Archive for the ‘Gene Therapy Research’ Category

AMES, Iowa, Oct. 10, 2012 /PRNewswire/ --NewLink Genetics Corporation (NLNK) announces launching of an open-label, randomized, multi-institutional Phase 3 study in patients with borderline resectable or locally advanced unresectable pancreatic cancer. The projected enrollment will be 280 subjects and patients will be randomized (1:1) to receive standard of care FOLFIRINOX plus or minus algenpantucel-L (HyperAcute-Pancreas) immunotherapy. The primary endpoint of the study will be to evaluate overall survival. Secondary objectives include evaluation of progression free survival and immunological response.

"We are excited to initiate an additional Phase 3 clinical trial for algenpantucel-L to potentially expand into a new indication for locally advanced pancreatic cancer. We have made significant progress in our Phase 3 trial with algenpantucel-L for resected pancreas cancer patients since its launch in May of 2010," commented Dr. Charles Link, Chief Executive Officer of NewLink. He added, "There is an enormous unmet need in the pancreatic cancer market for both resectable and unresectable patients. The successful expansion of algenpantucel-L into a market segment for locally advanced disease would potentially more than double the patient population who might benefit from this immunotherapy treatment."

"We believe this new study will be favorably perceived by the clinicians as they will have a promising clinical trial to offer patients with this devastating disease," commented Dr. Nick Vahanian, Chief Medical Officer of NewLink Genetics. "We have more than 70 major cancer centers currently enrolling patients in our ongoing Phase 3 trial for resected pancreatic cancer patients. We believe these relationships will enable us to efficiently implement this new Phase 3 clinical trial, since the majority of locally advanced patients are evaluated at the same centers as the resectable patients."

About algenpantucel-L

NewLink's algenpantucel-L immunotherapy product candidate consists of a group of two allogeneic pancreatic cancer tumor cell lines that were modified to express Alpha-Gal. These cell lines were chosen to provide a broad coverage of pancreatic cancer antigens. Each of the modified cell lines is grown in large cultures, harvested, irradiated and packaged. Approximately 150 million cells of each HyperAcute Pancreas cell line are given by intradermal injection with each treatment.

About the Phase 3 Study

This trial is an open-label, randomized, controlled, multi-center Phase 3 clinical trial, evaluating patients with borderline resectable or locally advanced unresectable pancreatic cancer. The primary endpoint of the clinical trial is overall survival, with secondary endpoints of progression-free survival, safety, toxicity and immunological responses. The study plans to enroll up to 280 patients. Standard-of-care regimens for patients with borderline resectable or locally advanced unresectable pancreatic cancer patients include FOLFIRINOX (an abbreviation for a chemotherapy combination that includes the drugs leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin). In the Phase 3 clinical trial, half of the patients will receive FOLFIRINOX with algenpantucel-L and the remainder will receive FOLFIRINOX without algenpantucel-L.

About Pancreatic Cancer

The American Cancer Society estimates that approximately 44,030 new cases of pancreatic cancer were diagnosed in the United States in 2011. Pancreatic cancer has generally been recognized as an aggressive form of cancer with non-specific initial symptoms, making it difficult to diagnose at an early stage. Due to the difficulty in diagnosis and the aggressive nature of this cancer, the National Cancer Institute estimates a 96% mortality rate is associated with this disease, and the American Cancer Society estimates one-year and five-year overall survival rates of about 24% and 5%, respectively.

Pancreatic cancer can generally be divided into three broad categories: (1) local disease, in which the cancer is confined to the pancreas and can be removed surgically, which is called resection; (2) locally advanced disease, in which the cancer has spread locally and may or may not be eligible for resection because it has invaded tissues that should not be removed, such as key nerves and arteries; and (3) metastatic disease, in which the tumor has spread beyond the region of the pancreas.

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NewLink Genetics Launches Phase 3 Clinical Trial of algenpantucel-L Immunotherapy in Patients with Borderline ...

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

Seattle Genetics, Inc. (SGEN) announced today that it will receive undisclosed milestone payments under its antibody-drug conjugate (ADC) collaboration with Genentech, a member of the Roche Group (RO.SW) (SWX:ROG) (RHHBY). The milestones were triggered by Genentechs advancement of two ADCs utilizing Seattle Genetics technology into phase II clinical development. The phase II randomized, open-label study is designed to evaluate the safety and efficacy of ADCs anti-CD22 (DCDT2980S, RG7593) and DCDS4501A (RG7596) each in combination with Rituxan (rituximab) in patients with relapsed or refractory follicular non-Hodgkin lymphoma and relapsed or refractory diffuse large B-cell lymphoma.

Progress by our ADC collaborators, notably Genentech entering phase II clinical development, highlight the continued promise of ADCs for the treatment of cancer and further support Seattle Genetics leadership position in the field, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. Across our internal and collaborator programs, there are more than 15 ADCs in clinical development utilizing our technology, spanning a range of both hematologic malignancies and solid tumors.

Under the ADC collaboration agreement, Genentech has rights to use Seattle Genetics ADC technology with antibodies against targets selected by Genentech. Genentech is responsible for research, product development, manufacturing and commercialization activities under the collaboration. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on net sales of any resulting ADC products.

ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents, such as monomethyl auristatin E (MMAE) and monomethyl auristatin F (MMAF), and stable linker systems that attach these cytotoxic agents to the antibody. Seattle Genetics linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The U.S. Food and Drug Administration granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of Seattle Genetics ADC technology and development plans for its ADC product candidates and its collaborators product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient safety or activity as our or our collaborators ADC product candidates move into and advance in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Companys quarterly report on Form 10-Q for the quarter ended June 30, 2012, filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Seattle Genetics Achieves Milestones as Genentech Advances Two Antibody-Drug Conjugates (ADCs) into Phase II Development

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 contract and a Phase 2 option from the National Cancer Institute (NCI) valued up to $1,683,503. The SBIR Contract funds the development of CLT-009, a first-in-class, human allogeneic Megakaryocyte Progenitor Cell therapy for the treatment of thrombocytopenia in cancer patients and allows the Company to conduct studies to enable an Investigational New Drug (IND) Application to be filed with the FDA in the next two years.

Thrombocytopenia is characterized as a significant reduction in the concentration of circulating platelets. Platelets are crucial in the process of coagulation to stop bleeding, and thrombocytopenia can increase the risk of severe bleeding in patients. It is becoming an increasingly common problem among oncology patients and a significant dose-limiting toxicity, especially in the treatment of hematological malignancies. Chemotherapy and radiation therapy are the most common causes of thrombocytopenia because the platelet-producing cells, megakaryocytes, and their precursors are highly sensitive to myelosuppressive cytotoxics and ionizing radiation. Thrombocytopenia typically occurs during the initial cycles of high-dose chemotherapy and radiation therapy, usually 614 days after administration. According to Datamonitor, the estimated incidence of cancer patients who suffer from significant chemotherapy-induced thrombocytopenia worldwide was approximately 200,000 in 2008.

Occurrence of severe thrombocytopenia may require dose reductions for chemotherapy regimens which can impact subsequent disease control and survival, especially in the treatment of hematological malignancies such as acute leukemia and high-risk myelodysplastic syndrome. Current treatment options include platelet transfusions which are costly and labor intensive and are associated with risks such as contamination and transmission of viral and bacterial infections. Recombinant human interleukin-11 is the only approved agent for chemotherapy induced thrombocytopenia but its use is limited and has only modest efficacy and significant side effects. CLT-009, a human Megakaryocyte Progenitor Cell product, would be an alternative treatment option, providing the critical megakayocyte progenitor cellular support to rapidly produce platelets in vivo and shorten the duration of severe thrombocytopenia following chemotherapy treatment.

We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. This contract allows us to not only leverage our experience in developing cellular therapies but also provides us with the ability to bring CLT-009 closer to the clinic. Our unique product portfolio, which now includes CLT-009, along with our CLT-008 myeloid progenitor cell product and our therapeutic antibodies targeting cancer stem cells, demonstrates our continued commitment to developing novel products for the benefit of cancer patients.

In addition to this SBIR contract, Cellerant has previously received grants from the National Institute of Health (NIH) in 2008 2010 to conduct research studies in platelet recovery which it has successfully completed. In its previous studies, Cellerant demonstrated that megakaryocyte progenitor cells were able to produce human platelets in preclinical models with in vivo functionality similar to that of normal human platelets.

This program is funded with Federal funds from the National Institute of Health, Department of Health and Human Services, under Contract No.HHSN261201200076C.

About CLT-009

CLT-009 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Megakaryocyte Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional platelets in vivo. Cellerant is developing CLT-009 as an effective treatment for chemotherapy and radiation-induced thrombocytopenia in cancer patients.

About Cellerant Therapeutics

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Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

NEW YORK, Oct. 8, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS), an emerging leader in the fast growing cell therapy market, announced today that data from its collaborative studies with the University of Michigan School of Dentistry further expands the therapeutic potential of its proprietary regenerative cell therapy product, "VSELSTM" (very small embryonic-like stem cells), by demonstrating bone regeneration capabilities in a study published online ahead of print1 in the journal Stem Cells and Development (DOI: 10.1089/scd.2012.0327). The paper highlights that human VSEL stem cells form human bone when implanted in the bone tissue of SCID mice.

VSELs are a population of stem cells found in adult bone marrow with potential regenerative properties similar to those of embryonic stem cells. NeoStem has shown that these cells can be mobilized into the peripheral blood, enabling a minimally invasive means for collecting what NeoStem believes to be a population of stem cells that have the potential to achieve the positive benefits associated with embryonic stem cells without the ethical or moral dilemmas or the potential negative effects known to be associated with embryonic stem cells.

This published controlled study, funded by NIH and led by Dr. Russell Taichman, Major Ash Collegiate Professor and Co-Director of the Scholars Program in Dental Leadership Department of Periodontics & Oral Medicine, University of Michigan and Dr. Aaron Havens, Department of Orthodontics and Pediatric Dentistry at University of Michigan, involved isolating G-CSF mobilized VSEL stem cells from the blood of healthy donors and transplanting them into burr holes made in the cranial bones of SCID mice. After three months, it was observed that the implanted VSEL stem cells had differentiated into human bone tissue in the crania of the mice. Dr. Taichman stated, "I believe this work represents a true partnership between Industry and Academic Institutions. Our findings that VSEL cells can generate human bone in animals would not have been feasible without the help and vision that Dr. Denis Rodgerson and his team at NeoStem brought to the table. It was my privilege to have been a part of this collaborative effort, and I see the resulting data as a significant milestone in stem cell therapy development. It is truly inspiring."

Dr. Robin Smith, Chairman and CEO of NeoStem, added, "This is very exciting data that we believe will be the foundation for future VSEL stem cell studies of bone regeneration in humans. We look forward to moving the development work from the laboratory into the clinic to develop a therapeutic stem cell product to enhance bone formation in humans."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

(1) Human Very Small Embryonic-Like Cells Generate Skeletal Structures, In Vivo. Havens A., et al., Stem Cells and Development.

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NeoStem Announces Very Small Embryonic-Like Cells (VSEL(TM)) Publication in Stem Cells and Development

A company with the first FDA-approved personalized cell therapy for reducing wrinkles has raised $45 million in a private stock sale. The financing was sought to improve manufacturing capacity for the therapy and advance other uses for it such as treating burn victims, according to a company statement.

Fibrocell Sciences aesthetic therapeutic, Laviv, secured got the green light from the U.S. Food and Drug Administration last year. Laviv uses individuals fibroblast cells to reduce nasolabial fold wrinkles, creases on the face that start from the outer corners of the nose and go down to the corners of the mouth. It also has an acne therapy in phase 3 clinical trials and a burn scar therapy in phase 2 trials.

The Exton, Pennsylvania biopharmaceutical companys personalized cell development platform technology isolates, purifies and multiplies a patients fibroblast cells, connective skin cells that make collagen.

Additionally, Fibrocell agreed to a strategic collaboration with biotechnology firm Intrexon which can provide genome engineering, cell processing, and cell system engineering, among other services, to help advance Fibrocells personalized cell therapy program.

As part of the financing deal, Third Security LLC will get two seats on Fibrocells board.

Personalized stem cell development fits into the broader category of personalized medicine, regarded as the future of medicine in which therapies will be better targeted to individuals and more effective.

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Biopharma with personalized cell therapy raises $45M in stock sale, forges collaboration deal

SILVER SPRING, Md., Oct. 8, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced the presentation today of additional safety and efficacy data from a second Phase 2 pancreatic cancer clinical trial. The new trial data was presented by Dr. John Dangerfield, COO of the Nuvilex subsidiary Austrianova Singapore Pte Ltd (ASPL) at the ISCGT Meeting. The trial data presented used the same encapsulated cytochrome P450 expressing cells followed by chemotherapy to treat pancreatic cancer that were used in the previously published trial and confirmed results generated in the previous trial.

The Phase 2 pancreatic cancer trial approach being advanced by Nuvilex, and its subsidiary ASPL, works through the ability of special, cellulose sulphate encapsulated, living cells expressing cytochrome P450 CYP 2B1. These cells are able to convert the inactive chemotherapy drug ifosfamide to its active form at the site they are placed in. As a result, the encapsulated cells create a high level of drug in the area of the pancreatic tumor where the treatment can provide for the greatest anti-tumor effect, coupled with a significant reduction in side-effects since much lower doses of the chemotherapeutic drug need to be used.

The major findings reported at the ISCGT meeting revealed that safety and efficacy data from a total of 27 patients is now available, approximately doubling the number of patient data previously released. In this expanded patient group no immunological, capsule, or cell-related adverse events from the live cell encapsulated treatment approach were reported. Moreover and most importantly, the data presented confirmed the approximate doubling of median survival when compared to the data available for the current standard treatment, Gemzar. In addition, there was a doubling of the number of 1 year survivors treated with encapsulated cells plus chemotherapy compared to the standard Gemzar treatment. Another significant finding comes from the fact that the treatment procedure was successfully performed at 4 different cancer treatment centers in Europe by three different interventional radiologists.

ASPL's CEO, Dr Brian Salmons, said, "The additional data presented at the ISCGT meeting confirms the safety of the capsule material, the implantation procedure and the long term safety of implanting cells in the body inside the cellulose sulphate encapsulation material. Lastly, the survival benefit of the first trial in terms of median survival and 1 year survival was confirmed and therefore the importance of the treatment was verified."

Dr. Robert F. Ryan, CEO of Nuvilex, said, "This data provides us with additional confidence as we undertake the next steps in the development of the treatment of pancreatic cancer as well as other solid tumors."

About Nuvilex

Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Substantial progress in multiple areas will be providing the Company with increased potential and we look forward to bringing those forward shortly. Our company's clinical offerings will include cancer, diabetes and other treatments using the company's cell and gene therapy expertise and live-cell encapsulation technology.

The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13494

Safe Harbor Statement

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

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Nuvilex Reports Additional Safety and Efficacy Data From Second Phase 2 Pancreatic Cancer Trial

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

Contact: Jane Bunce, ICR Science Communuications Manager jane.bunce@icr.ac.uk 44-207-153-5106 Institute of Cancer Research

Scientists have designed a blood test that reads genetic changes like a barcode and can pick out aggressive prostate cancers by their particular pattern of gene activity.

A team at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust found reading the pattern of genes switched on and off in blood cells could accurately detect which advanced prostate cancers had the worst survival.

And the researchers believe the blood test could eventually be used alongside the existing PSA test at diagnosis to select patients who need immediate treatment.

The test, described in The Lancet Oncology today (Tuesday 9 October), is unique because it assesses changes in the pattern of gene activity in blood cells triggered by a tumour elsewhere in the body.

Study senior author Professor Johann de Bono, leader of the prostate cancer targeted therapy team at The Institute of Cancer Research, London, and honorary consultant at The Royal Marsden NHS Foundation Trust, said: "Prostate cancer is a very diverse disease some people live with it for years without symptoms but for others it can be aggressive and life-threatening so it's vital we develop reliable tests to tell the different types apart.

"We've shown it is possible to learn more about prostate cancers by the signs they leave in the blood, allowing us to develop a test that is potentially more accurate than those available now and easier for patients than taking a biopsy. Our test reads the pattern of genetic activity like a barcode, picking up signs that a patient is likely to have a more aggressive cancer. Doctors should then be able to adjust the treatment they give accordingly."

Researchers scanned all the genes present in blood samples from 100 patients with prostate cancer at the ICR's and The Royal Marsden's joint Drug Development Unit in London and The Beatson West of Scotland Cancer Centre in Glasgow. They included 69 patients with advanced cancer and 31 control patients thought to have low-risk, early-stage cancer, who were being managed by active surveillance.

Using statistical modelling, they divided the patients into four groups reflecting their pattern of gene activity the barcode. When they reviewed all the patients' progress after almost two-and-a-half years, they found patients in one group had survived for significantly less time than patients in the others. Further modelling identified nine key active genes that were shared by all patients in the group.

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Scientists develop 'barcode' blood test for aggressive prostate cancer

Scientists at the Gladstone Institutes have mapped the precise frequency by which genes get turned on across the human genome, providing new insight into the most fundamental of cellular processesand revealing new clues as to what happens when this process goes awry.

In a study being published this week online in the Proceedings of the National Academy of Sciences, Gladstone Investigator Leor Weinberger, PhD, and his research team describe how a gene's on-and-off switchingcalled "bursting"is the predominant method by which genes make proteins. By gaining an understanding of this underlying mechanism, this discovery has the potential to vastly help researchers learn what happens at the molecular level when this mechanism is disruptedsuch as in cancer or when exposed to a particular drug.

The manufacture, or synthesis, of proteins takes place inside every cell. DNA and geneswhich house the instructions for making proteinsare stored within the nucleus of each cell. When a gene is switched on, those instructions are transcribed as a copy onto RNA, another type of genetic material that then directs the protein synthesis. Proteins perform a variety of functions within the cellfrom the breaking down and digesting fats to resisting foreign invaders, such as bacteria or viruses. The timing and frequency with which a particular protein is synthesized is crucial to maintaining the health of the cell.

"Much like flicking on a light switch, genes get 'switched on' at specific intervals to initiate the fundamental biological process of protein synthesis," said Dr. Weinberger, who is also an associate professor at the University of California, San Francisco (UCSF), with which Gladstone is affiliated. "Until recently, the process was thought to be continuousonce a gene is switched on, it stays on, churning out protein products at a steady pace like a garden hose. But recently, some studies have suggested the oppositethat DNA produces RNA molecules in rapid-fire 'staccato' bursts. We decided to investigate how common this rapid-fire bursting was across the genome."

In laboratory experiments, Dr. Weinberger and his team inserted a green fluorescent protein, or "vector," into the DNA of Jurkat T lymphocytesa type of white blood cell that helps maintain a healthy human immune system. From this they generated new cells in which the vector was integrated into any one of thousands of gene segmentswith each segment glowing green when it was activated, or "switched on." This allowed the researchers to see exactly how gene activation occurred across the entire human genome.

"Our analysis reveals support for the "bursting" hypothesisthe genes acted as a sort of strobe lighttranscribing RNA in rapid-fire bursts," said Roy Dar, PhD, a Gladstone postdoctoral fellow and one of the paper's lead authors. "We observed that the bursting frequency increases until, over time, it reaches a particular threshold. At that point higher protein levels are reached by increasing the size of the bursts, eventually coming to a halt when no more protein product is needed. These results are a huge step towards understanding the basic molecular mechanism behind gene regulation."

"Dr. Weinberger and colleagues have shown that there is a single rule governing the behavior of all genes in the genome. Their findings in human cells complement and extend similar findings made recently in other organisms," said Arjun Raj, PhD, assistant professor of bioengineering at the University of Pennsylvania and an expert in imaging single molecules within cells.

The team believes that this new-found understanding of this fundamental biological processthat genomic bursts account for the majority of instances of protein productionholds clues to discovering how the disruption of these bursts could be harmful.

"For example, in certain cancers, genes may be switched on at the wrong times, eventually leading to the formation of tumors," said Brandon Razooky, a Gladstone and UCSF graduate student and the paper's other lead author. "This is also a good example of how the basic science being performed here at Gladstone provides a solid foundation with which to prevent, treat and ultimately cure some of the world's most devastating diseases."

Journal reference: Proceedings of the National Academy of Sciences

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Scientists discover gene 'bursting' plays key role in protein production

By Ed Carty

Monday, October 08, 2012

Scientists at NUI Maynooth have pinpointed how control and regulation of a specific gene could combat debilitating diseases like multiple sclerosis.

After three years of research the team is in the early stages of trying to uncover how to manipulate the Pellino3 gene to tackle serious illnesses.

Research published in the US journal Nature Immunology showed the genes critical function is to regulate the amount of protective proteins released by immune systems to fight a virus.

Professor Paul Moynagh said it was a significant breakthrough in viralimmunology.

"The research has much potential for the treatment of major auto-immune diseases and the next step is to determine how the exploitation of Pellino3 can physiologically impact on specific conditions," he said.

NUI Maynooth discovered that Pellino3 acts like a brake to stop overproduction of interferons, the protective proteins.

If the gene is not working as designed, overproduction of interferons can lead to debilitating inflammatory diseases such as lupus while those of us who do not produce enough are more at risk of MS and hepatitis.

The research paper says controlling production linked to Pellino3 is critical in the treatment of viral disease.

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Maynooth geneticists make MS breakthrough

ScienceDaily (Oct. 8, 2012) A variant in a gene involved with inflammation and the immune response is linked with a decreased risk of lung cancer. That is the finding of an analysis published early online in CANCER, a peer-reviewed journal of the American Cancer Society. The results add to the growing body of literature implicating these processes in the development of lung cancer.

Meredith Shiels, PhD, MHS and Anil Chaturvedi, PhD, of the National Cancer Institute in Rockville, MD, and their colleagues analyzed 1,429 variants in inflammation- and immunity-related genes from 378 patients with lung cancer and 450 healthy controls from the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial. The investigators observed a significant link between lung cancer and 81 single nucleotide polymorphisms (SNPs) located in 44 genes.

They then compared these results with observed or imputed data from four recently completed genome-wide association studies (GWAS) that included 5,739 lung cancer cases and 5,848 controls. Of the 81 SNPs, one in particular -- named rs4648127 and located within the NFKB1 gene -- was associated with lung cancer in both analyses. This SNP was linked with an estimated 44 percent reduced risk of lung cancer in the cancer screening trial and a 21 percent reduced risk in the combined GWAS analysis.

The NF-B, or nuclear factor kappa B, protein that is produced in part from the NFKB1 gene is known to play an important role in immunity and inflammation by regulating gene expression, cell death, and cell proliferation. Also, previous research has shown that immunity and inflammation may affect the development of lung cancer. "Our study provides further evidence that inflammation may be associated with lung cancer risk," said Dr. Shiels. She added that future studies should further examine the NFKB1 gene and its relationship with lung cancer risk.

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Gene variant linked with reduced lung cancer risk

MONDAY, Oct. 8 (HealthDay News) -- A gene variant linked with a decreased risk of lung cancer has been identified by researchers.

The variant occurs in a gene involved with inflammation and immune response. The findings add to growing evidence linking inflammation and immune response with the development of lung cancer, according to the study authors.

They looked at more than 1,400 variants in inflammation- and immunity-related genes from 378 lung cancer patients and 450 healthy people. They found that a variant called "rs4648127" in the NFKB1 gene was associated with a 21 percent to 44 percent reduced risk of lung cancer.

A protein produced in part from the NFKB1 gene is known to play an important role in inflammation and immunity by regulating gene expression, cell death and cell proliferation.

The study was published online Oct. 8 in the journal Cancer.

"Our study provides further evidence that inflammation may be associated with lung cancer risk," study co-author Meredith Shiels, of the U.S. National Cancer Institute, said in a journal news release.

Further research is needed to learn more about the link between the NFKB1 gene and lung cancer, she added.

While the study found an association between a gene variant and lung cancer risk, it did not prove a cause-and-effect relationship.

-- Robert Preidt

Copyright 2012 HealthDay. All rights reserved.

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Scientists Link Gene to Lower Risk of Lung Cancer

Published: Sunday, October 7, 2012, 12:01 a.m.

California voters will soon decide whether to require certain raw and processed foods to carry such a label.

In a closely watched test of consumers' appetite for genetically modified foods, the special label is being pushed by organic farmers and advocates who are concerned about what people eat even though the federal government and many scientists contend such foods are safe.

More than just food packaging is at stake. The outcome could reverberate through American agriculture, which has long tinkered with the genes of plants to reduce disease, ward off insects and boost the food supply.

International food and chemical conglomerates, including Monsanto Co. and DuPont Co., have contributed about $35 million to defeat Proposition 37 on the November ballot. It also would ban labeling or advertising genetically altered food as "natural." Its supporters have raised just about one-tenth of that amount.

If voters approve the initiative, California would become the first state to require disclosure of a broad range of foods containing genetically modified organisms, or GMOs. Food makers would have to add a label or reformulate their products to avoid it. Supermarkets would be charged with making sure their shelves are stocked with correctly labeled items.

Genetically altered plants grown from seeds engineered in the laboratory have been a mainstay for more than a decade. Much of the corn, soybean, sugar beets and cotton cultivated in the United States today have been tweaked to resist pesticides or insects. Most of the biotech crops are used for animal feed or as ingredients in processed foods including cookies, cereal, potato chips and salad dressing.

Proponents say explicit labeling gives consumers information about how a product is made and allows them to decide whether to choose foods with genetically modified ingredients.

"They're fed up. They want to know what's in their food," said Stacy Malkan, spokeswoman for the California Right to Know campaign.

Agribusiness, farmers and retailers oppose the initiative, claiming it would lead to higher grocery bills and leave the state open to frivolous lawsuits. Kathy Fairbanks, spokeswoman for the No on 37 campaign, said labels would be interpreted as a warning and confuse shoppers.

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California to test appetite for GMO food

ScienceDaily (Oct. 8, 2012) McGill researchers have identified a small region in the genome that conclusively plays a role in the development of psychiatric disease and obesity. The key lies in the genomic deletion of brain-derived neurotrophic factor, or BDNF, a nervous system growth factor that plays a critical role in brain development.

To determine the role of BDNF in humans, Prof. Carl Ernst, from McGill's Department of Psychiatry, Faculty of Medicine, screened over 35,000 people referred for genetic screening at clinics and over 30,000 control subjects in Canada, the U.S., and Europe. Overall, five individuals were identified with BDNF deletions, all of whom were obese, had a mild-moderate intellectual impairment, and had a mood disorder. Children had anxiety disorders, aggressive disorders, or attention deficit-hyperactivity disorder (ADHD), while post-pubescent subjects had anxiety and major depressive disorders. Subjects gradually gained weight as they aged, suggesting that obesity is a long-term process when BDNF is deleted.

"Scientists have been trying to find a region of the genome which plays a role in human psychopathology, searching for answers anywhere in our DNA that may give us a clue to the genetic causes of these types of disorders," says Prof. Ernst, who is also a researcher at the Douglas Mental Health University Institute. "Our study conclusively links a single region of the genome to mood and anxiety."

The findings, published in the Archives of General Psychiatry, reveal for the first time the link between BDNF deletion, cognition, and weight gain in humans. BDNF has been suspected to have many functions in the brain based on animal studies, but no study had shown what happens when BDNF is missing from the human genome. This research provides a step toward better understanding human behaviour and mood by clearly identifying genes that may be involved in mental disorders.

"Mood and anxiety can be seen like a house of cards. In this case, the walls of the house represent the myriad of biological interactions that maintain the structure," says Ernst, "Studying these moving parts can be tricky, so teasing apart even a single event is important. Linking a deletion in BDNF conclusively to mood and anxiety really tells us that it is possible to dissect the biological pathways involved in determining how we feel and act.

We now have a molecular pathway we are confident is involved in psychopathology," adds Ernst, "Because thousands of genes are involved in mood, anxiety, or obesity, it allows us to root our studies on a solid foundation. All of the participants in our study had mild-moderate intellectual disability, but most people with these cognitive problems do not have psychiatric problems -- so what is it about deletion of BDNF that affects mood? My hope now is to test the hypothesis that boosting BDNF in people with anxiety or depression might improve brain health."

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The above story is reprinted from materials provided by McGill University, via EurekAlert!, a service of AAAS.

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Genetic mutation linked to psychiatric disease and obesity

TAMPA A new cocktail of cancer-fighting drugs can help patients with advanced melanoma, a Moffitt Cancer Center researcher has reported in a study to be published in the New England Journal of Medicine.

The new research builds on recent advances in therapies for advanced melanoma that center on targeting its genetic fingerprint. Until recently, the deadly skin cancer was considered nearly untreatable in its later stages.

Drugs now are available that can block a mutation in a gene called BRAF, which fuels the cancer. The mutation is present in about half of melanoma cases. If caught early, lesions can be removed surgically, but doctors traditionally had few options once melanoma spreads throughout the body.

Dr. Jeffrey Weber, director of Moffitt's Melanoma Research Center of Excellence, was among the leaders of a national team that sought better results by combining drug therapies to inhibit the BRAF mutation and overcome the tumor's ability to grow resistant to the drugs.

The results of their complex study, involving about 250 patients, are now available online and will publish in print in the Nov. 15 edition of the prestigious New England Journal of Medicine.

Researchers found they could improve the outcome for patients through a combination of two drugs, dabrafenib and trametinib. Patients receiving the combination therapy saw their cancers go into remission for 9 1/2 months, compared to 5 1/2 months for those on dabrafenib, a BRAF inhibitor, alone.

Patients receiving the combination treatment also saw their tumors shrink at a higher rate than those receiving the single drug.

"This is an evolutionary development which has important implications," Weber said. "What this shows is you can, to some degree, reverse (drug) resistance."

Additionally, researchers saw more patients respond to the combination therapy. And fewer of them experienced common side effects, which can include additional (though less serious) skin cancers.

The research was funded by GlaxoSmithKline, which makes the two drugs. The study involved about two dozen researchers at major cancer centers in the United States and Australia.

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Moffitt Cancer Center researcher advances melanoma treatment in New England Journal of Medicine

Editor's Choice Academic Journal Main Category: Parkinson's Disease Also Included In: Genetics Article Date: 08 Oct 2012 - 0:00 PDT

Current ratings for: Parkinson's Risk Linked To Specific Genetic Variants

5 (1 votes)

The researchers say they have carried out the first ever genome-wide evaluation of genetic variants linked to Parkinson's disease.

Jeanne Latourelle, DSc, and Richard H. Myers, PhD, explained that a recent study published by the PDGC (PD Genome Wide Association Study Consortium) had shown that people with genetic variants in or close to the genes HLA, MAPT, SNCA, RIT2, and GAK/DGKQ had a higher-than-average risk of developing Parkinson's disease. However, in that study, the mechanism behind the higher risk had not been determined.

Boston University School of Medicine reported in PLOS ONE in July 2012 that the FOXO1 gene plays an important part in the pathological mechanisms of Parkinson's disease. That study is said to have used the largest number of brain samples used in a wide-genome expression study of PD.

Latourelle suggested that perhaps a genetic variant might change how a gene is expressed in the brain, resulting in a higher risk of developing Parkinson's.

The scientists say that their findings may pave the way for treatments to correct the genetic variants and thus possibly reverse the effects of Parkinson's disease.

They determined gene expression by using a microarray that screened what the effects of genetic variants were on the expression of genes located very near the variant - called cis-effects - and genes that were far from the variant, such as genes on a totally different chromosome, called trans-effect. To recap - cis-effects are those on very nearby genes, while trans-effect are those on distant genes.

When they analyzed the cis-effects, it was observed that many genetic variants in the MAPT region showed a significant association with the expression of multiple nearby genes, including gene LOC644246, the duplicated genes LRRC37A and LRRC37A2, and the gene DCAKD.

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Parkinson's Risk Linked To Specific Genetic Variants

BUDAPEST, HUNGARY--(Marketwire - Oct 8, 2012) - Genetic Immunity ( OTCBB : PWRV ) is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation and Technology.

"To establish a GMP manufacturing facility is a major milestone for Genetic Immunity. Initially, it will serve our need to produce high quality ingredients to our nanomedicine products tested in clinical trials. We developed our GMP manufacturing technology and processes to be suitable to upgrade them to a commercial scale. This approval demonstrates the capability of our team to advance our DermaVir HIV-specific immunotherapy to the market, and our new candidate products from the bench to the bedside,"said Dr. Julianna Lisziewicz, CEO of Genetic Immunity.

The GMP status is provided for the manufacturing and the validated quality control processes of the Active Pharmaceutical Ingredient of our immunotherapeutic nanomedicine products.Genetic Immunity has a state of the art R&D laboratory that includes a dedicated GMP facility. Due to the platform feature of our plasmid DNA based nanomedicine technology, only the nucleotide sequence of the DNA is specific for the target disease. Consequently, the manufacturing and the quality control process of the lead and all pipeline products is the same. This means that the GMP facility can be used for the manufacturing all products of Genetic Immunity regardless of clinical stage. The common GMP manufacturing technology simplifies the regulatory process, saves costs and time in clinical development, and reduces time to market approval of medicinal products.

"With this GMP facility we have successfully closed the manufacturing gap between clinical trial scale and the commercial production. With continuous development of the manufacturing processes we are able to control the costs and achieve a competitive price for each market segments at an attractive ROI ratio for every product. We are strongly focused on the market and are well prepared for large scale manufacturing for our planned Expanded Access program of DermaVir," said Mr. Viktor Rozsnyay, CEO of Power of the Dream Ventures.

Genetic Immunity is a wholly owned subsidiary of Power of the Dream Ventures, Inc. ( OTCBB : PWRV ).

About Genetic Immunity Genetic Immunity is part of Power of the Dream Ventures, Inc. (PWRV) committed to bring innovative Hungarian products and services to public. GeneticImmunity is a clinical stage technology company committed to discovering, developing, manufacturing and commercializing a new class of immunotherapeutic biologic drugs for the treatment of viral infections, cancer and allergy. The Company's two distinguished technology platforms will revolutionize the treatment of these chronic diseases. Our Langerhans cell targeting nanomedicines are exceptional in both safety and immune modulating activity boosting specific Th1-type central memory T cells. Such immune responses differ from antibodies induced by vaccines. These are essential to eliminate infected cells or cancerous cells, and balance the immune reactivity in response to allergens. Our IT team generated a complex algorithm to match the mechanism of action of our drugs with clinical efficacy. In the future, we will predict the clinical and immunological benefits of our drugs based on the patient's disease and genomic background. The unique mixture of our technologies represents the next generation of personalized but not individualized medicines ensuring a longer and higher economic return. Genetic Immunity's primary focus is the development of DermaVir that acts to boost the immune system of HIV-infected people to eliminate the infected cells that remained in the reservoirs after successful antiretroviral treatment. Three clinical trials conducted in EU and US showed that DermaVir immunizations were as safe as placebo and only four sequential patch treatments were required to reduce the HIV infected cells in the blood within 24 weeks.

In 1988 Drs. Lisziewicz and Lori founded the Genetic Immunity in the US after they described the 1st patient whose immune system was boosted to control HIV after treatment interruption (Lisziewicz et al. New England Journal of Medicine 1999) that lead to the invention of DermaVir. The Company's innovative technology team directed by Dr. Lisziewicz, a champion of immune busting therapies, is now headquartered in Budapest (Hungary). For more information please visit http://www.geneticimmunity.com

Forward-looking statements Statements in this press release that are not strictly historical in nature constitute forward-looking statements qualified in their entirety by this cautionary statement. Forward-looking statements include, without limitation, statements regarding business combination and similar transactions, prospective performance and opportunities and the outlook for the companies' businesses, including, without limitation, the ability of PWRV to advance Genetic Immunity's product pipeline or develop a curative immunotherapy for HIV, performance and opportunities and regulatory approvals, the anticipated timing of data from clinical data; the possibility of unfavorable results of the company's clinical trials; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. All forward-looking statements are based on information currently available to the companies, and the companies assume no obligation to update any such forward-looking statements.

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Genetic Immunity Receives GMP Certification for In-House Manufacturing Facility

LOS ANGELES, Oct.8, 2012 /PRNewswire/ --Response Genetics, Inc. (RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, announced today that on October 5, 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. (the "Company") is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic testing services for cancer. The Company's technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed and paraffin-embedded specimens. The Company's principal customers include oncologists and pathologists. In addition to diagnostic testing services, the Company generates revenue from the sale 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 http://www.responsegenetics.com.

Forward-Looking Statement Notice

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

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company, to provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into areas of companion diagnostics, to continue to execute on its business strategy and operations, to continue to analyze cancer samples and the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, or to successfully file a registration statement with the Securities Exchange Commission ("SEC"), and other statements identified by words such as "project," "may," "could," "would," "should," "believe," "expect," "anticipate," "estimate," "intend," "plan" 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 SEC. 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.

Investor Relations Contact:

Company Contact:

Peter Rahmer

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Response Genetics Regains Compliance with NASDAQ Listing Standards

BRUSSELS--(BUSINESS WIRE)--

Delphi Genetics SA (Delphi) has announced today a broad licensing agreement with a subsidiary of Merck & Co., Inc., known as MSD outside the United States and Canada, for the use of the StabyExpress technology, which allows high yield, cost effective protein expression without the use of antibiotics.

Under the agreement, Merck receives a non-exclusive license to use the StabyExpress technology for protein expression in research and product development. In exchange, Delphi is eligible to receive milestone payments associated with the development of Merck product candidates that utilize the StabyExpress technology, as well as royalties on sales of such products. The financial details of the agreement were not disclosed.

Cdric Szpirer PhD, Delphi Genetics Founder and CEO, explained: This is Delphi's first broad-based licensing agreement that covers potential use of the StabyExpress technology for protein based product in the areas of human and animal health.

Guy Hlin, CBO, added: This is the third licensing agreement that we have announced with a world leading healthcare company. The non-exclusive nature of this agreement enables us to consider similar collaborations with other strategic partners, including partners in other fields than biopharma production.

Delphi also has licensing agreements with Sanofi-Pasteur, announced in June 2009, and with GSK, announced in September 2010.

About StabyExpress

StabyExpress technology can be applied to any industrial protein production process that involves bacterial fermentation. Biopharmaceutical production represents a rapidly growing market and its share of the overall medication market today is estimated at 15%. Moreover, the technology is consistent with the recommendations of the FDA and the EMA with regard to the elimination of Antibiotic Resistance Genes in protein production processes for both human and veterinary uses. Currently, Antibiotic Resistance Genes are used as selection markers for the design of the majority of the genetic systems enabling protein production. The technology is also usable to produce DNA vaccines in order to avoid completely the use of antibiotics resistance genes from DNA cloning to DNA production.

About Delphi Genetics SA

Founded at the end of 2001, Delphi Genetics develops more effective products and technologies for genetic engineering and for protein expression in bacteria by using its unique expertise in the field of plasmid stabilisation systems. Delphi Genetics patented StabyExpress technology increases the recombinant protein production output without the use of antibiotics, which is the traditional approach. In January 2012, together with academic and Biotech key-players, Delphi Genetics announced its participation in a research project during the next 3 years for the development of DNA vaccines using the technology. Other research projects are under way to adapt the technology to mammalian cells and yeast.

Original post:
Delphi Genetics Grants Merck License for the Use of the StabyExpress™ System

STOCKHOLM--(BUSINESS WIRE)--

Regulatory News:

Diamyd Medical AB has entered into an agreement for the sale of the U.S. subsidiary, Diamyd, Inc., involved in drug development primarily relating to the NTDDS platform with applications in pain and neuropathy among others. The buyer, Periphagen Holdings, Inc., is owned by members of the management of Diamyd, Inc. The agreement is subject to approval of an Extraordinary General Meeting of Diamyd Medical. By reason of the divestment, Diamyd Medical will postpone its Year End Report to October 31, 2012.

Under the agreement, in addition to the shares in Diamyd, Inc., Periphagen Holdings, Inc. assumes the intellectual property rights to the patented Nerve Targeting Drug Delivery System (NTDDS) technology, and all costs and revenues related to the business from September 1, 2012. The divestment will improve Diamyd Medical's operating profit/loss by approximately SEK 18 million during fiscal year 2012/13 compared to if the Company would have continued financing the development of the NTDDS platform.

During the fiscal year 2011/12, due to the transaction, impairment of intangible assets related to the NTDDS platform will have an adverse effect of SEK 17 million on operating profit/loss. The cash flow is not affected. Other immediate accounting effects and transaction costs attributable to the divestment are estimated to have an adverse effect on profit/loss during 2012/13 by approximately SEK 3 million. The impact on cash flow is minor.

The purchase price amounts to one dollar and shares in the acquiring company, providing Diamyd Medical a holding of 10 percent in Periphagen Holdings, Inc. In addition, Diamyd Medical may receive up to USD 10 million, primarily in milestone payments, as well as 10 percent of upfront payments and other payments Periphagen Holdings, Inc. may receive from future partners, and royalties on future sales of NTDDS based drugs.

The divestment immediately and significantly reduces Diamyd Medicals costs, whilst we retain the right to share in future successes of the NTDDS platform. The development projects will receive full focus from their dedicated new owners, which makes it a great solution for both parties as well as for the NTDDS platform, says Peter Zerhouni, President and CEO of Diamyd Medical.

We remain passionate about the NTDDS technology and have been involved since the research on nerve targeted gene delivery was initiated at the University of Pittsburgh in the 90s. It is a dream come true to increase our focus and run the business as our own, says Darren Wolfe, President of Diamyd, Inc. and Periphagen Holdings, Inc.

The transaction is a management buyout, where the purchasing corporation is owned by members of the management of Diamyd, Inc. The audit and consultancy firm Grant Thornton has prepared a fairness opinion regarding the transaction, and judge that, from a financial perspective, the terms are fair to the shareholders of Diamyd Medical. The agreement is subject to approval from Diamyd Medical's shareholders at an Extraordinary General Meeting to be held on October 30, 2012.

The board of directors has decided to postpone Diamyd Medical's Year End Report for the 2011/12 fiscal year, until the Extraordinary General Meeting has considered the transaction, as the meeting's decision will have an impact on the information in the Year End Report. The original date for the report was October 16, 2012. The new date for the Year End Report is October 31, 2012.

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Diamyd Medical divests U.S. gene therapy company

irishtimes.com - Last Updated: Sunday, October 7, 2012, 18:00

Scientists at NUI Maynooth have pinpointed how control and regulation of a specific gene could combat debilitating diseases like multiple sclerosis.

After three years of research the team is in the early stages of trying to uncover how to manipulate the Pellino3 gene to tackle serious illnesses.

Research published in the US journal Nature Immunology showed the genes critical function is to regulate the amount of protective proteins released by our immune systems to fight a virus.

Professor Paul Moynagh said it was a significant breakthrough in viral immunology.

The research has much potential for the treatment of major auto-immune diseases and the next step is to determine how the exploitation of Pellino3 can physiologically impact on specific conditions, he said.

NUI Maynooth discovered that Pellino3 acts like a brake to stop overproduction of interferons, the protective proteins.

If the gene is not working as designed, overproduction of interferons can lead to debilitating inflammatory diseases such as lupus while those of us who do not produce enough are more at risk of MS and hepatitis.

The research paper says controlling production linked to Pellino3 is critical in the treatment of viral disease.

Prof Moynagh expects to carry out another two years of experimental research before the team can think about the long road to licensing a drug.

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Scientists target MS gene

Scientists at NUI Maynooth have pinpointed how control and regulation of a specific gene could combat debilitating diseases such as multiple sclerosis.

After three years of research the team is in the early stages of trying to uncover how to manipulate the Pellino3 gene to tackle serious illnesses.

Research published in the US journal Nature Immunology showed the gene's critical function is to regulate the amount of protective proteins released by our immune systems to fight a virus.

Professor Paul Moynagh said it was a significant breakthrough in viral immunology.

"The research has much potential for the treatment of major auto-immune diseases and the next step is to determine how the exploitation of Pellino3 can physiologically impact on specific conditions," he said.

NUI Maynooth discovered that Pellino3 acts like a brake to stop overproduction of interferons, the protective proteins. If the gene is not working as designed, overproduction of interferons can lead to debilitating inflammatory diseases such as lupus while those of us who do not produce enough are more at risk of MS and hepatitis.

The research paper says controlling production linked to Pellino3 is critical in the treatment of viral disease.

Prof Moynagh expects to carry out another two years of experimental research before the team can think about the long road to licensing a drug.

The 10-strong research team at NUI Maynooth has produced an early stage molecular drug that can target Pellino3. They are performing early stage studies in disease models asking if it can alleviate symptoms.

Prof Moynagh: "The ultimate objective of our project is the development, production and commercialisation of pharmaceuticals which can help to combat immune-mediated diseases such as MS. Our results demonstrate the importance of continued investment in basic research, which feeds the pipeline through which pharmaceutical development and disease treatment can occur."

Excerpt from:
Scientists study gene link to MS

The Irish Times - Monday, October 8, 2012

DICK AHLSTROM, Science Editor

NEW TREATMENTS for multiple sclerosis (MS) and other auto-immune diseases could flow from an important discovery made by scientists at NUI Maynooth.

They were trying to understand the role of a gene called Pellino3 and how it comes into play when a person develops a viral infection.

They found it acts as a braking system that helps to regulate the immune response during infection. Details of the work, led by Paul Moynagh, director of the Institute of Immunology at NUI Maynooth, are published today in the prestigious journal Nature Immunology.

The gene regulates production of proteins called interferons, explained Prof Moynagh. These are released by the body as soon as it detects an invading virus. As their name implies, they interfere with the viruss ability to replicate and to invade nearby cells.

The release of these powerful proteins must be kept under check however, said Prof Moynagh. If they are not tightly controlled the person can end up with auto-immune diseases.

If too many interferons are released it can lead to inflammatory diseases such as lupus, while having too few available during infection can trigger diseases such as multiple sclerosis and support damage caused by other viruses such as hepatitis.

The 10 scientists in his group did intensive research into the role of Pellino3, using a mouse model, and have clarified its function in regulating the production of interferons. Pellino3 seems to be a key molecule for switching interferons off, he said.

Prof Moynagh, who is also the new head of the Department of Biology at Maynooth, won a Science Foundation Ireland principal investigator award in support of the research. The Health Research Board also backed the work via the PhD Scholars Programme in Immunology.

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Gene could be used to treat MS

1:00 AM A highly contested California vote over specialized labeling could have implications for U.S. agribusinesses.

By ALICIA CHANG/The Associated Press

LOS ANGELES Calories. Nutrients. Serving size. How about "produced with genetic engineering?"

click image to enlarge

A corn-based food product carrying a label identifying it as not containing genetically modified organisms, or GMOs, is sold at the Lassens Natural Foods & Vitamins store in the Los Feliz district of Los Angeles on Friday.

The Associated Press

California voters will soon decide whether to require certain raw and processed foods to carry such a label.

In a closely watched test of consumers' appetite for genetically modified foods, the special label is being pushed by organic farmers and advocates who are concerned about what people eat even though the federal government and many scientists contend such foods are safe.

More than just food packaging is at stake. The outcome could reverberate through American agriculture, which has long tinkered with the genes of plants to reduce disease, ward off insects and boost the food supply.

International food and chemical conglomerates, including Monsanto Co. and DuPont Co., have contributed about $35 million to defeat Proposition 37 on the November ballot. It also would ban labeling or advertising genetically altered food as "natural." Its supporters have raised just about one-tenth of that amount.

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Do we have an appetite for genetically modified food?

The Associated Press Published Sunday, Oct. 7, 2012 10:03AM EDT

LOS ANGELES -- Calories. Nutrients. Serving size. How about "produced with genetic engineering?"

California voters will soon decide whether to require certain raw and processed foods to carry such a label.

In a closely watched test of consumers' appetite for genetically modified foods, the special label is being pushed by organic farmers and advocates who are concerned about what people eat even though the federal government and many scientists contend such foods are safe.

More than just food packaging is at stake. The outcome could reverberate through American agriculture, which has long tinkered with the genes of plants to reduce disease, ward off insects and boost the food supply.

International food and chemical conglomerates, including Monsanto Co. and DuPont Co., have contributed about $35 million to defeat Proposition 37 on the November ballot. It also would ban labeling or advertising genetically altered food as "natural." Its supporters have raised just about one-tenth of that amount.

If voters approve the initiative, California would become the first state to require disclosure of a broad range of foods containing genetically modified organisms, or GMOs. Food makers would have to add a label or reformulate their products to avoid it. Supermarkets would be charged with making sure their shelves are stocked with correctly labeled items.

Genetically altered plants grown from seeds engineered in the laboratory have been a mainstay for more than a decade. Much of the corn, soybean, sugar beets and cotton cultivated in the United States today have been tweaked to resist pesticides or insects. Most of the biotech crops are used for animal feed or as ingredients in processed foods including cookies, cereal, potato chips and salad dressing.

Proponents say explicit labeling gives consumers information about how a product is made and allows them to decide whether to choose foods with genetically modified ingredients.

"They're fed up. They want to know what's in their food," said Stacy Malkan, spokeswoman for the California Right to Know campaign.

Read more from the original source:
California initiative to test appetite for 'genetically engineered' food

LOS ANGELES (AP) -- Calories. Nutrients. Serving size. How about "produced with genetic engineering?"

California voters will soon decide whether to require certain raw and processed foods to carry such a label.

In a closely watched test of consumers' appetite for genetically modified foods, the special label is being pushed by organic farmers and advocates who are concerned about what people eat even though the federal government and many scientists contend such foods are safe.

More than just food packaging is at stake. The outcome could reverberate through American agriculture, which has long tinkered with the genes of plants to reduce disease, ward off insects and boost the food supply.

International food and chemical conglomerates, including Monsanto Co. and DuPont Co., have contributed about $35 million to defeat Proposition 37 on the November ballot. It also would ban labeling or advertising genetically altered food as "natural." Its supporters have raised just about one-tenth of that amount.

If voters approve the initiative, California would become the first state to require disclosure of a broad range of foods containing genetically modified organisms, or GMOs. Food makers would have to add a label or reformulate their products to avoid it. Supermarkets would be charged with making sure their shelves are stocked with correctly labeled items.

Genetically altered plants grown from seeds engineered in the laboratory have been a mainstay for

Proponents say explicit labeling gives consumers information about how a product is made and allows them to decide whether to choose foods with genetically modified ingredients.

"They're fed up. They want to know what's in their food," said Stacy Malkan, spokeswoman for the California Right to Know campaign.

Agribusiness, farmers and retailers oppose the initiative, claiming it would lead to higher grocery bills and leave the state open to frivolous lawsuits. Kathy Fairbanks, spokeswoman for the No on 37 campaign, said labels would be interpreted as a warning and confuse shoppers.

The rest is here:
California initiative will test appetite for genetically modified foods