Introducing: iPSC Collection from Tauopathy Patients – Alzforum

23 Oct 2019

A multi-institutional group, including members of the Tau Consortium, unveiled a stem cell tool kit for scientists studying primary tauopathies. In the November 12 issue of Stem Cell Reports, researchers co-led by Celeste Karch ofWashington University, St. Louis, and Alison Goate and Sally Temple of Icahn School of Medicine in New York, describe a collection of fibroblasts, induced pluripotent stem cells, and neural precursor cells. The cells come from 140 skin samples, some given by donors with richly documented clinical histories who carry pathogenic MAPT mutations or risk variants. Others come from noncarrier family members, patients with a sporadic tauopathy, and cognitively normal controls. The set includes induced pluripotent stem cell lines from 31 donors and 21 CRISPR-engineered isogenic lines. The cells are available to other researchers for study.

These types of high-quality repositories are becoming increasingly important for the scientific community, Clive Svendsen of the Cedars-Sinai Medical Center in Los Angeles wrote to Alzforum.

This is the way the field is going, agreed Lawrence Golbe of CurePSP, New York. Golbes organization funds research into progressive nuclear palsy (PSP) and related disorders, and collaborates with the Tau Consortium on other projects. Enthusiastic about the resources potential, Golbe hopes CurePSP grantees will get an automatic pass to use the cells.

Choice Mutations. Cells in the new iPSC collection carry some of the most common MAPT mutations, covering a wide range of clinical and neuropathological phenotypes of frontotemporal lobe dementia (FTLD)-Tau. [Courtesy of Karch et al., 2019.]

Tauopathies have proven difficult to study in animal models, in part because unlike other neuropathologies, they seem to afflict only humans (Heuer et al., 2012). Moreover, while adult human brains express approximately equal amounts of the tau spliced isoforms 3R and 4R, rodents produce almost exclusively 4R (Trabzuni et al., 2012). This is problematic. For example, leading proposals to explain how tau mutations cause disease point to abnormalities in splicing and microtubule binding, which differ between isoforms. The models we had been focusing on were not capturing the complexity of MAPT in human cells, said first author Karch. As a result, human induced pluripotent stem cells (iPSCs) have been gaining popularity in the field. The NINDS Human Cell and Data Repository is helping meet the demand by offering iPSC lines derived from 10 patients harboring MAPT mutations.

However, Karch and her collaborators think the field could benefit from a larger and more diverse collection of human cells, including isogenic iPSC lines. To accomplish this, they collected skin samples from 140 people carrying MAPT pathogenic mutations or risk variants, non-mutation carriers, and patients with sporadic PSP or corticobasal syndrome (CBS), most with comprehensive clinical histories. Although a few cells came from the NINDS repository, most came from patients participating in longitudinal studies at the Memory and Aging Center at the University of California, San Francisco, and the Knight Alzheimer Disease Research Center at WashU. The clinical records of most of these patients include detailed neurological and neuropathological workups, as well as fluid biomarkers and neuroimaging data collected from MRI, A-PET, and tau-PET studies.

To capture a broad range of phenotypes associated with some of the most common MAPT mutations, the authors created 36 fibroblast lines and 29 iPSC lines from individuals carrying the P301L, S305I,IVS10+16, V337M, G389R, and R406W mutations, as well as from carriers of the A152T variant, which increases the risk for both PSP and CBS (image above). The latter could be particularly useful for dissecting the mechanisms that underlie the phenotypic differences between the two diseases. The researchers also obtained iPSC lines from two noncarrier family members, and two people who suffered from autopsy-confirmed sporadic PSP. In addition, they stored fibroblast lines from 12 patients with sporadic PSP, five with CBS, 10 with a mixed PSP/CBS presentation, and 69 cognitively normal controls.

Biopsies are available for 27 of the 31 patients whose cells were used to generate iPSCs, and autopsy data for seven, including the two cases of sporadic PSP.

Importantly, the researchers edited 21 iPSC lines using CRISPR/Cas 9. They corrected cells with these mutations: MAPT IVS10+16,P301L, S305I, R406W, and V337M. Conversely, they inserted into control iPSCs these mutations: R5H, P301L,G389R, S305I, or S305S.

The authors also created a stem cell line carrying MAPT P301S,a mutation commonly overexpressed in tauopathy mouse models but not present in the available donors, by editing the P301L line. Isogenic lines are so powerful, particularly in these diseases which are so variable in their onset and progression, even within the same family, said Karch. Gnter Hglinger and Tabea Strauss at the German Center for Neurodegenerative Disease (DZNE) in Munich agreed. Having a pool of cell lines with different disease-linked mutations and risk variants from several individuals and their isogenic control cells is an excellent resource for the research community to enlighten disease mechanisms, they wrote (full comment below).

Several of the reported lines have already starred in recent studies of tauopathy mechanisms and candidate therapies (e.g., Sep 2019 conference news; Nakamura et al., 2019; Hernandez et al., 2019; Silva et al., 2019).

Karch and colleagues have partially differentiated some of the iPSCs and stored them as neural progenitor cells (NPCs), so that researchers can relatively easily thaw, expand, and differentiate them into neurons. These NPCs have proved useful for large-scale functional-genomics studies, proteomics, and genetic modifier screens (e.g., Cheng et al., 2017; Boselli et al., 2017;Tian et al., 2019).

In addition, the authors inserted a neurogenin-2 transgene into two healthy controls and two MAPT mutant stem cells, P301L and R406W. Neurogenin-2 enables low-cost, large-scale differentiation of stem cells into homogenous excitatory neurons. These transgenic cells are particularly useful for high-throughput drug screens (Wang et al., 2017; Sohn et al., 2019).

Researchers can request all the reported cells online at http://neuralsci.org/tau. They must provide a summary of experimental plans, an institutional material transfer agreement, and a nominal fee to cover maintenance and distribution costs. Karch said the process resembles that of the Coriell Institute and the NINDS repository. Our goal is to share with as few hurdles as possible, she said.

While the authors are still reprogramming fibroblasts they have already collected, they also plan to add more causative mutations, generate more isogenic lines, and obtain more cells from members of the same families to help shed light on phenotypic variability. In addition, Karch said, she hopes repository users will resubmit lines with new modifications they generate.

Jeffrey Rothstein, Johns Hopkins University, Baltimore, welcomed the new resource. I think it is great they have assembled this collection, he said. Rothstein founded and co-directs the Answer ALS research project, which has amassed 600 iPSC lines from controls and patients with amyotrophic lateral sclerosis (ALS).

Rothstein suggested the tauopathy collection may want to prioritize adding cells from donors with the most common form of disease, that is, sporadic. His group aims to generate 1,000 iPSC lines, with a large fraction representing sporadic diseasealso the most common form of ALSto identify the most prevalent disease subtypes. One strategy that has helped his group build their collection, he said, is using peripheral blood mononuclear cells instead of fibroblasts to create iPSCs. More donors are willing to donate blood than have a piece of skin punched out. In addition, iPSCs derived from blood cells are genetically more stable, he noted.

Rothstein emphasized the importance of assembling a large collection of healthy controls. Although isogenic controls are of great value, he cautioned they can be subject to artifacts. One problem is that the cell population can change due to selective pressures during CRISPR editing (Budde et al., 2017). To address this, Karch and colleagues are collecting not only modified iPSC clones, but also control clones that have gone through the editing pipeline but remain unmodified.

Stem-cell users studying tauopathies face another challenge: iPSC-derived neurons express primarily the fetal isoform of tau, 3R0N. However, citing a study that shows three-dimensional neuronal cultures switch to the adult profile relatively quickly (Miguel et al., 2019), Hglinger and Strauss wrote, [It] allows us to be optimistic that current challenges of this model system can be overcome in the future.Marina Chicurel

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Introducing: iPSC Collection from Tauopathy Patients - Alzforum

Acorn Biolabs partners with Executive Health Centre to become first clinic in North America to offer non-invasive stem cell collection – Canada…

TORONTO, Oct. 23, 2019 /CNW/ -Acorn Biolabs, a pioneer in non-invasive stem cell collection, today announced a strategic partnership with Toronto-based Executive Health Centre, a medical wellness centre and leader in precision and personalized medicine. Under the agreement, Executive Health Centre will become the first clinic in North America to offer its patients the ability to have their stem cells banked through a method that involves simply plucking a few hair follicles from a person's head.

Acorn's innovative method allows for full genome collection without the need for surgery or other painful and invasive procedures, making stem cell collection significantly more affordable and accessible for everyone.

"Our partnership with Acorn is tremendously exciting for the future of healthcare," says Dr. Elaine Chin, founder of Executive Health Centre. "Stem cells play a critical role in predictive analytics and will allow us to identify and prevent diseases before they happen, in addition to creating the possibility for an array of personalized regenerative treatments in the future."

Once stem cells are collected, Acorn uses a proprietary method of keeping cells viable during transport and storage, turning collected hair follicles into a highly valuable and accessible resource for regenerative medicine and genetics. Not only are these stem cells securely stored for future use, but the company's scientists can also extract critical genetic information that will unlock valuable data about a person's health that has never been available before.With this partnership, Executive Health Centre patients will also have access to Acorn's genetic age reports that provide insights into a person's aging process.

"Dr. Chin has been a trailblazer in using biometric and monitoring technology with her patients, and has established herself as an eminent thought leader in this space. For Acorn to combine our technology with her clinic's expertise is a major win not just for patients, but also for the broader industry as a whole," says Dr. Drew Taylor, co-founder and CEO of Acorn. "Both Executive Health Centre and Acorn strongly believe that our cells are the future of healthcare, and we're thrilled to be working together in making regenerative medicine accessible to more and more people."

Media AvailabilityTime: 4:00 p.m.Location: Executive Health Centre, 4120 Yonge Street, Toronto, ONDr. Drew Taylor and Dr. Elaine Chin are available for interviews.

About Acorn Biolabs, Inc.Founded in 2017 by Steven ten Holder, Patrick Pumputis and Dr. Drew Taylor and borne out of years of research, Acorn is a healthcare technology company. Based at Johnson & Johnson INNOVATION JLABS in Toronto, Acorn is focused on giving every human being the best chance to experience more healthy years with its easy, affordable and non-invasive live-cell collection, analysis and cryopreservation service. Acorn helps you live a longer, healthier tomorrow by freezing the clock on your cells today.Visit http://www.acorn.me.

About Executive Health CentreThe Executive Health Centre is recognized for its visionary work in personalized, preventative healthcare. Dr. Elaine Chin, founder of the Executive Health Centre, established North America's first physician and naturopathic doctor-integrated health clinic in 1997 at the Mississauga Hospital (now Trillium Health Partners). Today, the combined expertise of this innovative model is unmatched in North America and provides its patients the best in seamless integrative medicine and rejuvenation therapies. Dr. Chin is also the author of "Lifelines Unlocking the Secrets of Your Telomeres for a Longer, Healthier Life," on The Globe and Mail's Top 10 Bestseller List. Visit: http://www.executivehealthcentre.com.

SOURCE Acorn Biolabs

For further information: Morgan McLellan, E: morgan@providentcomms.com, C: 647-802-4825

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Bloomington Vet Joins Study For Stem Cell Therapy To Treat Dogs With Arthritis – WGLT News

The Eastland Companion Animal Hospital in Bloomington is asking dog owners if they want to participate in research on using stem cells to treat dogs with arthritis.

Local dogs wouldjoin a double-blind, placebo-controlled studyto show the effectiveness of stem cells in treating large dogs(70 pounds or more) with arthritis in up to two joints of the knee, hip, elbow, or shoulder. The veterinary clinic has partnered with Animal Cell Therapies, who it's worked with before, to bring this study to Bloomington.

Dr. Kathy Petrucci, founder and CEO of Animal Cell Therapies, explained how dogs will receive the treatment.

The dogs that will receive the stem cells will be sedated, Petrucci said. Depending on what joints are affected, they will receive up to two injections in the joint and they will also receive an IV dose of stem cells.

The FDA oversees the cells that are received from donors for the study. Mothers donating these cells are screened for diseases, and cells are tested for any infections to ensure safety.

Stem cell therapy has been controversial, especially related to humans.

I think a lot of the controversy comes from the misunderstanding of the cell types, Petrucci said. The research in stem cells first started centered around embryonic or fetal tissue use. Its controversial to use embryos and fetal tissues for treatment for anything. The fact that we are using a disposable tissue as our cell sources makes it not controversial at all.

Why Umbilical-Derived Cells

Petrucci explained why umbilical-derived cells are more effective in treating arthritis versus other sources.

We looked at fat, bone marrow, embryonic cells, Petrucci said. The embryonic cells are a lot more unpredictable, and the bone marrow cells are more difficult to work with and less predictable. We didnt think the fat cells are as potent as umbilical-derived cells. Umbilical-derived cells are a lot younger and theyre a little bit more predictable. They are more easy to collect. We obtain cells from donors when the tissue would be normally thrown away. Theres no surgery required, no extra biopsies to obtain fat, no bone marrow from research animals. Its a good, ethical source of stem cells.

Umbilical-derived stem cells have proven successful in past studies on treatment for arthritis, according to Petrucci.

We did a study at the University of Florida on elbows only and we had success with that study, Petrucci said. We had good success with dogs under 70 pounds and (less) success with dogs over 70 pounds, so we changed our dose, which is why were testing dogs 70 pounds and over in this study.

Criteria for eligibility includes dogs weighing 70 pounds or more, being one year of age or older, in general good health, no neurologic issues, arthritis in up to two joints of the knee, hip, elbow, or shoulder, and have all four functioning limbs.

Owners must bring their dogs back to the clinic after 30 days to check for progress and complete a questionnaire. About 50 to 100 dogs are expected to participate in the study.

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Stem Cell Treatment - Excerpt

Stem Cell Research - Full Story

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Bloomington Vet Joins Study For Stem Cell Therapy To Treat Dogs With Arthritis - WGLT News

Stem Cell Therapy Market Will Achieve 10.2% CAGR to Cross $15bn by 2025: Global Market Insights, Inc. – Herald-Mail Media

Global Stem Cell Therapy Market value will achieve over 10% CAGR to surpass USD 15 billion by 2025; according to a new research report by Global Market Insights, Inc. Rapid advancements in stem cell therapies in developed region such as North America and Europe will boost industry growth. Key industry players are indulged in introducing novel stem cell therapies that address limitations of existing therapies. Significant efficiency possessed by stem cell therapy has increased its preference in treatment of cancer that should positively impact the industry growth. However, high cost associated with stem cell therapies may hinder stem cell therapy industry growth to certain extent.

Increasing prevalence of chronic disease such as cancer, cardiovascular diseases will surge the demand for stem cell therapy business. Stem cell therapies have unique properties, such as immunosuppression, secretion of bioactive factors that fosters the development of tumor targeting technologies. Introduction of innovations in the regenerative medicine will help in conquering challenges in combating numerous diseases that should foster the industry growth.

Allogenic segment of stem cell therapy market accounted for over 39.5% revenue in 2018. Significant growth is attributed to the advantages associated with allogenic stem cell therapies. Allogenic stem cell involves transfer of stem cell from donor to patients. It overrules the limitations of autologous stem cell therapy such as difficulty in obtaining healthy and sufficient amount of stem cells from patients of diabetes, rheumatoid arthritis and other chronic diseases. Therefore, people have started relying more on the allogenic regenerative therapies that should augment the segmental growth.

Cardiovascular segment of stem cell therapy market is anticipated to witness around 9.5% CAGR throughout the forecast time frame. Increasing incidence of cardiovascular disease and growing healthcare concerns will surge the demand for stem cells employed in cardiovascular diseases. According to WHO, every year 17.9 million people die of cardiovascular disease. Stem cell therapies possess enormous potential to replace the conventional cardiovascular treatments that should increase its adoption over the forecast period.

Stem Cell Therapy Market Statistics, By Application

1.2. Oncology 1.2.1. Market size, by region, 2014-2025 (USD Million)

1.3. Orthopedic 1.3.1. Market size, by region, 2014-2025 (USD Million)

1.4. Cardiovascular 1.4.1. Market size, by region, 2014-2025 (USD Million)

1.5. Neurology 1.5.1. Market size, by region, 2014-2025 (USD Million)

1.6. Others 1.6.1. Market size, by region, 2014-2025 (USD Million)

Browse key industry insights spread across 130 pages with 91 market data tables & 8 figures & charts from the report, Stem Cell Therapy Market Forecast 2019 - 2025 in detail along with the table of contents:

Clinics segment of stem cell therapy industry was valued at USD 2.5 billion in 2018. Considerable revenue size is attributed to superior treatment provided by clinics to cure life threating disease. Clinics are equipped with advance equipment and skilled workforce that ultimately enhance treatment outcomes. Moreover, clinics are believed to provide sophisticated stem cell therapies that will stimulate the segmental growth.

North America stem cell therapy market held over 9.5% CAGR in 2018 owing to favorable regulatory scenario and demographic trends. Improving regulatory scenario for stem cell therapies in the U.S. and Canada should positively impact the market growth. For instance, FDA has framed pre-marketing authorization rules for the commercialization of stem cell therapies. This helps to minimize adverse events caused due to defective regenerative therapies. Moreover, several companies focus on R&D activities to develop innovative stem cell therapies that should surge the regional growth.

Notable industry players operational in industry are Astellas Pharma, Cellectis, Celyad, DiscGenics, Gamida Cell, Capricor Therapeutics, Novadip Biosciences, Cellular Dynamics, CESCA Therapeutics, OxStem, ReNeuron Group, Mesoblast, and Takeda Pharmaceuticals. Industry players are adopting strategic initiatives such as collaborations product launches, geographic expansions, mergers and acquisitions in order to sustain industry competition and acquire prominent market. For instance, in 2019 Gamida cell formed agreement with Lonza to commercialize omidubicel after its FDA approval. Omiducel is potential life-saving stem cell treatment for treating hematologic malignancies. Thus, such collaborations will boost the companys growth considerably.

Bioreactors Market Growth Report 2025: Biopharmaceutical products are individualized products with highly specific manufacturing requirements. Advanced biopharmaceutical manufacturing technologies have enabled development of effective drug delivery systems and drug device combination products. Some of the key industry players operating in the market include Eppendorf, GE Healthcare, Merck Millipore, Sartorius, and Thermo Fisher Scientific.

About Global Market Insights

Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider; offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.

Arun Hegde Corporate Sales, USA Global Market Insights, Inc. Phone:1-302-846-7766 Toll Free:1-888-689-0688 Email: sales@gminsights.com

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Stem Cell Therapy Market Will Achieve 10.2% CAGR to Cross $15bn by 2025: Global Market Insights, Inc. - Herald-Mail Media

NIH and Gates Foundation lay out ambitious plan to bring gene-based treatments for HIV and sickle cell disease to Africa – Science Magazine

A new $200 million collaboration aims to speed development of genetic cures for people in Africa with sickle cell disease (above) and, separately, HIV infection.

By Jon Cohen, Jocelyn KaiserOct. 23, 2019 , 5:00 PM

Two major U.S. biomedical research funders plan to each put at least $100 million over 4 years toward bringing cutting-edge, gene-based treatments to a part of the world that often struggles to provide access to even basic medicines: sub-Saharan Africa. The National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation today announced the unusual collaboration to launch clinical trials for gene-based cures for HIV and sickle cell disease within the region in the coming decade.

The ambitious goal is to steer clear of expensive, logistically impractical strategies that require stem cell transplantation, and instead develop simpler, affordable ways of delivering genes or gene-editing drugs that can cure these diseases. Yes, this is audacious, NIH Director Francis Collins said during a press teleconference this morning on the project. But if we dont put our best minds, resources, and visions together right now, we would not live up to our mandate to bring the best science to those who are suffering.

After decades of work and setbacks, the traditional gene therapy approach of delivering DNA into the body to replace a defective gene or boost a proteins production is now reaching the clinic for several diseases, including inherited blindness, neuromuscular disease, and leukemia. Animal studies and some clinical trials have suggested that two diseases prevalent in Africa, HIV and sickle cell disease, can be treated by gene therapies or newer genome-editing tools such as CRISPR.

But in most cases, introducing those therapeutic genes or the components of a genome editor involves removing stem cells from the body, adding or modifying genes, then reinfusing the cells back into the body. That is essentially a stem cell transplant with ones own cells, an expensive procedure that is also typically risky because physicians wipe out most of a patients existing stem cells with chemotherapy so the corrected cells can engraft and grow. It remains out of reach for most people in sub-Saharan Africa, where few places have the medical infrastructure to support such intensive interventions.

Yet sub-Saharan Africa is home to about two-thirds of the 20 million people with sickle cell disease and the 38 million living with HIV. The NIH-Gates partnership is an incredible opportunity to find new therapies and possible cures for two diseases that affect millions of Africans and to make them available at affordable costs, said Matshidiso Moeti, who heads the Regional Office for Africa at the World Health Organization.

Anthony Fauci, director of NIHs National Institute of Allergy and Infectious Diseases, noted that if this collaboration pans out, it could also lead to enormous cost savings. If we do successfully achieve an HIV cure, it will ultimately be important not only for millions of individuals with HIV, but also will save hundreds of billions of dollars in health care costs, said Fauci, whose institute already funds a major HIV cure initiative.

In sickle cell disease, which involves a defect in the oxygen-carrying hemoglobin in red blood cells, several ongoing gene therapy and gene-editing clinical trials in the United States and Europe are either adding a new hemoglobin gene to cells or turning on the gene for a fetal form of the protein. Other clinical trials for HIV have used CRISPR or other genome editors in stem cells to cripple a receptor, CCR5, that the virus depends on to establish infection.

Instead of modifying a persons stem cells and transplanting them back, the new collaboration will seek to ferry a therapeutic gene or gene-editing tools directly into the body (in vivo) with vectorssuch as harmless viruses or nanoparticles, Collins said. The treatment itself would be similar to a simple blood transfusion. Although studies are already underway with viral vectors that deliver new genes to certain tissues in people, in vivo gene therapy has only been used to modify blood stem cells in animal models of certain diseases. Figuring out how to home in on and modify those cells in people is a big part of the collaborations plan, Collins said.

Hematologist Alexis Thompson of the Northwestern University Feinberg School of Medicine in Chicago, Illinois, who is involved with some sickle cell gene therapy trials, calls the NIH-Gates collaboration phenomenal.But, she says, a more urgent need is to expand efforts to screen newborns in Africa for sickle cell disease and treat them with antibiotics; at the moment, the majority die before age 5 from bacterial infections because the sickled cells impair the spleens ability to filter bacteria and make antibodies. Unless more children with sickle cell disease mutations survive longer, there will be few to be cured with the new gene-based treatments, Thompson says. Its almost being able to crawl or walk before you sprint.(Gates and NIH say they plan to support screening efforts outside of the new collaboration.)

For HIV, a big impetus for the cure push builds on two people infected with the AIDS virus who were cured with stem cell transplants. These two men each had blood cancers that required the transplants, which intentionally used blood from donors who had white blood cells with crippled CCR5 receptors. After the transplants, whatever HIV remained in these men could not enter new host cells, and their infections petered out. This new initiative hopes to speed development of direct injections of gene editor components that can target theCCR5gene in blood cells and cripple it. The potential beauty of in vivo gene editing is that it might be given ultimately as a single shot, curing everyone in a scalable manner, says Steven Deeks, a leading HIV cure researcher at the University of California, San Francisco.

The collaboration will also try to speed development of more experimental interventions that directly excise HIVs genetic material from a patients cells or allow people to artificially make superpotent antibodies against the virus. This might be science fiction now, but one day may be a real possibility, Deeks says.

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NIH and Gates Foundation lay out ambitious plan to bring gene-based treatments for HIV and sickle cell disease to Africa - Science Magazine

Orchard Therapeutics Presents Data from OTL-200 in Patients with Metachromatic Leukodystrophy Using Cryopreservation – BioSpace

BOSTON and LONDON, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced initial results from a clinical trial with a cryopreserved formulation of OTL-200, a gene therapy in development for the treatment of metachromatic leukodystrophy (MLD) at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy. The initial data show that cellular engraftment with OTL-200 using a cryopreserved formulation is similar to that observed using a fresh formulation with the longest patient having 12 months of follow-up since treatment. The data are being featured this week in a poster session at the European Society of Gene & Cell Therapy (ESGCT) Annual Congress in Barcelona, Spain.

MLD is a devastating and rapidly progressing disease with no standard treatment options. In its most severe forms, patients will not survive beyond their first decade of life.

These data compare the initial results of OTL-200 in the first four MLD patients treated using a cryopreserved formulation to a previously presented integrated analysis of 29 patients treated with a fresh formulation that demonstrated meaningful clinical outcomes. Hematopoietic stem cells are collected, purified and transduced in the same way for both formulations. For the cryopreserved formulation, following transduction, the gene-corrected cells are placed in a specific medium that allows them to be stably frozen. After successful testing and release, the cryopreserved cells are shipped to the site of care where they are thawed and administered to patients who have received conditioning.

Presenting the first supportive data on OTL-200 using a cryopreserved formulation represents a cross-functional effort involving our clinical, CMC and regulatory teams as we prepare for the upcoming European regulatory submission for MLD followed by a BLA in the U.S., said Mark Rothera, president and chief executive officer of Orchard. If approved, a cryopreserved formulation of OTL-200 would more readily facilitate global commercialization and patient access efforts, which are key elements in our mission to deliver potentially curative therapies to patients suffering from often-deadly rare diseases.

Mr. Rothera continued, With over 40 patients now treated using a cryopreserved formulation across our pipeline of six clinical-stage programs, we are confident our approach is supported by a robust set of evidence.

Study Results At the time of the analysis, four early-onset MLD patients (two late infantile and two early juvenile) have been treated with the cryopreserved formulation of OTL-200. All patients are alive and were followed for a minimum of one month, with the longest follow-up out to 12 months in the first patient treated (median follow-up of 0.38 years). The age at the time of treatment ranged from seven months to 42 months.

The initial results in patients receiving the cryopreserved formulation (n=4) demonstrated the following:

Figure 1. Profiles of VCN in bone marrow CD34+ cells: OTL-200 cryopreserved vs. OTL-200 fresh

https://www.globenewswire.com/NewsRoom/AttachmentNg/83f41457-927b-4b1b-9ac2-9d48ac10353a

Figure 2. ARSA activity profile in peripheral blood: OTL-200 cryopreserved vs. OTL-200 fresh

https://www.globenewswire.com/NewsRoom/AttachmentNg/393ca5f0-98ad-47f8-b723-35c5c6c08d8f

c = cryopreserved; f = fresh; Sbj. = subject

We are pleased that these initial data suggest that using gene-corrected cells that have been cryopreserved has a similar impact on clinical biomarkers for early-onset MLD patients as the OTL-200 fresh formulation, said Dr. Valeria Calbi, a hematologist at San Raffaele Scientific Institute and SR-Tiget and an investigator of the study. The four treated patients showed good levels of engraftment of gene-corrected cells and reconstitution of ARSA activity at multiple time points, as well as encouraging early trends in GMFM scores that we look forward to evaluating with additional follow-up. We believe that these data further support the positive benefit / risk profile of OTL-200 as a therapy with potential lifelong benefit for patients with MLD.

Next Steps for OTL-200 Orchard remains on track to submit a marketing authorization application, or MAA, in Europe for MLD in the first half of 2020, as well as a biologics licensing application, or BLA, in the U.S. approximately one year later.

About MLD and OTL-200Metachromatic leukodystrophy (MLD) is a rare and life-threatening inherited disease of the bodys metabolic system occurring in approximately one in every 100,000 live births. MLD is caused by a mutation in the arylsulfatase-A (ARSA) gene that results in the accumulation of sulfatides in the brain and other areas of the body, including the liver, the gallbladder, kidneys, and/or spleen. Over time, the nervous system is damaged and patients with MLD will experience neurological problems such as motor, behavioral and cognitive regression, severe spasticity and seizures, finding it more and more difficult to move, talk, swallow, eat and see. Currently, there are no effective treatments for MLD. In its late infantile form, mortality at 5 years from onset is estimated at 50% and 44% at 10 years for juvenile patients.1 OTL-200 is an ex vivo, autologous, hematopoietic stem cell-based gene therapy being studied for the treatment of MLD. OTL-200 was acquired from GSK in April 2018 and originated from a pioneering collaboration between GSK and the Hospital San Raffaele and Fondazione Telethon, acting through their joint San Raffaele-Telethon Institute for Gene Therapy in Milan, initiated in 2010.

About OrchardOrchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies.

Orchards portfolio of ex vivo, autologous, hematopoietic stem cell (HSC) based gene therapies includes Strimvelis, a gammaretroviral vector-based gene therapy and the first such treatment approved by the European Medicines Agency for severe combined immune deficiency due to adenosine deaminase deficiency (ADA-SCID). Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies are all based on lentiviral vector-based gene modification of autologous HSCs and include three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD), transfusion-dependent beta-thalassemia (TDT) and mucopolysaccharidosis type I (MPS-I), as well as an extensive preclinical pipeline. Strimvelis, as well as the programs in MLD, WAS and TDT were acquired by Orchard from GSK in April 2018 and originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy initiated in 2010.

Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston.

Forward-Looking StatementsThis press release contains certain forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards expectations regarding the timing of regulatory submissions for approval of its product candidates, including OTL-200 for the treatment of metachromatic leukodystrophy, the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates, the timing of announcement of clinical data for its product candidates, including OTL-200, and the likelihood that such data will be positive and support further clinical development and regulatory approval of its product candidates, and the likelihood of approval of such product candidates by the applicable regulatory authorities. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, without limitation: the risk that any one or more of Orchards product candidates, including OTL-200, will not be successfully developed or commercialized, the risk of cessation or delay of any of Orchards ongoing or planned clinical trials, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates, the delay of any of Orchards regulatory submissions, the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates, the receipt of restricted marketing approvals, and the risk of delays in Orchards ability to commercialize its product candidates, if approved. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading Risk Factors in Orchards annual report on Form 20-F for the year ended December 31, 2018 as filed with the U.S. Securities and Exchange Commission (SEC) on March 22, 2019, as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

1Mahmood et al. Metachromatic Leukodystrophy: A Case of Triplets with the Late Infantile Variant and a Systematic Review of the Literature. Journal of Child Neurology 2010, DOI: http://doi.org/10.1177/0883073809341669

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaMolly CameronManager, Corporate Communications+1 978-339-3378media@orchard-tx.com

Figure 1

Profiles of VCN in bone marrow CD34+ cells: OTL-200 cryopreserved vs. OTL-200 fresh

Figure 2

ARSA activity profile in peripheral blood: OTL-200 cryopreserved vs. OTL-200 fresh; c = cryopreserved; f = fresh; Sbj. = subject

See the article here:
Orchard Therapeutics Presents Data from OTL-200 in Patients with Metachromatic Leukodystrophy Using Cryopreservation - BioSpace

Brave Glasgow mum’s desperate bid to raise funds for MS treatment in Mexico – Evening Times

A Glasgow mum fears she will be confined to a wheelchair for the rest of her life if she cannot afford vital stem cell treatment abroad.

Sinad Kirkland is desperately trying to raise thousands of pounds to travel to Mexico after being diagnosed with Multiple Sclerosis in 2015.

The 48-year-old, originally from Dublin but has lived in the city for 25 years, was first misdiagnosed with carpel tunnel syndrome.

But her family were dealt a devastating blow when Sinad fell poorly four years ago.

She was taken to the Royal Alexandra Hospital in Paisley where she was diagnosed with the illness.

Multiple Sclerosis, or MS, is a lifelong condition that affects the brain and spinal chord, and is the number one cause of disability in younger adults.

To make matters worse, the mum-of-one was later diagnosed with Progressive-Relapsing MS, meaning she is in a steadily worsening state with acute relapses but no remissions.

When I was admitted to the RAH in November that year I had no idea MS was or what it would mean for me, Sinad told the Evening Times.

I was very much in the opinion that I could continue as normal, but the reality is thats far from the truth.

There has been a progression of things getting worse, and this year things rapidly declined.

I fear that if nothing is done I will be in a wheelchair within a year or so.

My mobility has been majorly reduced, getting around is very hard.

I have to stop with fatigue and tiredness, my legs just dont work like they used to.

A GoFundMe fundraising page has been set up to help cover costs for Sinad to get chemotherapy with stem cell treatment in Mexico.

Around 13,000 has been raised so far, with the aim to raise around 40,000.

While there is no cure for MS, its hoped the treatment will stop things getting worse.

Sinad says that despite treatment trials in the UK, there is little chance they will be available to her for a few years.

She added: So I have no other choice, I either have to raise the money and try the treatment in Mexico, or just accept that I will be confined to a wheelchair and continue to get worse.

Sinad has praised her amazing 11-year-old daughter Erin for helping her get through the illness.

She added: I have little use left in my right hand, so my husband Fraser has been a massive support he always cooks the meals and works around the house.

Hes been a massive emotional support through it all.

Commenting on the success of the fundraiser so far, she added: The response has been amazing.

My family in Ireland and people over here too have just been so great.

I never believed it would do so well but Im so grateful that it is. Its very humbling.

You can view the fundraiser at here.

Go here to see the original:
Brave Glasgow mum's desperate bid to raise funds for MS treatment in Mexico - Evening Times

Bransholme dad diagnosed with cancer weeks after baby arrived desperate to marry ‘amazing’ girlfriend – Hull Daily Mail

A Bransholme dad has vowed to wed his partner after being diagnosed with cancer just six weeks after the birth of their daughter.

Darren Watson, 34, had only just celebrated the arrival of his daughter Amelia in February this year when doctors at Castle Hill Hospital told him about the devastating discovery of a primary mediastinal large b-cell lymphoma in his chest.

The mass, which is the size of a fist and resting above his heart, was quickly treated with chemotherapy, but harsher methods, including radiotherapy and stem cell treatments, are now needed to rid Darren of the cancerous lump.

Darren is desperate to marry his 36-year-old partner Claire Larter who has been his rock throughout the past seven months.

Darren has set up a crowdfunding appeal in a bid to make their planned April 2020 wedding the "special day this amazing woman deserves".

He said: "I have an amazing girlfriend and family, she has coped so well and it's things like this that put your life into perspective.

"I couldn't imagine my life without her, so I'd like to aim and give her a very special wedding she deserves."

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The pair have been together for five years and between them have four children.

Before the diagnosis, Darren was active and worked as a full-time carer which he has had to give up due to him feeling drained with his rigorous cancer treatment.

Darren, who has had extended spells away from his family while being treated in hospital, described his family's year as "pretty bad" and hailed Claire's unwavering support during testing times.

He said: "The start of the year was great, Amelia was born on February 18, but six weeks later I was diagnosed with cancer.

"I had symptoms at that time, but I didn't know what it was. I was kept in hospital until they diagnosed me after I was sent for a scan.

"It has been pretty hard, especially my girlfriend having a house to run, kids to sort, newborn baby and visiting me. We have decided to try make something good out of this and get married."

He hopes the wedding will give the family something to look forward to and to focus on in the coming months.

Posting on their fundraising page, Darren said: "We are basically asking if any friends and family would like to help donate so I can try make this day the special day this amazing woman deserves."

To donate, visit their Go Fund Me page here.

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Bransholme dad diagnosed with cancer weeks after baby arrived desperate to marry 'amazing' girlfriend - Hull Daily Mail

Judge approves further cancer treatment for boy, 5, against father’s wishes – BreakingNews.ie

A five-year-old boy who has cancer with a low survival rate is to have high dose chemotherapy and other treatments urgently in line with the wishes of his mother and treating doctors but against the wishes of his father, the president of the High Court has ordered.

Mr Justice Peter Kelly said he wished the child well, as did all concerned for his welfare, and hoped the curative intent treatment (CIN) will achieve a cure.

"A 10-20% chance of cure even with the undoubted horrible side effects of the treatment is to be preferred to the virtual certainty of death."

The treatment will be carefully monitored and will be discontinued if it proves ineffective or the child cannot tolerate it, he stressed.

The father had opposed the CIN treatment on grounds of limited chance of cure and because the child had not reacted well to earlier chemotherapy. He wanted the boy to instead have palliative intent management and to enjoy what he believed would be the boy's last Christmas with the family.

He said he had told his son, who appears well at present and is asymptomatic, he would not be subject to further chemotherapy.

After intensive discussions, the father had reluctantly agreed before the court the proposed treatment could take place after Christmas but the treating consultant said deferral to 2020 would be with palliative intent because of the risk of the tumour becoming active again and the proposed CIN is already two months behind the recommended time because of the efforts to reach a consensus between the parents.

The boy had told a child psychologist he has "kid cancer" "all around my body" and does not want any more "chemo".

He also said, if the cancer did not go away "on its own", he might have chemo, immediately changed his mind about that, and was aware his parents disagreed about more chemo. His father had given him CBD oil for the cancer, he also said.

In his judgment, Mr Justice Kelly noted the hospital took High Court wardship proceedings following its inability to secure agreement between the parents on treatment. The boy was made a ward of court and his views were represented by the general solicitor for wards of court.

The judge stressed he accepted both parents love their son and want the best for him.

The judge concluded on the evidence it was in the boy's best interests the CIN should be proceeded with.

There is "a strong legal presumption in favour of taking all steps to preserve life", he said.

While that presumption is not irrefutable, the medical experts unanimously believe, on balance, the CIN treatment should proceed, he said.

It would be in line with well-established protocols, will last a year if carried out in full and is "mainstream treatment and not experimental".

While the survival rate is as low as 10-20%, there is a "realistic possibility" of cure and not to have the CIN meant no such possibility.

He found the mother had taken a "balanced and rational" approach and she could understand the importance of the child enjoying Christmas "but not at the price of losing future Christmases".

The father had been "rather more affected by emotion and sentiment than by reason" and had a "very fixed" view on the matter. His wish to give his son a last enjoyable Christmas presupposed the tumour does not become active and his belief in CBD oil was not based on any medical evidence.

In relation to the boy's views, the judge believed he was influenced by his father's approach to "no more chemo" and lacks the maturity or insight to understand his position.

The first element of the treatment is for one month and it could be finished by late November with the effect the boy may have an enjoyable Christmas without treatment, he said.

The boy was diagnosed with a paediatric cancer (HRN) in October 2018. Following an inadequate response to induction chemotherapy, his diagnosis was reclassified as very high risk neuroblastoma (VHRN).

HRN has a five-year survival rate of about 50% and the five-year survival rate for VHRN is 10 to 20%.

The next phase of the proposed treatment involved high dose chemotherapy and stem cell rescue.

Because of the boy's inadequate initial response to treatment, his consultant oncologist proposed to further intensify the chemotherapy. That approach was endorsed by other consultants, including from Great Ormond Street Hospital for Children in London.

The judge said the proposed treatment is associated with significant treatment related morbidity, a mortality risk of 2-3% and is "very unpleasant" with "likely" side effects including infection, hair loss, nausea/vomiting and mouth sores and "possible" side effects including a 10% or less chance of liver disease.

The evidence was the proposed CIN is likely to extend survival time and it was recommended on balance by the treating team whose recommendation was accepted by the mother but not the father.

Read more here:
Judge approves further cancer treatment for boy, 5, against father's wishes - BreakingNews.ie

Mum’s heartbreaking choice to not bond with newborn son after cancer diagnosis – Mirror Online

Just weeks after her baby son was born, Hannah Toohill made a heartbreaking decision.

The mum-of-two had been diagnosed with an incurable blood cancer after giving birth to little Fraser 11 weeks early.

Believing she only had months to live, the 29-year-old made the tough decision that it would be better if he never got to know her.

Convinced it was the best thing to do, Hannah kept her distance for the first few months of Fraser's life while she also went through gruelling treatment.

Desperate to spend more time with her son it was only when she realised it would prolong her life that she changed her mind, reports the Daily Record.

Amazingly, one year on, Hannah has marked Fraser's first birthday and the first anniversary of her multiple myeloma cancer diagnosis.

Now she wants her experience to inspire others with incurable cancer not to give up on living life.

Hannah, from Dingwall, Easter Ross, said: When I was first diagnosed, I couldnt get my head around the fact the type of cancer I had was incurable.

"I loved Fraser so much, I wanted to be with him. But I didnt want to bond with him because I thought that if I was going to die, then it would kinder on him if he hadnt got to know me.

I thought the right thing was to spend time with my daughter Catherine, who knew me already and would have memories with me. So while my husband spent time with Fraser every day, I hardly ever went to the hospital to visit him.

My mindset only started to change when I realised the treatment I was receiving was working and I was actually doing OK.

Now I cant get enough of Fraser we have such a wonderful relationship. Hes such a mummys boy.

Hannah was diagnosed with multiple myeloma last October, three weeks after giving birth prematurely to Fraser.

Hannah said: Myeloma was never something any of my pregnancy team would have looked for. I was told it was almost unheard of in someone my age, and that while the condition could be treated, there was no cure.

The consultant told me, Please dont Google . But I did and, from what I read, I was sure I had just months to live.

Hannah started four months of chemotherapy before being sent 170 miles from home to the Queen Elizabeth University Hospital in Glasgow for a stem cell transplant.

She said: Most people are kept in hospital for 14 days after a stem cell transplant but I was in for five weeks, as I didnt recover quickly enough probably because my body hadnt had time to recover from pregnancy before my cancer treatment began.

Catherine came down to visit a few times but I didnt see Fraser at all.

When Hannah was finally allowed home, her recovery came on in leaps and bounds.

As she grew mentally and physically stronger, she started to spend more time helping to care for both her children.

Twelve months on from her diagnosis, Hannahs cancer is in remission, and while she knows it will return one day, she doesnt dwell on her illness.

Hannah, who plans to return to work next year, said: The treatment Ive had has worked so well there is no sign of cancer in my blood.

My cancer is asleep and while I know it will wake up again one day, no one knows when that will be.

It could be in six months or in six years there is no way to predict. I just have to hope that, in the meantime, scientists will find a cure.

"I dont waste a lot of time thinking about my illness it doesnt often cross my mind that I have cancer.

Instead, Im enjoying living my life, doing as much with my children as I possibly can. I know how precious life is and I dont intend to waste a minute.

Hannah is grateful for all the support she has received including from her family, friends and medical staff who helped care for Fraser for the first 10 weeks of his life.

She has also received support from the charity Myeloma UK, which provides information and support to anyone affected by the disease and helps funds research towards finding new treatments and a possible cure.

Hannah added: Ive learned you can live life even when you are diagnosed with a cancer that currently has no cure. My advice to others is keep positive.

Originally posted here:
Mum's heartbreaking choice to not bond with newborn son after cancer diagnosis - Mirror Online