking my nervous system from within, Joceline said. Stem cells will be taken from my bone marrow or blood before my immune system is wiped out with chemotherapy. My cells are then reintroduced into my blood, where they grow a new immune system which will hopefully no longer attack my nerves or have any memory of MS.

The aim of HSCT is to completely halt progression, putting MS into remission with no requirement for immunosuppressant drug therapy. The success rate for relapsing remitting MS is 80% - 90% which is absolutely phenomenal compared to the limited available drug treatments, which only aim to slow down disability.

HSCT is available on the NHS, however there is a very strict criteria for which I do not qualify. The expense of the treatment and the increased pressures on the public purse mean the NHS will only treat patients who have been diagnosed for fewer than 15 years.

I have been diagnosed for 18 years.

I had prepared myself for this possibility and, for the last year, have been researching treatment with The National Pirogov Medical Centre Russia (Moscow). Russia has been pioneering in their use of HSCT to treat MS and are world renowned for their expertise and care. Im excited to have a treatment date in March 2021 which fills me with hope for a future free from progression. I need your help to get there.

Joceline, who loves making stop-motion animation puppets and props and playing musical instruments, says the treatment will cost 40,800, and the flights 800.

She has launched a Go Fund Me page at https://gf.me/u/y538k2 which has already seen donations of more than 26,000.

I am incredibly grateful for any help you can give towards enabling me to access this life-changing treatment, she said.

After almost two decades of managing MS flare-ups and their consequences, its hard to put into words just what a future without them would mean to me.

Thank you for reading this and for any help you can put towards this goal.

Read more:
Haywards Heath woman's bid to fund stem cell treatment to combat MS - Mid Sussex Times

As the second wave of the pandemic engulfs us and the world works at warp speed to develop vaccines and therapies to respond, the importance of regenerative medicine has never been higher. Since 2017, Goldman Sachs has touted the sector as one of the most compelling areas for venture capital investment. With billions of dollars of global government spending being poured into the search for vaccines and therapies to respond to the novel coronavirus, and with the FDA having now granted approval to the first vaccines based on CRISPR mRNA gene-editing technologies, business models based on regenerative medicines are commanding record values. Despite the flood of cash into regenerative medicine, legal and ethical considerations will continue to cause much controversy.

Regenerative medicine ultimately accelerates the human bodys healing process. It is an area of biomedical sciences that involves medical treatments to repair or replace damaged cells, tissues, or organs. Instead of merely focusing on the symptoms, regenerative medicine uses cellular therapies, tissue engineering, medical devices, and artificial organs to improve peoples health. For example, stem cell therapies, tissue grafts, and organ transplants are all part of regenerative medicine.

Today, cellular and acellular regenerative medicines are often used in clinical procedures such as cell, immunomodulation, and tissue engineering therapies. They have the potential to effectively treat many chronic diseases, including Alzheimers, Parkinsons and cardiovascular disorders, osteoporosis, and spinal cord injuries.

A small number of unscrupulous actors, according to the FDA, however, have seized on the clinical promise of regenerative medicine to offer patients unproven treatments. The FDA and other regulators are challenged to provide assurances of safety for these therapies without stifling development, as well as to approve treatments based on manipulation of stem cells derived from human and animal embryos given the ethical issues involved.

In the future, stem cell research will play an increasingly outsized role in regenerative medicine techniques. In November 2020, voters in California narrowly passed Proposition 14, a referendum to approve $5.5 billion in new government funding for stem cell research. Other governments around the world are doing the same.

Today, the growing prevalence of chronic medical ailments and genetic disorders across the globe is a primary factor driving the regenerative medicine industrys growth, according to the Regenerative Medicine Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025. The increasing aging population, prone to various musculoskeletal, oncological, dermatological, and cardiological disorders, is a key growth driver. Widespread adoption of organ transplantation is another contributing factor to this growth in market share. The current pandemic that began in January 2020, however, has changed the paradigm for regenerative medicine.

Market applications are burgeoning. Regenerative medicine can prevent and cure disease through effective vaccines and efficacious therapies. It can minimize the risk of organ rejection post-transplant and speed recovery. Technological advancements in cell-based therapies, such as the development of 3-D bioprinting techniques and the adoption of artificial intelligence in the production of regenerative medicines, are also stimulating growth. These advancements also facilitate dermatological grafting procedures to treat burns, bone defects, and skin wounds. Other factors, including extensive research and development activities in medical sciences and improving healthcare infrastructure, are also predicted to drive the market even further.

According to the Alliance for Regenerative Medicine, there are approaching approximately 1,000 companies focusing on this evolving area worldwide. These new companies are focusing on gene therapy, cell therapy and tissue engineering therapeutic developers. More than half of these companies are in North America, followed by almost a quarter in Europe and Israel and approximately 20% in Asia. More than 50% of these companies are focusing on cell therapy and gene therapy.

From 2014 to 2019, the global regenerative medicine market experienced a nearly 16% CAGR. Companies involved in gene and cell therapies as well as other regenerative medicine areas raised $4.8 billion during the first half of 2019, including $2.6 billion in the second quarter. Meanwhile, companies in Europe and Israel saw an acceleration of fundraising, with $1.3 billion amassed in just the first half of 2019, representing a 17% increase over the same period in 2018. Project Warp Speed has attracted billions of dollars of U.S. government spending, and similar efforts are ongoing in China, Russia, the European Union and among other major powers. Consequently, regenerative medicine has never before benefited from such a combination of public and private investment.

Whenever the viability and quality of human life are at stake, ethical and legal considerations always arise.

The modern ethical controversy surrounding regenerative medicine began in 1998 when research scientists at the University of Wisconsin succeeded in deriving and growing stem cells from early-stage human embryos. Ethicists and right-to-life activists protested that scientists were taking away human life (embryos) to conduct scientific experiments. Left unchecked, so the argument went, doctors could usurp nature and play God by developing the power to create and terminate life. A society where human life could be fundamentally perverted by medicine conjured up comparisons to Nazi Germany and Frankenstein. In 2001, then-U.S. President George W. Bush cut off federal funding for any research involving newly created embryonic stem cell lines, but agreed to continue funding research on 60 existing stem cell lines, where the life and death decision ha[d] already been made. The State of California responded in 2004 and again in 2020 with voter-approved programs directing billions of funding into stem cell research, making the region the global hub of regenerative medicine.

The use of human-derived embryonic stem cells, or animal-derived stem cells, continues to cause much controversy among ethicists and society at large. Some fear the risks of enrolling humans in experimental stem cell studies. Others fear the use of organs from human-animal chimeras in transplantation.

While these techniques have the potential to cure disease and save lives, they also have the potential to forever alter the nature of life as we know it and fundamental aspects of our society.

In the United States, legal jurisdiction for regulating regenerative medicine on a federal level lies with the FDA and in a patchwork of state laws, R&D funding programs and non-binding, NGO-promulgated statements of policy. The main responsibility of the FDA is to protect the public from dangerous products and ensure its safety, including overseeing medications for humans and animals, vaccines, and more.

During the Trump Administration, the FDA has largely focused on enabling developers to gain product approvals through a less burdensome and costly process. In numerous policy statements, the FDA under President Trump has deferred questions about the efficacy of new regenerative health products to the free markets, so long as they posed no serious safety or toxicity concerns.

The U.S. federal government is now transitioning to an administration led by President-elect Biden. The president-elect has spent many years advocating for increased R&D funding and going for moonshots. With a new mandate from the U.S. electorate to address the coronavirus, more money will be earmarked for regenerative medicines and stem cell research. How this will affect the release of new products into the market remains to be seen.

Regenerative medicine is poised to change the way we live, work and interact like never before. The fourth industrial revolution is upon us. CRISPR gene-editing technologies, facilitated by quantum-computing capabilities at the edge of a computer network powered by 5G telecommunications bandwidths, artificial intelligence and machine learning, have changed the game for regenerative medicine. We can foresee a day when those suffering from paralysis regain movement, when a damaged heart reverses course through regeneration, and when a diagnosis of Alzheimers Disease no longer means neurodegeneration. What a wonderful day that will be.

Changing the traditional healthcare model and moving from cure to prevention will take time.

The rise in chronic disease and the effort to reduce healthcare costs presents a large opportunity for the field of regenerative medicine.

As the continent becomes a bigger player, western companies should explore the potential prospects.

Topics from regenerative medicine to artificial intelligence to cannabis will be discussed.

More:
Regenerative Medicine: Market Trends and Legal Developments on the Horizon for 2021 - MedTech Intelligence

Non-invasive, wearable tech could usher in a new generation of personalized therapeutics. Unveiled ... [+] today, startup Nsos aims to treat rheumatoid arthritis by reinforcing the brains natural pathways.

They look like earbuds, feel like earbudsbut when you put them in, theyre completely silent. Thats because these earbuds arent for playing music or listening in on a video call. Instead, they deliver a finely-tuned electrical field to the brain.

Unveiled today, the earbud-like devices are a revolutionary rheumatoid arthritis treatment pioneered by neurotech startup Nsos.These wearable therapeutics may sound like science fiction. Even Nsos founder and CEO, Konstantinos Alataris, calls them a moonshot idea. But according to the data from Nsoss first clinical study, these devices are hardly far-fetched.

Normally, autoimmune diseases are treated with medication. In the case of rheumatoid arthritis, the current best treatments are over-the-counter pills like ibuprofen or prescription immunosuppressants like Humira. But these medications are not without side effects. And in the case of Humira, the medication must be injected under the skin, an uncomfortable routine for many patients. But what if there was a way to treat painful conditions like rheumatoid arthritis without pills or needles?

What if the medicine was electric?

Thats what Nsos is aiming to achieve through a novel therapeutic approach the company is dubbing e-mmunotherapy. If successful, this will be the first wearable, non-invasive treatment for an immune system disorder.

Neuroscience and immunology were once thought to be completely separate fields. But its now understood that these two systems are in constant communication with each other. The brain simultaneously generates thoughts and actions while taking care of critical functions like heartbeat and body temperature. It turns out that the brain also plays a major part in regulating inflammation. When these neural inflammation networks go haywire, it can result in immune system disorders like rheumatoid arthritis.

Nsos first e-mmunotherapy proof of concept works by sending electrical signals to the brain to reinforce its natural pathways. This is an opportunity to take a biological pathway, how the brain controls an overactive immune response, and restore it using an electrical field, mimicking the brain's language, says Alataris. So far, the companys wearable tech approach looks promising. Patients of the companys pilot clinical trial reported reduced severity of their rheumatoid arthritis symptoms comparable to the results of current medications.

Nsos Founder and CEO, Konstantinos Alataris, PhD.

Alataris already has deep experience in electrical therapeutics. He was previously the founder and CEO of Nevro, a company that produces subdural spinal cord stimulation devices for chronic pain. Similar startups, like Elon Musks Neuralink, rely on implanted electrode arrays. But this is the first time that electrical signals will be delivered through a fully external device.

If approved, these devices could dramatically simplify the treatment for inflammation-driven conditions. The earbuds would only need to be worn for a few minutes each day and the positive effects would increase over time. By reinforcing the proper neural pathways, the devices teach the brain to remember the positive changes. Not only does this provide sustained relief, it also hits closer to the root of the illness, addressing brain signals rather than chemical ones.

Nsos also recognizes the unique nature of each patients condition. Using machine learning, Alataris says the devices will eventually be able to deliver personalized electric fields depending on a patient's disease progression. Your therapy, your electrical field, your path sequence, at the end [they] will be different than mine, says Alataris.

With $16.5 million in funding led by Mayfield Fund, Nsos is already in process to test their devices in randomized control trials. If successful, the results will be submitted for FDA approval. But Alataris is clear that it will be years before these devices can be prescribed for patientsvalidation through data comes first. We don't want to step too far off. Were putting one foot in front of the other based on the data, says Alataris. With the increasing rise of scientific misinformation, establishing trust with the public through data is more important than ever.

If Nsos first devices are effective in retraining the brains inflammatory response, it could open the door to a wide range of therapeutic options. More and more conditions, from diabetes to mental health disorders, are being newly understood in the context of inflammation. Indeed, Nesos is already developing two more products to address migraine prevention and postpartum depression.

For Alataris, this is the next level of neuroscience. We are still at the very early stage of what is possible and what we can possibly do. To have these big dreams, you need data to stand on. We dont want to go chasing dragons here, but its a very exciting time, says Alataris. If validated, Nsos technology may be the first step towards a new future of therapeutics.

Im the founder of SynBioBeta, and some of the companies that I write about are sponsors of the SynBioBeta conference and weekly digest, including the Mayfield Fund. Thank you to Desiree Ho for additional research and reporting in this article.

Original post:
What If You Could Change Your Immune System By Wearing Earbuds? Meet The Startup That Could Make It Possible - Forbes

After the initial results of the Pfizer-BioNTech and Moderna vaccines exceeded even the wildest efficacy expectations, one could be forgiven for believing weve found the answer to reclaiming our lives from the grip of COVID-19. In reality, its a little more complicated.

Cases of reinfection are beginning to emerge, showing that protective antibodies may not have the longevity we were hoping for. This poses the question: Is it more important to elicit a robust antibody response, T cell response, or both? Secondly, what is the approach or delivery platform that will achieve the collective robust immune response to finally end the pandemic?

BioSpace spoke with a few companies that have some ingenious ideas at different stages of preclinical and clinical development.

First, Science 101:

The human body contains a B cell responsible for generating and secreting antibodies, which play the important role of blocking viruses. Antibodies do wane, however, and have the potential to become less effective if the virus mutates, which already appears to be happening as cases of COVID-19 reinfection begin to emerge.

Then there are T cells which come in two main types. Helper T cells (CD4+T cells) stimulate the B cells to make antibodies and help killer cells to develop. Killer T cells (CD8+ T-cells) act as a type of clean-up hitter, killing infected host cells and activating other immune cells, enabling viral clearance. Importantly, they can also turn into Memory CD8 T cells which provide a long-lasting immune response.

All of these play a critical role in the adaptive immune system response.

Viral clearance is what is so important to prevent transmission. In my mind, at least, the best way to stop a pandemic is not just to protect the blocking, but to clear the virus if it does get in and reduce transmission, said Dr. Patrick Soon-Shiong, head of NantWorks, the parent company of NantKwest Inc. and ImmunityBio, which are collaborating on a vaccine designed to elicit both an antibody and a T cell response.

Soon-Shiong went on to say that the vaccines currently in late phase development have focused mainly on eliciting a strong antibody response with the Spike (S) protein.

The S protein is the protein that would stimulate an antibody, as well as some level of T cells, but not very strong. The S protein is what every vaccine thats in Phase III right now, Moderna, Pfizer, AstraZeneca, Johnson & Johnson are targeting, because thats the antibody approach, he explained. In fact, none of the phase III protocols actually mention T cells. They do in an exploratory way, but not in a definitive way of measuring the T cells.

The NantKwest and ImmunityBio approach combines the commonly targeted S protein with the lesser known N protein (nucleocapsid protein) which is essential for the virus to survive. They are also using a second-generation adenovirus vector which precludes the possibility of the vaccine becoming ineffective after the first dose, a risk inherent in first-generation adenovirus vector vaccines.

NantKwest Senior Director of Infectious Diseases, Jeffrey Safrit, explained that the nucleocapsid is viewed as a particularly strong stimulator of cellular immunity and improves the generation of memory T cells. T cell mediated immunity has been shown to last significantly longer than antibody-mediated immunity, he added.

In an oft-referenced study published in Nature, Drs. Nina Le Bert and Anthony T. Tan at Duke-NUS Medical School in Singapore showed that patients who recovered from the SARS CoV-1 virus possessed long-lasting memory T cells 17 years after the 2003 outbreak. In addition, the T cells displayed robust cross-reactivity to the N protein of SARS-CoV-2.

This indicates that T cells may just be the ticket to widespread immunity.

The duo announced positive interim safety data from its Phase I dose study on November 10.

Aiming for a More Robust Antibody Response

Abpro Corp., a biotechnology company developing next generation antibody therapies for severe disease, is targeting a more robust antibody response with its therapeutic, ABP 300, which is based on neutralizing monoclonal antibodies.

The company recently completed a Phase 1 study in humans, which will read out in Q1 2021. It also announceddatafrom a challenge study in rhesus monkeyspublished inNature Communications, whichshowed that a single dose of ABP 300 blocks infection of SARS-CoV-2 in prophylactic treatment and clears the virus in three days in a therapeutic setting.

ABP 300 also displayed the potential to neutralize eight SARS-CoV-2 strains with reported high-frequency mutations. This could prove a critical asset in the long-term fight against COVID-19.

Abpro Executive Chairman and Co-Founder Ian Chan said that a neutralizing antibody is exactly the way it sounds. It basically prevents the virus from entering human cells.

Chan further explained that neutralizing antibodies can be an effective one-two punch as both a treatment and a prophylactic.

Neutralizing antibodies have shown that they may be potential first line therapies for mild-to-moderate patients. And then secondly, they can also be used as a preventative type of treatment as well, said Chan.

If someone has not yet received a vaccine or somehow [is] unable to generate an immune response after vaccination and gets infected, then a therapy will be needed. Together, vaccines and therapies will form a potent combination to help mankind get the pandemic under control.

Chan told BioSpace that Abpro would like to get the drug to patients early in 2021.

Targeting the T Cell Response

OSE Immunotherapeutics, a clinical stage biotech focused on controlling the immune system in immuno-oncology and autoimmune diseases, plans to launch the Phase I trial of its vaccine candidate, CoVepiT, in December.

CoVepiT is based on optimized peptides selected to induce a lasting sentinel T lymphocyte immune response against SARS-CoV-2. OSE Chief Scientific Officer, Nicolas Poirier, is adamant about the advantages of his companys T cell specific approach.

We are developing a vaccine that addresses the T cell response only, and the idea, or the advantage, of that strategy is that we are developing a long term or lasting protective response, Poirier said. We can unfortunately expect that the antibody protection will be transient because of what we learned from the past coronavirus infection. And of course, we do not yet have sufficient data from the first-generation vaccines to say that they will be protective from the longer term or midterm.

OSE researchers analyzed more than 46,000 SARS-CoV-2 samples from patients around the world to identify matching vaccine targets. They then compared these samples to SARS-CoV-1 and MERS in order to identify targets that had the best chance of remaining unchanged in the face of mutations or the emergence of another strain.

Preclinical data show that the vaccine activates T memory cell responses. OSE plans to initiate Phase I trials in December and anticipates clinical data early in 2021.

The Combination Approach

Heat Biologics Inc. in collaboration with the University of Miami, is developing a "combination" vaccine that stimulates both antibody and T cell responses. Founder and CEO Jeff Wolf sees the antibody and T cell approaches as a one-two punch to the coronavirus.

Personally, I think you need both, especially in elderly and patients with comorbidities, because these people are really the most impacted by this, Wolf said. I think its clear from the data thats out there, you have patients who have generated a robust antibody response and then they come down with a severe case of COVID months later. So even though people think they have protection, they really dont.

Heats vaccine works by engineering multiple protein regions of the SARS-CoV-2 virus into its proprietary gp96 platform to create combined antibody and T cell immunity. When delivered to the body through the vaccines cells, the gp96 protein is then able to show the SARS-CoV-2 proteins to the immune system in a powerful way that activates a power T cell response.

Heat has previously used the go96 platform in preclinical studies against Simian immunodeficiency virus (SIV), HIV, and the Zika virus.

In terms of long term immunity against SARS-CoV-2, only time will tell what the magic ingredients turn out to be, but when it comes to a deadly pandemic that has killed more than 1.4 million people globally and more than 260,000 in the U.S. alone, the verdict is clear: we need to cover all our bases with all of our antibodies and T cells on board.

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Biotechs Developing Innovative Ways to Activate the Immune System Against COVID-19 - BioSpace

Q: As we go into the winter months and illness chances increase, what can I do to boost my immune system?

A: Your question is on the minds of many consumers, as more people have been reaching for vitamin supplements and seeking out healthy foods to improve their immune system amid the COVID-19 pandemic. In fact, 77% of consumers say they want to eat healthier to boost their immunity during the pandemic, according to a study by Archer Daniels Midland, a Chicago-based, food-processing company.

Building and maintaining a healthy immune system starts with focusing on good nutrition, said Beth Stefura, a family and consumer sciences educator for Ohio State University Extension. OSU Extension is the outreach arm of The Ohio State University College of Food, Agricultural, and Environmental Sciences (CFAES).

Our bodys ability to fight infection and disease depends on our immune system, she writes in Live Well and Boost Your Immune System, a blog post at the Live Healthy Live Well website. Eat well by choosing nutrient-rich foods, she adds.

The site, which can be found at livehealthyosu.com, is a free information resource that offers science-based consumer information and insights. Its written by OSU Extension educators and specialists in family and consumer sciences who promote health and wellness.

In the blog post, Stefura lists multiple foods that can help boost your immune system, including foods rich in:

Vitamin D, which plays a wide variety of roles in boosting the immune system, including helping the body absorb calcium, which builds strong bones and prevents osteoporosis. Your muscles, nerves, the immune system, and many other bodily functions all require vitamin D to do their jobs properly. Good food sources of vitamin D include fortified milk and fortified orange juice; fatty fish such as salmon, tuna, and mackerel; eggs and egg yolks; mushrooms; beef liver; cheese; and fortified breakfast cereals.

Vitamin C, which is essential for the growth and repair of tissue throughout the body. Good food sources of vitamin C include kiwi, broccoli, tomatoes, berries, Brussels sprouts, cantaloupe, cauliflower, grapefruit, honeydew, kale, mango, nectarine, orange, snow peas, sweet potato and strawberries. Red, green, and yellow peppers are also great sources of vitamin C.

Beta carotene, which studies suggest may enhance immune cell function and has been shown to strengthen the bodys infection-fighting methods. Good sources of beta carotene include carrots, sweet potatoes, winter squash, mango, tomatoes, beets, broccoli, cantaloupe, green peppers, kale, mangoes, turnip and collard greens, nectarines, peaches and watermelon.

Zinc, which helps the immune system fight off invading bacteria and viruses and is key to optimal immune function. Foods containing zinc include red meat, seafood, sunflower seeds, pumpkin seeds, oysters, poultry, beans, nuts, whole grains and some fortified cereals.

Stefura also says that minimizing your intake of sugar, processed foods and alcohol, as well as managing stress and getting enough sleep is key to boosting your immune system.

Lack of sleep contributes to a variety of health concerns, including a weakened immune system, she writes. Seven to nine hours is recommended each day for adults, and children need eight to 14 hours depending on their age.

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Chow Line: Healthy ways to improve immunity - The Bryan Times

Although COVID-19 primarily attacks the respiratory system, the virus can affect almost every organ and tissues in the human body, including immune and digestive systems.

An approach to reduce the impact of COVID-19 on health and well-being includes looking after what you eat and your lifestyle.

The GMFH editing team had time to speak with INRAE Research Director Jol Dor on what have we learned from the last months on the role of nutrition and a healthy gut microbiome for reducing the risk of contracting COVID-19.

Not only do chronic conditions, promoted by unhealthy eating, clearly increase the risk of contracting or developing a more severe form of Covid-19, but also it is well established that these come with low-grade inflammation. It is also clear that anti-inflammatory drugs may beneficially contribute to avoid severe forms involving the so-called inflammatory storm* typical of severe Covid-19. It is hence reasonable to speculate that improving gut microbiota profile by personalized nutrition and supplementation known to improve immunity can be one of the prophylactic ways by which the impact of this disease can be minimized.

The risk of developing a severe form of Covid-19 is higher in older people, and in people of all ages with pre-existing medical conditions that share as a common feature an inflammatory context (heart or lung conditions, weakened immune systems, severe obesity, diabetes, asthma).

In this context, any means of promoting immune homeostasis could possibly be protective. For example, probiotics with the ability to protect from diarrhea or to reduce gut permeability could help.

The current concept is that the dialogue between the microbiota and the immune system is central to mechanisms of infection and expression of the disease in Covid-19. Alteration of natural defenses (immunosuppression, immunosenescence, low grade inflammation) will induce dysbiosis. In turn, altered natural defenses and altered microbiota may mutually sustain one-another, favoring uncontrolled inflammation. Persistence of dysbiosis following resolution of major symptoms could explain long and difficult recovery from associated symptoms (altered gut transit, joint pain, headaches, anxiety, allergic symptoms, loss of taste and smell).

The scientific literature on microbiota changes in the old age documents a loss of richness which is associated with diminished reactivity of natural defenses. With loss of microbiota richness, the ecosystem will be less robust to assaults such as infection. It will neither fight nor recover as well. If in addition natural defenses are also diminished, infectious bacteria or viruses will induce more severe consequences. In such contexts it is a good preventive attitude to take care of the microbiota with a rather high diversity of fibers, in other words a large variety of raw or cooked vegetables and fruits that may confer protective benefits on the gut barrier and thereby the microbiota. Ideally, one would want to include probiotics from food sources or in the form of supplements and micronutrients documented for their ability to protect from gut hyper-permeability, inflammation, oxidative stress and possibly visceral sensitivity. For instance, the combination of yogurt and fruits contributes to intake of beneficial probiotic bacteria and key nutrients associated with increased gut microbiota diversity, including prebiotic fibers, vitamins and minerals.

We are truly microbial, we are ecosystems and we live in symbiosis with our microbiota that provides numerous beneficial functions. Preserving the richness and functionality of our gut microbiota will certainly help and possibly reduce the risk of contracting or developing a severe form of Covid. We should see this as a preventive and protective measure that should in addition have many more benefits as it will reduce the risk of numerous chronic conditions.

* Proteins that play a role in signalling to other cells how to regulate their activity and function (fight off disease for example).** Meaning the absence of the virus in the organism.

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Nutrition, immunity and COVID-19: what have we learned during last months? - Gut Microbiota for Health

We could all use a little extra immune support this year. And, if were being honest, we will probably need to keep our focus on immune support for quite a while to come.

While there are many ways to support our immune system, these are the supplements that I consider to be foundational for immune health.

Vitamin D: Study after study has shown that one of the most important things that we can do to support our immune system is to make sure that we have adequate vitamin D levels. Its much tougher to keep our vitamin D levels in a healthy range during the winter months due to lack of sunshine. Therefore, many health care providers suggest that we take a little extra vitamin D in supplement form in the winter. I usually suggest supplementing with somewhere around 5,000 iu per day in the colder months, but check with your doctor because they can fine tune your levels and suggest an amount that is right for you. If you find that it is tough for you to get your vitamin D levels into a healthy range, then talk with your doctor about adding supporting co-factors like magnesium and vitamin K2.

Vitamin C: Everybody knows we need vitamin C for a healthy immune system. And while many foods contain this important vitamin, I like to make sure to supplement with a little extra during the winter months just to make sure Im getting a reliable daily amount. I shoot for around 2,000 mg to 3,000 mg a day, and since vitamin C is usually found in its water-soluble forms, I suggest taking 1,000-mg tablets or capsules three times a day with your meals if possible.

Zinc: New research has been showing that we need to also be focusing on the amount of zinc we get daily. Low levels of this important mineral have been linked to a harmful inflammatory response during certain illnesses. Zinc is available in capsules, tablets, liquid and lozenges. All of those options are fine just try to get the one that you are most likely to keep up with. Personally I like the lozenges in the winter months because most lozenges contain other immune helpers like elderberry, echinacea and vitamin C. Try to supplement with between 15 mg and 30 mg per day.

We need to treat our immune systems with care, especially these days. So, give these simple supplements a try.

Travis Lemon is a certified herbalist and co-owner of Tulsi at The Market in Huntington. He has worked in the natural health and wellness industry for more than 14 years. He can

be contacted at travislemonmh@gmail.com.

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Travis Lemon: Are you taking these immune heavy hitters? - Huntington Herald Dispatch