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GeneTx and Ultragenyx Announce Presentation of Phase 1/2 Data on Investigational GTX-102 in Patients with Angelman Syndrome – GlobeNewswire

Posted: December 6, 2020 at 10:37 am

Results presented at Foundation for Angelman Syndrome Therapeutics (FAST) Global Summit

Additional data, including EEG findings, support prior initial indications of activity and there were no new adverse events

SARASOTA, Fla. and NOVATO, Calif., Dec. 05, 2020 (GLOBE NEWSWIRE) -- GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), companies partnered in the development of intrathecally administered GTX-102, an investigational treatment for Angelman syndrome, today announced the presentation of data from the Phase 1/2 study of GTX-102 at the Foundation for Angelman Syndrome Therapeutics (FAST) Global Summit. Details regarding the scientific basis for GTX-102 targeting in Angelman syndrome were presented along with additional supportive clinical data on EEG and other endpoints, along with further description of the safety events. Additional nonclinical study data were included showing substantial silencing activity at low repeat doses along with chronic nonclinical safety data at higher doses compared to dosing in the human study. Presentations were made by Scott Stromatt, M.D., Chief Medical Officer of GeneTx and Elizabeth M. Berry-Kravis, M.D., Ph.D. Professor of Pediatrics, Neurological Sciences and Biochemistry at Rush University on Friday December 4th, and by Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx, on Saturday, December 5th.

I am excited by the preliminary findings presented at the FAST scientific symposium. A tremendous amount of work was put into understanding the UBE3A-AS transcript and developing GTX-102, so it is great to see how those efforts have translated into initial indications of effect in the clinical study in patients with Angelman syndrome, said Scott V. Dindot, Ph.D., Associate Professor, Texas A&M University, and Executive Director, Molecular Genetics at Ultragenyx. I am grateful to be a part of this endeavor, and I look forward to seeing what the future holds for the Angelman syndrome community.

GTX-102 demonstrates a paternal UBE3A gene targeting strategy can result in substantial clinical activity and in a more rapid time frame than we expected, stated Dr. Scott Stromatt. We better understand the serious adverse events reported with GTX-102 at higher doses and we see a way forward to redose patients and to enroll new patients into the clinical trial. We are working with FDA to reach agreement on a modified trial design.

Study Design and Dosing

Five patients in three dose cohorts were enrolled who all had deletions in the UBE3A locus as the cause of Angelman syndrome and were treated with a monthly intrathecal dose of GTX-102 that increased for each of the first four doses provided to each patient. Two patients in cohort 1 received a monthly ascending dose sequence of 3.3 mg, 10 mg, 20 mg, and 36 mg, with the first patient receiving one additional fifth dose in an extension amendment at the 36 mg level. Two patients in cohort 2 received three sequential monthly doses of 10 mg, 20 mg, and 36 mg. One patient in cohort 3 received a single dose of 20 mg. Further dosing was stopped once the first serious adverse event occurred, as previously described.

Pharmacokinetic results indicate that plasma levels of GTX-102 were dose proportional. GTX-102 was not detectable in the blood or cerebrospinal fluid (CSF) in samples taken one month after the last dose and prior to subsequent monthly doses, indicating that the drug did not accumulate in the blood or CSF.

Interim Efficacy Results

Previously disclosed improvements in the Clinical Global Impression of Improvement Scale for Angelman Syndrome (CGI-I-AS) were presented along with detailed individual results for both global scores and individual domains. The mean change was +2.4 in the CGI-I-AS global score and all patients had at least 3 domains of improvement and 2 domains of much improved or very much improved at this interim assessment.

CommunicationCommunication was one of the most impaired functions in these five patients based on baseline scores and is the most important disease domain for families according to a recently published disease concept model1. Detailed scores from the communication domain of the CGI-I-AS showed much improved or very much improved scores in four of five subjects along with supportive detailed data from other scores. In the Bayley Scales of Infant and Toddler Development (Bayley-4), multiple patients improved on receptive or expressive communication sub-scales. In the Observed Reported Communication Ability (ORCA) measure of expressive, receptive, and pragmatic communication, three patients, ages 5, 10, and 15, demonstrated clinically relevant increases at day 128 and two patients did not have notable changes.

EEG and SeizuresAt baseline, all patients had stable seizure control per protocol requirements and did not have reports of seizures as adverse events during the study. Blinded independent central electroencephalogram (EEG) readings were conducted at baseline and day 128 (day 86 for patient 5) for four of five treated patients to assess delta waves and epileptiform discharges among other findings common in Angelman syndrome. Qualitative readings of the EEGs indicate decreases in the prevalence of notched delta waves in three of the four evaluated patients with patient 1 showing minimal change or a slight increase. Decreases in the prevalence of epileptiform discharges were also observed in three of the four evaluated patients with patient 5 showing minimal change or a slight increase. Quantitative analysis of the EEGs completed to date in the first two patients showed decreases in relative delta power (2-4 Hz) in both evaluated patients after beginning GTX-102. These are preliminary findings and, due to normal variability in EEG tracings, the assessments will be repeated after longer-term treatment with GTX-102.

Gross Motor and Fine MotorPreliminary readings from the ActiMyo device that measures hourly distance walked, stride length, and stride speed, support the utility of this functional measure. One patient, who initially had a decrease in distance walked due to the lower extremity weakness SAE, later was able to exhibit a meaningful increase from baseline as the SAE resolved. Other improvements in fine motor function previously disclosed were presented.

Length of EffectThe clinical changes observed appear to last at least 3 to 5 months from the last dose. To date, most of the subjects have retained many caregiver-reported clinical changes observed but some patients are observed to be experiencing some loss of effect. The long period of observed clinical response post-dose would support use of a maintenance dosing regimen of every 3 months, if an appropriate and safe dosing regimen is identified.

Additional Interim Safety Results

As previously reported, all patients had a grade 1 or 2 serious adverse event (SAE) of lower extremity weakness associated with local inflammation in the region of intrathecal administration in the lower back at the higher doses of GTX-102. The SAE has fully resolved in all five patients.

The SAE occurred between 6 and 30 days after the last infusion of 36 mg in four patients and 20 mg in one patient. In patient 1, the SAE was not observed until after the second dose at the 36 mg level. Clinical improvements observed in the study have been sustained beyond resolution of the SAE and the negative impact of the SAE on gross motor function in certain patients has recovered with resolution of the SAE.

No new adverse events have been reported since the last update. No patients have withdrawn from the study.

Additional Nonclinical Data

Results from additional non-human primate (NHP) studies were also reported including both single dose and repeat dose studies conducted for as long as six months. Toxicology assessments indicated acute clinical observations including sporadic transient lower limb weakness generally resolving by 24 hours after dosing. There was no observation throughout these studies of delayed-onset weakness similar to the human study SAE, which included single doses as high as 10 mg (equivalent to a dose in humans of approximately 110 mg) or at repeat monthly doses as high as 5 mg (human equivalent of approximately 56 mg per dose). No kidney or platelet toxicities were observed in the NHP studies.

The NHP studies also assessed knockdown of the UBE3A-antisense (UBE3A-AS) transcript, the RNA that inhibits expression of the paternal UBE3A allele in Angelman syndrome. Monthly dosing of GTX-102 showed substantial reduction of the UBE3A-AS transcript at monthly doses of 1, 2, and 3 mg. UBE3A-AS reduction occurred in multiple brain regions relevant to Angelman syndrome.

Scientific Detail on GTX-102 Targeting

Detail was presented on the GTX-102 target region in the UBE3A-AS transcript. Dr. Dindots work on understanding the molecular genetics of the antisense transcripts allowed the discovery of a more potent place to target an antisense oligonucleotide (ASO) for the knockdown of the repressive antisense RNA transcripts to induce more UBE3A expression. The manuscript describing the work performed by Dr. Dindots laboratory is currently under review.

Update on Clinical Study Next Steps

The companies will propose a plan to the FDA to resume enrollment and dosing in the study which is currently on hold. The proposed plan is to amend the dosing and titration regimen to start at a low dose and titrate individually, based on patient age and response to GTX-102. The maximum dose will be below 20 mg, which is the lowest dose at which the lower extremity weakness SAE was observed. Also, a new administration procedure will be used to minimize duration of exposure at the injection site. The companies aim to resume enrollment as soon as possible following receipt of guidance and approval from the FDA.

1: Willgoss, T.et al.Measuring What Matters to Individuals with Angelman Syndrome and Their Families: Development of a Patient-Centered Disease Concept Model.Child Psychiatry Hum Dev(2020). https://doi.org/10.1007/s10578-020-01051-z

About Angelman Syndrome

Angelman syndrome is a rare, neurogenetic disorder caused by loss-of-function of the maternally inherited allele of the UBE3A gene. The maternal-specific inheritance pattern of Angelman syndrome is due to genomic imprinting of UBE3A in neurons of the central nervous system, a naturally occurring phenomenon in which the maternal UBE3A allele is expressed and the paternal UBE3A is not. Silencing of the paternal UBE3A allele is regulated by the UBE3A antisense transcript (UBE3A-AS), the intended target of GTX-102. In almost all cases of Angelman syndrome, the maternal UBE3A allele is either missing or mutated, resulting in limited to no protein expression. This condition is typically not inherited but instead occurs spontaneously. It is estimated to affect 1 in 12,000 to 1 in 20,000 people globally.

Individuals with Angelman syndrome have developmental delay, balance issues, motor impairment, and debilitating seizures. Some individuals with Angelman syndrome are unable to walk and most do not speak. Anxiety and disturbed sleep can be serious challenges in individuals with Angelman syndrome. While individuals with Angelman syndrome have a normal lifespan, they require continuous care and are unable to live independently. Angelman syndrome is not a degenerative disorder, but the loss of the UBE3A protein expression in neurons results in abnormal communications between neurons. Angelman syndrome is often misdiagnosed as autism or cerebral palsy. There are no currently approved therapies for Angelman syndrome; however, several symptoms of this disorder can be reversed in adult animal models of Angelman syndrome suggesting that improvement of symptoms can potentially be achieved at any age.

About GTX-102

GTX-102 is an investigational antisense oligonucleotide designed to target and inhibit expression of UBE3A-AS. Nonclinical studies show that GTX-102 reduces the levels of UBE3A-AS and reactivates expression of the paternal UBE3A allele in neurons of the CNS. Reactivation of paternal UBE3A expression in animal models of Angelman syndrome has been associated with improvements in some of the neurological symptoms associated with the condition. GTX-102 has been granted Orphan Drug Designation, Rare Pediatric Disease Designation, and Fast Track Designation from the U.S. Food and Drug Administration (FDA). In August 2019, GeneTx and Ultragenyx announced a partnership to develop GTX-102, with Ultragenyx receiving an exclusive option to acquire GeneTx.

About GeneTx Biotherapeutics

GeneTx Biotherapeutics LLC is a startup biotechnology company singularly focused on developing and commercializing a safe and effective antisense therapeutic for the treatment of Angelman syndrome. GeneTx was launched by FAST, a patient advocacy organization and the largest non-governmental funder of Angelman syndrome research. GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017.

About Ultragenyx

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyxs strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the companys website at http://www.ultragenyx.com.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx's expectations and projections regarding its business plans and objectives for GTX-102, the therapeutic potential and clinical benefits of GTX-102, expectations regarding the safety and tolerability of GTX-102, and future clinical developments for GTX-102 are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the Companys ability to successfully develop GTX-102 at lower doses, including the resolution of adverse events that were seen at higher doses, whether lower doses of GTX-102 are sufficiently effective to support the continued development of the program, the effects from the COVID-19 pandemic on the companys commercialization activities, business and operating results, smaller than anticipated market opportunities for the companys products and product candidates, manufacturing risks, competition from other therapies or products, uncertainties related to insurance coverage and reimbursement status of the companys newly approved products, the companys evolving integrated commercial organization, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the companys future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyxs products and drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx's Quarterly Report on Form 10-Q filed with theSecurities and Exchange CommissiononOctober 27, 2020, and its subsequent periodic reports filed with theSecurities and Exchange Commission.

ContactsUltragenyx Pharmaceutical Inc.Investors & MediaJoshua Higa415-660-0951

GeneTxPaula Evans630-639-7271Paula.Evans@GeneTxBio.com

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GeneTx and Ultragenyx Announce Presentation of Phase 1/2 Data on Investigational GTX-102 in Patients with Angelman Syndrome - GlobeNewswire

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Grantees Awarded as Part of the Breast Cancer Research Project Between NCCN and Lilly Oncology – Newswise

Posted: December 4, 2020 at 11:58 am

PLYMOUTH MEETING, PA [December 3, 2020] The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) today announced five projects selected to receive funding for clinical and preclinical evaluation of abemaciclib. Abemaciclib is a cyclin dependent kinase (CDK) 4 & 6 inhibitor used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The proposals were reviewed and awarded by a scientific steering committee made up of experts from NCCN Member Institutions, and the NCCN ORP is handling project oversight. Research funding is being provided by a grant from Eli Lilly and Company.

The selected projects are:

Congratulations to all of these accomplished grantees, said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. We are eager to learn more about which patients develop resistance to CDK 4 & 6 inhibitors, the potential underlying mechanisms, and ways in which such resistance can be overcome, in order to improve the application of this potentially life-prolonging therapy. This research is one of the many ways we work to improve longevity and quality-of-life for people with metastatic breast cancer.

I have had a frontline view of how metastatic breast cancer can be unpredictable and complex, said Maura Dickler, MD, Vice President, Late Phase Development, Lilly Oncology. Every day the lives ofan estimated 115 women and menin the United States are lost as a result of this disease. Lilly is honored to support this research because it is critical in furthering our efforts to improve treatment options for people living with metastatic breast cancer.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

* The preclinical studies by Drs. Olmez and Zeng have already begun. The remainder are expected to commence in mid-2021.

# # #

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg, and Twitter @NCCN.

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Grantees Awarded as Part of the Breast Cancer Research Project Between NCCN and Lilly Oncology - Newswise

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Astronauts harvest radishes grown aboard the International Space Station – CNN

Posted: at 11:57 am

On Monday, NASA flight engineer Kate Rubins pulled out 20 radish plants grown in the space station's Advanced Plant Habitat, wrapping them in foil for cold storage until they can make the voyage back to Earth next year.

"I've worked on APH since the beginning, and each new crop that we're able to grow brings me great joy because what we learn from them will help NASA send astronauts to Mars and bring them back safely," said Nicole Dufour, the Advanced Plant Habitat program manager at NASA's Kennedy Space Center, in a news release.

Back on the ground, scientists at the Kennedy Space Center in Florida are growing radishes in a control group set for harvest on December 15. The researchers will compare the space-grown radishes to the veggies grown on Earth, checking on how space produce measures up on providing the minerals and nutrients astronauts need as they prepare for longer trips.

Meanwhile, astronauts will repeat the radish experiment in the heavens, planting and harvesting another round of radish crop to give scientists more data to draw from.

With their short cultivation time, radishes present potential advantages as a food source for future astronauts embarking on deep space missions in years to come. The radishes grow quickly, and they can reach full maturity in 27 days.

The root vegetables also don't require much maintenance from the crew as they grow.

"Radishes provide great research possibilities by virtue of their sensitive bulb formation," said Karl Hasenstein, a professor of biology at the University of Louisiana and the principal investigator on the project, in a news release.

Researchers will analyze the effects of carbon dioxide on the radishes as well as how the vegetables acquire and distribute minerals, according to Hasenstein, who has run plant experiments with NASA since 1995.

Astronauts have grown 15 different types of plants on the station, including eight different types of leafy greens. And NASA has already tested more than 100 crops on Earth, identifying which candidates to try out next in space.

"Growing a range of crops helps us determine which plants thrive in microgravity and offer the best variety and nutritional balance for astronauts on long-duration missions," Dufour said.

Years of research with space crops

Researchers at NASA began experiments using its Vegetable Production Systems growth chambers back in 2014 shortly after they were delivered to the space station.

In August 2015, NASA shared a video that features American astronauts Dr. Kjell Lindgren and Scott Kelly floating aboard the station, saying "Cheers" and eating the space-grown treat.

"Tastes good," Kelly said.

Getting space agriculture right matters because the nutrients in the prepackaged food that astronauts currently eat in space degrade over a period of time, NASA said.

Getting humans to Mars and back safely over a two- or three-year mission requires growing food along the way. That not only gives astronauts more of a vibrant supply of fresh nutrients on the voyage; it also serves an emotional need as they tend to crops that are both a figurative and literal taste of home, according to the agency.

The NASA Artemis program aims to land the first woman and next man on the moon in 2024, and to establish a sustained presence on the moon by 2028. From there, the agency will be poised to begin staging its next big leap, to Mars.

But before we make it to the red planet, we've first got to make a tasty green space salad.

CNN's Ashley Strickland contributed to this story.

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Art projects from 2 students head to the International Space Station – KCTV Kansas City

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Art projects from 2 students head to the International Space Station - KCTV Kansas City

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Celebrating 20 years of space station research, discovery | Technology Today – Theredstonerocket

Posted: at 11:57 am

The past 20 years aboard the International Space Station have yielded scientific and technological advancements in the only laboratory available for long-duration microgravity research. These include fundamental disease research, the discovery of steadily burning cool flames, new water purification systems, and drug development using protein crystals.

Fundamental disease research: Those impacted by Alzheimers disease, Parkinsons disease, cancer, asthma or heart disease have been personally touched by space station research. Microgravity research has provided new insights to scientists studying these diseases. Studying cells, organoids, and protein clusters without the influence of gravity or even the forces of container walls can help researchers get a clearer understanding of their properties, behaviors and responses to treatments.

Without the interference of Earths gravity, Alzheimers researchers on the space station have studied protein clusters that can cause neurodegenerative diseases. Cancer researchers studied the growth of endothelial cells on the space station.

Discovery of steadily burning cool flames: Fire typically conjures thoughts of heat, but special flames created aboard the space station keep things a bit cooler. When scientists burned fuel droplets in the Flame Extinguishing Experiment study, something unexpected occurred. A fuel droplet appeared to extinguish but actually continued to burn without a visible flame. The fire went out twice once with and once without a visible flame. This is the first time scientists observed large droplets of heptane fuel that had dual modes of combustion and extinction. The second stage was sustained by what is known as cool flame chemical heat release.

Removing gravity from studies of combustion allows for exploration of the basic principles of flames. Cool flames have been produced on Earth, but they quickly flicker out.

New water purification systems: The space stations life support system was developed to provide the crew with clean air and water. The Water Recovery System purifies and filters the stations water, recovering and recycling 93% of the water astronauts use in space. This technology is licensed for adaption into an Earth-based water treatment system, with the first ground-based water filtration systems using NASA technology installed in Iraq in 2006 Marshall engineers helped install and test the system in the northern village of Kendala, after the pump for the villages deep-water well failed. Station research studies likeAquaMembranehave also tested out other innovative water systems.

Efficiently recycling wastewater aboard the space station reduces the need to provide water through resupply missions. As humans travel deeper into space, resupply will be unachievable, making these systems a necessity. The restrictions imposed by the requirements of space prompted innovation that was applied to Earth.

Water is vital for human survival. Unfortunately, many people around the world lack access to clean water. At-risk areas can gain access to advanced filtration and purification systems through technology developed for the space station, making a lifesaving difference in these communities.

Drug development using protein crystals: Humans are composed of more than 100,000 types of proteins. Each protein provides information related to health. Studying these proteins by crystallizing them helps scientists learn more about the body and potential disease treatments.

Protein crystals grown on Earth are affected by gravity, which may alter the way the molecules align on the crystal. Researchers have discovered that growing crystals aboard the space station allows for slower growth and higher quality crystals. This high-quality crystallization allows scientists to identify the structures of disease-causing proteins to develop a new medications and effective treatments. Protein crystal growth experiments conducted aboard the space station have provided insights into numerous diseases, from cancer to gum disease.

One of the most promising results of these station experiments has come from thestudyof a protein associated with Duchenne Muscular Dystrophy, an incurable genetic disorder that affects 1 in 3,600 young boys. A treatment based on this research is in clinical trials.

Another investigation, PCG-5, sought to grow the therapeutic antibody Keytruda in a more uniform crystalline form. The goal was toimprovethe drug so it can be delivered by injection rather than an IV treatment.

Editors note: This is the first in a five-part series highlighting scientific and technological breakthroughs that have been achieved over the past two decades as a result of International Space Station science. This research helps humanity explore farther into space while also benefiting life on Earth. The Payload Operations Integration Center at Marshall Space Flight Center schedules, assists with, and coordinates all experiments on the stations U.S. Orbital Segment.

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HemoCue Lab-Accuracy: Soon Counting White Blood Cells in Outer Space. Innovative Technology Onboard SpaceX Falcon 9 Mission CRS-21 – Bound for…

Posted: at 11:57 am

STOCKHOLM, Dec. 2, 2020 /PRNewswire/ -- On December 5, 2020 at 11:37 AM ET, new critical research projects fly on the 21st SpaceX Cargo Mission heading for the International Space Station (ISS). HemoCue is proud to announce its participation in this adventure and for being selected in the critical research and technology demonstration run by NASA Human Research Program. A small drop of blood can be an ocean of knowledge - perhaps even in outer space.

With close to 40 years of experience providing quality and trusted technology to customers worldwide, HemoCue is proud to support the NASA Human Research project and provide the crew members on board the International Space Station with this unique benefit of running a total white blood cell (WBC) count including a 5-part differential within minutes*. Verification of an autonomous capability for blood analysis on the space station is an important step toward meeting the health care needs of crew members on future explorative missions, including projects like e.g. NASA's Artemis program to the Moon.

The research project will test the ability of the HemoCue device to provide quick and accurate counts of total and differentiated white blood cells in microgravity. A successful demonstration means that the device could be considered for use on future exploration missions to indicate the presence of certain medical conditions, diagnose illnesses, monitor conditions such as bacterial/viral infections or radiation exposure, track the response to treatment, and assess the severity of an illness during interplanetary spaceflight.

"HemoCue has been at the forefront of point-of-care testing technology for close to 40 years and we intend to continue to innovate and advance the healthcare industry long into the future. I am excited to see how our dedication and innovation can touch people's lives in the years to come - and now soon also being used by astronauts on board the ISS. We are eager to see how the ease of use, lab-accuracy and well-known HemoCue quality will provide the astronauts on board the ISS with assistance in diagnosing and treating medical conditions even in this demanding environment", says Christophe Duret, CEO at HemoCue.

"HemoCue products have been tested in evaluation projects in demanding environments over the years. From 0 gravity tests preparing for space flights, extreme conditions in Antarctica, tough expeditions in Himalaya and travelling with drones in Malawi - our products and technologies have been exposed to the most challenging situations in the past and have now also shown that the ease of use and robustness makes them qualified even for space research missions", Christophe Duret concludes.

December 2, 2020Christophe Duret, CEOHemoCue AB

*HemoCue WBC DIFF System is not available in the US.

For additional information about HemoCue AB and our products and services, visit http://www.hemocue.com.

HemoCue Corporate Head OfficeHemoCue AB | Kuvettgatan 1 | SE-262 71 ngelholm, Sweden.Email: [emailprotected]| Phone: +46 77570 02 10 | Fax: +46431 48 12 25 | Web: http://www.hemocue.com

About HemoCue

HemoCue is a global leader in a field of diagnostics known as near-patient, or point-of-care, testing. In 1982, HemoCue AB, based in ngelholm, Sweden, introduced the first system making accurate hemoglobin testing possible in near-patient settings. Since then, more than 400,000 HemoCue systems have been sold worldwide. The company offers point-of-care tests for hemoglobin, glucose, urine albumin, HbA1c, total and differential white blood cell count. HemoCue subsidiaries, franchises, and third-party distributors supply HemoCue products in more than 130 countries worldwide. HemoCue has been part of the Danaher Corporation's diagnostic platform since April 2013. Additional company information is available at http://www.hemocue.com

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HemoCue Lab-Accuracy: Soon Counting White Blood Cells in Outer Space. Innovative Technology Onboard SpaceX Falcon 9 Mission CRS-21 - Bound for...

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Proposed New Russian Space Station Will Be Able to Monitor the Entire World – Space Daily

Posted: at 11:57 am

On Thursday, Russia's Energia Corporation, tasked with managing Russian modules aboard the International Space Station, proposed the creation of a new, national orbital space station, to be deployed sometime after the year 2024.

Russia's next orbital space station may be deployed at an orbit that will allow it to keep an eye on the entire surface of the Earth, and the Arctic region in particular. That's according to an Energia Rocket and Space Corporation document submitted to the Russian Academy of Sciences' Space Council seen by Sputnik.

According to the company, two orbital inclinations - 72 and 98 degrees, have been proposed for the new station, with the latter suggested for the first time ever.

A 72 degree inclination would allow the station to observe the Earth's surface at latitudes up to 80 degrees, giving a clear view of most of the planet's surface, including the outer ring of the Arctic Circle and the prospective Northern Sea Route transport artery. An orbital inclination of 98 degrees would enable for the entirety of the Earth to be monitored by the station.

Dr. Andrei Ionin, a member of the Tsiolkovsky Russian Academy of Cosmonautics, and senior expert on Russia's GPS equivalent, GLONASS, says an inclination of 98 degrees could assist in the monitoring of northern territories, although less expensive Russian satellites weighing 15 kg apiece are also capable of doing the same job.

"No one has ever set up space stations at such inclinations. Such orbits are necessary for observing the Earth. They are convenient because the Sun is consistently situated at a certain angle, this is called the sun-synchronous orbit, and the equipment for filming needs to be calibrated only once," Ionin explained.

Russia has contributed vast economic and military resources in recent years to shoring up its presence in the Arctic in an effort to turn its northern territories into a major driver for economic growth, both through the exploration of the region's vast untapped natural resources, and the creation of a new major transport route to ease trade between Europe and Asia.

New Russian Space StationEnergia Corporation has been lobbying for the creation of a new, autonomous Russian space station for years. On Thursday, at a meeting chaired by Russian Academy of Sciences President Alexander Sergeev, Vladimir Soloviev, Energia's deputy director-general, indicated that Russia needs to consider creating a new national space station because the International Space Station's systems are beginning to show their age. Soloviev later also clarified that Russia has no plans to give up on the ISS or end its existing partnerships with other space-faring nations.

The new proposed Russian space station is expected to have between three and seven modules, and to host crews of between two to four people. It is expected to be deployed at some point after 2024, although no exact time frames have been set thus far.

In October, Soloviev indicated that the new Russian station would be similar in design to the Mir, a Soviet space station design which operated between 1986 and 2001, and which in many ways served as a precursor to the ISS.

According to the senior Russian space industry official, the station could include a commercial module for accommodating four space tourists, with the module including two large portholes and Wi-Fi access. Additionally, engineers plan to make it possible to regularly dock the station to a free-flying lab module.

At present, it's planned to launch the station's modules using the new Angara-A5 heavy lift launch vehicle, which is capable of launching at least 24.5 tonnes of useful cargo into orbit. Earlier this year, Energia proposed using the Angara-A5 as an inexpensive means to send Russian cosmonauts to the Moon and back without the need to develop a new super-heavy lift rocket.

Source: RIA Novosti

Related LinksEnergia CorporationSpace Tourism, Space Transport and Space Exploration News

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ISS astronauts celebrated Thanksgiving aboard the space station – SlashGear

Posted: at 11:57 am

Thanksgiving 2020 was as much of a mess for most people as the majority of the year has been. Many were unable to visit family due to social distancing. Astronauts aboard the ISS were about as socially distanced from their families as you can get, but they still celebrated Thanksgiving. NASA astronaut Kate Rubins talked about what the astronauts did aboard the ISS as it orbited the Earth at 17,500 miles an hour.

She noted that her and the three other NASA astronauts were excited to celebrate the holiday in space with their international crewmembers. To the astronauts aboard the station are from Russia, and another is from Japan. American astronauts currently aboard the station include Rubins, Michael Hopkins, Victor Glover, and Shannon Walker. Rubins noted they would enjoy each others company and that the astronauts would speak to family members on the phone.

Glover noted that the astronauts plan to have cornbread dressing, with the caveat that their stuffing came and paste form. The astronauts also got to have turkey and other traditional Thanksgiving dishes. Walker was most excited about the astronauts getting to stream a football game aboard the ISS.

The astronauts from other countries where Thanksgiving isnt typically celebrated also shared some special foods. Japanese astronaut Noguchi intended to share curry rice, red beans and rice, and seafood prepared by high school students from Japan. Theres no word if the Russian astronauts added anything to the Thanksgiving celebration.

The crew aboard the ISS currently numbers seven, and most will be on the space station for six months as the crew works on maintenance and research. Six months seems like a long time to eat most of your food as a paste. We cant help but wonder how good turkey paste would taste.

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Op-ed | China, the moon, Mars, and beyond an opportunity for human cooperation – SpaceNews

Posted: at 11:57 am

SpaceNews photo illustration

China this week is conducting a robotic lunar sample return mission, something the United States has never done.

The grab-and-go sample return is proceeding while a Chinese lunar rover is wrapping up its second year of service on the moon on its far side,something also never done by the United States.

Another Chinese rover mission, Tianwen-1, is on its way to Mars and scheduled to land there in February around the same time NASAs Mars 2020 rover and the United Arab Emirates Hope orbiter are due to reach the red planet.

And China is scheduled to launch the first element of its space station early next year as well.

Beyond? They have described a mission to be launched in 2024 to reach 100 astronomical units (roughly 100 times the distance between the Earth and the sun) in 2049 to commemorate the 100th anniversary of founding of the Peoples Republic of China.

It is not a space race; they havent challenged the U.S. and we are largely ignoring these developments. They may have a human landing goal, but not until the 2030s. They are proceeding methodically with human spaceflight, focusing on a space station not on the critical path to the moon.

In the meantime, they are also undertaking robotic solar system goals. Why? Surely not for any militaristic or economic goals. It is equally doubtful that understanding lunar and Martian geology or the physics of the interstellar medium is a high strategic priority.

And, as we already know, there is no national security advantage to human spaceflight in Earth orbit, so their space station is not for that. National security comes from automated spacecraft with communications, remote sensing and other robotic capabilities. It seems to me that China is heading to the moon, Mars and beyond because they want to be a great country leading the world not just in one or two areas but in all areas of science and technology part of their long-term effort for economic growth.

The change of U.S. presidential administrations in January, U.S. and Chinese robotic Mars landings in February, and the dawning recognition that the U.S. Artemis lunar landing goal is unrealistic creates an opportunity for rethinking Americas human space goals perhaps redirecting them to serve American national goals instead of merely those of the space industry.

We have only done that twice in all of the space age once with Apollo to demonstrate American Cold War technological superiority, and then with bringing the Russians into the International Space Station to forestall them selling post-Soviet arms to rogue states. With the incoming administration of U.S. President-elect Joe Biden wanting to bring American foreign policy back from isolation and confrontation, the space program could play a role by engaging China on the creation of an international lunar station, boosting our space program and giving us a benign foreign policy initiative.

Engage China!? That is totally anathema to current American policy and broader attitudes. Probably the only thing the Biden and Trump administrations agree on is being tough on China. And the space community would rather have another space race for its own advantage.

But another space race is not likely, not with all the other competing domestic priorities and it would serve no U.S. strategic goal. The growing Chinese economy is seen as a threat, not as an opportunity. But so far, the U.S. reaction has been defensiveness to weakly hide behind walls and other barriers, and a lot of hand-wringing. If we want to act strong (but not dangerously), we might try co-option through cooperation. Invite them to play on our field of 350 million people, instead of allowing ourselves to play on their field of 1.4 billion.

Engaging China, given the current policy climate, would be difficult. It would involve dealing with hawks and hard-liners amid a backdrop of contentious issues: notably trade, security and human rights.

The best bet would be to start with something symbolic, as the U.S. and Russia did with the Apollo-Soyuz mission in 1975 and the Shuttle-Mir program in the mid-1990s.

Inviting a taikonaut to the International Space Station would be a harmless gesture that would raise public interest in the ISS. China also might value gaining some ISS experience prior to operating its own space station.

Each nations current lunar and Mars programs would continue on their current course, but could be gradually enhanced with international cooperation while serving the bigger context of human activity on the moon and Mars.

Those expecting commercial development and other private ventures on the moon will find Earths nearest neighbor large enough to accommodate lots of interests. Chinas presence is not uncertain they are doing that anyway. The scale and the reality of lunar development can only be enhanced by coordination and cooperation.

The political risks of lunar engagement are small but the potential payoff is large: cooperation on a great venture off this world, increasing mutual understanding on it.

Louis Friedman is the co-founder and executive director emeritus of The Planetary Society.

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Theres Fabric on the Space Station That Scientists Are Using to Listen for Space Dust Impacts – Universe Today

Posted: at 11:57 am

One of the biggest threats to the International Space Station (ISS) comes from micrometeoroid impacts. A small hole in the wrong place can throw the resident astronauts into a life threatening situation. Currently, there is no active program to monitor these types of impacts, though scientists think they must be common given the ubiquity of small objects in the ISSs orbit. An interdisciplinary team from MIT hopes to provide some data to support that theory by using an extremely unusual impact sensor made almost entirely out of fabric.

Exterior paneling on the ISS is already covered in a fabric material called Beta cloth, which gives the space station its distinctive white color. The teflon-laced fiberglass material is designed to protect the space station from small scale impacts. However, it does not actively monitor whether or where an impact has occurred, making it difficult for astronauts to determine if a piece of the fabric needs to be repaired or replaced.

Enter the material designed by the team at MIT. It uses thermally drawn acoustic fibers which are hypersensitive to mechanical vibrations. The fabric also converts those mechanical vibrations directly into electric energy using the piezoelectric effect. Hooking wires up to individual patches of material would provide a grid-like structure and allow engineers to count the number and size of impacts affecting the fabric.

Samples of these highly sensitive fabrics, as well as others that have electronics embedded directly in them, were sent to the ISS earlier in November. While the samples remain unpowered for now, a 10cm x 10cm swatch is currently attached to the exterior of the ISS. The team plans to expose the sample to the rigors of space for one year, after which it will be returned to Earth and analyzed for any changes.

In addition to analyzing the return sample, the team plans to launch powered versions of the fabrics in late 2021 or early 2022. Powered fabrics are not only useful to detect debris impacts though. The team also plans to brainstorm other use cases for the material. Numerous applications have already been developed on the ground, but space is a new frontier for this novel technology.

Ideas include everything from the detection of cosmic dust to haptic feedback and communication networks embedded in the fabrics of space suits. Since the idea of using these fabrics in space is still so new, the inventors at MIT are exploring many potential options to truly understand the potential of this ground-breaking technology. If they prove up to the challenge, the ISS, and many other permanently space-faring vehicles, might get a whole new high-tech set of clothes.

Learn More:MIT News 3 Questions: Using fabric to listen to space dustTevo News MIT Team send high-tech fabrics into spaceHackster.io Future Astronauts Could Gain a Sense of Touch Thanks to MIT Smart Fabrics Aboard the ISS

Lead Image Credit: JAXA / Space edited by MIT News

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