Nuvilex Announces Substantial Development in Pancreatic Cancer Research
SILVER SPRING, Md., July 17, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), a biotechnology provider of cell and gene therapy solutions, announced today a significant new development in pancreatic cancer research. Pancreatic tumor models in animals have not existed previously that accurately mimic human pancreatic cancer. This research advancement, accomplished by the Nuvilex subsidiary, Austrianova Singapore and their colleagues was just published in the journal PLoS One.
Dr. Robert F. Ryan, Chief Executive Officer of Nuvilex, commented, "The usefulness of this mouse model for future development of Nuvilex's pancreatic cancer treatments is significant. They will become a critical tool for the testing of our next generation of encapsulated live-cell pancreatic cancer treatments, particularly for producing active chemotherapeutic drugs at the tumor site. We believe our Cell-In-A-Box(R) live-cell encapsulated technology has important advantages over standard chemotherapy and radiation-based treatments, especially since it has been shown to work in the presence of low dose chemotherapy."
Dr. Walter Gunzburg, added, "The pancreatic cancer mouse models were created with our colleagues at the University of Vienna Veterinary School and are clinically important since they mimic human pancreatic cancer. Most cancers, including pancreatic, involve changes in only one organ, location and cell type, which was the major accomplishment of this model. The most important aspect of this model system is the location of pancreatic tumor cells to the pancreas, exactly like what is observed in pancreatic cancer patients."
The paper substantially advanced the mouse models made using human pancreatic tumor cells since the tumor cells were implanted in the pancreas, unlike the usual subcutaneous models. This new model is designed for advancing and fine tuning the Nuvilex pancreatic cancer encapsulated live-cell treatments that have already been successfully used in humans and is being prepared for late stage pancreatic cancer clinical trials by Nuvilex and Austrianova Singapore.
Austrianova Singapore's Chief Executive, Dr. Brian Salmons, stated, "We are excited by these new models since they should allow greater insight into developing more advanced therapies and improvements even as we prepare for our next human pancreatic cancer clinical trial. From what we have learned to date, these models are more relevant for the human pancreatic cancer and should aid in the development of more robust pancreatic cancer treatments."
Dr. Ryan concluded, "In the United States, pancreatic cancer remains the fourth leading cause of death from all cancers and has the highest mortality rate. We hope to use these mouse models for advancing our next generation pancreatic cancer treatment, which is already underway. Furthermore, they could become useful not only for our work, but for potentially generating revenue from other companies developing their own treatments for pancreatic cancer. Most importantly, this innovation brings Nuvilex one step closer to expanding our cell therapy treatments for pancreatic cancer, including the one under development for late Phase 2 clinical trials."
About Nuvilex
Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Our company's clinical offerings will include cancer, diabetes and other treatments using the company's cell and gene therapy expertise and live-cell encapsulation technology.
The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13494
Safe Harbor Statement
See original here:
Nuvilex Announces Substantial Development in Pancreatic Cancer Research
Recommendation and review posted by Bethany Smith
Research and Markets: Engineering Complex Phenotypes in Industrial Strains
DUBLIN--(BUSINESS WIRE)--
Research and Markets (http://www.researchandmarkets.com/research/gzsgbq/engineering_comple) has announced the addition of John Wiley and Sons Ltd's new report "Engineering Complex Phenotypes in Industrial Strains" to their offering.
This book highlights current trends and developments in the area of engineering strains. The book details the current and future tools used in the production of bulk chemicals and biofuels from renewable biomass using green technologies. Complex phenotypes are traits in a microbe that requires multiple genetic changes to be modulated simultaneously in the microorganism's DNA. Knowing what those genetic changes are for a given trait and how to make those changes in the most efficient way forms the motivation behind writing this book.
This book explains the newer tools to develop and enable engineered strains at time scales much faster that the natural evolution process so that we can increase a cells' production of a certain substance, increase process productivity, and extend metabolic capability. This book provides a one stop platform of reference for practicing researchers in the field of industrial biotechnology.
This book also explains that the commercial success of a process that uses microbial catalysts over platforms that use chemical catalysts and fossil fuels depends on the time it takes to engineer these microbes to perform the desired reaction under harsh manufacturing conditions and at rates that meets the criteria for economic feasibility.
Key Topics Covered:
- Foreword
- PREFACE
- CHAPTER 1 Classical Strain Engineering
- CHAPTER 2 Tracer-based Analysis of Metabolic Flux Networks
More here:
Research and Markets: Engineering Complex Phenotypes in Industrial Strains
Recommendation and review posted by Bethany Smith
New therapeutic target for prostate cancer identified
Public release date: 17-Jul-2012 [ | E-mail | Share ]
Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News
New Rochelle, NY, July 16, 2012A small, naturally occurring nucleic acid sequence, called a microRNA, known to regulate a number of different cancers, appears to alter the activity of the androgen receptor, which plays a critical role in prostate cancer. Directly targeting microRNA-125b to block androgen receptor activity represents a novel approach for treating castrate-resistant prostate cancer. This promising new strategy for improving the effectiveness of anti-androgenic and other hormonal therapies is described in an article in BioResearch Open Access, a new bimonthly peer-reviewed open access journal from Mary Ann Liebert, Inc.. The article is available free online at the BioResearch Open Access website.
Prostate cancer is the most common non-skin cancer affecting men and the second most common cause of cancer death among men. In the article "miR-125b Regulation of Androgen Receptor Signaling Via Modulation of the Receptor Complex Co-Repressor NCOR2," Xiaoping Yang, Lynne Bernis, Lih-Jen Su, Dexiang Gao, and Thomas Flaig, University of Colorado Denver (Aurora) and University of Minnesota (Duluth), looked for targets of microRNA-125b that might shed light on its role in regulating prostate cancer and found that it directly inhibits NCOR2, which acts to repress the androgen receptor. The authors point out that "the androgen receptor is a critical therapeutic target in prostate cancer" and that alterations in the receptor are essential for the development of castrate-resistant prostate cancer, in which the disease no longer responds to hormonal therapies.
"This research provides new insight into the mechanism of miR-125b regulation of castrate-resistance prostate cancer through the identification of a novel target for miR-125b," says Editor-in-Chief Jane Taylor, PhD, MRC Centre for Regenerative Medicine, University of Edinburgh, Scotland. "The clinical implications of this study are that targeted regulation of this miRNA may lead to more effective anticancer therapies."
###
About the Journal
BioResearch Open Access is a bimonthly peer-reviewed open access journal that provides a new rapid-publication forum for a broad range of scientific topics including molecular and cellular biology, tissue engineering and biomaterials, bioengineering, regenerative medicine, stem cells, gene therapy, systems biology, genetics, biochemistry, virology, microbiology, and neuroscience. All articles are published within 4 weeks of acceptance and are fully open access and posted on PubMedCentral. All journal content is available online at the BioResearch Open Access website.
About the Publisher
Mary Ann Liebert, Inc., is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Tissue Engineering, Stem Cells and Development, Human Gene Therapy and HGT Methods, and AIDS Research and Human Retroviruses. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc. website.
Excerpt from:
New therapeutic target for prostate cancer identified
Recommendation and review posted by Bethany Smith
Test cuts need for prostate cancer repeat biopsy
SAN DIEGO Karim Kader, M.D., Ph.D., associate clinical professor at the UC San Diego School of Medicine, together with a team of researchers from Wake Forest University School of Medicine, have developed a genetic test to predict a man's risk for prostate cancer. Use of the test could reduce the need for repeat biopsies in men who have had a negative biopsy. Results of the multicenter study were recently published online in the journal of European Urology.
"The genetic test outperformed the PSA test in assessing cancer risk," said Kader, co-investigator and urologic surgeon at UC San Diego Health System. "If results of this blood test were factored into prostate cancer predictors such as total free PSA, free PSA, number of core samples taken at biopsy and family history, we would have a more accurate picture of a whether or not a man is likely to develop the sometimes fatal disease."
Kader and researchers evaluated 1,654 men in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) clinical trial. All the men had biopsies and consented to genetic studies that looked for the presence of germline single nucleotide polymorphisms (SNPs). SNPs are genetic variations within an individual's DNA sequence which may have a positive association with prostate cancer risk as well as other chronic diseases.
"Avoiding repeat procedures, particularly in older men, can help reduce the risk of infection and potential hospitalizations," said Kader. "The genetic score is available at any time in a man's lifetime and could be used as a pre-screening test thus leaving aggressive PSA screening to men at a higher genetic risk."
About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. In 2012, more than 241,700 new cases of prostate cancer will be diagnosed. During the course of diagnosing patients, more than one million men are biopsied each year in the U.S. Approximately 30 percent go on to have repeat biopsies.
Funding for this study was partially supported by a National Cancer Institute RC2 grant (CA148463) and a research contract by GlaxoSmithKline.
Researchers included Kader and Jianfeng Xu who led the team from Wake Forest University School of Medicine, including Jielin Sun, Seong-Tae Kim, Fang-Chi Hsu, Ralph B. D'Agostino Jr., Sha Tao, Zheng Zhang, Aubrey R. Turner, Deborah A. Meyers, Eugene R. Bleecker, Frank M. Torti, John D. McConnell and S. Lilly Zheng; Brian H. Reck, Paul J. Newcombe, Greg T. Platek, Colin F. Spraggs, John C. Whittaker, Lynn D. Condreay and Roger S. Rittmaster of GlaxoSmithKline; Brian R. Lane of Spectrum Health; William B. Isaacs of Johns Hopkins Medical Institutions; and Jeffery M. Trent of Van Andel Research Center.
More here:
Test cuts need for prostate cancer repeat biopsy
Recommendation and review posted by Bethany Smith
New test may help predict prostate cancer
ScienceDaily (July 17, 2012) Karim Kader, MD, PhD, associate clinical professor at the UC San Diego School of Medicine, together with a team of researchers from Wake Forest University School of Medicine, have developed a genetic test to predict a man's risk for prostate cancer. Use of the test could reduce the need for repeat biopsies in men who have had a negative biopsy.
Results of the multicenter study were recently published online in the journal of European Urology.
"The genetic test outperformed the PSA test in assessing cancer risk," said Kader, co-investigator and urologic surgeon at UC San Diego Health System. "If results of this blood test were factored into prostate cancer predictors such as total free PSA, free PSA, number of core samples taken at biopsy, and family history, we would have a more accurate picture of a whether or not a man is likely to develop the sometimes fatal disease."
Kader and researchers evaluated 1,654 men in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) clinical trial. All the men had biopsies and consented to genetic studies that looked for the presence of germline single nucleotide polymorphisms (SNPs). SNPs are genetic variations within an individual's DNA sequence which may have a positive association with prostate cancer risk as well as other chronic diseases.
"Avoiding repeat procedures, particularly in older men, can help reduce the risk of infection and potential hospitalizations," said Kader. "The genetic score is available at any time in a man's lifetime and could be used as a pre-screening test thus leaving aggressive PSA screening to men at a higher genetic risk."
About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. In 2012, more than 241,700 new cases of prostate cancer will be diagnosed. During the course of diagnosing patients, more than one million men are biopsied each year in the U.S. Approximately 30 percent go on to have repeat biopsies.
Funding for this study was partially supported by a National Cancer Institute RC2 grant (CA148463) and a research contract by GlaxoSmithKline.
Share this story on Facebook, Twitter, and Google:
Other social bookmarking and sharing tools:
Story Source:
Read this article:
New test may help predict prostate cancer
Recommendation and review posted by Bethany Smith
Drug shown to improve memory in those with Down syndrome
Public release date: 17-Jul-2012 [ | E-mail | Share ]
Contact: Jacque Montgomery jacque.montgomery@ucdenver.edu 303-928-9093 University of Colorado Denver
AURORA, Colo. (July 17, 2012) Researchers at the University of Colorado School of Medicine have found a drug that boosts memory function in those with Down syndrome, a major milestone in the treatment of this genetic disorder that could significantly improve quality of life.
"Before now there had never been any positive results in attempts to improve cognitive abilities in persons with Down syndrome through medication," said Alberto Costa, MD, Ph.D., who led the four- year study at the CU School of Medicine. "This is the first time we have been able to move the needle at all and that means improvement is possible."
The study was published today in the journal Translational Psychiatry.
Costa, an associate professor of medicine, and his colleagues studied 38 adolescents and young adults with Down syndrome. Half took the drug memantine, used to treat Alzheimer's disease, and the others took a placebo.
Costa's research team hypothesized that memantine, which improved memory in mice with Down syndrome, could increase test scores of young adults with the disorder in the area of spatial and episodic memory, functions associated with the hippocampus region of the brain.
Participants underwent a 16-week course of either memantine or a placebo while scientists compared the adaptive and cognitive function of the two groups.
While they found no major difference between the groups in adaptive and most measures of cognitive ability, researchers discovered that those taking memantine showed significant improvement in verbal episodic memory. One of the lowest functioning individuals in the study saw a ten-fold increase in memory skills.
"People who took the medicine and memorized long lists of words did significantly better than those who took the placebo," said Costa, a neuroscientist specializing in Down syndrome research. "This is a first step in a longer quest to see how we can improve the quality of life for those with Down syndrome."
Read more:
Drug shown to improve memory in those with Down syndrome
Recommendation and review posted by Bethany Smith
CGC Genetics Rolls out BeadXpress-based Test for Skeletal Dysplasia
Edison Liu has been elected to the Foundation for the National Institutes of Health's board of directors. His term began on June 19.
Liu is the president and CEO of the Jackson Laboratory and president of the Human Genome Organization. He joined the Jackson Laboratory from the Genome Institute of Singapore, where he was the founding executive director. Prior to that, he was the scientific director of the National Cancer Institute's division of clinical sciences.
Gene synthesis company Gen9 has appointed Kevin Munnelly to be president and CEO and Martin Goldberg to be chief operating officer.
Munnelly previously was general manager in Life Technologies' global next-generation qPCR business, and he was VP and GM of Biotrove, which Life Technologies acquired in 2009. Goldberg spent 17 years at Affymetrix, where he most recently oversaw the company's technology and product development efforts.
23andMe has named Andy Page to its board of directors. He currently serves as president of Gilt Group. Previously he served as chief operating and financial officer at PlayPhone; chief financial officer and senior vice president of business strategy at StubHub; and has held senior executive positions at Panasas, ONI Systems, and Robertson Stephens & Company.
View original post here:
CGC Genetics Rolls out BeadXpress-based Test for Skeletal Dysplasia
Recommendation and review posted by Bethany Smith
Can Genetics Prevent The Transmission Of Malaria?
July 17, 2012
Image Credit: PD-USGOV-HHS-CDC
redOrbit Staff & Wire Reports Your Universe Online
Malaria kills more than 800,000 people worldwide every year and many of those victims are children.
Researchers are now reporting that they have genetically modified a bacterium commonly found in the mosquitos mid gut and found that the parasite that causes malaria in people does not survive in mosquitoes carrying the modified bacterium.
The researchers, from the Johns Hopkins Malaria Research Institute, modified the bacterium Pantoea agglomerans to secrete proteins toxic to the malaria parasite, but the toxins do not harm the mosquito or humans.
According to their study, published in PNAS, the modified bacterium was 98 percent effective in reducing the malaria parasite load in mosquitoes.
In the past, we worked to genetically modify the mosquito to resist malaria, but genetic modification of bacteria is a simpler approach, said Marcelo Jacobs-Lorena, PhD, senior author of the study and a professor with Johns Hopkins Bloomberg School of Public Health. The ultimate goal is to completely prevent the mosquito from spreading the malaria parasite to people.
During the study, Jacobs-Lorena and his colleagues found that the engineered P. agglomerans strains repressed development of the deadliest human malaria parasite Plasmodium falciparum and rodent malaria parasite Plasmodium berghei by up to approximately 98 percent within the mosquito. The number of mosquitoes carrying parasites decreased by up to 84 percent.
We demonstrate the use of an engineered symbiotic bacterium to interfere with the development of P. falciparum in the mosquito. These findings provide the foundation for the use of genetically modified symbiotic bacteria as a powerful tool to combat malaria, said Jacobs-Lorena.
Read more:
Can Genetics Prevent The Transmission Of Malaria?
Recommendation and review posted by Bethany Smith
AxoGen, Inc. Makes First Commercial Shipment of Avance® Nerve Graft to Distributor in Italy
ALACHUA, Fla.--(BUSINESS WIRE)--
AxoGen, Inc. (AXGN), a leading regenerative medicine company focused on the development and commercialization of products and technologies for peripheral nerve reconstruction and regeneration, today announced approval by the Rizzoli Orthopaedic Institute of its first commercial shipment of Avance Nerve Graft to MD for Life, its new distribution partner in Italy. Avance Nerve Graft is a processed nerve allograft for bridging nerve discontinuities (gaps created when nerves are severed). By eliminating a second surgery to harvest the patients own nerve tissue for use in the repair, Avance Nerve Graft offers an alternative to traditional autograft nerve repair procedures.
The Rizzoli Orthopaedic Institute is Italys largest tissue bank and handles review and approval of all donors of AxoGen processed nerve allograft tissue to assure quality.
"Our ongoing partnership with the prestigious Rizzoli Orthopaedic Institute underscores the quality of AxoGens tissue processing and confirms the growing demand for Avance Nerve Graft in markets outside of the United States," said Karen Zaderej, AxoGen's Chief Executive Officer. "AxoGen is committed to providing innovative technologies of the highest standards to surgeons worldwide for the treatment and reconstruction of injured peripheral nerves.
To date, thousands of patients who have suffered traumatic injuries have been surgically implanted with AxoGens products. In addition to Avance Nerve Graft, the Companys portfolio of products and technologies include AxoGuard Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard Nerve Protector, a bioscaffold used to reinforce a coaptation site, wrap a partially severed nerve or isolate and protect nerve tissue.
About AxoGen, Inc.
AxoGen (AXGN) is a leading regenerative medicine company with a portfolio of proprietary products and technologies for peripheral nerve reconstruction and regeneration. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body and their damage can result in the loss of function and feeling. In order to improve surgical reconstruction and regeneration of peripheral nerves, AxoGen has developed and licensed patented and patent-pending technologies, which are used in its portfolio of products. This portfolio includes Avance Nerve Graft, a commercially available allograft nerve for bridging nerve discontinuities (a gap created when the nerve is severed) of 5mm to 70mm in length. Avance Nerve Graft is sterilized and processed using a patented cleaning process that preserves the inherent and relevant structural characteristics of the tissue, allowing regenerating axons to grow through the scaffold to the motor or sensory organ.
AxoGens portfolio also includes AxoGuard Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard Nerve Protector, a bioscaffold used to reinforce a coaptation site, wrap a partially severed nerve or isolate and protect nerve tissue.
AxoGen is bringing the science of nerve repair to life with thousands of surgical implants of AxoGen products performed in hospitals and surgery centers across the United States, including military hospitals serving U.S. service men and women.
AxoGen is the parent of its wholly owned operating subsidiary, AxoGen Corporation. AxoGens principal executive office and operations are located in Alachua, FL.
Excerpt from:
AxoGen, Inc. Makes First Commercial Shipment of Avance® Nerve Graft to Distributor in Italy
Recommendation and review posted by sam
Juventas Therapeutics Raises $22.2 Million Series B Financing
CLEVELAND, July 16, 2012 /PRNewswire/ --Juventas Therapeutics, a clinical-stage regenerative medicine company, announced today that it has closed a $22.2 million Series B financing that was co-led by Triathlon Medical Venture Partners and New Science Ventures. All previous venture firms, including Fletcher Spaght Ventures, Reservoir Venture Partners and Early Stage Partners participated in the round. Also joining the syndicate are new investors Takeda Ventures, Venture Investors, Global Cardiovascular Innovation Center, Tri-State Growth Fund, Glengary and select angel investors.
The proceeds will fund completion of ongoing Phase II clinical trials investigating the use of JVS-100 in treating patients with chronic heart failure or critical limb ischemia. Both trials are actively enrolling patients. JVS-100, the Company's lead product, encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevent ongoing cell death and restore blood flow.
"The funds raised through this Series B will carry us through significant clinical milestones," states Rahul Aras, Ph.D., President & CEO of Juventas Therapeutics. "The fact that the round was oversubscribed and added several new investors to an already strong syndicate speaks to the excitement that is building around regenerative medicine, and specifically, the unique factor-based strategy employed by Juventas."
Clinical studies by several companies have demonstrated that delivery of adult stem cells to patients suffering from heart failure or critical limb ischemia has the potential to promote tissue repair and improve clinical outcomes. In spite of these clinical findings, questions remain about the affordability and accessibility of cell-based therapy for the general population. Rather than deliver cells, Juventas delivers JVS-100, which activates natural stem cell based repair pathways that lie dormant in a patient. This allows the benefits of regenerative medicine without the complexity of cell therapy. While currently focused on cardiovascular disease, the clinical potential for JVS-100 is broad.
Last year, Juventas Therapeutics spun-off SironRX Therapeutics to focus on development of dermal and bone related applications for JVS-100. In 2011, SironRX raised $3.4 million through a Series A financing led by North Coast Angel Fund and received $1 million in grant funding through the Ohio Third Frontier program. The Company is currently enrolling a Phase Ib randomized, placebo-controlled, double-blinded clinical trial investigating dermal JVS-100 delivery to accelerate wound closure and reduce scar formation.
"Juventas provides a commercially viable solution to delivering regenerative therapies and has the potential to address a broad range of clinical applications" states George Emont, Managing Partner for Triathlon Medical Ventures and Chairman for Juventas. We are pleased to have raised these funds for the two Phase II clinical trials and additional development as the company looks toward its Phase III trials and eventual commercialization".
About Juventas TherapeuticsJuventas Therapeutics, (www.juventasinc.com) headquartered in Cleveland, OH, is a privately-held clinical-stage biotechnology company developing a pipeline of regenerative therapies to treat lifethreatening diseases. Founded in 2007 with an exclusive license from Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to initiation of mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Takeda Ventures, Triathlon Medical Venture Partners, Venture Investors, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, Glengary, The Global Cardiovascular Innovation Center, Tri-State Growth Fund, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received non-dilutive grant support through the Ohio Third Frontier-funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center and Center for Stem Cell & Regenerative Medicine.
See the original post here:
Juventas Therapeutics Raises $22.2 Million Series B Financing
Recommendation and review posted by sam
NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement
ALLENDALE, N.J. and WILMINGTON, Del., July 16, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized Contract Development and Manufacturing Organization (CDMO), and SOTIO, LLC, a Delaware limited liability company that is responsible for organizing the U.S. part of a global pivotal Phase 3 clinical trial of SOTIO, LLC's affiliate, SOTIO a.s. ("SOTIO"), announced today that SOTIO, LLC has retained the services of PCT to manufacture clinical products for SOTIO's U.S. part of a global pivotal Phase 3 clinical trial. SOTIO, LLC is an affiliate of a Czech Republic-based biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. SOTIO, LLC will use the services of PCT to transfer and qualify at PCT's Allendale, New Jersey facility, SOTIO's GMP manufacturing process for the U.S. part of a global pivotal Phase 3 clinical trial for SOTIO's autologous dendritic cell vaccine expected to launch in early 2013, subject to FDA approval.
As part of this agreement, PCT will complete a technology transfer of SOTIO's current product manufacturing and analytical procedures into PCT's ongoing CDMO operations. PCT will then implement and perform process qualification at the Allendale facility, and manufacture, store, and release the product for SOTIO's U.S. part of its global pivotal Phase 3 trial. The U.S. part of this double-blinded, randomized trial will enroll up to 250 patients and will be SOTIO's first trial in the U.S.
"We are very excited to enter into this agreement to continue and to expand on our relationship with SOTIO, LLC, an innovator for cellular immunotherapies to treat prostate cancer," said Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. "Given our best in class capabilities in the manufacture and distribution of cell-based immunotherapies, we are pleased to work with SOTIO, LLC to assist with bringing this exciting therapy and its potential to the U.S. PCT will offer SOTIO, LLC the same expertise and dedicated service it has offered past clients like the Dendreon Corporation (DNDN), for whom we were the primary manufacturer for PROVENGE(R) for more than seven years during its clinical trials."
"This agreement with PCT represents a major risk mitigation step in conducting the U.S. part of our global pivotal Phase 3 clinical trial," said Karel Nohejl, Chairman and CEO of SOTIO. "PCT has significant experience in manufacturing patient-specific products and capabilities to provide the scale-up needed for late-stage clinical trials. PCT's competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for SOTIO, LLC as we look forward to launching this trial in anticipation of entering the U.S. market."
"PCT offers cell therapy companies around the world a cost-effective method to transfer product candidate development to the U.S. and launch their products commercially," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "PCT's track record, experience with technology transfer, and U.S. footprint including its East and West Coast (Mountain View, California) facilities, make it an excellent partner for companies like SOTIO, LLC. Manufacturing contracts for cell therapy products can generate millions of dollars of revenue for the manufacturing partner over the span of a late stage clinical trial. We foresee meaningful client base growth as therapeutic development companies from Europe and Asia seek access to the American market and look for a U.S. contract development and manufacturing partner."
About SOTIO Group
SOTIO Group is a biotechnology group developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Its mission is to develop new medical therapies using SOTIO's proprietary cell-based technologies to treat highly unmet medical conditions using SOTIO's immunotherapy platform. World renowned scientists are working at SOTIO's research facilities in Prague using state-of-the art technologies to understand the role of dendritic cells in the therapeutic activation of the body's immune response. SOTIO plans to start a global pivotal Phase 3 clinical trial which will enroll U.S. as well as E.U. patients under the supervision of FDA and EMA. SOTIO, LLC is an affiliate of SOTIO and is responsible for organizing SOTIO Group's activities in the United States.
For more information on SOTIO, please visit http://www.sotio.com
About NeoStem, Inc.
NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.
See the original post here:
NeoStem's Subsidiary, Progenitor Cell Therapy, and SOTIO Enter Into a Phase 3 Manufacturing Services Agreement
Recommendation and review posted by Bethany Smith
TiGenix Signs Up 4th Major Hospital in the Netherlands for Innovative Cartilage Repair Therapy
LEUVEN, BELGIUM--(Marketwire -07/17/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today that after obtaining national reimbursement for ChondroCelect in the Netherlands last month, the company has now contracted with four major hospitals to make its innovative cartilage repair therapy available to their patients on a routine basis: University Medical Center Utrecht, University Hospital Maastricht, Martini Hospital Groningen, and, most recently, the Elisabeth Hospital Tilburg. Discussions with other Cartilage Expert Centers are ongoing. Reimbursement for ChondroCelect in the Netherlands is retroactive per January 1, 2011.
"Our close collaboration with the Dutch hospitals is key to making ChondroCelect available to patients in the Netherlands," said Eduardo Bravo, CEO of TiGenix. "Dutch scientists and clinicians have made important contributions to the development of this innovative cartilage repair therapy. Patients who suffer from cartilage lesions in the knee that cause recurrent pain and can be incapacitating can now be routinely treated and literally find their footing again. We expect to soon expand the number of hospitals in the Netherlands where ChondroCelect is available."
Damage to the articular cartilage in the knee can be caused by sports or professional activities in which the knee is repeatedly and forcefully impacted. It is a condition that predominantly occurs in young adults, who as a result suffer from recurrent pain, locking or limited range of motion, and risk being incapacitated. TiGenix has developed ChondroCelect as a therapy to help patients regain their mobility and fully active lives by effectively repairing the damaged cartilage in the knee.
About ChondroCelect ChondroCelect for cartilage regeneration in the knee is an implantation suspension of characterized viable autologous (from the patient her- or himself) cartilage cells. The product is administered to patients in an autologous chondrocyte implantation procedure known as Characterized Chondrocyte Implantation (CCI), a surgical procedure to treat cartilage defects, in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.
Cartilage defects of the knee are very common and the spontaneous healing capacity of cartilage is limited. Currently, roughly 2 million cases of articular cartilage defects of the knee are diagnosed worldwide every year. TiGenix estimates that in Europe and the United States around 130,000 patients are eligible for treatment with cartilage regeneration products such as ChondroCelect.
ChondroCelect is the first cell-based product to successfully complete the entire development track from research to clinical development, and was approved by the European Medicines Agency as an Advanced Medicinal Therapy Product in October 2009. ChondroCelect is to date the only EMA approved cartilage repair therapy, and is commercially available in Belgium, the Netherlands, Luxemburg, Germany, the United Kingdom, Finland, and Spain.
About TiGenixTiGenix NV (EURONEXT:TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit http://www.tigenix.com.
Forward-looking informationThis 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 recognized 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.
Go here to see the original:
TiGenix Signs Up 4th Major Hospital in the Netherlands for Innovative Cartilage Repair Therapy
Recommendation and review posted by Bethany Smith
Gene mutations linked to Gehrig's disease
WORCESTER, Mass., July 16 (UPI) -- U.S. researchers say newly discovered gene mutations in amyotrophic lateral sclerosis, or Lou Gehrig's disease, shed light on how ALS leads to paralysis.
John Landers of the University of Massachusetts Medical School in Worcester said ALS attacks motor neurons, the nerve cells responsible for controlling muscles leading to paralysis and difficulty swallowing.
Landers and international researchers searched for gene mutations in two large families with an inherited form of ALS, using a technique to decode only the protein-encoding portions of DNA.
The deep sequencing of the exome led to the identification of several different mutations in the gene for profilin -- PFN1 -- which were present only in the family members that developed ALS.
After identifying the PFN1 mutations in ALS patients, the researchers demonstrated that the mutations inhibited axon, or nerve, growth in laboratory-grown motor neurons as well.
The study, published in the journal Nature, found mutant profilin accumulated in clumps in neural cells associated with ALS, Parkinson's and Alzheimer's.
"This discovery is highly significant and opens a new avenue of research," Amelie Gubitz, program director at the National Institute of Neurological Disorders and Stroke, which funded the research. "There is growing evidence that ALS may be caused by a variety of cellular defects, and that it is a not a disorder with a single origin. Whether and where these disease pathways converge is an active area of research with important implications for therapy development."
See the rest here:
Gene mutations linked to Gehrig's disease
Recommendation and review posted by Bethany Smith
Novavax In Collaboration For New Malaria Vaccine In India
(RTTNews.com) - Novavax Inc. (NVAX) said Monday it has formed a new collaboration with CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology to develop a novel malaria vaccine in India.
Novavax said the collaboration will combine the advanced vaccine technology of Novavax with the malaria vaccine research capabilities of International Centre for Genetic Engineering and Biotechnology, or ICGEB, and vaccine manufacturing capability of CPL Biologicals, or CPLB.
The project is being funded by India'sDepartment of Biotechnology Vaccine Grand Challenge Program.
Malaria remains a major public health problem in many regions of the tropical world. Forty percent of the world's population lives in malaria endemic regions of Africa, Asia and Central and South America.
About 210 million cases of malaria are reported each year, leading to around 650,000 deaths, primarily in children less than five years of age.
For comments and feedback: contact editorial@rttnews.com
See the original post:
Novavax In Collaboration For New Malaria Vaccine In India
Recommendation and review posted by Bethany Smith
Novavax will help develop new malaria vaccine
ROCKVILLE, Md. (AP) -- Drug developer Novavax Inc. said Monday that it will work with the government of India to develop a new malaria vaccine.
Novavax said it will work with the International Centre for Genetic Engineering and Biotechnology and CPL Biologicals. India's Department of Biotechnology will fund the project, which will be managed by the not-for-profit Malaria Vaccine Development Program, based in New Delhi. The company said around 210 million cases of malaria are diagnosed every year and 650,000 people die of the disease.
Novavax, based in Rockville, Md., develops vaccines that are genetically engineered virus-like particles. The particles resemble a virus but do not have the genetic material a virus needs to reproduce itself. The company is conducting clinical trials of vaccines for seasonal and pandemic influenza and for respiratory syncytial virus, or RSV, which can cause life-threatening respiratory infections in infants.
CPL Biologicals is a joint venture of Novavax and privately held Cadila Pharmaceuticals, based in Ahmedabad, India.
Shares of Novavax lost 3 cents to $2.04 in afternoon trading.
Original post:
Novavax will help develop new malaria vaccine
Recommendation and review posted by Bethany Smith
NOVAVAX, CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology Announce Collaboration …
ROCKVILLE, Md., July 16, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), CPL Biologicals (CPLB) and the International Centre for Genetic Engineering and Biotechnology (ICGEB), today announced that they have formed a new collaboration to develop a novel malaria vaccine in India. This unique public-private partnership will combine the advanced vaccine technology of Novavax with the malaria vaccine research capabilities of ICGEB and vaccine manufacturing capability of CPLB, to develop a new and effective malaria vaccine. The project is being funded by India's Department of Biotechnology Vaccine Grand Challenge Program and will be managed by the Malaria Vaccine Development Program, a New Delhi-based not-for-profit organization established to support the development of malaria vaccines.
Novavax's virus-like particle (VLP) vaccine technology platform will be applied to construct malaria vaccine candidates, which CPLB will manufacture for advanced preclinical studies, clinical trials and commercialization. The partners will develop and evaluate VLPs that express Plasmodium falciparum circumsporozoite protein (PfCSP), which has been used to develop the only recombinant malaria vaccine that has shown efficacy in field trials. After establishing the feasibility of Novavax's technology, the partners will explore the possibility of producing additional VLPs against antigens from other stages of malaria parasites. The partners believe a multi-stage VLP malaria vaccine has the potential for higher efficacy compared to vaccines based on a single antigen or that target only one stage of the malaria parasite.
Malaria remains a major public health problem in many regions of the tropical world. Forty percent of the world's population lives in malaria endemic regions of Africa, Asia and Central and South America. Despite the widespread use of insecticides, bed nets and other malaria control efforts, there are approximately 210 million cases of malaria each year that lead to around 650,000 deaths, primarily in children less than five years of age. There is an urgent need for malaria vaccines with high efficacy that can be used in conjunction with other control efforts to provide protection against malaria.
Dr. Virander Chauhan, Ph.D., Director of ICGEB, New Delhi, which will provide their extensive experience in pre-clinical and clinical development of vaccines, said, "ICGEB is excited about the possibility of working with Novavax and CPLB to advance malaria vaccine development."
Indravadan A Modi, Chairman of Cadila Pharmaceuticals Ltd, said, "CPLB will develop manufacturing processes for the vaccine candidates and will provide GMP production capability in support of this initiative." He also stated, "Malaria is a common health problem for tropical countries and efforts have been ongoing for years for its eradication. I am confident that a multi-stage VLP malaria vaccine will prove beneficial in saving precious lives by restricting morbidity and mortality associated with malaria."
Dr. Gale Smith, Novavax's Vice President Vaccine Development, stated: "Novavax is honored to be working with leading malaria experts at ICGEB and with the Department of Biotechnology of the Government of India to support the development and production of malaria vaccine candidates by Novavax and CPLB. By combining our knowledge and experience with these partners to pursue the most advanced malaria vaccine concepts, we hope to one day have an effective vaccine against one of the world's most devastating diseases."
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle vaccine technology, as well as new and efficient manufacturing approaches, the company produces novel vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: http://www.novavax.com.
About CPLB
CPL Biologicals Pvt. Ltd., a joint-venture biotechnology company established by Novavax Inc. and Cadila Pharmaceuticals, one of the largest privately held pharmaceutical companies in India based in Ahmedabad, manufactures VLP-based influenza vaccines developed by Novavax. CPLB has made rapid progress with the completion and validation of its state-of-the-art manufacturing facility, which is now operational and capable of producing a significant volume of novel vaccine doses every year. This facility utilizes the identical single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, Maryland.
Read the rest here:
NOVAVAX, CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology Announce Collaboration ...
Recommendation and review posted by Bethany Smith
China Genetic Engineering Drug Industry Report, 2011-2012
NEW YORK, July 16, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
China Genetic Engineering Drug Industry Report, 2011-2012
China gets a late start in developing genetic engineering drug industry, but has achieved leapfrog advance. At present, China has at least one hundred enterprises involved in genetic engineering drugs. In recent years, the compound growth rate of genetic engineering drug market in China is as high as 49%, with an average gross margin of more than 80%. However, the technology strength and efficacy of locally produced genetic engineering drugs are relatively weak. In particular, the pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) for injection of CSPC Pharmaceutical Group Limited that approved for marketing in March 2012 is the only homemade long-acting protein product. Still, due to the impetus of huge market capacity as well as a package of preferential policies, many domestic enterprises, including GeneScience Pharmaceuticals, Amoytop and Anhui Anke Biotechnology, are accelerating the industrialized research of long-acting protein drugs.
Monoclonal antibody is one of the most promising genetic engineering drugs. As of May 2012, SFDA approved the marketing of a total of 18 monoclonal antibody drugs. Among these drugs, nearly 60% are foreign brands including Roche, Merck and Novartis with the combined sales accounting for three fourths of the Chinese monoclonal antibody drug market. However, with the marketing of monoclonal antibody drugs made by companies such as Shanghai CP Guojian Pharmaceutical and Biotech Pharmaceutical, the market share of homemade monoclonal antibody industry is on the rise gradually.
In addition, recombinant human erythropoietin, recombinant human interferon, recombinant human growth hormone, recombinant human granulocyte-colony stimulating factor and recombinant human insulin are among the important genetic engineering drugs. As of late 2011, China had roughly 20 recombinant EPO manufacturers that approved for marketing of related products. In particular, as former EPO preparation exporters to China, enterprises including America-based Amgen and Germany-based Boehringer Mannheim GmbH have withdrawn from the Chinese market owning to low price competition. Presently, the Chinese EPO market is dominated by domestic manufacturers including 3SBio Inc. and DIAO Group. In 2011, the sales of 3SBio Inc. accounted for 42.7% in China's EPO market. As such, impacted by channel, price competition and other factors, recombinant human growth hormone and recombinant human granulocyte-colony stimulating factor markets are also dominated by domestic enterprises.
In the recombinant human interferon market, the high-performance long-acting interferon of Schering-Plough and Roche still maintained huge consumption in Chinese market in spite of the high prices. In recent years, the market share of imported long-acting interferon has remained at 60% or so in China.
Moreover, due to improving economic level and raising awareness of people, foreign-branded recombinant human insulin in Chinese market are predominant, occupying 90% market share in the corresponding period.
Although China lags behind in terms of the overall level of genetic engineering drugs, the industry has accumulated rich R&D and industrialization experience as well as capital reserves. Thus, with a host of genetic engineering drug patents to become due, Chinese enterprises, such as Walvax, are committed to the industrialization research of monoclonal antibody, long-acting recombinant protein drugs and other generic drugs with high technical barriers. On April 26th, 2012, Walvax announced to invest in Shanghai Fengmao in next four years to develop and produce genetic engineering generic drugs including rituximab, bevacizumab, adalimumab, panitumumab, denosumab and long-acting EPO.
Papermaking
See the rest here:
China Genetic Engineering Drug Industry Report, 2011-2012
Recommendation and review posted by Bethany Smith
Oracle Health Sciences Translational Research Center to Support Cancer Research UK's Development of Targeted Cancer …
REDWOOD SHORES, CA -- (Marketwire) -- 07/16/12 -- Oracle (NASDAQ: ORCL)
News Facts
To support its vision of beating cancer in the United Kingdom, Cancer Research UK, the world's largest not-for-profit cancer research organization, will be working with Oracle Health Sciences Translational Research Center as the foundation for a new analytical environment that will help the charity combine the genetic and clinical data from its Stratified Medicine Programme. Together with AstraZeneca, Pfizer and the UK government's Technology Strategy Board, Cancer Research UK is working to demonstrate a national service that will provide standardized, high-quality and cost-effective genetic testing of tumors linked to clinical data. This system has already tested two thousand tumors from patients across 24 clinical sites, and set up data capture covering diagnostics, genetics, treatment and outcomes. Cancer Research UK will use Cohort Explorer which is part of the Oracle Health Sciences Translational Research Center to create a flexible, web-accessible analytical platform and interface that enables program affiliates to effectively and rapidly search and retrieve anonymized diagnostic, treatment and outcome data to accelerate research. The platform will enable researchers and physicians to gain the insight needed to identify patient populations with similar characteristics and advance personalized cancer treatments.
Supporting Quotes
"Our new analytical platform, which we are building with Oracle Health Sciences Translational Research Center, is an exciting addition to the future of our Stratified Medicine Programme and its goal of combining genetic testing of tumors with clinical data capture to determine more effective treatment," said Monica Jones, Enterprise Architect and Informatics Lead, Cancer Research UK's Stratified Medicine Programme. "Organizations committed to advancing medical science require powerful analytical solutions to reveal insight that was previously locked away at the molecular level," said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences. "Oracle Health Sciences Translational Research Center provides a robust foundation for Cancer Research UK's analytical environment that will enable it to extend genetic testing of tumors and ultimately advance the development of more targeted and effective treatments."
Supporting Resources
Oracle in Health Sciences Cancer Research UK Oracle Health Sciences Translational Research Center Oracle Healthcare Data Warehouse Foundation Follow Oracle Health Sciences on Twitter Join the Oracle Health Sciences Community on Facebook Oracle Health Sciences on YouTube
About Oracle Oracle engineers hardware and software to work together in the cloud and in your data center. For more information about Oracle (NASDAQ: ORCL), visit http://www.oracle.com.
About Oracle in IndustriesOracle industry solutions leverage the company's best-in-class portfolio of products to address complex business processes relevant to health sciences, helping speed time to market, reduce costs, and gain a competitive edge.
Follow this link:
Oracle Health Sciences Translational Research Center to Support Cancer Research UK's Development of Targeted Cancer ...
Recommendation and review posted by Bethany Smith
Acquisition of Navigenics Expands Life Technologies' Capabilities in Diagnostics
CARLSBAD, Calif., July 16, 2012 /PRNewswire/ -- Life Technologies Corporation (LIFE) today announced the acquisition of Navigenics, Inc. This acquisition represents Life Technologies' first step in executing against a strategy to build out its molecular diagnostics business through internal development, partnerships and select acquisitions.
"Genetic analysis is becoming increasingly accessible, cost-effective and a critical part of patient clinical management," said David Agus, M.D. co-founder of Navigenics, professor of Medicine and Engineering at the University of Southern California, and author of The End of Illness. "As a result, physicians have more complete and accurate information about the patient than ever before, which is translating into more effective, individualized care programs for patients."
"The advent of personalized medicine will require a combination of technologies and informatics focused on delivering relevant information to the treating physician," said Ronnie Andrews, president of Medical Sciences at Life Technologies. "Navigenics has pioneered the synthesis and communication of complex genomic information, and we will now pivot the company's effort to date and focus on becoming a comprehensive provider of technology and informatics to pathologists and oncologists worldwide."
Navigenics' multidisciplinary expertise, including its technology infrastructure, user interfaces, online platforms, genomic support services, and an experienced team, will play a central role in the delivery of Life Technologies' molecular diagnostic model. The company's established CLIA-certified laboratory, licensed throughout the United States, will be employed for design and validation of new diagnostics assays. Life Technologies plans to develop and offer lab-developed tests as well as commercialized assays that have been approved by FDA and other regulatory authorities. Life will also continue to build partnerships with pharmaceutical companies for companion diagnostic development, including participating in clinical trials, which is enabled by the CLIA lab acquisition.
Navigenics' extensive clinical program provides Life Technologies with a leadership position in clinician and patient education and support, which will be leveraged by Life Technologies in building its diagnostics business. The platform includes a network of oncologists, pathologists, and genetic counselors, who will be available to support community-based physicians in the adoption of genetic medicine and assist them in understanding these innovative types of medical information.
"Since our founding in 2006, Navigenics has blazed a pioneering trail in bringing genomics to the everyday reality of physicians, patients, and health plans," said Vance Vanier, M.D., president and chief executive officer of Navigenics. "Life Technologies' entry into the clinical diagnostics market, coupled with the scope of their clinical vision, signals that personalized medicine is no longer a distant future promise, but today's reality. We are thrilled to be at the center of their powerful initiative, which will improve countless lives."
"Complex diseases like cancer require physicians to receive and interpret data from the genome, transcriptome and proteome. Life Technologies is the only company in the industry today with the breadth of technology to span the full continuum of diagnostic information necessary to effectively manage such diseases," said Gregory T. Lucier, chairman and chief executive officer of Life Technologies. "The Navigenics informatics platform allows us to now transform the data from our instrument systems into actionable information and deliver it in real time to physicians around the world."
As Life Technologies expands its molecular diagnostics business, its philosophical focus on clinically relevant, medically endorsed applications aligns with that of Navigenics. In compliance with existing policies and informed consent, all customer information will be protected and handled according to regulatory guidelines, in alignment with Navigenics' founding principle of protecting the privacy and security of its customers' genetic information. The Navigenics Health Compass set of genetic analysis services will honor existing commitments but not take in new business.
Life Technologies is also currently developing diagnostic tests across multiple platforms. In October 2011, Life Technologies announced a partnership to develop a companion diagnostic for GlaxoSmithKline's MAGE-A3 cancer immunotherapy. Life Technologies also has an assay development partnership with Gen-Probe, and recently announced collaborations with Boston Children's Hospital and the Hospital for Sick Children in Toronto to develop the company's next generation sequencers for clinical research in pediatric diseases.
About Life TechnologiesLife Technologies Corporation (LIFE) is a global biotechnology company with customers in more than 160 countries using its innovative solutions to solve some of today's most difficult scientific challenges. Quality and innovation are accessible to every lab with its reliable and easy-to-use solutions spanning the biological spectrum with more than 50,000 products for agricultural biotechnology, translational research, molecular medicine and diagnostics, stem cell-based therapies, forensics, food safety and animal health. Its systems, reagents and consumables represent some of the most cited brands in scientific research including: Ion Torrent, Applied Biosystems, Invitrogen, GIBCO, Ambion, Molecular Probes, Novex, and TaqMan. Life Technologies employs approximately 10,400 people and upholds its ongoing commitment to innovation with more than 4,000 patents and exclusive licenses. LIFE had sales of $3.7 billion in 2011. Visit us at our website: http://www.lifetechnologies.com.
See the original post:
Acquisition of Navigenics Expands Life Technologies' Capabilities in Diagnostics
Recommendation and review posted by Bethany Smith
'Nanorobot' can be programmed to target different diseases
(Phys.org) -- University of Florida researchers have moved a step closer to treating diseases on a cellular level by creating a tiny particle that can be programmed to shut down the genetic production line that cranks out disease-related proteins.
In laboratory tests, these newly created nanorobots all but eradicated hepatitis C virus infection. The programmable nature of the particle makes it potentially useful against diseases such as cancer and other viral infections.
The research effort, led by Y. Charles Cao, a UF associate professor of chemistry, and Dr. Chen Liu, a professor of pathology and endowed chair in gastrointestinal and liver research in the UF College of Medicine, is described online this week in the Proceedings of the National Academy of Sciences.
This is a novel technology that may have broad application because it can target essentially any gene we want, Liu said. This opens the door to new fields so we can test many other things. Were excited about it.
During the past five decades, nanoparticles particles so small that tens of thousands of them can fit on the head of a pin have emerged as a viable foundation for new ways to diagnose, monitor and treat disease. Nanoparticle-based technologies are already in use in medical settings, such as in genetic testing and for pinpointing genetic markers of disease. And several related therapies are at varying stages of clinical trial.
The Holy Grail of nanotherapy is an agent so exquisitely selective that it enters only diseased cells, targets only the specified disease process within those cells and leaves healthy cells unharmed.
To demonstrate how this can work, Cao and colleagues, with funding from the National Institutes of Health, the Office of Naval Research and the UF Research Opportunity Seed Fund, created and tested a particle that targets hepatitis C virus in the liver and prevents the virus from making copies of itself.
Hepatitis C infection causes liver inflammation, which can eventually lead to scarring and cirrhosis. The disease is transmitted via contact with infected blood, most commonly through injection drug use, needlestick injuries in medical settings, and birth to an infected mother. More than 3 million people in the United States are infected and about 17,000 new cases are diagnosed each year, according to the Centers for Disease Control and Prevention. Patients can go many years without symptoms, which can include nausea, fatigue and abdominal discomfort.
Current hepatitis C treatments involve the use of drugs that attack the replication machinery of the virus. But the therapies are only partially effective, on average helping less than 50 percent of patients, according to studies published in The New England Journal of Medicine and other journals. Side effects vary widely from one medication to another, and can include flu-like symptoms, anemia and anxiety.
Cao and colleagues, including graduate student Soon Hye Yang and postdoctoral associates Zhongliang Wang, Hongyan Liu and Tie Wang, wanted to improve on the concept of interfering with the viral genetic material in a way that boosted therapy effectiveness and reduced side effects.
Read this article:
'Nanorobot' can be programmed to target different diseases
Recommendation and review posted by Bethany Smith
Life Technologies Acquires Consumer Genetics Testing Firm Navigenics
Edison Liu has been elected to the Foundation for the National Institutes of Health's board of directors. His term began on June 19.
Liu is the president and CEO of the Jackson Laboratory and president of the Human Genome Organization. He joined the Jackson Laboratory from the Genome Institute of Singapore, where he was the founding executive director. Prior to that, he was the scientific director of the National Cancer Institute's division of clinical sciences.
Gene synthesis company Gen9 has appointed Kevin Munnelly to be president and CEO and Martin Goldberg to be chief operating officer.
Munnelly previously was general manager in Life Technologies' global next-generation qPCR business, and he was VP and GM of Biotrove, which Life Technologies acquired in 2009. Goldberg spent 17 years at Affymetrix, where he most recently oversaw the company's technology and product development efforts.
23andMe has named Andy Page to its board of directors. He currently serves as president of Gilt Group. Previously he served as chief operating and financial officer at PlayPhone; chief financial officer and senior vice president of business strategy at StubHub; and has held senior executive positions at Panasas, ONI Systems, and Robertson Stephens & Company.
Follow this link:
Life Technologies Acquires Consumer Genetics Testing Firm Navigenics
Recommendation and review posted by Bethany Smith
Twins genetics, environment linked
A new study has revealed that environmental factors play a vital role in forming the newborn epigenetic profile with consequences that can last a lifetime.
An international team of researchers analyzed a number of twin pairs, both identical and fraternal, who are ideal for epigenetic study as they share the same mother but have their own umbilical cord and amniotic sac, and in the case of identical twins, also share the same genetic make-up.
Experimental studies on animal models have demonstrated that the environment shapes the epigenetic profile across the genome, called the epigenome, particularly in the womb. The research also has indicated that even in identical twins, there are widespread differences in the epigenetic profile of twins at birth.
"This must be due to events that happened to one twin and not the other," said senior author of the report Dr. Jeffrey Craig of the Murdoch Childrens Research Institute (MCRI) in Australia.
Although twins share a womb, the influence of specific tissues like the placenta and umbilical cord can be different for each fetus, and likely affects the epigenetic profile, Craig added.
The recent findings suggest the unique environmental experiences in the womb may have a more profound effect on epigenetic factors that influence health throughout life than previously thought, researchers concluded.
FGP/GHN
Go here to read the rest:
Twins genetics, environment linked
Recommendation and review posted by Bethany Smith
Gene therapy treatment extends lives of mice with fatal disease
ScienceDaily (July 16, 2012) A team of University of Missouri researchers has found that introducing a missing gene into the central nervous system could help extend the lives of patients with Spinal Muscular Atrophy (SMA) -- the leading genetic cause of infantile death in the world.
SMA is a rare genetic disease that is inherited by one in 6,000 children who often die young because there is no cure. Children who inherit SMA are missing a gene that produces a protein which directs nerves in the spine to give commands to muscles.
The MU team, led by Christian Lorson, professor in the Department of Veterinary Pathobiology and the Department of Molecular Microbiology and Immunology, introduced the missing gene into mice born with SMA through two different methods: intravenously and directly into the mice's central nervous systems. While both methods were effective in extending the lives of the mice, Lorson found that introducing the missing gene directly into the central nervous system extended the lives of the mice longer.
"Typically, mice born with SMA only live five or six days, but by introducing the missing SMN gene into the mice's central nervous systems, we were able to extend their lives 10-25 days longer than SMA mice who go untreated," said Lorson, who works in the MU Bond Life Sciences Center and the College of Veterinary Medicine. "While this system is still not perfect, what our study did show is that the direct administration of the missing gene into the central nervous system provides some degree of rescue and a profound extension of survival."
There are several different types of SMA that appear in humans, depending on the age that symptoms begin to appear. Lorson believes that introducing the missing gene through the central nervous system is a way to potentially treat humans regardless of what SMA type they have.
"This is a treatment method that is very close to being a reality for human patients," Lorson said. "Clinical trials of SMA treatment using gene therapy are likely to begin in next 12-18 months, barring any unforeseen problems."
The study, "Direct central nervous system delivery provides enhanced protection following vector mediated gene replacement in a severe model of Spinal Muscular Atrophy," was published in Biochemical and Biophysical Research Communications. Co-authors of the study include Jacqueline Glascock and Monir Shababi from MU College of Veterinary Medicine.
Share this story on Facebook, Twitter, and Google:
Other social bookmarking and sharing tools:
Story Source:
See the original post:
Gene therapy treatment extends lives of mice with fatal disease
Recommendation and review posted by Bethany Smith
Gene therapy treatment extends lives of mice with fatal disease, MU study finds
Public release date: 16-Jul-2012 [ | E-mail | Share ]
Contact: Nathan Hurst hurstn@missouri.edu 573-882-6217 University of Missouri-Columbia
COLUMBIA, Mo. A team of University of Missouri researchers has found that introducing a missing gene into the central nervous system could help extend the lives of patients with Spinal Muscular Atrophy (SMA) the leading genetic cause of infantile death in the world.
SMA is a rare genetic disease that is inherited by one in 6,000 children who often die young because there is no cure. Children who inherit SMA are missing a gene that produces a protein which directs nerves in the spine to give commands to muscles.
The MU team, led by Christian Lorson, professor in the Department of Veterinary Pathobiology and the Department of Molecular Microbiology and Immunology, introduced the missing gene into mice born with SMA through two different methods: intravenously and directly into the mice's central nervous systems. While both methods were effective in extending the lives of the mice, Lorson found that introducing the missing gene directly into the central nervous system extended the lives of the mice longer.
"Typically, mice born with SMA only live five or six days, but by introducing the missing SMN gene into the mice's central nervous systems, we were able to extend their lives 10-25 days longer than SMA mice who go untreated," said Lorson, who works in the MU Bond Life Sciences Center and the College of Veterinary Medicine. "While this system is still not perfect, what our study did show is that the direct administration of the missing gene into the central nervous system provides some degree of rescue and a profound extension of survival."
There are several different types of SMA that appear in humans, depending on the age that symptoms begin to appear. Lorson believes that introducing the missing gene through the central nervous system is a way to potentially treat humans regardless of what SMA type they have.
"This is a treatment method that is very close to being a reality for human patients," Lorson said. "Clinical trials of SMA treatment using gene therapy are likely to begin in next 12-18 months, barring any unforeseen problems."
###
The study, "Direct central nervous system delivery provides enhanced protection following vector mediated gene replacement in a severe model of Spinal Muscular Atrophy", was published in Biochemical and Biophysical Research Communications. Co-authors of the study include Jacqueline Glascock and Monir Shababi from MU College of Veterinary Medicine.
Excerpt from:
Gene therapy treatment extends lives of mice with fatal disease, MU study finds
Recommendation and review posted by Bethany Smith
Three F&N Out-Do Yourself Awards presented for civic consciousness and compassion
16th July, 2012
A paraplegic who helps other spinal cord injury victims, a couple who have dedicated their lives to helping underprivileged and refugee children break the cycle of poverty and a blind teacher who pushes his blind students to excel in their studies these four Malaysians were recognised by Fraser & Neave Holdings Bhd in the 6th F&N Out-Do Yourself Award (OYA).
The recipients were selected by a panel of judges headed by former Chief Justice Tun Mohamed Dzaiddin Hj Abdullah and comprising distinguished editors from leading media publications in Malaysia, for going beyond the call of duty to perform extraordinary deeds involving civic consciousness and compassion.
Launched in conjunction with F&Ns 125th anniversary in 2008, the F&N OYA is aimed at recognizing ordinary individuals for various acts of selflessness ranging from bravery, chivalry, civic consciousness and promoting nation building to outstanding sports or academic achievements.
The 6th F&N OYA was presented to Leonard Chua, Elisha, Petrina Satvinder and Koh Chai Swee.
OYA Patron, Tan Sri Shahrir bin Abdul Samad handed out the awards alongside Tengku Syed Badarudin Jamalullail, F&N Holdings Bhd Chairman, Tun Mohamed Dzaiddin Hj Abdullah and Dato Ng Jui Sia, F&N Holdings Bhd CEO. The recipients are awarded a cheque for RM5,000, certificate, plaque and F&N products.
Nominees for the award are identified largely based on stories written or highlighted through common mass media channels. Dato Ng said that while these mediums have been a rich source of inspirational stories, F&N is mindful that there are many deeds that have not been highlighted due to various unavoidable factors.
Read more from the original source:
Three F&N Out-Do Yourself Awards presented for civic consciousness and compassion
Recommendation and review posted by sam