StemCell Therapy

Olaparib (Lynparza) significantly improved overall survival (OS) versus enzalutamide (Xtandi) or abiraterone acetate (Zytiga) in patients with metastatic castration-resistant prostate cancer (mCRPC) who harbor BRCA1, BRCA2, and/or ATM aberrations, according to results from the final OS analysis of the pivotal phase 3 PROfound trial (NCT02987543).1

In the trial, patients with mCRPC who progressed on previous treatment with a new hormonal agent and harbored BRCA1, BRCA2, or ATM aberrations (n = 245; cohort A) or other alterations in the homologous recombination repair (HRR) pathway (n = 142; cohort B) were randomized 2:1 to receive either olaparib or enzalutamide or abiraterone acetate.

Final OS data from cohorts A and B were presented during the 2020 ESMO Virtual Scientific Program. Results showed that the median OS in cohort A was significantly longer with olaparib than with physicians choice (HR 0.69; 95% CI 0.50-0.97; P = .0175).1In cohort B, the median OS was 14.1 months with olaparib versus 11.5 months with the control (HR, 0.96; 95% CI, 0.63-1.49).

What is exciting about this particular trial is that it showed the feasibility of personalizing care and using precision medicine strategies to preselect patients to maximize the chance of benefit for those who are candidates for these treatments, said Maha H.A. Hussain, MD, FACP, FASCO.We can also help patients avoid unnecessary exposure to ineffective treatments.

Previously published data showed that olaparib resulted in a 66% reduction in the risk of disease progression or death compared with abiraterone or enzalutamide (HR, 0.34; 95% CI, 0.25-0.47;P<.0001).2 Based on these results, the FDA approved olaparib in May 2020 for the treatment of adult patients with deleterious or suspected deleterious germline or somatic HRR genemutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone.

In an interview with OncLive, Hussain, the Genevieve E. Teuton Professor of Medicine in the Department of Medicine of the Division of Hematology Oncology and the deputy director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, further discussed the updated findings from the PROfound trial, its clinical significance in the treatment of patients with mCRPC paradigm, and the promise of precision medicine.

Hussain: PROfound is a randomized phase 3 clinical trial. It is one of the first precision medicine clinical trials to complete; patients were preselected based on specific genomic alterations and then randomized accordingly. Patients with mutations in the HRR genes or DNA damage repair genes were assigned to 2 different cohorts. The primary cohort was [comprised of] patients who had BRCA1/2 or ATM mutations, while cohort 2 included [those who harbored] other genes that are involved in the HRR pathway. Patients were randomized 2:1 to olaparib or standard of care per physicians choice of either abiraterone and prednisone or enzalutamide. The primary end point [of the trial] was radiographic progression-free survival (rPFS), which is a meaningful clinical end point, while OS was one of the several key secondary end points [examined].

Data from the Stand Up to Cancer highlighted the fact that over 20% of patients with mCRPC have significant mutations in the DNA repair pathway or the HRR genes. That [research] underscored the fact that this is a clinically relevant pathway to go after. At the time that [the PROfound trial was being designed] we saw evidence of benefit [with this approach] in other tumors [such as] breast and ovarian cancers, and then subsequently, in pancreatic cancer.

The specific pathway relevance is that both normal cells and cancer cells need to repair themselves when there is damage; the HRR pathway is involved in that repair process. However, are alterations or mutations [are present], the cells are not able to repair themselves and they fall back into a different pathway, which is the PARP pathway. Basically, PARP agents tend to inhibit that enzyme so that the [cancer] cells cannot repair themselves.

[Earlier data from the trial were previously published] this past summer. Johann de Bono, MB, ChB, PhD, of The Institute of Cancer Research was the first author on the publication in the New England Journal of Medicine, which highlighted [data regarding] the primary end point of rPFS. In this particular presentation delivered at the 2020 ESMO Virtual Congress, [investigators] reported OS [data from] cohorts A and B.

We saw that the benefit [with olaparib is] not only in terms of rPFS; the benefit translated into a median OS benefit of over 4 months between the arms, despite crossover from the control arm to the olaparib arm at time of progression. Additionally, the risk of death was reduced by 31%, which is very clinically significant. In [the cohort of patients who harbored the] other 12 genes, other than BRCA1/2 and ATM, we saw a trend in OS improvement but it was not statistically significant. The trend was about a little bit over 2 months of a difference. When adjusting for crossover, the trend improved although it was still not statistically significant. However, several patients in cohort B experienced clinical benefits from treatment. The primary benefit [with olaparib] still seems to be driven by BRCA primarily.

No; the overall safety was very much consistent with what was known about olaparib. The most common adverse effects observed included anemia, nausea, and fatigue. Most of these were low-grade events, aside from the anemia. Many of these patients were heavily pretreated; while they might have previously received abiraterone or enzalutamide, they would have also received chemotherapy and other potential anticancer treatment and be fairly advanced in the course of their disease. The findings, overall, are really not surprising and the safety profile very much consistent with what has been observed with the agent in other tumors.

We have reached a major benchmark in the management of this disease. Ever since the original observations regarding androgen deprivation [therapy] in prostate cancer and subsequent treatments, and certainly since the time I entered the field in the early 1990s, prostate cancer management has been more of a one-size-fits-all approach. In fact, when we give chemotherapy and hormone treatment we don't preselect [patients].

We still have [a lot of work to do]. Patients with metastatic castration-resistant disease continue to die from prostate cancer; they also suffer from pain and other factors involved with this disease. This [research] highlights the feasibility of performing precision medicine trials. It also shows us that meaningful clinical benefits could be achieved in these patients. I would hope that our partners across the spectrum will invest further in conducting more clinical trials.

The observation that we've seen with olaparib also opens up the door for potential combination clinical trials, both in castration-resistant disease and potentially in earlier stages of disease, where we might get a better return on investment from a clinical perspective.

Genomic profile evaluation for patients is critical moving forward, not only for the purpose of treatment for the patient. Conducting or counseling the patient regarding germline testing and tumor genomics evaluation in preparation for future treatment is also very critical. Obviously, genetic testing is associated with genetic counseling, [which may allow patients] and potential blood relatives [to get ahead of the game].

Tissue-based genomic evaluation will open the door for the patient to explore different treatments, and [certain] genomic alterations might qualify them for different clinical trials opportunities. [This work] underscores the hope for patients that their cancer can be managed better with genomically targeted treatments, specifically, in this case, the PARP inhibitor. [Now we can build on] these observations in terms of different treatment strategies and combinations.

Excerpt from:
PROfound Trial With Olaparib Shows Feasibility of Personalizing Care in mCRPC - OncLive

Fifteen weeks into her second pregnancy, Katrina Villegas and her husband learned their baby girl had trisomy 13, a chromosomal disorder that causes severe disabilities and is usually fatal.

"Its really just a whirlwind situation for a few weeks," said Villegas, recalling how her baby's heart defects and other abnormalities began showing up on her ultrasounds. "We just tried to do as much research as we could about trisomy 13 and what that would mean for our daughter. At the end of the day we decided that we didnt want her suffering, so we ended up inducing the pregnancy early."

Villegas, who contributes to the TODAY Parenting Team, recalls feeling blindsided when she had to sign paperwork for a "medical abortion" prior to her induction.

"I lost it because it wasnt an abortion in my head," said Villegas. "This was a child that we wanted. We were making one of the hardest decisions you can make as a parent, which was to spare her pain."

In the face of fetal abnormalities that will cause death or severe suffering, it's not uncommon for a expectant mother to choose a termination for medical reasons (TFMR). Though it's not an official medical term, online loss support groups and parents who have been through it coined the term to describe their unique experience. The American College of Obstetricians and Gynecologists has released an official statement explaining that in some cases, abortion is a medical necessity.

Still, parents who choose TFMR often feel weighed down by feelings of guilt or secrecy, unsure how to grieve the loss and caught between identifying with having had a miscarriage or an abortion. Some don't tell friends and family for fear of judgment. Some feel unwelcome in pregnancy loss support groups.

On August 8, 2017, Villegas gave birth to her daughter, April Rey Villegas, who lived for 11 minutes before passing away in her mom's arms.

"She held my hand pretty much the entire time," the Germantown, Maryland, mom recalled. "Everybody in the family that wanted to come meet April got to do so and have a few special moments with her."

Villegas, who blogs about her loss at Terminations Remembered, says making the decision to end a pregnancy for medical reasons was isolating.

"When you think about coping with grief, one of the things people need to do is be able to process and talk, especially to the people they love and care about," said Villegas. "But often in this situation, parents dont tell the whole story and they dont talk about it openly even to people in their close circle because of the fear of judgment."

Wilmaris Soto-Ramos was 16 weeks into her first pregnancy when she received devastating news at an ultrasound appointment.

"Doctors came into the room and told me the extremities of our baby were really abnormal," Soto-Ramos told TODAY Parents. "Her feet were clubbed, her arms werent moving and she also had fluid in her brain."

Soto-Ramos and her partner were referred to a genetic counselor, who performed an amniocentesis, a procedure used to test for genetic abnormalities.

"In that amniocentesis they kind of found the same results," Soto-Ramos, who lives in Pawtucket, Rhode Island, shared. "The doctor looked at me and said, 'Most parents would terminate a pregnancy like this and you should, too,' which was really heartbreaking."

As she considered how to proceed with her own pregnancy, Soto-Ramos went on a quest for answers.

For the next five weeks Soto-Ramos visited specialists for more tests, until finally learning her daughter had a severe case of arthrogryposis, a rare genetic condition that affects the joints and muscles.

"Because it also affected her brain, she really wasnt viable," explained Soto-Ramos. "If she was to live, she would be wheelchair bound. She wouldnt be able to speak, talk, hear or eat. They also told me if I continued the pregnancy she would probably pass away regardless because of the fluid in her brain."

Soto-Ramos made the decision to end her pregnancy, allowing doctors to induce labor at 22 weeks gestation. On May 9, 2019, her daughter, Angelis Yawa Larbi, was delivered.

"She passed away in the birth canal as she was coming out," Soto-Ramos recalled. "Its something I really struggled with because I'm somebody who is pro-choice and, for me, this was a very-much-wanted pregnancy."

Dr. Christine Greves, an OB-GYN in Orlando, Florida, says it's the job of doctors to support, not judge, women who are faced with this devastating scenario.

"If a patient of mine was to come and talk to me about it, I would tell her there are different options and encourage her to find out more information," said Greves, who does not perform TFMR and typically refers patients to a maternal-fetal medicine specialist when abnormalities are detected in a pregnancy. "More knowledge can be helpful from the standpoint of providing peace with whatever decision they choose."

She said a doctor may suggest termination for medical reasons to a pregnant woman for two reasons: when a fetus is considered not viable due to a medical condition detected in utero or when a mother's life is at risk if she continues a pregnancy.

"When people get this sad news, their doctor tells them the possible outcome of carrying the pregnancy to term," explained Greves. "They explain what could happen either fully delivering the baby and then having the baby pass away, or as far as the maternal indication goes, making sure the patient is aware they could die if they go through with the pregnancy."

At the time of her daughter April's birth, Villegas' older daughter, Caroline, was two. Caroline asked to meet her baby sister after she was born, and has continued asking difficult questions about grief and loss in the years since her death. It's these conversations, combined with a desire to tell her 1-year-old son, William, about the sister that died before his birth, that led Villegas to write five children's books dealing with TFMR.

With titles like "Our Baby is Going to Die," and "The Baby Before You Died," the books explain both surgical termination and induction, and tackle difficult topics like expressing grief and remembering the baby who was lost.

Soto-Ramos says she's experienced isolation, even feeling excluded from some infant loss support groups because she chose to terminate her pregnancy. A licensed clinical social worker, Soto-Ramos is in the process of becoming a bereavement doula and hopes to help women cope with their grief and get the answers they need about their options.

"I found, especially for me being a woman of color, it was really difficult to get answers within the medical system and I had to go look for them, which was traumatizing on its own," said Soto-Ramos. "But Im glad I did because had I listened to the first doctor who told me to terminate my pregnancy without knowing what was going on, I would have always wondered, 'What if?'"

"I love my daughter so much and so deeply and know my decision was out of love, not out of fear about something a doctor told me," Soto-Ramos added. "It was because I loved her and knew what was going on."

Soto-Ramos kept trying to have a child, and she was pregnant when she talked to TODAY Parents for this story. On October 4, she gave birth to a healthy baby girl.

More on pregnancy loss:

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Termination for medical reasons: Moms share TFMR stories - TODAY

Children with chronic kidney disease spent about 30% longer in the hospital (an average of 2.8 days compared to 1.8 days for those without a chronic kidney disease) with nearly 60% more in hospital expenses ($8,755 per hospitalization compared to $5,016.)

Children with chronic kidney disease were also 50% more likely to die during hospitalization.

Data on in-hospital mortality for children with chronic illnesses is lacking, but we know that hospitalizations with a chronic kidney disease diagnosis have a higher mortality than those with other chronic condition diagnoses with the exception of heart failure, Modi says.

The fact that these children are potentially at higher risk of death while hospitalized should prompt providers to closely evaluate management strategies.

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That may mean bringing nephrologists in earlier if they are not already involved in patients care, making sure to avoid medications that could make kidney function worse as well as other steps that will improve care for these patients, Modi notes.

The high health care expenses for hospitalized pediatric patients with end-stage kidney disease, including dialysis, transplantation, and associated complications may be comparable to hospitalized heart failure patients, authors say.

Kidney disease may be associated with more medical complexities, authors say. The causes of chronic kidney disease in children include genetic disorders, congenital anomalies that may be part of a multi-organ system syndrome and systemic inflammatory disorders. A recent study from the UK reported that adult kidney disease patients also have a greater degree of medical complexity than patients seen by any other specialty.

Chronic kidney disease can be a devastating illness with many long-term consequences, Modi says. Some features of chronic kidney disease that start during childhood will have a significant impact on patients lives through adulthood.

We need further studies to better understand the health care needs and delivery of care to hospitalized children with chronic kidney disease in order to optimize health outcomes."

Excerpt from:
Children with Chronic Kidney Disease Have Outsized Health Burden - Michigan Medicine

For a honey bee, few things are more important than recognizing your nestmates. Being able to tell a nestmate from an invader could mean the difference between a honey-stocked hive and a long, lean winter.

New research from Washington University in St. Louis shows that honey bees rely on chemical cues related to their shared gut microbial communities, instead of genetic relatedness, to identify members of their colony.

Most people only pay attention to the genetics of the actual bee, said Yehuda Ben-Shahar, professor of biology in Arts & Sciences and corresponding author of the study published Oct. 14 in Science Advances. What we show is that it is genetic, but its the genetics of the bacteria.

Honey bees recognize and respond to chemical signals from other bees that they detect from skin compounds known as cuticular hydrocarbons, or CHCs. This study determined that a bees particular CHC profile is dependent on its microbiome the bacteria that make up its gut microbial community and is not something innate or genetic to the bee alone.

Different colonies do in fact have colony-specific microbiomes, which has never been shown before, said Cassondra L. Vernier, postdoctoral associate at the University of Illinois, who earned her biology PhD working with Ben-Shahar at Washington University.

Bees are constantly sharing food with one another and exchanging this microbiome just within their colony, said Vernier, first author of the new study.

Co-authors include Gautam Dantas, professor of pathology and immunology and of molecular microbiology at Washington University School of Medicine in St. Louis, and Joel Levine at the University of Toronto Mississauga. The work was conducted in part with bees housed at Tyson Research Center, the environmental field station for Washington University.

The importance of this paper is that its one of the first papers that actually shows that the microbiome is involved in the basic social biology of honey bees and not just affecting their health, Vernier said. The microbiome is involved in how the colony as a whole functions, and how they are able to maintain nest defenses, rather than just immune defense within an individual.

The gut microbial community or microbiome supplies humans and other animals with vitamins, helps digest food, regulates inflammation and keeps disease-causing microbes in check. Increasingly a topic of research interest, scientists have discovered many ways that the microbiome blurs the borders between a host and its bacteria.

The microbiome has been found to influence communication in several different organisms including, notably, large animals like hyenas.

For honey bees, this study shows that the microbiome plays a critical role in defining the tightly regulated chemical signals for group membership.

Until recently, most scientists thought that honey bees identified nestmates by picking up on a homogenized scent that they recognize from members of their own colony a kind of hive B.O., Ben-Shahar joked.

Bee colonies are usually composed of highly related individuals. But the chemical signals that allow bees to recognize each other are not determined by genetics alone. Researchers know this because baby bees can be placed into other colonies without being rejected up until a certain age and level of development.

It has to be something that they acquire during their lifetime that defines their nestmate recognition cues, Vernier said.

In previous work, Vernier and Ben-Shahar showed that bees develop different scent profiles as they age, and that gatekeeper bees respond differently to foragers returning to the hive compared with younger bees that have never ventured outside.

That research established a relationship between nestmate recognition and the clearly defined, age-dependent division of labor typical to honey bee hives.

Only when a bee is old enough to interact with others outside of the hive does it become recognizable to others. That was a clue for the researchers.

If you grow a honey bee in isolation, it will never develop a complete microbiome, Vernier said. It actually has to acquire most of it from interactions with other bees.

For this study, researchers determined that forager bees from different honey bee colonies have different gut microbial communities and CHC profiles by sequencing gut samples and analyzing cuticular extracts. The scientists also conducted cross-hive fostering experiments, raising groups of newly hatched bees in either their own colonies or unrelated colonies.

In the fostering experiments, the researchers found that both source- and host-colony related factors contribute to variations in the overall gut microbial community of individual bees. Of the 14 microbial taxa that significantly differed between treatments, six were similar between bees that shared the same hive environment while they grew up regardless of actual genetic relatedness.

The researchers also found that they could manipulate the microbiome of sister bees by feeding different microbes to newly hatched bees. In addition to developing different gut microbial communities, the bees also grew to have different CHC profiles.

They were unrecognizable to their siblings, Vernier said. Manipulating the microbiome was enough to cause sister bees to develop different scent profiles.

This new work is significant in part because it shows an integral role for the microbiome in the essential, everyday social interactions of honey bees, the Earths most important pollinators, researchers said.

For bees, some of the most complex aspects of their social behavior basically depends on bacteria more than anything else! Ben-Shahar said.

It doesnt matter how related they are, he said. Their ability to say you belong to this group basically depends on getting the right bacteria at the right time. Otherwise, they are blind to it.

And bee ID is key.

The biggest enemy to honey bees is other bees.

During fall, when plants stop producing nectar, there is a period of time when robbing is very prevalent in colonies, Vernier said. Robbing bees will find other colonies, and if theyre able to get in and take some honey, they will go back to their own nests and signal, Hey, go over there. Theres a nest thats not good at guarding, and we can steal their honey.

Robber bees will take that honey and leave the other colony to starve, she said. Its a very strong pressure.

Robbing deprives both the host bees and their associated bacteria with important resources which may have been the original drive to form this special bacteria-animal partnership, the researchers said.

Ben-Shahar and Verniers previous research with honey bees showed that graduating to forager status was a requirement for social membership. Read more.

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'Honey bee, it's me' | The Source - Washington University in St. Louis Newsroom

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Tools developed to probe the virome could aid in variety of research

Researchers at Washington University School of Medicine in St. Louis have received an $8.5 million grant to study the role of gut viruses in inflammatory bowel disease. Tools developed in the course of the project could accelerate research into other roles of the virome in health and disease.

The communities of bacteria that live in our digestive tracts help digest food and produce vitamins, protect against pathogens, and promote the healthy functioning of our immune system. But alongside gut bacteria thrives a vast community of viruses, and we know little about their impact on health and disease.

Efforts to study the gut viral community known as the virome have been hindered by a lack of tools to analyze viral diversity. Researchers at Washington University School of Medicine in St. Louis have received an $8.5 million grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH) to develop the tools needed to study the role of the virome in inflammatory bowel disease. Once developed, such tools could be applied widely, opening up new avenues of research into the role of the virome in normal physiology and development, as well as diseases such as diabetes, AIDS and cancer.

The virome has been linked to a number of conditions inflammatory bowel disease, malnutrition, graft-versus-host disease and there is also some evidence that the virome supports human health in some ways, said principal investigator David Wang, PhD, a professor of molecular microbiology, and of pathology and immunology. But the problem that plagues virome studies is that people find an association, and then they cant pursue it. Once you find an association, the next step is to see what happens when you introduce the virus to an animal. Does it cause the disease? Make it worse? But there are no tools to carry this out.

Tools to analyze the viral community are relatively scarce partly because viruses are more diverse than bacteria. All bacteria carry certain basic housekeeping genes necessary for life, notably the 16S ribosomal RNA gene. Scientists use this universal gene to screen mixed communities of unidentified bacteria by pulling out all the 16S ribosomal RNA genes and using the sequences to classify the bacteria into families. There is no equivalent universal gene among viruses.

Wang and colleagues previously have discovered differences between the viromes of people with inflammatory bowel disease and healthy people. Inflammatory bowel disease is caused by chronic inflammation in the digestive tract and characterized by persistent diarrhea and abdominal pain. The researchers found that people with the condition carry more Caudovirales, a group of viruses that infects bacteria, and anelloviruses, a family of viruses that infects human cells, in their intestines. But they do not yet know what, if anything, the presence of these viruses means.

The new grant will allow the researchers to follow a group of people with inflammatory bowel disease over time, along with healthy members of their households for comparison. Inflammatory bowel disease tends to be cyclical, flaring up and then resolving again and again. By taking repeated stool samples and analyzing the genetic material of the viruses in such samples, the researchers will be able to see how the makeup of the gut viral community changes over the course of the disease, and gauge whether any particular groups of viruses become more abundant during flare-ups or resolutions. They also will assess what effect treatment has on the virome.

Such analysis will require the development of computational tools to identify the viruses by their genetic sequences, classify them into family groups, identify potential genes within viral sequences, and propose functions of the genes.

With the tools we have now, more than half the sequences cant be classified because they are not similar enough to known sequences, Wang said. We frequently cant even tell whether weve found a virus that infects bacteria or human cells.

Wang and colleagues also will develop ways to cultivate viruses so they can study them. As nonliving things, viruses require a living cell to multiply, which makes cultivation in the lab tricky. To grow viruses that infect human cells, researchers must first culture human cells and then infect them with viruses. But the majority of the viruses in the intestinal tract are likely to infect bacteria, not human cells. Such viruses known as bacteriophages, Latin for bacteria eaters are even more complicated: Researchers must first identify the correct bacterial species from among the thousands in our intestines, culture that species, and then attempt to grow the virus within the bacterial culture.

In previous work, we established the first culture system for a gut virus, Wang said. Were relying on our experience there to try to culture more of these novel viruses. Some of these might actually grow in a quite straightforward way, its just that no one has tried yet. And once we have the viruses, then we can use them to start doing experiments in animal models of inflammatory bowel disease.

The impact of the gut bacterial community on human health is a hot topic of study, with a possible role in health conditions ranging from autoimmunity to heart disease to psychiatric illnesses. The virome may prove to be equally consequential if only we can find a way to investigate it.

This isnt a typical grant, because part of its goal is to build resources that will then be available to the scientific community, Wang said. Creating tools is unsexy and usually unfundable. But we have to build these tools before we can answer the exciting questions.

Along with Wang, the research team includes Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine, and Scott Handley, PhD, an associate professor of pathology and immunology, both at Washington University; Thaddeus Stappenbeck, MD, PhD, of the Cleveland Clinic; and collaborators at Cambridge University in the United Kingdom, San Diego State University in California, and Flinders University in Australia.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

See more here:
Role of gut viruses in inflammatory bowel disease is focus of $8.5 million grant - Washington University School of Medicine in St. Louis

Aro Biotherapeutics today announced the appointments of Christopher K. Mirabelli, Ph.D., to its Board of Directors and Masad J. Damha, Ph.D., to its Scientific Advisory Board. Drs. Mirabelli and Damha will provide strategic and scientific counsel on the development of novel Centyrin-RNA therapeutic candidates.

"We are excited to welcome Chris, a well-recognized leader in drug development, to our Board of Directors. As the founder of multiple successful biotechnology companies, and an industry veteran with demonstrated experience in the development of new therapies, his insight and guidance will be invaluable as we advance the development of our pipeline of Centyrin-based therapeutic candidates," said Susan Dillon, Ph.D., Co-Founder and Chief Executive Officer of Aro.

Dr. Mirabelli has spent over 35 years in the pharmaceutical and biotechnology industries as a research scientist, senior executive, and venture capital investor. Currently, he is a managing director of the venture capital firm HealthCare Ventures. Dr. Mirabelli is currently Chairman of the Board of Directors of Leap Therapeutics, where he was the Chief Executive Officer from its founding in 2015 until 2020. Previously, Dr. Mirabelli was Chief Executive Officer and Chairman of the Board of Directors of LeukoSite from its founding in 1993 until its acquisition by Millennium Pharmaceuticals in 1999. Dr. Mirabelli was also a Co-Founder of Ionis Pharmaceuticals. He began his industry career in R&D at SmithKline & French Laboratories, and earned his Ph.D. in Molecular Pharmacology from Baylor College of Medicine and his B.S. in Biology from State University of New York (SUNY) at Fredonia.

"I am looking forward to serving on Aros Board of Directors and working with Sue and her team to further advance their proprietary drug-targeting technology," commented Dr. Mirabelli. "The use of antibodies to target drugs to sites of disease in patients has many limitations. Aros novel approach to overcoming these barriers is unique, and Im excited to contribute to the continued development of their pipeline of next-generation biotherapeutic candidates."

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"We are pleased to have Masad join Aros Scientific Advisory Board. His work in nucleic acid drug discovery and development has been at the forefront of oligonucleotide research, and his scientific insights will be instrumental as we continue to leverage the promise of Centyrins to achieve new therapeutic mechanisms of action," said Karyn ONeil, Ph.D., Co-Founder and Chief Scientific Officer of Aro.

Dr. Damha is a Distinguished James McGill Professor of Chemistry at McGill University. His research group focuses on synthesis and structural analyses of chemically modified oligonucleotides directed toward biomedical and diagnostic applications. His 200+ publications and dozens of issued patents have been widely cited and used in both fundamental sciences and oligonucleotide-based therapeutic applications. Dr. Damha is the recipient of several awards from the Canadian Society for Chemistry, the Queen Elizabeth II Diamond Jubilee Medal (Governor General of Canada), and McGills Fessenden Professorship in Science Innovation. He is currently President of the International Society of Nucleosides, Nucleotides, Nucleic Acids, and he has served as President of the Oligonucleotide Therapeutics Society. Dr. Damha was awarded a Ph.D. in Organic Chemistry and B.Sc. in Chemistry from McGill University.

Dr. Damha commented, "I am very pleased to join Aro Biotherapeutics Scientific Advisory Board and contribute to the development of innovative therapies that enable efficient and specific delivery of nucleic acid conjugates that address important disease targets."

About Aro Biotherapeutics

Aro is a biotechnology company focused on the research and development of a new generation of protein biologics called Centyrins. The company is developing a wholly-owned pipeline of Centyrins and is working with leaders in the industry on leveraging Centyrins for tissue-specific targeting of therapeutics, including nucleic acid drugs for a diverse set of diseases. For more information, visit http://www.arobiotx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201013005040/en/

Contacts

Mike BeyerSam Brown Inc.mikebeyer@sambrown.com 312-961-2502

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Aro Biotherapeutics Appoints Biotechnology Executive Dr. Christopher Mirabelli to its Board of Directors and Nucleic Acid Therapeutics Expert Dr....

Pharmaceutical & Biotechnology Environmental Monitoring Market Analysis, Growth by Top Companies, Trends by Types and Application, Forecast to 2026Published: 11 hours ago Author: Ashwin NaphadeCategory: #news

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Pharmaceutical & Biotechnology Environmental Monitoring Market Analysis, Growth by Top Companies, Trends by Types and Application, Forecast to...

The 63 rating InvestorsObserver gives to Kiniksa Pharmaceuticals Ltd (KNSA) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 75 percent of stocks in the Biotechnology industry, KNSAs 63 overall rating means the stock scores better than 63 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 63 would rank higher than 63 percent of all stocks.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Kiniksa Pharmaceuticals Ltd (KNSA) stock is trading at $21.13 as of 3:25 PM on Monday, Oct 12, an increase of $0.17, or 0.84% from the previous closing price of $20.95. Volume today is 531,806 compared to average volume of 460,930. The stock has traded between $20.21 and $21.24 so far today.

Click Here to get the full Stock Score Report on Kiniksa Pharmaceuticals Ltd (KNSA) Stock.

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Is Kiniksa Pharmaceuticals Ltd (KNSA) the Top Pick in the Biotechnology Industry? - InvestorsObserver

Turning Point Therapeutics Inc (TPTX) is near the top in its industry group according to InvestorsObserver. TPTX gets an overall rating of 64. That means it scores higher than 64 percent of stocks. Turning Point Therapeutics Inc gets a 78 rank in the Biotechnology industry. Biotechnology is number 27 out of 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 64 would rank higher than 64 percent of all stocks.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

Turning Point Therapeutics Inc (TPTX) stock is trading at $121.08 as of 11:51 AM on Monday, Oct 12, a gain of $9.27, or 8.29% from the previous closing price of $111.81. The stock has traded between $113.22 and $121.91 so far today. Volume today is 388,776 compared to average volume of 403,050.

Click Here to get the full Stock Score Report on Turning Point Therapeutics Inc (TPTX) Stock.

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Is Turning Point Therapeutics Inc (TPTX) the Top Pick in the Biotechnology Industry? - InvestorsObserver

A rating of 24 puts CEL-SCI Corporation (CVM) near the bottom of the Biotechnology industry according to InvestorsObserver. CEL-SCI Corporation's score of 24 means it scores higher than 24% of stocks in the industry. CEL-SCI Corporation also received an overall rating of 36, putting it above 36% of all stocks. Biotechnology is ranked 27 out of the 148 industries.

Analyzing stocks can be hard. There are tons of numbers and ratios, and it can be hard to remember what they all mean and what counts as good for a given value. InvestorsObserver ranks stocks on eight different metrics. We percentile rank most of our scores to make it easy for investors to understand. A score of 36 means the stock is more attractive than 36 percent of stocks.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

CEL-SCI Corporation (CVM) stock is trading at $14.94 as of 3:23 PM on Monday, Oct 12, a rise of $0.07, or 0.47% from the previous closing price of $14.87. Volume today is less active than usual. So far 366,839 shares have traded compared to average volume of 545,816 shares. The stock has traded between $14.20 and $15.23 so far today.

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Is CEL-SCI Corporation (CVM) The Right Choice in Biotechnology? - InvestorsObserver

The research report on the global Pharmaceutical and Biotechnology Machines Market outlines Pharmaceutical and Biotechnology Machines market size, value chain structure, regional assessment, industrial environment, and forecast between 2020 to 2026. The rapidly averting industry scenario and current as well as future evaluation of the world Pharmaceutical and Biotechnology Machines market also reported in this study. The report on the global Pharmaceutical and Biotechnology Machines market has been characterized into topological regions, product types, application and prime vendors. Moreover, it delivers different investment opportunities and possible threats based on the intelligent analysis.

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Crucial players involved in this report:

Air LiquideLinde HealthcarePraxairAir ProductsTaiyo Nippon SansoMatheson GasAtlas Copco ABMesser GroupSOL GroupNorcoSicgil India LimitedShenzhen GaofaShenwei MedicalBeijing OrientNanning Lantian

Pharmaceutical and Biotechnology Machines Market fragmentation by product types:

OxygenNitrous OxideMedical AirOthers(Nitrogen, Carbon Dioxide and Helium)

Application covered in this report are:

Hospitals (Labs & Clinics)Home HealthcareUniversities/Research InstitutionsPharmaceutical & Biotechnology Industries

The report on the global Pharmaceutical and Biotechnology Machines market has been fabricated by identifying performance of the respective industry alongside its substantial parameters. The information furnished in the Pharmaceutical and Biotechnology Machines market report is easy to understand so that readers can get detailed statistics about each and every facet in elaborated manner. Different elements including drivers, risks, restraints and opportunities for the Pharmaceutical and Biotechnology Machines market are also explained in brief.

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The world Pharmaceutical and Biotechnology Machines market report 2020-2026 is helpful guide for clients along with a large set of customized and systematic data regarding some industrial tactics as it calls for industry-oriented outcomes to offer feasibility studies for clients needs. The global Pharmaceutical and Biotechnology Machines market report has been crafted through qualified and verifiable factors of the Pharmaceutical and Biotechnology Machines market data functioning in the real-time scenarios.

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Study On Pharmaceutical and Biotechnology Machines Market (impact of COVID-19) 2020-2026: Air Liquide, Linde Healthcare, Praxair, Air Products -...

SAN FRANCISCO, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Nitrome Biosciences (Nitrome), a privately-held biopharmaceutical company developing a platform around its newly discovered class of enzymes to target Parkinsons disease and many other age-related and inflammation disorders, today announced that it has appointed Perry Karsen, a seasoned leader with 35 years of life sciences experience, as executive chairman of its board of directors.

Perry is a highly respected industry executive with significant expertise in leading and growing successful biopharmaceutical companies, said Irene Griswold-Prenner, Ph.D., founder, chief executive officer and chief scientific officer of Nitrome. Perrys strategic counsel and business acumen will be invaluable to Nitrome as we build out a wholly-owned first-in-class enzyme therapeutics platform based on our novel scientific discoveries.

Perry Karsen was the chief executive officer of Celgene Cellular Therapeutics, a division of Celgene Corporation, from 2013 until his retirement in 2015. Previously, Perry held the position of executive vice president and chief operations officer at Celgene, serving in various management positions, including as senior vice president and head of worldwide business development and president of the Asia/Pacific region. Perry was the president and chief executive officer of Pearl Therapeutics, a biotechnology company subsequently acquired by Astra-Zeneca. In addition, Perry held executive positions at Human Genome Sciences, Bristol-Myers Squibb, Genentech and Abbott Laboratories earlier in his career. He also was a general partner at Pequot Ventures focusing on investments in biotechnology and medical devices. Perry has a Bachelor of Science in biological sciences from the University of Illinois, Urbana, a Master of Arts in teaching biology from Duke University, and an MBA from the Kellogg School of Management at Northwestern University. Perry serves on the board of directors and as chair of several private and public biotechnology companies, and on the board of The Gladstone Foundation. He is also a former member of the board of directors and the executive committee of the Biotechnology Innovation Organization (BIO).

Perry Karsen added, I am very excited to be a part of the Nitrome team and look forward to helping the company realize the vast potential for patients of its enzyme therapeutics platform. Irenes breakthrough discovery could be the key to unraveling degeneration evidenced in many age and inflammation related conditions. The potential for Nitrome to advance science and medicine while impacting patients is profound.

About Nitrome BiosciencesNitrome Biosciences is a platform company developing drugs against a newly identified class of enzymes which play a harmful role in a variety of age and inflammation dependent diseases. The therapies that Nitrome is developing will target these enzymes and potentially help slow or halt the progression of diseases including Parkinsons, Nitromes lead indication. The company also aims to expand its proprietary platform to include other diseases, such as other neurodegenerative diseases, macular degeneration, heart disease and cancer. Nitrome has been widely recognized and has won multiple awards including the prestigious Target Advancement grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF). For more information, please visit the companys website at http://www.nitromebiosciences.com.

Investor Relations Contact:Alexandra SantosWheelhouse Life Science Advisorsasantos@wheelhouselsa.com

Media Contact:Aljanae Reynolds Wheelhouse Life Science Advisorsareynolds@wheelhouselsa.com

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Nitrome Biosciences Appoints Industry Veteran Perry Karsen as Executive Chairman of the Board of Directors - GlobeNewswire

A rating of 85 puts SpringWorks Therapeutics Inc (SWTX) near the top of the Biotechnology industry according to InvestorsObserver. SpringWorks Therapeutics Inc's score of 85 means it scores higher than 85% of stocks in the industry. SpringWorks Therapeutics Inc also received an overall rating of 69, putting it above 69% of all stocks. Biotechnology is ranked 23 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

SpringWorks Therapeutics Inc (SWTX) stock is trading at $55.01 as of 11:44 AM on Friday, Oct 9, an increase of $3.03, or 5.83% from the previous closing price of $51.98. The stock has traded between $52.79 and $56.45 so far today. Volume today is 339,767 compared to average volume of 364,745.

Click Here to get the full Stock Score Report on SpringWorks Therapeutics Inc (SWTX) Stock.

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Where Does SpringWorks Therapeutics Inc (SWTX) Stock Fall in the Biotechnology Field? - InvestorsObserver

Unity Biotechnology Inc (UBX) is around the bottom of the Biotechnology industry according to InvestorsObserver. UBX received an overall rating of 35, which means that it scores higher than 35 percent of all stocks. Unity Biotechnology Inc also achieved a score of 23 in the Biotechnology industry, putting it above 23 percent of Biotechnology stocks. Biotechnology is ranked 27 out of the 148 industries.

Analyzing stocks can be hard. There are tons of numbers and ratios, and it can be hard to remember what they all mean and what counts as good for a given value. InvestorsObserver ranks stocks on eight different metrics. We percentile rank most of our scores to make it easy for investors to understand. A score of 35 means the stock is more attractive than 35 percent of stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Unity Biotechnology Inc (UBX) stock is trading at $3.95 as of 1:21 PM on Monday, Oct 12, a rise of $0.17, or 4.6% from the previous closing price of $3.78. The stock has traded between $3.81 and $4.15 so far today. Volume today is 893,480 compared to average volume of 976,910.

Click Here to get the full Stock Score Report on Unity Biotechnology Inc (UBX) Stock.

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Does Unity Biotechnology Inc (UBX) Have What it Takes to be in Your Portfolio? - InvestorsObserver

Exploring Essential Issues for Improving Therapeutic Cancer Vaccine Trial Design

MIRAMAR, Fla., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is happy to announce that a review article on therapeutic cancer vaccines has been published in the peer-reviewed journal Cancers. The paper highlights the importance of proper clinical design in terms of selected groups of patients, taking into consideration (a) changes in initially established standard-of-care treatments; (b) the appropriate follow-up period necessary to achieve meaningful results; (c) statistical considerations for the delay of treatment effects (i.e., time for development of an effective immune response), thus excluding irrelevant early events; and (d) appropriate biomarkers that could guide vaccinations with clinical benefits to patients.

The authors of the paper* have extensive experience with AE37 immunotherapeutic vaccine as principal investigators in the companys breast and prostate cancer trials. The paper clearly describes why the Phase IIb clinical trial of AE37 in breast cancer demonstrated a statistically significant clinical benefit for certain subgroups of patients in the trial (advanced stage disease with low HER2 or triple negative breast cancer) while failing to meet the primary endpoint in the entire intent-to-treat (ITT) study population. The introduction of Herceptin (trastuzumab) as the standard of care during the long-term follow-up of the trial skewed the results such that the benefit of AE37 could not be detected in the statistical analysis. However, when looking at patients in subgroups that did not receive Herceptin, the positive benefits of AE37 on survival become apparent. Patient selection and protocol design that accounts for changes in standard of care are the key to future study designs.

The authors note that the survival benefit with AE37 and other cancer vaccines also require prolonged follow-up because the immune system takes time to activate against the tumor. Therefore, the survival curves only start to diverge after 12 months from treatment initiation. Future trials need to use statistical methods that account for the delayed immune response to exclude early events in order to accurately evaluate the efficacy of immunotherapeutic vaccines.

Further, responders to immunotherapy may be determined using biomarker evaluation, which for AE37 is gamma-interferon, a cytokine secreted by T-cells activated by the Ii-Key vaccine. Those patients who responded to AE37 with strong site reactions and gamma interferon induction demonstrated the most clinical benefit in survival. The use of biomarkers to evaluate cancer vaccine efficacy can significantly improve protocol design and shorten the time from Phase II to Phase III.

This peer-reviewed paper provides further validation of our Ii-Key immunotherapeutic cancer vaccines, said Generex President & CEO Joe Moscato. The recently published results of the AE37 Phase IIb breast cancer trial in over 300 women showed a statistically significant benefit to patients with advanced disease and low HER2 expression, and six of seven AE37 patients with triple negative breast cancer and advanced disease are still alive even after 10 years. As I have said for many years, the introduction of Herceptin as standard of care during the 7-year trial masked the benefit of AE37 in this subgroup, but for those patients who are not eligible for Herceptin therapy, AE37 offers new hope.

Mr. Moscato continued, The paper also validates our future plans for AE37 clinical development, as we plan to initiate a trial in bladder cancer at a preeminent cancer center to evaluate the tumor microenvironment and biomarkers associated with immune system activation by Ii-Key cancer vaccines. As per the authors, and with the help of our scientific and clinical advisory board, we will conduct well-designed clinical trials to support the full potential of AE37 and our other Ii-Key vaccines for cancer and infectious diseases to activate the immune system, and to turn it effectively against a patients tumor.

* The authors Drs. Constantin N. Baxevanis, Sotirios P. Fortis, Alexandros Ardavanis, and Sonia A. Perez of the St. Savas Cancer Hospital in Athens, Greece have previously been investigators for AE37 clinical trials. The company and the authors have no current affiliation.

About NuGenerex Immuno-Oncology

NuGenerex Immuno-Oncology, a public subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate, independent public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Mercks Keytruda) for the treatment of triple negative breast cancer.

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:Generex Biotechnology Corporation

Joseph Moscato646-599-6222

Todd Falls1-800-391-6755 Extension 222investor@generex.com

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Generex Subsidiary NuGenerex Immuno-Oncology Announces Publication of a Review Article on Cancer Vaccines Highlighting AE37 (Ii-Key-HER2)...

October is Blindness Awareness Month, a day set aside to shed light on the importance of vision care and educational outreach. One local organization works year-round to bring awareness, but also to help people around the globe to have healthy vision.

On Saturday, CharityVision, which is based in Provo, celebrated Blindness Awareness Month by holding World Sight Day Art at the The Shops at Riverwoods. The event was open to all community members who wanted to come celebrate sight and the blessings it brings.

Artists were on hand so visitors could watch them create their works. Easels, art supplies and coloring pages were available and people were encouraged to bring their own art projects. The prompt of the day was, Because I see

Our goal is to help people be aware of their vision and the beauty they can see, said Anadine Marshall, CharityVision program director. We want to bring awareness that, all over the world, people struggle with vision.

According to http://www.charityvision.org, Dr. William Jackson, founder, was serving a mission for his church in the Philippines in 1987. While there, he realized that the optimal healthcare solution was not to be found in foreign doctors making medical mission trips. Rather, the solution was with local healthcare professionals.

He organized teams of local professionals who were willing and able to help the vulnerable of their own country who were living with cleft lip, cleft palate, cataracts and club foot. Then called the Deseret International Foundation, it was the beginning of CharityVision.

In the early 2000s, the organization, which is funded largely through donations and some business partnerships, began focusing on eye care.

In just over 30 years, CharityVision has expanded to 26 countries and hundreds of partnerships with local hospitals, doctors and clinics around the globe, it reads on the website.

Doug Jackson, Dr. Jacksons son, now oversees the organization. According to him, CharityVision provided 146,000 surgeries around the world last year alone. Doug Jackson said that the organization helps to provide help to people with all types of vision-related problems. Cataracts are the most commonly treated condition, he said.

When we think of cataracts, we often think of someones vision getting somewhat blurry, but for most of the people that CharityVision helps in other countries, the cataracts have caused complete blindness.

With surgery, they go from blind to sight, Doug Jackson said.

Many of the people we help have nowhere to turn. They cant work, cant go to school, Doug Jackson said. We say, Youre not forgotten.

The organization sends equipment and supplies and at times, sends expeditions to countries. But mostly, support is given to the local doctors and programs in various locations so local people in need are able to get help.

In addition to the international support that CharityVison gives, the organization helps people locally as well. Through the Sight Buddies program, children in Utah County schools are screened. Based on the initial screenings, those who need further screening are able to do that with an eye doctor and can even receive free eyeglasses through the program.

There are 2.2 billion people in the world who dont have access to eyecare who need it, Doug Jackson said. Many have nowhere to turn, they cant work, they cant go to school. We say, Youre not forgotten. When you give somebody their sight back, you give them the world.

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Provo-based organization CharityVision sees way to fight blindness - Daily Herald

By Express News Service

BENGALURU: The economic burden from vision impairment in India for 2020 amounts to Rs 88,900 crore, and 35% of causes of blindness are preventable and early detection can greatly reduce the economic impact, according to the Status of Child Eye Health in India report published by NGO Orbis which works to prevent and treat vision impairment.

The report, released on World Sight Day, also found that between 2019-20, the loss to gross national income due to blindness in adults would be Rs 9,06,200 crore and Rs 3,31,100 crore for children, for 10 and 40 lost working years, respectively. This includes the loss of economically productive years for both the visually impaired and their care-givers.Many of the conditions that affect children are detectable and treatable, said Dr Rishi Raj Borah, country director at Orbis India. The report brings to light 8-10 conditions in children, which, if diagnosed early, can prevent childhood blindness. These include childhood cataract and glaucoma, he said.

Other factors that affect treatment include availability of doctors. Urban areas have one ophthalmologist for 10,000 people but in rural areas it is one for every 2,50,000. Some children have eye problems at birth, while others develop them by the age of 10. Half of them are detectable and treatable, Dr Borah said.

The shortage of paediatric ophthamologists and paediatric optometrists in India apart, the lack of attention to ophthalmological conditions in primary healthcare also has serious implications for early diagnosis. General physicians and nurses at PHCs may not have the knowledge or time to examine a childs eyes. There is a lack of specialists and sufficient staff at PHCs, and in villages. Anganwadi and ASHA workers also arent trained to detect eye problems, said Dr Parikshit Gogate, paediatric ophthalmologist.

The lack of awareness that blindness can be detected early and even treated combined with stigma associated with it also acts as a preventive factor in seeking help. There is a mindset among parents that younger children do not need spectacles and that only older people suffer from blindness, Dr. Gogate added.Another reason is the lack of public health infrastructure such as specialised equipment, screening mechanism and charts to detect and treat cases. There is also a lack of coordination between gynaecologists, paediatricians and ophthalmologists, the report said.

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Blindness to cost India Rs 88k crore in 2020: Report - The New Indian Express

BERKELEY, Calif., Oct. 6, 2020 /PRNewswire/ -- Seva Foundation is proud to announce the winners of its 2020 Call For Ideas to identify innovative technology-based solutions to improve eye care delivery. The Berkeley-based vision care humanitarian organization has committed up to $250k to spark innovation in technology to transform lives by restoring sight.

This year's winners are as follows:

Globally, at least 2.2 billion people have a vision impairment, and of these, 1 billion people have a vision impairment that could have been prevented or has yet to be addressed.

"For over four decades, Seva has invested in and used cutting edge technology to deliver world-class care for people in need," says Kate Moynihan, Executive Director of Seva Foundation. "Through our Global Sight Network, these innovations will help us to further extend our reach, and transform more lives than ever before."

"With this support from Seva Foundation, we are excited to explore whether artificial intelligence can be applied to low-cost camera systems," says Dr. Parag Shah of Aravind. "This could help us achieve the goal of eliminating blindness from ROP in India and around the world."

About Seva

Seva is a global nonprofit eye care organization that transforms lives by restoring sight and preventing blindness. Since 1978, Seva has provided sight-saving surgeries, eyeglasses, medicine, and other eye care services to more than 44 million people in underserved communities around the world. We work with partners in more than 20 different countries around the world, including the USA. To find out more, visit http://www.seva.orgor email [emailprotected].

SOURCE Seva Foundation

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Call for Ideas: Innovative Technology to Reduce Visual Impairment & Blindness - PRNewswire

Like spring crocuses peeking out of the melting snow, DC-area theaters are beginning to formulate a path back to their audiences, tentative but real. Shakespeare Theatre Company is among the first to do so, with a six-production portfolio not quite a schedule, as dates have not been announced of plays, some virtual, some in person under strict social-distancing protocols, and some both.

On the in person side will be the Donmar Warehouse production of Blindness, an immersive theater production for forty patrons at Harman Hall. Imagine a pandemic which causes blindness and you get the premise of the show, which will be done in darkness. There will be no actors on the stage. The audience will instead hear Juliet Stevensons recorded voice through headphones. Simon Stephens, who adapted The Curious Incident of the Dog in the Night-Time, has put this show together from Jos Saramagos novel.

STC kicks off its digital season, and its STC Digital program, with the world premiere of Patrick Pages one-actor play All The Devils Are Here: How Shakespeare Invented the Villain. Page, himself an expert theatrical villain (he played a memorable Claudius here, and on Broadway has played Scar, the Grinch, the Green Goblin and, in Hadestown, Hades) here takes on the roles of Macbeth, Iago and Claudius (among others) by way of showing us the evolution of Shakespeares villains and our own. While any ticket holder will be able to see the play, STC Season subscribers will have an opportunity for a talkback session with Page.

Juliet Stevenson purrs and seethes in our headphones: as the only sighted survivor, she records turmoil and violence when the afflicted turn against each other, said the Guardian, Ben and Max Ringhams soundscape brilliantly conjures up spaciousness, movement and intimacy. Stevenson seems to prowl around the spectators; a lighter snaps on as if inside our heads. Walter Meierjohann, who directed the show in London, will direct it here.

Tickets for both All The Devils Are Here and Blindness will become available on November 16.

Some time later were not sure when STC will present Ionescos The Chairs. This is a story about an old man and an old woman, setting up chairs so that the whole world, such as it is, can hear a lecture about the old mans discovery. As the audience files in, the old man and the woman speak to them, but the remarkable thing about the audience is that itsinvisible. Or maybe absent. Is this a post-apocalyptic world? Maybe. Is the old mans discovery about the secret of existence? Maybe. Is there actually going to be a speaker? Maybe. Longtime STC Associate Artistic Director Alan Paul directs; this play will be available both in person and digitally.

OK, imagine this. It is 1833, and we are at Londons Royal Theatre. The greatest Shakespearean actor of his time, Edmund Kean, is playing Othello in blackface, of course. Suddenly, Kean collapses on stage! Quick! Bring in the understudy! Butcould this be the understudy? An actual Black actor the American Ira Aldridge? In Lolita Chakrabartis Red Velvet, the response is electric: Britain was full of people theater professionals, critics, and audience alike who thought that by taking the stage Aldridge would bring about the end of civilization. Aldridge, who came to England because he knew he would never get a chance to act in America, responded with personal charisma and a gift for confabulation at one point claiming, falsely, to have been born in Senegal. Chakrabartis play is a fascinating character study of Aldridge, who it sees as an essentially tragic figure, a genius and proto-method actor who was hunted and haunted to his professional end and allowed no personal weakness, said the Chicago Tribunes Chris Jones in a somewhat mixed review. And it serves as a reminder that there is nothing new about our conversations over casting and race. Jade King Carroll directs.

DCTS Guide: The 2020-2021 DC area theatrical season

STC will round out its season with two classics. In Arthur Millers The Crucible, the accusations of hysterical children, led by a manipulative teenager, induce a regional psychosis which results in the deaths of dozens of innocent people. Does this have a contemporary resonance? It certainly did for Miller when he wrote it, and it does for director Whitney White, who directed The Amen Corner B.C. (Before Covid). She has an ambitious plan for this production, says STC Artistic Director Simon Godwin. Whitney is going to revitalize Millers political drama for our times.

And Godwin himself will be helming As You Like It, the Bards magical voyage to the Forest of Arden. You remember As You Like It: The brawling de Boys; ancient Adam; the wrestling match; the Good Duke and the Bad Duke; the forbidden passion of Orlando and Rosalind; love poems posted on trees; melancholy Jacques; all the worlds a stage; girls disguised as boys the whole nine yards. Godwin calls it one of my favorite Shakespearean comedies, an escape from the politics of the court into a green world of wonder, love, and family reunions.

The Chairs, Red Velvet, The Crucible and As You Like It will be available both digitally and in (socially distanced) person.

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A first-of-its-kind medical journal study published on Sept. 24 shows that as many as 3,217 intended donations of corneas from the eyes of gay and bisexual men in 2018 that could have restored the vision of blind people through cornea transplant surgery were disqualified under an outdated U.S. Food and Drug Administration policy aimed at preventing HIV infection.

The study released by JAMA Ophthalmology, an American Medical Association journal, says the little-known FDA policy prohibits the donation of corneas from men who have had sex with men in the past five years from the time of the planned donation. It points out that the policy has not been revised since the FDA adopted it in 1994 despite major scientific advancements in the detection of HIV in human tissue within eight to 10 days after infection.

With millions of people across the world in need of corneal transplants, these discarded corneas from gay and bisexual men could be used to address the shortage and safely restore vision to thousands of patients with corneal blindness or visual impairment, said Dr. Michael A. Puente, assistant professor of ophthalmology at the University of Colorado School of Medicine and lead author of the study.

With modern virologic testing and a better understanding of the low risk of HIV transmission through corneal transplants, this five-year deferral policy for gay men is not supported by current science, Puente, an eye surgeon, said in a statement. We ask federal regulators to reconsider these outdated policies which are depriving patients of the possibility of sight restoration, he said.

Medical literature on cornea donations and corneal transplant surgery states that similar to heart transplants, corneas can only be donated by people who have died, many of whom have left an advance directive to become an organ or tissue donor.

The statement accompanying the study says all corneal donors in the United States are required to undergo three separate HIV tests. Puente told the Washington Blade the HIV tests can be performed shortly before a terminally ill person dies or shortly after death as long as at least one of the tests is performed within seven days of the time the cornea is donated.

Up until 2015, the FDA adhered to a lifetime ban on men who have sex with men, referred to as MSM, from donating blood. The FDA announced that year that a review it conducted concluded that a lifetime ban was no longer scientifically justified and recommended that MSM considering donating blood be sexually abstinent for one year. In April of this year the FDA lowered the period of abstinence for MSM blood donors to three months.

If its safe for gay men to donate their blood after three months of abstinence, I can think of no scientific reason to continue to require gay men to be abstinent for five years to donate their eyes, Puente said. This policy can be changed without increasing the risk of HIV transmission, and I would urge authorities to act as soon as possible to help patients who are waiting for sight-restoring surgery.

The medical journal article says to the knowledge of the teams of researchers who conducted the study, no case of HIV transmission from a corneal transplant has been reported anywhere in the world. The article notes that in cases where a corneal donor was discovered to be HIV positive after a transplant surgery had taken place, none of the recipients contracted HIV.

One reason for the low transmissibility of HIV via corneal transplant is thought to be the corneas avascularity, which prevents the cornea from being a major reservoir of the virus, according to the article. Studies analyzing the corneas of HIV-infected patients have consistently found that that HIV is not present in most of the corneas of HIV-positive patients, it reports.

The statement accompanying the study says the U.S. and Canada are outliers in policies restricting corneal donations for MSM. It notes that Canada currently requires MSM to have been abstinent for one year prior to a corneal donation.

Many countries, including Spain, Italy, Mexico, Chile, and Argentina, allow gay and bisexual men to donate their eye tissue just as easily as heterosexual donors, the statement says. Other countries have deferral periods far shorter than five years, says the statement. For example, the United Kingdom allows corneal donation by gay and bisexual men after only three months of abstinence, while the Netherlands and France only require gay and bisexual corneal donors to be abstinent for four months.

Puente told the Blade he learned that members of Congress urged the FDA to modify its MSM cornea donation policy in 2013 and the Eye Bank Association of America in 2017 also called for a change in the policy, but the FDA chose to leave the 1994 policy in place.

Monique Richards, a spokesperson for the FDA, told the Blade in an email in response to a Blade inquiry about the MSM corneal donor policy, that the current policy is based on recommendations by the U.S. Centers for Disease Control and Preventions 1994 guidelines published in its journal Morbidity and Mortality Weekly Report.

Research has shown that a history of male-to-male sexual contact was associated with a 62-fold increased risk for being HIV positive, whereas the increase in risk for a history of multiple sexual partners of the opposite sex was 2.3 fold, Richards said.

She added that the Centers for Disease Control and Prevention points out that about two-thirds of all new HIV infections in the United states occur in MSM, who make up only 2 percent of the total U.S. population.

The FDA will continue to review its [tissue] donor deferral policies to ensure they reflect the most up-to-date scientific knowledge, Richards said. This process must be data-driven, so the time frame for future changes is not something we can predict.

The JAMA Ophthalmology article can be accessed here.

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Thousands denied cure for blindness due to ban on tissue donation from gay men - Washington Blade