StemCell Therapy

VANCOUVER, Washington, March 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).

The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients. The laboratory evaluation of the first four patients treated with leronlimab revealed that the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm (including IL-6 and TNF alpha) were much improved. The results of the three additional patients are expected this week.

Jacob Lalezari, M.D., Interim Chief Medical Officer of CytoDyn, commented, The preliminary results observed in patients who were severely ill with COVID-19 and treated with leronlimab are encouraging. Although the data set is still small, we saw fairly rapid and positive laboratory responses in all 4 patients treated, and in three of the 4 patients these laboratory results were associated with a favorable clinical outcome. We eagerly await the results of additional patients treated under the FDAs emergency IND program, as well as the results of several randomized clinical trials about to start.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, added, We remain encouraged and hopeful that leronlimab will help patients from this devastating and relentless disease. We will aggressively pursue treatment for COVID-19 patients, and to explore leronlimabs role in helping to alleviate the impending burden of supply chain and institutional capacity issues.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

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

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

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

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

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

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Companys cash position, (ii) the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv) the Companys ability to enter into partnership or licensing arrangements with third parties, (v) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Companys ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Companys clinical trials, (viii) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients - Associated Press

As COVID-19 restricts residents from leaving their homes, Monongalia County is faced with a lack of blood donors.

The American Red Cross is facing a severe blood shortage due to an unprecedented number of blood drive cancellations during this coronavirus outbreak, said Jason Keeling, executive director of the American Red Cross local chapter.

Nationally, 7,000 Red Cross blood drives have been canceled with 63 being canceled in West Virginia.

Due to the cancellations, West Virginia is down 1,800 pints of blood from its typical intake, which would usually be enough to save up to 600 lives.

Keeling said contributions from the public are now desperately needed to save lives.

It inhibits the nations ability to have blood supply available for those that need it most such as cancer patients and those needing emergency procedures, Keeling said.

The Centers for Disease Control encourages anyone who is healthy even if they are social distancing to donate.

Keeling said additional precautionary measures are being taken to protect staff and those who choose to donate. He said everyone who comes in to donate is having their temperature taken first and using social distancing.

Those who have traveled abroad to China, Hong Kong, Macau, Iran, Italy and South Korea within the last 28 days are asked not to donate.

Hospitals, including WVU Medicine, have been working through the shortage to ensure those who need donations the most are not left without them.

Aaron Shmookler, assistant professor in the WVU department of pathology, anatomy, and laboratory medicine said WVU Medicine has postponed or canceled elective surgeries to avoid any complications.

Hematopoietic stem cell transplants, which is often used to treat cancer, have also been delayed. Schmookler said many of the blood products for this type of cellular therapy come from donors living outside the United States, which has made it difficult to administer the products to those who need them.

We have routine blood orders not being filled to 100%, Schmookler said. Although generally we have maintained stock of our inventory, over time a dwindling blood supply will make it more difficult to provide transfusion support when clinically indicated.

WVU Medicine has continued to treat patients with complex medical issues, including hemorrhagic shock, postpartum bleeding, surgery, cancer, and heart disease. Schmookler said blood has never been denied to those who need it.

In the case that the COVID-19 pandemic continues to escalate, and the blood supplies continue to diminish, Schmookler said it would force hospitals to make a difficult decision.

This coordinated effort is essential to ensure that the best clinical and laboratory decisions are made for each patient who needs blood, he said. The worst possible plan would be having to make very, very difficult and complex ethical decisions on who receives those last precious units of available blood. I am certainly hopeful for the best.

Several local blood drives are still scheduled for the coming weeks, and residents are encouraged to register by visiting http://www.redcrossblood.org.

Morgantown Red Cross drives will be held 9 a.m.-6 p.m. Monday and Tuesday, 11 a.m.-5 p.m. Wednesday, noon-5:30 p.m. Thursday and noon-5 p.m. Friday at the Morgantown Red Cross office.

From noon-4 p.m. April 7, an additional drive will be held at the Fresh Harvest Church in Morgantown.

I implore everyone who is healthy and eligible to please donate blood, Schmookler said. Call your local blood donation center, make an appointment, and help me and my professional clinical and laboratory colleagues in the hospital care for our relatives, our loved ones, and our friends.

By Gabriella Brown

TWEET @DominionPostWV

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Blood donors in high demand - Dominion Post - The Dominion Post

In severe cases, it can also cause deadly hardening of internal organs like the lungs

MADISON, Wis. A year ago, Chuck Beschta couldn't walk more than a few minutes without stopping to rest.

"Just going out and doing normal activities outside raking the lawn mowing the grass shoveling the driveway whatever;snow blowing, those became impossible."

After months of testing he was diagnosed with severe scleroderma, which was hardening his skin but even worse. it was hardening his lungs, making it hard to breathe.

Scleroderma is an autoimmune rheumatic disease where an overproduction of collagen produced in the body tissues.

But in severe cases, it can also cause deadly hardening of internal organs like the lungs, giving some patients little hope of surviving.

Chuck's case was getting more dire.

"He was getting worse despite the best therapy we had to offer," explained Dr. Kevin McKown, a rheumatologist at the University of Wisconsin Hospital in Madison

Dr. McKown recommended a stem cell transplant newly approved for scleroderma to reboot chucks immune system.

"There's a process by which they try to remove the autoreactive immune cells, the cells that are caught in the immune process and then they infuse that back in and hope that the body will basically take up and graft that immune system

Rheumatologists at University of Wisconsin Health tested the treatment since they have already been conducting bone marrow transplants for decades.

Surgeons take out a sample of the patient's bone marrow, isolate the stem cells, and use radiation and chemotherapy to clean out their immune system. The same stem cells are later injected back into the patient's immune system with the hope that new cells will grow and the system is rid of the bad ones.

The process is dangerous when the cells are taken out because the patient's immune system is more vulnerable, making infections more likely to occur.

Chuck saw almost immediate results. His skin was softer and his breathing improved.

He hopes his scleroderma has been cured.

"I think we can be optimistic and so far the people who have been followed out as far as 10 years out don't seem to be getting it back," said Dr. McKown.

After four and a half years, 79% of patients who underwent the treatment were alive without serious complications compared to 50% that were treated with the original drugs.

Without a transplant, less than half the patients, like Chuck, who have diffuse scleroderma and severe lung disease live 10 years past diagnosis. stem cell transplants are commonly used to treat leukemia and lymphoma, cancers that affect the blood and lymphatic system.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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YOUR HEALTH: A rare disease that hardens the skin - WQAD.com

Welcome to the Regulatory Focus COVID-19 Therapeutics Tracker, your go-to resource for information on developing COVID-19 treatment candidates.As COVID-19 continues to spread around the globe, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace.In the US, funding is led by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH), while some companies also are funding their own COVID-19 research. Internationally, the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) have called for targeted efforts to develop therapies against COVID-19.While no specifically approved treatments, stakeholders are looking to repurpose approved drugs that have worked against similar coronaviruses in the past or are hypothesized to attack or immobilize SARS-CoV-2 based on the mechanism of action. Plasma and stem cells from patients who have recovered from COVID-19 also are being investigated.This tracker will be updated weekly with the latest in developments for these treatment candidates.Investigational candidates for COVID-19Drug: RemdesivirMedication class: AntiviralDeveloper: Gilead SciencesOriginal use: Treatment for Ebola and Marburg virus infectionsRationale: Remdesivir, an intravenous drug that inhibits viral replication, has shown in vitro and in vivo activity against SARS-CoV-2. It was originally developed as a treatment for Ebola that ultimately proved less effective than other therapies, but has shown effectiveness in animal studies against other coronaviruses.Trials: Two Phase 3 trials in China from Capital Medical University looking at mild and moderate (NCT04252664) and severe COVID-19 cases (NCT04257656); the Phase 3 ACTT trial from National Institute of Allergy and Infectious Diseases (NIAID); two phase 3 international studies from Gilead examining moderate (NCT04292730) and severe COVID-19 cases (NCT04292899); and a treatment arm of the World Health Organization (WHO) SOLIDARITY trial.Status: All Phase 3 trials except SOLIDARITY are currently recruiting. Capital Medical Universitys trials are expected to be completed in late April and early May 2020. Gilead Sciences international trials have an estimated study completion date of May 2020. NIAIDs trial is recruiting, with an estimated completion date in April 2023.

Therapy: Convalescent plasmaMedication class: ImmunoglobulinRationale: Researchers have theorized that convalescent plasma could be used as passive immunotherapy in other coronaviruses such as MERS and in SARS-CoV-2 to help neutralize the virus.Trials: Eight studies in China examining inactivated convalescent plasma are in various stages, both recruiting and not recruiting.Outcome: Preliminary findings indicate convalescent plasma may be beneficial for patients with COVID-19. A case series of 5 patients in China with COVID-19 and acute respiratory distress syndrome treated with convalescent plasma showed the therapy improved their clinical status.Status: On 24 March, the FDA allowed the use of convalescent plasma from recovered cases of COVID-19 as an emergency investigational new drug (eIND) for patients with serious or immediately life-threatening COVID-19 infections.

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COVID-19 Therapeutics Tracker - Regulatory Focus

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Adam Castillejo (pictured), 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancer.

The second person to be cured of HIV has revealed how he was more fearful of dying from cancer than Aids and considered ending his life at Dignitas.Adam Castillejo, 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancer.He remained anonymous until he decided he wanted to be seen as an ambassador of hope after struggling with his health for almost two decades.Mr Castillejo, who was born in Venezuela and moved to London in 2002, was diagnosed with blood cancer in 2012, having already lived with HIV since 2003.His last hope of cancer survival was a bone marrow transplant from a donor with HIV-resistant genes that could wipe out his cancer and virus in one fell swoop.But in a powerful interview with The Sunday Times,Mr Castillejo admitted that he was more fearful of dying from stage 4 Hodgkins lymphoma than Aids.Calling the second diagnosis another death sentence, the sou-chef revealed that he panicked because cancer can kill you faster than HIV.Adam Castillejo, 40, was known only as the London Patient when doctors revealed his success story last March after a stem cell transplant to treat his cancerMr Castillejo embarked upon a gruelling treatment regime that left him physically emaciated and pushed the Venezuelan to the mental edge.Both illnesses became one because you had to deal with the anti-retroviral medications not interfering with thechemotherapy regime and vice versa, he said.By the end of 2014, he said that he had given up on battling the two illnesses, and had made up his mind to end it all at Dignitas in Switzerland.Around this time,Mr Castillejo disappeared, and was found four days later outside London psychologically broken. He does not remember this period.Doctors gave him six months to live, before a switch flicked.At that time I accepted straight away, because what choice have I got? I would rather die fighting, he explained.Within days, he met with Dr Ian Gabriel at the Chelsea and Westminster Hospital, who advised that he could attempt a bone marrow transplant.The procedure in May 2016 meantMr Castillejo was cleared of both cancer and HIV.But he lost five stone and took 60 pills a day, revealing: I told my doctors there werent enough hours in the day to take all the medication I needed.Mr Castillejo, who was born in Venezuela and moved to London in 2002, was diagnosed with blood cancer in 2012, having already lived with HIV since 2003An American man treated in Germany 12 years ago called Timothy Ray Brown (pictured) the so-called Berlin Patient also survived the transplantHe also developed mouth ulcers which inhibited his ability to eat, and his anti-retroviral medication had to be crushed and washed down.Mr Castillejo also claimed that he felt victimised and guilty when he told people that he was suffering from HIV, saying: This is a punishment for you.The Venezuelan chef is the second person to have survived the life-threatening technique and come out the other side HIV-free.An American man treated in Germany 12 years ago called Timothy Ray Brown the so-called Berlin Patient also survived the transplant.He was put into an induced coma for six months, however.Experts have hailed the treatment as a milestone in the fight against HIV, but are urging caution when calling it a cure so early on.In the context of HIV infection, the term cure means there are no virus-carrying cells left.Anti-retroviral therapy is very effective at reducing the viral load in the blood of infected individuals so that it cannot be transmitted to others.Unfortunately, the Berlin and London Patients cases do not change the reality much for 37 million HIV patients.The treatment is unlikely to have potential on a wider scale because both Mr Castillejo and Mr Ray Brown were given stem cells to treat cancer, not HIV.Stem cell and bone marrow transplants are life-threatening operations with huge risks. Patients can suffer a fatal reaction if substitute immune cells dont take.In his private life, Mr Castillejo likes to walk the streets of Shoreditch and travel.Kat Smithson, director of policy at National AIDS Trust, said: We applaud the London Patient Adam Castillejo for sharing his unique experience of having his HIV cured following a bone-marrow transplant to treat cancer. Mr Castillejo has been through a long and extremely challenging journey with his health, within which HIV is just one part.His decision to speak about his experience without anonymity can only enrich our understanding of his experience on a human level, and we thank him for this.Theres still a great deal of stigma around HIV which can make it harder for people to access the services and support they need and for people to talk openly about HIV.His story helps raise much-needed awareness of HIV, but broader than that its a story about incredible resilience, determination and hope.How a stem cell transplant cured the Berlin and London Patients and how it can go badly wrongUsually, HIV patients expect to stay on daily pills for life to suppress the virus. When drugs are stopped, the virus roars back, usually in two to three weeksThe vast majority of humans carry the gene CCR5.In many ways, it is incredibly unhelpful. It affects our odds of surviving and recovering from a stroke, according to recent research.And it is the main access point for HIV to overtake our immune systems.But some people carry a mutations that prevents CCR5 from expressing itself, effectively blocking or eliminating the gene.Those few people in the world are called elite controllers by HIV experts. They are naturally resistant to HIV.If the virus ever entered their body, they would naturally control the virus as if they were taking the virus-suppressing drugs that HIV patients require.Both the Berlin patient and the London patient received stem cells donated from people with that crucial mutation.WHY HAS IT NEVER WORKED BEFORE?There are many reasons this hasnt worked, Dr Janet Siliciano, at the Johns Hopkins University School of Medicine, told DailyMail.com.1. FINDING DONORSIts incredibly difficult to find HLA-matched bone marrow [i.e. someone with the same proteins in their blood as you], Dr Siliciano said.Its even more difficult to find the CCR5 mutation.2. INEFFECTIVE TRANSPLANT LEADS TO CANCER RELAPSESecond, there is a risk that the bone marrow wont take.Sometimes you dont become fully chimeric, meaning you still have a lot of your own cells.This means they will not defeat the cancer if it returns again.3. THE OLD IMMUNE SYSTEM ATTACKS THE NEW ONEThe other most common reason this approach has failed is graft-versus-host disease: whenthe patients immune system tries to attack the incoming, replacement immune system, causing a fatal reaction in most.4. UNKNOWN QUANTITIESInterestingly, both the Berlin patient and the London patient experienced complications that are normally lethal in most other cases.And experts believe that those complications helped their cases.Timothy Ray Brown, the Berlin patient, had both his cancer returned and he developed graft-versus-host disease, putting him in a coma and requiring a second bone marrow transplant.The London patient had one: he suffered graft-versus-host disease.Against the odds, they both survived, HIV-free.Some believe that, ironically, graft-versus-host disease might have helped both of them to further obliterate their HIV.But there is no way to control or replicate that safely.

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Adam Castillejo 'feared dying of cancer more than Aids and considered ending it all at Dignitas' Daily Mail - westofthepond.com

A BUCKLEY man is one step closer to a clean bill of health after receiving life-saving treatment.

The Leader previously reported that Matt Davies was given 12-months to live without a stem cell transplant, which sparked a massive support network, with thousands signing up to become a donor.

Wife Sarah Davies urged people to sign up to become a donor, which could save the lives of many people and over 7,000 had signed up from her link alone.

Before Christmas, Matt was given the news that there was a match for him and he could start his treatment in January.

She told the Leader: It was a success, at the moment the cells in his body are 99.5 per cent donor and 0.5 per cent his. In time they will be 100 per cent donor so its definitely working which is fantastic.

We are on day 67 and on day 100 we can have a bone marrow scan to find out what stage we are.

GvHD is our biggest worry at the moment. Small amounts after a transplant can be good because it means his body is fighting but in huge amounts it can be damaging. It is starting to affect his gut now.

Because we live in Wales and have done for several years, we couldnt get the funding for the therapy which is what the Christie does, but we are now in the process of getting the drug for him, we are in constant talks so its a frustrating game at the moment.

We need to start this medication to get rid of this GvHD before it becomes chronic, so we are still in the process of getting that drug but hes doing really well.

Graft versus host disease (GvHD) is a condition that might occur after a transplant. In GvHD, the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells then attack the body.

Matt was diagnosed with cancer last year and beat it, however less than eight months later after having his three-monthly routine bone marrow results he was told the leukaemia was back and his only option was a stem cell transplant.

He has since made significant progress however the pair say they are worried about the latest coronavirus outbreak due to Matt essentially having no immune system.

Sarah said: At the moment with coronavirus its very scary because he has a low immune system, he is basically starting from scratch with his immune system so cant get immunisations until he is one year old. We have decided to take the kids out of school because we dont want him catching anything.

Hes done absolutely fantastic and is now back to eating.

Matt has been really lucky. They are pleased with his progress, but they would like his GvHD levels to be lower.

Although Matt faced no real complications during the treatment however has lost a significant amount of weight.

A JustGiving Page has been set up to raise funds for the Christie in Manchester where Matt has been receiving his treatment.

Sarah added: Even still now I will be walking somewhere and random people who Ive never met before will ask me how he is doing. Its actually been so positive. I dont think people realise how much it has helped, just them asking it has really helped us get through this and knowing that a lot of people are supporting us.

On social media we have spoken to so many people in similar situations as ours, its about helping one another, and we have made friends for life.

Thank you so much for your support, it means a lot to us and its lovely for us to read all the comments, even if we cannot reply to them all.

Matts progress can be found on social media via the Team Davies Facebook and Instagram page.

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Buckley couple thank community for their support as dad-of-two receives life-saving treatment | The Leader - LeaderLive

Despite dozens of federal employees testing positive for the COVID-19 coronavirus this month, and despite the White House asking executive agencies to offer maximum telework flexibilities to eligible workers, most of the 2.1 million people who make up the federal workforce are reportedly still being forced to report to their offices.

For weeks, the Trump administration said it was preparing federal employees to be capable of handling a heavy workload while telecommuting, but the administration has been very slow in rolling out any specifics regarding the transition and very few on the federal workforce are currently being permitted to work remotely. That includes many who told the Washington Post on Sundaythat they are already fully set up to work from home.

One senior manager at a federal agency who spoke on the condition of anonymity told the Post that those in charge are scared to death to make decisions on remote work without getting explicit approval from the top.

Every agency is scared to death to do anything without getting approval, and they dont want to be first, the senior manager said.

Lauri Dahlem, a legal assistant at the Social Security Administrations disability hearing office in Michigan, told the Post that her request to work remotely was denied despite the fact that her husband was recovering from complications from a stem cell transplant to treat cancer and all of her work can be completed from home.

My supervisor said I was exempted because Im only taking care of someone whos sick, said Dahlem, an Army veteran and former military police officer.I want to work. Im a very capable worker. Its insane.

Dahlem also noted that all eight of the administrative law judges that work in her office were still hearing cases in-person as of Friday.

Were seeing agency after agency not release people to work from home, David Cann, director of field services and education at the American Federation of Government Employees, also told the news outlet.If Im a manager who is a jerk, or disengaged, theyre saying, Im not going to do it.

[image via Drew Angerer/Getty Images]

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Many Federal Workers Must Still Go to Work Because Agencies Are Scared to Death of Making Decisions - Law & Crime

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You can't see the virus behind the world's latest pandemic with the naked eye but, plotted on a graph, it looks like one side of a mountain, climbing skyward as case numbers soar past 197,000 people in little more than three months. Eventually, epidemiologists say, that trajectory will start to fall. Immunity in the population will build up against the mystery illness, now known as COVID-19, and it will begin to die out.

But in the middle, there will still be that mountain peak the curve everyone is talking about. The steeper it is, the more exponential the spread of the virus; the flatter it is, the slower, the less stress on health services, and the more lives that will be saved in the months ahead.

So how do we flatten the curve? What is herd immunity? And what are countries around the world, including Australia, doing to fix the picture?

This graph shows the theory behind "flattening the curve". Many doctors including in Australia say the capacity of most healthcare systems fall below the dotted line, making the peak likely to be even more intense and the need for containment, not just a slowdown more critical.Credit:Matthew Absalom-Wong

The fight against COVID-19 is about medicine, of course. But its also about mathematics (and money). When a new epidemic explodes onto the scene, experts look for two main numbers: how many people each patient will infect and how many people will die from the disease. This helps them plot an arc for the outbreak: how far it will likely spread before a vaccine is rolled out or enough people who have recovered from the illness with virus-fighting antibodies in their system build up "herd immunity" against it.

Flattening this curve means slowing how fast the virus moves through the community. There might still be a lot of cases. But limiting opportunities for the bug to jump from person to person by adopting "social distancing" measures (such as staying 1.5 metres away from others and avoiding public spaces) as well as improving hygiene and isolating those infected or exposed will stretch out the spread of COVID-19 over time, giving doctors, economies (and vaccine-makers) space to breathe.

If the curve keeps climbing, we will see a surge of cases needing medical intervention all at once and hospitals will likely run out of life-saving machines such as ventilators, which have been critical in treating patients stricken by more serious cases of the respiratory illness. That would push up the death toll and force impossible triage choices like the ones already facing doctors on the frontlines of the Italian outbreak (where an age limit has even been proposed in intensive care wards to free up beds for a growing number of younger patients in their 40s and 50s). It's why some doctors, including in Australia, say simply flattening the curve will not be enough to push it back into the reach of the healthcare system - the virus must be stopped in its tracks through containment in line with what the World Health Organisation is calling for, and even the lockdowns seen in China.

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So far it's estimated about one in five people infected with the new virus will need medical intervention such as ventilation to recover and about 1 per cent of all patients will die. That's 10 times higher than the mortality rate for seasonal flu but still much less than the first (and now infamous) coronavirus outbreak SARS in 2003. Unfortunately, the new virus is also more infectious. Each person with COVID-19 is likely to infect two or three people meaning that growth curve can quickly become exponential, according to the Grattan Institute.

Every day counts once the pandemic clock starts ticking, warns Dr Michael Ryan, who heads up the WHO's emergency response team. "Be fast. Have no regrets," he told the world on March 13. "You must be the first mover. The virus will always get you if you dont move quickly."

During the world's last severe pandemic, the 1918 Spanish flu, the US city of Philadelphia took 14 days to mount a public health response after its first case, even pressing ahead with a big public march. St Louis, meanwhile, cracked down on people's movement and gatherings within just two days of the influenza strain entering its borders. By the end of the crisis, its death toll was less than half of Philadelphia's.

Dr Stephen Duckett and his colleagues at Grattan have been tracking the scale and speed of new COVID-19 infections in nations all around the world. Cases might appear in just a trickle at first but, once countries crack the 100 mark, the virus seems to either explode rapidly such as in China initially, and then Iran, Italy, the US, and Spain or slow to a flatter line as has been recorded elsewhere including Singapore and Hong Kong. Dr Duckett says nations that moved fast to test and track suspected cases and then brought in tough social distancing or containment measures along the lines of the St Louis model have already seen their infection growth fall, even after rapid early spread.

In lieu of a vaccine, countries from China and Italy to the US and Israel are turning to increasingly medieval methods to stem the tide of the pandemic, closing borders, raising barricades and shutting down much of daily life such as restaurants and workplaces. Other countries like Singapore and Taiwan have brought their case loads under control by getting ahead of the curve early rather than bringing in lockdowns later, ramping up testing, forensically tracing cases back to other people who may have been exposed and making social distancing the norm. (The Philippines has even temporarily quarantined its financial markets, becoming the first country to shut down financial trading in response to the pandemic).

Australia still has comparatively few patients with COVID-19 compared to other parts of the world but our own curve is accelerating. New cases have more than tripled in the past week alone, climbing from 112 on March 10 to 454 as of March 17.

"We're on the scary part of the curve," Dr Duckett says. "Italy had about the same number of cases on February 26, and now has more than 28,000."

In places like Italy, patients doubled roughly every two days. This past week, Australian cases doubled about every 3-4 days, Dr Duckett says, putting us on a similar trajectory to the UK and Spain.

Australian health authorities have also been meeting daily to wargame likely infection rates. Deputy Chief Medical Officer Paul Kelly has said the best outcome is that the virus infects just 20 per cent of the Australian population 5 million people but 60 per cent of Australians, or 15 million, could catch it, a catastrophic scenario for hospitals.

The Morrison government is ramping up medical resources and staff and has already banned "non-essential" indoor gatherings of more than 100 people, (and public events over 500). But so far it's stopped short of telling people to stay home from work, school or restaurants or off public transport in line with some other countries like the US and the UK. As the outbreak gathers steam, many experts, including doctors, are now asking: why wait?

Prime Minister Scott Morrison says Australian schools, like those in Singapore, will stay open at this stage, based on advice closures would cause unnecessary disruption considering only a tiny fraction of confirmed COVID-19 cases so far have been in children. Health Minister Greg Hunt says we need to adopt a "war-time spirit" and work together to get through the next few months. Of course, under the exponential maths of contagion, that actually means our lives need to take a step (or two) farther apart. Chief Medical Officer Brendan Murphy urges people to think before every physical interaction - washing their hands, cutting out handshaking and kissing hello and keeping clear of others as much as possible. (The US, meanwhile, is telling people to avoid meeting in groups of more than 10 and in Austria that number is down to a cosy five.)

COVID-19 first emerged in humans in late 2019, at a wet market in the sprawling city of Wuhan, China. At first, local authorities were perplexed by the mysterious cases of pneumonia and tried to keep them quiet. The illness was not formally linked to a new strain of coronavirus until early January, when millions of people were already travelling for the country's biggest holiday, Lunar New Year. Infections exploded.

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But then China's Communist government did something without precedent in modern times it locked down cities and transport across huge swathes of the country, grounding tens of millions. Factories shut down. Schools and offices closed. Streets emptied.

At the time, such a move seemed unthinkable in a Western democracy (and there are still concerns for those stuck under Wuhan's enduring lockdown). But, in the maths, it appears to be working. China was clocking up more than 3000 new cases a day in early February. By mid-March, that number had fallen to less than 30. Its government has already claimed "a great victory" over the virus, even as it prepares for a possible second wave. The WHO says the turnaround is a sign the pandemic can still be contained with "aggressive measures", lashing countries for their slow responses thus far.

But it's less clear if lockdowns will work for Europe or the Middle East, the next frontiers of the pandemic. In Italy and Iran, early cases appeared to again spread under the radar until a sudden surge hit hospitals (and even Iran's parliament). Both governments were slow to act; in Iran, for reportedly political reasons. In Italy, the government was at first reluctant to impose such draconian measures on its densely populated cities, like turning soccer fans away from matches or closing bars. But blockades in the north, where the outbreak began, failed to stop infections leaking into the rest of the country and beyond.

Now Italy has gone into its own style of lockdown (followed by countries such as Spain, France and Germany, as cases in those nations also rise). People are mostly staying home, shops are running on restricted hours and people queuing for supplies must stand 1.5 metres apart. From their windows, Italians in home quarantine sing to each other.

Some experts point out that the two countries which appear to have turned the tide on a rapid outbreak China and South Korea have gone further than just lockdowns. Knowing most infections so far have come from close contact in hospitals or family groups, those with (and sometimes without symptoms) are taken out of their homes and put into hospital isolation instead a move recommendedby the WHO. Milder cases are kept together in huge pop-up fever clinics, often in converted stadiums and gymnasiums, and those still being tested kept away from confirmed cases, after old horror stories of infection circulating in SARS quarantine.

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Both countries, including success stories such as Singapore, Hong Kong and Taiwan, have also been aggressively hunting for cases temperatures are taken before entering any building. If you have a fever, you must roll up to a specialised clinic or "drive-through" for testing.

These parts of the world have been hit hard by dangerous coroanvirus outbreaks of the past, including SARS, Dr Duckett notes, and so their people were already primed for the health checks to come. When word came from China that another coronavirus had jumped from animals to humans, countries like Singapore and Taiwan acted quickly. Social distancing has since been playing out without need for stricter lockdowns or domestic travel bans. While Hong Kong faced criticism for not closing its borders to mainland China fast enough, months of anti-Beijing protests means schools were already teaching online and many people working from home.

South Korea, meanwhile, saw cases erupt within a religious sect and quickly deployed particularly exhaustive detective work to track down close contacts of known cases famously using CCTV to trace people back to a specific bus or taxi and even prosecuting those who lied about their movements.

The island nation of Singapore looked in danger of being overrun in February when it was recording the second-highest volume of cases outside China. But it has since flattened its own curve through quick detection and diagnosis as well as strictly enforced home quarantines (featuring spot checks and twice-daily location monitoring with serious penalties applying for a breach.) Meanwhile, countries such as China, Iran and Israel are deploying their notoriously invasive surveillance networks, including tracking phones, to keep tabs on people under isolation and close in on suspected cases.

Australia also has powers to order people into quarantine and some states such as Victoria have started to mobilise police forces to help enforce such orders if required. But other experts including Adjunct Professor at UNSW Bill Bowtell, who helped design Australia's response to the AIDS crisis, have warned punitive measures will only keep people away from testing clinics.

Lining up for a "fever clinic" at Sir Charles Gairdner hospital in Perth.Credit:Nine

WHO director general Tedros Adhanom Ghebreyesus has blasted governments around the world for giving up on widespread testing and contact tracing, "the backbone" of any response, even as they ramp up social distancing measures.

"You cannot fight a fire blindfolded and we cannot stop this pandemic if we don't know who is infected," he said on March 16. "Test every suspected case. If they test positive, isolate them and find out who they have been in contact with. And test those people too."

A lab test for samples of the virus was created quickly. But faster blood tests are still only widely available in China, where diagnosis has been industrialised. At a fever clinic, you will be met by a healthcare worker in full protective gear, testing white blood cell counts and deploying handheld portable CAT scanners to check for the tell-tale "ground glass" inflammation of COVID-19 in the lungs. Even there, a recent study found two thirds of reported cases could be traced back to undiagnosed patients suggesting the virus could be spreading under the radar even from people with fewer symptoms who shed less virus.

In the US, low testing rates and diagnosis delays from a botched roll-out of intial tests has been blamed for a sudden explosion of cases across Washington, New York and California many fear the US has since missed its window for containment.

As test kits run low elsewhere, Australia is only testing people considered at risk either from recent overseas travel, exposure to a confirmed case or, in some cases, an unexplained and severe bout of pneumonia. But aged care residents and doctors with symptoms can now be tested too. Health Minister Greg Hunt insists Australia is still testing more than most countries: 81,000 tests so far, with an additional 97,000 kits set to arrive in clinics.

The term "herd immunity" has now also gone viral amid speculation Britain's government was lagging behind other nations in imposing social distancing measures as part of a bold plan to allow the virus to sweep through the population, (and so build up their immunity against it).

In the modern era, community resistance to a virus is commonly achieved through a vaccine. Experts, including in Australia, have warned that stalling protections against COVID-19 for the sake of encouraging natural resistance among "the herd" could be "catastrophic", costing lives without much slow down.

The United Kingdom still plans to seal off those considered particularly vulnerable to complications from the new virus, including the old, unwell and pregnant women, for three months. But it's since brought forward social distancing - following the US in announcing new measures warning people to stay home from work and to avoid crowded public places such as pubs and cinemas.

Now the Netherlands has revealed it will embrace a COVID-19 strategy of its own based on herd immunity, saying mass lockdowns are not feasible.

Analysis of virus-fighting strategies by the Imperial College London found targeted measures such as isolating those exposed to the virus or at risk of serious complications could reduce peak demand on hospitals by about two thirds. But researchers noted this would still result in hundreds of thousands of deaths and instead recommended a wider "suppression" where more people in the community stay home.

The problem, as Professor Murphy in Australia has also stressed, is keeping it up over the months ahead without burn out. "You can't just shut things down for two weeks and that's it. It has to keep going."

Sherryn Groch is the explainer reporter for The Age and The Sydney Morning Herald.

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Coronavirus: How are countries flattening the curve and do lockdowns work? - Sydney Morning Herald

Museums in New York have closed their doors to the public, the citys opera is silent, Broadway lights are fading as the city bans all gatherings exceeding 500 people.

NY Governor Andrew Cuomo has already publicized this restriction on gatherings hat include more than 500 people. However, it is just a temporary ban and soon the coronavirus is under control, everything would be back to normal he says.

He has also announced the time for this ban. It would be imposed this Friday, at 5 pm in the evening, all across the US. But it doesnt include public services centers like hospitals, dispensaries, nursing homes, schools, etc.

Ban on the Broadway theaters has already been made effective as of April 12thand confirmed by the Broadway League, which is a local organization of producers and proprietors of these Broadway theatres.

Also read- Can Scientists Cure HIV With Stem Cell Therapy?

Governor Cuomo says; As soon as we can go back to normal well go back to normal. But we are still ascending, we are still on the upward trajectory of this disease.

So far, the city has reported 95 confirmed cases of coronavirus, confirms Cuomo. There are 300+ reported cases all across the US and the maximum number of these cases are being reported from a suburban area of New York City, New Rochelle.

Different cultural groups in the city have acknowledged the ban, showing support in coronavirus prevention plan by the government. Three of the most important public places shutting down for an unannounced time include the Metropolitan Museum of Art in three locations, the Metropolitan Opera and Carnegie Hall.

President of the museum, Daniel Weiss said in his statement that; The Mets priority is to protect and support our staff, volunteers, and visitors,

He didnt give any date for Museum reopening.

On the other side, the opera company has confirmed canceling all the shows and performances till March 31st. In addition to that, Carnegie Hall has also confirmed closing for all types of public gatherings till the end of this month.

Closing of all these places shows that the New York administration is taking extreme measures to save the residents from coronavirus outbreak. On Wednesday, Cuomo announced that New York Citys famous St. Patricks Day Parade is postponed for this year. This is the first time in the last 258 years that New York would not witness its historic parade.

Also read- Coronaviruss Life is Just Three Days, New Test Reveals

The city Mayor Bill de Blasio wrote in this tweet implying that the parade is not completely canceled but it may be announced on another day when the country is over this coronavirus fear.

Although coronavirus doesnt seem that dangerous; it only causes minor health problems such as flu, cough, and sore throat, leading to fever. But the older people and those with compromised immunity are at a high risk of complications that could take their lives.

Fortunately, a majority of coronavirus infected people are under treatment and showing recovery. In fact, China has discharged thousands of patients after a complete recovery.

The World Health Organization explains that people at an early stage of infection can be completely recovered within two weeks. However, the severe cases of coronavirus may take up to six weeks to show any sign of recovery. Additionally, the recovery time is highly dependent upon the age and health status of the patient.

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Coronavirus Fear- New York Bans All Gatherings that Exceed 500 People - TheHealthMania

After the World Health Organization (WHO) declared that thecoronavirus outbreakis officially a pandemic, countries around the world have responded accordingly.Universitiesin Canada and the US are closing, non-essential conferences andsports leaguesare being canceled, and people are being advised to halt all travel plans. Anyone can get infected, and the only way to slow down the outbreak is toreduce the number of people getting infected.

Amidst this fear, the most widespread advice for anyone experiencing symptoms is tosocially distance themselves. But what, exactly, does that mean? How is this different from self-isolation? What if you live with family? What if only one person in a family of four is experiencing symptoms? Why is this even important?

How do I know if I need to socially distance myself? How is that different from self-isolation and strict isolation?

Everyone should besocially distancingthemselves! Essentially, that means deliberately distancing yourself from other individuals to reduce COVID-19 transmission rates.

On the other hand,self-isolationor self-quarantine is when you have been in contact with someone who was diagnosed with the coronavirus, or someone who was exhibiting symptoms. Self-isolation also applies for people who are asymptomatic, but have secondary medical issues (diabetes, heart condition) that may make a coronavirus infection more dangerous for them.

Lastly,isolationis when you have been diagnosed with COVID-19, or if you are exhibiting any flu-like symptoms. At this point, you will receive instructions for isolation from your medical provider.

What does social distancing entail?

If possible,do not leave the house. Try to stay at least six feet away from other people, and avoid coming in direct contact with them. Social distancing can also be done by avoiding crowds and mass gatherings, canceling upcoming events, working from home, moving classes online, and communicating electronically instead of personally visiting people.

What if I live with other people?

Even if no one in the household is exhibiting symptoms, it is best to keep distance for at least two weeks, which would be the viruss incubation period.On the other hand, if you need to self-isolate, try to sleep in separate rooms, and keep6 feet away from each other. Frequently wash your hands, andfrequently keep your surrounding areas clean. If possible, avoid touching your face, especially after being in contact with shared possessions or furniture. Wash all plates and utensils thoroughly with warm soap and water, or use a dishwasher with a drying cycle.

How can I help vulnerable people?

If there are vulnerable and at-risk individuals in your neighborhood, consider getting groceries and other essentials for them, and leave the items at their doorstep. Frequently call or check up on your friends and family, since social distancing can be quite lonely.

Why is social distancing important for everyone, including young and asymptomatic people?

According to data fromSouth Korean authorities, translated byDr. Eric Feigl-Ding, young people between the ages of 20 and 29 are carrying 30% of the disease in South Korea, with the majority beingasymptomatic, meaning they are not experiencing symptoms. This means that while you mayfeelfine, if you are sick you can still infect a large number of people by just being out and about!

Why is social distancing important?

By now you have probably seen a version of the graph that explains why we need to "flatten the curve." Through social distancing and pro-active measures, we can not only delay the "peak" of the outbreak, easing demand for hospital and emergency services, but can also reduce how bad the outbreak could be.

Do you still have questions about social distancing, isolation, or anything else about the coronavirus pandemic?

Ask our community of scientists now!

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What does social distancing really mean? - Massive Science

Transfusion of red blood cells (RBCs) is a life-saving treatment for numerous conditions such as severe anaemia, injury-related trauma, supportive care in cardiovascular surgery, transplant surgery, pregnancy-related complications, solid malignancies and blood-related cancers.

However, blood banks particularly in developing countries often face a severe shortage of whole blood as well as components of blood like red blood cells.

Researchers across the world are exploring possibilities to generate RBCs outside the body (in vitro) from haematopoietic stem cells (HSCs). These HSCs have the capability to give rise to the different types of cells found in the blood. Various groups have been able to produce RBCs in the laboratory from HSCs.

However, the process takes a long time - around twenty-one days. The resources required to grow cells in the laboratory over such a long duration can be very expensive for generation of RBCs on a large scale for clinical purposes.

A team of researchers led by Dr. L. S. Limaye, ex-scientist at the Department of Biotechnologys National Centre for Cell Science (NCCS) at Pune have found a way to tackle the issue.

They have found that the process can be speeded up by adding a very low concentration of a small protein molecule called `transforming growth factor 1 (TGF-1), along with a hormone called `erythropoietin (EPO), to the growth medium. They could cut down the process time by three days.

Dr. Limaye noted that several tests to assess the quality of the cells formed, and examination of many of their characteristics, including physical appearance, revealed that the RBCs formed using this procedure were normal.

The findings are worthy of further exploration. Additional investigations based on the insights gained from these studies could help assess the relevance of using this approach for blood transfusions in the future. The researchers have published a report on their work in the journal, `Stem Cell Research and Therapy.

(India Science Wire)

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New approach to speed up red blood cells generation in the lab - BusinessLine

The Peers family were overjoyed when doctors told them Callum had beaten cancer.

Life returned to normal but, tragically, it would not stay that way.

The battling ten-year-old, who has twice successful fought cancer, has the disease once again.

This time the odds are heavily stacked against him. Doctors here give him just a ten per cent chance of living more than five years.

But his parents are determined to fight on and are pinning their hopes on pioneering drug trials.

They are trying to raise 150,000 to get Callum treatment in the US that is not available on the NHS.

Callums mum Nicola, 37, said: Seeing my son fight this disease for seven years has been heartbreaking but he has never given up.

Hes fought it and beaten it twice and I know he can do it again. We must give him that chance. I am not losing my boy.

Callum, of Leigh, Gtr Manchester, was just three when he began getting symptoms. Nicola first took Callum to his GP with stomach pains.

In June 2013, after hed turned four, he was diagnosed with an aggressive stage-4 neuroblastoma.

She said: It was such a shock when they told us, the last thing we expected. It was a body blow.

I was heartbroken but I had to carry on and be strong for Callum.

We told him he had a lump in his tummy and was having medicine for it. He was a little hero and never complained.

Callum had an operation to remove a tumour in his stomach and gruelling chemotherapy, immunotherapy and stem cell treatment.

He lost his hair, endured sickness, lethargy, high temperatures and spent months in hospital.

Then, in December 2014, the family got the news they were hoping for when his scans came back all clear.

Nicola recalled: We were over the moon. Life slowly went back to normal and we started going on family caravan holidays again.

But just over two years later, in January 2017, when Callum was getting ready for school he complained of feeling unwell.

Nicola noticed a lump on his neck. An emergency scan at the hospital confirmed the cancer had returned.

Nicola said: To get that news a second time was devastating. It could easily have broken us, but we had to fight on.

Callum had three types of chemo and after 12 months in and out of hospital he had kicked the cancer again.

But in August last year there was a lump on his neck and Nicola knew what to expect. The cancer had spread to the right side of his stomach. She said: Id thought after his treatment had finished the second time we were going to go back to normal.

Being told again and again your boy has cancer is awful.

Since then a tumour on Callums chest has been surgically removed and, days before his tenth birthday, another growing on his spine, which could have paralysed him, was taken out.

He has been through more chemo and radiotherapy, been rushed into intensive care with complications four times.

He spent his Christmas at Great Ormond Street hospital in London. Nicola said: Callum is the definition of a fighter. I know he can beat this again and beat it for good.

Treatment options in the UK for Callum have run out but Nicola and his dad Alan, 56, brothers Jake, 19, Joshua, 18, and Cameron, nine, and sister Bethany, 17, arent giving up hope.

Helen Devos Childrens Hospital in Michigan is one of the few centres offering a treatment that works by targeting specific cancer stem cell pathways. Nicola spoke to consultants there and said: Children are going over there and are still clear of disease years and years later.

Callum has been through so much. He just carries on and he deserves this chance.

Were all feeling really hopeful. Its been proven to work.

She added: I know Callum can win his fight if we can give him the best possible chance.

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'I'm not losing my boy,' sobs mum after son is diagnosed with cancer for third time - Mirror Online

A few months ago Victoria Beckham uploaded a picture of kissing herself kissing her daughter Brooklyn on her lips. This was to wish Brooklyns birthday. Although it was meant to be a happy post, but it agitated a new discussion in comments discussing if its okay to kiss your child on lips or not.

Doctors say that it is necessary for children to feel loved and protected in a house. But lip kissing a child might not be the best way to express the parents love towards children they say. Is it really that problematic? Here is what childrens psychologists say on this.

As lips and mouth are considered as personal boundaries of any person, it is necessary to understand that it also applies to children. Kissing on lips even my parents can probably change the understanding of what is personal for a child.

A child psychologist named Charlotte Reznickexplains that when parents kiss their child on lips, it gives a sign that it is okay to do that and anyone can intrude their personal space and do the same without any problem.

But this behavior is not just limited to kissing but also applies to tightly wrap around the body, forced kisses, force food, aggressive tickles, etc. So this type of invasive parents might increase their kid to develop a condition called victim syndrome which practically makes the child unable to say NO and maintain a personal boundary while interacting with others.

Also read- Breakthrough Research Identifies A Potential Treatment For Ulcerative Colitis

Researchers, doctors, and dentists all warn parents to avoid unnecessary physical contact with the child. There are tons of bacteria, viruses, and fungi that are harmless for adults but might cause an infection in children when they re kissed or hugged unnecessary.

Young children have a weak immune system as compared to adults, which is why they are at a high risk of such microbial transmissions, Charlotte Reznickfurther clarifies that a number of extremely dangerous pathogens could be transmitted via saliva which is bad for their health.

When kissing on lips to a child is made common, he may start embracing it as an act of sympathy and may start kissing other people the same way. It is normal for a child to behave the same way as he sees his parents doing whether at home or outside. So this behavior might initiate a child to kiss other children or adults on the lips, the same way as his parents do to him, considering it normal.

Also read- Can Scientists Cure HIV With Stem Cell Therapy?

The psychologistadvisesparents to understand that even if this kissing on lips look like an innocent lovey gesture, the child may learn and mimic it with people without realizing the intimate complications of it. That is why psychologists suggest to kiss your child only on cheeks or forehead and never on lips.

Share your views if you think kissing your child on kiss is acceptable and normal. If you agree, also share until which age this could be done and is the parent-kid kiss onthe lipsacceptable regardless of the gender differences or not.

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Is it Okay to Kiss your Kids on the Lips? Psychologists Say NO - TheHealthMania

BEIJING: Chinese researchers are studying the use of stem cell technology in the treatment of people critically ill with the novel coronavirus disease (Covid-19), according to the Science and Technology Daily.

Four Covid-19 patients who received stem cell treatment while in a serious condition have been discharged from hospital after recovery, and the clinical trial of the therapy will be further expanded, Vice-Minister of Science and Technology Xu Nanping was quoted by the paper as saying.

Stem cells can self-renew or multiply while maintaining the potential to develop into other types of cells.

They can become cells of the blood, heart, lungs or other body parts.

Stem cells also have a strong secretory function, promoting the formation of new blood vessels, cell proliferation and differentiation and inhibiting inflammatory response, experts say.

Stem cell therapy has been used in the treatment of some infectious diseases and complications. For instance, it has been tried in treating H7N9 avian flu and showed good results.

According to the Ministry of Science and Technology, the Chinese Academy of Sciences has developed a new stem cell drug, CAStem, which has shown promising results in animal experiments.

The research team has applied for urgent assessment by the National Medical Products Administration.

Approvals by the ethics committee, and clinical observation and evaluation are in progress.

A research team from the fifth medical centre of the Chinese PLA General Hospital is cooperating with hospitals and institutions in Wuhan, the epicentre of the epidemic, and North Chinas Tianjin municipality to conduct clinical research on the safety and effectiveness of mesenchymal stem cell therapy in treating Covid-19 patients. China Daily/ANN

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Stem cell therapy used to treat severe cases - The Star Online

By Partnered Content Mar 2, 2020

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Most of you reading this would have probably never heard of such a disease. My hope is, after taking time to read this, that you will know what myeloma is and have a better understanding of bone marrow cancer in general.

So, lets get started!

Your bone marrow is the factory where all your blood cells are made. This includes red blood cells (they carry the oxygen in your blood), white blood cells (your bodys defence against infections) and platelets (small fragments that prevent and stop bleeding).

The production of these cells by the bone marrow is very well controlled by your body, both in terms of the amount and the type of cells produced. If you have an infection, for instance, your body tells the stem cells in your bone marrow to make more white blood cells to help fight the infection. In such instances, an immature, baby cell gets produced in your bone marrow which then needs to go through various stages of growth and development to become a mature white blood cell. It is then released from the bone marrow into your bloodstream to go and do the job it was destined for, to fight the infection.

This process usually runs quite smoothly, but things can, unfortunately go horribly wrong. Sometimes your body makes a mistake in the production of a white blood cell, almost like a programming error which occurs in the DNA (blueprint) of the cell. It often recognizes its mistake and corrects it, but occasionally this abnormal cell has the ability to hide from your bodys defences, doesnt listen to your bodys commands anymore and can start to increase in number without anything controlling it. This causes a variety of problems and is then called cancer.

Depending on the type of white blood cell and where in its development the programming error occurs, a person can either develop a type of bone marrow cancer (usually leukaemia or myeloma) or lymphoma (glandular cancer), which is also a type of cancer that develops from an abnormal white blood cell.

That brings us to myeloma (also called multiple myeloma or plasma cell myeloma). Myeloma is a type of bone marrow cancer that develops when a programming error occurs in the development of a specific type of white blood cell, called a plasma cell. To understand myeloma better, it is important to understand what role a plasma cell plays under normal circumstances.

They are indeed an integral part of your bodys immune system. Any infection that you may develop gets recognized by your plasma cells. They respond by rapidly producing small proteins called antibodies, which are almost like homing missiles, programmed to go and destroy only that specific virus or bacteria that is making you ill.

After an infection, some of the antibodies remain in your bloodstream and if you are exposed to that exact virus or bacteria again, they are ready to attack immediately, thereby limiting the infection. This is the rationale behind childhood vaccination; to stimulate the production of antibodies which patrol your bloodstream and protect you when you get exposed to infections like measles, polio and many others.

If these plasma cells become cancerous however, they rapidly increase in number, taking over the bone marrow and producing a massive amount of an abnormal antibody which can cause a whole array of problems. This increase in antibody levels in the bloodstream can be measured with a blood test and is also used to monitor the response to treatment.. What are thesymptoms of myeloma?

The abnormal plasma cells in the bone marrow overwhelms the normal bone marrow which most commonly leads to an inability to produce enough red blood cells. This is called anaemia. Symptoms of anaemia are related to the bodys inability to carry sufficient oxygen to your organs and include worsening fatigue, shortness of breath and dizziness.

The abnormal plasma cells also have the ability to weaken your bones. This can either be a generalized loss of bone strength (called osteoporosis), or it can lead to numerous holes being eaten in your bones. This can be seen on an X-Ray or other types of scans. It often results in significant bone pain or even worse, severe fractures with minimal- or even no trauma at all.

Bones are rich in calcium, and if they are being eaten away, their calcium content is released into the bloodstream causing an elevated blood calcium level. This can lead to dehydration, kidney failure and numerous other symptoms.

As mentioned before, the plasma cells in the bone marrow releases a massive amount of abnormal antibodies into the bloodstream. They can clog up your kidneys and cause significant- and often irreversible kidney failure. This can seriously complicate the management of the disease.

These are by far the most common features of myeloma:

Anaemia, bone lesions or fractures, hypercalcaemia and kidney failure.There are numerous other symptoms which can occur, albeit less common.

Is myeloma treatable?

Myeloma is indeed a treatable condition, but there are a couple of important treatment principles to understand.

For most people, myeloma is not a curable disease. It can, however, be carefully managed and the aim of treatment is to provide a good quality of life for as many years as possible. No patients disease is the same and where we sometimes have patients with myeloma living in excess of ten years after being diagnosed, other patients are unfortunately less fortunate and have a form of the disease that is resistant to treatment which can take its toll after only a couple of months.

We perform DNA-tests on the cancer cells and look at various other blood results in an attempt to identify those patients with high-risk disease, who potentially need more intense treatment than others.

The goal of treatment is to destroy as many abnormal plasma cells in the bone marrow as possible. This leads to recovery of the normal bone marrow and minimises the risk of any further complications, giving the body a chance to recover from any complications caused prior to treatment.

For many decades, the backbone of the treatment for myeloma was a combination of two different type of drugs: Chemotherapy and high dosages of cortisone. This is usually quite well tolerated.

The last couple of years, however, have seen an explosion of newer therapies for the treatment of myeloma. This started years ago with the discovery that Thalidomide, was extremely effective for the treatment of myeloma. Soon, more of these so-called novel therapies were developed, leading to a significant increase in the survival of patients who have access to these drugs.

The latest and most impressive of these treatments are certainly the development of monoclonal antibodies and CAR-T cells, both of which are extremely effective even in high risk or resistant myeloma. There is so much excitement about all the newer therapies, but access remains a challenge in theSouth African market.

A strong collaborative effort is required amongst pharmaceutical companies, government and medical schemes, to improve the current access of newer drugs. Nevertheless, some of these drugs have been around for many years and the costs have come down considerably, making it accessible to more people.

The initial treatment of myeloma generally consists of varying combinations of these drugs depending on the patients age, physical condition and of course, the available funding.

We usually use 3 different drugs in combination (a so-called triplet regimen) which has been proven to be very effective. Once the treatment is started, we take blood regularly to monitor the abnormal antibody levels in the blood which, as mentioned earlier, is a surrogate indicator of the number of cancer cells remaining in the bone marrow.

If we dont see a significant downward trend, the disease is likely resistant to that specific treatment combination and treatment should be adjusted accordingly. However, if the antibody levels come down significantly, we are on the right track and can continue with the same treatment until an optimal response is obtained or the development of side-effects forces us to make an adjustment.

After 4-6 months of treatment, the hope is to see no sign of any abnormal antibodies or cancer cells anymore (we call this a remission), or at least a dramatic reduction. We do however know that although we sometimes dont pick up any sign of residual disease, it is merely because the available tests are not sensitive enough. There will always be some cancer cells that remain.

As a general principle, however, the less residual disease, the longer it usually takes before it causes problems again. Because of this, we usually treat younger patients more aggressively in an attempt to obtain a deeper remission. The biggest difference in younger patients is the use of an autologous stem cell transplant as a 2nd phase of treatment to try and obtain or deepen a remission.

We harvest the patients bone marrow stem cells and keep them frozen until needed. We then administer a single high dose chemotherapy which destroys many of the remaining cancer cells, but in the process, it also destroys the normal bone marrow, without which you cannot survive. The patients stem cells are then thawed and given back to them like a blood transfusion.

After about two weeks of close monitoring in the hospital, the stem cells start to function and the patient subsequently has his/her own bone marrow back, hopefully with significantly less myeloma. The age cut-off for such a procedure is arbitrary because it largely depends on the physical condition of the patient. Most people in South Africa, however, use the age of 70 as a cut off, sometimes a bit older if the patient is in exceptional condition for his/her age.

The median age of people diagnosed with myeloma worldwide is about 70 years. The available data, however, suggests that the median age in South Africa is considerably younger, somewhere around the age of 60 years. Due to this, as well as the problems with drug availability in South Africa, we often rely quite heavily on stem cell transplantation as an important part of treatment. If enough stem cells are harvested and cryopreserved, such a transplant can be repeated on numerous occasions to improve disease control.

After a transplant, as well as for those patients who are not candidates for a transplant, a form of low-intensity maintenance therapy is often started as the next phase of treatment in an attempt to keep the disease under control for as long as possible. This duration varies considerably. We hope for a couple of years, but it is unfortunately sometimes just a couple of months before the disease worsens, after which more intense treatment needs to be restarted again and the above cycle repeats itself. The remission duration gives us a good indication regarding the nature and prognosis of the disease.

There is so much more detail about myeloma to share, but the bottom line is this: Although myeloma is not a curable cancer and can lead to devastating complications, there is good treatment available which can help many patients enjoy a good quality of life for many years.

It is important to diagnose myeloma early, so if you have some of the symptoms mentioned earlier, please contact your General Practitioner for further investigation. If any abnormalities are detected, your GP can refer you to aClinical Haematologist, who specialises in bone marrow cancers and are best equipped to treat your myeloma.

We are all very excited about the future of myeloma treatment and hope that the treating physicians, pharmaceutical companies and government can take hands to ensure proper treatment for all the people in South Africa who suffer from this disease.

This article was compiled by Dr. Hannes Koornhof (Chairman of SACHAS)MBChB, FCP (SA), Dip HIV Man (SA), Cert Clin Haematology (SA) PhysSponsored by JANSSEN PHARMACEUTICA(PTY) LTD/(EDMS) BPK. (Reg. No./Regnr. 1980/011122/07); No 2, Medical Road, Halfway House, Midrand, 1685.www.janssen.com.

Medical Info Line: 0860 11 11 17. EM-27036

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Everything you need to know about Myeloma - IOL

Aaron Lipschitz (5) from Sea Point, Cape Town

Of the few known cases worldwide, Aaron is the only child who is unable to tolerate any food without becoming very ill. The only nutrition he has been able to cope with is a hypoallergenic formula called Similac Alimentum. He is currently fed via a MIC-KEY feeding port in his stomach.

As there is currently no cure for Aarons condition, the only way for him to overcome his recurrent infections and survive this condition, was to have a bone marrow transplant.

To help cover the costs of finding an international bone marrow donor, as well as assist his family with his ongoing medical expenses, acampaignwas created on donations based crowdfunding platform, BackaBuddy.

Over the course of two years, the BackaBuddy campaign has raised over R1 629 017.18 to support Aaron with contributions from over 978 donors both locally and abroad.

Finally in August 2018, Aarons family got the call they had been waiting for.

With the support ofThe South African Bone Marrow Registry, a 100% bone marrow match was found for Aaron overseas. At only 3 years old, Aaron underwent chemotherapy to destroy his current defective immune system before it was replaced with the donors bone marrow.

The risky procedure was met with complications when Aaron developed a very rare reaction to the new bone marrow, called a Cytokine Storm, which landed him in Red Cross ICU for a month. The fact that he was able to survive the transplant is a miracle, says Aarons mom, Taryn.

Aaron is a fighter in the true sense of the word. His doctors were trying to prepare us for the worst and I told them to wait and seeAaron survived against all odds. He has the most incredible zest for life and thirst for knowledge. says Taryn.

WATCH: Short documentary video on Aaron when he was 4 years old:

Since the bone marrow transplant, Aaron seems to be getting fewer infections but unfortunately, his immune system has not reconstituted as well or as quickly as doctors would have liked. To boost his immune system, he needs to have weekly immunoglobulin treatment.

When the transplant had no significant change on Aarons inability to tolerate food, his medical team decided to do a whole-genome sequencing to determine the root of the problem. They soon discovered a second rare genetic variant known as Fox P3, the gene responsible for the overall regulation of a persons immune system, which may be contributing to the food allergy component of Aarons condition.

Doctors also believe this second diagnosis may also explain why Aarons immune system responded so slowly to his bone marrow transplant.

Despite surviving such a tough procedure, Aaron still has a very long and challenging journey ahead. Whenever we feel that we are getting close to the summit of this mountain, the mountain seems to become higher. All we can do is keep our heads down and keep putting one foot in front of the other. says Taryn.

On the 8th of March, nine Capetonians lead by Rebettzin Sara Wineberg, will take on the Cape Town Cycle Tour, cycling a distance of 109 km to raise fundsfor Aarons ongoing medical expenses.

Aaron currently survives on a hypoallergenic formula administered 3-4 times a day via a MIC-KEY feeding tube in his stomach.

He still requires weekly immunoglobulin infusions where a tiny needle is inserted under the skin in his stomach to administer the infusion.

Aaron is in occupational therapy, physiotherapy and play therapy to help support him and allow him to lead the most normal life possible.

Rebbetzin Sara Wineberg from Sea Point, Cape Town, is excited to take on the Cape Town Cycle Tour for the second time, this year

I met Aaron when he was in the ICU just after his bone marrow transplant, things were not looking good and I came together with a group of women to pray for him. I have witnessed the miracle that is Aaron, he is our miracle and I want to help see more miracles come through for him and his family! says Sara.

Taking on the Cycle Tour for the first time, high schoolers from Cape Town Torah High School, Yehuda Hecht (16), Nissim Brett (15) and Joseph Meltzer (15) are enthusiastic to support Aarons treatment and make a positive difference. They will also be joined by Rabbi Pinni Hecht, Elenor Miller, Ronit Netter, Terry Deats and Aliyah Kaimowitz.

We are so fortunate that along this very challenging trail we have many angels helping us carry this load. Its been a relief to restart Aarons BackaBuddy campaign. Aaron still has a very long and challenging journey ahead. The years of high medical costs have really taken a financial toll on our family. says Taryn

Ahead of the Cycle Tour this Sunday, the Riding for Aaron campaign has already raised a total of R94 699.18 towards the fundraising target of R120 000 with contributions from 128 donors.

The Lipschitz family would like to encourage all South Africans, to register as bone marrow donors to give children like Aaron a second chance at life.

To date, theSABMRhas helped save the lives of nearly 500 patients with life-threatening blood disorders by matching them with healthy, unrelated bone marrow donors from South Africa and the rest of the world.

According to SABMR, Sustainability Portfolio Manager, Kamiel Singh, there are currently only 74 000 donors registered on the site to cater to over 57 million South Africans.

We are urging people to go onto theSABMR websiteto register as a bone marrow/stem cell donor. The process is as simple as making a phone call, filling out a form and having a mouth swab taken. You could save Aaron or another person waiting for their miracle. says Taryn

Register to become a bone marrow donor with the SABMR[click here]

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Cape Town Cycle Heroes Raising Funds for 5-Year-Old with Rare Genetic Condition - SAPeople News

Postmenopausal osteoporosis is the most common bone disease. It is characterized by reduced bone mass and microscopic changes in the architecture resulting in impaired strength of bones, with consequent increased susceptibility to fracture, which results in high medical expenditures and substantial morbidity with a decrease in quality of life [1, 2]. The bone mineral density (BMD) reduces with age in the entire population, and women are particularly at higher risk since they rapidly lose bone in the peri- and post- menopausal periods [2]. Age, sex, family history, low baseline weight, weight loss, and alcohol use in women, and smoking in men are generally associated with low BMD [2]. Owing to an increasing life expectancy, the number of patients has been progressively increasing worldwide [3]. One of the most debilitating complications of osteoporosis is hip fracture, which has an estimated probability of 3.5% in men and 14.6% in women around the age of 50years old. Approximately 2050% patients with hip fracture suffer from a decreased quality of life, depression, loss of self-esteem, and social isolation, which leads to the drastic elevation of one-year mortality rate, up to 1460% [4,5,6,7]. Vertebral fractures are extremely common complications of osteoporosis and often asymptomatic. However, multiple vertebral thoracic fractures may induce restrictive lung disease and secondary heart problems. Lumbar fractures may cause gastrointestinal complaints, back pain (both, acute and chronic), depression, and positional restriction, resulting in increased mortality [7, 8]. In view of these numerous complications, the main objective of treating postmenopausal osteoporosis is the prevention of future fractures.

The two types of treatment options for osteoporosis include anti-resorptive and anabolic agents. Anti-resorptive drugs include bisphosphonates (e.g. alendronate, minodronate (MIN), etidronate, risedronate, pamidronate, and zoledronate), selective estrogen-receptor modulators (raloxifene and bazedoxifene), active vitamin D3 derivatives (alfacalcidol and eldecalcitol), a fully human monoclonal antibody to receptor activator of nuclear factor -B ligand (RANKL; denosumab), and thyroid hormone (calcitonin). Anabolic agents include parathyroid hormone (teriparatide), parathyroid-related peptide synthetic analogs (abaloparatide), and a sclerostin inhibitor (romosozumab) [9]. Among these treatment options, bisphosphonates are the most widely used all over the world. MIN is a third-generation bisphosphonate and the strongest inhibitor of bone resorption among the currently available oral bisphosphonates. In terms of bone resorption inhibition, MIN is 1000-fold more effective than etidronate and 10100-fold more effective than alendronate [10]. Large randomized, placebo-controlled, double-blind clinical trials revealed a significant increase in bone mineral density (BMD) of both, the lumbar spine and femoral neck over 3years of MIN therapy and a risk reduction in vertebral fractures in Japanese women with postmenopausal osteoporosis [11]. Therefore, MIN continues to be one of the most widely used bisphosphonates in Japan.

Denosumab is a fully human monoclonal anti-RANKL IgG2 antibody that inhibits the binding of RANKL to its receptor on osteoclasts, thereby decreasing the bone-resorption activity of mature osteoclasts [12]. In the phase 3 Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6Months (FREEDOM) trial, denosumab treatment significantly reduces the incidence of new vertebral, nonvertebral, and hip fractures compared with placebo treatment [13]. Furthermore, in the FREEDOM Extension trial, 10-year treatment with denosumab increases the BMD of patients progressively with a significantly lower incidence of fracture [14]. In Japan, denosumab is currently one of the first treatment options, as evidenced by the report that sales of denosumab exceed that of each bisphosphonate [15]. Lyu et al. performed a meta-analysis of 10 eligible trials including 5361 participants comparing denosumab and bisphosphonates [16]. Denosumab increases BMD more than bisphosphonates at the lumbar spine, total hip, and femoral neck. Furthermore, one study showed that denosumab has a lower osteoporotic fracture incidence than alendronate at 24months (risk ratio, 0.51; 95% confidence interval, 0.27 to 0.97) [17]. Based on this clinical evidence, both denosumab and bisphosphonates are widely prescribed for osteoporosis in Japan. However, since denosumab is more easily administered by two annual injections with less complication, which may possibly increase the compliance rate, it appears to be the better choice between the two drugs. Therefore, we assumed that it can be considered as a reasonable treatment option to switch from bisphosphonates to denosumab in the clinical setting. However, only a few studies have reported the efficacy of switching from bisphosphonates to denosumab; therefore, the evidence level remains low.

In view of these findings, we advised patients treated with MIN for more than 2years to switch to denosumab if they agreed after the detailed explanation of each drug from treating physicians. In this study, we aimed to retrospectively evaluate the treatment effects of patients who switched to denosumab and compared with those of patients who continued MIN treatment.

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Clinical effects of switching from minodronate to denosumab treatment in patients with postmenopausal osteoporosis: a retrospective study - BMC Blogs...

VANCOUVER, Washington, March 02, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today continued positive data for its mTNBC and MBC patients.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyns mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). Results from the patients earlier CT scan indicated a more than 25% tumor shrinkage within the first few weeks of treatment with leronlimab. Most importantly, after more than five months of treatment with leronlimab and Carboplatin, the patient not only has zero CTC and zero EMT, but also zero detectible CAML (cancer-associated microphages like cells).

Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patients radiologist cancelled 2nd round of treatment due to leronlimabs effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has and continues to be the only treatment in place for brain metastasis after radiation was administered to this patient in July 2019. Four and one-half months after successful radiation treatment, the patient received her first dose of leronlimab (700 mg) and no other drugs to treat the brain metastasis. The 56% shrinkage in the brain lesions occurred after only two once-weekly injections of leronlimab. After 10 weeks of treatment with leronlimab, this patients CTC and EMT results were all zeros (results reported on 2/12/2020). The patients CT scan in mid-February was reported as stable.

Patient #3: Enrolled on 1/3/2020. This patients CAML counts decreased from 45 to 30. CTC+EMT are stable and there has been no change in the total number. Despite positive results, this patient stopped treatment due to complications with her implanted port, which was unrelated to leronlimab.

Patient #4: Enrolled on 1/7/2020. This patients total CTC dropped by 75% in the first two weeks of treatment with leronlimab. After almost five weeks of treatment, the CTC remained at zero.

Patient #5: Enrolled on 2/4/2020. This patient has traveled from England to receive leronlimab. Initial response from treatment indicated tumor shrinkage and, importantly, CTC dropped to zero after three weeks of leronlimab treatment.

Patients #6 and #7: Enrolled and waiting for the first results post-baseline results.

Patients #8 through #10: Will be injected in early March.

Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, Patients continue to be actively enrolled in this trial based on the expression of CCR5 on lymphocytes and macrophages in the tumor microenvironment. The proposed mechanism of action (MOA) consisting of inhibition of Tregs and repolarization of macrophages has demonstrated a predictable, sustained response that has reduced the size of primary and metastatic tumors and reduced circulating tumor cells in all patients tested so far.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, These findings are solidifying our belief of the four mechanism of actions (MOA) for leronlimab in the treatment of cancer, as previously verified through preclinical animal studies and in published papers. These MOAs indicate that leronlimab may potentially stop metastasis in many types of solid tumor cancers, trigger the bodys immune response system to destroy the cancer tumor and perhaps more. This could represent the beginning of the transformation of CytoDyn from a potential leader in HIV therapy to providing potentially a new innovative treatment opportunity to patients with various forms of cancer and potentially NASH, GvHD, MS, and perhaps many more indications. With the possibility of our first approval in HIV late this year, we could have over 30 label expansion opportunities post-HIV approval.

Story continues

About Triple-Negative Breast CancerTriple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growthestrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene. TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur. Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective.

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

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

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

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

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

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

CYTODYN CONTACTS

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

Originally posted here:
CytoDyn Reports Remarkable Outcomes for Additional Cancer Patients in mTNBC Trial; Following an Overwhelming Community Response, CytoDyn Expects to...

Given the quite reasonable concerns this past week over the blinding of three womenby a stem cell clinic injecting fat stem cells into eyes, I thought it was time to take a look at stem-cell-procedure complications. All medical procedures have complications. So what bar can we use to see if those complications are reasonable, and how should those be reported and measured?

First, to decide what complications might be reasonable, we need to understand the playing field of common side effects of conventional treatments. So what are some common complications in my world of orthopedic care, and how often do they happen?

So conventional procedures and widely used medications can have big time complications and rates!

To date, I think weve reported the most comprehensive paper on stem-cell-related complications. In more than 2,300 patients and 3,000 procedures, the total complication rate was 2.0%. Of those, four were deemed to be more serious and definitely related to the procedure by at least one independent reviewer not related to our group. Since this is out of 3.012, this is a serious-complication rate of 0.13%. Pretty small compared to the rates reported above for common orthopedic procedures.

This week we saw reported that the complication rate for the fat stem cell clinic that blinded three consecutive patients was approximately 0.01%. That seems about ten times less, despite the significant reported complications. Why? The data is an apples to oranges comparison.

For our reported data, a registry infrastructure was used where questionnaires were sent to every patient, and if they failed to respond, telephone calls were made. Based on conversations I have had with participating physicians, the stem cell outfit with the complications uses a passive system where the doctors are told to report the complications. Its likely that pinging patients about whats wrong can find more complications when compared to relying on a busy physician to report his or her complications.

Regrettably, the stem cell outfit that blinded these patients hasnt published any safety data on the widespread use of fat stem cells, so there is no research to review. This is concerning.

As you can see from the above risks, stem-cell-based orthopedic therapies have low-risk profiles when compared to conventional orthopedic procedures. Hence, when complications do occur, they are rare. However, to determine risk, efficacy is also needed as part of the calculus. So lets look at knee replacement.

So how good is knee replacement compared to garden-variety physical therapy (PT)? Not great. In a recent study (video below), 3 in 4 knee-replacement candidates undergoing PT instead of surgery decided not get a knee replacement after one year.Also you need to amputate 56 knees to find just one patient who reports more than a 15% functional improvement as a result of this maximally invasive surgery.

Looking at the relative efficacy of two procedures is hard without a head-to-head comparison trial. However, in the case of knee arthritis, we can comparetwo different studies that both compare to PT. In the above caseof knee replacement, we know how that invasive procedure fared, and below well look at a same-day stem cell procedure.

For the stem cell procedure, well be looking at the Regenexx bone-marrow-based version. Below is a graphic that discusses that out of more than 5,000 knee stem-cell-treated patients, as of this month, only about 12% went on to get a knee replacement despite their treatment at 12 years. This was based on 100% response rate from a random sample of 100 registry patients.

Below are the yet unpublished results of our randomized controlled trial where knee-replacement candidates were treated with our Regenexx knee stem cell procedure versus physical therapy:

The patients with a stem cell procedure report more knee function more quickly compared to the physical therapy group (listed here as Exercise Therapy). The PT group crossed over to the stem cell procedure at three months, which is why the PT data is only tracked for that long.

So comparing risks and benefits of these two therapies, the risk of knee replacement is significantly greater and the outcome based on a randomized controlled trial is likely no better than a stem cell injection. Hence, the risk/benefit of a Regenexx-protocol knee stem cell procedure is good compared to traditional care.

The upshot? While the risks of stem cell therapy are likely lower than most traditional treatments, for some indications, like injecting fat stem cells in the eye, that equation goes in the wrong direction. The goal with todays review was also to open a debate about when stem cell therapy is likely the better option.So lets have a reasonable discussion about stem cell risks and not throw the baby out with the bathwater!

See the article here:
complication rates stem cell procedures - Regenexx

Stem cell therapies have the potential to treat many conditions, but so far theres little proof that they do. Even so, clinics around the world offer stem cell-based treatments for a host of medical problems. New research warns that some of these treatments might not be effective and can, in fact, cause harm sometimes many years down the line.

A report in the journal CMAJ details the case of a 38-year-old man who developed a benign tumor on his spinal cord that his doctors linked to an experimental stem cell treatment he received 12 years earlier. They said his case highlights the hazards of unproven stem cell-based therapies, as well as the length of time it can take for serious problems to arise.

The worst-case scenario is not necessarily that [stem cell therapy] doesnt work, said Dr. Nanette Hache, one of the mans physicians and a professor of radiology at Memorial University of Newfoundland. There can be other complications, such as tumor formation.

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When the man was 20 years old, he injured his spine during a trampoline accident. Even after surgery and rehabilitation, he was left with some paralysis in his arms and severe paralysis in his legs and torso. At age 26, he underwent a stem cell procedure in Portugal that involved transplanting cells from inside his nose onto the spot of his spinal cord injury. The goal was to alleviate his pain and perhaps even help him walk again.

For people who have run out of conventional options, the choice to try something that hasnt been solidly tested could seem low risk and high reward.

You can imagine if you had this type of injury youd want to research it and see if there was anything out there that could potentially help you, Hache said. Even if wasnt mainstream medicine.

Instead of relief, the man experienced additional pain and never gained extra use of his arms or legs. Twelve years later, he was referred to Hache and her colleagues after he noticed decreasing function in his arms and bladder over the previous three or four years.

The team identified a large mass on the upper part of his spine. When they analyzed samples taken from the mass, they matched the cells in the samples to the type of cells that had been transplanted into his spinal cord: cells from the olfactory mucosa the mucous membrane that lines the nasal cavities.

Hache and her colleagues surgically removed part of the mans tumor but could not remove it entirely without risking further injury. While the tumor isnt considered cancerous, the team is using radiation to help slow its regrowth.

Cells from inside the nose may seem like a strange choice for a spinal graft, but the olfactory mucosa is easy to access and contains cells that can differentiate to form various cell types. Scientists are studying their use in stem cell transplants, and there is some evidence to support the idea that this approach could help patients recover from spinal cord injuries.

The procedure has shown some promise in animal models, and the team in Portugal that performed the mans transplant published a pilot study of the procedure in 20 individuals with spinal cord injuries. They reported improvements in about half of them. Other studies had similar findings.

But as Hache and her colleagues point out in the CMAJ report, these studies examined a small number of patients and were neither randomized nor blinded. Given the lack of controls, it is difficult to know whether any improvements were due to the transplant or to the rehabilitation that patients underwent after surgery.

University of Minnesota bioethicist Leigh Turner said this case demonstrates what can happen when techniques and cells that arent fully understood are used to treat disease.

If you put the wrong kinds of cells in the wrong location in the human body, there can be unwanted effects that just arent clear at the time, he said. And they arent necessarily picked up in preclinical research or with animal models.

Some stem cell-based therapies, like bone marrow transplants, are known to be relatively safe and effective. For many other stem cell approaches though, Hache and others believe that more research is needed before they are offered to patients.

The patient she treated joins what may be a growing group of people who experience serious complications from stem cell transplants. A 2018 analysis reported 35 cases of complications or deaths following unproven stem cell-based treatments, including loss of vision, infections, cardiovascular complications, and cancer. While the researchers acknowledged that some of these problems could have been caused by the implant procedure, others are likely the direct result of the yet unproven treatments using stem cells, they wrote.

Cases like this sometimes bring up concerns about stem cell tourism, in which people travel to different countries for operations and treatments that arent available or accessible in their home countries.

While this patient did travel to Portugal, Turner, who has long voiced criticism of clinics that offer unproven treatments, said his case is complicated.

Its not quite as simple as individuals from Canada, United States, and elsewhere going to some kind of dodgy, obscure clinic in the far ends of the world, Turner said, pointing out that the doctor who performed the transplant has published in peer-reviewed journals and appears to have observed few adverse effects in the patients he and his team treated and tracked.

Stem cell-based therapies are available in North America, and the United States actually has the largest number of stem cell clinics in the world. But invasive procedures like this tend to happen more often outside the U.S. and Canada, Hache said.

There are several known cases in which individuals developed similar spinal tumors after undergoing stem cell transplants using olfactory mucosal cells. At least one of them received a stem cell transplant from the same medical team in Portugal as the man Hache is now treating. In its pilot study, the Portuguese team followed patients after their surgery for an average of about 28 months. For Haches patient, that would not have been long enough to detect the mass that eventually grew on his spine.

Its such a slow process for these tumors to grow, Hache said. The latency period can be years and in his case was greater than seven years.

Given the longer time frame needed for such side effects to show, similar cases could arise down the line. There could also be patients who are experiencing long-term effects that havent led to case reports.

Are there other individuals walking around who have these complications and they just didnt make it into the academic literature? Turner said. I think its a possibility. It may be that from a long-term perspective, the safety profile is different. We need to be aware of the possibility of long-term complications.

Stem cell clinics in North America and around the world have been criticized for advertising unproven therapies to patients.

Because people are vulnerable and because theyve got this illness and theyre desperate for a cure of some sort, theyre willing to take risks, Hache said. And they pay a good sum of money to have these treatments done.

The case report notes that olfactory mucosal transplants cost about $50,000, which does not take into account expenses for travel, accommodation, and recovery. Patients may be aware of the costs and some of the risks, said Hache, but cases like this show how many unknowns remain regarding the long-term effects of unproven stem cell therapies.

The patient probably figured, at the end of the day I guess I lost that money and I am not any better, Hache said. Not realizing that there was a worse outcome.

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