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WCTF.org Transplant NewsTransplant news, links, and other general medical news -- updated regularly.Tuesday, April 15, 2008AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes (Marketwire via Yahoo! Finance)
AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes (Marketwire via Yahoo! Finance)
AtheroGenics, Inc., a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today released topline results from a planned interim analysis of its ongoing ANDES Phase 3 clinical trial of AGI-1067 for the treatment of Type 2 diabetes. Department of Surgery - CT - Lung Transplant
Lung Transplant . Under the direction of Dr. Frederick L. Grover, the Lung Transplant Program at the University of Colorado Health Sciences Center was initiated in the Fall of 1991 [continued]
Two Prominent Nebraska Doctors Become Patients in Living Donor Liver Transplant
Two Prominent Nebraska Doctors Become Patients in Living Donor Liver Transplant
OMAHA, Neb., April 15 /PRNewswire/ -- As the State of Nebraska's Chief Medical Officer, Joann Schaefer, M.D. knows a great deal about large-scale public health issues. The same goes for Gary Gorby, M.D., the Chief of Infectious Diseases at Creighton University Medical Center. Right now, both physicians are focusing on the big job of recovering as patients themselves. (Photo: http://www.newscom.com/cgi-bin/prnh/20080415/LATU118LOGO) Dr. Schaefer, 40, said she has known for several years the need for a liver transplant may arise. In the last several months it did. "In three months, I went from being extremely healthy to this," Dr. Schaefer said before the transplant. "Then eight weeks ago, I realized something was not quite right." Her liver disorder caused cirrhosis, or scarring of the liver. That condition created portal hypertension, a condition that caused serious complications for Dr. Schaefer including fatigue, bleeding and fluid retention. "Her condition was most likely inherited," said Michael Sorrell, M.D., gastroenterologist and co-founder of the liver transplant program at The Nebraska Medical Center. "Dr. Schaefer's grandmother had died from liver disease in her 50s," Dr. Sorrell said. "My doctor said it's time for a transplant, my quality of life was not going to get better," said Dr. Schaefer. She did not have to look far for a donor, at least nine family members and friends volunteered. Dr. Schaefer jokingly called it her "lucky lobe search," referring to the left or right lobe of the donor's liver that would be transplanted into her body. Neighbor, friend and fellow physician Dr. Gary Gorby was a match. "I've known for sometime she was going to need a transplant," said Dr. Gorby. "I knew our blood types matched. I also knew she wouldn't be high on the list for a cadaver donor. You don't get the opportunity very often to save a friend's life." Liver transplants from living donors are a relatively new medical procedure. Although kidneys have been transplanted from living donors since 1954, the first adult to adult living liver transplant didn't take place until 1997. "The operation is becoming more common because the demand for livers far outpaces the number of organs from deceased donors," said Alan Langnas, D.O., Chief of Transplantation at The Nebraska Medical Center and Professor of Surgery at UNMC. "Living donor transplants have great potential for changing the face of liver transplantation in the future." On Monday, March 31, two transplant teams prepped for two simultaneous surgeries at The Nebraska Medical Center. Dr. Langnas removed the diseased liver from Dr. Schaefer, while at the same time the donor's transplant surgeon, Debra Sudan, M.D., removed approximately half of Dr. Gorby's liver. Both surgeons then worked together to transplant the portion of Dr. Gorby's liver into Dr. Schaefer's body. "The normal size for the liver is about one percent of a person's body mass," Dr. Sudan explained. "That's the target size for the transplant liver in order to optimize early liver function and its ability to regenerate." Dr. Sudan added that the liver is unique in this trait. "The size increases as much as 100 percent in both donor and recipient, often within six to 12 weeks." For major surgery, the risks for a liver donor are relatively low. The typical operation runs a 10 percent chance of complications and less than 1 percent chance of death, said Dr. Sudan. Even with the risks associated with the transplant, Dr. Gorby felt the chance to help a friend outweighed the risk. "I know it's a big surgery -- it's not a hangnail," said Dr. Gorby before the transplant. "I have realistic anxiety. I expect it'll hurt, but I expect it'll go well." For the recipient, the most serious complications are rare, but can occur if the new liver does not function properly or if blood vessels develop clots. "Liver transplant recipients can also develop infections or rejection of the new liver, but these conditions are usually easily controlled with medication," said Dr. Langnas. "There are significant advantages to receiving an organ from a living donor. The surgery can be planned to occur when the recipient is healthy instead of waiting until the disease is in its advanced stages," added Dr. Langnas. "The living donor organs in general function better than deceased donor organs." After more than a week recovering from the surgeries, both Dr. Gorby and Dr. Schaefer said they felt strong and both went home from the hospital. "I could tell a difference right away," Dr. Schaefer said after the transplant. "I feel stupendous." Both physicians plan to spend at least two months recovering from surgery before returning to work. Dr. Schaefer hoped by making her story public, she would inspire more people to become organ donors. Nationally, more than 98,000 people await organ transplants. Two days after the transplant, Dr. Schaefer said she had received e-mails from people who said her transplant had inspired them to become donors. "If one person marks their drivers' license to become a donor after hearing about it, then it's all worth it," she said. Dr. Gorby heard similar remarks even before the transplant. "People would say, 'It makes me want to be a better person.' If this gets other people thinking about becoming donors, that's great to hear." With a reputation for excellence, innovation and extraordinary patient care, The Nebraska Medical Center has earned J.D. Power and Associates' Hospital of Distinction award for inpatient services for three consecutive years. It also received the 2007 Consumer Choice Award, a mark of patient satisfaction as selected by healthcare consumers and has achieved Magnet recognition status for nursing excellence, Thomson 100 Top Hospitals Performance Improvement Leader recognition, as well as the Award of Progress from the state of Nebraska's Edgerton Quality Awards Program. As the teaching hospital for the University of Nebraska Medical Center, this 689 licensed bed academic medical center has an international reputation for providing solid organ and bone marrow transplantation services and is well known nationally and regionally for its oncology, neurology and cardiology programs. The Nebraska Medical Center can be found online at http://www.nebraskamed.com/ UNMC is the only public health science center in the state. Its educational programs are responsible for training more health professionals practicing in Nebraska than any other institution. Through its commitment to education, research, patient care and outreach, UNMC has established itself as one of the country's leading centers in cancer, transplantation biology, bioterrorism preparedness, neurodegenerative diseases, cardiovascular diseases, genetics, biomedical technology and ophthalmology. UNMC's research funding from external sources is now nearly $80 million annually and has resulted in the creation of more than 2,400 highly skilled jobs in the state. UNMC's physician practice group, UNMC Physicians, includes more than 460 physicians in 50 specialties and subspecialties. They practice primarily in The Nebraska Medical Center, UNMC's teaching hospital. For more information, go to UNMC's Web site at http://www.unmc.edu/.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20080415/LATU118LOGO http://photoarchive.ap.org/ CONTACT: Paul Baltes, +1-402-552-2282, pbaltes@nebraskamed.com, or Web site: http://www.unmc.edu/
FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment
FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment
- Phase II study extension shows 68-73% of patients with multiple sclerosis remained relapse-free after three years of treatment with oral FTY720 - New data demonstrate 89% of patients free from active brain lesions - the injury caused by MS - three years after starting treatment - MS, a devastating disease causing progressive disability, affects 2.5 million people worldwide including many young adults - FTY720 regulatory filings planned before end of 2009 in US and EU EAST HANOVER, N.J., April 15 /PRNewswire-FirstCall/ -- The investigational oral therapy FTY720 (fingolimod) continues to demonstrate sustained benefits in patients with multiple sclerosis (MS) after three years of treatment, according to new clinical data presented today from an ongoing Phase II study extension. Results showed that 73% of patients who began the study on FTY720 5 mg remained free from relapses after three years, and 68% of those who began the study on FTY720 1.25 mg remained relapse-free. The figures after two years of treatment were 77% and 75% respectively. On the basis of comparable efficacy and a better safety profile, all patients have been transferred to FTY720 1.25 mg in the study extension. The 36-month data also showed an average annualized relapse rate of 0.20, equivalent to one relapse in five years, while 89% of patients were free of the active brain lesions characteristic of MS as measured by magnetic resonance imaging (MRI) three years after starting treatment. The results were presented at the 60th annual meeting of the American Academy of Neurology (AAN) in Chicago, USA. "These new data demonstrate the exciting potential for FTY720 to reduce relapse rates in MS patients with a convenient once-daily pill," said Professor Giancarlo Comi, Professor of Neurology at the University Vita-Salute San Raffaele in Milan, Italy. "An effective oral treatment would be a significant breakthrough in the management of MS. That is why these results are encouraging -- because we are seeing substantial benefits of FTY720 maintained over time in this clinical trial." FTY720 is a novel, once-daily, oral treatment in worldwide Phase III clinical development for the treatment of relapsing-remitting MS, the form of the disease that affects approximately 85% of people diagnosed with MS. More than 2.5 million people worldwide are affected by MS, the most common non-traumatic cause of neurological disability in young people. Regulatory filings for FTY720 are expected in the US and EU before the end of 2009. "The FTY720 Phase III program is the largest conducted in MS to date, and demonstrates our long-term commitment to the field of MS therapy," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "It is especially encouraging to see that FTY720 continues to demonstrate sustained efficacy by helping the majority of patients to remain free of relapses as the study progresses." FTY720 has the potential to be the first in a new class of therapies for MS that act on inflammation by modulating sphingosine-1-phosphate receptors (S1P-R), reducing the number of inflammatory immune cells, called lymphocytes, from reaching the brain. In addition, FTY720 reaches the brain and S1P-Rs are present on central nervous system (CNS) tissue, so FTY720 may have a direct beneficial effect on MS within the CNS. This additional potential mechanism of action is supported by new preclinical data being presented at AAN. The Phase II study presented at AAN began with a six-month placebo-controlled phase in which 281 patients with relapsing MS received placebo, FTY720 1.25 mg or FTY720 5 mg once-daily. This was followed by a long-term extension in which all patients took FTY720. At the end of three years, 173 patients were in the extension, which is still ongoing. The study has been conducted in Canada and 10 European countries. Results from the six-month placebo-controlled trial showed that FTY720 reduced relapse rates by more than 50% compared to placebo. Current first-line therapies for MS reduced relapse rates by 30-35% on average in two-year studies. Among patients originally on placebo who converted to active therapy in the extension, 51% were free of relapses at three years. The figure at two years was 57%. FTY720 has been generally well tolerated throughout the three years of the Phase II study and its extension, with the most common adverse events being nasopharyngitis, headache, fatigue and influenza. Increases in alanine aminotransferase (liver enzymes) were observed in 16% of patients. Dermatological screening of patients was implemented in the extension after a small number of cases of localized skin malignancies were reported. Novartis continues to study FTY720 in an ongoing, blinded Phase III clinical trial program. This program includes comprehensive monitoring that will further assess and characterize the safety profile of FTY720. For more information about the clinical trial program, including eligibility criteria and location of U.S. study sites, patients can call the following toll-free number: 866-788-3930, or visit http://www.msclinicaltrials.com/. MS is caused by the destruction of myelin, which helps neurons carry electrical signals in the brain. The disease causes problems with muscle control and strength, vision, balance, sensation and mental function. MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (or "relapses") followed by complete or partial restoration of functions. Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "planned", "potential", "would", "encouraging", "expected", "commitment", "may", "continues", "will", or similar expressions, or by express or implied discussions regarding potential future regulatory filings or marketing approvals for FTY720 or regarding potential future revenues from FTY720. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with FTY720 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that FTY720 will be submitted to regulatory authorities for approval, or will be approved for sale in any market. Nor can there be any guarantee that FTY720 will achieve any particular levels of revenue in the future. In particular, management's expectations regarding FTY720 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE:NVS), which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/. Novartis Media Relations Beatrix Benz e-mail: media.relations@novartis.com Gina Moran
Ruth Metzler-Arnold +41 61 324 9980 Central phone no: +41 61 324 7944 e-mail: investor.relations@novartis.com North America Office Fax no: +1 212 830 2405 e-mail: investor.relations@novartis.com First Call Analyst:
CONTACT: Beatrix Benz, Novartis Global Media Relations, +41-61-324-7999, Web site: http://www.novartis.com/
Vion Pharmaceuticals Files Plan With Nasdaq
Vion Pharmaceuticals Files Plan With Nasdaq
NEW HAVEN, Conn., April 15 /PRNewswire-FirstCall/ -- Vion Pharmaceuticals, Inc. (NASDAQ:VION) today announced that it had filed a plan to achieve and sustain compliance with The Nasdaq Capital Market listing requirements, including the time frame for completion of the plan. Previously, the Company announced that it had received a letter, dated March 24, 2008, from The Nasdaq Stock Market, Inc., notifying the Company that it does not comply with Marketplace Rule 4310(c )(3). As a result, Nasdaq Staff is reviewing the Company's plan to regain eligibility for continued listing on The Nasdaq Capital Market. After the conclusion of Staff's review, if it is determined that the Company's plan does not adequately address the issues noted, Nasdaq will provide written notification that the Company's securities will be delisted. At that time, the Company may appeal the Staff's decision to a Nasdaq Listing Qualifications Panel. Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukemia. Clinical trials of Cloretazine(R) (VNP40101M) with temozolomide in brain tumors, and with stem cell transplantation in advanced hematologic malignancies, are also being conducted. Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com. This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's potential inability to obtain regulatory approval for its products, particularly Cloretazine(R) (VNP40101M), delayed or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies or clinical trials are not predictive of safety and efficacy results in later clinical trials, the need for additional research and testing, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward- looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2007. In particular, there can be no assurance as to the results of any of the Vion's clinical trials, that any of these trials will continue to full accrual, or that any of these trials will not be discontinued, modified, delayed or ceased altogether. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. COMPANY CONTACT: Vion Pharmaceuticals, Inc.
CONTACT: Alan Kessman, Chief Executive Officer, or Howard B. Johnson, Web site:
Lung Transplant - University of Chicago Medical Center
At the University of Chicago Medical Center, our lung transplant physicians are experienced in caring for patients with all types of advanced lung diseases. [continued]
Neuralstem Responds to Incorrect StemCells, Inc. Release on Patents
Neuralstem Responds to Incorrect StemCells, Inc. Release on Patents
ROCKVILLE, Md., April 15 /PRNewswire-FirstCall/ -- Neuralstem, Inc. (AMEX:CUR) today responds to an earlier press release by StemCells, Inc. by stating that StemCells, Inc. has completely mischaracterized the meaning of the US Patent and Trademark Office's most recent action. (Logo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO ) "First," said Neuralstem President & CEO Richard Garr, "contrary to STEM's statement, the numerous substantial amendments made by STEM to get these two patents allowed completely destroy any basis for their assertions of infringement by Neuralstem. "Second, I would like to remind everyone that the US Patent and Trademark Office upheld the patentability of Neuralstem's core technology in May, 2006, in response to a challenge from STEM. Our patents are not being challenged in this office action, nor in the suit which STEM brought against us. "Finally, while we believe that any attempt by STEM to reopen their baseless law suit will be unsuccessful, as we asserted in our original response, Neuralstem does not infringe upon any of their "old" claims, nor do we infringe upon any of the significantly modified claims that they salvaged in the reexamination process." About Neuralstem Neuralstem's patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. Major Central Nervous System diseases targeted by the Company with research programs currently underway include: Ischemic Paraplegia, Traumatic Spinal Cord Injury and ALS. The company's cells have extended the life of rats with ALS (Lou Gehrig's disease) as reported the journal TRANSPLANTATION, in collaboration with Johns Hopkins University researchers, and also reversed paralysis in rats with Ischemic Spastic Paraplegia, as reported in NEUROSCIENCE on June 29, 2007, in collaboration with researchers at University of California San Diego. The company has also developed immortalized human neural stem cells for in-vitro use in drug development for the academic and pharmaceutical markets. For further information, please visit http://www.neuralstem.com/. Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward- looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the quarterly report on Form 10-KSB for the year ended December 31, 2007. First Call Analyst: Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO http://photoarchive.ap.org/ CONTACT: Richard Garr, President of Neuralstem, Inc., +1-301-366-4960, Web site:
Immune Function in Adult Heart Transplant Patients Reflects Risk for Organ Rejection and Infection (PR Newswire via Yahoo! Finance)
Immune Function in Adult Heart Transplant Patients Reflects Risk for Organ Rejection and Infection (PR Newswire via Yahoo! Finance)
Results of an analysis of three years of data on the monitoring of cell-mediated immunity in adult patients undergoing heart transplantation at the University of California at Los Angeles Health System have demonstrated that ImmuKnow® values appear to closely reflect the immune function of the transplant recipient and patient risk for organ rejection and/or infection. Multi-Organ Transplant Program - UAMS Multi-Organ Transplant Program
Multi-Organ Transplant Program . A generation ago, a patient with a failing heart, kidneys, pancreas or liver had little chance of survival. Fortunately, today that has all changed [continued]
Sangamo BioSciences Announces Presentation of Data on ZFP Therapeutic for Glioblastoma at American Association for Cancer Research (AACR) Meeting
Sangamo BioSciences Announces Presentation of Data on ZFP Therapeutic for Glioblastoma at American Association for Cancer Research (AACR) Meeting
ZFN Modified Cells Show Glioblastoma Killing in the Presence of Dexamethasone in Mouse Tumor Model SAN DIEGO, April 15 /PRNewswire-FirstCall/ -- Sangamo BioSciences, Inc. (NASDAQ:SGMO) today announced the presentation of positive data in a mouse tumor model from its ZFP Therapeutic(TM) program for the treatment of glioblastoma multiforme (GBM), a progressive and usually fatal brain cancer. The data were presented in the New Approaches to Biological Therapy Session at the 2008 Annual Meeting of the American Association for Cancer Research (AACR) by Sangamo's collaborator Michael C.V. Jensen, M.D., Associate Chair, Division of Cancer Immunotherapeutics & Tumor Immunology, City of Hope. "In collaboration with Sangamo, we have successfully generated engineered T-cells that can destroy glioblastoma tumor cells in animals in the presence of glucocorticoids," said Dr. Jensen. "Treatment of recurrent GBM with modified T-cells, an otherwise promising approach for this cancer, is rendered ineffective by the use of glucocorticoids to control inflammation of the brain due to the tumor and surgery. These data show that we have solved that problem and are making significant progress in our efforts to create an 'off-the-shelf' cell-based product for the treatment of GBM. The ZFN(TM)-modification of the glucocorticoid receptor (GR) in our engineered T-cells protects the cells from the effects of glucocorticoids which would normally inhibit T-cell function, and in addition, does not alter their cytolytic or tumor-killing properties." Dr. Jensen has developed novel chimeric immunoreceptors called "zetakines" that can be engineered into human immune cells to generate a population of cells that can specifically recognize and destroy cancer cells. He has already used these engineered cells in clinical trials for malignant gliomas. In his current clinical protocol, T-cells are removed from a patient with GBM and modified to express the zetakine. These modified cells are infused into the brain following surgery for the targeted elimination of residual tumor cells. Frequently however, glucocorticoids, such as dexamethasone, must be administered to patients pre- and post-surgery to stop the brain-swelling caused by the tumor and surgery. Glucocorticoids inactivate or kill the T-cells through a protein known as the glucocorticoid receptor (GR), limiting the benefit of this novel therapy. Currently, this approach is also patient-specific or autologous, which makes it time and labor-intensive. Cells without a functional GR are drug-resistant and should therefore be available to destroy tumor cells. The aim of the collaboration is to use Sangamo's zinc finger DNA-binding protein nuclease (ZFN) gene modification technology to delete the GR in T-cells engineered to express the zetakine. The specific deletion of GR in the zetakine-expressing, anti-glioma T-cells allows them to be used in the presence of glucocorticoids and to be developed as an "off the shelf" or allogeneic cell product immediately available to GBM patients. The data presented at AACR suggest that this strategy is effective in animal models of the disease. Sangamo expects to file an Investigative New Drug (IND) application for this cell therapy in 2008. "These data demonstrate an important direct therapeutic application of our ZFN technology for the optimization of cell-based pharmaceuticals," said Edward Lanphier, Sangamo's president and CEO. "We are very pleased to be working with City of Hope and Mike Jensen and his team who have developed this novel approach to the treatment of GBM. We believe that, in combination with our proprietary ZFN technology, we have the opportunity to significantly broaden the patient population that could benefit from these advances." Data Presented at AACR Sangamo scientists have engineered ZFNs specifically targeted to the glucocorticoid receptor (GR) gene. Data were presented demonstrating that treatment of T-cells engineered to kill glioblastoma cells with these ZFNs results in the knockout of the GR gene creating glucocorticoid-resistant T-cells. These zetakine-positive, GR-negative T-cells killed glioblastoma cells in vitro. In addition, data were presented from a mouse model of GBM demonstrating that the T-cells were capable of killing tumor cells in the presence of the glucocorticoid dexamethasone. About Gliomas Gliomas are the most common type of primary brain tumors; 20,000 cases are diagnosed and 14,000 glioma-related deaths occur annually in the United States. Glioblastoma multiforme (GBM), a type of glioma, is rapidly progressive and nearly uniformly lethal. Currently, malignant glioma is managed through a combination of chemotherapy, surgery and radiation. With modern combination therapy, the mean duration of survival has increased to 82 weeks, although 5-year survival rates have only increased from 3% to 6%. Approximately 80% of recurrent tumors arise from remnants of the original incompletely resected tumor. The median survival of recurrent glioblastoma multiforme patients that are eligible to be treated with re-resection is 36 weeks. About Sangamo Sangamo BioSciences, Inc. is focused on the research and development of novel DNA-binding proteins for therapeutic gene regulation and modification. The most advanced ZFP Therapeutic(TM) development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy. Phase 1 clinical trials are ongoing to evaluate a ZFP Therapeutic for peripheral artery disease. Other therapeutic development programs are focused on stem cell mobilization, ALS, cancer, HIV/AIDS, neuropathic pain, nerve regeneration, Parkinson's disease and monogenic diseases. Sangamo's core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). By engineering ZFPs that recognize a specific DNA sequence Sangamo has created ZFP transcription factors (ZFP TF(TM)) that can control gene expression and, consequently, cell function. Sangamo is also developing sequence-specific ZFP Nucleases (ZFN(TM)) for gene modification. Sangamo has established strategic partnerships with companies outside of the human therapeutic space including Dow AgroSciences, Sigma-Aldrich Corporation and several companies applying its ZFP Technology to enhance the production of protein pharmaceuticals. For more information about Sangamo, visit the company's web site at http://www.sangamo.com/ . About City of Hope City of Hope is a leading research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as a Comprehensive Cancer Center, the highest honor bestowed by the National Cancer Institute, and a founding member of the National Comprehensive Cancer Network, City of Hope's research and treatment protocols advance care throughout the nation. City of Hope is located in Duarte, Calif., just northeast of Los Angeles, and is ranked as one of "America's Best Hospitals" in cancer and urology by U.S.News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation and genetics. For more information, visit http://www.cityofhope.org/. This press release may contain forward-looking statements based on Sangamo's current expectations. These forward-looking statements include, without limitation, references to the development of a novel cell therapy for the treatment of glioblastoma multiforme, research and development of other novel ZFP TFs and ZFNs, the initiation and results of clinical trials and therapeutic applications of Sangamo's ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, Sangamo's ability to develop commercially viable products and technological developments by our competitors. See the company's SEC filings, and in particular, the risk factors described in the company's Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release. First Call Analyst:
CONTACT: Elizabeth Wolffe, Ph.D. of Sangamo BioSciences, Inc., Web site: http://www.sangamo.com/
ARIUS presents new findings for anti-cancer antibody programs at AACR
ARIUS presents new findings for anti-cancer antibody programs at AACR
-ARIUS report new data and program updates on cancer stem cell targeting antibodies- TORONTO, April 15 /PRNewswire-FirstCall/ -- ARIUS Research Inc., (TSX: ARI), a biotechnology company discovering and developing the next wave of antibody therapeutics, today announced that it will be presenting new findings and program updates related to its CD44, TROP-2, CD59, and CD9 antibody programs at the American Association for Cancer Research (AACR) Annual Meeting held from April 12-16, 2008 in San Diego, California. "Our five presentations at AACR shows the tremendous progress we made over the last year with our lead programs. The new findings from our cancer stem cell programs targeting CD44 and CD9 are of particular interest to the scientific community as this is a promising new area of cancer research," said Dr. David Young, President and CEO of ARIUS. "Specifically, we have been able to demonstrate that our CD44 program has the potential for wide therapeutic application in solid tumors, as well as blood cancers. Our cancer stem cell antibody targeting CD9 differentially recognizes AML cancer stem cells compared to normal stem cells. Furthermore, treatment with this antibody can functionally reduce cancer stem cell self-renewal which has very important therapeutic implications." CD44 Cancer Stem Cell Program Preclinical development of huARH460-16-2, a humanized antibody to the CD44 cancer stem cell target. Abstract Number 3975. Experimental and Molecular Therapeutics 32, Tuesday, April 15, 2008, 8:00 AM ARIUS' ARH460-16-2, a functional antibody that targets CD44, has a new potential cancer indication for pancreatic cancer. The new findings show anti-tumor effects in an established BxPC3 human pancreatic cancer model (78.7% tumor growth inhibition at 2 mg/kg compared to control group). This antibody has broad effects in solid tumors since it have been shown to be effective in pancreatic, breast, liver, prostate cancer as well as AML. The results of the toxicology study support the ongoing development of the of the ARH460-16-2 antibody. Anti-CD44 antibody, ARH460-16-2, binds to human AML CD34+CD38- cancer stem cells and demonstrates anti-tumor activity in an AML xenograft model. Abstract Number 3976. Experimental and Molecular Therapeutics 32, Tuesday, April 15, 2008, 8:00 AM This presentation highlights the effects of ARIUS' CD44 targeting antibody, ARH460-16-2, on tumor cells from patients with various hematological cancers, including acute myeloid leukemia (AML). This antibody shows very potent anti-tumor effects in an AML tumor model (57% tumor growth inhibition at a 10 mg/kg compared to control group). In addition the antibody lead to an increase in the median survival to 62 days compared to 49 days in the control group. These results demonstrate that the ARH460-16-2 antibody has the potential for wide therapeutic application in hematological malignancies in addition to its application to the therapy of solid tumors. ARIUS' ARH460-16-2 antibody is currently being manufactured for human clinical studies. It targets CD44 which is a marker of cancer stem cells in a broad range of solid cancers and AML. The first toxicology studies have been completed for this antibody, and a U.S. FDA pre-IND meeting has been held earlier in the year. This antibody is unique among CD44 antibodies in that it has the capacity to cause tumor regression in established solid tumors. It can directly act on cancer cells to induce apoptosis, or programmed cell death. The antibody may be broadly applicable to solid tumors as well as hematologic cancers. CD9 Cancer Stem Cell Program Anti-CD9 antibody, AR40A746.2.3, inhibits tumor growth in pancreatic and breast cancer models and recognizes CD9 on CD34+CD38- leukemic cancer stem cells. Abstract Number 3993. Experimental and Molecular Therapeutics 32, Tuesday, April 15, 2008, 8:00 AM ARIUS has demonstrated that treatment with ARIUS' CD9 targeting antibody, AR40A746.2.3, induced apoptosis in BxPC-3 pancreatic cancer cell as a monotherapy. Moreover, apoptosis is achieved through inhibition of the AKT pathway, commonly believed to be an important pathway for cancer cell survival. New immunohistochemistry (IHC) studies using this antibody showed that CD9 is expressed in a variety of human tumor samples, resulting in moderate to high levels of staining in 61/82 (73.5%) of tumor cells from various organs including pancreas, prostate, stomach and liver. The antibody demonstrated potent anti-tumor efficacy in in vivo models of pancreatic, breast and AML cancers and treatment led to a decrease in phosphorylation of several receptor tyrosine kinases. CD9 is highly and differentially expressed in AML versus normal CD34+CD38- stem cells. Experiments strongly suggest that ARIUS' CD9 targeting antibody inhibits human AML outgrowth in pre-clinical studies. In secondary transplantation experiments, treatment with ARIUS' CD9 targeting antibody dramatically reduced the self-renewal capacity of AML cancer stem cells. CD9 is the first description of a marker that is differentially expressed on cancer versus normal stem cells. Trop-2 Signal Transduction Program AR47A6.4.2, a naked monoclonal antibody targeting Trop-2, exhibits anti-tumor efficacy in multiple human cancer models as a monotherapeutic agent and demonstrates efficacy in combination therapy. Abstract Number 3990. Experimental and Molecular Therapeutics 32, Tuesday, April 15, 2008, 8:00 AM ARIUS shows its Trop-2 targeting antibody, AR47A6.4.2, is involved in the MAPK pathway. This antibody demonstrated potent anti-tumor efficacy in human pancreatic, breast, colon and prostate cancer models. In combination with Gemcitabine, this antibody also inhibited tumor growth by 93% in a human pancreatic cancer model. ARIUS' Trop-2 targeting antibody is the only naked therapeutic antibody targeting Trop-2. A humanized version of this antibody has greater higher affinity than the murine version and will be used in a pre-clinical toxicology study. A cell line has been developed for the Trop-2 targeting antibody and it is currently in manufacturing to generate material for Phase I clinical studies. CD59 Complement Inhibitor Program A monoclonal antibody targeting CD59 (AR36A36.11.1), enhances complement activity and exhibits potent in vivo efficacy in multiple human cancer models. Abstract Number 3995. Experimental and Molecular Therapeutics 32, Tuesday, April 15, 2008, 8:00 AM ARIUS has expanded its expression profiling and has characterized the affinity for its CD59 targeting antibody, AR36A36.11.1. This antibody has demonstrated significant in vivo anti-tumor activity towards a broad range of high incidence cancers and is highly potent at low dose concentrations in tumor xenografts, comparing favorably to standard of care in breast and prostate cancer. The effectiveness of this very potent antibody may be attributed to its ability to block CD59 function, representing a novel approach to cancer treatment. Currently, there are no other reported naked therapeutic antibodies targeting CD59 in clinical development. A humanized version of ARIUS' CD59 targeting antibody demonstrated equivalent affinity and potency to the murine version, and a CHO cell line producing humanized AR36A36.11.1 has been generated to manufacture material for future clinical studies. About ARIUS ARIUS is a biotechnology company discovering and developing the next wave of antibody therapeutics. Established in 1999, ARIUS has built a proprietary technology platform, FunctionFIRST(TM), that rapidly identifies and selects antibodies based on their functional ability to affect disease. This antibody generation engine has enabled ARIUS to assemble a portfolio of more than 500 antibody candidates. In addition to the antibodies it is developing in-house, ARIUS has ongoing partnerships with key biotechnology and drug development companies. ARIUS is listed on the TSX under the symbol "ARI". For further information, visit www.ariusmabs.com Forward-Looking Statements Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements in this release include, but are not limited to, ARIUS successfully advancing its new product programs as well as licensing opportunities. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: early stage of development; technology and product development; dependence on and management of current and future corporate collaborations; future capital needs; uncertainty of additional funding; no assurance of market acceptance; dependence on proprietary technology and uncertainty of patent protection; intense competition; manufacturing and market uncertainties; and government regulation. These and other factors are described in detail in ARIUS' Annual Report, forthcoming news releases and other filings with Canadian securities regulatory authorities available at www.sedar.com. Forward-looking statements are based on our current expectations and ARIUS is not obligated to update such information to reflect later events or developments.
CONTACT: Warren Whitehead, C.M.A., Chief Financial Officer, ARIUS
Kiadis Pharma Receives Orphan Drug Designation for Rhitol(TM) From the FDA
Kiadis Pharma Receives Orphan Drug Designation for Rhitol(TM) From the FDA
AMSTERDAM, April 15/PRNewswire/ -- Biopharmaceutical company Kiadis Pharma announced today that the U.S. "The decision by the FDA to grant Rhitol(TM) orphan drug designation in The FDA's orphan drug designation is reserved for new therapies being About Rhitol(TM) Rhitol(TM) is under development as a treatment for patients with chronic About chronic GvHD GvHD is a condition that can develop after allogeneic bone marrow Source: Kiadis Pharma For more information please contact: Kiadis Pharma, Eefje Simpelaar, Director Communications, Email: e.simpelaar@kiadis.com, Tel: +31-20-8884815, Mob: +31-610829344 ------- Presentation of HeartWare Clinical Results
Presentation of HeartWare Clinical Results
Survival Rate of 91% Among First 23 Patients FRAMINGHAM, Mass., SYDNEY, Australia, April 15 /PRNewswire-FirstCall/ -- HeartWare Limited , a developer of miniaturized implantable heart pumps to treat advanced heart failure, today announced initial results from an international clinical trial of the HeartWare(R) Left Ventricular Assist System. The results were presented by Dr. Georg Wieselthaler, cardiothoracic surgeon at Vienna General Hospital, at the annual meeting of the International Society for Heart and Lung Transplantation held in Boston. The data presented by Dr Wieselthaler show a six-month survival rate of 91 percent among the first 23 patients implanted with the HeartWare device. Of the 23 patients, 21 patients met the primary endpoint of the trial, defined as survival to 180 days or transplantation. These included 19 patients who were supported by the HeartWare system at 180 days and two patients who received transplants, after 157 days and 176 days respectively. Dr. Wieselthaler noted that one of the key features of the pump is its small size, which allows it to be implanted in the chest, thereby avoiding the abdominal surgery generally required to implant competing devices. HeartWare CEO Mr. Douglas Godshall said the early clinical success of the HeartWare pump is a key outcome for the Company as it accelerates its efforts to make the device available to patients in the United States and around the world. "These results are very promising," Mr. Godshall said. "Our early data appears to validate the benefits we believe to be inherent in the design of our device -- namely its small size, pericardial placement and wearless mechanism. These results give us great confidence as we move towards the start of our U.S. clinical trial and towards commercial release of the product in Europe." To date a total of 32 patients have been enrolled in HeartWare's international clinical trial. The average duration of support across this patient group exceeds 220 days per patient. The cumulative period of support across the group exceeds 7,000 days or approximately 19 years. Eight of the patients have been supported by the HeartWare system for periods exceeding 12 months, including one patient who has been supported for more than 500 days. HeartWare plans to commence a U.S. trial in the middle of 2008. In the U.S. alone more than 5 million patients suffer from heart failure and fewer than 3,000 donor hearts become available each year. About HeartWare HeartWare develops and manufactures miniaturized implantable heart pumps, or Left Ventricular Assist Devices (LVADs), designed to treat patients suffering from advanced heart failure. The Company is developing the industry's smallest and least invasive pumps, which it believes will be the key to unlocking the potential of a large and underserved market. The HeartWare(R) LVAD is a full-output pump designed to be implanted in the chest, avoiding the abdominal surgery generally required to implant competing devices. The device is currently the subject of an international clinical trial involving five investigational centres in Europe and Australia. For further information: US Investor Relations
CONTACT: Howard Leibman, Director Corporate Development of HeartWare Web site:
California Pacific Medical Center's Department of Organ
California Pacific Medical Center's Department of Organ Transplantation for adult kidney, kidney-pancreas, heart and liver is one of the leading programs nationwide - offering [read more]
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