Tacitus Therapeutics Launches in Collaboration with Mount Sinai to Develop Stem Cell Therapies for Life-Threatening Diseases – PRNewswire

NEW YORK, Jan. 9, 2020 /PRNewswire/ -- Tacitus Therapeutics, a clinical-stage company, has launched in collaboration with the Mount Sinai Health System to develop stem cell therapies initially targeting blood cancers and related clotting disorders. Their first therapy, HSC100, currently is being investigated in a Phase I clinical trial1.

Tacitus is building upon technology developed by and exclusively licensed from Mount Sinai. Based on research by scientific co-founders Ronald Hoffman, M.D., and Camelia Iancu-Rubin, Ph.D., the technology includes proprietary cell expansion, differentiation and engineering methods. Together, these methods manufacture healthy cells that overcome the limitations of traditional allogeneic, or donor, cell transplantations.

Blood cancers comprise about 10% of new cancer cases in the U.S. each year, and almost 60,000 people die from blood cancer complications annually. Most blood cancers start in the bone marrow, where blood is produced. A common therapy for such blood cancers is a hematopoietic stem cell (HSC) treatment or, as more commonly referred to, bone marrow transplantation. In this process, doctors infuse healthy HSCs into the patient's bloodstream, where they migrate to the bone marrow to grow or engraft.

HSCs for this process can be collected from bone marrow, circulating blood, or umbilical cord blood (CB) of healthy donors. While HSC transplants are common, significant barriers to success exist, including high levels of graft-versus-host disease, low numbers of healthy cells obtained from CB, and increased risk of bleeding due to delayed megakaryocyte, or platelet, engraftment.

Hoffman and Iancu-Rubin are pioneers of bone marrow cell therapy treatments, and development of this technology was enabled by the New York State Stem Cell Science program, NYSTEM. As a New York State Department of Health initiative, NYSTEM awarded a $1 million grant to Hoffman in 2010 that supported the original research underpinning this platform technology. In 2015, NYSTEM awarded Hoffman and Iancu-Rubin an $8 million grant to translate the technology from the laboratory into the clinic, where it is currently in clinical trial1.

Hoffman also serves as Director of the Myeloproliferative Disorders Research Program and Professor of Medicine (Hematology and Medical Oncology) and Iancu-Rubin is Associate Professor of Pathology at the Icahn School of Medicine and Director of the Cellular Therapy Laboratory at Mount Sinai Hospital.

"Promising discoveries by Mount Sinai scientific thought leaders may lead to new, essential cell-based therapies that will broadly benefit patients," said Erik Lium, Executive Vice President and Chief Commercial Innovation Officer, Mount Sinai Innovation Partners. "We're pleased to be collaborating with Tacitus to launch the next stage of development for these technologies."

"Tacitus is committed in its mission to advance next-generation cell therapies with curative potential," said Carter Cliff, CEO of Tacitus. "Based on our founders' solid foundation of research, we are translating these discoveries into broad clinical practice as we look to dramatically improve the standard of care for patients with life-threatening conditions."

About HSC100

HSC100 is an investigational therapy based on allogeneic hematopoietic stem cells (HSC) expanded from umbilical cord blood. HSC100 is being investigated currently in an open-label Phase I clinical trial1 in the United States for treatment of hematological malignancies. The success of unmanipulated cord blood as a source of stem cells has been hampered by the small number of stem cells present in a single cord, leading to delayed engraftment and frequent graft failure. Our proprietary technology includes the use of an epigenetic modifier, valproic acid, to expand the number and the quality of HSCs found in cord blood collections. For more information on HSC100 clinical trials, please visit http://www.clinicaltrials.gov.

1ClinicalTrials.gov identifier NCT03885947.

About Tacitus Therapeutics

Tacitus Therapeutics is a clinical-stage biotechnology company developing advanced medicines for treatment of blood cancers, immune disorders and other intractable disease conditions. Our mission is to pioneer best-in-class therapies using proprietary cell expansion, differentiation and engineering platform technologies that overcome the limitations of traditional cell transplantation. Initial targets include a lead clinical program (HSC100) investigating the treatment of blood cancers, followed by preclinical programs to address clotting disorders and other serious unmet medical needs. For additional information, please visit http://www.tacitustherapeutics.com.

About Mount Sinai Health System

The Mount Sinai Health System is New York City's largest integrated delivery system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The Health System includes approximately 7,480 primary and specialty care physicians; 11 joint-venture ambulatory surgery centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 12 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Geriatrics, Gynecology, Nephrology, Neurology/Neurosurgery, and Orthopedics in the 2019-2020 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked nationally in five out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 12th nationally for Ophthalmology, Mount Sinai St. Luke's and Mount Sinai West are ranked 23rd nationally for Nephrology and 25th for Diabetes/Endocrinology, and Mount Sinai South Nassau is ranked 35th nationally for Urology. Mount Sinai Beth Israel, Mount Sinai St. Luke's, Mount Sinai West, and Mount Sinai South Nassau are ranked regionally. For more information, visit http://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

About Mount Sinai Innovation Partners (MSIP)

MSIP is responsible for driving the real-world application and commercialization of Mount Sinai discoveries and inventions and the development of research partnerships with industry. Our aim is to translate discoveries and inventions into health care products and services that benefit patients and society. MSIP is accountable for the full spectrum of commercialization activities required to bring Mount Sinai inventions to life. These activities include evaluating, patenting, marketing and licensing new technologies building research, collaborations and partnerships with commercial and nonprofit entities, material transfer and confidentiality, coaching innovators to advance commercially relevant translational discoveries, and actively fostering an ecosystem of entrepreneurship within the Mount Sinai research and health system communities. For more information, please visit http://www.ip.mountsinai.orgor find MSIP onLinkedIn, Twitter, Facebook,Medium, and YouTube.

Media Contacts:

Mount Sinai Cynthia Cleto Mount Sinai Innovation Partners (646) 605-7359 cynthia.cleto@mmsm.edu

Tacitus TherapeuticsJoleen RauRau Communications(608) 209-0792232130@email4pr.com

SOURCE Tacitus Therapeutics

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3D-printed Organs Give Hope to Transplant Patients Now. Powered by – Now. Powered by Northrop Grumman.

The 3D printer has won the hearts of manufacturers for its ability to create detailed products without the need for expensive and time-consuming prototyping. Everything from prosthetics to engines to football cleats have spun out of the technology.

But it couldnt create human organs, could it? Well, yes, it can. Scientists claim to have recently enhanced the performance and stability of 3D-printed organs, including a heart a development that would excite the Tin Man of The Wizard of Oz.

The real-life implications of organs created by 3D printing are vast and revolutionary. The printer could quickly produce organs to those in need of a transplant, and it could enhance the skills of surgeons by letting them practice on copied organs innovations many would say are worth copying on a large scale.

To be clear, the organs arent entirely the products of additive manufacturing, the term to describe 3D printing, but a recent development with the technology signals it will probably have a large role in advancing copied organs.

Creating organs through additive manufacturing had until now been largely unsuccessful. As described by Cosmos, laboratories have grown so-called organoids for the past decade. These miniaturized versions of the brain, heart and kidney help scientists study cancer, dementia and heart attacks. But with the models unable to expand beyond the size of a lentil, they couldnt incorporate the tubes that mimic blood vessels. Without those tubes, oxygen and nutrients struggle to reach the core of the organ.

It seemed as if the dream to produce ready-made full-sized organs in a lab would have to remain just that, a dream. But a recent breakthrough that combines human stem cells with a 3D-printed vascular channel could overcome the structural issues.

A new method of replication solves the size challenge by integrating 3D-printed vascular channels into living matrices of stem cells that form organ building blocks, according to the scientists who devised the technique SWIFT (sacrificial writing into functional tissue). The 3D printer infuses ink and gelatin into a matrix and the mix is then heated, melting the ink and leaving a channel that is then lined with cells found in human vessels. Stir in oxygen and nutrients and you have an organ. The researchers kept one such organ, a 1.5-centimeter mini-heart, beating on its own for more than a week.

The researchers from Harvard Universitys Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS) say SWIFT produces organ-specific tissues that have high cell density and functionality, a critical step toward large-scale and safe organ replacement and other uses.

This is an entirely new paradigm for tissue fabrication, Mark Skylar-Scott, a research associate at the Wyss Institute and one of the studys co-authors, told ScienceDaily. Rather than trying to 3D-print an entire organs worth of cells, SWIFT focuses on only printing the vessels necessary to support a living tissue construct that contains large quantities of (organ building blocks), which may ultimately be used therapeutically to repair and replace human organs with lab-grown versions containing patients own cells.

As ScienceDaily noted, 20 people die daily while waiting for an organ transplant in the U.S. More than 30,000 transplants are performed each year but its still not enough to whittle down the long waiting lists of those in need of a suitable organ. More than 113,000 people are currently awaiting word that their wait has ended. Artificial organs could lessen or eliminate the shortage.

Replicated organs could also give doctors an opportunity to practice difficult surgical procedures, a chance to enhance their skills without fear of doing harm to human patients. Similarly, 3D-printed organs could remove the need to try out new pharmaceutical drugs on human or even animal test subjects.

The ink is barely dry on the Harvard researchers test, but the scientific world is hoping their discovery can be replicated for years to come.

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Seattle Childrens faces widening array of lawsuits over fatal mold infections – Seattle Times

Beth Hutt is 5 months old and has never been home since her birth in August. She was born with a heart condition and rushed from Tacoma General Hospital to Seattle Childrens, where she has undergone three surgeries, beginning when she was 5 days old.

At some point during her stayat Seattle Childrens, Beth contracted an infection in her heart from the Aspergillus mold, a recurring problem that has sickened patients at the hospital as far back as 2001.

Beths parents, Katie and Micah Hutt, knew about the problems Seattle Childrens was having with Aspergillus but said it was a no-brainer to take her to Childrens.

We went into this situation believing that an issue had been found and it was fixed, Katie Hutt said.

On Wednesday, attorneys pursuing a class-action lawsuit against Childrens on behalf of the families of patients who have been sickened from the mold sought toadd Beth Hutt to the case.

The lawsuit, filed in December in King County Superior Court on behalf of four children or their estates, seeks class-action status for patients who were sickened by Aspergillus at Childrens between 2005 and 2017. A fifth patientwas added to the complaint before Beth Hutt.

In an emailed response, Seattle Childrens didnt answer questions about Beth Hutt.

We are working diligently to resolve these issues, including the claims that have been brought against Seattle Childrens related to past surgical site infections, the statement read. We are incredibly sorry for the impact this situation has had on our patients and families.

Beths second surgery was Nov. 7, three days before Childrens administrators closed three of the hospitals operating rooms,after the hospital announced it had found two possible cases of Aspergillus infections.Childrens closed the remaining operating rooms on Nov. 13 to sanitize them and inspect the air-handling system that serves the rooms.

The state Department of Health (DOH) said Wednesday that it had finished an investigation of the hospital, which it began in November after the hospital self-reported a case of Aspergillus to us. The agency said it did discover mold, but found the hospital to be following the states rules and found no evidence of deficient practices.

Last years problems with Aspergillus werent the first for Childrens. In October 2017, inspectors with the DOH cited the hospital for a serious violation over its failure to implement and monitor an effective infection prevention program.

In June 2018, Childrens closed two operating rooms and an equipment-storage room for three days after Aspergillus was detected and attributed to small gaps in the walls of the operating rooms.

Childrens problems with Aspergillus came to light again on May 18 last year, forcing it to close four operating rooms for more than six weeksbecause of the mold.

This time, the Aspergillus was attributed to a gap in the array of air filters in an air-handling unit serving the operating rooms, prompting the hospital to shut down, clean and install new units.Hospital officials wouldnt say Wednesday if those units were now installed.

Childrens chief executive, Dr. Jeff Sperring, has acknowledged 14 patients had been sickened by Aspergillus since 2001, six of whom died. He said the hospital had failed and blamed the hospital for not recognizing a connection between the infections and the air-handling units attached to its operating rooms.

One of the reasons Hutt was added to the lawsuit is because she is one of the most recent patients to be infected by the mold, which gives the complaint representation during a wider time frame, said attorney Karen Koehler, one of the lawyers handling the lawsuit.

Childrens, the regions premier pediatric hospital, faces a series of lawsuits related to the Aspergillus infections, including a suit filed in December by the family of an 11-year-old boy claiming he was infected during surgery in March 2019, and another that alleges a 4-year-old boy needed a second brain surgery in May related to his risk for Aspergillus exposure during surgery.

Aspergillus is a common mold that most people breathe daily without getting sick, but its risk to hospital patients has been known for decades. Patients with lung diseaseor weakened immune systems especially organ- or stem-cell transplant patients are at higher risk of developing Aspergillosis. In the most serious cases, symptoms range from a fever to coughing up blood, according to the Centers for Disease Control and Prevention.

The family of another patient, a teenager who played football, filed suit in late October. That suit alleges the hospital failed to take reasonably prudent measures to prevent Aspergillus from infecting their son, leaving him disabled.

Despite the Hutts frustration and anger with the hospitals administration and building services, they dont hold it against the nurses and doctors who have been working with their daughter.

We would not trade the level of care we have received for anything, said Beths father, Micah Hutt.

Beth Hutt is still at Seattle Childrens and had another surgery on Jan. 2.

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Seattle Childrens faces widening array of lawsuits over fatal mold infections - Seattle Times

Landisa: My cancer can relapse but here’s why I am not afraid of it any longer – News24

I was diagnosed with cancer in January 2018 when, as I prepared for the year ahead, I underwent my annual medical examination and the doctor saw a lump in my groin. It turned out be lymphoma.

From walking into his office as a healthy person showing no symptoms and motivated to start the new years working schedule, the cancer diagnosis brought my life to a sudden standstill. It felt unreal.

At first, I could not share the news with family and friends, because I could not believe that this was really happening to me. For weeks I could not say the word "cancer"; I refused to read up about the disease on the internet as I was scared to stumble over statistics of survival rates which would show what my chances were.

So many questions came up (and mostly out of anger and disbelief, I must admit): "Why me? What could be the cause of this? Was the healthy lifestyle I was living in reality flawed? Should I consult more doctors in the hope of a different diagnosis?"

It was something I had to work out for myself in private. After a few months, I had to accept that these questions will change nothing. The reality was that I had lymphoma, that medical research could not yet determine a cause for my type, and that there is no such thing as some magic guarantee of eternal health so that even after 58 years of near-perfect health, cancer can also cross my path.

With the encouragement and support of family and friends, I became rocksteady with a positive outlook towards the future; with my mind and heart set on hope and faith of a full recovery so that, God willing, I will become fit enough again for regular exercise and to return to work. That this diagnosis would be not the end of the road, but only a bend in the road. That the unknown treatment and medical procedures laying ahead will not scare me but rather be an "adventure" to take head-on and endure. Little did I know then that it would involve a marathon treatment programme spanning 18 months and comprising 13 sessions of chemotherapy, 20 sessions of radiation therapy and a stem cell transplant.

Hardly could we as a family have foreseen that our lifestyle would change so dramatically: the doctors put me on a strict neutropenic diet as well as effectively confine me to my home (my weakened immune system needed protection from the risk posed by potential infection transmitted via food or people).

Add on top of that a new routine involving things such as endless blood tests, doctor's appointments, days in hospital and in the chemo-room, blood transfusions, hands full of tablets, various biopsies and scans, very painful veins and arteries, weakness and extremely low energy levels, and even the impact of a transplant procedure.

For me these tough times quickly changed into a mere memory on June 20, 2019 when the doctors declared me cancer-free. The gratefulness and relief when you hear the words "the tests show that all signs of cancer disappeared" is hard, if not impossible, to express in words.

It immediately puts the endurance into perspective.

Looking back at the past two years: what a learning curve and what an experience for me!

It made me realise the fragility of our health and the suddenness in which it can be lost; that cancer indiscriminately affects young and old alike; and that there is hope, because cancer can be cured!

Cancer fundamentally changed the way I look at life. It taught me that life is a gift handed to us one day at a time, wrapped in 24-hour packages.

It is up to us to take that gift each morning, open it up and make the best of what it holds for us on that day.

Yesterday's gift is gone forever, and tomorrow might bring something worse than today, or maybe today's gift is the last one in this life. Cancer taught me that it is not about tomorrow, it's all about today - I only have today.

And an inner peace fills me now with the realisation that I had the privilege to receive the prized and valuable gift of life.

"And once the storm is over, you wont remember how you made it through, how you managed to survive. You wont even be sure whether the storm is really over. But one thing is certain. When you come out of the storm, you wont be the same person who walked in. Thats what this storms all about." - Haruki Murakam

Do you have a story to share? Send it tolandisa@news24.comand include your contact details and a photo. VisitLandisafor more stories.

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Landisa: My cancer can relapse but here's why I am not afraid of it any longer - News24

‘You wouldn’t give it to your worst enemy’: what it’s like to live with Lyme disease – Telegraph.co.uk

When Sarah Hook was rushed to hospital in 2015, she was struggling to breathe,her heart was racing and she was experiencing an intense rush of adrenaline.I felt like I had drunk 100 coffees, she remembers.

Initially, doctors identified her symptoms as a panic attack but Hook,had never had one before. A month later, she realised theterrifying episode could in fact have been linked to a tick bite that had occurred 10 years previously.I didn't do anything about the tick bite," she says. "I left it, (but) looking back I can see that my health has been deteriorating since then. Id left it so long my body crashed.

Six months after her hospitalisation, a blood test at a private clinic confirmed that Hook had Lyme disease,a tick-borne infectious disease which can cause extreme fatigue, nerve damage, and neurological issues. Ever since, she has been unable to work and has had to move back in with her parents in Berkshire.

Its such a systemic illness, the symptoms morph and change," she says. "You can just feel like youve got rid of one and it can just pop up somewhere else. I think that's why it feels so exhausting.

This week, US singer Justin Bieber announced on Instagram that he is battling the disease.While a lot of people kept saying Justin Bieber looks like s***, on meth etc. they failed to realise I've been recently diagnosed with Lyme disease, the 25-year-old wrote, referencing speculation about his health afterpictures showed him looking exhausted, with blotchy skin.

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'You wouldn't give it to your worst enemy': what it's like to live with Lyme disease - Telegraph.co.uk

The ‘supercells’ that cured an infant’s grave genetic illness – Japan Today

When a person's immune system is impaired by a genetic disease, a bone-marrow transplant can be a powerful therapeutic tool, but with a major downside: during the first few months the recipient's defenses against viruses are severely weakened. The slightest infection can lead to a hospital trip.

A still-experimental type of treatment known as T-cell therapy aims to assist during this vulnerable period -- the months during which the body is rebuilding its natural defenses. After two decades of clinical trials, the technology has been refined, and is being used to treat more and more patients, many of them children.

A boy named Johan is one of them.

Today he is a mischievous, smiling toddler with a thick shock of light-brown hair, who never tires, playfully tormenting the family's puppy, Henry. There is no sign of the three-year-long medical and emotional roller-coaster ride he and his family, who live in an affluent Washington suburb, have been on.

The first traumatic surprise came with the results of a pregnancy test: Johan was not planned.

"That was a huge shock. I cried," said his mother, 39-year-old Maren Chamorro.

She had known since childhood that she carried a gene that can be fatal in a child's first 10 years, chronic granulomatous disease (CGD). Her brother died of it at the age of seven. The inexorable laws of genetics meant that Maren had a one in four chance of transmitting it to her child.

For their first children, she and her husband Ricardo had chosen in-vitro fertilization, allowing the embryos to be genetically tested before implantation.

Their twins Thomas and Joanna were born -- both disease-free -- seven and a half years ago. But in Johan's case, a post-birth genetic test quickly confirmed the worst: he had CGD.

After conferring with experts at Children's National Hospital in Washington, the couple took one of the most important decisions of their lives: Johan would receive a bone-marrow transplant, a risky procedure but one that would give him a chance of a cure.

"Obviously, the fact that Maren had lost a sibling at a young age from the disease played a big role," Ricardo confided.

Bone marrow, the spongy tissue inside bones, serves as the body's "factory" for the production of blood cells -- both red and white.

Johan's white blood cells were incapable of fighting off bacteria and fungal infections. A simple bacterial infection, of negligible concern in a healthy child, could spread out of control in his young body.

Luckily, Johan's brother Thomas, six years old at the time, was a perfect match. In April 2018, doctors first "cleansed" Johan's marrow using chemotherapy. They then took a small amount of marrow from Thomas's hip bones using a long, thin needle.

From that sample they extracted "supercells," as Thomas calls them -- stem cells, which they reinjected into Johan's veins. Those cells would eventually settle in his bone marrow -- and begin producing normal white blood cells.

The second step was preventive cell therapy, under an experimental program led by immunologist Michael Keller at Children's National Hospital.

The part of the immune system that protects against bacteria can be rebuilt in only a matter of weeks; but for viruses, the natural process takes at least three months.

From Thomas's blood, doctors extracted specialized white blood cells -- T-cells -- that had already encountered six viruses.

Keller grew them for 10 days in an incubator, creating an army of hundreds of millions of those specialized T-cells. The result: a fluffy white substance contained in a small glass vial.

Those T-cells were then injected into Johan's veins, immediately conferring protection against the six viruses.

"He has his brother's immune system," said Keller, an assistant professor at Children's National.

Johan's mother confirmed as much: today, when Thomas and Johan catch a cold, they have the same symptoms, and for nearly the same amount of time.

"I think it's pretty cool to have immunity from your big brother," Maren Chamorro said.

This therapeutic approach -- boosting the body's immune system using cells from a donor or one's own genetically modified cells -- is known as immunotherapy.

Its main use so far has been against cancer, but Keller hopes it will soon become available against viruses for patients, like Johan, who suffer from depressed immune systems.

The chief obstacles to that happening are the complexity of the process and the costs, which can run to many thousands of dollars. These factors currently restrict the procedure to some 30 medical centers in the United States.

For Johan, a year and a half after his bone marrow transplant, everything points to a complete success.

"It's neat to see him processing things, and especially play outside in the mud," his mother said. "You know, what a gift!"

Her only concern now is the same as any mother would have -- that when her son does fall ill, others in the family might catch the same bug.

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The 'supercells' that cured an infant's grave genetic illness - Japan Today

Edited Transcript of BYSI.OQ earnings conference call or presentation 18-Dec-19 1:00pm GMT – Yahoo Finance

NEW YORK Jan 8, 2020 (Thomson StreetEvents) -- Edited Transcript of BeyondSpring Inc earnings conference call or presentation Wednesday, December 18, 2019 at 1:00:00pm GMT

BeyondSpring Inc. - CFO

BeyondSpring Inc. - Co-Founder, Chairman & CEO

* Ramon W. Mohanlal

BeyondSpring Inc. - Executive VP of Research & Development and Chief Medical Officer

* Richard J. Daly

BeyondSpring Inc. - COO

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* David Schemelia;Kanan, Corbin, Schupak & Aronow, Inc.

Good day, everyone, and welcome to BeyondSpring's Third Quarter 2019 Conference Call. My name is Rob, and I'll be your operator on today's call. Please be advised that this call is being recorded.

At this time, I would like to turn the call over to the host, David Schemelia, Senior Vice President at KCSA Strategic Communications.

Thank you, operator, and thank you, everyone, for joining today's call. I would like to advise listeners that remarks made on today's call may reflect forward-looking statements relating to such matters as BeyondSpring's clinical and preclinical research and development activities and results, regulatory and commercial plans, industry trends, marketing potentials, collaborative initiatives and financial projections, among others. While management believes that its assumptions, expectations and projections are reasonable in view of current available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this call for a variety of reasons, including those described in the forward-looking statements and risk factors sections of the company's 20-F and other filings with the SEC, which are available on the Investors section of BeyondSpring's website.

Joining us on today's call is Dr. Lan Huang, BeyondSpring's Chairman and Chief Executive Officer; Dr. Ramon Mohanlal, Executive Vice President of Research, Development and Chief Medical Officer; Richard Daly, Chief Operating Officer; and Edward Liu, Chief Financial Officer.

It is now my pleasure to turn the call over to Dr. Lan Huang.

Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [3]

Thank you for joining today's call. Thank you, David. For those of you who are just now starting to follow our story, BeyondSpring is a global biopharmaceutical company focused on the development of transforming immuno-oncology cancer therapies for unmet medical needs. The last quarter had been very exciting with a few significant milestones achieved. First, our lead asset, first-in-class agent, Plinabulin is on track to file an NDA for non-small cell lung cancer and the prevention of chemotherapy-induced neutropenia or CIN indications in China and in the U.S. in the next 6 to 18 months, leading with the filing in China for CIN around quarter 1 2020.

Second, with Plinabulin validated as a potent inducer for Antigen Presenting Cells or APC inducer with recent publications in cell journals, Plinabulin has the potential future indications with triple combo combining with PD-1 or PD-L1 antibodies and chemo or radiation for multiple cancer indications.

Last but not the least, Plinabulin's recent U.S. patent granted in brain tumors adds to its robust patent portfolio of 75 granted patents in 36 jurisdictions with protection to 2036, including composition of matter patents. Thus, we have a very long patent runway to realize Plinabulin's clinical and commercial potential.

Since our last update, we continue to progress in our clinical studies. In October, we reported that the first patient was enrolled in the company's Study 106, a global Phase III clinical trial, with Plinabulin in combination with G-CSF to prevent CIN, designed to show superiority in CIN and bone pain control compared to G-CSF alone. As you know, G-CSF is the standard of care for CIN for the last 30 years, with annual sales over $7 billion globally.

In addition, I'm very pleased to report that after 5 years of efforts, collaborating with leading scientists at University of Basel and Mass. General, we have uncovered Plinabulin's unique mechanism in cancer treatment and in CIN control. Plinabulin's anti-cancer in new mechanisms work as a potent agent to induce standard cell maturation and T-cell activation were published in the prestigious peer-reviewed cell publication, Chem and Cell Reports, in September.

Recently, Plinabulin's mechanism in CIN control by reversing chemo-induced bone marrow suppression and its effects in reducing CIN with multiple chemo with different mechanism as published in Cancer Chemotherapy and Pharmacology this month. This paper further validates what we have observed in human studies in Plinabulin's durable anticancer benefit and CIN control with multiple chemo and synergizes with G-CSF.

On the financing side, in late October, we completed a public offering, significantly expanding our institutional shareholder base and strengthening our balance sheet as we advance our clinical pipeline towards NDA submissions in the U.S. and China. So as you see, it has been a very busy few months for BeyondSpring.

All in all, we view Plinabulin as a pipeline in the drug. To date, Plinabulin has treated more than 580 patients with good tolerability. The fundamental indications of Plinabulin are in non-small cell lung cancer and in CIN with multiple clinical studies confirming Plinabulin's benefit, some with high statistical significance. Most of the second and third-line non-small cell lung cancer and CIN indications are severely unmet medical need indications. First, in patients with second and third-line non-small cell lung cancer who are EGFR wild type, which accounts to 85% of Western patients, there are very few approved therapies available, and current treatment options have a modest median OS, or overall survival rate, of 8 to 10 months, but at the expense of severe adverse events, such as severe neutropenia and quality of life. Even response rate with PD-1 inhibitor monotherapy is around 20%, with a median survival benefit of only 2.8 months compared to docetaxel, the standard of care in this patient population.

Secondly, in CIN, the current standard of care is G-CSF monotherapy with a long-lasting version Neulasta being the market leader. However, after using Neulasta, about 90% of patients with high-risk chemotherapy still develop grade 3 or 4 neutropenia. Grade 3 or 4 neutropenia requires the chemotherapy dose to be reduced, the next cycle to be delayed, the regimen to be downgraded or be discontinued altogether. So we call this 4Ds, all of which result in significant reduced survival outcomes for patients. Thus, we are very confident Plinabulin has the potential to disrupt the current treatment landscape and greatly improve overall patient outcomes and quality of life.

Our regulatory strategy is submitting NDAs in China for CIN in the first quarter of 2020 and for non-small lung cancer in the second half of 2020. We also plan to submit NDAs in the U.S. for CIN in the second half of 2020 and for non-small cell lung cancer in the first half of 2021. This staggered NDA filing strategies for both China and the U.S. allows agencies in both countries to sufficiently review the Plinabulin's preclinical, safety and CMC sections when we submit for the NDA for the CIN indication.

And when it comes to the submission for the non-small cell lung cancer indication, since the same preclinical and CMC sections of Plinabulin submissions have been reviewed, we expect the review and approval process will be much accelerated. Such an approach has been adopted by FibroGen with its innovative, first-in-class asset, which successfully obtained regulatory approval in China first with a speedy time line ahead of the U.S. approval.

In November of this year, we had a successful pre-NDA meeting with the U.S. FDA and reached alignment that our current safety data needs requirement for NDA filing for both indications of Plinabulin. We believe Plinabulin's transforming potential in triple combo of combining Plinabulin, PD-1 or PD-L1 antibodies and radiation or chemotherapy for the treatment of multiple cancer types. This triple combination approach optimizes utility of immunotherapy as radiation or chemotherapy generate tumor antigen, Plinabulin's DC maturation effect optimizes presentation of this tumor antigens to cytotoxic T cells and checkpoint inhibitors-enabled activated T cells to kill cancer cells. In other words, Plinabulin's steps on the gas, PD-1 releases the brake. So this triple combination approach could be a powerful cocktail that resembles the powerful HIV cocktail therapy, which transformed HIV from a deadly disease to a chronic disease with patients having normal life expectancy.

In addition, we remain on track to advance 3 preclinical immune agents, BPI-002, 003, and 004 and the research platform using ubiquitin-mediated degradation pathways, the Nobel prize-winning technology, which can target 70% of (inaudible) target, as we have a leading team working on this.

Now I'm turning the call over to Dr. Ramon Mohanlal, who will discuss our recent clinical developments in more detail.

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Ramon W. Mohanlal, BeyondSpring Inc. - Executive VP of Research & Development and Chief Medical Officer [4]

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Thank you, Lan. First, I would like to provide an update to our registrational trials for our lead asset, Plinabulin. First, non-small cell lung cancer study 103 is a 554 patient Phase III registrational study, evaluating the anticancer effects of Plinabulin in combination with docetaxel compared to docetaxel alone in second and third-line non-small cell lung cancer, with its primary endpoint of median overall survival. To date, we have enrolled approximately 480 patients in the U.S., Australia and China. The study has 2 prespecified interim analysis: the first when 1/3 of the patient's death is reached; and the second, when 2/3 of the patient deaths are reached.

Earlier this year, we reached the first interim analysis and Data and Safety Monitoring Board, or DSMB, recommended the trial to continue with no change to the protocol specified number of patients. Final results of the trial at a death rate of 439 patients are expected to be available in the second half of 2020.

Second, Studies 105 and 106, evaluates Plinabulin's effect in the prevention of chemotherapy-induced neutropenia. We have aligned with U.S. and China FDA that 105 and 106 studies would support the broad CIN label for all cancers, all chemos and to be combined with G-CSF.

Study 105 is a Phase II/III registrational trial of Plinabulin after the standard regimen of docetaxel in advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer patients in the U.S., China, Russia and the Ukraine. Previous data from the Phase II portion of this trial already demonstrated that Plinabulin, given as single-dose cycle on the same day of chemotherapy would be as effective as Neulasta, with the benefit of causing much less bone pain, improved quality of life, offering a superior immune profile compared with Neulasta and having the potential to mitigate thrombocytopenia. Plinabulin's non-G-CSF based unique mechanism of action, potentially makes it complementary to Neulasta in preventing CIN. In December last year, we announced in a prespecified interim analysis, the Phase III portion of Study 105 met its primary endpoint of noninferiority with Plinabulin at a 40-milligram fixed dose versus Neulasta at 6 milligrams for DSN in the first cycle.

Study 106 evaluates the combination of Plinabulin with Neulasta versus Neulasta alone to prevent CIN and bone pain, in patients receiving TAC chemotherapy, which is a triple combination of Taxotere, doxorubicin and cyclophosphamide in breast cancer patients. Previous top line data from the Phase II portion of this trial suggests, firstly, a significant improvement in efficacy in treating CIN; secondly, a significant decrease in the percentage of patients experiencing grade 3 or 4 CIN; thirdly, a more than 90% reduction in patients experiencing bone pain; and lastly, a reduced potential immune suppressive phenotype, when adding Plinabulin to the standard of care.

The Phase III portion of the Study 106 will compare Plinabulin at a 40-milligram fixed dose combined with 6-milligram Neulasta versus 6-milligram of Neulasta alone in a double-blind study. The intent of the study is to show superiority in DSN in the first cycle as the primary endpoint. We have already enrolled the first patient in this study in October. The data generated to date suggests that Plinabulin offers a novel approach to preventing CIN and bone pain in patients receiving chemotherapy. Minimizing neutropenia and bone pain would allow more patients to receive a full dose of chemotherapy and complete their chemotherapy treatment, implying that the addition of Plinabulin to G-CSF has the potential to significantly improve the current CIN standard of care, resulting in better anticancer outcomes and patient quality of life.

Positive clinical results of Plinabulin have been accepted for presentations at world-leading conferences. In late September and early October, we presented 2 posters at ESMO. The first poster focus on the novel trial design for Study 103 and its success compared with the failed Javelin Lung 200 trial. Researchers surmised that the open-label design of Javelin versus single blinded Study 103 trial, attributed to Javelin's failure as patients dropped out of the study prior to receiving the first dose.

The second poster evaluated in Study 106 the effects of Neulasta combined with Plinabulin on absolute neutrophil and platelet count and measured the frequency of thrombocytopenia. Our data show that the combination appears to have a superior product profile of Neulasta in CIN control, platelet counts and bone pain.

Additionally, we recently presented 2 e-publications on Study 105 at ASH, highlighting Plinabulin's ability to protect hematopoietic stem cells which differentiates into neutrophils and other white blood cell types. The mechanism of action preclinical paper is consistent with this message.

Lastly, BeyondSpring presented a poster at ASH on Study 106, which provides rationale for the addition of Plinabulin to Neulasta due to their complementary mechanism of action for the prevention against chemotherapy to achieve synergy.

With that, I'll now turn the call over to Rich, who will discuss our commercial and partnership strategy.

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Richard J. Daly, BeyondSpring Inc. - COO [5]

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Thanks, Ramon. As you've heard, our clinical data continues to support our belief that Plinabulin can improve the standard of care to positively affect the lives of cancer patients, those who require the prevention of chemo-induced neutropenia and those seeking innovative new options in the treatment of non-small cell lung cancer. To that end, we're working diligently to advance our organization for commercialization on both fronts. As we await additional clinical readouts in 2020, the upcoming year holds immense promise for the company and potentially for the patients and providers we hope to serve.

First, we'll address CIN. Recently published data in Lancet forecast continued growth in chemotherapy from 9.8 million to 15 million cycles between now and 2040, a 53% increase. We share this growth-oriented view of the opportunity in CIN.

As mentioned earlier, CIN continues to persist despite the use of G-CSF and cause clinicians to change or reduce dose of patients' regimens, which can have devastating effects on anticancer outcome. In fact, CIN is the most frequent cause of change for chemotherapy regimens. Our clinical program and recently completed proprietary market research tells us that Plinabulin, used together with G-CSF, has the potential to play a major role in both improving the standard of care and benefiting the patient's quality of life.

Even small changes in chemotherapy doses or brief delays in chemotherapy infusion can have detrimental effects on overall survival. Just a 15% reduction in chemotherapy doses can result in a 50% reduction in overall survival. This fact is not lost on oncologists. In fact, upon learning about the benefits of Plinabulin plus G-CSF combination therapy in blinded market research, 65% of doctors and KOLs we interviewed were excited at the prospect of treating patients with Plinabulin. It's clear, doctors are receptive to new treatment options for CIN and understand there is a high unmet medical need in the market.

Our market research and clinical research continues to build the case for Plinabulin as a therapy that can improve the standard of care in cancer therapy. By developing Plinabulin to work with and to enhance G-CSF therapy, the goal is to allow HCPs to avoid the 4Ds mentioned earlier and provide stable chemotherapy doses, sustained chemotherapy cycles and the strongest chemotherapy regimens. Moreover, our proprietary market research continues to indicate that oncologists are favorable towards the Plinabulin enabling product profile and physicians quickly grasp the logic of the complementary mechanisms of action of both Plinabulin and GCSF. This means the speed of Plinabulin's onset versus the delayed onset of G-CSF, the superior absolute neutrophil count and the reduction of bone pain.

The Plinabulin plus GCSF combination shows tremendous promise in enabling oncologists and their patients to adhere unabated to the individualized treatment plan and avoid the 4Ds. Additionally, our goals go beyond preventing neutropenia and bone pain. We see Plinabulin's clinical benefits as a way for providers to potentially generate better chemotherapeutic outcomes, empower oncologists to choose the most appropriate, most aggressive therapy for patients and have confidence that neutropenia can be significantly reduced and patients can remain on their targeted chemotherapy. Our ongoing data generation, both clinical and market research continues to give us confidence that combination therapy, that is Plinabulin plus G-CSF, can offer an improved standard of care.

Additionally, we believe that market dynamics such as the growth of chemotherapy and the success of combination approach highlights CIN as a growth opportunity. In short, the combination approach is proving to provide a number of benefits for clinicians, patients and payers, including significantly reduced neutropenia with the goal of avoiding the 4Ds and driving a stable, sustained cycle with the strongest dose of chemo and improved bone pain profile to ensure enhanced therapeutic experience and the potential for greater persistency and clinical data that suggests anticancer activity. Our clinical data validates a clearly differentiated product profile and our market research indicates a clear and compelling market need for new therapies to improve the standard of care and CIN.

Now transitioning to non-small cell lung cancer. Non-small cell lung cancer is one of the most exciting therapeutic areas in all of medicine today and continues to evolve rapidly. Advancements in the care with the approval of I/O therapies for first line creates a need for new options in second and third-line therapy. The advancement of I/O therapy presents a great opportunity for BeyondSpring, Plinabulin and patients. Plinabulin's clinical data to date in our non-small cell therapy lung cancer program demonstrates promise as an effective agent in second and third-line therapy. Given the dearth of effective options for patients at this advanced stage, we are excited about the prospects of delivering clinically meaningful data and results for patients with Plinabulin for non-small cell lung cancer.

As we consider life cycle management for Plinabulin, we look to our early work in combination with I/O compounds. It is our hope that we may demonstrate benefits over and above that which is currently seen with I/O alone. This may represent an additional significant growth opportunity to help patients and providers struggling to address this devastating disease.

Now moving on to business development. We believe Plinabulin has tremendous potential as the CIN and non-small cell lung cancer anticancer therapy. As mentioned earlier, our most recent market research with over 100 HCPs as well as payers, gives us confidence that the data we have generated to date demonstrate differentiated product profile. Additionally, receptivity of these oncologists and payers to the profile is indicative of an unmet market need.

We see these responses echoed in our business development efforts with great interest coming from potential partners. As we prepare for upcoming data inflection points, we are well positioned to maximize the value for Plinabulin both here, in the U.S. and abroad, through our go-to-market strategies. A recent ZS study showed that 7 out of 10 companies launching their first oncology product in the U.S. went to market on their own due to the potential strength of the U.S. P&L, while 70% partnered in Europe. For both CIN and non-small cell lung cancer, the U.S. represents more than 75% of the global value, and we are prepared to optimize this value through our business development and commercialization efforts. We look forward to updating you on our progress as we go forward.

In closing, our clinical profile is excellent and fills a clear unmet need in the market. We have the potential to set a new standard of care. Our market research indicates HCPs recognize that Plinabulin is a differentiated product with significant clinical potential. HCPs are also excited about the opportunity to use Plinabulin in the prevention and treatment of CIN to keep patients on the most appropriate, most aggressive chemotherapy regimen. As we prepare to file NDAs for Plinabulin in China and the U.S. for CIN and non-small cell lung cancer, our U.S. and global commercialization plans are aligned with our development and regulatory time lines. We are taking steps to ensure BeyondSpring can bring Plinabulin to the market so that we optimize the benefits for patients, providers and shareholders.

With that, I'll now turn the call over to Edward, who will provide a financial update. Edward?

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Dongheng Liu, BeyondSpring Inc. - CFO [6]

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Thanks, Rich. I'll now briefly discuss our third quarter 2019 financial results. For greater detail related to these results, I refer you to our press release issued this morning and to our 6-K filing, both of which can be accessed under the Investors section of our website.

With that said, I now highlight some key numbers. R&D expenses in the third quarter of 2019 was $7.2 million compared to $14.1 million in the same period last year. The decrease of $6.9 million was largely attributable to a $3.9 million decrease in CRO expenses and other service fees related to clinical trials, a $0.5 million decrease in preclinical trials and a $0.5 million decrease in noncash share-based compensation.

G&A expenses were $2.5 million in the third quarter of 2019 compared to $1.5 million for the same quarter of 2018. The $1 million increase was mainly due to a $0.7 million market research expense incurred during the quarter. Net loss attributable to BeyondSpring in the third quarter of 2019 was $9.4 million compared to $14.9 million for the same period of last year.

Our cash balance at the end of Q3 was $24.7 million. Subsequent to the third quarter on October 24, we successfully completed a $25.8 million follow-on equity offering.

The transaction was led by the Decheng Capital and attracted a strong demand from high-quality U.S.-based institutional investors. This transaction, together with the financing in July, continued to significantly improve the liquidity of our stock.

With our strengthened balance sheet, we are confident that our current cash resources are sufficient to support our clinical trials and submit NDAs for Plinabulin for the treatment of CIN and non-small cell lung cancer in both the U.S. and China, and to advance our immuno-oncology pipeline as well as our ubiquitination protein degradation research platform.

With that, I'll now turn the call back over to Lan for the conclusion. Lan?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [7]

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Thank you, Edward. As you can tell, we are extremely proud of our clinical development efforts and the flow of data that further validates Plinabulin's favorable drug profile to improve cancer care. Plinabulin is the only novel agent in development, which combines anticancer and CIN prevention potential. Looking ahead, we expect many important data and regulatory milestones in 2020, which will transform us from a clinical-stage company to a commercial-stage company.

Together with our shareholders, investors and partners, we are working hard to continue to create value and deliver innovative medicines to the patients in severely unmet medical needs all over the world. I look forward to keeping you updated on our progress towards that goal in the coming months.

We have integrated U.S. and China resources to achieve time and cost efficiency in the 2 largest pharmaceutical markets in the world. We believe that this unique and scalable business model will maximize the return for our shareholders.

To those of you who have been on this journey with us, we want to thank you for your trust and your support. To those new to our mission, 2020 promises to be an exciting year as we anticipate NDA filings for Plinabulin in both the U.S. and China in the near future. We look forward to continue this journey with you.

Thank you for your attention. And now I'm turning this back to the operator.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question is coming from the line of Joe Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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Lan, since you guys have such a unique inroads into the Chinese market based on your relationships there and things like the Thousand Talent Award -- Thousand Talent Innovator Award, et cetera. I was just curious your status of your discussions with both the CFDA and the Chinese government with regard to both things like pricing and reimbursement and manufacturing and as part of that question, what remains outstanding other than data for you to deliver the NDA?

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Lan Huang, BeyondSpring Inc. - Co-Founder, Chairman & CEO [3]

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Thank you so much, Joe, and thank you for your continued support and I believe in our company and also in Plinabulin. So yes, thanks for this great question. So as you see that not only I do have the Thousand Talent Award from the government but also we -- Plinabulin also has this certain 5-year grant from the Chinese government, and that basically is the most important innovation grant from the state government, and that does give us the regulatory speed in the expedited review and also later to be potentially included in the national insurance. One example for the speedy review is for our CIN indication, we received the CTA for Phase III initiation from CFDA within one month after package submission, which is really a historical record because most of those approval takes 1 year to 2 years.

So as you see that we do have continued discussion with the CFDA regarding the submission readiness of our package, and as you see from our target, we are on track to submit quarter 1 of 2020. And currently, for the manufacturing, we do use CMOs in China to manufacture for the China domestic NDA filing. And so that's a check and a clinical trial data actually currently just our -- as always, I said, it's 105 Phase III interim plus the 106 Phase II data is supporting the submission and so those are set. And for the safety database, that's set because we have -- already had 580 patients treated with Plinabulin. The safety database is only 300 and also the quality before the trials has been checked. So those actually have all the data ready to be submitted.

And but then you had a question regarding the pricing and then potentially getting to the insurance system. So we probably can use FibroGen as a significant example, right? So FibroGen does have this innovative first-in-class anemia drug and it got China FDA approval first, recently, in the beginning of the year and -- ahead of the U.S. approval. And that was a speedy approval after all data is in, it's 2 months afterwards, it was approved.

And then secondly, it was just recently got into the national insurance with a very good pricing because it is the only drug in the category. So you can see that Plinabulin potentially could also follow similar steps like FibroGen, which has set a very, very good example for us. And as you know, actually Dr. Peony Yu, who is the Chief Medical Officer of FibroGen, she's on our SAB board.

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Operator [4]

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(Operator Instructions) The next question is from the line of Andy Hsieh with William Blair.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [5]

Originally posted here:
Edited Transcript of BYSI.OQ earnings conference call or presentation 18-Dec-19 1:00pm GMT - Yahoo Finance

How These Practitioners Can Help with New Year, New You Goals – Milwaukee Magazine

This is a sponsored story

The start of a new year is the perfect time to prioritize self-care and set health and wellness goals, so make 2020 your happiest yet with a new, enhanced version of you. Use this guide to find the doctors, therapists and practitioners that can help you look and feel your best.

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Aqua, under the direction of Dr. Christopher Hussussian, is a full-service salon, spa and med spa offering a wide range of services in a luxurious setting on Pewaukee Lake. Whether you are hoping to change the way you look or feel or both Aqua has a solution to enhance your skin and hair for both body and face. New services for the new year include hair restoration for both men and women using PRP (platelet-rich plasma) with biotin and a new weight-loss program using the HCG hormone. They also offer advanced laser hair removal, Clear Lift skin tightening, ThermiVa and CoolSculpting, a popular nonsurgical fat cell reduction with lasting results. A consultation can help you decide what services would work best to achieve a healthier, happier version of yourself.

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What if you could use undesired fat from your belly to get rid of the bags under your eyes? Sounds too good to be true, right? Anew Skin and Wellness has a procedure that is done right in the office with long lasting results. The nano-fat transfer removes a small amount of fat with micro liposuction. That fat is harvested for re-injection to the appropriate areas of the face, neck, earlobes, hands and thighs. It can also be used to plump thin lips, smooth cellulite and scars and restore skin elasticity. The nano-fat transfer is safe, effective, economical and helps clients look their best. The in-office procedure provides long-lasting results because the bodys stem cells can turn the aging skin into new, rejuvenated skin. Its the natural way to tighten and smooth skin, allowing you to turn back the clock without a surgical face- or neck-lift.

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Dr. Arvind Ahuja has provided neurosurgical and endovascular care in southeastern Wisconsin for more than 20 years for brain, spine, artery and peripheral nerve conditions. Whether patients come to Neurosurgery and Endovascular Associates for neck and/or arm pain, back and/or leg pain or headache, the first step is always diagnostic testing to determine the cause of the pain, rather than just treating the symptoms. Often through treatments like medication, steroid injections, physical therapies and if need be surgery, patients achieve improved functioning and long-term relief. Ahujas specialized training in the nervous system is incredibly effective in treating spinal conditions, and his treatments give patients the opportunity to live a happier and morefunctional life.

See the rest here:
How These Practitioners Can Help with New Year, New You Goals - Milwaukee Magazine

Summerside gym needs donations for three-year-old boy with cancerous brain tumors – The Journal Pioneer

SUMMERSIDE, P.E.I.

A Summerside family are going through an unimaginable experience that has left them shaken to the core.

Matthew and Victoria Sara Kingyen grew concerned when their three-year-old son Camden woke to severe headaches, and one morning with vomiting, over a nine-day span before Christmas.

On Dec. 10 I decided to take Camden to see his family doctor, but her appointments were full for the day, so I took him to the emergency department in Summersides Prince County Hospital around 9 a.m., explained Victoria.

After an examination at the Prince County Hospital, it was decided Camden should have a CT Scan to hopefully rule out anything major.

But doctors had devasting news for the couple.

"Everyday we hope well wake up from this awful nightmare." - Victoria Sara Kingyen

We were told there was a mass cancerous tumour (Medulloblastoma) in his brain. A neurosurgeon at the IWK Health Centre in Halifax was notified and reviewed Camdens scan. They requested us to be at IWK as soon as possible, and we were transported by ambulance, arriving that evening at 6 p.m., she continued.

Camden had a 90-minute MRI (magnetic resonance imaging) scan at the IWK that revealed smaller tumors surrounding the large mass, including tumors all the way down his spine.

Brain surgery was required, and after chemotherapy.

His case is advanced and will require an aggressive treatment plan. We were all absolutely shocked at the news after the CT scan and then again after the MRI. Our life changed in an instant and now we are helping our beautiful baby boy fight for his life.

Everyday we hope well wake up from this awful nightmare. My husband Matt, owner of Advanced Builders Inc. in Summerside, will be travelling back and forth between P.E.I. and Halifax, and then to Toronto, while I stay with Camden at the hospitals, continued Victoria, who added Camdens older brother has been coping well so far from the separation.

Camden requires nine-weeks of chemotherapy treatment at the IWK, which started on Jan. 3.

After the treatment, if his body is responding, we will travel to the Hospital for Sick Children in Toronto for an extra nine-weeks of what they call big chemotherapy.

During his first treatments at the IWK, Victoria and Camden will make two short trips to Toronto for stem cell harvesting. Stem cells will be harvested to essentially rescue his body from the chemotherapy as the doses increase.

Before Camden started chemotherapy, he had four surgeries over Christmas, said Victoria, who gave up work to take care of her son full-time.

Aaron Dawson, owner of Hustle Athletic Training Inc. in Summerside, is hosting a fundraiser called Push-ups for Cam to help support the family.

When I was at my former location, I was a personal trainer for Matt Kingyen, and his company called Advanced Builders Inc. did all the renovations of this gym and made Hustle what it is today. Victoria is also my bookkeeper here, Dawson explained his connection to the family.

I learned about their son a couple of weeks ago, and things have happened fairly quickly since then. It was a shock. I have three small kids of my own, they play with the Kingyen children, so it breaks your heart. I wanted to help the family in some way, he said.

Dawson is looking for pledges per push-up, which will take place at Hustle Athletic Training Inc.located at 465 Water Street in Summerside on Jan. 18 at 3 p.m.

You can pledge $1 per push-up, so if I end up doing 200 push-ups in the hour, you owe $200. Its totally up to you how much you pledge it could even be 1 cent, he said.

Hustle Athletic Training Inc. will collect pledge donations after the event that's open to the public and will be filmed live on the gyms Facebook page.

To learn more visit, facebook.com/HustleAthleticTrainingPEI or call Aaron Dawson on, 902-315-1950.

Pledge forms can be downloaded here.

Here is the original post:
Summerside gym needs donations for three-year-old boy with cancerous brain tumors - The Journal Pioneer

West Norwood girl, 3, dies in her parents’ arms after brave battle with leukaemia – MyLondon

An inspirational young girl from South London who bravely battled leukaemia for 18 months has died.

Esme Handley, 3, was diagnosed with high risk acute myeloid leukaemia (AML) while on holiday in Greece in June 2018.

The courageous toddler, who lived in West Norwood with her parents Will and Rebecca, underwent extensive treatment after more than 400,000 was raised through donations.

But Esme's condition deteriorated in recent months and she died in her parents' arms on New Year's Day.

Writing on her Facebook page , called Esme Lion Heart, Will and Rebecca said: "If you look to the sky tonight you will see a star shining brighter than any other.

"Our darling girl went onwards with her journey at midday [on January 1]. She was peaceful and in our arms and knew how ridiculously adored she was."

Esme was just 22 months old when her parents were given the heartbreaking news that she had leukaemia.

They became concerned with some bruising on her body after a fall, and after being told the news by doctors spent the second night of the holiday "in tears".

Esme's blood tests were examined at a regional hospital, which led to the diagnosis.

On what would have been the third day of the holiday, the family flew back to London and went straight to King's College Hospital, where doctors confirmed Esme had AML.

Esme, who loved lions, narwhals and playing hide and seek outside, was then transferred to the Royal Marsden, where she spent five months as an in-patient. In September 2018 she received a stem cell transplant, after three rounds of intense chemotherapy.

In November 2018, Esme was told she could go home, to the delight of her family. But in April last year, after six months ofrecovering, the family were told the leukaemia had returned.

In November, Will and Rebecca were told Esme only had a matter of weeks to live after being told the leukaemia was "out of control".

The family spent the last weeks of Esme's life at the Royal Marsden.

Before Esme died and in a bid to fund a second stem cell transplant which was not eligible on the NHS, the family set up a gofundme page to fund the 500,000 needed for the private treatment.

The page has raised 428,000 from over 10,000 donations, and was the biggest appeal created in 2019 in the UK, according to gofundme.

Will and Rebecca are now determined to build a lasting legacy foundation in Esme's name and say any unspent money will be donated to The Children's Cancer and Leukaemia Group.

"Given how desperately poor the funding is into paediatric AML research, we feel even more strongly about this now," Esme's parents said.

"So a large chunk of the cash we have remaining (after spending some on novel drugs and supportive care) will be donated to AML research to try and spare future families the pain and anguish we have experienced.

"Our darling little girl, however, was SO, SO much more than cancer and we owe it to her to ensure she isnt forgotten.

"Therefore, we are going to increase our fundraising target so in time we can create some kind of legacy foundation in Esme's name. If our story has touched you, please help us to achieve this by donating or simply sharing far and wide."

Although Esme spent Christmas in hospital, she was still treated to a number of special trips.

Having been bed-ridden for nearly three months, she was taken out of her room in her pushchair and visited the Christmas trees around the hospital, taking baubles for her own tree.

Esme saw the Christmas lights in Morden and was treated to a private screening of Frozen 2 at Everyman Esher, complete with Elsa and Anna impersonators who sang to Esme.

The family also had puppet theatre performers, therapy dogs and ZooLabs collection of creepy crawlies and rodents visit Esme's room.

Will and Rebecca have understandably been left heartbroken by their only daughters death.

"We gave up everything to get Esme through this," said Will.

"Childhood cancer has quite literally become our entire life - we know nothing else.

"Weve lived in total isolation, not really going anywhere or seeing anyone since June 2018 - so the thought of the future, let alone a future without Esme, feels very uncertain, very lonely and very bleak."

To visit the gofundme page go to http://www.gofundme.com/help-2-year-old-esme-cure-her-leukaemia .

Want more news? Go to our homepage .

Got a story? Email samuel.truelove@reachplc.com.

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We will provide you with the latest traffic and travel updates, including updates on train and London Underground services, in areas including Southwark, Croydon, Greenwich, Lewisham, Wandsworth, Merton, Lambeth and Brixton.

The latest breaking news will be brought straight to your news feed including updates from the police, ambulance and fire brigade. We will also bring you updates from our courts and councils, as well as more lighthearted long reads.

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West Norwood girl, 3, dies in her parents' arms after brave battle with leukaemia - MyLondon