Aleafia Health Announces Change to Board of Directors
By Dr. Matthew Watson
TORONTO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Aleafia Health Inc. (TSX: AH, OTC: ALEAF) (“Aleafia Health” or the “Company”) today announced that Rhonda Lawson has resigned as a director of the Company.
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Aleafia Health Announces Change to Board of Directors
Elevian Targets Aging to Solve Humanity’s Toughest Diseases – BioSpace
By daniellenierenberg
Mark Allen, CEO of Elevian, pictured above. Photo courtesy of Elevian.
Once the domain of mythical fountains of youth and movies like The Curious Case of Benjamin Button, the science of aging prevention and reversal is beginning to enter the mainstream with reputable academic institutions launching companies to accomplish this once improbable feat.
One such company, Elevian, founded by a team of Harvard scientists and physician-turned entrepreneurDr. Mark Allen, is working to restore regenerative capacity with the aim of preventing and treating age-related diseases. A critical factor, they say, is a single protein called Growth differentiation factor 11 (GDF11).
Allen, Elevians chief executive officer, first became interested in the science of aging after taking a course focused on exponential thinking.
All of a sudden, problems that were heretofore unsolvable become solvable, Allen said of the theory that is the opposite of incremental and encourages one to think outside of the box. They talked about examples of problems that weve always thought to be unsolvable, one of them being aging and longevity. So that was it for me. I was like thats perfect for me. Thats what I want to work on.
Searching for clues into the diseases associated with aging, Elevians founders, including Harvard professor of Stem Cell and Regenerative BiologyDr. Amy Wagers, mined the proteome, looking into how proteins change with age. They uncovered several, including one with potentially groundbreaking regenerative capabilities, GDF11.
Elevian believes that this single protein, a key player in the circulatory system, could be a game-changer in regenerative medicine.
GDF11 is one of those proteins that change with age, Allen said. They [the founders] really dug into GDF11 because so little was known about it at the time of their discoveries. They did side-by-side studies with the parabiosis model, injecting just GDF11, to see if it could reproduce some of the effects of parabiosis in the aged animal. And they found, much to everybodys surprise, that replenishing just this one circulating factor was able to reproduce the beneficial effects of parabiosis.
Parabiosis, which means living beside, is performed by joining two living organisms surgically to develop a single, shared physiology. It has been used to study conjoined twins, and more recently, in a 1972 lifespan study attaching old and young rats, scientists Frederic C. Ludwig and Robert M. Elashoff showed evidence of an extended lifespan for the older animals.
As a post-doc at Harvard, Dr. Wagers expanded upon this research using modern histology techniques. When Wagers and her colleagues attached the circulatory systems of young mice to old ones, they found strong evidence of a biological reversal of cardiac hypertrophy, which occurs with aging. They attributed this to GDF11 in a paper published in Science in 2014 and recognized as a runner-up to the publications Breakthrough of the Year.
What they found is that the old animals exposed to young blood experienced a biological reversal of aging by many different measures. Their brains grow younger, their hearts grow younger, their lungs, their bones all over their body. And interestingly, the young animals exposed to old blood have accelerated aging. So this is just really strong proof that circulating factors regulate aging, said Allen.
The mechanism of action appears to be that GDF11 binds directly to the endothelial projectors, the cells that line our blood vessels and improve both the quality and quantity of the vasculature. It does not cross the blood-brain barrier, so we think its mechanism is primarily by improving vasculature, he explained.
Elevian, the recent beneficiary of an initial round of seed financing, is actioning this potent protein to develop a potential regenerative treatment for stroke patients.
English biomedical gerontologist Aubrey de Grey, whom Allen credits with doing a lot to start the medical field of aging reversal, outlined several hallmarks of aging in his 2007 book, Ending Aging. These include stem cell exhaustion, protein aggregate buildup, failed intercellular communicationand senescent cells.
One of the barriers to developing therapeutics based on these factors is the inherent incongruence with the usual regulatory approval systems. Following customary protocol, proving that a drug prevents aging or age-related diseases would quite literally take a lifetime.
Theres no regulatory path for treating aging. Even doing a prevention trial would take years and years and years, because you have to take people and wait until they get disease to see effects. So instead, to get a drug to market, we take the opposite extreme. We look at what is the most devastating possible disease, unmet need, where we could treat for the shortest possible duration and see clinically meaningful effects, Allen explained.
Elevian decided on stroke, which is the number two cause of death worldwide and the third leading cause of disability.
The only existing treatments for a stroke are limited to the acute phase, where an IV injection of a drug such as recombinant tissue plasminogen activator (tPA) (Activase)restores blood flow by dissolving the clot causing the event.
In an ischemic stroke, which makes up 87% of cases, a blood clot forms and prevents blood and oxygen from reaching an area of the brain, impacting breathing and heart function and often leading to paralysis. This is where Elevian believes a drug utilizing GDF11, which acts on the circulatory system, holds such promise for rehabilitation.
Allen revealed that his team has already demonstrated GDF11s impact on stroke-stricken animals.
When we give GDF11 to animals that have had strokes and are paralyzed or have severe motor function debilitation, it returns them almost to normal function. It significantly improves motor function recovery, he said.
On the strength of these preclinical results, Elevian is gearing up to enter human clinical trials with GDF11 for the treatment of stroke.
We really got the green light to go into humans based upon the animal data that we got there, Allen said, adding that there is still a lot of work to be done before they reach this phase. We still have to scale up production of the drug and we have to do extensive safety and toxicology tests IND-enabling studies. The longest pole in the tent is figuring out how to make manufacturing costs effective. The cost of goods is going to be really, really high. So were doing a lot of work in process development right now, and then were going to hand it off to a manufacturing partner to scale up. Were about two years from initiating our human clinical trial in stroke.
Another unmet need where Elevian believes GDF11 can have an impact is Type 2 diabetes, a disorder whose pathology is also intricately connected to the circulatory system and often to aging.
Along with blood clotting factors, glucose resides within the inside lining of blood vessels. In Type 2 diabetics, the lining of an individuals blood vessels begins to become glycosylated, which causes them to narrow, impeding blood flow. Glucose tolerance is known to decrease with age.
In a study published in March 2020, Wagers and her colleagues stated that GDF11 was shown to significantly improve glucose tolerance in aged mice and increase glucose homeostasis, under a variety of dietary conditions.
Allen believes that addressing the aging process is the ultimate exponential strategy to solving a whole host of humanitys biggest killers:
This idea that we could, by targeting the aging progress, potentially promote healthy aging, promote a healthy longevity, and reduce the burden of age-related diseases, and that the same treatment could be used to treat and prevent multiple age-related diseases. That concept was like, why arent we working on that? Why are we spending billions of dollars on Alzheimers and billions of dollars on cancer, billions of dollars on heart disease? We could instead target the aging process and potentially treat them all.
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Elevian Targets Aging to Solve Humanity's Toughest Diseases - BioSpace
The Cardiac Rhythm Management Market to undergo an exponential transformation between 2015 and 2021 NeighborWebSJ – NeighborWebSJ
By daniellenierenberg
Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases. Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.
North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.
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Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.
Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market.
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Some of the major companies operating in the global cardiac rhythm management market areMedtronic, Abbott Laboratories, Boston Scientific, St. Jude Medical, Altera, and Sorin.Other companies with significant presence in the global cardiac rhythm management market include
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Alberta Health to cover $2.8-million gene therapy treatment on case-by-case basis – Edmonton Journal
By daniellenierenberg
And for some families this wait is excruciating, he said at a Wednesday news conference.
Shandro said there is no specific budget or cap on how much the government will spend, but that it was working with drug manufacturer Novartis to provide access. Nearly 70 per cent of children with spinal muscular atrophy type 1 do not live past age two. The drug is typically only approved for children under two.
We just dont want kids to fall through the cracks, said Shandro.
Susi Vander Wyk, executive director of Cure SMA Canada, thanked the province for making a decision she said is saving lives.
Its a fairly new treatment, so we dont know the long-term future of it, but we sure know that it has an astounding impact on these babies, she said at the news conference.
The earlier they receive the treatment, the better their prognosis, Vander Wyk said.
Time is ticking for them.
For Lana Martin, whose two-year-old son Kaysen Martin received the Zolgensma treatment in December after fundraising and an anonymous $1.4 million donation, the news was a huge step towards more kids accessing the drug.
Its still early after Kaysens treatment, but hes already more confident in his movements and doesnt tire as easily, said Martin.
He can now officially completely roll from one side of the room to the other side of the room, and he was not able to do that before, she said.
Martin said it was difficult for her and her husband, normally private people, to advocate publicly for the drugs coverage, but shes glad they did.
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Transforming optimism: finding new ways to treat rare cancers – Cancer Research UK – Science Blog
By daniellenierenberg
Cancer is an extremely complex disease. There are over 200 different types, some of which are considered common and others which are classified as rare cancers. But what exactly does it mean if a cancer is rare?
Usually, it means it only affects a small handful of people, but doctors might also call a cancer rare if it starts in an uncommon place in the body, or if the cancer is an unusual type and requires special treatment.
For secondary central nervous system (CNS) lymphoma, its an incredibly rare cancer for a combination of these reasons.
Secondary CNS lymphoma is a type of lymphoma thats spread to the brain and spinal cord nervous system after originating elsewhere in the body. And as well as being a rare cancer, secondary CNS lymphoma is an aggressive cancer, which has relatively low survival rates.
However, the latest results from the Stand Up To Cancer-funded MARIETTA clinical trial, which details a new potentially transforming treatment, has shed a glimmer of hope for patients and doctors alike.
We spoke to Dr Kate Cwynarski, who led the study in the UK, about what the latest results could mean for patients with secondary CNS lymphoma.
With a rare cancer such as secondary CNS lymphoma, finding a large enough group of patients can be a real challenge. And in cases like this, researchers have to think on a global scale.
Its a rare disease. So the reality of it is that you would not get this information if we just performed a trial in the UK, says Cwynarski. International collaboration is the only way to do it.
The MARIETTA trial is the largest study focused on patients with secondary CNS lymphoma, involving 24 centres across 4 countries and recruiting a total of 79 patients. It involved the International Extranodal Lymphoma Group (IELSG) lead by Professor Andres Ferreri in Italy and it built on the success of prior research with this group. In the UK, the trial was managed by CRUK Southampton CTU.
In particular, findings from a previous clinical trial partly funded by us, which tested treatments for primary CNS lymphoma, a lymphoma thats only found in the brain, helped inform the design of this clinical trial.
The IELSG-32 trial tested the benefits of an intensive chemotherapy regimen known as MATRIX, followed by either whole brain radiotherapy or a stem cell transplant using the patients own cells.
Cwynarski describes the IELSG-32 trial as practice changing, and its from these impressive results that the MARIETTA trial was developed. So we adapted a strategy that was successful in treating primary CNS lymphoma in the IELSG-32 trial and added another chemotherapy regimen, called R-ICE, to help treat the systemic disease on top of the secondary brain disease.
Cwynarski specialises in lymphoma, so she has treated SCNSL patients both on and off the trial. One of the big benefits of this trial, she describes, is that the inclusion criteria for the cohort more accurately reflected the patients she sees in her clinic and referral practice.
This trial included patients up to 70 years of age. And it wasnt just focused on fit, young people. So I have to say I think it was meaningful, because it included the kind of patients that we actually see.
The trial also included people regardless of when their secondary CNS lymphoma was diagnosed, whether that was when someone was originally diagnosed with lymphoma, during treatment, or after their cancer had come back.
And the results look promising. A total of 49 patients (65%) responded to the treatment in some way, with 37 people going on to have a stem cell transplant. 100% of the patients who had the stem cell transplant had not seen their cancer recur a year after registering onto the trial. We are optimistic many will be cured of this aggressive lymphoma.
But the trial also picked up differences between groups. While the regime was effective to an extent in every sub-group, the most significant results were seen in patients whose CNS disease was discovered at initial lymphoma diagnosis. Within this group, 71% of patients had lived for 2 years without their cancer growing.
A result which has never been seen before.
The results of the trial have completely transformed the teams optimism when meeting new patients. We really have identified a regimen which is intensive, but its potentially curative, concludes Cwynarski, and the word cure is not something weve really used before when talking about this disease.
Recently, Cwynarski has been busy filling out a cohort of her patients DVLA forms, confirming they are fit to drive again after being 2 years treatment free. So thats an amazing success and it was very symbolic as a reminder that these people have been alive and off all treatment for 2 years.
Moments like this are a reflection of the huge impact the MARIETTA trial has had for real people, like Maureen Brewster.
Maureen was diagnosed with lymphatic cancer of the liver in 2011 and was under the watchful eyes of a consultant during her treatment. But in the summer of 2016, I started to have very extreme headaches, says Maureen.
After getting an emergency appointment, she was taken to A&E and admitted to hospital straight away. I was transferred to the National Neurology hospital in Russell Square for a biopsy. They thought I might have had a stroke. But it wasnt. Instead, Maureen was diagnosed with a secondary cancer in her brain.
When Maureen was transferred to UCLH, she was told about the MARIETTA trial. I could have chosen not to go on the trial, but being part of it meant that I would get more examinations and monitoring. So it was more reassuring to be on the trial, she says.
Maureen during treatment.
Maureen went through 8 tough months of chemotherapy before having a stem cell transplant in the summer of 2017. During one round of chemo in the hospital I became ill with an infection and really thought I was going to die. The last chemo prior to me having stem cell transplant was so strong it really had an impact on me and I couldnt eat I felt very poorly for a few weeks.
Maureens stem cell transplant went smoothly and prior to COVID-19, she was having regular check-ups and scans in hospital.
Prior to the first lockdown in March 2020, Maureen was able to do some volunteering and also go back to work, teaching a course on Project Management at a local adult college. In April 2019 I also secured a part-time job as a User Involvement Co-ordinator. It was great to get back to that level.
Dr Cwynarski emphasises that while the trial was a great success for some, it also exposed a group of patients who didnt do so well on the treatment.
The results threw up a real disparity and uncovered an unmet need in a particular group of patients. For the group of patients whose cancer had already failed to respond to a chemotherapy treatment, known as R-CHOP, at the follow up of 2 years, only 20% had not experienced their cancer progressing or getting worse.
We need to target this cohort of patients in a different way, says Cwynarski. So really the challenge is, can we identify experimental agents be it different biological agents or immunotherapies such as CAR T cell therapy in the patients who have relapsed, and maybe bringing these therapies into the frontline.
Lilly
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Transforming optimism: finding new ways to treat rare cancers - Cancer Research UK - Science Blog
Stem Cell Therapy Market 2021: Global Key Players, Trends, Share, Industry Size, Segmentation, Forecast To 2027 KSU | The Sentinel Newspaper – KSU |…
By daniellenierenberg
Stem Cell Therapy Market is valued at USD 9.32 Billion in 2018 and expected to reach USD 16.51 Billion by 2025 with the CAGR of 8.5% over the forecast period.
Rising prevalence of chronic diseases, increasing spend on research & development and increasing collaboration between industry and academia driving the growth of stem cell therapy market.
Scope of Stem Cell Therapy Market-
Stem cells therapy also known as regenerative medicine therapy, stem-cell therapy is the use of stem cells to prevent or treat the condition or disease. Stem cell are the special type of cells those differentiated from other type of cell into two defining characteristics including the ability to differentiate into a specialized adult cell type and perpetual self-renewal. Under the appropriate conditions in the body or a laboratory stem cells are capable to build every tissue called daughter cells in the human body; hence these cells have great potential for future therapeutic uses in tissue regeneration and repair. Among stem cell pluripotent are the type of cell that can become any cell in the adult body, and multipotent type of cell are restricted to becoming a more limited population of cells.
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The stem cell therapy has been used to treat people with conditions including leukemia and lymphoma, however this is the only form of stem-cell therapy which is widely practiced. Prochymal are another stem-cell therapy was conditionally approved in Canada in 2012 for the treatment of acute graft-vs-host disease in children those are not responding to steroids. Nevertheless, hematopoietic stem cell transplantation is the only established therapy using stem cells. This therapy involves the bone marrow transplantation.
Stem cell therapy market report is segmented based on type, therapeutic application, cell source and by regional & country level. Based upon type, stem cell therapy market is classified into allogeneic stem cell therapy market and autologous market.
Stem Cell Therapy Companies:
Stem cell therapy market report covers prominent players like,
Based upon therapeutic application, stem cell therapy market is classified into musculoskeletal disorders, wounds and injuries, cardiovascular diseases, surgeries, gastrointestinal diseases and other applications. Based upon cell source, stem cell therapy market is classified into adipose tissue-derived mesenchymal stem cells, bone marrow-derived mesenchymal stem cells, cord blood/embryonic stem cells and other cell sources
The regions covered in this stem cell therapy market report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, market of stem cell therapy is sub divided into U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.
Stem Cell Therapy Market Segmentation
By Type
Allogeneic Stem Cell Therapy Market, By Application
Autologous Market, By Application
By Therapeutic Application
By Cell Source
Stem Cell Therapy Market Dynamics
Rising spend on research and development activities in the research institutes and biotech industries driving the growth of the stem cell therapy market during the forecast period. For instance, in January 2010, U. S. based Augusta University initiated Phase I clinical trial to evaluate the safety and effectiveness of a single, autologous cord blood stem infusion for treatment of cerebral palsy in children. The study is estimated to complete in July 2020. Additionally, increasing prevalence of chronic diseases creating the demand of stem cell therapy. For instance, as per the international diabetes federation, in 2019, around 463 million population across the world were living with diabetes; by 2045 it is expected to rise around 700 million. Among all 79% of population with diabetes were living in low- and middle-income countries. These all factors are fuelling the growth of market over the forecast period. On the other flip, probabilities of getting success is less in the therapeutics by stem cell may restrain the growth of market. Nevertheless, Advancement of technologies and government initiative to encourage research in stem cell therapy expected to create lucrative opportunity in stem cell therapy market over the forecast period.
Stem Cell Therapy Market Regional Analysis
North America is dominating the stem cell therapy market due increasing adoption rate of novel stem cell therapies fueling the growth of market in the region. Additionally, favorable government initiatives have encouraging the regional market growth. For instance, government of Canada has initiated Strategic Innovation Fund Program, in which gov will invests in research activities carried out for stem cell therapies. In addition, good reimbursing scheme in the region helping patient to spend more on health. Above mentioned factors are expected to drive the North America over the forecast period.
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UTV documentary tells of young Belfast woman’s lasting legacy to promote stem cell donation – The Irish News
By daniellenierenberg
EIMEAR Gooderham (ne Smyth) was just 25 when she died peacefully in hospital with her family at her bedside.
It was just a week after she had married Phillip Gooderham in hospital and she was buried in the wedding dress she never got to wear.
Almost two years on, her family hope a television documentary about Eimear - a make-up artist from the Coolnasilla area of west Belfast - will help create a positive and lasting legacy in her memory.
The programme, due to be broadcast on UTV and presented by journalist Sarah Clarke, features Eimear's own video diaries, which she had hoped would raise awareness of a campaign for stem cell donors that she launched before her death.
Ms Clarke said the documentary had aimed to "follow Eimear's journey, treatment and her recovery".
"She was very open about her battle and while a lot of the programme is distressing, it shows how courageous Eimear was," she said.
Eimear was diagnosed with stage two Hodgkins Lymphoma, a type of blood cancer, in September 2016.
She underwent 12 cycles of intensive chemotherapy and was given the all-clear in spring 2017.
But the disease returned and in December that year, Eimear was treated with an autologous stem cell transplant, intensive chemotherapy and her own stem cells returned afterwards to rescue her bone marrow from the effect of the treatment.
Months later she was given the good news she was in remission, but the Hodgkins Lymphoma returned again and doctors said her best chance of survival was another stem cell transplant - this time from a donor.
With neither of her siblings a match, she desperately needed to find a stem cell donor.
Eimear and her father Sean launched an appeal to raise awareness of the stem cell register, which allows donors of the correct tissue types to be matched with patients.
Their campaign saw the number of people joining the register in Northern Ireland soar.
Determined to use her own experience to help others, Eimear began filming videos on her phone for the UTV documentary.
Her desire to show her cancer battle as well as her upbeat outlook on life are reflected in the diaries, with many filmed as she underwent treatment.
Speaking ahead of the broadcast tonight, Ms Clarke said her own family's cancer battle had also inspired her to tell Eimear's story.
"In 2017, my nephew Jack was diagnosed with leukaemia, aged just 15," she said.
"I remember my brother Simon, who is a doctor, saying they may have to pursue a stem cell transplant. He knew how difficult it would be to find a match and to endure.
"Fortunately Jack didn't need it, but he had to undergo a year of intensive chemo and four years of maintenance chemo.
"It was rough and a very difficult period and thankfully he's now in remission, but it made me relate to Eimear and San's appeal."
On October 31 2018 - a year before Eimear and Phillip had planned to marry - she received her stem cell transplant.
A video extract of the days after the operation shows Eimear describe how "it's been really rough", as the donor's cells began attacking her cells - a condition known as graft versus host disease.
Despite being discharged from hospital, months later she became ill again with complications associated with the transplant - she was losing her brave battle.
Phillip tells the programme: "I wanted to tell her it was going to be ok, but I didn't want to lie to her. I wanted it to be over so she wasn't in pain".
In June 2019, the couple tied the knot and Eimear got "her final wish".
"We had had it planned, we had to cancel our wedding so it was, in the most horrific circumstances, the nicest way to end her life, by her getting her final wish," said Phillip.
Eimear died on June 27 2019.
Since then her family have continued to campaign to raise awareness of stem cell donation.
Her father Sean said they hope the programme will "highlight the need for more people in Northern Ireland to join the stem cell donor register, especially young men aged between 16 and 30".
Sarah also said while the documentary is "not exactly the one we set out to make, its still one of hope and courage".
"It was Eimears dying wish to raise awareness of stem cell donation and to help further research into the treatment to help others," she said.
"She was adamant she wanted people to sign the register and raise awareness. Her family feel the onus is now on them to continue this.
"The programme pays tribute to a courageous young woman and her family's desire to create a positive and lasting legacy in her memory."
Up Close: Eimears Wish is on UTV at 10.45pm.
National Institute for Health and Care Excellence (NICE) recommends lenalidomide as a maintenance therapy for people with newly diagnosed multiple mye…
By daniellenierenberg
National Institute for Health and Care Excellence (NICE) recommends lenalidomide as a maintenance therapy for people with newly diagnosed multiple myeloma who have undergone a stem cell transplant
Uxbridge, UK, 27th January 2021: Celgene, a Bristol Myers Squibb (BMS) company, today announces that NICE has issued a Final Appraisal Document (FAD) recommending REVLIMID (lenalidomide) as maintenance treatment after an ASCT for newly diagnosed multiple myeloma in adults.[iv] From today, approximately 1150 eligible patients in England will have immediate access to lenalidomide as a treatment option, with interim funding provided via the Cancer Drugs Fund (CDF) before transferring to baseline commissioning. Lenalidomide is the first treatment to be made available on the NHS in this setting and provides an alternative to the standard watch-and-wait approach, allowing patients to receive active treatment to keep their cancer in remission.
Graham Jackson, Professor of Clinical Haematology at Newcastle Upon Tyne NHS Foundation Trust said: Multiple myeloma is a relapsing remitting disease where the goal of treatment is to ensure long periods of remission and a good quality of life. Maintenance therapy is integral to achieving this, particularly for newly diagnosed patients who have received a stem cell transplant. Having lenalidomide within our treatment armoury on the NHS will transform the way we manage the early stages of multiple myeloma. In clinical studies maintenance therapy has been shown to almost double the initial period of remission for this group of patients, so it is fantastic to be able to offer active treatment which can help to keep the cancer at bay.
Multiple myeloma is a cancer that affects the production of plasma cells in the bone marrow and in turn impacts the bodys immune system.[v] It is characterised by a relapsing-remitting pattern, which means that the disease goes through periods where the cancer is active and needs treatment, followed by periods where it is under control.[vi] Each time the cancer relapses, the length of time spent in remission shortens.[vii] The objective of maintenance therapy is to control the cancer during the period of remission and delay relapse of the disease.[viii]
Laura Kerby, Chief Executive of Myeloma UK said: We are delighted with this outcome. Patients who receive lenalidomide maintenance after high-dose therapy and stem cell transplant have a significant increase in overall survival, so the decision to make this available through the NHS is fantastic news.
Across the UK, around 1,500 newly diagnosed multiple myeloma patients undergo an ASCT each year,1,2 and most of them will eventually relapse.[ix] This first remission is a critical period for people with multiple myeloma, as it can be an indicator of the overall survival of the disease and it has been shown that effective maintenance therapy could be essential to long-term survival.[x]
Lynelle Hoch, General Manager at Bristol Myers Squibb UK & Ireland commented: Todays announcement marks an important milestone for those living with multiple myeloma, with lenalidomide being the first maintenance treatment option to be made accessible to eligible patients in England. We are grateful for the continued collaboration with NICE, healthcare professionals and Myeloma UK to ensure patients can benefit from lenalidomide in this setting.
Following the publication of this guidance, the NHS in Wales is expected to provide funding and resources for lenalidomide in this setting within two months. The treatment is already available on the NHS in Scotland and in Northern Ireland.[xi],[xii]
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National Institute for Health and Care Excellence (NICE) recommends lenalidomide as a maintenance therapy for people with newly diagnosed multiple mye...
BrainStorm-Cell Therapeutics to Announce Fourth Quarter and Fiscal Year 2020 Financial Results and Provide a Corporate Update – Yahoo Finance
By daniellenierenberg
NEW YORK, Jan. 28, 2021 /PRNewswire/ --BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and year ended December 31, 2020, and provide a corporate update, at 8:00 a.m., Eastern Time, on Thursday, February 4, 2020.
BrainStorm's CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research ,David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.
Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Wednesday, February 3, 2020.
The investment community may participate in the conference call by dialing the following numbers:
Participant Numbers:
Toll Free: 877-407-9205
International: 201-689-8054
Webcast URL: https://cutt.ly/vjBvkTp
Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.
Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.
Replay Number:
Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 39495
About NurOwn
The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
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About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is in active discussions with the FDA to identify regulatory pathways that may support NurOwn's approval in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.
For more information, visit the company's website at http://www.brainstorm-cell.com.
ContactsInvestor Relations:Corey Davis, Ph.D.LifeSci Advisors, LLCPhone: +1 646-465-1138cdavis@lifesciadvisors.com
Media:Paul TyahlaSmithSolvePhone: + 1.973.713.3768Paul.tyahla@smithsolve.com
View original content:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-announce-fourth-quarter-and-fiscal-year-2020-financial-results-and-provide-a-corporate-update-301217243.html
SOURCE Brainstorm Cell Therapeutics Inc
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BrainStorm-Cell Therapeutics to Announce Fourth Quarter and Fiscal Year 2020 Financial Results and Provide a Corporate Update - Yahoo Finance
ToolGen ties up with 3D bioprinting company to apply induced pluripotent stem cells to gene correction – Aju Business Daily
By daniellenierenberg
[Courtesy of ToolGen]
SEOUL --ToolGen, a South Korean developer of genome editing technology, tied up with T&R Biofab, a 3D bioprinting company, to cooperate in applying induced pluripotent stem cells to gene correction. ToolGen has original technology related to third-generation gene scissors to cut out genetic information in cells.
Induced pluripotent stem cells (iPSCs) are derived from skin or blood cells that have been reprogrammed back into an embryonic-like pluripotent state that enables the development of an unlimited source of any type of human cell needed for therapeutic purposes. iPSCs can be derived directly from adult tissues and bypass the need for embryos.
ToolGen signed a memorandum of understanding T&R Biofab, which prints human organs and tissues for clinical transplantation, to develop and utilize cells that combine iPSCs and gene calibration technologies. "Inductive pluripotent stem cells are an ideal platform for developing gene correction therapy because they can be segmented into various cells," said ToolGen co-CEO Kim Young-ho.
ToolGen has partnered with VivaZome Therapeutics, an Australian biotech company, to develop therapies based on exosomes which are recognized for their critical role in cell-to-cell communication and transportation. The market for exosome therapeutics has been growing rapidly, and many life science companies have launched tools and systems to support exosome research.
See the article here:
ToolGen ties up with 3D bioprinting company to apply induced pluripotent stem cells to gene correction - Aju Business Daily
Researchers use patients’ cells to test gene therapy for rare eye disease – National Institutes of Health
By daniellenierenberg
News Release
Thursday, January 28, 2021
Approach could provide new path for difficult-to-treat forms of Leber congenital amaurosis.
Scientists at the National Eye Institute (NEI) have developed a promising gene therapy strategy for a rare disease that causes severe vision loss in childhood. A form of Leber congenital amaurosis, the disease is caused by autosomal-dominant mutations in the CRX gene, which are challenging to treat with gene therapy. The scientists tested their approach using lab-made retinal tissues built from patient cells, called retinal organoids. This approach, which involved adding copies of the normal gene under its native control mechanism, partially restored CRX function. The study report appears today in Stem Cell Reports. NEI is part of the National Institutes of Health.
Our treatment approach, which adds more copies of the normal gene, could potentially treat autosomal-dominant LCA caused by a variety of mutations, said Anand Swaroop, Ph.D., chief of the NEI Neurobiology, Neurodegeneration and Repair Laboratory and senior author of the report.
The U.S. Food and Drug Administration approved Luxturna in 2017 for the treatment of LCA patients with mutations in a gene called RPE65. Although hailed as a major advance in gene therapy, Luxturna is ineffective against other forms of LCA, including those caused by autosomal-dominant mutations in CRX.
The CRX gene encodes a protein (also called CRX) that binds to DNA and instructs the retinas photoreceptors to make light-sensitive pigments called opsins. Without functional CRX protein, photoreceptors lose their ability to detect light and eventually die.
Disorders like autosomal-dominant LCA are tricky to treat with gene therapy, because adding more of the normal gene does not always restore function. People with autosomal-dominant mutations still have one normal copy of the gene, but the mutant version of the protein interferes with the normal protein. Sometimes, instead of restoring normal function, simply adding more of the normal protein can enhance the disease in unpredictable ways.
To explore how gene augmentation adding copies of the normal gene would affect autosomal-dominant LCA, Swaroops team, developed retinal organoids from two volunteers with LCA and from their unaffected family members. Led by Kamil Kruczek, Ph.D., a postdoctoral fellow in Swaroops lab, they built the complex retina-like tissues in several stages, starting with skin cells, inducing the production of mature photoreceptors and other retinal cells with the genetic profile of each volunteer. As expected, patient organoids made far less light-sensing opsin than the organoids made from unaffected family members.
To carefully control how much CRX gene would be expressed by the recipient photoreceptors, the team re-engineered the CRX promoter so it could be delivered with the CRX gene as part of the gene therapy. A promoter is a neighboring sequence of DNA that controls when and how genes are expressed. The researchers packed the gene and their engineered promoter inside a virus that shuttled them into the organoid photoreceptors.
The teams gene augmentation strategy restored some CRX protein function for organoids from both patients, driving expression of opsins in both types of photoreceptors: rods and cones.
The fact that this strategy worked for both CRX mutations was pretty exciting, said Swaroop. Gene augmentation may be a viable therapy for LCA caused by other autosomal-dominant mutations.
This proof-of-concept gene therapy study is the first step toward a potential treatment for a rare form of LCA, said Brian Brooks, M.D., NEI clinical director and co-author on the study. Its a great example of bench-to-bedside science, when researchers in basic and clinical science collaborate.
The current study was funded through the intramural programs of the NEI and the National Institute of Allergy and Infectious Diseases, both part of NIH. Patient samples were collected at the NIH Clinical Center, clinical trial number NCT01432847.
NEI has protected intellectual property around this technology which is available for licensing and or co-development. Details can be found on the NIH OTT Licensing website: Gene Therapy for Treatment of CRX-Autosomal Dominant Retinopathies | Office of Technology Transfer, NIH or by contacting NEI Office of Translational Research mala.dutta@nih.gov
Additional authors include: Zepeng Qu, James Gentry, Benjamin Fadl, Linn Gieser, Suja Hiriyanna, Zacahry Batz, Mugdha Samant, Ananya Samanta, Colin Chu, Laura Campello, and Zhijian Wu.
NEI leads the federal governments research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov.
About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
NIHTurning Discovery Into Health
Kruczek K. Qu Z, Gentry J, Fadl BR, Gieser L, Hiriyanna S, Batz Z, Samant M, Samanta A, Chu CJ, Campello L, Brooks BP, Wu Z, and Swaroop A. Gene therapy of dominantCRX-Leber congenital amaurosis using patient stem cell-derived retinal organoids.Stem Cell Reports, January 28, 2020.https://doi.org/10.1016/j.stemcr.2020.12.018
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Researchers use patients' cells to test gene therapy for rare eye disease - National Institutes of Health
Opdivo Side Effects: What They Are and How to Manage Them – Healthline
By daniellenierenberg
If you have cancer and your doctor recommends Opdivo to treat it, you may be wondering what side effects this drug might cause.
Opdivo (nivolumab) is a brand-name prescription medication used in adults to treat certain types of cancer. These include specific forms of bladder, colorectal, and esophageal cancer, as well as several other cancer types. Its also used in some children to treat colorectal cancer.
Opdivo is a biologic drug (a type of drug made from living cells). Specifically, its an immunotherapy treatment, which means it can cause side effects involving your immune system. Its given as an intravenous infusion (an injection into a vein thats given over a period of time). For more information about Opdivo, see this in-depth article.
Opdivo may be a long-term cancer treatment. Your doctor will decide the length of your treatment based on various factors, including what side effects you experience.
Read on to learn more about the possible mild and serious side effects of Opdivo.
Like all drugs, Opdivo may cause side effects in some people.
The more common side effects of Opdivo include:
For more information about rash as well as muscle, bone, and joint pain, see the Side effects explained section below.
Certain side effects may be more common if other cancer drugs, such as ipilimumab (Yervoy), are part of your treatment plan. You may have a higher risk for certain side effects depending on the type of cancer you have.
Talk with your doctor about your risk for side effects, given your specific treatment plan. Also tell them about any side effect symptoms you may have.
Learn more about Opdivos side effects in the next sections.
You may experience mild side effects with Opdivo, such as:
For more information about muscle, bone, and joint pain, see the Side effects explained section below.
Opdivo may cause mild side effects other than the ones listed above. See the Opdivo Medication Guide for details.
Opdivos mild side effects should be manageable, and theyll likely go away during your treatment. But some could also be signs of more serious side effects.
If any side effects bother you, get worse, or dont go away, talk with your doctor or pharmacist. Try to keep all of your appointments to get Opdivo unless your doctor stops your treatment.
Opdivo may cause serious side effects. While these are generally rare, some people may be at higher risk for certain serious side effects. For example, your risk for some side effects may increase if youre receiving both Opdivo and other drugs for your cancer.
Call your doctor right away if youre having any new or worsening symptoms. If your symptoms feel life threatening, call 911 or get emergency medical care right away.
Serious side effects can include:
For more information on hepatitis, type 1 diabetes, and allergic reaction, see the Side effects explained section below.
Talk with your doctor about your risk for serious side effects. Also let them know about any concerns you may have.
Get answers to some frequently asked questions about Opdivos side effects.
No, Opdivo shouldnt cause confusion. In clinical studies of Opdivo, confusion wasnt a reported side effect.
However, confusion may be a symptom of rare, serious side effects of Opdivo, such as:
Also, Opdivo can cause hyponatremia (low blood sodium levels). Confusion is a symptom of this condition, which was a common side effect in certain clinical studies of Opdivo.
If youre feeling disoriented or having trouble thinking clearly during Opdivo treatment, contact your doctor right away.
In clinical studies of Opdivo as a melanoma treatment, reported side effects were similar to those researchers found when looking at the drug to treat other cancers.
However, Opdivo isnt always used alone to treat melanoma. The risk of side effects may differ depending on your treatment plan. For more information, see the Opdivo Medication Guide.
If youre receiving Opdivo infusions to treat melanoma, ask your doctor about your side effect risks.
Side effects with Opdivo can happen at any time, including after stopping treatment.
For example, severe reactions have happened during Opdivo infusions. However, these are rare compared with mild or moderate infusion-related reactions. Some people have had reactions within 2 days after their infusion, although these are rare as well.
Opdivo may cause your immune system to attack healthy tissues or organs. This can happen anytime during or after stopping Opdivo treatment.
Symptoms of a severe reaction that may happen during an Opdivo infusion can include:
If you have these or other symptoms during an Opdivo infusion, immediately tell the healthcare provider who is giving you the infusion.
Though rare, people have had reactions up to 2 days after their infusion. You should watch for any new or bothersome symptoms on the days between your infusions, too.
If you have a severe reaction, your healthcare provider may stop your Opdivo infusion. If you have a mild or moderate reaction during your infusion, they may slow the rate of infusion or pause it to help manage your symptoms.
Yes, it can. For example, Opdivo treatment could increase your risk for pneumonia. Pneumonia is a serious infection of the air sacs in one or both of your lungs.
In clinical studies for certain cancers, pneumonia was one of the more common serious reactions when Opdivo was used alone or with the cancer drug ipilimumab (Yervoy).
In clinical studies for certain cancers, rare but fatal infections have also occurred when Opdivo was used alone or with other cancer drugs.
Upper respiratory tract infection, such as a cold, is a common side effect of Opdivo. Though upper respiratory tract infections arent usually serious, they can lead to secondary infections such as pneumonia.
See your doctor if you have any infection symptoms such as a cough, shortness of breath, or fever.
Learn more about some of the side effects Opdivo may cause.
You may have painful joints from treatment with Opdivo. Joint pain is a common side effect of the drug.
Muscle, back, and bone pain are also common side effects of Opdivo.
Opdivo can cause your immune system to attack healthy tissues, even after youve stopped the drug. This can happen to any part of your body, including your joints. Rarely, arthritis (swelling in your joints) has occurred with Opdivo treatment.
If youre experiencing pain in your joints or other areas of your body during or after Opdivo treatment, talk with your doctor. They can check your symptoms and suggest ways you can manage them.
For mild joint pain, they may recommend you take an over-the-counter pain reliever, such as ibuprofen (Advil or Motrin). They may also suggest applying ice packs or warm compresses to your joints.
Rash is a common side effect of Opdivo.
In rare cases, Opdivo may cause a severe skin reaction, such as Stevens-Johnson syndrome. It may also result in allergic reactions, which may be mild or serious. Rash can be a symptom of both of these reactions.
During and after Opdivo treatment, contact your doctor if you have a rash that bothers you, gets worse, or doesnt go away. Get emergency medical care right away if you have blisters, peeling skin, or rash accompanied by fever, swelling, or trouble breathing. These could be signs of a severe, life threatening reaction.
If your symptoms are mild to moderate, your doctor may suggest that you manage them with a topical cream or ointment, such as hydrocortisone cream.
If youre having a severe skin reaction, your healthcare provider will pause or permanently stop your Opdivo infusions. Theyll manage the reaction with corticosteroids, such as prednisone, or other immune-suppressing drugs.
Though rare, Opdivo treatment may cause your immune system to attack healthy tissues, including your liver. When this happens, it can cause inflammation (swelling and damage) of your liver known as hepatitis.
This side effect may be more likely to happen if your treatment plan includes both Opdivo and the cancer drug ipilimumab (Yervoy).
If you have hepatitis from Opdivo treatment, your healthcare provider will pause or permanently stop your infusions. Theyll manage the condition with a corticosteroid drug, such as prednisone. In some cases, you may need to take another immune-suppressing drug.
During and after stopping Opdivo treatment, tell your doctor if you have any symptoms of hepatitis, such as:
Rarely, Opdivo may cause type 1 diabetes. With type 1 diabetes, your blood glucose (sugar) level becomes too high because your pancreas isnt releasing insulin. If untreated, this can lead to serious complications. An example is diabetic ketoacidosis (high levels of blood acids called ketones), which can be fatal.
Your doctor may check your blood glucose level while youre getting Opdivo. During and after your treatment, watch for any diabetes or ketoacidosis symptoms, such as:
Remember, high blood glucose can cause severe complications. If you have any of the symptoms listed above, see your doctor or get medical care right away.
Like most drugs, Opdivo can cause an allergic reaction in some people. Symptoms can be mild or serious and can include:
For mild symptoms of an allergic reaction, such as a mild skin rash or itching, call your doctor right away. They may suggest an over-the-counter oral antihistamine, such as diphenhydramine (Benadryl), or a topical product, like hydrocortisone cream, to manage your allergic reaction.
If your doctor confirms you had a mild allergic reaction to Opdivo, theyll decide if you should continue receiving this drug.
If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.
If your doctor confirms you had a serious allergic reaction to Opdivo, theyll stop your Opdivo treatment and decide if another cancer treatment is right for you.
During your Opdivo treatment, consider keeping notes on any side effects youre having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.
Your side effect notes can include things like:
Sharing such notes with your doctor will help your doctor learn more about how Opdivo affects you. Your doctor can also use this information to adjust your treatment plan if needed.
Opdivo may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before starting Opdivo. Factors to consider include those mentioned below.
Stem cell or organ transplant. Opdivo treatment before or after an allogenic hematopoietic stem cell transplant (transplant of blood-forming cells from a genetic match) could cause serious or fatal problems.
If youre planning a stem cell transplant or have had one, talk with your doctor about the safety of Opdivo treatment. Also tell your doctor if youve received an organ transplant.
Allergic reaction. If youve had an allergic reaction to Opdivo or any of its ingredients, Opdivo shouldnt be part of your cancer treatment. Ask your doctor what other medications are better options for you.
Immune system problems. With Opdivo treatment, your immune system may attack healthy tissues.
Before starting Opdivo, tell your doctor if you have an autoimmune or inflammatory condition, such as Crohns disease, ulcerative colitis, or lupus. Tell them even if your condition is in remission (times when youre symptom-free).
History of chest radiation. Opdivo may cause a serious side effect of the lungs called pneumonitis. Your risk for pneumonitis may be higher if youve had radiation treatment to your chest.
Before starting Opdivo, tell your doctor about any past chest radiation treatments youve had and if youve received other drugs similar to Opdivo.
Nervous system problems. In rare cases, Opdivo treatment may cause your immune system to attack your nervous system, including your brain, spinal cord, or nerves.
Before starting Opdivo, tell your doctor if youve had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barr syndrome.
Opdivo doesnt interact with alcohol.
However, alcohol can harm your liver. In rare cases, Opdivo can cause inflammation (swelling and damage) of your liver known as hepatitis. Opdivo can be used to treat some liver cancers.
Ask your doctor if its safe to consume alcohol while being treated with Opdivo.
Its unsafe to be treated with Opdivo during pregnancy. If youre able to become pregnant, youll need to get a pregnancy test before starting Opdivo to make sure youre not pregnant.
Youll also need to use effective birth control during treatment and for at least 5 months after your last infusion.
Opdivos manufacturer hasnt given recommendations about contraception for people taking Opdivo who have a partner who can become pregnant. If you have questions or concerns about this, talk with your doctor.
Its unknown if Opdivo is safe to use while breastfeeding. You shouldnt breastfeed during Opdivo treatment or for at least 5 months after your last infusion.
Before starting Opdivo, talk with your doctor about safe ways to feed your child.
Opdivo may help treat your type of cancer. At the same time, it can put you at risk for rare but serious side effects. However, most common symptoms of Opdivo are mild or manageable.
If youre wondering about Opdivos side effects, talk with your doctor or pharmacist. Ask questions to get the answers you need to feel confident about your cancer treatment. Here are a few to get you started:
My doctor said thyroid problems are possible serious side effects of Opdivo. What symptoms should I watch for?
Opdivo may cause your immune system to attack your thyroid gland, resulting in thyroiditis (inflammation of the thyroid gland). Though thyroiditis isnt usually serious, it can lead to hypothyroidism (low thyroid levels) or hyperthyroidism (high thyroid levels).
Hypothyroidism may happen more often, especially when Opdivo is used with ipilimumab (Yervoy).
Symptoms of hypothyroidism include increased weight, fatigue (lack of energy), and feeling cold. They also include a slow heart rate, depression, and a puffy face.
Symptoms of hyperthyroidism include a fast heart rate, high blood pressure, shaking hands, and trouble sleeping.
Call your doctor if you have any of the above symptoms. They may pause or stop your Opdivo treatment depending on how severe the side effect is. Your doctor may also recommend that you take other medication to treat your hypothyroidism or hyperthyroidism.
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Opdivo Side Effects: What They Are and How to Manage Them - Healthline
Protein identified that may help treat Parkinsons disease – Medical News Today
By daniellenierenberg
Scientists have identified a protein that can slow or stop some signs of Parkinsons disease in mice.
The team found that the bone morphogenetic proteins 5 and 7 (BMP5/7) can have these effects in a mouse model of the disease.
This research, which appears in the journal Brain, may be the first step toward developing a new treatment for Parkinsons disease.
This type of brain disorder typically affects people over the age of 60, and the symptoms worsen with time.
Common symptoms include stiffness, difficulty walking, tremors, and trouble with balance and coordination.
The disease can also affect the ability to speak and lead to mood changes, tiredness, and memory loss.
Parkinsons Foundation report that about 1 million people in the United States had the disease in 2020, with about 10 million affected globally.
Despite this prevalence, scientists are still unsure why Parkinsons disease affects some people and not others, and there is currently no cure.
The National Institute on Aging note that some cases of Parkinsons disease seem to be hereditary. In other words, the disease can emerge in different generations of a family but for many people with the disease, there appears to be no family history.
Researchers believe that multiple factors may affect a persons risk, including genetics, exposure to environmental toxins, and age.
Since there is currently no cure for Parkinsons disease, treatments typically focus on alleviating its symptoms.
Existing treatments can help alleviate of Parkinsons disease, such as stiffness. However, they may work less well, or not work, for others, such as tremors or a loss of coordination.
Though researchers are still unsure why some develop the disease and others do not, they understand what occurs in the brain of a person with Parkinsons.
The disease causes the neurons in the part of the brain that controls movement to stop working or die. The brain region, therefore, produces less of the chemical dopamine, which helps a person maintain smooth, purposeful movement, as the National Institute of Neurological Disorders and Stroke observe.
Also, Lewy bodies occur in the brains of some people with Parkinsons disease. These bodies are clumps primarily made up of misfolded forms of the protein alpha-synuclein.
In their recent study paper, the scientists refer to research suggesting that neurotrophic factors molecules that help neurons survive and thrive could, in theory, restore the function of neurons that produce dopamine. However, the clinical benefit of these factors had yet to be proven.
The team focused on bone morphogenetic proteins 5 and 7 (BMP5/7). They had previously shown that BMP5/7 has an important role in dopamine-producing neurons in mice.
In the latest study, the scientists wanted to see whether BMP5/7 could protect the neurons of mice against the damaging effects of misfolded alpha-synuclein proteins.
To do this, they injected one group of mice with a viral vector that caused misfolded alpha-synuclein proteins to form in their brains. They used other mice as a control group. The scientists then injected the mice with the BMP5/7 protein.
The researchers found that the BMP5/7 protein had a significant protective effect against the misfolded alpha-synuclein proteins.
According to senior study author Dr. Claude Brodski, of the Israel-based Ben-Gurion University of the Negevs Department of Physiology and Cell Biology, We found that BMP5/7 treatment can, in a Parkinsons disease mouse model, efficiently prevent movement impairments caused by the accumulation of alpha-synuclein and reverse the loss of dopamine-producing brain cells. He continues:
These findings are very promising, since they suggest that BMP5/7 could slow or stop Parkinsons disease progression. Currently, we are focusing all our efforts on bringing our discovery closer to clinical application.
The universitys technology transfer company, BGN Technologies, is currently looking to bring the development to the market.
Dr. Galit Mazooz-Perlmuter, the companys senior vice president of bio-pharma business development, notes that There is a vast need for new therapies to treat Parkinsons disease, especially in advanced stages of the disease.
Dr. Brodskis findings, although still in their early stages, offer a disease-modified drug target that will address this devastating condition. We are now seeking an industry partner for further development of this patent-pending invention.
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Protein identified that may help treat Parkinsons disease - Medical News Today
Why Hair Goes Gray, and How to Cover It If You Want To – NewBeauty Magazine
By daniellenierenberg
Lets get into the science behind it: As hair is being formed, melanocytes inject pigment into keratinocytesthe cells containing keratinwhich is the protein making up hair, skin and nails, says Wayne, NJ plastic surgeon and hair specialist Jeffrey B. Wise, MD. Over time, melanocytes continue to inject pigment into the hairs keratin, which is where hair gets its color. In the aging process, melanocytes slow down and eventually stop secreting melanin, which causes a lack of pigment, and the hair turns gray.
According to Chicago dermatologist Dr. Quenby Erickson, going gray is programmed in our genetic code, which means we can get clues as to how extensively and when it will happen by looking at our parents. However, a 2020 study published in Science Daily shows there may also be a link between stress and gray hair. When testing on mice, researchers found that the type of nerve involved in the fight-or-flight response causes permanent damage to the pigment-regenerating stem cells in the hair follicle. The study makes perfect sense, says Dr. Wise. Stress is a huge factor in premature aging, as well as hair thinning. Naturally, it should also affect hair graying as well. There is also a lot of evidence that shows smoking cigarettes plays a role in making hair go gray earlier.
Color isnt always the only factor either; textural changes can ensue as well. Some people are blessed with gorgeous gray hair, but for most of us, the gray is accompanied with thinning and rougher texture that leave our hair finer and harder to style, Dr. Erickson says. There are no proven ways to prevent hair from turning gray, but both Drs. Erickson and Wise have seen some promising results from platelet-rich plasma (PRP) injections. Because these treatments are aimed at waking up your own stem cells, they could potentially reinvigorate melanocyte production as well, explains Dr. Wise. We have seen growth of darker, thicker hairs on some of our stem cell therapy patients, even though the original goal was to combat thinning. Treatment results are dependent on the patients individual conditions, so realistic expectations should be set by your doctor.
Celebrity colorists Chad Kenyon and Rita Hazan say none of their clients embraced their grays during quarantine, or they tried, but caved eventually. For those in camp cover them up, topical dyes and root concealers can help camouflage. The process to cover gray hair is the same on both blonds and darker shades, but my clients with lighter hair can go longer in between touch-ups because gray hairs blend with blond hairs more easily, says Kenyon. Celebrity colorist Aura Friedman often suggests adding a darker pepper tone to silver hair for people who feel more comfortable being darker, but dont want the two-, three- or four-week regrowth touch-up thats needed.
For those who want to permanently cover their grays at home, Nikki Lee, celebrity colorist and cofounder of Nine Zero One Salon, recommends Garnier Nutrisse Nourishing Color Creme ($8). There are more than 75 shades and you can easily find your match using a virtual shade selector, she says. If DIY color makes you nervous, temporary root sprays are great to use in between salon appointments.
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Why Hair Goes Gray, and How to Cover It If You Want To - NewBeauty Magazine
T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2020 Results
By Dr. Matthew Watson
Strengthens Balance Sheet Through Amendment of Loan Agreement with CRG Strengthens Balance Sheet Through Amendment of Loan Agreement with CRG
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T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2020 Results
Apellis Announces Closing of Previously Announced Exchanges of Approximately $126.1 Million in Principal Amount of Its 3.500% Convertible Senior Notes…
By Dr. Matthew Watson
WALTHAM, Mass., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq:APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced the closing of its previously announced privately negotiated exchange transactions (the “Exchange Transactions”) with certain holders of its 3.500% Convertible Senior Notes due 2026 issued in September 2019 (the “Notes”). In the Exchange Transactions, the holders exchanged approximately $126.1 million in aggregate principal amount of Notes and Apellis issued an aggregate of 3,906,869 shares of its common stock.
Syneos Health Schedules Fourth Quarter and Full Year 2020 Earnings Call for Thursday, February 18, 2021
By Dr. Matthew Watson
MORRISVILLE, N.C., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, will release its fourth quarter and full year 2020 financial results on Thursday, February 18, 2021, prior to its earnings call at 8:00 a.m. ET.
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Syneos Health Schedules Fourth Quarter and Full Year 2020 Earnings Call for Thursday, February 18, 2021
Sorrento Announces Positive Preliminary Results of Phase 1b Study of COVI-MSC™ for Treatment of ICU COVID-19 Patients
By Dr. Matthew Watson
SAN DIEGO, Jan. 26, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc.?(Nasdaq: SRNE, "Sorrento") announced today positive preliminary results from its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™) for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS). This ongoing study (PSC-CP-004) is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106 cells/kg. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. The secondary objective is to evaluate efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.
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Sorrento Announces Positive Preliminary Results of Phase 1b Study of COVI-MSC™ for Treatment of ICU COVID-19 Patients
Immunicum AB (publ) Plans to Expand its Research and Process Development Facilities in Leiden, the Netherlands
By Dr. Matthew Watson
Press Release
Tiziana Life Sciences plc ("Tiziana" or the "Company") – Tiziana Files Registration Statement on Form F-3 with U.S. Securities and…
By Dr. Matthew Watson
NEW YORK and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA / LSE: TILS), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announces that it has filed a “universal” shelf registration statement on Form F-3 (File No. 333-252441) (the "Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") in relation to up to US$250,000,000 in market value of its securities.
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Tiziana Life Sciences plc ("Tiziana" or the "Company") - Tiziana Files Registration Statement on Form F-3 with U.S. Securities and...