StemCell Therapy

SAN DIEGO, June 15, 2012 /PRNewswire/ --ViaCyte, Inc. today announced the appointment of seasoned entrepreneur, Paul Laikind, Ph.D., as President & Chief Executive Officer. Allan Robins, Ph.D., who was serving as Acting CEO, will continue in his role as Vice President & Chief Technology Officer. ViaCyte is a leading pre-clinical company developing a novel cell therapy product for the treatment of insulin dependent diabetes.

Dr. Laikind brings over 25 years of leadership experience in the biotechnology and life sciences industry to ViaCyte. He is a serial entrepreneur, who co-founded three San Diego companies, Gensia Pharmaceuticals Inc., Viagene Inc., and Metabasis Therapeutics Inc., serving in various executive positions including President and CEO. All three companies went public and were eventually acquired. Most recently, he served as Chief Business Officer and Senior Vice President of Business Development at the Sanford-Burnham Medical Research Institute.

"Paul brings to ViaCyte a wealth of experience in managing new businesses based on highly innovative life sciences technologies," said Fred Middleton, Chairman of ViaCyte. "We are pleased to have him join to lead ViaCyte through our next phase of development in bringing our transformative stem cell therapy to patients with diabetes. We believe Paul's leadership and business development skills will greatly assist us in our strategy to be a leader in regenerative medicine therapy and to capitalize on our current technology leadership position in the development of stem cell therapy."

As Sanford-Burnham's first Chief Business Officer, Dr. Laikind set a new direction for the Institute's business development activity through a combination of licensing and strategic partnerships with large pharmaceutical organizations, including collaborations with Pfizer's Centers for Therapeutic Innovation, Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, and Takeda Pharmaceutical. Working with the Institute's leadership team he helped establish a sophisticated infrastructure for advanced drug discovery and development at Sanford-Burnham.

Prior to Sanford-Burnham, Dr. Laikind served as President & CEO from 1999-2008 for Metabasis Therapeutics, which developed new therapies for metabolic and liver diseases. Dr. Laikind co-founded Gensia Pharmaceuticals in 1986, was a board member of the company and held various executive leadership positions. While at Gensia he was responsible for establishing a number of important strategic partnerships. In 1997, he was part of a team that restructured Gensia to focus on specialty pharmaceuticals. The restructured company was renamed Gensia Sicor and went on to be acquired for over $3 billion by Teva Pharmaceutical Industries in 2004. Soon after founding Gensia, he was co-founder of Viagene, a gene therapy company. Viagene completed an initial public offering in 1993 and was acquired in 1995 by Chiron Inc., now a subsidiary of Novartis Vaccines & Diagnostics.

Dr. Laikind earned his Ph.D. in biochemistry from the University of California, San Diego and is the inventor on a number of key patents.

"ViaCyte addresses one of the largest commercial and medical opportunities in stem-cell-derived therapeutics, and its team is internationally recognized for its scientific leadership," said Dr. Laikind. "I look forward to working with ViaCyte through clinical development and market launch of its first important product that promises to change the way we treat insulin dependent diabetes."

About ViaCyte

ViaCyte is a preclinical cell therapy company focused on diabetes. The Company's technology is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.

ViaCyte is a private company headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine.

Originally posted here:
ViaCyte Appoints Dr. Paul Laikind Chief Executive Officer

CARLSBAD, Calif.--(BUSINESS WIRE) --

International Stem Cell Corporation (OTCBB: ISCO) http://www.internationalstemcell.com announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs." TTFs are designed to pass into stem cells and direct the stem cells to change into specific cell types that can be both therapeutically-useful and can be used as revenue-generating research products.

In contrast to more traditional cell therapy methods this technology does not require the use of viruses or chemicals, and has the potential to produce safe therapeutic cells from stem cells. In addition, the TTF proteins are naturally eliminated by the cells when no longer required, a characteristic that further improves safety. The Company intends that this technology, once perfected, will first be used to create revenue-generating research products for sale through Lifeline Cell Technologys international distribution channels to the academic, biotechnology and pharmaceutical markets for cellular proteins, including the quickly growing markets for the study of stem cell biology and drug testing.

According to Jeffrey Janus, Lifeline Cell Technologys CEO, These proteins can be sold into the market for cellular proteins which exceeds $700 million and represents an excellent opportunity for LCT to grow sales. Since the technology also has broad application in research and therapy, it should provide ISCO with future out-licensing opportunities to the biotechnology and pharmaceutical industries.

About International Stem Cell Corporation International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

Forward-looking Statements Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

Copyright 2012 Business Wire.

Continued here:
International Stem Cell Corporation Scientists Create New Protein-Based Stem Cell Technology

SAN DIEGO, June 15, 2012 /PRNewswire/ --ViaCyte, Inc. today announced the appointment of seasoned entrepreneur, Paul Laikind, Ph.D., as President & Chief Executive Officer. Allan Robins, Ph.D., who was serving as Acting CEO, will continue in his role as Vice President & Chief Technology Officer. ViaCyte is a leading pre-clinical company developing a novel cell therapy product for the treatment of insulin dependent diabetes.

Dr. Laikind brings over 25 years of leadership experience in the biotechnology and life sciences industry to ViaCyte. He is a serial entrepreneur, who co-founded three San Diego companies, Gensia Pharmaceuticals Inc., Viagene Inc., and Metabasis Therapeutics Inc., serving in various executive positions including President and CEO. All three companies went public and were eventually acquired. Most recently, he served as Chief Business Officer and Senior Vice President of Business Development at the Sanford-Burnham Medical Research Institute.

"Paul brings to ViaCyte a wealth of experience in managing new businesses based on highly innovative life sciences technologies," said Fred Middleton, Chairman of ViaCyte. "We are pleased to have him join to lead ViaCyte through our next phase of development in bringing our transformative stem cell therapy to patients with diabetes. We believe Paul's leadership and business development skills will greatly assist us in our strategy to be a leader in regenerative medicine therapy and to capitalize on our current technology leadership position in the development of stem cell therapy."

As Sanford-Burnham's first Chief Business Officer, Dr. Laikind set a new direction for the Institute's business development activity through a combination of licensing and strategic partnerships with large pharmaceutical organizations, including collaborations with Pfizer's Centers for Therapeutic Innovation, Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, and Takeda Pharmaceutical. Working with the Institute's leadership team he helped establish a sophisticated infrastructure for advanced drug discovery and development at Sanford-Burnham.

Prior to Sanford-Burnham, Dr. Laikind served as President & CEO from 1999-2008 for Metabasis Therapeutics, which developed new therapies for metabolic and liver diseases. Dr. Laikind co-founded Gensia Pharmaceuticals in 1986, was a board member of the company and held various executive leadership positions. While at Gensia he was responsible for establishing a number of important strategic partnerships. In 1997, he was part of a team that restructured Gensia to focus on specialty pharmaceuticals. The restructured company was renamed Gensia Sicor and went on to be acquired for over $3 billion by Teva Pharmaceutical Industries in 2004. Soon after founding Gensia, he was co-founder of Viagene, a gene therapy company. Viagene completed an initial public offering in 1993 and was acquired in 1995 by Chiron Inc., now a subsidiary of Novartis Vaccines & Diagnostics.

Dr. Laikind earned his Ph.D. in biochemistry from the University of California, San Diego and is the inventor on a number of key patents.

"ViaCyte addresses one of the largest commercial and medical opportunities in stem-cell-derived therapeutics, and its team is internationally recognized for its scientific leadership," said Dr. Laikind. "I look forward to working with ViaCyte through clinical development and market launch of its first important product that promises to change the way we treat insulin dependent diabetes."

About ViaCyte

ViaCyte is a preclinical cell therapy company focused on diabetes. The Company's technology is based on pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.

ViaCyte is a private company headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine.

More here:
ViaCyte Appoints Dr. Paul Laikind Chief Executive Officer

Diabetes currently afflicts approximately 285 million people worldwide, about 6.4 percent of the global population. The World Health Organization projects that this number is set to rise to 366 million by the year 2030.

According to the American Diabetes Association, 1.9 million new cases of diabetes are diagnosed in people aged 20 years and older in 2010, an estimated 7.0 million Americans have undiagnosed diabetes, and another 79 million have pre-diabetes. In addition, approximately 25.8 million children and adults in the United States-8.3% of the population-have diabetes.

Several kinds of treatment for diabetes are currently available, but all of them present specific drawbacks to the patient. For example, insulin therapy can trigger everything from weight gain to hypoglycemia, and its administration must be constantly controlled and monitored by the patient. A novel approach to this problem is currently being pursued by a small biotech company named Orgenesis, which initiated its approach by asking the following question: What if a diabetes patient`s own cells-extracted from his or her own mature tissue-could be made to produce insulin, secreting the compound automatically when needed? This particular variety of cell therapy is a form of what has been dubbed "autologous cell replacement."

For years, the concept of harvesting stem cells and re-implanting them into one`s own body to regenerate organs and tissues has been embraced and researched in animal models. The treatment being developed by Orgenesis consists of several steps. First, a standard liver biopsy is taken from a diabetes patient in a clinical center and sent to a laboratory. In the lab, the liver cells are first propagated in vitro. Some of these cells are then manipulated with a therapeutic agent (i.e., the "master regulator" PDX-1 that governs pancreas development, or additional pancreatic transcription factors in adenovirus-vector) that converts a subpopulation of liver cells into different cells with pancreatic islet phenotype and function.

The therapeutic agent triggers a cascade of events, converting the cells into "autologous insulin-producing" (AIP) cells. These cells now act similarly to the beta cells that produce insulin in the pancreas of healthy individuals. Insulin is not only produced, but also stored and secreted in a glucose-regulated manner.

Back at the clinical center, the newly formed AIP cells are then transplanted in a standard infusion procedure back to the patient`s liver where they secrete insulin. Since the initial liver cells were taken from the patient himself or herself, there is no chance of rejection. Orgenesis has successfully tested its technology in mice, rats and pigs, and is working toward initiating clinical trials in humans.

The surprising capacity to activate pancreatic lineage in the liver was first demonstrated in mice by systemic PDX-1 administration using recombinant adenovirus gene delivery. PDX-1 plays a dual and central role in regulating both pancreas organogenesis in embryo and beta cell function in adults. The capacity of PDX-1 to direct pancreas development has been demonstrated in mature fully differentiated liver in vivo, both in mice and in Xenopus, possibly via a process called trans-differentiation. This describes an irreversible switch of one type of differentiated cell into another differentiated cell. AIP therapy seems to be safer than other options, as it does not alter the host genome but only alters the set of expressed genetic information that seems to be highly specific to the reprogramming protocol. In addition, no human organ donations or embryo-derived cells are required.

This form of therapy, if proven to be workable in clinical trials, would provide several advantages over other insulin-dependent diabetes therapies currently being studied. First, it frees the patient from daily involvement in the monitoring of blood glucose levels, numerous insulin injections and watching food intake and exercise. Indeed, the body itself is now continuously controlling blood glucose levels. In addition to avoiding the chance of autoimmune rejection, the procedure is only minimally invasive.

In summary, the use of adult human liver cells for generating functional insulin-producing tissue may pave the way to autologous implantations, thus allowing the diabetic patient to be the donor of his or her own insulin-producing tissue.

- - - - - - - -

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Orgenesis' Sarah Ferber, Ph.D on Using a Diabetes Patient's Own Liver Cells as a Novel Source of Insulin

ScienceDaily (June 14, 2012) Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Health's registry, making the cells available for federally-funded research.

U-M now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntington's disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at U-M and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three U-M stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at U-M's Center for Reproductive Medicine, others from as far away as Portland, OR. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of U-M-derived stem cell lines accepted to the NIH registry includes:

"Our last three years of work have really begun to pay off, paving the way for scientists worldwide to make novel discoveries that will benefit human health in the near future," says Gary Smith, Ph.D., who derived the lines and also is co-director of the U-M Consortium for Stem Cell Therapies, part of the A. Alfred Taubman Medical Research Institute.

"Each cell line accepted to the registry demonstrates our attention to details of proper oversight, consenting, and following of NIH guidelines," says Sue O'Shea, Ph.D., professor of Cell and Developmental Biology at the U-M Medical School, and co-director of the Consortium for Stem Cell Therapies.

U-M is one of only three academic institutions to have disease-specific stem cell lines listed in the national registry, says Smith, who is a professor in the Department of Obstetrics and Gynecology at the University of Michigan Medical School. The first line, a genetically normal one, was accepted to the registry in February.

See the original post here:
Six new stem cell lines now publicly available

The graft was accepted by the girl's immune system as it was built from her own cells

By Claire Bates

PUBLISHED: 10:24 EST, 14 June 2012 | UPDATED: 10:35 EST, 14 June 2012

The pioneering technique successfully restored the girl's blood flow

A 10-year-old girl has been given a vein transplant using a blood vessel grown from her own stem cells.

It is the first time such an operation has been undertaken, marking a milestone in tissue engineering.

Similar techniques may in future offer hope for at-risk patients undergoing bypass surgery.

The girl had a blocked hepatic portal vein, which drains blood from the gut and spleen to the liver.

Without treatment, the condition can lead to serious complications including internal bleeding, spleen enlargement and even death.

Traditionally bypass surgery has been used to restore portal blood flow, using sections of vein taken from other parts of the body. This can cause other problems and is not always successful.

Read more:
Girl, 10, has vein transplant using a blood vessel grown from her own stem cells

ANN ARBOR Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the National Institutes of Healths registry, making the cells available for federally funded research.

UM now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntingtons disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at UM and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three UM stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at UMs Center for Reproductive Medicine, others from as far away as Portland, Ore. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of UM-derived stem cell lines accepted to the NIH registry includes:

UM9-1PGD Hemophilia B

UM17-1PGD Huntingtons disease

UM38-2PGD- HypertrophicCardiomyopathy (MYBPC3)

Excerpt from:
Six New UM Stem Cell Lines Now Publicly Available

Six new U-M stem cell lines now publicly available to help researchers find treatments for disease

Lines in US registry will help studies on Huntingtons disease, hemophilia & more

Newswise ANN ARBOR, Mich. Six new human embryonic stem cell lines derived at the University of Michigan have just been placed on the U.S. National Institutes of Healths registry, making the cells available for federally-funded research.

U-M now has a total of eight cell lines on the registry, including five that carry genetic mutations for serious diseases such as the severe bleeding disorder hemophilia B, the fatal brain disorder Huntingtons disease and the heart condition called hypertrophic cardiomyopathy, which causes sudden death in athletes and others.

Researchers at U-M and around the country can now begin using the stem cell lines to study the origins of these diseases and potential treatments. Two of the cell lines are believed to be the first in the world bearing that particular disease gene.

The three U-M stem cell lines now in the registry that do not carry disease genes are also useful for general studies and as comparisons for stem cells with disease genes. In all, there are 163 stem cell lines in the federal registry, most of them without major disease genes.

Each of the lines was derived from a cluster of about 30 cells removed from a donated five-day-old embryo roughly the size of the period at the end of this sentence. The embryos carrying disease genes were created for reproductive purposes, tested and found to be affected with a genetic disorder, deemed not suitable for implantation and would have otherwise been discarded if not donated by the couples who donated them.

Some came from couples having fertility treatment at U-Ms Center for Reproductive Medicine, others from as far away as Portland, OR. Some were never frozen, which may mean that the stem cells will have unique characteristics and utilities.

The full list of U-M-derived stem cell lines accepted to the NIH registry includes:

UM9-1PGD Hemophilia B UM17-1 PGD Huntingtons disease UM38-2 PGD - Hypertrophic Cardiomyopathy (MYBPC3) UM15-4 PGD - Hydroxysteroid Dehydrogenase 4 Deficiency, a rare hormone disorder UM11-1PGD - Charcot-Marie-Tooth disease Type 1A UM4-6 no disease gene UM14-1 no disease gene UM14-2 no disease gene

Read more from the original source:
Six New U-M Stem Cell Lines Now Publicly Available

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

Continued here:
Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for ...

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (ISCO) http://www.internationalstemcell.com announced that scientists in its wholly-owned subsidiary, Lifeline Cell Technology (LCT), have developed a technology to modify human stem cells by using engineered proteins, called "transducible transcription factors" or "TTFs." TTFs are designed to pass into stem cells and direct the stem cells to change into specific cell types that can be both therapeutically-useful and can be used as revenue-generating research products.

In contrast to more traditional cell therapy methods this technology does not require the use of viruses or chemicals, and has the potential to produce safe therapeutic cells from stem cells. In addition, the TTF proteins are naturally eliminated by the cells when no longer required, a characteristic that further improves safety. The Company intends that this technology, once perfected, will first be used to create revenue-generating research products for sale through Lifeline Cell Technologys international distribution channels to the academic, biotechnology and pharmaceutical markets for cellular proteins, including the quickly growing markets for the study of stem cell biology and drug testing.

According to Jeffrey Janus, Lifeline Cell Technologys CEO, These proteins can be sold into the market for cellular proteins which exceeds $700 million and represents an excellent opportunity for LCT to grow sales. Since the technology also has broad application in research and therapy, it should provide ISCO with future out-licensing opportunities to the biotechnology and pharmaceutical industries.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

The rest is here:
International Stem Cell Corporation Scientists Create New Protein-Based Stem Cell Technology

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), announced today it has received consent from New Zealand to market its first-in-class stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. With this decision New Zealand joins Canada, which last month became the worlds first internationally recognized regulatory authority to grant approval to a stem cell drug. Prochymal is also the first therapy approved for GvHD - a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. I would like to thank the professionals at Medsafe for their thoughtful and expeditious review of this complex application. I would also like to thank the team at Osiris that continues to do an outstanding job of making Prochymal available to children around the world suffering from the devastating effects of GvHD."

Osiris submitted a New Medicine Application (NMA) to Medsafe(New Zealand's medical regulatory agency) in May of 2011, and was granted Priority Review in June of 2011. Priority review provides expedited review for new drugs which offer a significant clinical advantage over current treatment options. Prochymal was granted provisional consent under Section 23 of the Medicines Act 1981.

"The incidence of GvHD is likely to rise as the demographic profile of our transplant population evolves," said Hans Klingemann, M.D., Ph.D., a Professor of Medicine and the Director of the Bone Marrow & Hematopoietic Stem Cell Transplant Program at Tufts University School of Medicine. "Effective strategies to manage the often lethal consequences of GvHD reduce the overall risk to transplantation and provide the transplant physician with better options when approaching their most difficult cases.

Clinical trials have shown that Prochymal is able to induce an objective, clinically meaningful response in 61-64 percent of children with GvHD that is otherwise refractory to treatment. Furthermore, treatment response with Prochymal resulted in a statistically significant improvement in survival.

As a mother who watched my son Christian suffer and die from the horrifying effects of GvHD, while waiting for the regulatory approvals necessary to allow him access to Prochymal, words cannot express how happy I am that significant progress is finally being made, said Sandy Barker, President and Co-founder of the Gold Rush Cure Foundation. We are proud to stand side-by-side with Osiris in this historic battle for our children around the world. Our motto is 'not one more child, not one more family' and when it comes to GvHD mortality, zero is the only acceptable number.

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). It is expected that Prochymal will be commercially available in New Zealand later this year.

About GvHD

GvHD represents a major unmet medical need with no approved treatment until Prochymal. GvHD is the leading cause of transplant related mortality, in which immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Severe GvHD can cause blistering of the skin, intestinal hemorrhage and liver failure. Severe GvHD is extremely painful and fatal in up to 80 percent of cases. Currently, steroids are used as first-line therapy with a success rate of only 30-50 percent. When steroids fail, treatment options are limited to immunosuppressive agents used off-label with little benefit and significant toxicities.

Excerpt from:
Osiris Receives Second Approval for Life-Saving Stem Cell Drug; Prochymal Granted Marketing Consent by New Zealand

Doctors in Sweden have replaced a vital blocked blood vessel in a 10-year-old girl using the first vein grown in a lab from a patient's own stem cells.

Don't miss these Health stories

A CPAP device, the Darth Vader-like mask used to ease breathing in sleep apnea sufferers, might be the least attractive thing a man can wear at night, but it could wind up improving his sex life, according to a new study released today at an annual meeting of sleep experts.

The successful transplant operation, reported online in The Lancet medical journal on Thursday, marks a further advance in the search for ways to make new body parts.

It could open the door to stem cell-based grafts for heart bypass and dialysis patients who lack suitable blood vessels for replacement surgery, and the Swedish team said it is now working with an undisclosed company to commercialize the process.

"I'm very optimistic that in the near future we will be able to get both arteries and veins transplanted on a large scale," said Suchitra Sumitran-Holgersson, professor of transplantation biology at the University of Gothenburg, and a member of the team that performed the operation in March 2011.

The advantage of using tissue grown from a patient's own cells is that there is no risk of organ rejection and hence no need for lifelong immunosuppressive drugs.

Four years ago, a 30-year-old woman received the world's first transplant of a tailor-made windpipe, grown in a similar way by seeding a stripped-down donor organ with her own stem cells. Other such trachea operations have followed since.

The latest case involved a young girl with an obstructed hepatic portal vein, which drains blood from the intestines and spleen to the liver. Its blockage can be fatal.

The team from the University of Gothenburg took a 9 cm (3.5 inch) section of groin vein from a deceased donor and removed all the living cells, leaving just a protein scaffold tube. Stem cells extracted from the girl's bone marrow were then injected onto the tube and two weeks later the graft was implanted.

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Vein grown from stem cells saves girl

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced updated survival data from a pivotal Phase II clinical trial of single-agent brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of the majority of types of HL.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and suggest that brentuximab vedotin may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of brentuximab vedotin every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of brentuximab vedotin while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Brentuximab vedotin is not approved for use outside the United States. The marketing authorization application for brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency for review in June 2011.

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Millennium Highlights Updated Survival Data from ADCETRIS® (Brentuximab Vedotin) Pivotal Trial in Patients with ...

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Cell Therapeutics Appoints New Chief Medical Officer

Cryo-Save Group N.V. (Euronext: CRYO, `Cryo-Save`, or `the Group`), the leading international stem cell storage company and the largest family stem cell bank in Europe, announced today that it did not get the permission to process and store stem cells in France along with an update on the cost savings program.

In addition to the cessation of the Cryo-Lip activities in the US and the cutback of the Cryo-Lip activities in Europe as previously disclosed in the first quarter trading update, the Group decided to dismantle its French operations. After more than 3 years of disputes with the healthcare authorities in France, including several court cases, Cryo-Save recently got confirmed that it will not get the permission from the authorities to collect, process and store stem cells from umbilical cord blood. The decision includes laying-off the French employees, discontinuing the litigations and indemnity procedures and selling off the building in Lyon. Together with some other smaller implemented cost savings, the Group has currently realised sustainable cost savings of at least 2 million per annum. Further cost savings are being considered.

Arnoud van Tulder, Chief Executive Officer, commented:

"We are certainly very disappointed that the French authorities take this negative position, which deviates from all other European countries. Expectant parents in France are now refrained from storing their stem cells from umbilical cord blood and tissue for their family, which is, beside France, allowed across the whole world.

We are truly convinced that the impact of the cost saving measures together with the restoration of the Cryo-Save business, which is well underway, will result in sustainably improved top- and bottom-line results as of the second half of the year."

Enquiries:

Free footage is available on http://www.videobankonline.com.

About Cryo-Save (www.cryo-save.com/group)

Cryo-Save, the leading international family stem cell bank, stores more than 200,000 samples from umbilical cord blood, cord tissue and adipose tissue. There are already many diseases treatable by the use of stem cells, and the number of treatments will only increase. Driven by its international business strategy, Cryo-Save is now represented in over 40 countries on 3 continents, with ultra-modern processing and storage facilities in Belgium, Germany, Dubai, India and South Africa.

The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

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Cryo-Save Group N.V: Further cost savings with closure of France

For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells, another example of scientists producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. Last March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 9-centimetre section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a process that took about two weeks. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

"This is the future for tissue engineering, where we can make tailor-made organs for patients," said Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors.

She and colleagues published the results of their work online Thursday in the British medical journal Lancet. The work was paid for by the Swedish government.

The science is still preliminary and one year after the vein was transplanted, it needed to be replaced with another lab-grown vein when doctors noticed the blood flow had dropped. Experts from University College London raised questions in an accompanying commentary about how cost-effective the procedure might be, citing "acute pressures" on health systems that might make these treatments impractical for many patients.

Sumitran-Holgersson estimated the cost at between $6,000 and $10,000.

Similar methods have already been used to make new windpipes and urethras for patients. Doctors in Poland have also made blood vessels grown from donated skin cells for dialysis patients.

Patients with the girl's condition are usually treated with a vein transplant from their own leg, a donated vein, or a liver transplant. Those options can be complicated in children and using a donated vein or liver also requires taking anti-rejection medicines.

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Vein grown from girl's own stem cells transplanted

June 14, 2012

Brett Smith for redOrbit.com

A successful transplant operation in Sweden points to a medical future where your doctor can grow a transplant organ from your own cells, making organ donation a thing of the past.

Doctors have now successfully transplanted a vein grown with a patients own stem cells without complications or the need for immunosuppressants, according to a report published this week in The Lancet. The patient was a 10-year-old girl in Sweden who was suffering from a potentially fatal blockage in the vein which drains blood from the intestines and spleen to the liver.

Last March, a team of doctors at the University of Gothenburg decided to grow the new blood vessel used to bypass the blocked vein instead of using an invasive neck or leg surgery to extract one of her own.

The young girl in this report was spared the trauma of having veins harvested from the deep neck or leg with the associated risk of lower limb disorders, and avoided the need for a liver or multivisceral transplantation, Martin Birchall and George Hamilton of University College London wrote in The Lancet.

To start the procedure, doctors took a three-inch section of a cadaver groin vein and stripped it of all living cells, leaving only an inert protein structure. The team then injected it with blood-forming stem cells taken from the girls bone marrow. After growing the vein for two weeks in an incubator, the stem cells had multiplied and converted into vein wall cells, to create a biologically-engineered replacement. The new vein was then implanted into the patient a year ago.

The new stem-cells derived graft resulted not only in good blood flow rates and normal laboratory test values but also, in strikingly improved quality of life for the patient, the report said.

In noting the success of the transplant, the doctors reported that the patient grew 2 inches and gained 11 pounds over the following year. In addition, her parents said that she was more physically active, had improved articulated speech, and had concentrated better on her studies.

The only major complication was the slight constriction of the vein nine months after the operation, which was corrected in a follow-up procedure. During the course of following up on the operation, scientists found no antibodies for the donor vein in the girls blood. This meant her body was not rejecting the transplant because it was recognized as being made of her own cells.

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Doctors Use Stem Cells To Grow Vein For Young Patient

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for ...

SARANAC LAKE, N.Y.--(BUSINESS WIRE)--

The Trudeau Institute today announced that faculty member Laura Haynes, Ph.D., was awarded a grant from the National Institutes of Health (NIH) to study how aging impacts the immune systems response to influenza infection and vaccination. Entitled Aging and Immunity to Infections, the award is one of the largest program grants funded this year by the NIHs National Institute on Aging, amounting to more than $9 million over a five-year period. The grant further funds Dr. Haynes breakthrough study regarding age-related decline in immune functionality that was just released online in the scientific journal Aging Cell.

Infectious diseases, such as influenza, lead to increased disease and mortality in the elderly. Annually in the United States, influenza causes 200,000 hospitalizations and 36,000 deaths, 90 percent of which occur in older adults. Additionally, the elderly are more vulnerable to infection because vaccine efficacy is significantly reduced in older populations. While it is well known that the adaptive immune response to influenza infection and immunization declines with aging, the Haynes laboratorys recent studies found that there are additional changes in the immune system that had not been previously appreciated. These newly discovered changes contribute significantly to the age-related decline in immune function.

Earlier research from Dr. Haynes lab has shown that there are age-related declines in the function of immune cells that respond to vaccination. Specifically, immune cells from aged individuals show slower and reduced overall functional responses when compared with cells from younger individuals. They also successfully demonstrated that these changes are intrinsic to the immune cells themselves. That is, even if aged cells are transferred into young hosts, they still exhibit reduced function.

Breakthrough Research in the Immune Response in the Elderly Leads to NIH Grant

Dr. Haynes recent investigation of the factors responsible for the decline in immune response to vaccination in elderly patients has led to a major breakthrough. Their study, led by postdoctoral fellow Julie Lefebvre, was published online on June 11, 2012 in the scientific journal Aging Cell. The study demonstrates that, in addition to intrinsic defects in aged immune cells, there are changes in the aged environment, including secondary lymphoid tissues such as the spleen and lymph nodes. These changes are the result of disorganized expression of molecules that direct immune cell movement. The result is that immune cells in aged individuals are not directed properly, and their response is slower as a result.

This revelation helps explain how aging impacts the immune system and the mechanisms involved. Only when the specific defects are determined can strategies be developed to overcome these defects and develop more effective vaccines for the elderly.

Importantly, this study also demonstrates that one of the main factors responsible for this delay is an age-related change in the molecules that direct the movement of immune cells. Small molecules in the immune system, known as chemokines, are responsible for the proper movement of immune cells during a response to vaccination or infection. Proper movement of the cells is essential for a robust immune response since many immune system cells function via direct cell-to-cell contact with each other. Without this contact, the immune response is much less effective. This is the first time this kind of mechanism has been appreciated in aged individuals.

Future Research Focuses on How Aging Impacts Response to Flu and Infection

With the support of the $9 million multi-year grant from the NIH, the Trudeau research will focus on how aging impacts the immune response to influenza infection and vaccination and then importantly move this research to human trials.

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Trudeau Institute announces $9 Million Translational Research Award

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

Seattle Genetics, Inc. (SGEN) today announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and demonstrate that ADCETRIS may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of ADCETRIS every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of ADCETRIS while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior 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 prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

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Seattle Genetics Highlights Updated Survival Data from ADCETRIS® Pivotal Trial in Patients with Relapsed or Refractory ...