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Research and Markets: Gene Therapy Market to 2018 – Product Development Slowed by Clinical Failures, Close Regulatory …

Posted: July 9, 2012 at 4:12 pm

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/kxltqj/gene_therapy_marke) has announced the addition of the "Gene Therapy Market to 2018 - Product Development Slowed by Clinical Failures, Close Regulatory Surveillance and High Compliance Standards" report to their offering.

Gene Therapy: the Next Big Step in Cancer Treatments.

The fight against cancer is leading a new movement in gene therapy, as the failure of conventional cancer therapies is fuelling demand for new treatments, according to a new report by healthcare experts GBI Research.

The new report* states that gene therapy technology is still in its nascent stage, and high levels of regulatory surveillance in clinical development is affecting progress. However, the increasing potential of upcoming treatments and shortcomings in traditional therapies is gradually leading to broader acceptance of gene therapy in medicine.

Therapies such as chemotherapy and hormone therapy control the progression of diseases, but are often associated with severe side effects, such as nausea, hair loss and abnormal blood cell counts. Once administered, the drugs induce systemic action throughout the body, and patients often die due to the side effects of treatment rather than the cancer itself. The inability of these conventional therapies to cure diseases has created a significant unmet need in the treatment of cancer, as well as Human Immunodeficiency Virus (HIV), autoimmune diseases, and viral infections.

Targeted therapies such as monoclonal antibodies, stem cell therapies, Ribonucliec Acid (RNA) therapies and gene therapies have initially shown better efficacy and safety profiles compared to chemotherapies.

Gene therapy has several promising drug candidates, which are likely to drive the growth of the gene therapy market if clinical trials are successful. Collategene by AnGes MG, Cardium Therapeutics' Generx, and Vical Incorporation's Allovectin-7 are in development for a wide range of cancer indications, and are expected to compete in the oncology therapeutics market as the market acceptance of gene therapy improves over time.

Companies Mentioned

- ReGenX Biosciences

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Needle-Sharing by Sex Workers Tied to Spread of Syphilis

Posted: July 8, 2012 at 3:55 pm

(HealthDay News) -- Needle-sharing among drug abusers may play as big a role as risky sexual behavior in the transmission of syphilis, a new study suggests.

American and Mexican researchers interviewed more than 900 female sex workers in the Mexican border towns of Tijuana and Ciudad Juarez, which are adjacent to San Diego and El Paso, Texas, respectively. The sex workers, who were also tested for HIV and sexually transmitted diseases (STDs), operate legally in the two Mexican towns, which are located on major drug trafficking routes.

The researchers found that female sex workers who didn't have HIV, but tested positive for active syphilis infection, were more likely than those without active syphilis infection to inject drugs, to use illegal drugs before or during sex in the past month, and to have U.S. clients who had higher rates of drug use, including the use of injection drugs. Read more…

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Needle-Sharing by Sex Workers Tied to Spread of Syphilis

Posted: July 8, 2012 at 3:54 pm

(HealthDay News) -- Needle-sharing among drug abusers may play as big a role as risky sexual behavior in the transmission of syphilis, a new study suggests.

American and Mexican researchers interviewed more than 900 female sex workers in the Mexican border towns of Tijuana and Ciudad Juarez, which are adjacent to San Diego and El Paso, Texas, respectively. The sex workers, who were also tested for HIV and sexually transmitted diseases (STDs), operate legally in the two Mexican towns, which are located on major drug trafficking routes.

The researchers found that female sex workers who didn't have HIV, but tested positive for active syphilis infection, were more likely than those without active syphilis infection to inject drugs, to use illegal drugs before or during sex in the past month, and to have U.S. clients who had higher rates of drug use, including the use of injection drugs. Read more…

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Stem cell therapy ‘turns back clock’

Posted: July 7, 2012 at 7:14 am

MANILA, Philippines Stem cell therapy, aside from being a potential cure for a wide range of illnesses, can also make a patient look and feel younger, a stem cell therapist said.

Dr. Ricardo Quiones, a cosmetic surgeon and dermatologist, has trained to conduct stem cell therapy, which he describes as the future of medicine.

Quiones said stem cell therapy has become popular for its ability to regenerate and heal properties of adult stem cells.

As we grow old, our stem cells dramatically decline. When we were children, we had 80 million stem cells. As we reach the age of 40, our stem cells decline to 35 million, he told Mornings@ANC on Friday.

Quiones explained that the procedure is similar to turning back the clock because it can increase a persons stem cells to 100 million.

Ive done two patients from Zamboanga City. I called them up after the procedure and they told me they look younger. They have the stamina, the vigor and they have felt an increase in short-term memory, powers of attention and concentration, he said.

Quiones also said the procedure has the potential to cure diabetes, heart damage, brain damage such as Parkinsons and Alzheimers, osteoarthritis, stroke, baldness and even sports injuries.

3-hour procedure

Quiones said any patient, except those diagnosed with cancer, can undergo the procedure, which he said will only last for about 3 to 4 hours.

After receiving clearance from a physician and passing medical and laboratory tests, anesthesia will be administered to a patient before stem cells are harvested.

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First Study Targeting Colorectal Cancer Stem Cells to Begin

Posted: July 7, 2012 at 6:18 am

SCHAUMBURG, Ill.--(BUSINESS WIRE)--

The Gateway for Cancer ResearchSM (www.demandcurestoday.org) announces an exciting new Gateway-funded phase II study using ADAPT therapy for treatment of metastatic colorectal cancer based on a 2010 AACR presentation by Dr. Lin and his collaborators.

The clinical trial, being led by Dr. Edward Lin, a medical oncologist at the University of Washington, Fred Hutchinson Cancer Research Center and an accomplished researcher and expert in gastrointestinal cancers, is the first to specifically target colon cancer stem cells.

The study will use a unique combination drug therapy of Capecitabine (a chemotherapy drug) and Celecoxib (an FDA approved arthritis medication) to wake up and to kill colon cancer stem cells. The treatment works by activating cancer stem cells that hibernate during chemotherapya chief cause of treatment failureso they can be destroyed. The proper sequence is necessary to consistently kill the dormant cells. The ADAPT concept was proposed by Drs. Lin and Linheng Li, a prominent stem cell biologist.

It is a very powerful drug combination with good preliminary results. Pilot studies have shown significantly increased survival rates compared with conventional therapy. Of 124 treated patients, 40% of those treated with this protocol achieved complete remission or near remission with a median survival of 93.7 months and only 1/3 of the patients had surgical removal of the metastasis. The average length of survival for stage IV colorectal cancer patients on conventional treatment is about 20-24 months and 46 months for complete responders.

A lot of patients we didnt expect to see live, are living and thriving, says Dr. Lin. It also allows a good quality of life for patients. The treatment is offering an immediate benefit to todays cancer patients. 95% of participants are out and about in their daily lives, doing what they need to do without skipping a beat.

Thomas Oberdorf, a 5-year colorectal cancer survivor who benefitted from Dr. Lins treatment protocol is grateful. As a stage IV colorectal cancer patient, I hoped to live another two years to see my daughter through to age 11. Thanks to Dr. Lins treatment protocol, I am healthy and am hoping for another 50 years, said Oberdorf who did not miss a beat as CFO of a large organization during the course of his treatment.

The drug combination allowed a good quality of life for most patients. An independent randomized phase III study also showed that celecoxib reduced capecitabine induced hand foot syndrome that was observed by Dr. Lin.

Tiffany Heigle, a stage IV colon cancer patient when she first met with Dr. Lin, credits him for 10 years of survival and precious time with her family. Because of Dr. Lins new treatment approach, I can enjoy being a mom to my 18-year-old freshman in college and my 15-year-old freshman in high school, says Heigle. I have been allowed to see them grow up due to this research.

Colorectal cancer is the number 3 killer and an estimated 1.2 million people around the globe have the disease. More than 70,000 deaths per year in the US alone are attributed to colorectal cancer and for patients with stage IV disease; five year survival is under 10% with current treatments. Surgery remains the only treatment that yielded long term survival and this may be changed by the current study.

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Key proteins to aid self-renewing skin identified

Posted: July 6, 2012 at 8:12 pm

Washington, July 6 : In a new study, researchers including one of an Indian origin have described how human epidermal progenitor cells and stem cells control transcription factors to avoid premature differentiation, preserving their ability to produce new skin cells throughout life.

The findings provide new insights into the role and importance of exosomes and their targeted gene transcripts, and may help point the way to new drugs or therapies for not just skin diseases, but other disorders in which stem and progenitor cell populations are affected.

Stem cells, of course, are specialized cells capable of endlessly replicating to become any type of cell needed, a process known as differentiation. Progenitor cells are more limited, typically differentiating into a specific type of cell and able to divide only a fixed number of times.

Throughout life, human skin self-renews. Progenitor and stem cells deep in the epidermis constantly produce new skin cells called keratinocytes that gradually rise to the surface where they will be sloughed off. One of the ways that stem and progenitor cells maintain internal health during their lives is through the exosome - a collection of approximately 11 proteins responsible for degrading and recycling different RNA elements, such as messenger RNA that wear out or that contain errors resulting in the translation of dysfunctional proteins which could potentially be deleterious to the cell.

"In short," said George L. Sen, PhD, assistant professor of medicine and cellular and molecular medicine at the University of California, San Diego School of Medicine, "the exosome functions as a surveillance system in cells to regulate the normal turnover of RNAs as well as to destroy RNAs with errors in them."

Sen and colleagues Devendra S. Mistry, PhD, a postdoctoral research fellow, and staff scientist Yifang Chen, MD, PhD, discovered that in the epidermis the exosome functions to target and destroy mRNAs that encode for transcription factors that induce differentiation.

Specifically, they found that the exosome degrades a transcription factor called GRHL3 in epidermal progenitor cells, keeping the latter undifferentiated. Upon receiving differentiation inducing signals, the progenitor cells lose expression of certain subunits of the exosome which leads to higher levels of GRHL3 protein. This increase in GRHL3 levels promotes the differentiation of the progenitor cells.

"Without a functioning exosome in progenitor cells," said Sen, "the progenitor cells prematurely differentiate due to increased levels of GRHL3 resulting in loss of epidermal tissue over time."

Sen said the findings could have particular relevance if future research determines that mutations in exosome genes are linked to skin disorders or other diseases.

"Recently there was a study showing that recessive mutations in a subunit of the exosome complex can lead to pontocerebellar hypoplasia, a rare neurological disorder characterized by impaired development or atrophy of parts of the brain," said Sen.

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An economical, effective and biocompatible gene therapy strategy promotes cardiac repair

Posted: July 6, 2012 at 8:12 pm

Public release date: 6-Jul-2012 [ | E-mail | Share ]

Contact: Dr. Changfa Guo guo.changfa@zs-hospital.sh.cn Society for Experimental Biology and Medicine

Dr Changfa Guo, Professor Chunsheng Wang and their co-investigators from Zhongshan hospital Fudan University, Shanghai, China have established a novel hyperbranched poly(amidoamine) (hPAMAM) nanoparticle based hypoxia regulated vascular endothelial growth factor (HRE-VEGF) gene therapy strategy which is an excellent substitute for the current expensive and uncontrollable VEGF gene delivery system. This discovery, reported in the June 2012 issue of Experimental Biology and Medicine, provides an economical, feasible and biocompatible gene therapy strategy for cardiac repair.

Transplantation of VEGF gene manipulated mesenchymal stem cells (MSCs) has been proposed as a promising therapeutic method for cardiac repair after myocardium infarction. However, the gene delivery system, including the VEGF gene and delivery vehicle, needs to be optimized. On one hand, long-term and uncontrollable VEGF over-expression in vivo has been observed to lead to hemangioma formation instead of functional vessels in animal models. On the other hand, though non-viral gene vector can circumvent the limitations of virus, drawbacks of the current non-viral vectors, such as complex synthesis procedure, limited transfection efficiency and high cytotoxicity, still needs to be overcome.

Co-investigators, Drs. Kai Zhu and Hao Lai, said "Hypoxia response elements were inserted into the promoter region of VEGF gene to form HRE-VEGF, which provided a safer alternative to the conventionally available VEGF gene". "The HRE-VEGF up-regulates gene expression under hypoxic conditions caused by ischemic myocardium and turns it off under normoxia condition when the regional oxygen supply is adequate."

The hPAMAM nanoparticles, which exhibit high gene transfection efficiency and low cytotoxicity during the gene delivery process, can be synthesized by a simpler and more economical one-step/pot polymerization technique. Drs. Zhu and Lai, said "Using the hPAMAM based gene delivery approach, our published and unpublished results explicitly demonstrated that it was an economical, effective and biocompatible gene delivery vehicle".

Dr Guo concluded that "Treatment with hPAMAM-HRE-VEGF transfected MSCs after myocardium infarction improved the myocardial VEGF level, which improved graft MSC survival, increased neovascularization and ultimately improved heart function. And this novel VEGF gene delivery system may have clinical relevance for tissue repair in other ischemic diseases".

Dr. Steve Goodman, Editor-in-Chief of Experimental Biology and Medicine said "Guo and colleagues have provided an exciting new nanoparticle based gene therapy for cardiac repair. This novel approach has great promise for repair of the heart after myocardial infarction."

###

Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership visit http://www.sebm.org. If you are interested in publishing in the journal please visit http://ebm.rsmjournals.com/

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An economical, effective and biocompatible gene therapy strategy promotes cardiac repair

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Diabetes drug helps brain growth, makes mice smarter

Posted: July 6, 2012 at 8:12 pm

SACRAMENTO, CA. - A drug used to treat diabetes encourages the brain to grow and repair itself, afinding with far-reaching implications for the treatment of Alzheimers and brain injury, a new study published in Cell: Stem Cell reports.

The widely used diabetes drug metformin comes with the unexpected side effect of causing the growth of new neurons in the brain and makes mice smarter, the July 6th issue of Cell Stem Cell, a Cell Press publication, said. The study has potentially wide-reaching implications for the treatment of Alzheimers in humans and brain related injury.

The discovery has important implications for brain repair because it works not by introducing new stem cells but rather by spurring those that are already present into action, said the study's lead author Freda Miller of the University of Toronto-affiliated Hospital for Sick Children. And since the drug is already so widely used and so safe it means doctors could quickly begin using the drug for brain therapy treatment.

Earlier work by Miller's team highlighted a pathway known as aPKC-CBP for its essential role in telling neural stem cells where and when to differentiate into mature neurons, the report said. Other researchers had found before them that the same pathway is important for the metabolic effects of the drug metformin, but in liver cells.

"We put two and two together," Miller says. If metformin activates the CBP pathway in the liver, they thought, maybe it could also do that in neural stem cells of the brain to encourage brain repairm, he said.

Mice taking metformin not only showed an increase in the birth of new neurons, but they proved to become smarter by being better able to learn the location of a hidden platform in a standard maze test of spatial learning. The new evidence lends support to that promising idea in both mouse brains and human cells.

While it remains to be seen whether the very popular diabetes drug might already be serving as a brain booster for those who are now taking it, there are early hints the drug may have cognitive benefits for people with Alzheimer's disease. Scientists had speculated those improvements were the result of better diabetes control, Miller says, but it now appears that metformin may improve Alzheimer's symptoms by enhancing brain repair.

Miller says they now hope to test whether metformin might help repair the brains of those who have suffered brain injury due to trauma or radiation therapies for cancer.

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An economical, effective and biocompatible gene therapy strategy promotes cardiac repair

Posted: July 6, 2012 at 7:17 pm

Public release date: 6-Jul-2012 [ | E-mail | Share ]

Contact: Dr. Changfa Guo guo.changfa@zs-hospital.sh.cn Society for Experimental Biology and Medicine

Dr Changfa Guo, Professor Chunsheng Wang and their co-investigators from Zhongshan hospital Fudan University, Shanghai, China have established a novel hyperbranched poly(amidoamine) (hPAMAM) nanoparticle based hypoxia regulated vascular endothelial growth factor (HRE-VEGF) gene therapy strategy which is an excellent substitute for the current expensive and uncontrollable VEGF gene delivery system. This discovery, reported in the June 2012 issue of Experimental Biology and Medicine, provides an economical, feasible and biocompatible gene therapy strategy for cardiac repair.

Transplantation of VEGF gene manipulated mesenchymal stem cells (MSCs) has been proposed as a promising therapeutic method for cardiac repair after myocardium infarction. However, the gene delivery system, including the VEGF gene and delivery vehicle, needs to be optimized. On one hand, long-term and uncontrollable VEGF over-expression in vivo has been observed to lead to hemangioma formation instead of functional vessels in animal models. On the other hand, though non-viral gene vector can circumvent the limitations of virus, drawbacks of the current non-viral vectors, such as complex synthesis procedure, limited transfection efficiency and high cytotoxicity, still needs to be overcome.

Co-investigators, Drs. Kai Zhu and Hao Lai, said "Hypoxia response elements were inserted into the promoter region of VEGF gene to form HRE-VEGF, which provided a safer alternative to the conventionally available VEGF gene". "The HRE-VEGF up-regulates gene expression under hypoxic conditions caused by ischemic myocardium and turns it off under normoxia condition when the regional oxygen supply is adequate."

The hPAMAM nanoparticles, which exhibit high gene transfection efficiency and low cytotoxicity during the gene delivery process, can be synthesized by a simpler and more economical one-step/pot polymerization technique. Drs. Zhu and Lai, said "Using the hPAMAM based gene delivery approach, our published and unpublished results explicitly demonstrated that it was an economical, effective and biocompatible gene delivery vehicle".

Dr Guo concluded that "Treatment with hPAMAM-HRE-VEGF transfected MSCs after myocardium infarction improved the myocardial VEGF level, which improved graft MSC survival, increased neovascularization and ultimately improved heart function. And this novel VEGF gene delivery system may have clinical relevance for tissue repair in other ischemic diseases".

Dr. Steve Goodman, Editor-in-Chief of Experimental Biology and Medicine said "Guo and colleagues have provided an exciting new nanoparticle based gene therapy for cardiac repair. This novel approach has great promise for repair of the heart after myocardial infarction."

###

Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership visit http://www.sebm.org. If you are interested in publishing in the journal please visit http://ebm.rsmjournals.com/

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Donate marrow, stem cells Friday to honor fallen police officer

Posted: July 6, 2012 at 7:16 pm

Celena Hollis

DENVER If you want to honor slain police officer Celena Hollis, who was killed at a City Park Jazz festival last month, the Denver Police Departments District 2 is urging you to donate your bone marrow or stem cells.

Hollis was instrumental in setting up this donor drive before her death and donated her organs after her passing. She was also an advocate for minorities, serving as the president for the Denver Police Department Black Police Officers Organization

All of that considered, Hollis colleagues are hoping to continue the self-less work that came to define the fallen officer.

July is African American Bone Marrow Awareness Month and the goal is to raise awareness about the critical need for African Americans to join the national Be The Match Registry, said Dianna Hemphill, Public Relations Specialist at the Bonfils Blood Center, where the drive will be held Friday from 11 a.m. 2 p.m. (Directions can be found here.)

More than 10,000 people from all ethnic backgrounds are diagnosed with life-threatening blood diseases every year. Approximately 70 percent of these patients do not have a compatible donor in their family or are unable to use their own cells. At that point, they need to search the Be The Match Registry for an unrelated donor.

Only 25 percent of that registry is ethnically diverse.

Thats why the need for more diverse donors is critical, Bonfils Vice President of Marketing Jessica Maitland said.

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