Category Archives: Cell Therapy

Regenerative cell therapy, tissue engineering are future treatments ModernMedicine There have been major changes in the way keratoplasty has been performed over the past 15 years. Data from the Singapore Corneal Transplant Study shows there have been improved outcomes in the lamellar surgical techniques compared to the full ...

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Regenerative cell therapy, tissue engineering are future treatments - ModernMedicine

VALBONNE, France--(BUSINESS WIRE)--Regulatory News:

TxCell SA (Paris:TXCL) (FR0010127662 TXCL), a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe inflammatory and autoimmune diseases as well as transplant rejection, today announces that Stphane Boissel, CEO of TxCell, will present in upcoming cell therapy conferences.

Mr. Boissel will present an update on TxCells ENTrIA CAR-Treg platform at the 5th Alliance for Regenerative Medicine (ARM) Annual Cell & Gene Therapy Investor Day which will be held on April 27, 2017 in Boston (US). The TxCell presentation will be coupled with an interview by Joshua Schimmer, MD, Managing Director and Senior Biotech Equity Research Analyst at Piper Jaffray & Co. The presentation and interview will take place at 5:00pm local time (Harborside Room).

Mr. Boissel will also be participating to a panel discussion entitled Biotech Perspective: The opportunities of cell & gene therapy and why now? at the Investment for Advanced Therapies Summit which will be held on May 3, 2017 in London (UK). This panel discussion will take place at 9:15am local time.

In addition, Mr. Boissel and other members from TxCell will attend the International Society for Cellular Therapy (ISCT) 2017 Annual Meeting which will be held on May 3-6, 2017, in London.

About TxCell http://www.txcell.com

TxCell is a biotechnology company that develops platforms for innovative, personalized T cell immunotherapies for the treatment of severe inflammatory and autoimmune diseases with high unmet medical need. TxCell is targeting a range of autoimmune diseases (both T-cell and B-cell-mediated) including Crohns disease, lupus nephritis, bullous pemphigoid and multiple sclerosis, as well as transplant rejection.

TxCell is the only clinical-stage cellular therapy company fully dedicated to the science of regulatory T lymphocytes (Tregs). Tregs are a recently discovered T cell population for which anti-inflammatory properties have been demonstrated. Contrary to conventional approaches based on non-specific polyclonal Tregs, TxCell is exclusively developing antigen-specific Tregs. This antigen specificity may either come from genetic modifications with Chimeric Antigen Receptor (CAR) or from pre-existing Treg cell T-Cell Receptor (TCR). TxCell is developing two proprietary technology platforms, ENTrIA, which is composed of genetically-engineered Tregs, and ASTrIA, which is composed of non-modified naturally antigen-specific Tregs.

Based in Sophia-Antipolis, France, TxCell is listed on Euronext Paris and currently has 46 employees.

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Financial and business conferences

5th Annual Cell & Gene Therapy Investor Day (ARM)

Scientific and medical conferences

22e congrs Nantes Actualits Transplantation (NAT)

Forward-Looking Statements - TxCell

This press release contains certain forward-looking statements relating to the business of TxCell, which shall not be considered per se as historical facts, including TxCells ability to develop, market, commercialize and achieve market acceptance for specific products, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements, needs for additional financing. In addition, even if the actual results or development of TxCell are consistent with the forward-looking statements contained in this press release, those results or developments of TxCell may not be indicative of their in the future.

In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. Although the management of TxCell believes that these forward-looking statements are reasonably made, they are based largely on the current expectations of TxCell as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of TxCell could be affected by, among other things, uncertainties involved in the development of the Companys products, which may not succeed, or in the delivery of TxCells products marketing authorizations by the relevant regulatory authorities and, in general, any factor that could affects TxCell capacity to commercialize the products it develops, as well as, any other risk and uncertainties developed or identified in any public documents filed by TxCell with the AMF, included those listed in chapter 4 Risk factors of the 2015 document de rfrence (registration document) approved by the AMF on May 24, 2016 under number R.16-048 and in the section 5.1 of the update of the registration document filed with the AMF on January 24, 2107 under number D.16-0346-A01. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be accurate, precise and fairly presented), TxCell is providing the information in these materials as of this press release, and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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TxCell to Provide CAR-Treg Update in Upcoming Cell Therapy Conferences - Business Wire (press release)

The global stem cell therapy market to grow at a CAGR of 36.52% during the period 2017-2021.

The report, Global Stem Cell Therapy Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

The latest trend gaining momentum in the market is evolution of new destinations in the development of stem cell therapies. Traditionally, the US and European countries are the key destinations for clinical trials for stem cell therapy products. However, the transformation of regulatory landscape in countries such as Japan and South Korea has made these regions as attractive destinations for the development of stem cell therapy products.

According to the report, one of the major drivers for this market is increase in federal funding in stem cell therapy. Research and clinical trials of stem cell therapy require huge investment, which many research institutes and small companies cannot afford. Therefore, many federal organizations provide funding to these institutes and small companies to help their innovative ideas in the development of stem cell therapies. Worldwide, many government organizations have noticed the importance of regenerative medicine, and thus they have allocated funds and grants in that area. For instance, in the US, the NIH and CIRM provide most of the funds.

Key vendors

Key Topics Covered:

Part 01: Executive summary

Part 02: Scope of the report

Part 03: Research Methodology

Part 04: Introduction

Part 05: Understanding of stem cell therapy

Part 06: Ethical issues and regulatory landscape

Part 07: Key clinical trials

Part 08: Market landscape

Part 09: Market segmentation by therapy

Part 10: Market segmentation by applications

Part 11: Geographical segmentation

Part 12: Market drivers

Part 13: Impact of drivers

Part 14: Market challenges

Part 15: Impact of drivers and challenges

Part 16: Market trends

Part 17: Vendor landscape

Part 18: Key vendor analysis

For more information about this report visit http://www.researchandmarkets.com/research/gdv8s6/global_stem_cell

Media Contact:

Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-stem-cell-therapy-market---analysis-technologies-and-forecasts-to-2021---increasing-demand-to-develop-effective-drugs-for-cardiology-and-degenerative-disorders---research-and-markets-300444066.html

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Global Stem Cell Therapy Market - Analysis, Technologies and Forecasts to 2021 - Increasing Demand to Develop ... - PR Newswire (press release)

DUBLIN, April 24, 2017 /PRNewswire/ --

Research and Markets has announced the addition of the "Global Stem Cell Therapy Market 2017-2021" report to their offering.

Research and Markets Logo

The global stem cell therapy market to grow at a CAGR of 36.52% during the period 2017-2021.

The report, Global Stem Cell Therapy Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

The latest trend gaining momentum in the market is evolution of new destinations in the development of stem cell therapies. Traditionally, the US and European countries are the key destinations for clinical trials for stem cell therapy products. However, the transformation of regulatory landscape in countries such as Japan and South Korea has made these regions as attractive destinations for the development of stem cell therapy products.

According to the report, one of the major drivers for this market is increase in federal funding in stem cell therapy. Research and clinical trials of stem cell therapy require huge investment, which many research institutes and small companies cannot afford. Therefore, many federal organizations provide funding to these institutes and small companies to help their innovative ideas in the development of stem cell therapies. Worldwide, many government organizations have noticed the importance of regenerative medicine, and thus they have allocated funds and grants in that area. For instance, in the US, the NIH and CIRM provide most of the funds.

Key vendors

Key Topics Covered:

Part 01: Executive summary

Part 02: Scope of the report

Part 03: Research Methodology

Part 04: Introduction

Part 05: Understanding of stem cell therapy

Part 06: Ethical issues and regulatory landscape

Part 07: Key clinical trials

Part 08: Market landscape

Part 09: Market segmentation by therapy

Part 10: Market segmentation by applications

Part 11: Geographical segmentation

Part 12: Market drivers

Part 13: Impact of drivers

Part 14: Market challenges

Part 15: Impact of drivers and challenges

Part 16: Market trends

Part 17: Vendor landscape

Part 18: Key vendor analysis

For more information about this report visit http://www.researchandmarkets.com/research/gdv8s6/global_stem_cell

Media Contact:

Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-stem-cell-therapy-market---analysis-technologies-and-forecasts-to-2021---increasing-demand-to-develop-effective-drugs-for-cardiology-and-degenerative-disorders---research-and-markets-300444066.html

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Global Stem Cell Therapy Market - Analysis, Technologies and ... - Yahoo Finance

Skiing in Aspen, Sean Fair mistimed a landing and felt a shooting pain in his right knee as he crumpled into the snow. He had to slide down the steep slope on his left ski. The doctor revealed that Fairs agony originated from a quarter-sized hole in the cartilage of his knee.

For an active person like Fair, traditional surgery options, like a total knee replacement, restrict motion and are less than ideal. Advances in experimental cartilage repair stem cell treatments, however, now offer new opportunities for young patients to preserve mobility, that defining value of youth.

Fair played football, among other sports, in high school. He played tennis in college and continued to play until he had his ski incident at the age of 31.

All of a sudden, not being able to do anything, I felt 80, he said. All my friends would play tennis together but I would have to sit back and watch.

Sean Fair was diagnosed with OCD, or osteochondritis dissecans. This condition typically develops in teenagers but doesnt usually present symptoms until adulthood when the joint experiences some form of trauma. OCD lesions involve holes, cracks, or loose articular cartilage in a joint.

Fair met with Dr. Andreas Gomoll, an orthopedic surgeon at the Brigham and Womens Hospital in Boston. They discussed knee replacement surgery, microfracture surgery and the possibility of using healthy cartilage from a cadaver donor.

Knee replacement surgery for patients as young as Fair often results with low satisfaction. People who receive the standard metal and plastic knee replacement are functionally limited and face unexpected physical challenges when it comes to activities more intense than a walk. Microfracture surgery would be better, but Fairs injury was too large for that to be practical. Fair and Gomoll decided to wait for a cadaver donor. While waiting, however, Fair joined a clinical trial to test a new approach that would fill the gap in his cartilage with stem cells.

Stem cells can be thought of as undecided cells. Theyre mostly present in embryos and neonates, but they are also found in adults as well. Given the correct environment, and depending on the type of stem cell, they can become more specific cells, like muscle cells or cartilage-forming cells. In Fairs case, Gomoll used donated umbilical cord stem cells from healthy babies delivered in the US. Umbilical cord stem cells are useful because they are able to morph into cartilage-forming cells, they dont require the destruction of an embryo and they have immunosuppressive properties that wouldnt cause Fairs body to reject them.

Anatomical representation of the human knee.

The procedure looked simple. Gomoll made a vertical incision in Fairs kneecap, cutting through the skin and the yellow fat to expose the white cartilage. Gomoll used stainless steel tools to clamp open the incision, while he used a metal ring spanner to scrape the edges of the cartilage pothole. (Picture using a spoon to carve a hole in a large eraser.) Next, the surgeon drilled seven coffee stirrer-sized holes into the bone at the bottom of the quarter-sized pothole. He injected the clear stem cell gel into each coffee stirrer-sized hole and then filled the quarter-sized hole up to its edges with the rest of the stem cell gel. Gomoll smoothed down the stem cell gel like icing on a cake. Then he sutured the wound closed.

Fair wasnt quick to start walking right after the procedure. His knee needed to heal and then he would have to follow a strict rehabilitation process of weekly physical therapy sessions.

Months after his surgery, the stem cells in Fairs knee developed into chondrocytes, cells that secrete a matrix of cartilage, and sealed the pothole in Fairs knee. As of now, Fair is thankful for his treatment. His right knee has healed, but hes still not at 100 percent.

My other knee unfortunately, because of all the issues the [right knee] had, also needs reconstruction, Fair said. Ive got to be careful when I carry my two-and-half-yearold down the steps. Functionally I can walk. I can chase him. I can outrun him, still. Other than that, its not a lot of peripheral movement I can do yet.

According to Gomoll, about 15 other Americans have received the same experimental treatment as Fair. Before this therapy can be offered at any hospital in the US, the clinical trial must obtain FDA approval after proving its efficacy with a larger, more randomized sample of patients. But Gomoll doesnt seem too worried. He says hundreds of patients in South Korea have already undergone the same procedure. Getting there will take some time and money; running comprehensive trials is expensive. Once the procedure is approved, Gomoll imagines thousands of cartilage damaged patients like Fair would potentially be treated with stem cells in the United States.

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Experimental Stem Cell Therapy Could Treat Damaged Knee Cartilage - BU News Service

DUBLIN--(BUSINESS WIRE)--

Research and Markets has announced the addition of the "Global CAR T Cell Therapy Market & Clinical Trials Insight 2022" report to their offering.

The report highlights the ongoing clinical and non-clinical advancement in the field of Car T Cell Therapy. As per report findings, the promise of CAR modified T cell therapy derives from its combined immunologic benefits and include the specificity of a targeted antibody, the ability to expand the T cell population and the potential for long term persistence to facilitate the ongoing tumor surveillance. The success in early phase trials, assess the feasibility of evaluating the treatment modality across the multiple centers and in larger patients. Currently, there are 99 CAR T Cell based therapies in clinical pipeline and most of them belong to Phase-I and Phase-I/II clinical trials.

In recent years, researchers have identified the chimeric antigen receptor as a potential target for molecular genetics to insert a new epitopes on the receptor region which allows a degree of control of the immune system. CAR T cell therapy satisfy the need to explore new and efficacious adoptive T cell therapy. The gene transfer technology could efficiently introduce the genes encoding CARs into the immune effector cells. The transferring of engineered T cells provides the specific antigen binding in a non-major histocompatibility complex.

The promise of CAR modified T cell therapy derives from its combined immunologic benefits and include the specificity of a targeted antibody, the ability to expand the T cell population and the potential for long term persistence to facilitate the ongoing tumor surveillance. The success in early phase trials, assess the feasibility of evaluating the treatment modality across the multiple centers and in larger patients.

Companies Mentioned

Key Topics Covered:

1. Chimeric Antigen Receptor (CAR) T Cell Therapy - Next Era in Immuno Oncology

2. Evolution of Chimeric Antigen Receptor (CAR) T-Cell Design

3. Principle of Chimeric Antigen Receptor Design

4. CAR T Cell Therapies Delivery Pipeline & Mechanism of Action

5. Approaches to Improve the CAR T Cell Therapy

6. Global CAR T Cell Therapy Clinical Trials for Cancer Treatment

7. Global CAR T Cell Therapies Clinical Pipeline by Company, Indication & Phase

8. Global Market Scenario of CAR T Cell Therapy

9. Global Market Size of CAR T Cell Therapy

10. Global CAR T Cell Therapy Market Dynamics

11. Global CAR T Cell Therapy Market Future Prospects

12. Competitive Landscap

For more information about this report visit http://www.researchandmarkets.com/research/3h29l7/global_car_t_cell

View source version on businesswire.com: http://www.businesswire.com/news/home/20170424006562/en/

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Global CAR T Cell Therapy Market & Clinical Trials Insight 2022: 99 ... - Yahoo Finance

LOS ANGELES--(BUSINESS WIRE)--

HemaCare Corporation (HEMA), a leader in cell and tissue collection, processing and cell therapy solutions, will be exhibiting at the annual meeting of the International Society of Cell Therapy (ISCT) in London, UK, May 3-6, 2017. This year marks the 25th anniversary of the ISCT, a global society that unites clinicians, researchers, regulators, technologists and industry partners with a shared vision to translate cellular therapy into clinical practice. HemaCare will meet with its customers and European distributors at the conference and showcase its growing portfolio for cell therapy developers around the world.

Attending this meeting enables us to capture the latest developments in cell therapy and better serve our customer needs, said Pete van der Wal, Chief Executive Officer for HemaCare.The field of cell therapy is rapidly evolving. Our products and services are embedded in some of the most critical phases of translational research, enabling scientists to work with high quality human cells from our well-characterized donor pool.

The conference is being held at ExCel London Conference Center. Look for us there, or view our products and services at http://www.hemacare.com.

About HemaCare

HemaCare specializes in the customization of human-derived biological products and services for customers research and cell therapy protocols. HemaCares network of FDA-registered, GMP/GTP-compliant collection centers ensures donor material is available for fresh shipment to customers, as well as for internal use within HemaCares isolation laboratory. In this laboratory, human biological material such as peripheral blood, bone marrow, and cord blood from donor and patient subjects is isolated into various primary cell types for distribution to customers in fresh and frozen formats. HemaCare's extensive registry of well-characterized repeat donors provides consistent primary human cells and biological products for advanced biomedical research and cellular therapy process development.

For 39 years, HemaCare has provided human-derived primary blood cells and tissues for biomedical research, supported cell therapy clinical trials and commercialization with apheresis collections, and provided a wide range of consulting services. HemaCare directly supports benchtop immunology and oncology research, compound screening for drug discovery, and assay development and qualification, as well as enables customers to advance both autologous and allogeneic cellular therapies. For more information, please visit http://www.hemacare.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170424005274/en/

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HemaCare Will Attend International Society of Cell Therapy in London - Yahoo Finance

SALT LAKE CITY, UT--(Marketwired - Apr 20, 2017) - PolarityTE, Inc. ("Polarity") ( NASDAQ : COOL ) announces the signing of a manufacturing agreement with Cell Therapy and Regenerative Medicine ("CTRM") at the University of Utah School of Medicine. CTRM is the established manufacturer of hematopoietic stem cell transplants for renowned institutions of the Salt Lake region such as the Huntsman Cancer Institute and Primary Children's Hospital. In addition, CTRM manufactures a variety of regenerative medicine products, is FACT accredited, and has technical expertise in current Good Tissue Practice (cGTP) and current Good Manufacturing Practice (cGMP).

Denver Lough, MD, PhD, Chairman and CEO, stated, "This agreement with CTRM should provide PolarityTE with rapid clinical translation of the promising products we are developing, and takes us one step closer to achieving our goal of clinical application of our launch product, SkinTE. As we prepare for market entry in 2018, our established relationship with CTRM creates a springboard for the anticipated scale-up to address the large burn and chronic wound markets, with the pursuit of our own independent manufacturing facility. Plans are solidifying for a unique solution to both commercial and emergent relief manufacturing of SkinTE and future Polarity products. Our goal is not only to meet demand, but also to be able to deliver promptly around the globe when urgent response is needed."

About Cell Therapy and Regenerative Medicine (CTRM) CTRM at the University of Utah is engaged in delivering some of the world's most advanced cellular therapies to patients.CTRM provides unique resources and expertise that feworganizations can internally create to achieve large scale manufacturing of cell- and tissue-based products for clinical trials.Highly experienced CTRM staff support the Blood and Marrow Transplant (BMT) Programs at Huntsman Cancer Institute and Primary Children's Hospital to deliver high quality stem cell products for the treatment of adult and pediatric patients diagnosed with leukemia, lymphoma, aplastic anemia and other types of blood diseases and disorders.CTRM is also developing and providing novel clinical grade cellular and tissue engineered products via comprehensive "bench" to "bedside" services that coordinate efforts of clinicians, entrepreneurs, researchers and bioengineers. CTRM with its industry partners is translating some of the newest cellular and tissue based discoveries into clinical applications to extend and improve the quality of life for individuals suffering from debilitating diseases and injuries.For more information go to http://www.medicine.utah.edu/cell.

About PolarityTE, Inc. PolarityTE, Inc. is the owner of a novel regenerative medicine and tissue engineering platform developed and patented by Denver Lough, MD, PhD. This radical and proprietary technology employs a patient's own cells for the healing of full-thickness functionally-polarized tissues. If clinically successful, the PolarityTE platform will be able to provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. It is because PolarityTE uses a natural and biologically sound platform technology, which is readily adaptable to a wide spectrum of organ and tissue systems, that the company and its world-renowned clinical advisory board, are poised to drastically change the field and future of translational regenerative medicine. More information can be found online at http://www.polarityte.com.

Forward Looking Statements Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "should'" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

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PolarityTE(TM), Inc. Enters Formal Agreement with Cell Therapy and ... - Yahoo Finance

Administration of autologous HER2-specific chimeric antigen receptor (CAR)-modified virus specific T Cells (VSTs) was safe and had clinical benefit for some patients with progressive glioblastoma, a disease with limited effective therapeutic options.

Results of a small phase I study of this monotherapy were published in JAMA Oncology, by Nabil Ahmed, MD, MPH, of Baylor College of Medicine in Houston, and colleagues.

CAR T-cell therapies are an attractive strategy to improve the outcomes for patients with glioblastoma, they wrote. In our study, we infused HER2-CAR VSTs intravenously because T cells can travel to the brain after intravenous injections, as evidenced by clinical responses after the infusion of tumor-infiltrating lymphocytes for melanoma brain metastasis and by detection of CD19-CAR T cells in the cerebrospinal fluid of patients with B-precursor leukemia.

The study included 17 patients with progressive HER2-positive glioblastoma (10 patients aged 18 or older; 7 patients younger than 18). Patients were given one or more infusions of autologous VSTs specific for cytomegalovirus, Epstein-Barr virus, or adenovirus and genetically modified to express HER2-CARs. Six patients were given multiple infusions.

Infusions were well tolerated with no dose limiting toxicities presenting. Two patients had grade 2 seizures and/or headaches, which the researchers wrote were probably related to the T-cell infusion.

Although HER2-CAR VSTs did not expand, they were detected in the peripheral blood for up to 12 months after the infusion.

Although we did not observe an expansion of HER2-CAR VSTs in the peripheral blood, T cells could have expanded at glioblastoma sites. At 6 weeks after T-cell infusion, the MRI scans of patients 3, 7, 10, 16, and 17 showed an increase in peritumoral edema, the researchers wrote. Although these patients were classified as having a progressive disease, it is likely that the imaging changes for some of these patients were due to inflammatory responses, indicative of local T-cell expansion, especially since these patients survived for more than 6 months.

Only 16 of the 17 patients were evaluable for response. Patients underwent brain MRI 6 weeks after T-cell infusion. One patient had a partial response for longer than 9 months and seven patients had stable disease for between 8 weeks to 29 months. Three patients with stable disease are alive without any evidence of progression from 24 to 29 months of follow-up. Eight patients progressed after the infusion.

The median overall survival was 11.1 months from the first T-cell infusion and 24.5 months from diagnosis.

The researchers noted that the inclusion of children in the study, who have a better prognosis than adults, may have affected the results; however, there was no significant difference between the survival probability for children and that for adults in this clinical study.

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HER2-Specific CAR T-Cell Therapy Active in Progressive ... - Cancer Network

Administration of autologous HER2-specific chimeric antigen receptor (CAR)-modified virus specific T Cells (VSTs) was safe and had clinical benefit for some patients with progressive glioblastoma, a disease with limited effective therapeutic options.

Results of a small phase I study of this monotherapy were published in JAMA Oncology, by Nabil Ahmed, MD, MPH, of Baylor College of Medicine in Houston, and colleagues.

CAR T-cell therapies are an attractive strategy to improve the outcomes for patients with glioblastoma, they wrote. In our study, we infused HER2-CAR VSTs intravenously because T cells can travel to the brain after intravenous injections, as evidenced by clinical responses after the infusion of tumor-infiltrating lymphocytes for melanoma brain metastasis and by detection of CD19-CAR T cells in the cerebrospinal fluid of patients with B-precursor leukemia.

The study included 17 patients with progressive HER2-positive glioblastoma (10 patients aged 18 or older; 7 patients younger than 18). Patients were given one or more infusions of autologous VSTs specific for cytomegalovirus, Epstein-Barr virus, or adenovirus and genetically modified to express HER2-CARs. Six patients were given multiple infusions.

Infusions were well tolerated with no dose limiting toxicities presenting. Two patients had grade 2 seizures and/or headaches, which the researchers wrote were probably related to the T-cell infusion.

Although HER2-CAR VSTs did not expand, they were detected in the peripheral blood for up to 12 months after the infusion.

Although we did not observe an expansion of HER2-CAR VSTs in the peripheral blood, T cells could have expanded at glioblastoma sites. At 6 weeks after T-cell infusion, the MRI scans of patients 3, 7, 10, 16, and 17 showed an increase in peritumoral edema, the researchers wrote. Although these patients were classified as having a progressive disease, it is likely that the imaging changes for some of these patients were due to inflammatory responses, indicative of local T-cell expansion, especially since these patients survived for more than 6 months.

Only 16 of the 17 patients were evaluable for response. Patients underwent brain MRI 6 weeks after T-cell infusion. One patient had a partial response for longer than 9 months and seven patients had stable disease for between 8 weeks to 29 months. Three patients with stable disease are alive without any evidence of progression from 24 to 29 months of follow-up. Eight patients progressed after the infusion.

The median overall survival was 11.1 months from the first T-cell infusion and 24.5 months from diagnosis.

The researchers noted that the inclusion of children in the study, who have a better prognosis than adults, may have affected the results; however, there was no significant difference between the survival probability for children and that for adults in this clinical study.

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HER2-Specific CAR T-Cell Therapy Active in Progressive Glioblastoma - Cancer Network