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Category Archives: Georgia Stem Cells

A plant that ‘cannot die’ reveals its genetic secrets – The Independent

Posted: August 5, 2021 at 2:39 am

The longest-lived leaves in the plant kingdom can be found only in the harsh, hyperarid desert that crosses the boundary between southern Angola and northern Namibia.

A desert is not, of course, the most hospitable place for living things to grow, let alone leafy greens, but the Namib Desert the worlds oldest, with parts receiving less than 2 inches of precipitation a year is where Welwitschia calls home.

In Afrikaans, the plant is named tweeblaarkanniedood, which means two leaves that cannot die. The naming is apt: Welwitschia grows only two leaves and continuously in a lifetime that can last millenniums.

Most plants develop a leaf, and thats it, says Andrew Leitch, a plant geneticist at Queen Mary University of London. This plant can live thousands of years, and it never stops growing. When it does stop growing, its dead.

Some of the largest plants are believed to be more than 3,000 years old, with two leaves steadily growing since the beginning of the Iron Age, when the Phoenician alphabet was invented and David was crowned King of Israel.

By some accounts, Welwitschia is not much to look at. Its two fibrous leaves, buffeted by dry desert winds and fed on by thirsty animals, become shredded and curled over time, giving Welwitschia a distinctly octopus-like look. One 19th-century director of Kew Gardens remarked, It is out of the question the most wonderful plant ever brought to this country and one of the ugliest.

But since it was first discovered, Welwitschia has captivated biologists including Charles Darwin and botanist Friedrich Welwitsch, after whom the plant is named; it is said that when Welwitsch first came across the plant in 1859, he could do nothing but kneel down on the burning soil and gaze at it, half in fear lest a touch should prove it a figment of the imagination.

When we see that the plant can live in this environment for so long and preserve its DNA and proteins, I feel like we can find hints for how to improve agriculture

In a study published recently in Nature Communications, researchers report some of the genetic secrets behind Welwitschias unique shape, extreme longevity and profound resilience.

Jim Leebens-Mack, a plant biologist at the University of Georgia not involved in the study, says it gives us a foundation for better understanding how Welwitschia does all the crazy stuff that it does.

The Welwitschia genome reflects the plants arid and nutrient-poor surroundings. And its genetic history seems to correspond with environmental history.

Approximately 86 million years ago, after a mistake in cell division, the entire Welwitschia genome doubled during a time of increased aridity and prolonged drought in the region and possibly the formation of the Namib Desert itself, says Tao Wan, a botanist at the Fairy Lake Botanical Garden in Shenzhen, China, and lead author of the study. He says that extreme stress is often associated with such genome duplication events.

Leitch, a co-author of the study, adds that duplicated genes are also released from their original functions, potentially taking on new ones.

However, having more genetic material comes with a cost, Wan says.

The most basic activity for life is DNA replication, he says, so if you have a big genome, it is really energy-consuming to maintain life, especially in such a harsh environment.

To make matters worse, a large amount of Welwitschias genome is junk self-replicating DNA sequences called retrotransposons.

Now that junk needs to be replicated, repaired, Leitch says.

The researchers detected a burst of retrotransposons activity 1 to 2 million years ago, most likely because of increased temperature stress. But to counteract this, the Welwitschia genome underwent widespread epigenetic changes that silenced the junk DNA through a process called DNA methylation.

This process, along with other selective forces, drastically pared down the size and energetic maintenance cost of Welwitschias duplicated library of DNA, Wan says, giving it a very efficient, low-cost genome.

The plants leaves pour out of its base

(Getty/iStock)

The study also found that Welwitschia had other genetic tweaks hidden up its leaves.

The average plant leaf grows from the plants apexes, or the tippy-tops of its stem and branches. But Welwitschias original growing tip dies, and leaves instead pour out of a vulnerable area of the plants anatomy called the basal meristem, which supplies fresh cells to the growing plant, Wan says. A large number of copies or increased activity of some genes involved with efficient metabolism, cell growth and stress resilience in this area may help it continue to grow under extreme environmental stress. In a warming world, the genetic lessons that Welwitschia has to offer may help humans breed hardier, less thirsty crops.

When we see that the plant is able to live in this environment for so long and preserve its DNA and its proteins, I really feel like we can find hints for how to improve agriculture, Leebens-Mack says.

The study also underscores the importance of curiosity-driven research. When you encounter two leaves growing in a desert against all odds, kneel down in the burning soil and take a closer look.

From weird things, you discover weird things that help you understand things that you didnt know you didnt understand, Leitch says.

This article originally appeared in The New York Times

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Exploring science with a new generation of girls – US Embassy in Georgia

Posted: February 11, 2021 at 4:53 am

Kimberley Miner: https://www.ifthencollection.org/kimberleyrClimate Scientist and Research Assistant ProfessorLos Angeles, CA

From mountaintops to the depths of the seas, American women scientists are tackling global problems.

In the past, there were very few women in science, technology, engineering and math (STEM) jobs, but today women hold nearly 3 in 10 of those jobs.

The United Nations has designated February 11 the International Day of Women and Girls in Science. Thanks toinitiatives like IF/THEN, launched by the Lyda Hill Philanthropies and the American Association for the Advancement of Science, 125 women are mentoring girls who will join them as the scientific leaders of tomorrow. ShareAmerica talked to four of thesescience ambassadors.

Climate scientist and professor Kimberley Miner lets girls in on a secret. You dont have to be inherently good at science or math to be a scientist. With hard work, dedication and perseverance, you can succeed at STEM, said Miner, of NASAs Jet Propulsion Laboratory in the Los Angeles area.

Miner has sailed around Antarctica, gazed at the beauty of the northern lights in Alaska and led a team cataloging pollution all the way up Mount Everest. She loves exploration and advocates for preserving the sites she explores.

The world around us revolves around scientific principles. Understanding how and why it works is like the key to the kingdom it allows you to become whatever you want to be in life! Miner said. She has worked with various school groups, in virtual classrooms and with the Girls Scouts of America to help them find keys to the natural world.

Lataisia Jones is a cell nerd. A Ph.D. in biomedical science, she loves the artistry of seeing cells of different colors under her microscope as she experiments, trying to understand cell division, diabetes and brain development. She works as a scientist at the American Society for Microbiology in Washington.

She also founded Young Scientist Wednesday to teach patients at Childrens National Hospital in Washington. Females, she likes to remind girls, have superpowers. Not only are we intelligent, work hard and contribute on a wide scale to society, we are also capable of relating to the emotional sides of every situation and creating a well-rounded solution, she said.

As a Black woman, Jones sees theimportance of women and minorities entering STEM fields. STEM advances only when people from different backgrounds, cultures, ethnic groups, genders and identities come together to work on the worlds greatest mysteries, she said.

When Erin Smith talks about experiments she did in her kitchen as a girl, shes not exactly talking about ancient history. Smith is just 21 years old and a member of the Stanford University undergraduate class of 2023. Shes not waiting for a degree to start making a difference.

As a high school student, she co-founded a steminists group to teach coding to middle school girls.

She directs her mastery of technology toward the human brain, looking for ways to detect and monitor Parkinsons disease. She is developing FacePrint, an application that uses video technology to detect facial-expression impairments or behavioral indicators associated with the early stages of Parkinsons. FacePrint is in clinical trials with Stanford Medical School and the Michael J. Fox Foundation. I hope to help build a future where brain health is objective, personalized and preemptive, she said.

Smith hopes girls and women can develop a deeper sense of belonging in STEM fields, to share the full extent of their ideas and work, she said.

Katy Croff Bell changed the face of oceanography when she led the Nautilus Exploration Program, which probes the ocean floor and livestreams the spectacular view globally. When she took over the program, just 17 percent of the science and operations team was female. When she left 18 years later in 2017, the representation was 43 percent.

When ocean exploration is accessible to all talented people, she said, it will allow us to make wise decisions regarding the use, management and protection of the ocean, resulting in humankind thriving.

Bell grew up in San Diego loving the water. She went on to study ocean engineering, maritime archeology and geological oceanography. Today, she directs the Open Ocean Initiative at MIT Media Lab and is a fellow at the National Geographic Society.

As children, she said, one of the first questions we ask is Why? because we are trying to understand the world: Why is the sky blue? That same Why? drives science, because as adults we are still trying to understand the world [though] on a deeper level and how we can make the world a better place.

By U.S. Embassy Tbilisi | 9 February, 2021 | Topics: Gender Issues, History, News, Science & Tech | Tags: girls' education, mentorship, science, STEM, women in the workforce

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Stemcell Renewal Elixir GEORGIA LOUISE

Posted: September 25, 2020 at 8:56 pm

How To Apply: Apply two pumps and massage into face, neck and dcollet after cleansing. Apply twice daily.

STAR INGREDIENTS

Apple Stemcell Cultivated from a rare Swiss apple that can actually heal its own wounds, these stem cells are rich in epigenetic factors and metabolites, assuring the longevity of human skin cells.

Red Marine Algae Improves skin moisture and hydration, as well as firmness and elasticity. This algae also reduces of fine lines and increases cell turnover. High concentrations of L-Serine, an amino acid active in structuring the skins natural moisturizing factor, helps keep skin well-hydrated.

Hyaluronic Acid Made by producing enzymes from a bacteria-based biofermentation process, hyaluronic acid has the ability to absorb up to 1,000 times its own weight of water, making it the most efficient humectant moisturizer so far.

Ingredients: Water, Glyceryl Polyacrylate, Glycerin, Methyl Glu-ceth- 20, Malus Domestica Fruit Cell Culture, Ahnfeltia Concinna Extract, Dimethicone, Polysilicone-11, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Algae Extract, Polysorbate 80, Hydrolyzed Silk, Cucumis Sati- vus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Tocopher- yl Acetate, Polysorbate 20, Allantoin, Panthenol, Caprylyl Glycol, PVM/ MA Copolymer, Phenoxyethanol, Ethylhexylglycerin, Butylene Glycol, Lecithin, Hydroxyethylcellulose, Xanthan Gum, Tetrasodium EDTA.

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COVID is shifting the conversation about the medical application of CBD – Open Access Government

Posted: September 22, 2020 at 11:51 pm

COVID-19 has spread around the planet, sending billions of people into lockdown as health services struggle to cope. The statistics are startling global cases stand at 23,139,628 and with a total death toll of 801,795 and new daily cases rising (John Hopkins University data 23 Aug 2020), the outbreak has thrown an unprecedented challenge to the world and its citizens. So far, there is no approved treatment or vaccine.

While researchers around the world continue to explore different ways in combating COVID-19, some are looking into how cannabis derived CBD can offer benefits for those suffering from severe forms of this infection.

One recent study from the Dental College of Georgia and Medical College of Georgiashowed high CBD formulations could be effective in the treatment of acute respiratory distress syndrome, or ARDS. The condition, also known as a cytokine storm, has been seen in serious cases of coronavirus, and even affects patients with other viruses or autoimmune diseases. With ARDS, the patients own hyperactive autoimmune system inundates organs with cytokines, resulting in dangerous inflammation. This reaction can cause lung damage and eventual death in COVID-19 victims.

The study model showed CBD down-regulated the cytokines, which helped improve oxygen levels and supported recovery of damaged lung tissues. The researchers also intend to perform similar studies to understand how CBD might help other organs recover from the effects of the virus. Researchers from University of Nebraska and the Texas Biomedical Research Institute also took part. In apeer-reviewed article in Brain, Behaviour, and Immunity, the authors said further research is needed to understand if CBD can help patients infected by the virus.

Now early results from an ongoing Israeli study is adding to the growing evidence that cannabis ingredients could be a game changing treatment in the fight against COVID-19. The new terpene study is being performed by two Israeli research and development companies,Eybnawhich specializes in terpene based medicines, and CannaSoul Analytics. The study looks at a proprietary terpene formulation called NT-VRL, which was created by Eybna to treat inflammatory conditions such as the cytokine storm syndrome found in COVID-19 patients. The formulation contains 30 individual terpenes that are potential anti-inammatory agents all working together to create a positive impact.

While results are ongoing and are yet to be completed, peer reviewed or published, these are positive steps that warrants further investigation into the application of CBD.

This is far from the only investigation into CBD medical benefits.

Researchers at the University of Lethbridge in Alberta,Canada, revealed at the beginning of July that certain kinds of high CBD strains could help treat people infected with the virus or even prevent it from developing in the first place by managing to reduce virus receptors.

Study authors found extract from high CBD strains could help to regulate an enzyme that coronavirus attaches to thereby blocking the viruss ability to infect cells. Results were published on peer review website Preprints.

In Israel, there are several companies and trials underway on how CBD can be used to battle COVID-19. One such example is the partnership of InnoCan Pharma and Tel Aviv University who are working on a new treatment for COVID-19 using exosomes loaded with CBD. Exosomes are small particles created when stem cells multiply. The method will utilise the exosomes as homing missiles, as they can uniquely target cell organs that have been damaged.

As it stands, CBD is still an area under development for the treatment of COVID-19. While there have been some promising results on CBDs anti-inflammatory properties, more studies are needed before leading into clinical trials to test effectiveness. This can take anywhere from months to years.

Speed, agility, and innovation are required from governments, businesses, and society in crafting responses to cope with this evolving new normal. In this period of uncertainty, every therapeutic opportunity and avenue must be considered. CBD opens the door to various exciting possibilities.

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Robert E. Windsor, MD, is being recognized by Continental Who’s Who – PRNewswire

Posted: at 11:51 pm

ALPHARETTA,Ga., Sept. 21, 2020 /PRNewswire/ --Robert E. Windsor, MD, is being recognized by Continental Who's Who as a Distinguished Leader for his remarkable contributions in the field of Medicine and for his dedication and commitment as the President, Medical Director, and Regenerative Medicine Specialist at Georgia RegenRX.

Located in the greater Atlanta area at 5755 North Point Pkwy, Suite #72, Alpharetta, Georgia, Georgia RegenRX offers expert, caring pain management and regenerative medical services to the Atlanta metropolitan area. Dr. Windsor plans to expand his practice into all aspects of regenerative medicine to include aesthetics and life extension. He believes that people do not need to age physiologically nearly as rapidly as they traditionally have and that they should remain mentally and physically vital and continue to look good while they age. An acclaimed physician, he has helped thousands of patients recover from the pain and improve their quality of life.

Backed by more than three decades of experience, Dr. Windsor is a top physician in Fulton County and will be expanding his practice into Forsyth and Gwinnett counties in 2021. His areas of expertise include interventional pain medicine, interventional orthopedics, regenerative medicine (e.g., stem cell therapy), integrative medicine, longevity medicine, and pain management for arthritis, chronic spinal pain, and sports injuries. In addition to his administrative and clinical experience, he has held numerous faculty positions. He has been a Pain Management Fellowship Director at Emory University, a leader at the American Academy of Physical Medicine, and a Visiting Professor at the University of Pennsylvania and Temple University among others.

Pursuing a pain/rehabilitative/physical medicine career to help others, Dr. Windsor always keeps, "the patient first and foremost." He has been highly successful because he continues to learn and develops new and improved skill sets. He advises new doctors to, "Stay up to date on emerging technologies in the biological field (i.e.: Stem cells)". He loves his field, remaining in his career for so many years because of his fervor for improving the function and quality of life of injured, ill, and/or elderly people.

In preparation for his career, Dr. Windsor earned a medical degree from the Texas A&M University College of Medicine at the age of twenty-three. He went on to complete a competitive residency program in physical medicine and rehabilitation at the University of Texas Health Sciences Center at San Antonio. Then, he earned board certification in Physical Medicine, Electrodiagnostic Medicine, Pain Medicine, Pain Management, Age Management Medicine, and Regenerative Medicine and he is currently completing a fellowship in Aesthetic Medicine.

A frontrunner in his field, Dr. Windsor has been board certified by the American Board of Physical Medicine, American Board of Pain Medicine, American Board of Pain Management, American Board of Electrodiagnostic Medicine, American Board of Age Management Medicine, and the American Board of Regenerative Medicine. In appreciation of his service, Dr. Windsor was honored as America's Top Physician by the Consumers Research Council of America in 2014. The President of PASSOR, he has received the following PASSOR awards: Distinguished Clinician, Distinguished Committee, and Distinguished Member. He has been active in his field throughout his career, having previously served as the past-Executive Board Member of the AAPM&R.

A lifelong athlete, Dr. Windsor enjoys staying active. He likes lifting weights, snow skiing, scuba diving, boating, and skydiving. He is heavily involved with his family. He has many offspring, several of whom are engaged in the medical field.

Dr. Windsor dedicates this recognition to Stanley Herring, MD, Richard Derby, MD, Charles April, MD, and Daniel Dumitru, MD, Ph.D. For more information, please visit https://www.garegenrx.com

Contact: Katherine Green, 516-825-5634[emailprotected]

SOURCE Continental Who's Who

Georgia RegenRX, LLC

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Cytovia Therapeutics, Inc appoints Dr. Wei Li as Chief Scientific Officer to accelerate the development of iPSC CAR-NK Cell Therapy for Cancer – Yahoo…

Posted: June 6, 2020 at 4:46 am

NEW YORK, June 03, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, Inc (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer, today announces the appointment of Dr. Wei Li as acting Chief Scientific Officer (CSO), effective June 1, 2020.

During her biotech career, Dr. Li co-founded two companies and built up extensive expertise in all aspects of drug research and development, including preclinical development and pharmacology, clinical development and operations, regulatory affairs, biomarker development and biomanufacturing.

Most recently, Dr. Li was Chief Development Officer at OliX Pharmaceuticals, a leading public South Korean biotech company developing siRNA therapeutics for multiple indications. She also served as Executive Vice President, Product Development at Boston Biomedical, Inc (BBI) from 2007-2018, playing a key role in growing it from a start-up in 2007 to an industry leader in cancer stem cell research, including through the acquisition by Sumitomo Dainippon in 2012. Dr. Li led the development of napabucasin (BBI608), a first-in-class drug selected as one of the worlds top ten cancer drugs in late stage clinical development by Fierce Biotech. Dr. Li started her career at ArQule, a public biotech company developing targeted therapies for hematological malignancies and acquired by Merck &Co in 2019.

Wei Li holds a PhD in Molecular Virology from Georgia State University and completed her Postdoctoral Training at Harvard Medical School.

Dr. Wei Li said: I am thrilled to be joining the great team of scientists and entrepreneurs at Cytovia Therapeutics. NK-cell based therapeutics are at an inflection point. Initial clinical trials have shown promising safety and efficacy. Off-the-shelf manufacturing promises broader and faster patient access. Cytovia Therapeutics has an excellent iPSC CAR-NK platform and a strong pipeline in both hematological and solid tumors. It is tremendously exciting to be involved in this stage of the companys development.

Dr Daniel Teper, co-founder, Chairman and CEO of Cytovia Therapeutics, Inc said: We are delighted to welcome Dr. Wei Li to Cytovia Therapeutics as Chief Scientific Officer. Wei has a stellar track record of bringing innovative oncology drugs from discovery to clinical development. Her operational excellence and entrepreneurial drive will be critical to help bring multiple iPSC CAR NK therapeutics to initial clinical trials starting in 2021.

ABOUT CYTOVIA THERAPEUTICS, INCCytovia Therapeutics is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem and Macromoltek.

Learn more at http://www.cytoviatx.com

Contact for media enquiries at Cytovia Therapeutics, IncSophie BadrVP corporate Affairs Sophie.badre@cytoviatx.com1(929) 317 1565

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Athens hospital using biologic treatment on COVID-19 patients – Online Athens

Posted: June 2, 2020 at 9:43 pm

A local hospital is using a little-known medicine to treat COVID-19 patients after the FDA authorized compassionate use approval to administer the drug.

Landmark Hospital of Athens treated two patients with its first doses of the medicine last week, according to a press release from Landmark Hospitals, which operates six long-term acute-care hospitals in the Southeast, including its Athens hospital on Sunset Drive.

The medicine, called Organicell Flow, is a biologic product derived from amniotic fluid, which contains stem cells. Amniotic fluid is the protective fluid in the sac containing growing fetuses.

Landmark is providing the product to patients with advanced COVID-19 conditions, according to the company.

After receiving Organicell Flow intravenously last week, the two patients were clinically stable as of Wednesday, according to Landmark.

Organicell Regenerative Medicine of Boca Raton, Fla., manufactures the medicine from human amniotic fluid voluntarily donated during Cesarean section surgeries, according to Landmark.

Developed to promote wound healing, Organicell Flow contains more than 300 growth factors, cytokines and chemokines, as well as hyaluronic acid and exosomes, according to the press release.

The medicine can modulate a patients immune response. In some COVID-19 patients, their supercharged immune response can be as harmful as the actual coronavirus that causes COVID-19.

The condition, called cytokine storm syndrome, can damage lungs and other organs and can lead to death, said Landmark Hospitals Chairman Dr. William Kapp.

The data collected from the patients receiving compassionate use treatments will guide us to interventions that modulate COVID-19 immune response in the lungs and reduce systemic organ damage, Kapp said in Landmarks press release.

Organicell Flow is one of a number of medicines health providers around the world are trying out to treat COVID-19, which has claimed more than 100,000 lives in the United States so far and nearly 2,000 in Georgia.

Two other Athens hospitals have also recently received shipments of another drug that may help patients with COVID-19, remdesivir.

Gov. Brian Kemp announced earlier this week that the state was distributing more than 18,000 vials of remdesivir to more than 80 Georgia hospitals, enough to treat nearly 17,000 patients. The hospitals include Athens St. Marys Healthcare System and the Piedmont system that includes Piedmont Athens Regional and several other Georgia hospitals.

Remdesivir is being used to treat patients with serious symptoms such as low oxygen levels or pneumonia, according to the Georgia Department of Public Health.

Developed to treat people with Ebola virus disease, remdesivir has been shown to shorten the time of recovery from COVID-19 illness in hospitalized patients, but in the absence of thorough studies is considered investigational.

Standard treatment for COVID-19 includes oxygen therapy, mechanical ventilation and medicine to maintain blood pressure.

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Study reveals birth defects caused by flame retardant – University of Georgia

Posted: at 9:43 pm

Research focuses on mans exposure prior to contraception

A new study from the University of Georgia has shown that exposure to a now-banned flame retardant can alter the genetic code in sperm, leading to major health defects in children of exposed parents.

Published recently in Scientific Reports, the study is the first to investigate how polybrominated biphenyl-153 (PBB153), the primary chemical component of the flame retardant FireMaster, impacts paternal reproduction.

In 1973, an estimated 6.5 million Michigan residents were exposed to PBB153 when FireMaster was accidentally sent to state grain mills where it made its way into the food supply. In the decades since, a range of health problems including skin discoloration, headache, dizziness, joint pain and even some cancers have been linked to the exposure.

More striking, the children of those who were exposed seemed to experience a host of health issues as well, including reports of hernia or buildup in the scrotum for newborn sons and a higher chance of stillbirth or miscarriage among adult daughters.

Yet, little work has been done to understand how the chemical exposure could have impacted genes passed from an exposed father, said study author Katherine Greeson.

It is still a relatively new idea that a mans exposures prior to conception can impact the health of his children, said Greeson, an environmental health science doctoral student in Charles Easleys lab at UGAs College of Public Health and Regenerative Bioscience Center.

Most studies where a toxic effect is observed in children look only to the mothers and the same has been true of studies conducted on PBB153, she said.

Greeson and a team of researchers from UGA and Emory University used a unique combination of observational and laboratory approaches to demonstrate how PBB153 acted on sperm cells.

Typically, scientific studies are either epidemiological in nature and inherently observational or focus on bench science, but in this study, we did both, said Greeson.

This approach allowed the researchers to mimic the known blood exposure levels of PBB153 in a lab environment.

We were uniquely able to recreate this effect using our previously characterized human stem cell model for spermatogenesis, she said, which allowed us to study the mechanism that causes this effect in humans.

The team looked at the expression of different genes in their human spermatogenesis model after dosing with PBB153 and found marked alterations in gene expression between dosed and undosed cells, specifically at genes important to development, such as embryonic organ, limb, muscle, and nervous system development.

PBB153 causes changes to the DNA in sperm in a way that changes how the genes are turned on and off, said Greeson. PBB153 seems to turn on these genes in sperm which should be turned off, said Greeson, which may explain some of the endocrine-related health issues observed in the children of exposed parents.

Though the study used this model to directly replicate exposure to PBB153, Greeson says this approach could be used to better understand the impact of other environmental exposures on reproduction, including large-scale accidental exposures to toxic chemicals or everyday exposures.

Hopefully this work will lead to more studies combining epidemiology and bench science in the future, which will tell us more about why were seeing an effect from an environmental exposure in human populations and encourage experimental studies to more closely mimic human exposures, she said.

The study, Detrimental Effects of Flame Retardant, PBB153, Exposure on Sperm and Future Generations, published May 22. It is available online.

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Novant Health Initiates Phase 2b/3 Trial with CytoDyns Leronlimab for Severely and Critically Ill COVID-19 Patients – Yahoo Finance

Posted: May 11, 2020 at 11:45 pm

FDA has approved 54 Emergency INDs to allow access to leronlimab for severely and critically ill COVID-19 patients

VANCOUVER, Washington and WINSTON-SALEM, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Novant Health is initiating patient enrollment in CytoDyns Phase 2b/3 trial for severely and critically ill COVID-19 patients.

Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA). Preliminary results from this patient population led to the FDAs recent clearance for CytoDyns Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients.

Were grateful for our partnership with CytoDyn and the opportunity to bring cutting edge, innovative and investigative treatments to our community, said Eric Eskioglu, M.D. Executive Vice President and Chief Medical Officer for Novant Health. Since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility. A number of these patients have been enrolled and treated on the mild/moderate clinical trial. Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19. We are encouraged by early reports of efficacy of leronlimab from critically ill patients treated under an Emergency Use IND and we are eagerly awaiting the full results of both blinded studies for leronlimab in the near future from CytoDyn.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, We are once again very pleased Novant Health is seeking to partner with our health care professionals to help provide a potential therapeutic benefit to these COVID-19 patients. Thus far, we are grateful for the benefits leronlimab has provided to so many patients, as expressed to us by their families.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals and clinics throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

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In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. We would like to provide an update that the Biologics License Application (BLA) for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients will be considered completed after the clinical datasets are submitted on May 11, 2020. The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation and a rolling review previously assigned by the FDA and plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About Novant Health Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers a seamless and convenient healthcare experience to communities in Virginia, North and South Carolina, and Georgia. The Novant Health network cares for approximately 5 million patients annually at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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Novant Health Initiates Phase 2b/3 Trial with CytoDyns Leronlimab for Severely and Critically Ill COVID-19 Patients - Yahoo Finance

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CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -…

Posted: May 5, 2020 at 7:49 am

54 eINDs approved by FDA and 49 patients have been treated with leronlimab thus far

VANCOUVER, Washington, April 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administrations (FDA) emergency Investigational New Drug (eIND) program:

Eleven (11) Patients in NY hospital: All treated patients were in Intensive Care Units (ICU) because of acute respiratory failure, eight of whom were intubated (placed on mechanical ventilation). One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, we believe we were able to save the lives of four patients. All patient blood samples were evaluated and important powerful results from the effect of leronlimab were demonstrated in almost all of these patients. This data has been submitted to a prestigious journal and we expect the publication on Friday, May 1.

Twenty-three (23) patients in Southern California hospital: Six patients were in critical condition (intubated) and 17 patients were severely-ill, needing oxygen support. No death was reported. Out of 6 critical patients, all were intubated patients, 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator and one patient has shown deterioration in respiratory parameters. Of 17 severe condition (but not critical) patients, 11 patients demonstrated improvement in respiratory parameters (8 of them were discharged from hospital, including one patient in the news, Samantha Mottet), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients.

Three (3) patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of leronlimab treatment. Of these 3 patients, 2 were extubated (taken off ventilator) and 1 patient remains on a ventilator but improving.

One (1) patient in another NY hospital: Patient was taken off oxygen and discharged from hospital after leronlimab treatment.

One (1) patient in Northern California hospital: Patient is now weaning from ventilator and transferred to rehabilitation hospital.

Updates are pending for 10 other patients. Five additional patients have been approved to receive leronlimab under eINDs, which increases the total eINDs approved by the FDA to 54 patients.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing. The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) of affecting the viral load and restoring the immune system. With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

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SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries -...

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