Archive for the ‘Gene Therapy Research’ Category

Published: Wednesday, February 22, 2012 at 1:03 p.m. Last Modified: Wednesday, February 22, 2012 at 5:24 p.m.

The original benefactors to the University of Florida's Powell Gene Therapy Center have donated another $5 million.

The contribution by Earl and Christy Powell of Miami will establish a chair in gene therapy and genetics research at the UF Health Science Center, UF announced Wednesday. The Powells first donated $2 million in 2000 to UF's program in gene therapy research and the university renamed the center in their name.

The center has worked on gene therapies aimed at helping patients with inherited blindness and paralyzing neuromuscular diseases. The new chair will focus on the developing methods for the delivery of therapeutic genes to patients with a variety of diseases, according to UF.

Earl Powell is a former UF trustee and founding partner of Trivest Partners, a private equity investment firm in Miami.

- Nathan Crabbe

Powells donate $5 million to Gene Therapy Center Gainesville.comFebruary 22, 2012 5:24 PM

<p>The original benefactors to the University of Florida's Powell Gene Therapy Center have donated another $5 million.</p><p>The contribution by Earl and Christy Powell of Miami will establish a chair in gene therapy and genetics research at the UF Health Science Center, UF announced Wednesday. The Powells first donated $2 million in 2000 to UF's program in gene therapy research and the university renamed the center in their name. </p><p>The center has worked on gene therapies aimed at helping patients with inherited blindness and paralyzing neuromuscular diseases. The new chair will focus on the developing methods for the delivery of therapeutic genes to patients with a variety of diseases, according to UF. </p><p>Earl Powell is a former UF trustee and founding partner of Trivest Partners, a private equity investment firm in Miami.</p><p><i>- Nathan Crabbe</i></p>

Copyright 2012 Gainesville.com - All rights reserved. Restricted use only.

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Powells donate $5 million to Gene Therapy Center

OXFORD, England--(BUSINESSWIRE)--

Oxford Gene Technology (OGT), provider of innovative clinical genetics and diagnostic solutions to advance molecular medicine, announced today that it has entered into an exclusive licensing agreement with Inven2, the technology transfer office at Oslo University Hospital (OUS) and University of Oslo (UiO), for 12 highly promising colorectal cancer tissue biomarkers.

The exclusive license allows OGT to commercialise any resulting test developed using these biomarkers and to sublicense the markers to other parties. The DNA methylation biomarkers were developed in the laboratory of Professor Ragnhild A. Lothe, in the department of Cancer Prevention, the Norwegian Radium Hospital, part of the Oslo University Hospital.

OGT has validated the results obtained in Professor Lothe’s laboratory showing sensitivity of 93% and specificity of 90% when using tissue biopsies. Further work investigating the efficacy of these biomarkers in blood and faecal samples is ongoing.

“This licensing agreement gives OGT exclusive access to genetic markers which are associated with colorectal cancer.” stated Mike Evans, CEO, of OGT. “We believe that developing tests that include these genetic markers will permit the earlier identification of patients at risk of this disease and allow for more timely diagnosis and clinical interventions.” He added, “The higher specificity of this new panel of markers could provide a more robust screening tool than the tests currently used, while eventually lowering overall costs, which would be of significant benefit for both patients and the clinicians using them.”

“Biomarkers have the potential to greatly improve the accuracy and impact of colorectal cancer screening.” commented Professor Lothe, from the Norwegian Radium Hospital. “We look forward to continuing our collaborative efforts with OGT to develop and validate a future test which will help screen people early for this treatable form of cancer.”

Benedicte Bakke, Business Development Manager at Inven2 AS, Oslo technology transfer office, concluded: “We fully support the collaboration with Oxford Gene Technology to develop a new method of detecting colorectal cancer using these biomarkers. This deal demonstrates the importance of industry and academic collaboration in turning scientific excellence into products that address medical needs.”

-Ends-

Notes for editors:

About Oxford Gene Technology

Founded by Professor Ed Southern, Oxford Gene Technology (OGT) provides innovative clinical genetics and diagnostic solutions to advance molecular medicine. The company has two trading businesses, Biomarker Discovery and Clinical & Genomic Solutions. Biomarker Discovery: OGT delivers tailored biomarker discovery solutions that optimise drug and diagnostic development programmes. With expertise in genomic and proteomic diagnostic biomarkers, OGT provides highly specific customised biomarker panels for cancer and other diseases, both for direct sale and also for collaboration with partner companies. Clinical & Genomic Solutions: OGT’s Genefficiency™ is a unique combination of world-leading platforms, people, processing power and performance synchronised to deliver rapid, high-quality genomic data to customers worldwide. OGT’s CytoSure™ cytogenetics array, labelling and interpretation software products and services provide a complete solution for the detection of chromosomal abnormalities. Together, Genefficiency and CytoSure offer a unique, standardised and integrated solution for cytogenetics research.

For more information on the Company, please visit our website at: http://www.ogt.co.uk

CytoSure: For research use only. Not for use in diagnostic procedures.

About Inven2

Inven2 is the Technology Transfer Office for the University of Oslo and Oslo University Hospital, Norway's largest and leading university and hospital representing pioneering research. Inven2 is the largest contributor in Norway within the field of commercialization of research within Life Science. For more information on Inven2, please visit our website at: http://www.inven2.com

Colorectal cancer

Colorectal cancer (commonly known as colon or bowel cancer) is the 2nd most common cancer in women (behind breast) and the 3rd most common cancer in men (behind prostate and lung). Worldwide, 1.23 million new cases of bowel cancer were diagnosed in 2008. The chance of cure is much better if this cancer is detected at an early stage rather than at a later stage. In the past decade, there has been unprecedented progress in reducing colorectal cancer incidence and death rates; this progress has come about largely through the prevention and early detection of colorectal cancer through screening. However, it is estimated that there could be further improvement ? up to 20,000 fewer deaths from colorectal cancer over the next 20 years ? if just 60% of those eligible took up the invitation for bowel screening (Cancer research UK).

Colorectal cancer screening

In the UK, the current primary screening tool is the faecal occult blood test in England (FOBt; the Faecal immunochemical test, FIT, is used in Scotland). The test is based on determining the presence/absence of blood within a patients stool. Although the test does not diagnose colorectal cancer it directs patients for further evaluation should a positive test be returned to the health care professional. This could ultimately lead to a further examination entailing a colonoscopy. However, the presence of blood in the faeces can be due to a number of factors and so for every 10 people who undergo a colonoscopy 7 will have a ‘normal’ result. The poor positive predictive value of the FOBt leads to unnecessary concern for the patient and a huge cost implication for the NHS.

Consequently, there is a need for a robust preventive strategy that can stratify patients into appropriate screening or surveillance programmes for the early detection of cancer. Internationally, the chosen modality of colorectal cancer screening varies, with cost and availability of diagnostic resources likely to be leading factors in?uencing programme design. The majority of countries, where a national screening programme exists, employ the FOBt (inclusive of Japan and Taiwan). In North America and other European countries, there is ongoing regional colorectal cancer research initiatives/pilot programmes intended to evaluate the potential of implementing national screening programmes.

Recently, there has been growing interest in investigating biomarkers (aberrant hypermethylation of CpG islands) in patients who suffer from colorectal cancer to develop more accurate and patient-friendly tests.

Contact

Oxford Gene Technology
Stephen Archibald, Marketing Communications Manager
T: +44 (0) 1865 856826
F: +44 (0) 1865 848684
E: products@ogt.co.uk
W: www.ogt.co.uk
or
College Hill (PR Agency for OGT)
Melanie Toyne Sewell / Jayne Crook
T: +44 (0) 20 7457 2020
E:OGT@collegehill.com
or
Inven2
Benedicte Bakke, Business Development Manager
T: +47 03 44 40 29
E:Benedicte.bakke@inven2.com
W:www.inven2.com

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OGT Signs Licensing Deal for Colorectal Cancer Biomarkers

Public release date: 21-Feb-2012
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Contact: Cathia Falvey
cfalvey@liebertpub.com
914-740-2100
Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, February 21, 2012?Babies are not able to metabolize or excrete caffeine very well, so a breastfeeding mother's consumption of caffeine may lead to caffeine accumulation and symptoms such as wakefulness and irritability, according to an interview with expert Ruth Lawrence, MD, published in Journal of Caffeine Research, a peer-reviewed journal from Mary Ann Liebert, Inc. The interview is available on the Journal of Caffeine Research website at http://www.liebertpub.com/jcr.

Caffeine is found in a wide range of products in addition to coffee, tea, and chocolate, including soft drinks, sports drinks, and some over-the-counter medications.

In a provocative discussion with Dr. Ruth Lawrence, Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Jack E. James, PhD, Editor-in-Chief of Journal of Caffeine Research, asks a variety of probing questions. Is there a safe level of caffeine intake while breastfeeding? Are there potential long-term effects of caffeine exposure on development and intellect? Can a baby whose mother consumed caffeine during pregnancy experience withdrawal if she then abstains from caffeine while breastfeeding? Dr. Lawrence bases her responses on the scientific and medical evidence related to caffeine exposure in breastfed babies, and distinguishes between what is and what is not well understood in this developing field of study.

"Usually a mother, particularly if she is breastfeeding, is cautioned to limit her caffeine intake," says Dr. Lawrence, who is Editor-in-Chief of the peer-reviewed journal Breastfeeding Medicine. After giving birth, mothers "should consume all things in moderation and try to avoid the excesses that might really add up to a lot of caffeine."

###

About the Journal

Journal of Caffeine Research: The International Journal of Caffeine Science is a quarterly peer-reviewed journal published in print and online that covers the effects of caffeine on a wide range of diseases and conditions, including mood disorders, neurological disorders, cognitive performance, cardiovascular disease, and sports performance. The Journal explores all aspects of caffeine science including the biochemistry of caffeine; its actions on the human body; benefits, dangers, and contraindications; and caffeine addiction and withdrawal, across all stages of the human life span from prenatal exposure to end-of-life. Tables of content and a free sample issue may be viewed on the Journal of Caffeine Research website at http://www.liebertpub.com/jcr.

About the Company

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Breastfeeding Medicine, Journal of Medicinal Food, and Journal of Child and Adolescent Psychopharmacology. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available online at http://www.liebertpub.com.

Mary Ann Liebert, Inc. 140 Huguenot Street, New Rochelle, NY 10801-5215 http://www.liebertpub.com
Phone (914) 740-2100 (800) M-LIEBERT Fax (914) 740-2101

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Can consuming caffeine while breastfeeding harm your baby?

Benjamin "Benjy" Stacy so frightened maternity doctors with the color of his skin -- "as Blue as Lake Louise" -- that he was rushed just hours after his birth in 1975 to University of Kentucky Medical Center.

As a transfusion was being readied, the baby's grandmother suggested to doctors that he looked like the "blue Fugates of Troublesome Creek." Relatives described the boy's great-grandmother Luna Fugate as "blue all over," and "the bluest woman I ever saw."

In an unusual story that involves both genetics and geography, an entire family from isolated Appalachia was tinged blue. Their ancestral line began six generations earlier with a French orphan, Martin Fugate who settled in Eastern Kentucky.

Doctors don't see much of the rare blood disorder today, because mountain people have dispersed and the family gene pool is much more diverse.

But the Fugates' story still offers a window into a medical mystery that was solved through modern genetics and the sleuth-like energy of Dr. Madison Cawein III, a hematologist at the University of Kentucky's Lexington Medical Clinic.

Cawein died in 1985, but his family charts and blood samples led to a sharper understanding of the recessive diseases that only surface if both parents carry a defective gene.

Fugate's great-great-great-great grandson Benjamin "Benjy" Stacy so frightened maternity doctors when he was born in 1975, that they rushed him to a University of Kentucky medical clinic.

As a transfusion was being readied, Benjy's grandmother suggested to doctors that the boy looked like the "blue Fugates of Troublesome Creek." Relatives described the boy's great-grandmother Luna Fugate as "blue all over" and "the bluest woman I ever saw."

The most detailed account, "Blue People of Troublesome Creek," was published in 1982 by the University of Indiana's Cathy Trost, who described Benjy's skin as "almost purple."

The Fugate progeny had a genetic condition called methemoglobinemia, which was passed down through a recessive gene and blossomed through intermarriage.

"It's a fascinating story," said Dr. Ayalew Tefferi, a hematologist from Minnesota's Mayo Clinic. "It also exemplifies the intersection between disease and society, and the danger of misinformation and stigmatization."

Methemoglobinemia is a blood disorder in which an abnormal amount of methemoglobin -- a form of hemoglobin -- is produced, according to the National Institutes for Health. Hemoglobin is responsible for distributing oxygen to the body and without oxygen, the heart, brain and muscles can die.

In methemoglobinemia, the hemoglobin is unable to carry oxygen and it also makes it difficult for unaffected hemoglobin to release oxygen effectively to body tissues. Patients' lips are purple, the skin looks blue and the blood is "chocolate colored" because it is not oxygenated, according to Tefferi.

"You almost never see a patient with it today," he said. "It's a disease that one learns about in medical school and it is infrequent enough to be on every exam in hematology."

The disorder can be inherited, as was the case with the Fugate family, or caused by exposure to certain drugs and chemicals such as anesthetic drugs like benzocaine and xylocaine. The carcinogen benzene and nitrites used as meat additives can also be culprits, as well as certain antibiotics, including dapsone and chloroquine.

The genetic form of methemoglobinemia is caused by one of several genetic defects, according to Tefferi. The Fugates probably had a deficiency in the enzyme called cytochrome-b5 methemoglobin reductase, which is responsible for recessive congenital methemoglobinemia.

Normally, people have less approximately 1 percent of methemoglobin, a type of hemoglobin that is altered by being oxidized so is useless in carrying oxygen in the blood. When those levels rise to greater than 20 percent, heart abnormalities and seizures and even death can occur.

But at levels of between 10 and 20 percent a person can develop blue skin without any other symptoms. Most of blue Fugates never suffered any health effects and lived into their 80s and 90s.

"If you are between 1 percent and 10 percent, no one knows you have an abnormal level and this might be the case in a lot of unsuspecting patients," he said.

Many other recessive gene diseases, such as sickle cell anemia, Tay Sachs and cystic fibrosis can be lethal, he said.

"If I carry a bad recessive gene with a rare abnormality and married, the child probably wouldn't be sick, because it's very rare to meet another person with the [same] bad gene and the most frequent cause therefore is in-breeding," Tefferi said.

Such was the case with the Fugates.

Martin Fugate came to Troublesome Creek from France in 1820 and family folklore says he was blue. He married Elizabeth Smith, who also carried the recessive gene. Of their seven children, four were reported to be blue.

There were no railroads and few roads outside the region, so the community remained small and isolated. The Fugates married other Fugate cousins and families who lived nearby, with names like Combs, Smith, Ritchie and Stacy.

Benjy's father, Alva Stacy showed Trost his family tree and remarked, "If you'll notice -- I'm kin to myself," according to Trost.

One of Martin and Elizabeth Fugate's blue boys, Zachariah, married his mother's sister. One of their sons, Levy, married a Ritchie girl and had eight children, one of them Luna. Luna married John E. Stacy and they had 13 children.

Benjy descended from the Stacy line.

Originally posted here:
Genetics Solves Modern Mystery of Blue-Tinged Family

AUSTIN, Texas, Feb. 21, 2012 /PRNewswire/ -- Celling Biosciences announces a sponsorship of the 7th Annual Stem Cell Summit being held on February 21st at Bridgewaters New York in New York City. The Stem Cell Summit is consistently the premiere venue for the world's leaders in regenerative medicine to network and promote next generation technologies and cell therapies.

The meeting will feature more than 30 thought leaders in stem cell therapy including Dr. Kenneth Pettine of the Orthopedic Stem Cell Institute in Loveland, Colorado.  Dr. Pettine has teamed up with Celling Biosciences' SpineSmith Division to present "Adult Stem Cell Therapy for Orthopedic and Spine Conditions Resulting from Injury or Aging."  Dr. Pettine has become an innovator in the regenerative cell therapy market and believes "regenerative therapies will become the next standard of care in treating many orthopedic conditions." 

Following the Stem Cell Summit, Dr. Pettine will be presenting a discussion on regenerative therapies to the trainers and medical staff attending this year's NFL combine.  The NFL has recently gained attention from Peyton Manning going oversees to receive a cell therapy treatment for his cervical spine condition.  Dr. Pettine envisions a day when these professional athletes stop going to foreign countries to receive medical treatment.

The Orthopedic Stem Cell Institute provides state-of-the-art regenerative cell therapy using Celling Biosciences' ART 21 system. The ART 21 system processes bone marrow from the patient at the point of care to consistently produce a concentrate of regenerative cells with high yields of mononuclear stem cells in less than 15 minutes.  Celling Biosciences provides the cell separation systems along with the biomaterials and devices necessary to recreate the environment to promote healing. 

Kevin Dunworth, founder of Celling Biosciences, believes regenerative cell therapy has more to do with creating the optimal environment then just providing cells.  "We believe autologous cell therapy is a viable solution but physicians need to understand that these cells require the necessary substrate for delivery and the proper techniques for retrieval.  Our focus has been on providing not only cell separation technologies, medical devices and biomaterials but also the registered nurses to deliver the service so physicians can have the most consistent, reliable and predictable regenerative cell therapy for their patients."

Contact:
Tracy Gladden
Communications Manager
Tgladden@spinesmithusa.com
512-637-2050

About Celling Biosciences
Celling Biosciences, works closely with surgeons, scientists and engineers to research and develop innovative technologies in the field of regenerative medicine. http://www.cellingbiosciences.com and http://www.spinesmithusa.com

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Celling Biosciences Sponsors 7th Annual Stem Cell Summit

ATLANTA, GA--(Marketwire -02/21/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA.OB - News) (OTCQB: VSTA.OB - News), a biotechnology company applying stem cell technology for drug rescue and cell therapy, has retained MissionIR, a national investor relations consulting firm, to develop and implement a strategic investor relations campaign. Through a network of investor-oriented online websites and full suite of investor awareness services, MissionIR broadens the influence of publicly traded companies and enhances their ability to attract growth capital and improve shareholder value.

"VistaGen's work with human stem cell technology is groundbreaking," said Sherri Snyder, Director of Marketing at MissionIR. "The company's versatile platform, Human Clinical Trials in a Test Tube™, provides clinically relevant predictions of potential heart toxicity of new drug candidates long before they are ever tested on humans. Guided by a management team with decades of experience, VistaGen's stem cell technology can potentially save billions of dollars in the healthcare industry while recapturing prior R&D investment in once-promising new drug candidates."

"We are pleased to bring MissionIR on board as our external investor relations partner," said Shawn Singh, VistaGen's Chief Executive Officer. "The crucial work our company is doing can fundamentally change the way medicine is developed. Paired with MissionIR's global presence and sound investor relations programs, we can further grow our shareholder base and accelerate internal initiatives already in place to bring our stem cell technology platform to the forefront of drug development."

About MissionIR

MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. Through a full suite of investor relations and consultancy services, we help public companies develop and execute a strategic investor awareness plan as we've done for hundreds of others. Whether it's capital raising, increasing awareness among the financial community, or enhancing corporate communications, we offer a variety of solutions to meet the objectives of our clients.

For more information, visit http://www.MissionIR.com

About VistaGen Therapeutics

VistaGen is a biotechnology company applying human pluripotent stem cell technology for drug rescue and cell therapy. VistaGen's drug rescue activities combine its human pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, with modern medicinal chemistry to generate new chemical variants of once-promising small-molecule drug candidates. These are once-promising drug candidates discontinued by pharmaceutical companies during development due to heart toxicity, despite positive efficacy data demonstrating their potential therapeutic and commercial benefits. VistaGen uses its pluripotent stem cell technology to generate early indications, or predictions, of how humans will ultimately respond to new drug candidates before they are ever tested in humans.

Additionally, VistaGen's small molecule drug candidate, AV-101, is in Phase 1b development for treatment of neuropathic pain. Neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, affects approximately 1.8 million people in the U.S. alone. VistaGen plans to initiate Phase 2 clinical development of AV-101 in the fourth quarter of 2012. VistaGen is also exploring opportunities to leverage its current Phase 1 clinical program to enable additional Phase 2 clinical studies of AV-101 for epilepsy, Parkinson's disease and depression. To date, VistaGen has been awarded over $8.5 million from the NIH for development of AV-101.

Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen's Facebook page at http://www.facebook.com/VistaGen.

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VistaGen Therapeutics Engages MissionIR as Its Investor Relations Advisor

CAMBRIDGE, Mass., Feb. 21, 2012 (GLOBE NEWSWIRE) -- Pathfinder Cell Therapy, Inc. ("Pathfinder," or "the Company") (OTCQB:PFND.PK - News), a biotechnology company focused on the treatment of diabetes and other diseases characterized by organ-specific cell damage, today presented preliminary data highlighting the potential of the Company's unique cell-based therapy for treating diabetes at the 7th Annual New York Stem Cell Summit. Richard L. Franklin, M.D., Ph.D., Founder, CEO and President of Pathfinder, provided an overview of the Company's Pathfinder Cell ("PC") technology, and presented preclinical evidence demonstrating how treatment with PCs was able to reverse the symptoms of diabetes in two different mouse models.

Pathfinder Cells are a newly identified non-stem cell mammalian cell type that has the ability to stimulate regeneration of damaged tissue without being incorporated into the new tissue. In today's presentation, Dr. Franklin showed how recent experiments performed using a non-obese diabetic (NOD) mouse strain were supportive of earlier data that demonstrated complete reversal of diabetes in mice. The earlier results, which used a drug-induced diabetic mouse model, were published in Rejuvenation Research1. Though preliminary, the recent results are encouraging because the NOD mouse model is widely used and highly regarded as being predictive of human type-1 diabetes.

In three separate experiments using this model, 30-50% of the mice treated with PCs at the onset of diabetes returned to normal blood glucose levels. Of the mice that responded well to treatment, the effects tended to be long lasting, up to two months in some cases after just two doses. These results, which were generated by intravenous injection of PC's derived from rat pancreatic tissue, further demonstrate the remarkable ability of Pathfinder Cells to elicit their positive effect regardless of the organ, or even species, of origin.

"We are very encouraged by these preclinical results using NOD mice. This model is the gold standard for type-1 diabetes and the fact that recent experiments mirror what we've seen in previous models may be highly significant," stated Dr. Franklin. "We have many questions to answer about how PCs act in the body, but we believe, based on previous experiments, that PCs may stimulate regeneration of damaged islet cells that produce insulin. The current NOD mouse data also suggest that PCs may have an effect in modulating the auto-immune process in type 1 diabetes. We continue to conduct experiments aimed at elucidating the optimal dosing and other factors that may be responsible for producing a robust and long-lasting response, as this will be critical as we start to think about how PCs may be used in treating human diabetes."

In his presentation today, Dr. Franklin also provided further insight into the mechanism of action of PCs, based on recent animal experiments. It was observed previously that PCs produce microvesicles, which are known to play a role in intercellular communication, but through mechanisms that are poorly understood. In a recent experiment, Pathfinder was able to isolate these microvesicles from the PCs and treat animals directly with an injection containing microvesicles only. Remarkably, both PC- and microvesicle-treated mice exhibited similar reductions in blood glucose compared to controls using the same drug-induced diabetes mouse model. This suggests, not only that the microvesicles produced by PCs are central to the mechanism of action, but that the microvesicles alone appear to be sufficient to produce the full effect.

Dr. Franklin commented, "If confirmed, this finding could have a significant positive impact on the future of PC-based therapy. Due to the relatively small amount of material contained within the microvesicles, determining the specific factor(s) that are responsible for regenerating damaged tissue could be more straightforward than we first anticipated, bringing us closer to understanding the mechanism of action. There may also be a number of potential manufacturing and storage benefits to using microvesicles versus PCs that will be interesting to explore in parallel as we work to advance this innovative new therapeutic approach closer to human clinical development."

The New York Stem Cell Summit brings together cell therapy company executives, researchers, investors and physicians to explore investment opportunities in cell therapy research and innovation. More information can be found at http://www.stemcellsummit.com.

Presentation details Event: 7th Annual New York Stem Cell Summit Date: Tuesday, February 21, 2012 Place: Bridgewaters New York, 11 Fulton Street, New York, NY Time: 3:35 pm ET

About Pathfinder

Pathfinder is developing a novel cell-based therapy and has generated encouraging preclinical data in models of diabetes, renal disease, myocardial infarction, and critical limb ischemia, a severe form of peripheral vascular disease. Leveraging its internal discovery of Pathfinder Cells ("PCs") Pathfinder is pioneering a new field in regenerative medicine.

PCs are a newly identified mammalian cell type present in very low quantities in a variety of organs, including the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood. Early studies indicate that PCs stimulate regeneration of damaged tissues without the cells themselves being incorporated into the newly generated tissue. Based on testing to date, the cells appear to be "immune privileged," and their effects appear to be independent of the tissue source of PCs. For more information please visit: http://www.pathfindercelltherapy.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to obtain additional required financing; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results, if any; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; technological changes; and government regulation. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

1Karen Stevenson, Daxin Chen, Alan MacIntyre, Liane M McGlynn, Paul Montague, Rawiya Charif, Murali Subramaniam, W.D. George, Anthony P. Payne, R. Wayne Davies, Anthony Dorling, and Paul G. Shiels. Rejuvenation Research. April 2011, 14(2): 163-171. doi:10.1089/rej.2010.1099

The rest is here:
Pathfinder Presents Preliminary Data on New Regenerative Approach to Diabetes Treatment

The Supreme Court has delayed a decision on whether to hear a case that could affect the entire biotech industry -- one asking whether Myriad can own the patents on two breast cancer genes.

Because it had been scheduled for a conference discussion by the justices earlier this month, a decision about whether to consider the case was expected on Tuesday. But the Court declined to accept or reject the case, suggesting that the justices will want to discuss it again.

At issue us whether a single human gene, isolated from its cell and chromosome, is a natural product or a patentable piece of intellectual property.

The answer could have wide-reaching implications for the biotechnology sector, which relies on extensive research about genetic niches to create tailored therapies. If the fruits of such research could become essentially open-source, it could make many products a poor deal to develop. The industry believes that a ruling that genes cannot be patented could undermine many existing patents, too.

The case, Association of Molecular Pathology v. Myriad Geneticcs, concerns one of the first effective genetic  screening tests for cancer. Myriad isolated variations of two genes, BRCA1 and BRCA2, that can raise the risk of breast and ovarian cancer. Women use the tests to determine whether they are likely to develop tumors and many opt for enhanced screening or even prophylactic surgery if they learn they are positive.

Myriad has been protective of its genetic discovery, and has taken legal action against other companies that pursued tests based on the same gene patterns. They have also kept the cost of testing high—the full genetic analysis costs about $3,000, more than some insurance companies are willing to spend.

The challengers in the case want to make their own tests. Myriad, which has patented both the isolated genes and the processes it uses to decode them, says they should have exclusive rights to the genes.

Patent law allows inventors to protect their creations, but the Supreme Court has recognized an exception for “products of nature.” That exception means that companies can’t patent naturally occurring plants or bacteria, say, though they can patent synthetic copies or genetically modified organisms.

The Court has not yet considered the question of a single gene. A district court in Washington, D.C., found for the plantiffs, saying that the gene was a “product of nature” and therefore unpatentable. But the Federal Circuit Court found for the inventors, ruling that the gene, once removed from the body and unbound from neighboring genetic material, was a discrete product.

The American Civil Liberties Union says Myriad's patent has stopped other companies from researching and testing the patented genes, increasing costs for patients. "We hope that the Supreme Court will take this opportunity to recognize that genes are indeed unpatentable ‘products of nature,’ and that the only person who can own your genes is you," the ACLU wrote in a blog post.

Originally posted here:
Supreme Court To Say Yes or No to Gene Patenting Case

The Supreme Court has delayed a decision on whether to hear a case that could affect the entire biotech industry -- one asking whether Myriad Genetics can own the patents on two breast cancer genes.

Because it had been scheduled for a conference discussion by the justices earlier this month, a decision about whether to consider the case was expected on Tuesday. But the Court declined to accept or reject the case, suggesting that the justices will want to discuss it again.

At issue us whether a single human gene, isolated from its cell and chromosome, is a natural product or a patentable piece of intellectual property.

The answer could have wide-reaching implications for the biotechnology sector, which relies on extensive research about genetic niches to create tailored therapies. If the fruits of such research could become essentially open-source, it could make many products a poor deal to develop. The industry believes that a ruling that genes cannot be patented could undermine many existing patents, too.

The case, Association of Molecular Pathology v. Myriad Genetics, concerns one of the first effective genetic  screening tests for cancer. Myriad isolated variations of two genes, BRCA1 and BRCA2, that can raise the risk of breast and ovarian cancer. Women use the tests to determine whether they are likely to develop tumors and many opt for enhanced screening or even prophylactic surgery if they learn they are positive.

Myriad has been protective of its genetic discovery, and has taken legal action against other companies that pursued tests based on the same gene patterns. They have also kept the cost of testing high—the full genetic analysis costs about $3,000, more than some insurance companies are willing to spend.

The challengers in the case want to make their own tests. Myriad, which has patented both the isolated genes and the processes it uses to decode them, says they should have exclusive rights to the genes.

Patent law allows inventors to protect their creations, but the Supreme Court has recognized an exception for “products of nature.” That exception means that companies can’t patent naturally occurring plants or bacteria, say, though they can patent synthetic copies or genetically modified organisms.

The Court has not yet considered the question of a single gene. A district court in Washington, D.C., found for the plantiffs, saying that the gene was a “product of nature” and therefore unpatentable. But the Federal Circuit Court found for the inventors, ruling that the gene, once removed from the body and unbound from neighboring genetic material, was a discrete product.

The American Civil Liberties Union says Myriad's patent has stopped other companies from researching and testing the patented genes, increasing costs for patients. "We hope that the Supreme Court will take this opportunity to recognize that genes are indeed unpatentable ‘products of nature,’ and that the only person who can own your genes is you," the ACLU wrote in a blog post.

More here:
Supreme Court Still Considering Whether To Take Gene Patenting Case

Washington, Feb 22 (ANI): Scientists have discovered that a gene known to control lens development is also vital for the development of neurons responsible for mechanosensory - touch sensation - function.

Neurobiologists of the Max Delbruck Center for Molecular Medicine (MDC) Berlin-Buch found that in mice in which they had removed the c-Maf gene in the nerve cells, touch sensation is impaired.

This similarly applies to human carriers of a mutant c-Maf gene. People with such a mutation suffer already at a young age from cataracts, a clouding of the lens, which typically affects the elderly.

The patients, as demonstrated by Professor Carmen Birchmeier and Dr. Hagen Wende in collaboration with Professor Gary Lewin and Dr. Stefan Lechner, have difficulty holding objects such as a sheet of paper as a consequence of this mutation.

"c-Maf is an important gene for the development of the peripheral nerve cells," Professor Birchmeier, a developmental biologist, commented on the findings of her research group.

The gene controls the development of neurons that detect touch, the mechanosensory neurons. Previously, c-Maf was known as a key regulator of lens development.

Furthermore, the gene is also active in the dorsal root ganglia, an aggregate of nerve cells next to the spinal cord in which the cell bodies of mechanosensory neurons are localized.

The nerve cells form long axons, which terminate in the skin in touch corpuscles or at hair shafts.

These axons detect mechanical stimuli, which in turn are converted into electrical signals and transmitted to the brain. When you stroke your fingers over a surface, its structure triggers high-frequency vibrations in the finger, to which specific touch receptors, the Pacinian corpuscles, respond.

In mice with deactivated c-Maf gene only few Pacinian corpuscles are formed, and moreover these few are not intact.

The mice are therefore unable to recognize high-frequency vibrations. The same is true for a Swiss family with an inherited mutant c-Maf gene.

The consequence is that the affected patients develop cataracts at an early age and have an impaired sense of touch.(ANI)

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'Vision' gene also involved in sensing vibrations

Public release date: 21-Feb-2012
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Contact: Cathia Falvey
cfalvey@liebertpub.com
914-740-2100
Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, February 21, 2012?Faith-based advocacy has been cited as a valuable tool in combating childhood obesity, but evidence is needed to support this assertion and to define how the link between advocacy and policy can contribute to promoting permanent lifestyle changes. This article is part of a special issue of the journal Childhood Obesity celebrating the second anniversary of First Lady Michelle Obama's Let's Move! initiative. The issue includes a special Foreword by Mrs. Obama and is available free on the Childhood Obesity website at http://www.liebertpub.com/chi.

"Faith-Based Advocacy To End Childhood Obesity: Using Evidence-Based Information," an article by Michael Minor, AB, MBA, MS, EdD, Director, H.O.P.E. Health Initiative, National Baptist Convention, USA, Incorporated, Hernando, Mississippi, discusses the development of a national evidence-based paradigm to support the belief that faith-based advocacy can have an effective role in preventing childhood obesity.

This special Let's Move! issue has a wide range of contributions from leaders in the fight against childhood obesity including Secretary of Agriculture Tom Vilsack, NFL quarterback Drew Brees, Stephen Daniels, MD, PhD, Sandra Hassink, MD, Margo Wootan, DSc, and Editor-in-Chief David Katz, MD, MPH.

The issue covers a broad range of topics including creating environments that support routine physical activity and a healthy lifestyle, after-school obesity prevention programs, nutrition standards for school meals, faith-based advocacy efforts to end childhood obesity, gaming and technology for weight control, parent training programs for 2-4 year old Latino children, the role of sleep in childhood obesity, a roundtable discussion about what we don't know about childhood obesity, industry efforts to help children make healthy food choices, and success stories from the Let's Move! initiative.

"If we compare our efforts to overcome the peril of childhood obesity to a war, we must acknowledge that it is being waged, and can only be won, on multiple fronts," says David L. Katz, MD, MPH, Editor-in-Chief of Childhood Obesity and Director of Yale University's Prevention Research Center. "The faith-based community represents a veritable army of good works that can make a vitally important contribution to this campaign. Dr. Minor shows us how that can happen in an evidence-based manner. As we wait for evidence to catch up with on-going efforts, he also gives us reason?to have a little faith!"

###

About the Journal

Childhood Obesity is a bimonthly journal, published in print and online, and the journal of record for all aspects of communication on the broad spectrum of issues and strategies related to weight management and obesity prevention in children and adolescents. The Journal includes peer-reviewed articles documenting cutting-edge research and clinical studies, opinion pieces and roundtable discussions, profiles of successful programs and interventions, and updates on task force recommendations, global initiatives, and policy platforms. It reports on news and developments in science and medicine, features programs and initiatives developed in the public and private sector, and a Literature Watch. Tables of content and a sample issue may be viewed on the Childhood Obesity website at http://www.liebertpub.com/chi.

Childhood Obesity is partly funded by a grant from the W.K. Kellogg Foundation to ensure that the Journal is accessible as widely as possible, and to provide a framework that addresses the social and environmental conditions that influence opportunities for children to have access to healthy, affordable food and safe places to play and be physically active.

About the Company

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative medical and biomedical peer-reviewed journals, including Population Health Management, Pediatric Allergy, Immunology, and Pulmonology, Diabetes Technology & Therapeutics, and Metabolic Syndrome and Related Disorders. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, newsmagazines, and books is available online at http://www.liebertpub.com.

Mary Ann Liebert, Inc. 140 Huguenot St., New Rochelle, NY 10801-5215
Phone: (914) 740-2100 (800) M-LIEBERT Fax: (914) 740-2101 http://www.liebertpub.com

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Childhood obesity -- can faith-based organizations make a difference?

By Christopher Weaver

All the hype around genetic testing?has?doctors worried they’ve overlooked the most basic — and for now, the most effective — genomic tool at their disposal: A few questions about their patients? families.

As the WSJ reports today, British researchers showed that by systematically collecting detailed family history from patients, they boosted the number of patients at high risk for heart disease detected by standard assessment tools from 12% to 18%. Catching more high-risk patients would mean doctors could better steer preventive care that could avert heart attacks.

“In the genomic revolution, we?ve forgotten basic family history as a tool,” says Donna Arnett, a genetic epidemiologist at the University of Alabama at Birmingham and the president-elect of the American Heart Association. “I practice genetic epidemiology and look for genetic markers, but by far, the most important thing we can do in the prevention of heart disease is to identify family history,” says Arnett, who was not involved in the latest research.

The study, published today in the Annals of Internal Medicine, pushed patients to fill out detailed questionnaires — which asked, for instance, the age relatives suffered heart disease — and went far beyond the checked boxes most patients would recognize from doctors? waiting-room forms.

Other research has verified that certain types of family history, such as a parent who had a heart attack before reaching age 60, increases a patient?s heart disease risk by as much as 50%. Probability remains the best tool most doctors have to work with.

“Genetics was supposed to solve all that,” says Alfred Berg, professor of family medicine at the University of Washington. “You were supposed to do a test, and be able to say, ‘I know for sure’” whether a patient will have a heart attack, he says.

Yet, routine family history collect continues to show “at least as much promise as all this high-tech testing,” adds Berg, who until last year chaired a U.S. Centers for Disease Control and Prevention panel that examined genomic-testing products.

Of eight genetic tests developed in recent years by seven companies, none is so far backed by sufficient evidence that it can accurately predict heart disease, according to a recommendation on the latest heart disease screening technologies issued in late 2010 by the independent CDC panel. (The same is true for most of the diseases and testing products the group has analyzed.)

That high-tech genetics has so far been disappointing in the exam room is in part what?s inspiring researchers to revisit family history — a tool researchers already know works well.

The current research “began with the premise that there?s been a great hike in genetic testing,” says Nadeem Qureshi, the lead author of the NEW? study and a University of Nottingham researcher specializing in applied genetics. “But, family history is a great proxy for both genetics and environment, and it?s not being used in clinical practice.”

Image: iStockphoto

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Doctors Revive the Simplest Genetic Test

Public release date: 21-Feb-2012
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Contact: Margaret Allen
mallen@smu.edu
214-768-7664
Southern Methodist University

A majority of college students is receptive to donating blood or other genetic material for scientific research, according to a new study from Southern Methodist University, Dallas.

In what appears to be the first study to gauge college students' willingness to donate to a genetic biobank, the study surveyed 250 male and female undergraduate and graduate students.

Among those surveyed, 64 percent said they were willing to donate to a biobank, said study author Olivia Adolphson. Students filled out a two-page survey with 18 questions designed to assess their willingness to participate in a biobank, an archive of blood and tissue samples donated by individuals for the purpose of genetic research.

Student reasons include altruism, while barriers were privacy and lack of time

"Overall I found that my sample was very willing to participate in a biobank," said Adolphson, an undergraduate psychology researcher at SMU. "The reasons cited were altruism ? people want to help others ? as well as to advance scientific research and to help find cures. The barriers were concerns about privacy, lack of time, lack of interest and lack of knowledge."

Also from the study, students with a family health history of cancer, heart disease, high blood pressure, Alzheimer's, diabetes and other diseases were not more motivated than other students to donate to a biobank, Adolphson said.

Adolphson has been invited to present two posters on her study, "College Students' Perceptions of Genetic Biobanking," in April at the 33rd Annual Meeting and Scientific Sessions of the Society of Behavioral Medicine in New Orleans.

First study of its kind to look at college students in the United States

"This appears to be the first study to gauge college students' willingness to donate to a genetic biobank," said licensed clinical psychologist and the study's principal investigator Georita Frierson, an SMU assistant professor and health behaviors expert.

Of the students surveyed, 73 percent self-identified as white, while 27 percent self-identified as an ethnic minority. Before being given a description of a genetic biobank, 36 percent said they'd heard of the term. After being informed, 64 percent said they were willing to participate.

"Overall I found that the students who were more educated, the seniors, were more familiar with the concept of a biobank, and they were also more comfortable with it," Adolphson said. "So we think education plays a role in acceptance."

The research indicates that the medical community should do more to inform people about biobanks, Adolphson said.

Biobanks should educate people to familiarize them with concept

"The biobank community needs to educate people. And they need to use simple language that isn't intimidating, because lack of knowledge is a big barrier," she said. "From this research we saw that younger people are going to be willing to participate, because they are open-minded about the concept of research."

Adolphson's research followed a larger study by Frierson, which surveyed 135 adult Dallas-area residents who also attended one of Frierson's 28 focus groups on the subject of biobanks. That study found that 81 percent of the participants had never heard of biobanking. Before the educational focus groups, 64 percent said they would participate in a biobank. After focus groups, that number significantly jumped to 90 percent, Frierson said.

###

SMU is a nationally ranked private university in Dallas founded 100 years ago. Today, SMU enrolls nearly 11,000 students who benefit from the academic opportunities and international reach of seven degree-granting schools. For more information see http://www.smu.edu.

SMU has an uplink facility located on campus for live TV, radio, or online interviews. To speak with an SMU expert or book an SMU guest in the studio, call SMU News & Communications at 214-768-7650.

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Study finds college students willing to donate genetic material to biobanks for research

The Irish Times - Tuesday, February 21, 2012

DICK AHLSTROM

AUTISM: RESEARCHERS AROUND the world continue to struggle with the complexity of autism. They now believe that genetic factors and brain changes triggered by man-made chemicals in the environment are equally to blame for the development of autism in young children.

Efforts to track the causes of autism were discussed yesterday in a session at the American Association for the Advancement of Science’s annual meeting in Vancouver.

“Autism is a very complicated disorder,” said Prof Scott Selleck of Pennsylvania State University. “We have come to know it has many, many genetic contributors.”

A number of genetic alterations have emerged as important in autistic disorders but persistent chemicals in the environment including flame retardants and polychlorinated biphenyls were also important, he said. “The balance of genetic and environmental contributors is about equal. It is 50/50.”

The panel, which included Prof Janine LaSalle and Prof Isaac Pessah, both of the University of California Davis, was completely dismissive of the now discredited theory that autism in its various forms was caused by “refrigerator parents” or “refrigerator moms”, parents who interacted only minimally with their children.

The phraseology arose in the 1950s. “The idea was that autism was caused because parents were distant. That idea has done a lot of damage,” Prof Selleck said and he ruled it out as nonsense.

He described his own research, cataloguing the number of “copy number variations” in the genomes of those with autism. These were either copied additions to the genome or deletions left out of the genome.

Prof LaSalle described her work on how exposure to persistent chemicals such as flame retardants could cause long-lived changes in how collections of genes were expressed, for example the genes associated with building neurological networks. This was referred to as “epigenetics”, she said, and the complex system involved could be perturbed by low-level environmental chemicals.

She exposed mouse models to the flame retardant PBE-47 and polychlorinated biphenyl MECP-2 at minute levels that matched human exposures.

It affected both sociability of these mice and also their learning behaviour.

There were now upwards of 80,000 non-natural chemicals in the environment produced by industrial processes and other sources, said Prof Pessah. Few had been tested for their neurotoxicity despite human exposures to these substances.

Here is the original post:
Genetics and man-made chemicals equally to blame, say researchers

LOS ANGELES--(BUSINESS WIRE)--

Response Genetics, Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today that on February 16, 2012, the Company was notified that it has regained compliance with The NASDAQ Capital Market and its minimum market value of listed securities requirement. The Company regained compliance with NASDAQ Marketplace Rule 5550(b)(2) and was notified by NASDAQ that the delisting matter is now closed.

About Response Genetics, Inc.

Response Genetics, Inc. (“RGI”) (the “Company”) (Nasdaq: RGDX - News) is focused on the development and sale of molecular diagnostic tests for cancer. RGI’s technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed and paraffin-embedded specimens. In addition to diagnostic testing services, RGI also generates revenue from the sales of its proprietary analytical pharmacogenomic testing services of clinical trial specimens to the pharmaceutical industry. The Company’s headquarters is located in Los Angeles, California. For more information, please visit responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of RGI 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 remain compliant under Nasdaq listing rules, 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 Regains NASDAQ Compliance

The study is set for publication the week of Feb. 20 in the early edition of the Proceedings of the National Academy of Sciences.

"Many disease-causing microbes can evade one defensive action by a host plant, but we believe that most microbes would have difficulty overcoming a combination of two immune-system defenses," said UC Davis plant sciences professor Abhaya Dandekar, the lead researcher.

He and his colleagues tested this hypothesis on Xylella fastidiosa, the bacteria responsible for Pierce's disease in grapevines. Strains of the bacteria also attack and damage other host plants, including citrus, stone fruits, almonds, oleander, and certain shade trees, such as oaks, elms, maples and sycamores.

The findings further strengthen UC Davis' standing as a world leader in the science of plant improvement through advances in genetics, genomics, plant breeding and biodiversity.

First noted in California near Anaheim around 1884, Pierce's disease in grapevines is now known to exist in 28 California counties. From 1994 to 2000, the disease destroyed more than 1,000 acres of northern California grapevines, causing $30 million in damages. There is currently no known cure for Pierce's disease.

In grapevines, Xylella fastidiosa is carried from plant to plant by half-inch-long insects known as sharpshooters. The bacteria infect and clog the plant's water-transporting tissue, or xylem. Grapevines with Pierce's disease develop yellow and brown leaves and die within a few years.

To block such infections, the researchers engineered a hybrid gene by fusing together two genes that are responsible for two key functions of the plant's innate immune response: recognizing Xylella fastidiosa as a bacterial invader and destroying its outer membranes, causing the bacteria to die.

The researchers then inserted this hybrid gene into grapevines.

They found that sap from plants genetically engineered with the hybrid gene effectively killed Xylella fastidiosa in the laboratory. And grapevines engineered to carry the hybrid gene had significantly less leaf scorching and xylem clogging, indicating resistance to Pierce's disease.

Provided by University of California - Davis

Read this article:
Fused genes tackle deadly Pierce's disease in grapevines

By Matt Jones

NEW YORK (GenomeWeb News) –The Supreme Court of the United States on Friday began considering whether to take up the case between Myriad Genetics, the Association of American Pathology, and other plaintiffs and defendants that could either shore up or change current US laws covering gene patenting.

The Myriad gene patents case, officially the Association of Molecular Pathology, et al. v. US Patent and Trademark Office, centers on the assertion by AMP and others that 15 patents exclusively licensed Myriad covering BRCA1 and BRCA2 genes should be invalid because they claim rights to products of nature and as such are not patentable.

The case began its journey toward the highest court in 2009 when it was first filed in the Federal District Court, Southern District of New York against Myriad. The AMP suit was joined by the American Civil Liberties Union, the Public Patent Foundation, patient advocacy groups, and the academic research community, all with different interests in gene patenting policies.

The lawsuit claimed that Myriad maintains a monopoly over any genetic testing to determine the presence or absence of mutations on the human BRCA1 or BRCA2 genes, thereby stifling research and limiting women's options regarding their medical care.

In 2010, Judge Robert Sweet ruled that the Myriad patents are invalid, because the isolated DNA the patents covered are not markedly different from native DNA as it exists in nature, and are not patentable.

That ruling, however, which left Myriad and other companies holding similar genetic patents on uncertain ground, was mostly overturned on appeal – which was requested by both plaintiffs and defendants – by the US Court of Appeals for the Federal Circuit last summer.

The Court of Appeals decided that some kinds of DNA can be patented, such as cDNA molecules and other engineered molecules that are not found in nature, so most of Myriad's claims would be valid.

"We disagree [with the district court], as it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit," the court stated in its decision. "The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact."

It also said that the company's claim on an assay for cancer therapeutics is valid because it involved several transformative steps. However, the judges said that five of Myriad's broadest method claim patents are invalid because they effectively referred to a mental act, a way of comparing sequences to look for differences, which cannot be patented.

One aspect of this case that could affect the court's decision is that the Office of the Solicitor General in the Department of Justice filed an amicus brief with the appeals court siding with the plaintiffs and against Myriad.

Solicitor General Neal Katyal argued that the court should uphold what the Supreme Court has historically supported, the notion that there is "a cardinal distinction" between products of nature on the one hand and human-made inventions on the other. The process of isolating DNA would not be enough of a transformation to make it patentable, Katyal argued, otherwise "[the element] lithium would be patentable."

Because the solicitor general joined in the case, Robert Cook-Deegan, director of the Duke University Center for Genome Ethics, Law & Policy, thinks that the Supreme Court may not make an immediate decision to hear the case, but instead it may opt to bounce the case over to the DOJ for another review.

"The two majority judges from the CAFC went out of their way to criticize the solicitor general's oral arguments [in their ruling], and I would think the Supreme Court might want to hear if the solicitor general has changed their mind in light of those arguments, or if they want to have a chance to rebut the judge's arguments," Cook-Deegan told GenomeWeb Daily News.

"This is apparently fairly common. Sometimes the solicitor general is said to be the tenth justice on the Supreme Court," Cook-Deegan said.

Under that scenario, if the solicitor general's office still holds the same position it had in 2011 against gene patents, then the Supreme Court would be likely to take up the case.

After the CAFC ruling, Myriad and companies with similar technologies are in a stronger patent position than they were in the wake of the New York court's decision, Cook-Deegan said, but the field of gene patents can involve unique complexities, and any certainties about patent protections could quickly become less firm in an environment of constantly-evolving technologies. For example, how will deep sequencing in the clinic affect the business models of labs that center on ownership of a few patents?

Cook-Deegan said that the case has already had an impact. "It is actually a pretty big deal that the courts have resettled the matter of whether you can patent a cDNA or an engineered DNA. … It is also a big deal that they threw out the method claims," he said. "Those claims were much more likely to get in the way of whole genome sequencing, whole exome sequencing, and the new technologies, than the DNA molecule claims."

Cook-Deegan said the court could decide what its next step will be as early as this week.

Meanwhile, an Australian federal court this week is hearing arguments in a case challenging Myriad's gene patents there.

See the article here:
Supreme Court Considering Taking on Gene Patents Case

The Federal Court has been asked to decide if patents granted over segments of human DNA are valid. Photo: Phil Carrick

COMPANIES do not have the right to a patent over human gene sequences and genetic mutations because such biological material is a product of nature, a court has been told.

The patient advocacy group Cancer Voices has launched legal action against two biotechnology companies that hold patents over a genetic mutation linked to breast and ovarian cancer, known as BRCA1.

The Federal Court has been asked for the first time to decide if patents granted over segments of human DNA are valid.

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The US biotech company Myriad Genetics and the exclusive Australian licensee, Genetic Technologies, have a monopoly right to control the use of the BRCA1 mutation for research and development as well as diagnostic testing.

It was granted on the basis that the process of isolating the gene in a laboratory constituted an ''invention''.

In 2008, Genetic Technologies threatened to invoke its patent by ordering all laboratories to stop BRCA1 diagnostic testing but withdrew after a public backlash. The patent is enforced in the United States.

Rebecca Gilsenan, from Maurice Blackburn lawyers, which is running the case pro bono, said isolating a gene cannot amount to a patentable invention, as it is a ''discovery''.

Under Australian law, patents can only be granted over ''inventions'' which constitute a ''manner of manufacture'' or ''manner of new manufacture''.

The court, sitting in Sydney, must decide whether a natural biological material when isolated from its natural environment is a ''manner of manufacture''. Ms Gilsenan said the plaintiffs would argue there were no material structural or functional differences between a BRCA1 gene inside the body and one isolated from the body.

David Shavin, QC, for Myriad, told the court that when removed from the body and used to predict a person's predisposition to breast or ovarian cancer, the isolated nucleic acid is different to that in the cell.

''We are not seeking to patent the BRACA1 gene,'' he said. ''The thing that has been created and isolated is an artificially constructed state of affairs.''

Cancer Voices says allowing genetic mutations linked to specific diseases to be patented could restrict access to life-saving diagnostic procedures and discourage research.

''More and more research is leading to the genetic diagnosis of cancer,'' the group's executive director, John Stubbs, said outside court. ''They are our genes, we want to make sure they and the diagnostic tests that go along with them are protected.''

The second applicant, cancer survivor Yvonne D'Arcy, said she had taken action because she believed biological material should not be used for profit.

The hearing before Justice John Nicholas is expected to last up to eight days.

See the original post:
Court to consider gene patent

"More and more research is leading to the genetic diagnosis of cancer" ... Cancer Voices executive director John Stubbs. Photo: Anthony Johnson

COMPANIES do not have the right to a patent over human gene sequences and genetic mutations because such biological material is a product of nature, a court has been told.

The patient advocacy group Cancer Voices has launched landmark legal action against two biotechnology companies that hold patents over a genetic mutation linked to breast and ovarian cancer, known as BRCA1.

The Federal Court has been asked for the first time to decide if patents granted over segments of human DNA are valid.

Advertisement: Story continues below

The US biotech company Myriad Genetics and the exclusive Australian licensee, Genetic Technologies, have a monopoly right to control the use of the BRCA1 mutation for research and development as well as diagnostic testing.

It was granted on the basis that the process of isolating the gene from the human body in a laboratory constituted an "invention".

In 2008, Genetic Technologies threatened to invoke its patent by ordering all other laboratories to stop performing BRCA1 diagnostic testing but withdrew after a public backlash. The patent is enforced in the US.

Rebecca Gilsenan, from Maurice Blackburn lawyers, which is running the case pro bono, said isolating a gene from the human body cannot amount to a patentable invention, as it is merely a ''discovery''.

Under Australian law, patents can only be granted over "inventions" which constitute a "manner of manufacture" or "manner of new manufacture".

The court will have to decide whether a naturally occurring biological material when isolated from its natural environment is a ''manner of manufacture''.

Ms Gilsenan said the plaintiffs would argue there were no material structural or functional differences between a BRCA1 gene that is inside the body and a BRCA1 gene that has been isolated from the body.

However, David Shavin, QC, for Myriad, told the court that when removed from the body and used to predict a person's predisposition to breast or ovarian cancer, the isolated nucleic acid is, in fact, different to that which exists in the cell.

''We are not seeking to patent the BRACA1 gene,'' he said. ''The thing that has been created and isolated … is an artificially constructed state of affairs.''

Cancer Voices says allowing genetic mutations linked to specific diseases to be patented could restrict access to life-saving diagnostic procedures and actively discourage scientific research.

''More and more research is leading to the genetic diagnosis of cancer,'' the group's executive director, John Stubbs, said outside court. ''They are our genes, we want to make sure they and the diagnostic tests that go along with them are protected.''

The second applicant, breast cancer survivor Yvonne D'Arcy, said she has taken legal action as she believes biological material should not be used for profit.

''If you're really sick and its a genetic form of cancer, then everyone female down the line should be able to get the testing done at a price they can afford and if its patented, it won't be,'' she said.

In 2010, a US District Court ruled the same patent was invalid, but the decision was overturned on appeal last year. The American Council for Civil Liberties has petitioned the US Supreme Court to review the decision.

The hearing before Justice John Nicholas is expected to last up to eight days.

The rest is here:
Patient advocates test law on human gene patents

ScienceDaily (Feb. 20, 2012) — On the surface, it's simple: when night falls, our bodies get sleepy. But behind the scenes, a series of complex molecular events, controlled by our genes, is hard at work to make us groggy. Now, research suggests that a newly identified gene known as insomniac may play a role in keeping us asleep. By cloning and testing this gene in fruit flies, Rockefeller University researchers say they have discovered an entirely new mechanism by which sleep is regulated.

Nicholas Stavropoulos, a postdoc, and Michael W. Young, Richard and Jeanne Fisher Professor and head of the Laboratory of Genetics, conducted a genetic screen of approximately 21,000 fruit flies. Using a device that employs infrared beams to detect when the flies nod off, they discovered that mutations in the insomniac gene were associated with a dramatic reduction in sleep. While a typical fruit fly sleeps for average of 927 minutes a day, insomniac flies snoozed for just 317. The mutant flies also slept for shorter periods of time, and slept and woke more frequently.

"The results showed a dramatic loss of both the duration of the flies' sleep and their ability to remain asleep after they dozed off," says Stavropoulos. "But what's especially interesting is that the insomniac gene may function through homeostatic mechanisms. These are distinct from the well-studied circadian clock pathways linked to sleep, and have an effect on the body regardless of the time of day."

The scientists believe that insomniac works by engaging a specific series of protein degradation pathways in neurons through a complex known as Cul3. If correct, this would be the first time that a protein degradation pathway, in which specific proteins are eliminated within a cell, has been linked to sleep.

The researchers also examined the link between sleep and lifespan, finding that flies with mutations to the insomniac gene lived only about two-thirds as long as unaltered flies (other studies have suggested similar effects in both flies and rats that are deprived of sleep). But when the scientists eliminated insomniac only in neurons -- allowing it to remain in the rest of the flies' bodies -- this disparity was eliminated; the resulting animals slept poorly but lived just as long.

"This suggests that reduced sleep can be 'uncoupled' from reduced lifespan, supporting the idea that some disruptions of sleep do not affect overall health, at least as far as lifespan is concerned," Stavropoulos says.

Although flies and humans would appear to have little in common when it comes to lifestyle, scientists say that the mechanisms of sleep and wakefulness are likely to be quite similar.

"Sleep is a fundamental behavior in all animals, and it is poorly understood from a scientific standpoint," says Stavropoulos. "This work gives us several new clues about how sleep is controlled at the molecular level, and could prove useful in understanding and treating sleep disorders."

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Journal Reference:

Nicholas Stavropoulos, Michael W. Young. insomniac and Cullin-3 Regulate Sleep and Wakefulness in Drosophila. Neuron, 2011; 72 (6): 964 DOI: 10.1016/j.neuron.2011.12.003

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Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

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Gene affecting the ability to sleep discovered in fruit flies

Biomedical research lost one of its titans with the death of Marshall Nirenberg, the Nobel Prize-winning biochemist who, with the help of colleagues at the National Institutes of Health (NIH) and elsewhere, cracked the genetic code in 1961. His experiment showed how RNA transmits encoded information in DNA and directs the building of proteins (the National Museum of American History owns a copy of his chart of 64 3-letter combinations describing all possible amino acids, the building blocks of proteins, and the NIH has an excellent virtual exhibit about Nirenberg's work).

Nirenberg was the first federal employee to win the Nobel Prize in physiology or medicine. It made him an instant celebrity. While tempted by job offers in academe and elsewhere -- they were surely his for the asking -- Nirenberg ended up spending his entire career at the NIH. He said he just couldn't see giving up the freedom they gave him to pursue his research.

I had the privilege of meeting this quietly modest man a couple of times, as NIH is just up the pike from the museum in downtown D.C. That's Rockville Pike, the spine of the so-called I-270 biotech corridor, but Nirenberg worked there long before the region acquired its current moniker. The area's great research organizations, like NIH and the nearby National Institute of Standards and Technology -- which has garnered its own share of Nobel Prizes -- are cornerstones of the new technology corridor. But they rest on over a century of institution building, both private and public.

Federal science agencies tend to treasure their Nobel laureates. It's the sort of thing that private industrial research labs used to do, but say they can no longer afford. We are fortunate indeed that government agencies like NIH continue to do the far-horizon research that launches and sustains our nation's high-tech networks, the incubators of new technologies. A clear case, in my view, of government money well spent.

Image: Nirenberg performing an experiment in his lab c. 1962/National Institutes of Health.

This post also appears on the Smithsonian's O Say Can You See? blog, an Atlantic partner site.

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Cracking the Genetic Code

MONTREAL, QUEBEC--(Marketwire -02/20/12)- The Centre of Excellence in Personalized Medicine (Cepmed), announced today that they have launched a web-based Personalized Medicine Portal for Canadians and joined DNA Direct by Medco's Genomic Medicine Network (GMN).

Cepmed's Personalized Medicine Portal (Portal) provides information and decision making tools that will help patients understand how genetic testing can be used to inform treatment decisions and enable better communication between patients and providers. The Portal, available at http://www.cepmed.com, provides information about access to specific genetic tests in each Province. "Many of the stakeholders have told us that there is a dearth of reliable, evidence based information concerning personalized medicine tests. A centralized source of information about which tests exist, who should take them and how they should be interpreted is what we are offering through our partnership with DNA Direct by Medco. We believe this resource will contribute to improved patient outcomes and savings to the health care system." - Dr. Clarissa Desjardins - CEO, Cepmed.

According to the Personalized Medicine Coalition, there are more than 50 genetic tests currently available that can inform treatment decisions and drug therapy for a wide range of diseases.(i) With the availability of these tests, support and demand for personalized medicine is growing internationally. However, effective integration of personalized medicine into clinical care is challenging. It is widely thought that effective adoption of personalized medicine will require the participation of informed and engaged patients and healthcare providers.

Cepmed plans to use the Portal as a key element of implementation studies in personalized medicine, collaborating with healthcare providers, patient organizations and the public to define how personalized medicine is best applied within the Canadian health care system. These studies will be informed by Cepmed's participation in DNA Direct by Medco's GMN. The GMN brings together leaders in personalized medicine and offers opportunities to establish multi-site studies in genomics, with a particular focus on real-world or implementation studies.

"We are excited about this opportunity to expand our Genomic Medicine Network to include a premier personalized medicine organization in Canada," said Joan Kennedy, President of DNA Direct by Medco. "Cepmed will add a unique perspective and new types of collaboration opportunities across the network."

About DNA Direct

DNA Direct, a wholly owned subsidiary of Medco Health Solutions, Inc. (NYSE: MHS - News), delivers guidance and decision support for genomic medicine to patients, providers and payers. The company's comprehensive clinical programs are unique to genomic medicine and combine proprietary technology with genetic expertise; including a national call center of genetic experts, web-based applications, and educational resources and training. DNA Direct is based in San Francisco. For more information, visit http://www.dnadirect.com.

About Cepmed

Cepmed is a non-profit organization dedicated to promoting personalized medicine through research, commercialization, and education. Cepmed participates in several public-private partnerships that have funded studies in translational medicine and pharmacogenomics. Cepmed has established expert physician panels in cardiology, oncology, and a multi-disciplinary Strategic Advisory Panel. Cepmed is working with these panels to ensure that personalised medicine is effectively incorporated into routine medical practice, resulting in improved health care in Canada.

Founded by Dr. Jean Claude Tardif at the Montreal Heart Institute, Cepmed makes use of the Beaulieu-Saucier Pharmacogenomics Centre, the Montreal Heart Institute Coordinating Centre (MHICC) and the Montreal Heart Institute Biobank in its projects. It is a Centre of Excellence for Commercialization and Research (CECR) and supported by the Canadian Government and Genome Quebec as well as private partners including Merck, Pfizer, AstraZeneca and Novartis.

(i) "The Case for Personalized Medicine, 3rd Edition", published by the Personalized Medicine Coalition in 2011.

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Cepmed Launches Online Personalized Medicine Portal

By Daily Mail Reporter

Last updated at 3:15 PM on 17th February 2012

Created 5:25 PM on 6th February 2012

Bio-hazard: Scientists found three out of 234 people were virtually insensitive to the anthrax toxin. They said this could have implications for other pathogens like HIV

Some people have a natural genetic resistance to anthrax, according to scientists.

Research into anthrax found susceptibility to the deadly disease caused by the bacterium Bacillus anthracis varied from person to person - revealing that susceptibility to the toxin is a heritable genetic trait.

Among 234 people studied by researchers at the Stanford University School of Medicine in the United States, the cells of three people were virtually insensitive to the toxin, while the cells of some people were hundreds of times more sensitive than those of others.

The findings may have important implications for national security, as people known to be more resistant to anthrax exposure could be effective first-line responders in times of crises.

The research also highlights the fact that many lethal pathogens - including HIV, malaria, leprosy and hepatitis - rely on interactions with host genes to infect and replicate within human cells.

Inherited differences in the level of expression of these genes can lead to large variations in the relative susceptibility of different individuals to the pathogen.

Inherited differences in the level of expression of these genes can lead to large variations in the relative susceptibility of different individuals to the pathogen.

The senior author of the report, funded by the Defence Threat Reduction Agency of the U.S. Department of Defence, is Professor of genetics Stanley Cohen.

'Every pathogen has its own virulence strategy,' said Stanford professor of microbiology and immunology David Relman, who was not involved in the research.

'We already knew that infection by the same organisms in different people can have different outcomes.

'But until now it’s been very difficult to determine whether this variability was due to genetic or environmental factors.

'This is one of the few studies that has successfully identified a host-genetics-based molecular cause of this variability.'

In the new study, Prof Cohen and his colleagues found that variation in the level of expression of a gene that produces a cell-surface protein called CMG2 affects the success of the anthrax toxin in gaining entry into human cells.

The research suggests that analogous effects may occur in people exposed to anthrax bacteria.

Anthrax disease is caused by infection with the anthrax bacteria. Spores of the bacteria exist naturally in the environment.

When inhaled by humans or animals, the spores are transported by immune cells to lymph nodes, where the bacteria begin to multiply and are secreted into the bloodstream.

Once in the bloodstream, the bacteria begin to produce the anthrax toxin that infiltrates and kills host cells.

Many lethal pathogens - including HIV (pictured) malaria, leprosy and hepatitis - rely on interactions with host genes to infect and replicate within human cells

Untreated, anthrax infection can cause widespread tissue damage, bleeding and death.

The researchers studied immune cells called lymphocytes collected from 234 people of varying ethnic and geographic backgrounds: 84 Nigerians, 63 Americans whose ancestors came from northern and western Europe, 44 Japanese and 43 Han Chinese.

They found that, of the 234 samples, lymphocytes from three individuals of European ancestry were thousands of times more resistant to killing by an engineered hybrid toxin brought into the cells by protective antigen.

The extent of variation in sensitivity was surprising to the scientists.

Even excluding the virtually resistant cells, they sometimes had to apply as much as 250 times more toxin to kill a similar number of cells in one sample as in another.

In addition, they observed that cells isolated from parents and their children responded similarly, indicating that toxin sensitivity is an inherited trait.

Prof Relman said: 'This research offers an important proof of principle.

'They’ve showed that genetically-determined variations in the level of expression of a human protein can influence the susceptibility of host cells to anthrax toxin.

'The findings also provide a possible means for predicting who is likely to become seriously ill after exposure, which could be extremely useful when faced with a large number of exposed people, such as was the case during the 2001 anthrax attacks.

'Finally, they could lead to the development of novel treatment strategies, perhaps by blocking the interaction between the toxin and the receptor, or by down-regulating its expression.'

The authors note in the study that the research has implications beyond anthrax exposure.

Prof Cohen added: 'Our findings, which reveal the previously unsuspected magnitude of genetically determined differences in toxin sensitivity among cells from different individuals, suggest a broadly applicable approach for investigating pathogen susceptibility in diverse human populations.'

The research was published online in the Proceedings of the National Academy of Sciences.

Read more from the original source:
Genetic make-up determines whether we die from anthrax exposure

It's personal now: Alexis Borisy (left) and Michael Pellini lead an effort to make DNA data available to help cancer patients. Credit: Christopher Harting

Michael Pellini fires up his computer and opens a report on a patient with a tumor of the salivary gland. The patient had surgery, but the cancer recurred. That's when a biopsy was sent to Foundation Medicine, the company that Pellini runs, for a detailed DNA study. Foundation deciphered some 200 genes with a known link to cancer and found what he calls "actionable" mutations in three of them. That is, each genetic defect is the target of anticancer drugs undergoing testing—though not for salivary tumors. Should the patient take one of them? "Without the DNA, no one would have thought to try these drugs," says Pellini. 

Starting this spring, for about $5,000, any oncologist will be able to ship a sliver of tumor in a bar-coded package to Foundation's lab. Foundation will extract the DNA, sequence scores of cancer genes, and prepare a report to steer doctors and patients toward drugs, most still in early testing, that are known to target the cellular defects caused by the DNA errors the analysis turns up. Pellini says that about 70 percent of cases studied to date have yielded information that a doctor could act on—whether by prescribing a particular drug, stopping treatment with another, or enrolling the patient in a clinical trial.

The idea of personalized medicine tailored to an individual's genes isn't new. In fact, several of the key figures behind Foundation have been pursuing the idea for over a decade, with mixed success. "There is still a lot to prove," agrees Pellini, who says that Foundation is working with several medical centers to expand the evidence that DNA information can broadly guide cancer treatment.

Foundation's business model hinges on the convergence of three recent developments: a steep drop in the cost of decoding DNA, much new data about the genetics of cancer, and a growing effort by pharmaceutical companies to develop drugs that combat the specific DNA defects that prompt cells to become cancerous. Last year, two of the 10 cancer drugs approved by the U.S. Food and Drug Administration came with a companion DNA test (previously, only one drug had required such a test). So, for instance, doctors who want to prescribe Zelboraf, Roche's treatment for advanced skin cancer, first test the patient for the BRAFV 600E mutation, which is found in about half of all cases.

About a third of the 900 cancer drugs currently in clinical trials could eventually come to market with a DNA or other molecular test attached, according to drug benefits manager Medco. Foundation thinks it makes sense to look at all relevant genes at once—what it calls a "pan-cancer" test. By accurately decoding cancer genes, Foundation says, it uncovers not only the most commonly seen mutations but also rare ones that might give doctors additional clues. "You can see how it will get very expensive, if not impossible, to test for each individual marker separately," Foundation Medicine's COO, Kevin Krenitsky, says. A more complete study "switches on all the lights in the room."

So far, most of Foundation's business is coming from five drug companies seeking genetic explanations for why their cancer drugs work spectacularly in some patients but not at all in others. The industry has recognized that drugs targeted to subsets of patients cost less to develop, can get FDA approval faster, and can be sold for higher prices than traditional medications. "Our portfolio is full of targets where we're developing tests based on the biology of disease," says Nicholas Dracopoli, vice president for oncology biomarkers at Janssen R&D, which is among the companies that send samples to Foundation. "If a pathway isn't activated, you get no clinical benefit by inhibiting it. We have to know which pathway is driving the dissemination of the disease."

Cancer is the most important testing ground for the idea of targeted drugs. Worldwide spending on cancer drugs is expected to reach $80 billion this year—more than is spent on any other type of medicine. But "the average cancer drug only works about 25 percent of the time," says Randy Scott, executive chairman of the molecular diagnostics company Genomic Health, which sells a test that examines 16 breast-cancer genes. "That means as a society we're spending $60 billion on drugs that don't work."

Analyzing tumor DNA is also important because research over the past decade or so has demonstrated that different types of tumors can have genetic features in common, making them treatable with the same drugs. Consider Herceptin, the first cancer drug approved for use with a DNA test to determine who should receive it. The FDA cleared it in 1998 to target breast cancers that overexpress the HER2 gene, a change that drives the cancer cells to multiply. The same mutation has been found in gastric, ovarian, and other cancers—and indeed, in 2010 the drug was approved to treat gastric cancer. "We've always seen breast cancer as breast cancer. What if a breast cancer is actually like a gastric cancer and they both have the same genetic changes?" asks Jennifer Obel, an oncologist in Chicago who has used the Foundation test.

The science underlying Foundation Medicine had its roots in a 2007 paper published by Levi Garraway and Matthew Meyerson, cancer researchers at the Broad Institute, in Cambridge, Massachusetts. They came up with a speedy way to find 238 DNA mutations then known to make cells cancerous. At the time, DNA sequencing was still too expensive for a consumer test—but, Garraway says, "we realized it would be possible to generate a high-yield set of information for a reasonable cost." He and Meyerson began talking with Broad director Eric Lander about how to get that information into the hands of oncologists.

In the 1990s, Lander had helped start Millennium Pharmaceuticals, a genomics company that had boldly promised to revolutionize oncology using similar genetic research. Ultimately, Millennium abandoned the idea—but Lander was ready to try again and began contacting former colleagues to "discuss next steps in the genomics revolution," recalls Mark Levin, who had been Millennium's CEO.

Levin had since become an investor with Third Rock Ventures. Money was no object for Third Rock, but Levin was cautious—diagnostics businesses are difficult to build and sometimes offer low returns. What followed was nearly two years of strategizing between Broad scientists and a parade of patent lawyers, oncologists, and insurance experts, which Garraway describes as being "like a customized business-school curriculum around how we're going to do diagnostics in the new era."

In 2010, Levin's firm put $18 million into the company; Google Ventures and other investors have since followed suit with $15.5 million more. Though Foundation's goals echo some of Millennium's, its investors say the technology has finally caught up. "The vision was right 10 to 15 years ago, but things took time to develop," says Alexis Borisy, a partner with Third Rock who is chairman of Foundation. "What's different now is that genomics is leading to personalized actions."

One reason for the difference is the falling cost of acquiring DNA data. Consider that last year, before his death from pancreatic cancer, Apple founder Steve Jobs paid scientists more than $100,000 to decode all the DNA of both his cancerous and his normal cells. Today, the same feat might cost half as much, and some predict that it will soon cost a few thousand dollars.

So why pay $5,000 to know the status of only about 200 genes? Foundation has several answers. First, each gene is decoded not once but hundreds of times, to yield more accurate results. The company also scours the medical literature to provide doctors with the latest information on how genetic changes influence the efficacy of specific drugs. As Krenitsky puts it, data analysis, not data generation, is now the rate-limiting factor in cancer genomics.

Although most of Foundation's customers to date are drug companies, Borisy says the company intends to build its business around serving oncologists and patients. In the United States, 1.5 million cancer cases are diagnosed annually. Borisy estimates that Foundation will process 20,000 samples this year. At $5,000 per sample, it's easy to see how such a business could reward investors. "That's ... a $100-million-a-year business," says Borisy. "But that volume is still low if this truly fulfills its potential."

Pellini says Foundation is receiving mentoring from Google in how to achieve its aim of becoming a molecular "information company." It is developing apps, longitudinal databases, and social-media tools that a patient and a doctor might use, pulling out an iPad together to drill down from the Foundation report to relevant publications and clinical trials. "It will be a new way for the world to look at molecular information in all types of settings," he says.

Several practical obstacles stand in the way of that vision. One is that some important cancer-related genes have already been patented by other companies—notably BRCA1 and BRCA2, which are owned by Myriad Genetics. These genes help repair damaged DNA, and mutations in them increase the risk of breast or ovarian cancer. Although Myriad's claim to a monopoly on testing those genes is being contested in the courts and could be overturned, Pellini agrees that patents could pose problems for a pan-cancer test like Foundation's. That's one reason Foundation itself has been racing to file patent applications as it starts to make its own discoveries. Pellini says the goal is to build a "defensive" patent position that will give the company "freedom to operate."

Another obstacle is that the idea of using DNA to guide cancer treatment puts doctors in an unfamiliar position. Physicians, as well as the FDA and insurance companies, still classify tumors and drug treatments anatomically. "We're used to calling cancers breast, colon, salivary," says oncologist Thomas Davis, of the Dartmouth-Hitchcock Medical Center, in Lebanon, New Hampshire. "That was our shorthand for what to do, based on empirical experience: 'We tried this drug in salivary [gland] cancer and it didn't work.' 'We tried this one and 20 percent of the patients responded.'"

Now the familiar taxonomy is being replaced by a molecular one. It was Davis who ordered DNA tests from several companies for the patient with the salivary-gland tumor. "I got bowled over by the amount of very precise, specific molecular information," he says. "It's wonderful, but it's a little overwhelming." The most promising lead that came out of the testing, he thinks, was evidence of overactivity by the HER2 gene—a result he says was not picked up by Foundation but was found by a different test. That DNA clue suggests to him that he could try prescribing Herceptin, the breast-cancer drug, even though evidence is limited that it works in salivary-gland cancer. "My next challenge is to get the insurance to agree to pay for these expensive therapies based on rather speculative data," he says.

Insurance companies may also be unwilling to pay $5,000 for the pan-cancer test itself, at least initially. Some already balk at paying for well-established tests, says Christopher-Paul Milne, associate director of the Tufts Center for the Study of Drug Development, who calls reimbursement "one of the biggest impediments to personalized medicine." But Milne predicts that it's just a matter of time before payers come around as the number of medications targeted to people's DNA grows. "Once you get 10 drugs that require screening, or to where practitioners wouldn't think about using a drug without screening first, the floodgates will open," he says. "Soon, in cancer, this is the way you will do medicine."

Adrienne Burke was founding editor of Genome Technology magazine and is a contributor to Forbes.com and Yahoo Small Business Advisor.

Continued here:
Foundation Medicine: Personalizing Cancer Drugs

LONDON (ShareCast) - Strong growth in sales volumes in Asia has seen animal genetics firm Genus (Xetra: 762548 - news) increase revenue by almost a tenth in the first half of its financial year. Furthermore, after reviewing its dividend policy last year, the firm has decided to start paying an interim dividend for the first time this year. The board has approved an interim dividend of 4.5p per share payable on March 30th. Revenue for the six months ended December 31st rose 9% from £153.2m to £166.9m, a 10% increase at constant exchange rates (CER). Bovine sales volumes were up 8%, helped by strong increases in China and India particularly, while Porcine volumes, up 13%, were driven by growth in Asia as a whole. Genus, which focuses on creating advances in animal breeding through naturally applied biotechnology and quantitative genetics, said that the North American and Latin American markets also traded well, while European profits were affected by weak demand in a depressed European pig market. Higher sales, along with the benefits of refinancing in 2011 and lower interest rates, helped adjusted pre-tax profits rise 22% to £23.3m, from £19.1m the year before (+25% at CER). Adjusted results exclude the valuation movement on biological assets, amortisation of acquired intangible assets, share-based payment expense and exceptional items. Finance costs were £1.1m, well below the £3.8m recorded in the corresponding period in 2010. Statutory pre-tax profits were 13% higher at £26m, compared with Panmure Gordon's forecast of £22m. "Global (Chicago Options: ^RJSGTRUSD - news) population growth and increased urbanisation in developing countries is accelerating demand for protein in diets," said Chief Executive Karim Bitar. "This demand increase and pressure on prices, driven by higher feed costs, can only be met through improved efficiency and greater application of technology in farming. Genus' market-leading genetics are key ingredients in this quest for improved productivity," he said. Net (Frankfurt: A0Z22E - news) debt was £69.6m at the end of the period, compared with £78m the year before, but slightly ahead of the £67.9m at June 30th 2011. "The group is continuing to trade well in market conditions that remain favourable in most markets. As a result, the board expects the group to make further progress in the second half of the year in line with market expectations," the statement said. BC

Link:
Emerging markets boost sales at Genus