SILVER SPRING, Md., Aug. 9, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today an article describing cancer treatments under development by its wholly-owned subsidiary, Austrianova Singapore, has just been published in BioSpectrum Asia, the leading biotechnology industry magazine in Asia.

The invited article entitled "'Suicide genes' is the next step to cure cancer" was co-authored by Dr. Brian Salmons, Austrianova's President and CEO, and Dr. Walter Gunzburg, its Chairman. The article featured the Company's patented live cell encapsulation technology and pointed to the clinical success in the treatment of solid tumors, among other uses. The use of live encapsulated cells that locally catalyzed conversion of chemotherapeutic prodrugs to their active, cancer-killing forms at the site where they are needed was discussed since it has been shown to work well for pancreatic cancer. In the completed Phase 1/2 clinical trial, patients were noted to experience a doubling of the median survival time through disease improvement or stabilization and an important reduction in the side effects of the added chemotherapy treatment was observed while at the same time enhancing their anti-tumor effectiveness.

The safety and efficacy data obtained from clinical trials of the treatment of pancreatic and breast cancer solid tumors was reviewed in the article. In addition, there was also a discussion of additional preclinical data suggesting improved clinical benefits with fewer side effects than standard chemotherapy were also achievable for tumors such as hepatocellular (liver) cancer, squamous cell carcinoma, ovarian cancer, colon cancer metastases and possibly even brain tumors like glioma/glioblastoma.

Promising preclinical data has already demonstrated use of multiple prodrug activation systems. The data from this ongoing research offers the possibility of "personalized" therapies. There is even the possibility of combining these treatments with standard radiotherapy to have a greater effect and potential increased success in treating cancer patients. The article also points out that encapsulated cells can also be used to attack tumors by placing them in the body and allowing continuous production of tumor-honing toxic antibodies, such as Herceptin(R). Another means to attack cancer cells can be by placing into the body encapsulated living cells that excrete natural growth inhibitors like tumor necrosis factors (proteins that cause certain cells to die) or anti-angiogenic factors (proteins that inhibit new blood vessel formation). All of these antitumor strategies represent an arsenal that can be combined to attack cancer at many different levels.

Dr. Robert F. Ryan, CEO of Nuvilex said, "This article clearly points out the value and strengths of our proprietary living cell encapsulation technology for combating tumors, in particular many of those that represent unmet medical needs. Combining these strategies opens the way for carefully planned and combined living cell therapies as means for treating cancer simply on an individual patient basis. The ongoing work in the Company will serve to enhance our ability to provide new means to fight against the many and varied forms of this deadly group of diseases."

About Nuvilex

Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Substantial progress in multiple areas will be providing the Company with increased potential. 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

This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.

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Nuvilex Subsidiary Austrianova Singapore's Cancer Treatments Featured in Asia's Leading Biotech Industry Magazine

Recommendation and review posted by Bethany Smith

Newswise Bethesda, MDAugust 9, 2012 Listed below are the selected highlights for the August 2012 issue of the Genetics Society of Americas journal, GENETICS. The August issue is available online at http://www.genetics.org/content/current. Please credit GENETICS, Vol. 191, AUGUST 2012, Copyright 2012.

Please feel free to forward to colleagues who may be interested in these articles.

ISSUE HIGHLIGHTS

New negative feedback regulators of Egfr signaling in Drosophila, pp. 12131226 Jonathan P. Butchar, Donna Cain, Sathiya N. Manivannan, Andrea D. McCue, Liana Bonanno, Sarah Halula, Sharon Truesdell, Christina L. Austin, Thomas L. Jacobsen, and Amanda Simcox While much is known about the checks and balances necessary for the precise specification of fly wings, these authors show that we didnt know it all. They report the discovery of two new negative regulators in the Egfr pathway that are conserved in other animals. Because a perfect wing is of critical importance to flies, it is likely that more such controls will be discovered.

On the prospects of whole-genome association mapping in Saccharomyces cerevisiae, pp. 13451353 Caitlin F. Connelly and Joshua M. Akey Genome-wide association (GWA) studies have not caught on for model organisms. One challenge is population structure, which can result in spurious associations. This article shows that indeed, GWA studies in yeast are complicated by complex patterns of population structure that are not easily corrected by existing approaches. The authors expound on how careful study design and empirical tests of the effects of population structure will be necessary for carrying out GWA studies in model organisms. Suppressors, screens, and genes: An educational primer for use with A network of genes antagonistic to the LIN-35 retinoblastoma protein of Caenorhabditis elegans, pp. 1031-1035 Elizabeth A. De Stasio This is the first of a new series of articles in GENETICSEducational Primersdesigned to guide educators in the use of current scientific literature in the classroom (see editorial in this issue). In this Primer, Elizabeth De Stasio explains how Polley and Fay used RNA interference, suppressor screens, and synthetic phenotypes to elucidate the function of the retinoblastoma protein in C. elegans (see article in this issue). Each Primer provides necessary background for students and offers a sample approach to classroom use of the original article, including discussion questions.

A resolution of the mutation load paradox in humans, pp. 13211330 Yann Lesecque, Peter D. Keightley, and Adam Eyre-Walker It has been estimated that each of us receives, on average, at least two new harmful mutations from our parents. Previous theoretical work suggested that this high rate of harmful mutation should result in 88% of individuals failing to have offspring, and each female having to have more than 16 offspring on average, to maintain population size. Fortunately, those calculations are incorrect, as these authors show. They show that humans could tolerate hundreds of new harmful mutations if natural selection acts via competition between individuals.

SNP-ratio mapping (SRM): Identifying lethal alleles and mutations in complex genetic backgrounds by next-generation sequencing, pp. 13811386 Heike Lindner, Michael T. Raissig, Christian Sailer, Hiroko Shimosato-Asano, Rmy Bruggmann, and Ueli Grossniklaus Mutations in essential genes are difficult to identify. Here the authors present a method for quick identification of homozygous-lethal alleles by next-generation sequencing. The authors method, which can also be used to map second-site modifiers in complex genetic/transgenic backgrounds, can be applied to any genetic organism.

The mRNA decay pathway regulates the expression of the Flo11 adhesin and biofilm formation in Saccharomyces cerevisiae, pp. 13871391 Tricia L. Lo, Yue Qu, Nathalie Uwamahoro, Tara Quenault, Traude H. Beilharz, and Ana Traven The gene encoding the yeast cell-wall adhesin Flo11 offers an excellent platform for learning how gene expression is controlled by extracellular signals and developmental pathways. Regulated expression of the cell-wall adhesins is also relevant to virulence properties of pathogenic fungi and industrial applications with yeasts. These investigators discover a novel mechanism controlling FLO11 expression: the mRNA decay pathway inhibits the expression of transcriptional repressors of FLO11. Fluctuations of fitness distributions and the rate of Mullers ratchet, pp. 12831293 Richard A. Neher and Boris I. Shraiman Mullers ratchet is relentless, but its quantitative characterization has remained a challenge. This article offers a systematic analysis of the stochastic properties of the deleterious mutation selection-balance, and provides an accurate formula for the rate of Mullers ratchet.

A network of genes antagonistic to the LIN-35 retinoblastoma protein of Caenorhabditis elegans, pp. 13671380 Stanley R. G. Polley and David S. Fay The pRb tumor suppressor of Caenorhabditis elegans (LIN-35) regulates a diverse range of cellular and developmental processes. This article describes genes that were identified as genetic suppressors of phenotypes associated with LIN-35/pRb loss of function in the worm. Because the encoded proteins are highly conserved, these may represent candidate targets for anticancer therapies, as their inactivation alleviates defects associated with a commonly inactivated tumor suppressor in humans.

Transvection is common throughout the Drosophila genome, pp. 11291141 David J. Mellert and James W. Truman We know that cis-regulatory sequence elements can regulate transcription in trans, but what is the prevalence of their action in trans? These investigators show that trans interactions between transgenes inserted into the Drosophila genome is common, and provide insight into possible molecular mechanisms. Because trans interactions between transgenes can confound experimental strategies, the authors propose guidelines for using transgenes inserted via site-specific integration. and Comparing enhancer action in cis and in trans, pp. 11431155 Jack R. Bateman, Justine E. Johnson, and Melissa N. Locke Sometimes two chromosomes are close enough that an enhancer on one can communicate in trans with a promoter on its neighbor. How does this transvection work? This article describes a transgenic approach to the study of transvection that simplifies sequence manipulation and enables precise quantification of changes to gene expression when enhancers act in cis or trans.

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GENETICS Journal Highlights for August 2012

Recommendation and review posted by Bethany Smith

Public release date: 9-Aug-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-634-7302 Genetics Society of America

Bethesda, MDAugust 9, 2012 Listed below are the selected highlights for the August 2012 issue of the Genetics Society of America's journal, GENETICS. The August issue is available online at http://www.genetics.org/content/current. Please credit GENETICS, Vol. 191, AUGUST 2012, Copyright 2012.

Please feel free to forward to colleagues who may be interested in these articles.

ISSUE HIGHLIGHTS

New negative feedback regulators of Egfr signaling in Drosophila, pp. 1213 Jonathan P. Butchar, Donna Cain, Sathiya N. Manivannan, Andrea D. McCue, Liana Bonanno, Sarah Halula, Sharon Truesdell, Christina L. Austin, Thomas L. Jacobsen, and Amanda Simcox While much is known about the checks and balances necessary for the precise specification of fly wings, these authors show that we didn't know it all. They report the discovery of two new negative regulators in the Egfr pathway that are conserved in other animals. Because a perfect wing is of critical importance to flies, it is likely that more such controls will be discovered.

On the prospects of whole-genome association mapping in Saccharomyces cerevisiae, pp. 1345 Caitlin F. Connelly and Joshua M. Akey Genome-wide association (GWA) studies have not caught on for model organisms. One challenge is population structure, which can result in spurious associations. This article shows that indeed, GWA studies in yeast are complicated by complex patterns of population structure that are not easily corrected by existing approaches. The authors expound on how careful study design and empirical tests of the effects of population structure will be necessary for carrying out GWA studies in model organisms.

Suppressors, screens, and genes: An educational primer for use with "A network of genes antagonistic to the LIN-35 retinoblastoma protein of Caenorhabditis elegans", pp. 1031-1035 Elizabeth A. De Stasio This is the first of a new series of articles in GENETICS Educational Primers designed to guide educators in the use of current scientific literature in the classroom (see editorial in this issue). In this Primer, Elizabeth De Stasio explains how Polley and Fay used RNA interference, suppressor screens, and synthetic phenotypes to elucidate the function of the retinoblastoma protein in C. elegans (see article in this issue). Each Primer provides necessary background for students and offers a sample approach to classroom use of the original article, including discussion questions.

A resolution of the mutation load paradox in humans, pp. 1321 Yann Lesecque, Peter D. Keightley, and Adam Eyre-Walker It has been estimated that each of us receives, on average, at least two new harmful mutations from our parents. Previous theoretical work suggested that this high rate of harmful mutation should result in 88% of individuals failing to have offspring, and each female having to have more than 16 offspring on average, to maintain population size. Fortunately, those calculations are incorrect, as these authors show. They show that humans could tolerate hundreds of new harmful mutations if natural selection acts via competition between individuals.

SNP-ratio mapping (SRM): Identifying lethal alleles and mutations in complex genetic backgrounds by next-generation sequencing, pp. 1381 Heike Lindner, Michael T. Raissig, Christian Sailer, Hiroko Shimosato-Asano, Rmy Bruggmann, and Ueli Grossniklaus Mutations in essential genes are difficult to identify. Here the authors present a method for quick identification of homozygous-lethal alleles by next-generation sequencing. The authors' method, which can also be used to map second-site modifiers in complex genetic/transgenic backgrounds, can be applied to any genetic organism.

Read more here:
Genetics Society of Americas GENETICS journal highlights for August 2012

Recommendation and review posted by Bethany Smith

Public release date: 9-Aug-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-634-7302 Genetics Society of America

BETHESDA, MD August 9, 2012 -- As upper level undergraduate genetics instructors plan their syllabi for the fall semester, the Genetics Society of America's GENETICS journal offers a new educational resource, articles called "Primers." These articles are designed to bring cutting-edge scientific research into the classroom by making scientific papers accessible to students.

The principal learning goal of the Primer is to "make research and genetics accessible to a much broader audience, not just researchers, their postdocs and grad students, but also to undergraduates and their instructors," said Elizabeth A. De Stasio, Ph.D., a professor in the department of biology at Lawrence University in Appleton, Wisconsin, and editor of the Primer section in the GENETICS journal.

"With jargon and unfamiliar techniques, the primary research literature can be inaccessible to many students," Dr. De Stasio added. "The Primer article, tied to a research article published in the same issue of GENETICS, will provide guidelines for genetics instructors who want to expose their students to current research."

The August 2012 GENETICS Primer written by Dr. De Stasio is based on the article, "A Network of Genes Antagonistic to the LIN-35 Retinoblastoma Protein of Caenorhabditis elegans," by Stanley R. G. Polley and David S. Fay. The Primer introduces concepts of reverse genetics and RNA interference (RNAi), suppressor screens, synthetic phenotypes and phenocopy. Necessary background, explanations of concepts, as well as suggestions for using the article in the classroom and questions for classroom discussion are included.

"The intent is for the research article and the Primer to be used together in the context of a genetics classroom. We will be highlighting articles that teach and reinforce genetic principles and approaches, while concentrating on current, rather than classic discoveries," Dr. De Stasio noted. "Focusing the Primers on contemporary scientific literature will engage students in the learning process and guide them toward the process of scientific discovery." Dr. De Stasio expects the Journal to publish six Primer articles each year, about one in every other issue of GENETICS.

"Providing valuable educational resources like this that enhance the quality of genetics education, teaching and learning is one of our missions." said Mark Johnston, Editor-in-Chief of GENETICS. "Engaging students in the process of critically analyzing primary research is a vital part of research training."

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New Genetics educational resource promotes active learning

Recommendation and review posted by Bethany Smith

IRVINE, Calif. and AMSTERDAM, Aug. 9, 2012 /PRNewswire/ -- Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, today announced that Stefan Gluck, MD, PhD, will lead the company's Medical Advisory Board. As Chairman, Dr. Gluck is assembling a panel of leading medical oncologists, surgeons, scientists and pathologists to play a key role in advising Agendia on the clinical application of its extensive product pipeline, including its Symphony suite of FFPE based tests for breast cancer and its ColoPrint test for colon cancer.

"Agendia is at the forefront of the personalized medicine revolution, and as a medical oncologist, I am very excited and honored to collaborate with the company at such a critical time," said Dr. Gluck. "With a robust pipeline of new cancer profiles in development, I look forward to applying my knowledge and expertise to facilitate diagnosis, prognosis and cancer diagnostic development."

Dr. Gluck is a Sylvester Professor at the Miller School of Medicine at the University of Miami in Florida. From 20032008, he was the Clinical Director of the Braman Family Breast Cancer Institute. Before his move to Miami, Dr. Gluck was Director, Southern Alberta Breast Cancer Program at the Tom Baker Cancer Center, and a Professor in the departments of oncology, medicine, pharmacology and therapeutics at the University of Calgary in Alberta, Canada, and Deputy Head, Department of Oncology at the University of Calgary.

"Dr. Gluck brings over 20 years of clinical experience in the medical profession to Agendia's Medical Advisory Board," said David Macdonald, CEO of Agendia. "Agendia is committed to advancing the future of personalized medicine through the development of new diagnostic tests. Dr. Gluck's extensive knowledge and vast experience will provide our Medical Advisory Board with strong leadership as we continue to bring Agendia's rich product pipeline to market."

Dr. Gluck was presented the America's Top Oncologists award from Consumers' Research Council of America. He was also recognized as one of the Best Doctors in America from 2006 through 2012. He has authored or co-authored more than 200 articles. In addition, Dr Gluck has written or co-written a number of book chapters and numerous journal abstracts, and he has presented more than 350 papers at national and international meetings.

Dr Gluck completed his medical studies at the Free University of West Berlin, Germany. The internship in Berlin was followed by residency in internal medicine and fellowship in hematology at the Heinrich Heine Universitat in Dusseldorf, Germany, and a medical oncology and bone marrow transplant fellowship at the Princess Margaret Hospital, University of Toronto in Canada.

About Agendia:

Agendia is a leading molecular diagnostic company that develops and markets genomic-based diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, TargetPrint, an ER/PR/HER2 expression assay, and TheraPrint, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

For more information, please visit http://www.agendia.com.

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Agendia Appoints Dr. Stefan Gluck to Chair Medical Advisory Board

Recommendation and review posted by sam

ScienceDaily (Aug. 8, 2012) DNA holds the genetic code for all sorts of biological molecules and traits. But University of Illinois researchers have found that DNA's code can similarly shape metallic structures.

The team found that DNA segments can direct the shape of gold nanoparticles -- tiny gold crystals that have many applications in medicine, electronics and catalysis. Led by Yi Lu, the Schenck Professor of Chemistry at the U. of I., the team published its surprising findings in the journal Angewandte Chemie.

"DNA-encoded nanoparticle synthesis can provide us a facile but novel way to produce nanoparticles with predictable shape and properties," Lu said. "Such a discovery has potential impacts in bio-nanotechnology and applications in our everyday lives such as catalysis, sensing, imaging and medicine."

Gold nanoparticles have wide applications in both biology and materials science thanks to their unique physicochemical properties. Properties of a gold nanoparticle are largely determined by its shape and size, so it is critical to be able to tailor the properties of a nanoparticle for a specific application.

"We wondered whether different combinations of DNA sequences could constitute 'genetic codes' to direct the nanomaterial synthesis in a way similar to their direction of protein synthesis," said Zidong Wang, a recent graduate of Lu's group and the first author of the paper.

Gold nanoparticles are made by sewing tiny gold seeds in a solution of gold salt. Particles grow as gold in the salt solution deposits onto the seeds. Lu's group incubated the gold seeds with short segments of DNA before adding the salt solution, causing the particles to grow into various shapes determined by the genetic code of the DNA.

The DNA alphabet comprises four letters: A, T, G and C. The term genetic code refers to the sequence of these letters, called bases. The four bases and their combinations can bind differently with facets of gold nanoseeds and direct the nanoseeds' growth pathways, resulting in different shapes.

In their experiments, the researchers found that strands of repeating A's produced rough, round gold particles; T's, stars; C's, round, flat discs; G's, hexagons. Then the group tested DNA strands that were a combination of two bases, for example, 10 T's and 20 A's. They found that many of the bases compete with each other resulting in intermediate shapes, although A dominates over T.

Next, the researchers plan to investigate exactly how DNA codes direct nanoparticle growth. They also plan to apply their method to synthesize other types of nanomaterials with novel applications.

The National Science Foundation supported this work.

Continued here:
Oh, my stars and hexagons! DNA code shapes gold nanoparticles

Recommendation and review posted by Bethany Smith

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

Seattle Genetics, Inc. (SGEN) today reported financial results for the second quarter ended June 30, 2012. The company also highlighted progress with ADCETRIS (brentuximab vedotin) commercialization activities, ongoing and planned clinical trials and upcoming milestones.

As the leader in developing antibody-drug conjugate therapies, we along with our many collaborators are using our technology to change the way cancer is treated, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. We remain focused on making ADCETRIS available to patients, and we are delivering on this priority both through continued commercial initiatives for patients in the labeled indications, as well as through our robust clinical development of ADCETRIS in earlier lines of therapy and other CD30-positive malignancies. We are also focused on advancing our robust pipeline of ADC candidates and leveraging our ADC technology in collaborations to further advance the treatment of cancer.

Recent ADCETRIS Highlights

Other Recent Highlights

Upcoming Milestones

Second Quarter and First Six Months 2012 Financial Results

Revenues in the second quarter of 2012 were $48.8 million, compared to $13.1 million in the second quarter of 2011. Revenues for the six month period ended June 30, 2012 were $97.1 million, compared to $25.2 million in 2011. Revenues in 2012 include ADCETRIS net product sales of $34.7 million in the second quarter and $69.2 million for the year to date. Second quarter revenues in 2012 include ADCETRIS royalty revenues of $1.2 million related to sales of ADCETRIS by Millennium under its international named patient program. Revenues also reflect amounts earned under the companys ADCETRIS and ADC collaborations, which increased approximately 6 percent for the year-to-date in 2012 compared to 2011.

Total costs and expenses for the second quarter of 2012 were $66.1 million, compared to $64.8 million for the second quarter of 2011. For the first six months of 2012, total costs and expenses were $129.9 million, compared to $110.0 million in the first six months of 2011. The planned increases in 2012 costs and expenses were primarily driven by ADCETRIS commercialization and research and clinical development activities in addition to research and development of the companys other ADC pipeline programs.

Under the ADCETRIS collaboration with Millennium, development costs incurred by Seattle Genetics are included in research and development expense. Joint development costs are co-funded by Millennium on a 50:50 basis. Reimbursement payments received from Millennium are recognized as revenue over the development period of the collaboration along with other development payments received, including the upfront payment and milestone payments. Seattle Genetics co-funds development activities performed by Millennium under the collaboration, which reduces the amount of reimbursement payments received from Millennium.

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Seattle Genetics Reports Second Quarter 2012 Financial Results

Recommendation and review posted by Bethany Smith

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

Advanced Cell Technology, Inc. (ACT, OTCBB: ACTC)(the Company), a leader in the field of regenerative medicine, announced today second quarter financial results for the period ended June 30, 2012.

Highlights of the second quarter include:

Second Quarter 2012 Financial Results

ACT had revenue totaling $218,184 for the 2012 second quarter, compared to revenue of $153,688 in the prior year. Revenue was generated through license fees and royalty payments. Research and Development expenses for the three months ended June 30, 2012 and 2011 were $2,068,098 and $1,532,271 respectively.

The Company reported a loss from operations of $(4.5) million in the 2012 second quarter compared to a loss from operations of $(3.6) million in the 2011 second quarter. ACT reported a net loss of $(4.0) million or $(0.00) loss per share in the 2012 second quarter, compared to a net loss in the same period of 2011 of $(4.8) million, or $(0.0) per share.

Net cash used in operations for the 2012 second quarter was $2.9 million, compared to net cash used in operations of $3.3 million in the same period in 2011. The net cash used in operations was a result of ongoing clinical activities. The Company ended the 2012 second quarter with cash and cash equivalents of $9.9 million, compared to approximately $10.8 million as of March 31, 2012.

We are pleased with our progress to date in our ongoing Phase I/II clinical trials for the treatment of Stargardts Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD), said Gary Rabin, interim Chairman and CEO of ACT. The promising preliminary results from the first cohort have positioned the Company well as we enter the second cohort and higher dosage in our landmark macular degeneration trials.

The company will hold a conference call and webcast to discuss the second quarter results and provide a corporate update today at 4:30 p.m. eastern time.

Interested parties may access the call live by dialing (888) 264-3177 or 706-902-4345 and using conference ID 90962449. This event is also being streamed via webcast. The webcast is available at:

Originally posted here:
Advanced Cell Technology Announces 2012 Second Quarter Results

Recommendation and review posted by sam

LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.

"In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing the enrollment on time confirms our leadership position in the field. We anticipate reporting the results of the study no later than April 2013."

About Cx611 for rheumatoid arthritisCx611 is a suspension of expanded allogeneic adult stem cells derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or 'eASCs') that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study has enrolled 53 patients, divided in 3 cohorts with different dosing regimens. There are 23 centers open and the company expects the final results to be available in the first half of 2013.

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

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TiGenix Completes Patient Enrollment in Phase IIa Rheumatoid Arthritis Study

Recommendation and review posted by Bethany Smith

PALO ALTO, Calif.--(BUSINESS WIRE)--

CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the companys Corus CAD gene expression test for the evaluation of patients presenting with typical and atypical symptoms suggestive of coronary artery disease. With this decision, the Corus CAD gene expression test is now a covered benefit for more than 40 million Medicare enrollees in the U.S.

With a simple blood draw, Corus CAD can safely, accurately and conveniently help primary care clinicians and cardiologists assesswhether or not a stable non-diabetic patients symptoms are due to obstructive coronary artery disease (CAD), enabling many patients to avoid unnecessary invasive testing and exposure to imaging-related radiation risks or imaging agent intolerance. The test has been clinically validated in multiple independent patient cohorts, including two prospective, multicenter U.S. trials, PREDICT and COMPASS. Additionally, a retrospective, multicenter chart review study and the prospective IMPACT trial at Vanderbilt University demonstrated that Corus CAD use yielded significant and clinically relevant changes in patient management decisions in both primary care and cardiology settings.

"While the Corus CAD test was recognized by TIME Magazine as a top 10 medical breakthrough in 2010, the year the PREDICT validation study was published, fulfilling Medicare reimbursement criteria is now a major step forward," said Eric Topol, M.D., Principal Investigator of the PREDICT trial, Chief Academic Officer at Scripps Health and Professor of Genomics at The Scripps Research Institute. "Utilization of this gene expression test could lead to avoidance of a large number of unnecessary cardiac catheterization procedures and scans involving radiation." Dr. Topol has no financial relationship whatsoever with CardioDx.

Studies have shown that typical and atypical presentations of stable chest pain account for up to two percent of outpatient office visits each year in the U.S., but as many as 62 percent of stable patients who undergo elective invasive angiographic procedures are found to have no obstructive coronary artery blockage, despite broad usage of prior noninvasive imaging. The authors of a 2010 New England Journal of Medicine study of nearly 400,000 coronary angiography patients concluded that current modalities used to identify patients for elective invasive angiography to diagnose obstructive coronary artery disease have limitations, and that better methods are needed for patient risk stratification.

Identifying those symptomatic patients without a coronary blockage who may be able to avoid imaging or invasive testing is a significant problem for physicians, involving up to 10,000 patients daily in the U.S., said David Levison, President and CEO of CardioDx. By providing Medicare beneficiaries access to Corus CAD, this coverage decision enables patients to avoid unnecessary procedures and risks associated with cardiac imaging and elective invasive angiography, while helping payers address an area of significant health care spend.

About Corus CAD

With a simple blood draw, Corus CAD can help primary care clinicians and cardiologists exclude obstructive coronary artery disease as the cause of a stable non-diabetic patient's symptoms. It is the first sex-specific test for obstructive coronary artery disease, accounting for critical biological differences between men and women. The test is safe and does not expose patients to radiation risks or imaging agent intolerance. Corus CAD is intended for use in stable patients presenting with typical and atypical symptoms suggestive of obstructive coronary artery disease. Corus CAD is not intended for use in patients who are diabetic, have been diagnosed with prior myocardial infarction (MI) or have had a previous revascularization procedure, or are currently taking steroids, immunosuppressive agents or chemotherapeutic agents.

The Corus CAD test measures the RNA levels of 23 genes. Because blood cell RNA levels are altered when obstructive coronary artery disease is present, the Corus CAD score aids clinicians in assessing whether an individual patients symptoms may be due to obstructive coronary artery disease.

Corus CAD is commercially available through an innovative patient sample kit that includes everything needed for blood collection and express delivery to the companys CLIA-certified Palo Alto, Calif. laboratory. Test results are delivered promptly to the clinicians office. Corus CAD is currently available in the United States.

Link:
CardioDx Announces Medicare Coverage for Corus CAD Gene Expression Test for the Diagnosis of Obstructive Coronary ...

Recommendation and review posted by Bethany Smith

ScienceDaily (Aug. 7, 2012) Bioengineers at the University of California, San Diego have developed a method of modeling, simultaneously, an organism's metabolism and its underlying gene expression. In the emerging field of systems biology, scientists model cellular behavior in order to understand how processes such as metabolism and gene expression relate to one another and bring about certain characteristics in the larger organism.

In addition to serving as a platform for investigating fundamental biological questions, this technology enables far more detailed calculations of the total cost of synthesizing many different chemicals, including biofuels. Their method accounts, in molecular detail, for the material and energy required to keep a cell growing, the research team reported in the journal Nature Communications.

"This is a major advance in genome-scale analysis that accounts for the fundamental biological process of gene expression and notably expands the number of cellular phenotypes that we can compute," said Bernhard Palsson, Galetti Professor of Bioengineering, at the UC San Diego Jacobs School of Engineering.

"With this new method, it is now possible to perform computer simulations of systems-level molecular biology to formulate questions about fundamental life processes, the cellular impacts of genetic manipulation or to quantitatively analyze gene expression data," said Joshua Lerman, a Ph.D. candidate in Palsson's Systems Biology Research Group.

The team's method can be compared to understanding both the chemical reactions and the machinery that are required to refine crude oil into petrol in a large, industrial factory. Modeling metabolism tells you what biochemical reactions need to take place. Modeling the organism's gene expression tells you what kind of machinery you need. The team's method specifically accounts for the expression of enzymes, which are the molecular machines responsible for the biochemical processes of life. With this knowledge, it is possible to explore how an organism distributes its resources to promote growth and how genetic manipulation of these organisms alters this distribution.

"What you could hypothetically do with our model is simulate the total cost of producing a value-added product, such as a biofuel. That includes all the operating and maintenance costs," said Daniel Hyduke, a project scientist in Palsson's lab. Hyduke said the method has the potential to help streamline industrial metabolic engineering efforts by providing a near complete accounting of the minimal material and energy costs associated with novel strain designs for biofuel, commodity chemicals, and recombinant protein production.

Hyduke and Lerman prototyped the method on the minimal, yet metabolically versatile, hyperthermophile Thermotoga maritima. Because T. maritima is not currently ready for use in industrial applications, Hyduke and Lerman are working as part of a larger team to produce similar models for industrially relevant microorganisms, such as E. coli.

"We've built a virtual reality simulator of metabolism and gene expression for Thermotoga maritima, and shown that it much better approximates phenotypes of cells than modeling metabolism in isolation," said Lerman.

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Molecular economics: New computer models calculate systems-wide costs of gene expression

Recommendation and review posted by Bethany Smith

Story by Benjamin F. Kuo

Santa Monica-based Fundable (www.fundable.com) is a newly launched, crowdfunding site which is headed by local entrepreneur Wil Shroter. Recently, an interesting project popped up on the site--a a 2D to 3D conversion project, from the inventor of the original, LCD projector, Gene Dolgoff. Dolgoff has a fascinating background--he invented the first LCD projector, he helped inspire Star Trek's Holodeck, and he also is a serial entrepreneur who took his company public on the NASDAQ in the 90's. Since Dolgoff is raising money for his 2D-to-3D startup via Fundable, we thought it would be interesting to hear about the project, and how he ended up turning to Fundable.

Tell us about your project?

Gene Dolgoff: After years of research and development, we have developed technology which converts two dimensional video to 3D. Not only that, but we're able to display it on any display device, including TV sets, whether they are 2D or 3D, computers, projectors, and handheld devices. It was a series of different technologies we had ot develop and apply for patents on, and now that we have it, we're working on a prototype. Because we want to get into production, marketing, and sales, right now we're listing on Fundable.com. We have a contest for people to design what the case will look like, and we're using Fundable to raise $10,000 to give to the winner.

Why turn to crowdfunding and Fundable for this?

Gene Dolgoff: We were actually talking before there was a Fundable. We had been talking with another of their companies, the GoBig network, which is a membership organization of investors and entrepreneurs. We have a business plan and private placement on that site, and recently started searching for investors to raise the funds we needed to go into production, and start marketing and sales. We started talking with the folks at GoBig, and they ended up talking to people higher up in the organization, and then we ended up talking with their founders, including Wil. They told us that they were going to start this new, crowdfunding site, and we thought it would be great to be on it and started working together on it.

You've got an interesting story, can you talk about your road here?

Gene Dolgoff: When I was a young kid, I was fascinated by imagery. I wanted to learn about imagery, how the brain works, and how to make 3D images. I started making 3D images when I was thirteen, and at the time I was making lenticular 3D images with the guy who invented that process, victor Anderson. We also made a 3D, CRT television, which may have been the world's first 3D TV, which we had in the Brooklyn Museum in New York. In 1964, I started working on holography, and was one of the first in the world to work on that. Over the next decade, I invented the process of transfering that to printing, to things like credit cards and security applications, and many other different areas. The idea came to me for making a video projector that was brighter and better than CRTs, and it came to me how to do that in 1968.

I started experimenting with materials, and by 1970 I'd settled on liquid crystals, because it was a digital system. I had been a programmer since 1961, and was familiar with digital, and realized that was the way to go. It took until April of 1984, and by 1988 I had met someone to invest in it, and I started the world's first digital projector company, Projectavision. We got a contract form DARPA, the Defense Department agency in 1989, went public in 1999, raised $20M, and got lots of patents, licensed it to lots of companies, and also made our own product which showed up in stores. I was doing that until 1995. After I left, I started working on a lot of different areas, and one of those was 3D, lenticular printing. It was so much more advanced than back in 1960's, and we started selling posters in 3D for advertising. By late 2005 and 2006, we saw the return of 3D movies, made possible by the digital projectors. I realized now was the time to focus on consumer applications, because eventually everyone would want 3D TV in their home. So, we started developing the technology, and once that we put that together, we started looking for funding.

Can you talk a bit about your technology, and how it's different from other, 3D technology out there?

Read more here:
Gene Dolgoff's 3D Vision: Using Crowdfunding To Turn the World 3D

Recommendation and review posted by Bethany Smith

Public release date: 8-Aug-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, August 8, 2012Laparoscopic management of gallbladder disease offers a less invasive alternative to open surgery. Surgical outcomes continue to improve as new techniques and tools become available for performing laparoscopic gallbladder surgery, and these advances are highlighted in "Advances in Cholecystectomy Surgery (http://online.liebertpub.com/toc/lap/22/6)," a comprehensive special issue of Journal of Laparoendoscopic & Advanced Surgical Techniques (JLAST), a peer-reviewed journal published by Mary Ann Liebert, Inc. publishers (http://www.liebertpub.com). The issue is available free online at the Journal of Laparoendoscopic & Advanced Surgical Techniques (http://www.liebertpub.com/lap) website.

Samer Bessa, MD and coauthors, University of Alexandria, Egypt, compared the feasibility, safety, and side effects of laparoscopic cholecystectomy performed with general anesthesia, the standard of care, or with spinal anesthesia. In the accompanying Commentary on "Spinal Versus General Anesthesia for Day-Case Laparoscopic Cholecystectomy: A Prospective Randomized Study," (http://online.liebertpub.com/doi/full/10.1089/lap.2012.9992) Fred Luchette, MD, MSc, considers whether the risks of spinal anesthesia outweigh its potential benefits for this procedure.

Rajeev Sinha, MS, and Sharad Chandra, MD, DM, M.L.B. Medical College, Jhansi, Uttar Pradesh, India, described a group of patients who developed biliary peritonitis, a potentially serious adverse event, following laparoscopic gallbladder removal using a "scarless" single-site surgical technique known as LESS. L. Michael Brunt, MD, Washington University School of Medicine, St. Louis, MO, provides his insights on this study and its implications in Commentary on "Cystic Duct Leaks After Laparoendoscopic Single Site Cholecystectomy (LESS)": A Word of Caution (http://online.liebertpub.com/doi/full/10.1089/lap.2012.9993).

The issue also features articles on long-term experience with post-cholecystectomy bile duct injuries and outcomes of laparoendoscopic surgery, as well as experience with robotic surgery to remove bile duct cysts in pediatric patients.

Videos illustrating cutting-edge techniques in cholecystectomy (http://www.liebertpub.com/lpages/highlighted-cholecystectomy-videos/25/) are available in Videoscopy (http://www.liebertpub.com/vor), the videojournal component of Journal of Laraoendoscopic & Advanced Surgical Techniques.

"The modern era of laparoscopic surgery all started over 20 years ago with laparoscopic cholecystectomy," says Editor-in-Chief C. Daniel Smith, MD, Department of Surgery, Mayo Clinic, Jacksonville, FL. "Despite this long experience with MIS, the advancements in gallbladder surgery continue today. This special issue includes several manuscripts highlighting continued advancements in the care of patients with gallbladder disease and will provide even surgeons with extensive experience new insights into gallbladder procedures."

###

About the Journal

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New tools and techniques enhance laparoscopic gallbladder removal

Recommendation and review posted by Bethany Smith

ILIU: Positive PST Study Data

Brian Marckx, CFA

This morning (8/6/12) Interleukin Genetics (ILIU) announced that the University of Michigan revealed top-line results of the eagerly awaited PST test study. The top-line data is positive, in favor of Interleukin's PST study showing efficacy on the primary endpoint, change in tooth loss based on patient risk category.

The study, officially titled Periodontal Disease Prevention Study: A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease was funded by Renaissance Health Service and conducted by the University of Michigan. It examined 16 years worth of data from over 5,000 patients taken from a large dental claims database. It is the pivotal study which is expected to show that certain risk factors, including a positive result on ILIU's PST genotyping test, can help predict periodontal disease and determine the optimal number of dental cleanings per year, which will provide support to reimburse for the PST from dental insurance providers.

Top-line data from the study showed exactly what Interleukin hoped, that high risk patients are likely to benefit from more than one cleaning per year while low risk patients are not. Specifically the data showed that there was no significant difference between two dental cleanings and one dental cleaning in reducing the number of tooth extractions in the low-risk patient population (13.8% vs. 16.4%, p=0.092). By contrast there was a highly significant difference between two dental cleanings and one dental cleaning in reducing the number of tooth extractions in the high-risk patient population (16.9% vs. 22.1%, p=0.002).

Per the trial protocol, patients were categorized as low risk of tooth loss if they were non-smokers, did not have diabetes and were PST test negative. High risk were smokers, diabetic and PST test positive. Of particular interest is that the top-line data also shows a highly significant (p<0.001) correlation between the number of positive risk factors and extractions - implying that all risk factors (i.e. - including PST) are indicative of risk of tooth loss.

The full data set is expected to be submitted for publication by the UofM. Following publication, we expect that Interleukin's game plan will continue to be to roll out their PST test supported with dental insurance reimbursement from Renaissance Health/Delta Dental which touches as many as 54 million covered lives.

This top-line data, along with the early July news that Delta Dental injected $3 million in new financing to ILIU provides what we view as substantial support for the potential of ILIU's PST test.

We cover Interleukin Genetics with an Outperform rating and a $1.30 price target. Please visit scr.zacks.com to access a free copy of the full research report.

Zacks Investment Research

Originally posted here:
ILIU: Positive PST Study Data

Recommendation and review posted by Bethany Smith

ScienceDaily (Aug. 7, 2012) Investigators at Boston University School of Medicine (BUSM) and Veterans Affairs (VA) Boston Healthcare System have identified a new gene linked to post-traumatic stress disorder (PTSD). The findings, published online in Molecular Psychiatry, indicate that a gene known to play a role in protecting brain cells from the damaging effects of stress may also be involved in the development of PTSD.

The article reports the first positive results of a genome-wide association study (GWAS) of PTSD and suggests that variations in the retinoid-related orphan receptor alpha (RORA) gene are linked to the development of PTSD.

Mark W. Miller, PhD, associate professor at BUSM and a clinical research psychologist in the National Center for PTSD at VA Boston Healthcare System was the study's principal investigator. Mark Logue, PhD, research assistant professor at BUSM and Boston University School of Public Health and Clinton Baldwin, PhD, professor at BUSM, were co-first authors of the paper.

PTSD is a psychiatric disorder defined by serious changes in cognitive, emotional, behavioral and psychological functioning that can occur in response to a psychologically traumatic event. Previous studies have estimated that approximately eight percent of the U.S. population will develop PTSD in their lifetime. That number is significantly greater among combat veterans where as many as one out of five suffer symptoms of the disorder.

Previous GWAS studies have linked the RORA gene to other psychiatric conditions, including attention-deficit hyperactivity disorder, bipolar disorder, autism and depression.

"Like PTSD, all of these conditions have been linked to alterations in brain functioning, so it is particularly interesting that one of the primary functions of RORA is to protect brain cells from the damaging effects of oxidative stress, hypoxia and inflammation," said Miller.

Participants in the study were approximately 500 male and female veterans and their intimate partners, all of whom had experienced trauma and approximately half of whom had PTSD. The majority of the veterans had been exposed to trauma related to their military experience whereas their intimate partners had experienced trauma related to other experiences, such as sexual or physical assault, serious accidents, or the sudden death of a loved one. Each participant was interviewed by a trained clinician, and DNA was extracted from samples of their blood.

The DNA analysis examined approximately 1.5 million genetic markers for signs of association with PTSD and revealed a highly significant association with a variant (rs8042149) in the RORA gene. The researchers then looked for evidence of replication using data from the Detroit Neighborhood Health Study where they also found a significant, though weaker, association between RORA and PTSD.

"These results suggest that individuals with the RORA risk variant are more likely to develop PTSD following trauma exposure and point to a new avenue for research on how the brain responds to trauma," said Miller.

This study was supported by the National Institute on Mental Health of the National Institutes of Health under award number R01 MH079806 and a grant from the Department of Veterans Affairs.

See the original post:
New gene linked to PTSD identified

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass. & BOULDER, Colo.--(BUSINESS WIRE)--

Foundation Medicine, Inc. and Clovis Oncology, Inc. (CLVS) announced today that they have entered into a diagnostic collaboration. The goal of the collaboration is to develop an in-vitro diagnostic (IVD) to identify biomarkers to select cancer patients most likely to respond to Clovis product candidate rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor currently in Phase I/II clinical development.

We are pleased to collaborate with Foundation Medicine, said Patrick J. Mahaffy, president and CEO of Clovis Oncology. This continues our commitment to developing targeted therapies with companion diagnostics to identify the patients most likely to benefit from our therapeutics. Foundation Medicines leadership in next generation sequencing and genomic analysis make them an ideal partner to work with us on our rucaparib program.

Foundation Medicine and Clovis Oncology will analyze the genomic alterations found in tissue samples from patients to evaluate the feasibility of developing an IVD method to identify patients who have tumors more likely to respond to rucaparib.

In particular, the goal of the collaboration is to identify the additional genetic mutations beyond those in germ-line and somatic BRCA that are associated with defective DNA repair and may define appropriate tumor targets for rucaparib. In high-grade serous ovarian cancer, for example, this study has the potential to increase the percentage of ovarian cancer patients potentially eligible for rucaparib therapy from the 15 percent typically found to have germ-line mutations of BRCA to an estimated 40 to 50 percent who have DNA repair deficiencies caused by somatic mutations in a variety of genes.

Foundation Medicines core capability is the translation of genomic insights into clinically actionable information, said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. But even the most in-depth genomic profile for a patient is only as actionable as the available and relevant targeted therapies. Therefore, we are working to help expand the universe of targeted therapeutic options. Clovis Oncology, a recognized leader in patient-specific oncology drug development, is an ideal partner in this mission.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patients unique cancer. The companys initial clinical product, FoundationOne, is a fully informative genomic profile to identify a patients individual molecular alterations and match them with relevant targeted therapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.foundationmedicine.com.

See the article here:
Foundation Medicine and Clovis Oncology Announce Diagnostic Collaboration

Recommendation and review posted by Bethany Smith

LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.

"In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing the enrollment on time confirms our leadership position in the field. We anticipate reporting the results of the study no later than April 2013."

About Cx611 for rheumatoid arthritisCx611 is a suspension of expanded allogeneic adult stem cells derived from human adipose (fat) tissue (expanded Adipose derived Stem Cells or 'eASCs') that is delivered through intra-venous injection for the treatment of rheumatoid arthritis. The objective of the Phase IIa trial is to determine safety, feasibility, tolerance, and optimal dosing. This multicentre, placebo-controlled study has enrolled 53 patients, divided in 3 cohorts with different dosing regimens. There are 23 centers open and the company expects the final results to be available in the first half of 2013.

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

See the article here:
TiGenix Completes Patient Enrollment in Phase IIa Rheumatoid Arthritis Study

Recommendation and review posted by simmons

CLEARWATER, FL--(Marketwire -08/07/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced the appointment of Marina Pizarro, M.D. to its Scientific and Medical Board of Advisors (SAMBA). Chief Executive Officer Dwight Brunoehler stated, "The addition of Dr. Pizarro to Scientific and Medical Board of Advisors rounds out our team with expertise in the field of hair re-growth using stem cells. We look forward to her interaction with the members to help advance the Company's mission to improve the quality and longevity of life for all mankind through the use of ethically sourced stem cells."

Dr. Pizarro is currently the Medical Director for Biostem U.S. as well as their trainer for the Company's hair re-growth Affiliate Program. As the company accepts qualified affiliate physicians to administer The Biostem Method of hair re-growth throughout the United States, Dr. Pizarro will oversee their training at her Orlando, Florida location, where she is currently accepting patients. Dr. Pizarro will begin offering the Biostem Method in her Tampa and Jacksonville, Florida offices in the coming months. She will also assist in overseeing the set-up of another training facility overseas as the company expands its Medical Affiliate Program internationally.

Dr. Marina Pizarro holds the distinction of being the first female hair transplant physician in the industry and belongs to the elite group of surgeons who have performed over 30,000 hair transplant procedures in their careers. She received her medical degree from Ponce School of Medicine in Puerto Rico in 1985. After completing her residency in Orlando, Dr. Pizarro worked with world renowned hair transplant surgeon Dr. Constantine Chambers building one of the largest hair restoration practices in history. After five years, and after having performed thousands of procedures around the world while lecturing at hair restoration conventions, Dr. Pizarro opened her first two facilities in Orlando and Jacksonville, Florida in 1994, specializing in hair transplantation for both men and women. She currently has three facilities in Florida with the addition of her clinic in Tampa. Dr. Pizarro is a member of The International Society of Hair Restoration Surgery and the European Society of Hair Restoration Surgery.

About Biostem U.S. Corporation

Biostem U.S., Corporation (HAIR) (HAIR) is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem U.S. is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S. is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

The company's Board of Directors is headed by Chairman, Scott Crutchfield, who also acts as Senior Vice President of World Wide Operations for Crocs, Inc. (CROX) and includes Crocs, Inc. original member, Steve Beck.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com or by contacting Fox Communications Group at 310-974-6821.

Excerpt from:
Biostem U.S., Corporation Appoints Marina Pizarro, M.D. to Scientific and Medical Board of Advisors (SAMBA)

Recommendation and review posted by sam

Public release date: 7-Aug-2012 [ | E-mail | Share ]

Contact: Jia Liu liujia@genomics.cn BGI Shenzhen

August 7, 2012, Shenzhen, China BGI Tech Solutions Co., LTD, also referred to as "BGI Tech" and BGI Ark Biotechnology Co., LTD. (BAB), a biotechnology company dedicated to large scale production of transgenic and cloned animals, today announced that they have jointly developed an advanced transgenic mice platform for boosting human diseases and medical research, with the advantages of improved efficiency, high positive rate, available sex determination, fast turnaround time, and low cost.

In contrast to traditional transgenic techniques, the platform could provide more comprehensive technical services to efficiently generate transgenic mice for researchers worldwide. It covers a wide range of techniques and services, including DNA microinjection, blastocyst injection and tetraploid complementation assay, gene knockin, gene knockout and conditional gene knockout, targeting vector construction, embryo cryopreservation, in vitro fertilization (IVF) and embryo transfer, among others.

Transgenic mice serve as important models for embryonic development and disease pathogenesis research, and their use has dramatically increased for the past two decades. The mice and cell lines derived from them have also accelerated basic research by allowing scientists to relate functions to genes, dissect genetic pathways, and manipulate the cellular or biochemical properties of proteins.

"Based on the handmade cloning and sperm-mediated technologies, we could provide more efficient and economic access to transgenic mice and related research." said, Dr. Yutao Du, Director of BAB, and Vice President of BGI, "We have established a SPF-level facility covering 160 square meters, which could house more than 2,000 mice. The platform also has equipped with the full set of professional experimental equipment and a number of technical experts." she added.

With the high-throughput sequencing platform and profound experience in genomics, BGI Tech in addition provides solutions for gene detection, transgenic mice construction and gene function evaluation. Na Liu, Director of Product Management at BGI Tech, said, "There are significant research and commercial needs for a large scale transgenic mouse platform. We not only can provide the excellent transgenic tech support, but also work with researchers to design professional and personalized solutions. The combination of transgenic technology and high throughput sequencing technology will become an inevitable trend for genetic engineering and make great improvement in biomedical research and applications."

###

About BGI Ark Biotechnology Co., LTD.

BGI Ark Biotechnology Co., LTD. (BAB), affiliated to BGI, is a high-tech enterprise, mainly focusing on mass production of transgenic and cloned animals. Based on a core technology named Handmade Cloning (HMC), BAB has established a reliable and efficient standard production system, including vector construction, screening of genetically modified cell lines, reconstruction of cloned embryos, embryo transfer, etc. Compared with traditional cloning, the benefits of handmade cloning are great. Low equipment costs, a simple and rapid procedure and a higher in vitro efficiency are valuable for large scale research in medical and agricultural sciences.

See the article here:
BGI Tech and BAB jointly develop transgenic mice platform for biomedical research

Recommendation and review posted by Bethany Smith

Public release date: 7-Aug-2012 [ | E-mail | Share ]

Contact: Jenny Eriksen Leary jenny.eriksen@bmc.org 617-638-6841 Boston University Medical Center

(Boston) Investigators at Boston University School of Medicine (BUSM) and Veterans Affairs (VA) Boston Healthcare System have identified a new gene linked to post-traumatic stress disorder (PTSD). The findings, published online in Molecular Psychiatry, indicate that a gene known to play a role in protecting brain cells from the damaging effects of stress may also be involved in the development of PTSD.

The article reports the first positive results of a genome-wide association study (GWAS) of PTSD and suggests that variations in the retinoid-related orphan receptor alpha (RORA) gene are linked to the development of PTSD.

Mark W. Miller, PhD, associate professor at BUSM and a clinical research psychologist in the National Center for PTSD at VA Boston Healthcare System was the study's principal investigator. Mark Logue, PhD, research assistant professor at BUSM and Boston University School of Public Health and Clinton Baldwin, PhD, professor at BUSM, were co-first authors of the paper.

PTSD is a psychiatric disorder defined by serious changes in cognitive, emotional, behavioral and psychological functioning that can occur in response to a psychologically traumatic event. Previous studies have estimated that approximately eight percent of the U.S. population will develop PTSD in their lifetime. That number is significantly greater among combat veterans where as many as one out of five suffer symptoms of the disorder.

Previous GWAS studies have linked the RORA gene to other psychiatric conditions, including attention-deficit hyperactivity disorder, bipolar disorder, autism and depression.

"Like PTSD, all of these conditions have been linked to alterations in brain functioning, so it is particularly interesting that one of the primary functions of RORA is to protect brain cells from the damaging effects of oxidative stress, hypoxia and inflammation," said Miller.

Participants in the study were approximately 500 male and female veterans and their intimate partners, all of whom had experienced trauma and approximately half of whom had PTSD. The majority of the veterans had been exposed to trauma related to their military experience whereas their intimate partners had experienced trauma related to other experiences, such as sexual or physical assault, serious accidents, or the sudden death of a loved one. Each participant was interviewed by a trained clinician, and DNA was extracted from samples of their blood.

The DNA analysis examined approximately 1.5 million genetic markers for signs of association with PTSD and revealed a highly significant association with a variant (rs8042149) in the RORA gene. The researchers then looked for evidence of replication using data from the Detroit Neighborhood Health Study where they also found a significant, though weaker, association between RORA and PTSD.

See the rest here:
BUSM/VA Boston Healthcare System investigators identify new gene linked to PTSD

Recommendation and review posted by Bethany Smith

Public release date: 7-Aug-2012 [ | E-mail | Share ]

Contact: Jennifer Quigley jquigley@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, August 7, 2012The body's natural reaction to reject replacement proteins represents a major obstacle to the successful use of gene therapy to cure a range of life-threatening diseases. A novel method that uses the body's own immune cells to induce tolerance to a specific protein was shown to suppress the rejection response, as described in an article in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc. (http://www.liebertpub.com). The article is available free online at the Human Gene Therapy (http://www.liebertpub.com/hum) website.

"A major limitation of protein and gene therapeutics is the associated immune responses which can cause toxicity and diminish efficacy," says James M. Wilson, MD, PhD, Editor-in-Chief, and Director of the Gene Therapy Program, Department of Pathology and Laboratory Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia. "This clever use of immune modulators may prevent these untoward immune responses from happening."

Exposing a type of immune cell called dendritic cells to a specific therapeutic protein in the presence of immune-stimulating chemicals called cytokines leads to the creation of tolerogenic dendritic cells. These cells, when introduced into mice that are then given gene therapy designed to deliver the therapeutic protein of interest, allow the mice to tolerate, and not reject, the therapeutic protein.

Current approaches to induce partial or full tolerance to proteins replaced via gene therapy are expensive and are unsuccessful in as many as 40% of cases. The method described in this article by Gautam Sule and colleagues from Baylor College of Medicine and Howard Hughes Medical Institute, Houston, TX, offers advantages to support the long-term success of gene therapies. The authors report their findings in "Cytokine-Conditioned Dendritic Cells Induce Humoral Tolerance to Protein Therapy in Mice."

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(http://online.liebertpub.com/doi/full/10.1089/hum.2011.225)

About the Journal

Human Gene Therapy (http://www.liebertpub.com/hum), the Official Journal of the European Society of Gene and Cell Therapy, British Society for Gene and Cell Therapy, French Society of Cell and Gene Therapy, German Society of Gene Therapy, and five other gene therapy societies is an authoritative peer-reviewed journal published monthly in print and online that presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Tables of contents and a free sample issue may be viewed online at the Human Gene Therapy (http://www.liebertpub.com/hum) website.

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Method to prevent rejection of disease-fighting proteins described in Human Gene Therapy journal

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Public release date: 7-Aug-2012 [ | E-mail | Share ]

Contact: John Sterling jsterling@genengnews.com 914-740-2196 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, August 6, 2012Genetic Engineering & Biotechnology News (http://www.genengnews.com) (GEN) has launched a unique microsite called Biotech Boulevard (http://www.genengnews.com/biotechblvr). Biotech Boulevard features entrepreneurial biotechnology firms that are already making their mark on the global bioindustry. Many of these promising young companies are engaged in the discovery of novel therapeutics; others are developing new tools and technologies to support biotech activities ranging from early-stage R&D to biomanufacturing.

Each Biotech Boulevard listing includes a company name, website, logo, and short description of the company's field of focus. "Biotech Boulevard allows our website visitors to discover, invest, and collaborate," said John Sterling, Editor-in-Chief, GEN. "Company listings will be updated regularly."

"Biotech Boulevard is another GEN innovation that enables business growth in biotech," added Mary Ann Liebert, GEN publisher and president and CEO of Mary Ann Liebert, Inc. "And we are the best at that."

If you would like your company to be considered for possible inclusion in Biotech Boulevard, please email your company name and website to jsterling@genengnews.com

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Genetic Engineering & Biotechnology News (http://www.genengnews.com), which is published 21 times a year by Mary Ann Liebert, Inc. (http://www.liebertpub.com), is the most widely read biotechnology news magazine worldwide. It includes articles on Drug Discovery, Bioprocessing, OMICS, Biobusiness, and Translational Medicine.

AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.

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Genetic Engineering & Biotechnology News unveils 'Biotech Boulevard'

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Lawrence LeBlond for redOrbit.com Your Universe Online

Fainting is a fairly common occurrence in our society and about 25 percent of us will experience it at some point in our life. And now, a new study has found that there is a strong link between fainting and family. Studying identical and fraternal twins, researchers from Australia and the US suggest people who are predisposed to fainting get it through genetics.

Described as a sudden, brief loss of consciousness after blood pressure drops from the brain, fainting normally occurs due to an internal factor dehydration, heart problems, etc. But sometimes, black outs occur to some kind of out-of-body trigger, such as the sight of blood or after emotional distress. This type of fainting is known as vasovagal syncope.

Typically, fainting itself is not considered dangerous. Most people usually wake up a few seconds after they pass out. The dangerous part comes when they fall and possibly suffer an injury in the process.

The question of whether fainting is caused by genetic factors, environmental factors or a mixture of both has been the subject of debate, said study author Samuel F. Berkovic, MD, FRS, of the University of Melbourne in Victoria, Australia, and a member of the American Academy of Neurology.

Publishing the findings Neurology, the medical journal of the American Academy of Neurology, researchers questioned 51 sets of twins of the same gender between the ages of 9 and 69, of which at least one had a history of fainting. The team also gathered information about family history of fainting. They discovered that 57 percent of the twins in the study reported having typical fainting triggers.

Berkovic and colleagues found that among twins where one fainted, identical twins were nearly twice as likely to both faint compared to fraternal twins. The risk of fainting due to internal factors was also much higher in the identical twins than in the fraternal twins. The identical twins were much more likely to both experience fainting associated with typical triggers as well. In non-twin relatives, frequency of fainting was low, suggesting the way fainting is inherited does not rely on a single gene.

Our results suggest that while fainting appears to have a strong genetic component, there may be multiple genes and multiple environmental factors that influence the phenomenon, said Berkovic.

Simply put, there is now strong evidence that a simple faint, for example, one caused by sight of blood, fear, or unpleasant thoughts, can have a genetic component, Ezriel Kornel, MD, a neurologist at Northern Westchester Hospital in Mount Kisco, New York, told Brenda Goodman at WebMD.

Berkovic noted that even though identical twins were more likely to report outside triggers for their spells, it wasnt always the same trigger for both twins.

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Fainting Studies Conducted In Twins Show Strong Genetic Ties

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

Contact: Mike Sepanic msepanic@camden.rutgers.edu 856-225-6026 Rutgers University

CAMDEN A top national award for promising research scientists has been presented to Princeton resident Nir Yakoby, an assistant professor of biology at Rutgers UniversityCamden.

Yakoby has received a prestigious CAREER Award from the National Science Foundation. The five-year, $686,544 award, which is reviewed and renewed annually based on the scientific progress of the project, supports the RutgersCamden researcher's project "Dynamics and Diversity of Bone Morphogenetic Protein Signaling in Epithelial Cells."

The grant will allow Yakoby and his research lab team to study the processes that occur during the time that cells decide what to become. RutgersCamden student researchers will join Yakoby in using the fruit fly Drosophila as an experimental system to study how very similar layers of cells produce different numbers of tubes. Through this work, the RutgersCamden researcher will seek to understand how changes in the bone morphogenetic protein (BMP) signal create different morphologies.

In explaining his research, Yakoby posits the following questions: "Why do we have two arms and two legs and not three of each? Why do we have five fingers and not six?" The RutgersCamden researcher seeks to find those answers by examining the signals and processes that advise cells as they form organs.

"These questions are particularly intriguing since the cells in the human body all contain the same genetic information. However, the clear cells in the eyes' corneas are obviously very different from the cells that secrete insulin in the pancreas," notes Yakoby.

A major goal of the NSF CAREER Award is to integrate academic teaching with research in the lab. RutgersCamden students will participate in this research.

In the Yakoby Lab, RutgersCamden students use the fruit fly Drosophila as an experimental system to study how a layer of cells in the fly ovaries form an eggshell. The eggshell protects the developing embryo from the dry environment while allowing for respiration through tube-like snorkels called dorsal appendages (DAs). Just as animals have different numbers of fingers, the numbers of the eggshells' respiratory tubes differ among Drosophila species. Thus, the eggshell provides a unique opportunity to study how very similar layers of cells produce different numbers of tubes.

In humans, a signal named the bone morphogenetic protein (BMP) is necessary to define the development of fingers. The same signal controls the formation of the DAs on the Drosophila eggshell. Through his CAREER Award, Yakoby proposes to study how changes in the BMP signal allow for the formation of different numbers of DAs. Since the BMP signal is highly conserved between Drosophila and humans, understanding how changes in this signal create different morphologies will help to understand tissue pathologies and developmental defects which are associated with mal-regulation of the BMP signal.

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Rutgers-Camden genetics researcher receives NSF CAREER Award

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LOS ANGELES, Aug. 7, 2012 /PRNewswire/ --Response Genetics, Inc. (RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, will announce its second quarter financial results and give an operational update in a press release to be issued before the market opens on Tuesday, August 14, 2012. The company will host a conference call that same day at 10:00 a.m. EDT to discuss its financial results.

Conference Call Details

To access the conference call by phone on August 14 at 10:00 a.m. EDT, dial (800) 537-0745 or (253) 237-1142 for international participants. A telephone replay will be available beginning approximately two hours after the call through August 21, 2012 and may be accessed by dialing (855) 859-2056 or (404) 537-3406. The conference passcode for both the live call and replay is 18367261.

To access the live and archived webcast of the conference call, go to the Investor Relations section of the company's Web site at http://investor.responsegenetics.com. It is advised that participants connect at least 15 minutes prior to the call to allow for any software downloads that might be necessary.

About Response Genetics, Inc.

Response Genetics Inc. (the "Company") is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. The Company's principal customers include oncologists, pathologists and hospitals. In addition to diagnostic testing services, the Company generates revenue from the sale of its analytical testing services of clinical trial specimens to the pharmaceutical industry. The Company's headquarters is located in Los Angeles, California. For additional information, please visit http://www.responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of the Company related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company to continue to provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, to strengthen marketing capabilities, to expand the suite of ResponseDX products, to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into new areas such as companion diagnostics, to continue to execute on its business strategy and operations, to continue to analyze cancer samples, and the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as "projects," "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions.

These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

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Response Genetics, Inc. to Release Second Quarter Financial Results and Host Conference Call on August 14, 2012

Recommendation and review posted by Bethany Smith