Stem Cell Clinic

Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma …

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced that Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen. The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.

We are focused on making ADCETRIS available globally to all eligible patients with relapsed HL and sALCL. The approval of ADCETRIS in Canada, as well as the recent approval in the European Union, are important milestones to accomplish this goal, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Now that Health Canada has approved ADCETRIS, we are committed to working closely with public and private insurers to secure reimbursement coverage for patients in Canada.

The approval of ADCETRIS in Canada marks a significant milestone for patients with relapsed HL or sALCL who have had few new treatment options in several decades, Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada.

Health Canada grants NOC/c, a form of market approval, on the basis of promising evidence of clinical effectiveness, for products intended for the treatment of serious, life-threatening or severely debilitating illnesses that meet a serious unmet medical need or demonstrate a significant improvement in the benefit/risk profile over existing therapies. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the anticipated clinical benefit of ADCETRIS in these patients. Two confirmatory phase III clinical trials evaluating ADCETRIS in the front-line treatment setting of HL and mature T-cell lymphoma (MTCL), including sALCL, are currently underway and enrolling patients.

ADCETRIS (brentuximab vedotin) was issued marketing authorization under the NOC/c policy based on results from a single-arm, phase II pivotal trial in HL patients with relapsed or refractory disease following an ASCT and a single-arm, phase II pivotal trial in relapsed or refractory sALCL patients. ADCETRIS is administered in hospitals through IV infusion over 30 minutes every three weeks and patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately one year).

ADCETRIS is the first in a new class of antibody-drug conjugates (ADCs) to be approved in Canada. Using Seattle Genetics proprietary technology, the ADC consists of a monoclonal antibody directed to an antigen called CD30. The monoclonal antibody is connected to a cell-killing agent by a linker system that is designed to be stable in the bloodstream but to release the cell-killing agent into CD30-expressing cells, resulting in target cell death. The CD30 antigen is known to be expressed on the Reed-Sternberg cells of HL and on sALCL, an aggressive type of T-cell non-Hodgkin lymphoma.

Health Canadas approval of ADCETRIS is the first step in getting patients access to this important therapy, said Sue Robson, Executive Director of Lymphoma Foundation Canada. The Lymphoma Foundation is committed to working with Canada provincial governments to ensure that appropriate patients have access to this new therapy.

About Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma ...

Controversial Stem-Cell Company Moves Treatment out of U.S.

Celltex Therapeutics of Houston ceased treatment patients in the U.S. last year after a warning from regulators, and will now send patients for treatments to Mexico

By David Cyranoski and Nature magazine

Relations have soured between Celltex and RNL Bio since December 2011 when they launched their stem-cell bank in Sugar Land, Texas. Pictured: human neural stem cells from fetal cortex. Image: Flickr/GE Healthcare

US citizens who had pinned their hopes on a company being able to offer stem-cell treatments close to home will now need to travel a little farther. Celltex Therapeutics of Houston, Texas, stopped treating patients in the United States last year following a warning from regulators. A 25 January e-mail to Celltex customers indicates that the firm will now follow in the footsteps of many other companies offering unproven stem-cell therapies and send its patients abroad for treatment but only to Mexico.

The stem-cell treatments offered by Celltex involved extracting adult stem cells from a patient, culturing them and then reinjecting them in a bid to replenish damaged tissue. It had been offering the treatment for more than a year with one of its high-profile customers being Texas governor, Rick Perry when the US Food and Drug Administration (FDA) wrote to the company on 24 September 2012 advising it that the stem cells it harvested and grew were more than minimally manipulated during Celltex's procedures. As such, the FDA regarded the cells as drugs, which would require the agency's approval to be used in treatments. The FDA also warned that Celltex had failed to address problems in its cell processing that inspectors from the agency had identified in an April 2012 inspection of its cell bank in Sugar Land, Texas. Shortly after it received the letter, Celltex stopped injecting stem cells into patients.

For customers who still had cells banked at Celltex and were wondering how to get them out, things became more chaotic when Celltex and RNL Bio, a company based in Seoul, South Korea, which operated the processing center and bank in Sugar Land, sued each other over financial disagreements. Celltex had to issue a restraining order just to gain access to the cells.

The January e-mail from Celltex reassures customers that their cells are safely stored in a facility in Houston and adds: We anticipate that we will be able to offer our stem cell therapy services to physicians in Mexico starting very soon! The e-mail also says that the company is building a new laboratory in Houston, to be opened in March.

Celltex adds that it will carry out an FDA-approved clinical trial, to start shortly after a March meeting with the FDA, pending a positive review from the regulator. However, the company had said in a 25 October e-mail to patients that it would start such a trial within two months and that patient enrolment could begin in late November.

Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, says that the move to Mexico is "not surprising", given the companys difficulties in the United States.

As Celltex's stem culturing and banking technology was licensed from RNL Bio, it is also not clear whether it has the expertise needed to launch a clinical trial on its own, says Turner. "It would have to build a stem-cell company from the ground floor up. I wouldnt say it is anywhere near the starting line."

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Controversial Stem-Cell Company Moves Treatment out of U.S.

Researchers Study Link Between Exercise and Recovery Time in Stem Cell Transplantation

Newswise Researchers at the University of Illinois at Chicago College of Nursing have received a four-year grant to determine whether exercise can shorten recovery time for patients who undergo high-dose chemotherapy and stem cell transplantation.

High-dose chemotherapy followed by marrow or stem cell transplantation can cure blood-borne cancers like lymphoma and leukemia but poses a high risk of severe complications or even death during the first 100 days post-treatment, says Eileen Danaher Hacker, UIC associate professor of biobehavioral health science and lead researcher of the study.

Severe fatigue often accompanies chemotherapy, which can lead patients to decrease their physical activity, Hacker said. She developed an exercise program called Strength Training to Enhance Early Recovery, or STEER, that uses elastic resistance bands to increase muscle mass and functional ability and improve patients' quality of life.

She will recruit about 75 patients being treated by stem cell or marrow transplantation at the University of Illinois Hospital & Health Sciences System for the new study. They will either use the STEER program or participate in a health education program while continuing with their usual rest, activity and exercise.

Patients will exercise three times a week -- once supervised by health care professionals in a clinical setting, and twice at home, Hacker said. They will be assessed three times during the study for amount of physical activity, fatigue, muscle strength, functional ability, quality of life, and frailty.

Strength training, in comparison to other exercises, is most effective at building muscle mass, Hacker said, but few studies have focused on patients undergoing high-dose chemotherapy.

Muscle strength is needed for physical activity and for a body to function properly, she said. Without it, frailty and long-term disability may occur, even though the transplant survivors are cancer-free.

"Strength training is possible during the early recovery period if it is tailored to the individuals capabilities.

Hackers research-scholar grant from the American Cancer Society (RSG-13-054-01 PCSM) is for about $720,000 over four years.

UIC ranks among the nation's leading research universities and is Chicago's largest university with 27,000 students, 12,000 faculty and staff, 15 colleges and the state's major public medical center. A hallmark of the campus is the Great Cities Commitment, through which UIC faculty, students and staff engage with community, corporate, foundation and government partners in hundreds of programs to improve the quality of life in metropolitan areas around the world.For more information about UIC, please visit http://www.uic.edu.

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Researchers Study Link Between Exercise and Recovery Time in Stem Cell Transplantation

Lichen Sclerosus (LS) Patients Find Immediate Relief with Dr. Nathan Newman’s Stem Cell Lift®

BEVERLY HILLS, Calif.--(BUSINESS WIRE)--

Nathan Newman, MD, Board Certified Dermatologist, Cosmetic Surgeon and innovator of the Stem Cell Lift, is on the cutting-edge of the revolutionary advancements in stem cell therapy. He is providing an array of new, safe and effective treatment options for many conditions, such as Lichen Sclerosus et atrophicus (LS). LS is an auto immune skin disease that attacks male and female genital area, and usually causes severe pain, burning and itching to the vagina and male genitals. Until the application of the Stem Cell Lift, there has been no known effective treatment, which would provide any long term relief to the debilitating symptoms of LS. http://www.stem-cell-lift.com

The Stem Cell Lift is showing promising results in often providing immediate relief to patients suffering from LS. Dr. Newmans proprietary Stem Cell Lift delivers an enhanced amount of stem cells found in the patients own fat to the affected areas. The stem cells have the ability to reduce inflammation, improve circulation, and repair damaged cells and tissue, thereby providing almost immediate relief to this devastating condition.

Many women who have LS cant, or are afraid to have intercourse, as it is often too painful. Paula, a 34-year old female LS patient, endured 7 years of unending suffering and countless visits to numerous specialists. They merely prescribed her topical treatments that only gave her temporary relief from her devastating symptoms. Then she met Dr. Newman and had the Stem Cell Lift. Thrilled with the immediate, positive results, Paula remarks, The constant, intense, sensitive burning that I had had every single day for a year or more, was gone the very next morning. It was gone and its never come back.

While prevalent in women of all ages, LS appears more prominently in post-menopausal women (1 in 30), as well as men and some children. The disease is often misdiagnosed, enabling the symptoms to progress and worsen, often for many years. Even with a correct diagnosis, to date medical treatments for LS have been limited to strong corticosticosteroid ointments, which merely provide temporary relief of the itching and discomfort similar to a chronic yeast infection.

The Stem Cell Lift offers new hope for relief, often immediate, from the painful symptoms of this condition. LS patients from around the world are seeking out Dr. Newman and his Stem Cell Lift procedure because, after years of suffering, they are feeling free of the pain and discomfort of LS by using their own bodies' stem cells. The stem cells may also help stop the progression of the disease through their ability to inhibit the bodys immune system from attacking itself.

Patients treated with the Stem Cell Lift confirm that they experience fewer flare ups, which are shorter in duration. Post-Stem Cell Lift, most patients are able to discontinue the use of topical steroids and hormones and may be able to resume intimacy.

States Dr. Newman, "I hope to raise public awareness of this debilitating disease and inform patients that with the advent of the Stem Cell Lift, new treatment options are now available to LS patients."

For more information regarding Dr. Nathan Newman, The Stem Cell Lift and treatment for LS, please visit http://www.stem-cell-lift.com and his blog at http://newmansbeautyspot.blogspot.com/ or call 310-273-3344.

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Lichen Sclerosus (LS) Patients Find Immediate Relief with Dr. Nathan Newman’s Stem Cell Lift®

1 Millionth Blood Stem Cell Transplant Marks Major Medical Milestone

BERN, Switzerland, Jan. 30, 2013 (GLOBE NEWSWIRE) -- The collaborative work of medical scientists and physicians across the globe has resulted in a major medical milestone: the world's 1 millionth blood stem cell transplant, a procedure that has become a proven and essential therapy for many patients battling blood cancers like leukemia and lymphoma, as well as other critical diseases.

The Worldwide Network for Blood and Marrow Transplantation (WBMT) announced the landmark achievement today. The WBMT--a nonprofit scientific organization whose mission is promoting excellence in stem cell transplantation, stem cell donation and cellular therapy--said the 1 millionth transplant occurred in late December 2012. The finding is based on data collected by WBMT international member organizations involved in blood stem cell transplantation, which were analyzed and verified by the WBMT.

"One million transplants is a milestone that may surprise many people, because blood stem cell transplants were viewed as a rare procedure until the last decade or so," said Dietger Niederwieser, M.D., president of the WBMT and professor of medicine in the division of hematology and medical oncology at the University Hospital of Leipzig, Germany. "But important discoveries--and the vital cooperation of many scientists and physicians around the world--have dramatically improved outcomes for patients who undergo stem cell transplantation."

The first blood stem cell transplant was reported by Dr. E. Donnall Thomas in 1957, who received the Nobel Prize in 1990 for pioneering the use of this innovative approach to treatment of leukemia and other life-threatening diseases.

By the late 1960s, as knowledge of the requirements for matching patients with donors evolved, physicians were performing successful allogeneic transplants, using blood-forming stem cells from sibling donors (among the first in U.S., Holland and France). In 1973, the first successful transplant between two unrelated people occurred in New York, when a young boy received a transplant from a donor identified as a match through a blood bank in Denmark. In 1988, the first successful umbilical cord blood transplant was performed in Paris.

Since then, a near-exponential rise in all types of blood stem cell transplants, particularly from unrelated donors, has occurred. This is largely thanks to the willingness of now more than 20 million voluntary stem cell donors worldwide. Today, unrelated transplants are often as successful as those that use family donors.

International partners will help make this continued growth possible. Already, data from the World Marrow Donor Association (WMDA), a WBMT partner, show that nearly half of the transplants performed with unrelated donors cross an international border. International donor registries not only expand the pool of potential donors, they help advance the global science of transplantation through the exchange of information.

Founding partners of the WBMT include the Center for International Blood and Marrow Transplant Research(R) (CIBMTR), the Asia-Pacific Blood and Marrow Transplantation Group (APBMT), the European Group for Blood and Marrow Transplantation (EBMT) and the WMDA. Other regional and national organizations that participate and contribute data include the Australasian Bone Marrow Transplant Recipient Registry (ABMTRR), the Canadian Blood and Marrow Transplant Group (CBMTG), the Eastern Mediterranean Blood and Marrow Transplant Group (EMBMT) and the Sociedade Brasileira de Transplante de Medula Ossea (SBTMO), among others.

"It must be especially emphasized that WBMT has contributed to the advances of blood stem cell transplants in emerging countries in the Asia-Pacific region and in the other areas of the world, where the awareness to this medical procedure is sharply increasing," said Yoshihisa Kodera, vice president of WBMT, chairman of APBMT and professor of Aichi Medical University, Japan.

The World Health Organization (WHO) has recognized transplantation as an important global task, recently recognizing the WBMT as a non-governmental organization (NGO). "Transplantation has extended the lifespan of hundreds of thousands of patients worldwide and enhanced their quality of life," said Luc Noel, M.D., of WHO. "It has become the standard of care for many patients, and should no longer be restricted to affluent countries or individuals."

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1 Millionth Blood Stem Cell Transplant Marks Major Medical Milestone

Controversial stem-cell company moves treatment out of the United States

Celltex had hoped to culture and bank cells with its partner RNL Bio, before the two became embroiled in legal action.

Tyler Rudick

US citizens who want to have stem-cell treatments without travelling overseas may soon be able to get them south of the border. Celltex Therapeutics of Houston, Texas, ceased treating patients in the United States last year following a warning from regulators. A 25 January e-mail to Celltex customers indicates that the firm will now follow in the footsteps of many other companies offering unproven stem-cell therapies and send its patients abroad for treatment but no farther than Mexico.

Celltex had been offering stem-cell treatments for more than a year starting with Texas Governor Rick Perry in July 2011 when the US Food and Drug Administration (FDA) wrote to the company on 24 September advising it that the stem cells it harvested and grew from customers were more than minimally manipulated during Celltex's procedures. As such, the FDA regarded the cells as drugs, which would require the agency's approval to be used in treatments. The FDA also warned that Celltex had failed to address problems in its cell processing that the inspectors from the agency had identified in an April 2012 inspection of its cell bank in Sugar Land, Texas. Shortly after the letter, Celltex stopped injecting stem cells into patients.

For customers who still had cells banked at Celltex and were wondering how to get them out, things became more chaotic when Celltex and RNL Bio, a company based in Seoul, which operated the processing centre and bank, sued each other. Celltex had to issue a restraining order just to access the cells.

The January e-mail from Celltex reassures customers that their cells are safely stored in a facility in Houston and adds, We anticipate that we will be able to offer our stem cell therapy services to physicians in Mexico starting very soon! The e-mail adds that the company is constructing a new laboratory, to be opened in March.

Celltex also says it will carry out an FDA-approved clinical trial, to start shortly after a March meeting with the FDA. However, the company had said in a 25 October e-mail to patients that it would start such a trial within two months and that patient enrolment could begin as early as 30 days after that.

University of Minnesota bioethicist Leigh Turner says the move to Mexico is "not surprising", given the companys difficulties in the United States.

As Celltex's stem culturing and banking technology was licensed from RNL Bio, it's also not clear whether on its own it will still have the expertise needed to launch a clinical trial, says Turner. "It would have to build a stem-cell company from the ground floor up. I wouldnt say they are anywhere near the starting line."

Celltex did not respond to questions about how it would ship stem cells to Mexico or how it would perform the clinical research needed to seek FDA approval.

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Controversial stem-cell company moves treatment out of the United States

Stem cell transplant for sickle cell patients

A possible cure for a debilitating disease. It strikes one in 500 African Americans. Many live day-to-day on heavy painkillers. Now a new take on an old treatment may put an end to their suffering.

Dr. Damiano Rondelli, University of Illinois Hospital Hematologist: Its a social issue. Its not just a medical issue. The cost, the family involvement its a really big deal.

It is sickle cell anemia, an inherited defect of the red blood cells. More rigid than normal round cells, the crescent or sickle-shaped cells get stuck in small vessels, blocked from delivering oxygen to organs, tissues and joints.

Dr. Rondelli: Damage to lungs, kidneys, liver. The major symptom is pain.

Beverly Means, mother: His hand and feet had swollen up, and I took him to the hospital and they were telling me he had sickle cell. Never heard of it in my life.

But it was a disease that would take over Beverly Means life and the lives of two of her sons, Julius and Desmond.

Julius Means, sickle cell patient: Some of my first memories having sickle cell, playing one day and the next day not being able to even walk.

Diagnosed at eight-months-old, Julius has struggled with sickle cell disease for 25 years.

Julius Means: In and out of hospitals all the time. The majority of the pain would hit me in my legs and my back. So being a young kid and not being able to play with the other kids was pretty awful.

Beverly Means, mother: It was mental torture. It was hard. Devastating to watch your kids and you can do nothing.

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Stem cell transplant for sickle cell patients

New Hope for Type I Diabetes Patients

Seattle, Washington (PRWEB) January 29, 2013

Patients report success with stem cell treatment for diabetics. Traveling4Health&Retirement (THR) announces their choice of a stem cell surgeon sponsor in Buenos Aires, a popular South America destination location for overseas retirement and medical travel.

We are pleased to promote Dr. Alejandro Mesples as our medical services sponsor in Buenos Aires, said Ilene Little, CEO of Traveling4Health&Retirement.

Dr. Mesples has published several papers in medical journals on the results of his research and therapy and is widely known and accepted as the authority on stem cell based surgery for diabetes using the patients own stem cells.

Recent results of his ongoing research were published 1/22/13 in the latest issue (Vol.3 No.1,2013) of the SCD medical journal, paper ID 1080044.

The sponsor selection was based on patient-generated reviews, interviews with the company leadership, and the strong support for the potential of the therapy and associated research as expressed in letters received from professors at the University of Padua in Italy and a professor of Endocrinology at Johns Hopkins.

When patients rave about their medical outcomes and a providers customer service, that gets our attention, said Ilene Little, We only promote doctors and accept destination sponsorships from doctors whose patients and professional peers recommend their services.

Download and listen, for free, to the father of a nine year old girl describing her stem cell treatment by Dr. Mesples on the 1/15/13 Know Before You Go Show aired on the Overseas Radio Network.

Lara was 8 years old and had a diagnosis of type 1 (or juvenile) diabetes newly diagnosed (one month prior to my prescribing her treatment plan), said Dr. Mesples, In September, 2011, we performed a liver implant of bone marrow stem cells in order to stop the autoimmune attack to the pancreas.

Normally this type of diabetes is secondary to antibody-mediated destruction and its evolution is marked by the increase of antibodies levels, low c peptide (low pancreatic function), and early use of insulin in high doses.

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New Hope for Type I Diabetes Patients

TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid

Regulated information january 29, 2013

TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid

Leuven (BELGIUM), Madrid (SPAIN) - January 29, 2013 - TiGenix (Euronext Brussels: TIG), a leader in the field of cell therapy, announced today that further to the cGMP inspection by the Spanish health authorities it has successfully renewed its manufacturing authorization for stem cell products at its manufacturing facility in Madrid, Spain.

"The GMP facility in Madrid performs a vital function within our organization by manufacturing high-quality, clinical grade allogeneic stem cell products to fuel our key clinical programs," said Wilfried Dalemans, CTO of TiGenix. "It is an important stepping stone before we can move to commercial manufacturing at our state-of-the-art, central GMP manufacturing site in Sittard-Geleen, the Netherlands. Our strong cell therapy manufacturing capabilities place us at the forefront of the cell therapy industry."

For more information: Eduardo Bravo Claudia D`Augusta Chief Executive Officer Chief Financial Officer eduardo.bravo@tigenix.com claudia.daugusta@tigenix.com Hans Herklots hans.herklots@tigenix.com +32 16 39 79 73

About TiGenix

TiGenix NV (Euronext Brussels: TIG)is a leading European cell therapy companywith a marketed product for cartilage repair, ChondroCelect, and a strongpipeline with clinical stage allogeneic adult stem cell programsfor the treatment ofautoimmune and inflammatory diseases.TiGenixis based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (theNetherlands). For more information please visitwww.tigenix.com.

Forward-looking information

This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix` control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix` expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

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TiGenix successfully renews GMP license for stem cell manufacturing facility in Madrid