Friday, April 27, 2012

Study: New Tx Options for Pediatric Neuroblastoma


Study presents potential new treatment options for pediatric neuroblastoma patients.

Full press release follows.
SOURCE: Texas Children's Hospital
HOUSTONApril 27, 2012 /PRNewswire-USNewswire/ -- A nationwide study led by Dr. Jed Nuchtern, chief of the division of pediatric surgery at Texas Children's Hospital, a pediatric surgeon with Texas Children's Cancer Center and professor of surgery at Baylor College of Medicine, found that the majority of infants with a particular form of neuroblastoma – a childhood tumor that often requires intensive chemotherapy and surgery – excel in their overall progress and survival when the tumor is monitored without surgical resection.
The results of the study will be presented at the American Surgical Association's 132nd annual meeting being held in San Francisco from April 26 to 28.
In this 10-year study, surgeons and oncologists who identified babies less than 6 months of age with a small tumor suggestive of neuroblastoma were given the option of immediate surgery or monitoring the baby carefully via ultrasound and urine tests. Overall, 87 babies who had tumors found either prenatally or before 6 months of age were entered into the study.
Of 87 babies, only four underwent surgery immediately – all of whom did well – while 83 were followed carefully for at least 15 months. Of the group that was followed, 16 children had surgery due to changes on one of the screening studies with eight found to have stage one neuroblastoma and only two with higher stages. There were no tumors that required additional intensive chemotherapy. 
Most importantly, the three-year overall survival for the 83 babies who were followed by observation was 100 percent with median follow-up now of three years.  Overall, 81 percent of these young babies on the observation arm were spared the need for surgery. The results of this study reveal that it is safe to carefully observe babies – specifically infants less than 6 months of age – who have a special, small isolated neuroblastoma tumor. 
The investigators are now planning a study that will expand to include patients who are 1 years old at diagnosis and who have larger neuroblastoma tumors. The study was sponsored by the Children's Oncology Group and included participation by more than 100 physicians from more than 75 pediatric programs across the United States and Canada, including Texas Children's Cancer Center.
About Texas Children's Hospital
Texas Children's Hospital, a not-for-profit organization, is committed to creating a community of healthy children through excellence in patient care, education and research. Consistently ranked among the top children's hospitals in the nation, Texas Children's has recognized Centers of Excellence in multiple pediatric subspecialties including the Cancer and Heart Centers, and operates the largest primary pediatric care network in the country. Texas Children's is completing a $1.5 billion expansion, which includes the Jan and Dan Duncan Neurological Research Institute; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; and Texas Children's Hospital West Campus, a community hospital in suburban West Houston.  For more information on Texas Children's, go to www.texaschildrens.org. Get the latest news from Texas Children's by visiting the online newsroom and on Twitter at twitter.com/texaschildrens.
Contact: Elizabeth Shackouls
832-824-2108
ehshacko@texaschildrens.org 
SOURCE Texas Children's Hospital

Non-Invasive MicroPulse Therapy for glaucoma


IRIDEX makes peripheral devices and laser systems used to treat serious eye conditions including the three major causes of blindness: glaucoma, macular degeneration, and diabetic retinopathy. The firm is now launching its non-invasive MicroPulse Therapy for glaucoma.

Full press release follows.
SOURCE: IRIDEX Corporation

IRIDEX Introduces Non-Invasive MicroPulse™ Therapy for Glaucoma

Tissue-Sparing, Repeatable MicroPulse Laser Trabeculoplasty (MLT) Extends Versatility of IRIDEX Green (IQ 532) Laser

MOUNTAIN VIEW, Calif.April 27, 2012 /PRNewswire/ -- IRIDEX Corporation today announced the launch of a new non-invasive, in-office glaucoma procedure based on its proprietary MicroPulse™ technology.  The new glaucoma therapy, a tissue-sparing, repeatable therapy called MicroPulse Laser Trabeculoplasty (MLT), was introduced by IRIDEX at the recent American Society of Cataract and Refractive Surgery (ASCRS).
Glaucoma is the leading cause of adult irreversible blindness. It is estimated that more than 4 million people in the US and approximately 60 million people worldwide are afflicted with the disease today.
MLT was first introduced by IRIDEX in its infrared laser platforms, but recent technology advancements have now made it available with the IRIDEX green laser system (IQ 532), our most versatile and highest selling laser used by the broadest group of ophthalmologists. The unique ability of the IQ 532 to offer tissue-sparing repeatable therapies for both glaucoma and retinal diseases represents a market breakthrough as well as providing ophthalmologists a very high return on their capital investment, said Dr.Dominik Beck, IRIDEX President and CEO.
David Gossage, M.D., medical director of the Gossage Eye Institute, noted that the addition of the MicroPulse module to the IQ 532 system makes it a valid option for a much broader patient population than has historically been the case.
"Compared to other lasers used for the treatment of glaucoma, the IQ 532 with the MicroPulse module offers greater versatility because it can also be used for a range of other conditions including diabetic macular edema, proliferative diabetic retinopathy, and retinal tears," Dr. Gossage said.  "I'm comfortable offering MLT to glaucoma patients as a first-line option because of its potential to reduce intraocular pressure without causing tissue damage."
MLT produces laser pulses at very short durations to create a therapeutic response of lowering the intra-ocular pressure of a glaucoma patient without thermal damage. 
About MicroPulse Technology
MicroPulse is a tissue-sparing laser delivery therapy that works by electronically "chopping" the laser emission into trains of microsecond pulses. This enhances the physician's ability to more precisely control the laser effects on target tissues, offering the potential for ocular treatment with less collateral effects than conventional laser treatments.
 About IRIDEX
IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology and otolaryngology market. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 70 independent distributors into 107 countries. For further information, visit the Company's website at http://www.iridex.com/.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, relating to the our growth strategy, the addressable market of our products and MicroPulse laser therapy.  These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors.  Please see a detailed description of these and other risks contained in our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q which are filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
SOURCE IRIDEX Corporation
CONTACT: Company, Jim Mackaness, Chief Financial Officer, +1-650-940-4700, Investors, Matt Clawson, Allen & Caron, +1-949-474-4300, matt@allencaron.com
Web Site: http://www.iridex.com 

Thursday, April 26, 2012

Oncology News: FDA Advisory Committee to review NDA for carfilzomib


Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma.

Full press release follows.
SOURCE: Onyx Pharmaceuticals, Inc.
SOUTH SAN FRANCISCOApril 26, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. ODAC will review carfilzomib at its meeting on June 20, 2012. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is July 27, 2012.
"Multiple myeloma is a deadly disease for which there are no cures, and we are committed to bringing carfilzomib to patients as quickly as possible," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "Our team looks forward to discussing the potential efficacy benefit and safety profile of carfilzomib with the advisory committee and will continue to work closely with the FDA during its review."
About Oncologic Drugs Advisory Committee The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to FDA. 
About Multiple MyelomaMultiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow. In the United States, more than 50,000 people are living with multiple myeloma and approximately 20,000 new cases are diagnosed annually.(i) Worldwide, more than 180,000 people are living with multiple myeloma and approximately 86,000 new cases are diagnosed annually.(ii)
About Onyx Pharmaceuticals, Inc.Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com.
Forward-Looking StatementsThis news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the progress and results of the clinical development, the expanded access program, safety, regulatory processes, commercialization efforts or commercial potential of carfilzomib.  These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including risks related to the submission, review, potential approval of the NDA, development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2011, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release.  Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

(i) National Cancer Institute, Surveillance Epidemiology and End Results, 2007 Facts and Figures
(ii) International Agency for Research on Cancer, GLOBOCAN 2002 database
SOURCE Onyx Pharmaceuticals, Inc.
CONTACT: Investors, Amy Figueroa, Senior Director, Investor Relations, +1-650-266-2398, or Media, Lori Melancon, Senior Director, Corporate Communications, +1-650-266-2394, both of Onyx Pharmaceuticals, Inc.
Web Site: http://www.onyx.com 

Wednesday, April 25, 2012

Organ transplant news, kidney transplanted twice in 2 weeks


Kidney Transplanted Twice in Two Weeks.

Full press release follows.
SOURCE: Northwestern Memorial Hospital
Transplant recipient donates kidney after disease threatens the organ; re-implantation reverses damage and allows another patient to thrive
CHICAGOApril 25, 2012 /PRNewswire-USNewswire/ -- For the first time, a kidney that had been donated to a patient in need was removed and implanted into a new patient, the third individual to have the organ, after it failed in the first transplant recipient.  Ray Fearing, a 27-year-old Arlington Heights resident received the organ from his sister, Cera, after a long battle with focal segmental glomerulosclerosis (FSGS), a disease in which scar tissue develops on the part of the kidney that filters waste out of the blood, ultimately causing kidney failure.  When signs of his illness reoccurred just days after he received the organ and posed life-threatening symptoms, doctors informed Fearing that they would have no choice but to remove the failing kidney.  They also informed Fearing that he could potentially save someone else's life by donating the organ and allowing doctors to re-implant it into another patient in need of transplant, something that had never successfully been done before with a kidney. 
"In over 50 percent of cases, transplant does not stop the process of FSGS. When post surgery tests indicated that Ray was at risk of developing life-threatening conditions due to the reoccurrence of the disease, we had to remove the kidney before he deteriorated.  The kidney however was still a relatively healthy, viable organ that could be transplanted into someone else without FSGS," explained Lorenzo Gallon, MD, transplant nephrologist and medical director of the kidney transplant program Northwestern Memorial Hospital and associate professor of medicine and surgery at Northwestern University Feinberg School of Medicine.
Northwestern Medicine® experts and members of the medical ethics committee reviewed the proposed procedure and evaluated the decision prior to re-implanting the organ.  The group discussed potential risks, which included the possibility that the kidney would fail to recover from its current level of minor damage due to its short exposure to FSGS while implanted in Fearing, thus failing to function properly in a new patient. 
"After numerous discussions to carefully consider this first-ever procedure, we presented Ray with the option to donate his kidney to someone on the national kidney waiting list rather than discarding it," said Gallon.
Fearing did not hesitate when he found out he could help someone in need like himself. Two weeks after receiving his kidney transplant, he donated his kidney to 67-year-old surgeon and father of five, Erwin Gomez.
The organ regained function almost immediately after re-transplantation and just eight days after transplantation, tests showed a reversal of the damage caused by the FSGS in Fearing's body. 
"This is a ground-breaking medical moment because it suggests that it is possible to reverse the damage done to a kidney as a result of FSGS after it is re-transplanted into a body with a healthy circulatory system," said Joseph Leventhal, MD, PhD, transplant surgeon at Northwestern Memorial Hospital and associate professor of surgery and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine. "Not only did we save a viable organ from being discarded, we also made significant strides in better understanding the cause of FSGS, which has been relatively unknown, so we can better treat the disease in the future.  This proves that when an organ fails in one body, it may thrive in another."
This innovative idea and resulting discovery is featured in the April 26 issue of the New England Journal of Medicine.
Fearing is back on dialysis to control his FSGS and is hopeful he will receive another kidney transplant in the future.
"It may not have been my time, but I am grateful that I was able to help another patient," said Fearing.  "My day will come."
Northwestern Medicine is the shared vision that joins Northwestern Memorial HealthCare and Northwestern University Feinberg School of Medicine in a collaborative effort to transform medicine through quality healthcare, academic excellence and scientific discovery.  To learn more aboutNorthwestern's transplant program, visit the Kovler Organ Transplantation Center online, or call 312-695-0828.
About Northwestern Memorial HealthCareNorthwestern Memorial HealthCare is the parent of Chicago's Northwestern Memorial Hospital, an 894-bed academic medical center hospital and Northwestern Lake Forest Hospital, a 205-bed community hospital located in Lake Forest, Illinois. 
About Northwestern Memorial HospitalNorthwestern Memorial is one of the country's premier academic medical center hospitals and is the primary teaching hospital of the Northwestern University Feinberg School of Medicine.  Along with its Prentice Women's Hospital and Stone Institute of Psychiatry, the hospital comprises 894 beds, 1,705 affiliated physicians and 6,769 employees.  Northwestern Memorial is recognized for providing exemplary patient care and state-of-the art advancements in the areas of cardiovascular care; women's health; oncology; neurology and neurosurgery; solid organ and soft tissue transplants and orthopaedics.
Northwestern Memorial possesses nursing Magnet Status, the nation's highest recognition for patient care and nursing excellence.  It is also listed in 13 clinical specialties in U.S. News & World Report's2011 "America's Best Hospitals" guide and ranks No. 1 in Chicago in the 2011 U.S. News & World ReportBest Hospitals metro area rankings. For 12 years running, Northwestern Memorial has been rated among the "100 Best Companies for Working Mothers" guide by Working Mother magazine. The hospital is a recipient of the prestigious National Quality Health Care Award and has been chosen by Chicagoans as the Consumer Choice according to the National Research Corporation's annual survey for 13 years. 



SOURCE Northwestern Memorial Hospital
 CONTACT: Colleen Sheehan, +1-312-926-0755, csheehan@nmh.org
Web Site: http://www.nmh.org 

Tuesday, April 24, 2012

Successful Completion of First Cohort in Lung Cancer Trial


Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center

Demonstrates Positive Initial Imaging Results; Additional Clinical Results Expected by Mid-2012.

Full press release is below. 
Source: Novelos Therapeutics, Inc.
MADISON, Wis.April 24, 2012 /PRNewswire/ -- Novelos Therapeutics, Inc. (OTCQX: NVLT), a pharmaceutical company developing novel drugs for treatment and diagnosis of cancer, today announced that the University of Wisconsin Carbone Cancer Center, a leading oncology research institution, has successfully completed the first cohort in a Phase 1-2 positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with advanced non-small cell lung cancer (NSCLC).  The first cohort comprised three patients dosed with LIGHT at 5 mCi. Details of the trial design are available at www.clinicaltrials.gov ID: NCT00582283, or at www.novelos.com in the "Clinical Trials" section. Anne M. Traynor, M.D., is the trial's principal investigator. Detailed trial results are expected to be presented at a scientific venue at a later date.
"The preliminary results from the first cohort are encouraging. We see strong uptake of LIGHT in cancerous tumors against very low background and have not observed any adverse safety signals," said Dr. Traynor. "Although still early and in a small number of subjects, there is some suggestion that LIGHT imaging was more tumor-selective than the comparator modality 18F-fluorodeoxyglucose (18F-FDG) PET."
"Having observed initial cancer-specific uptake with LIGHT at 5 mCi in NSCLC patients, we now look forward to evaluating the next dose level in this indication," said Kim Hawkins, Vice President of Clinical Development of Novelos. "The protocol was prospectively designed to dose three patients at 3 mCi in the next cohort, as we seek to identify a minimally effective dose, and we look forward to obtaining these results in a few months."
"We are very pleased with the positive initial LIGHT imaging data in lung cancer patients obtained to date, and with our collaboration with the UW Carbone Cancer Center," said Harry Palmin, President and CEO of Novelos. "We believe these data begin to establish proof-of-concept for LIGHT as a PET imaging agent for NSCLC, could advance our partnering discussions and could be used to calculate effective doses for Phase 2 clinical trials of I-131-CLR1404 (HOT). HOT is our chemically identical small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells."
About LIGHTLIGHT is a small molecule imaging agent that we believe has first-in-class potential for selective detection of tumors and metastases in a broad range of cancers. LIGHT is comprised of a small, non-pharmacological quantity of CLR1404 (COLD, acting as a cancer-targeted delivery and retention vehicle) labeled with the short-lived radioisotope, iodine-124, a new PET imaging isotope. PET imaging used in conjunction with CT scanning has now become the imaging method of choice in oncology. In studies to date, LIGHT selectively illuminated malignant tumors in 52 of 54 animal models of cancer, demonstrating broad-spectrum, cancer-selective uptake and retention.  Investigator-sponsored Phase 1-2 trials of LIGHT as a PET imaging agent are ongoing. The trials include lung cancer, brain cancer and, starting in the second quarter of 2012, other solid tumors. These human trials, if successful, will serve three important purposes. First, they would provide proof-of-concept for LIGHT itself as a PET imaging agent with the potential to supplant the current "gold standard" agent, 18-fluoro-deoxyglucose (FDG), due to what we believe to be LIGHT's superior cancer-specificity and more favorable logistics of clinical use. Second, favorable results would advance partnering discussions for LIGHT. Third, tumor uptake data will accelerate clinical development of HOT by predicting efficacy and enabling calculation of efficacious doses of HOT for Phase 2 trials.
About the UW Carbone Cancer Center in Madison The University of Wisconsin Carbone Cancer Center (UWCCC) is recognized throughout the nation as one of the leading innovators in cancer research, quality patient care and active community involvement. It is the only comprehensive cancer center, as designated by the National Cancer Institute, in Wisconsin. An integral part of the UW School of Medicine and Public Health, the UWCCC unites physicians and scientists who work together in translating discoveries from research laboratories into new treatments that benefit cancer patients. To learn more about clinical studies and other initiatives, visitwww.uwhealth.org/uw-carbone-cancer-center/for-researchers/uwccc/28373.
About Novelos Therapeutics, Inc.We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer. Our three cancer-targeted compounds are selectively taken up and retained in cancer cells, including cancer stem cells, versus normal cells. Thus, our therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. This offers the potential for a paradigm shift in cancer therapy by providing efficacy versus all three major drivers of mortality in cancer: primary tumors, metastases and stem cell-based relapse. I-124-CLR1404 (LIGHT) is a small-molecule cancer-targeted PET imaging agent. We believe LIGHT has first-in-class potential and Phase 1-2 clinical trials are ongoing. I-131-CLR1404 (HOT) is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. We believe HOT also has first-in-class potential. HOT Phase 1b dose-escalation trial is ongoing and we expect HOT to enter Phase 2 trials in the first quarter of 2013 as a monotherapy for solid tumors with significant unmet medical need, subject to additional funding. CLR1404 (COLD), a pre-clinical cancer-targeted non-radioactive chemotherapy, works primarily through Akt inhibition. Together, we believe our compounds are able to "find, treat and follow" cancer anywhere in the body in a novel, effective and highly selective way. For additional information please visit www.novelos.com.
INVESTOR CONTACTS

J. Patrick Genn, Vice President of IR
Anne Marie Fields, Senior Vice President
Novelos Therapeutics, Inc.
LHA
Ph: (858) 775-7456
Ph: (212) 838-3777
Email: afields@lhai.com, @LHA_IR_PR
Novelos Therapeutics, Inc.
Madison, WI                Boston, MA
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our  pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.
SOURCE Novelos Therapeutics, Inc.

Monday, April 23, 2012

Nutrition news-mango study

Mango health news, from the National Mango Board.
Full press release is below.


New Research Suggests World's Most Popular Fruit May Also be One of the Healthiest

NHANES links mango consumption to better diet, while cellular study indicates compounds found in the fruit may target breast cancer cells.

SAN DIEGOApril 23, 2012 /PRNewswire/ -- Already one of the world's most popular fruits, scientists are discovering that mangos may also be one of the healthiest. New research, presented this week at the Federation of American Societies for Experimental Biology (FASEB) meeting in San Diego, not only suggests people who eat mangos have a better diet, but the fruit also contains a substance that may have an effect on breast cancer cell proliferation. 
Mango consumers may have better diets
The first study presented at the meeting suggests that individuals who consume mangos tend to have a better diet than consumers who do not. The researchers compared the diets of over 13,000 individuals participating in the National Health and Nutrition Examination Survey (NHANES) between 2001 and 2008 to the Healthy Eating Index (HEI), a quantitative measure of diet quality relative to federal dietary guidance. They found that those that regularly ate mangos scored higher on the HEI than those that did not.
Mango consumption was also compared to overall nutrient intake and physical health.  Compared to non-mango consumers, mango consumers had, on average, significantly increased intake of vitamin C, magnesium, potassium and dietary fiber, while having lower intake of sodium and total fat. In addition, they had a lower average body weight.
Additionally, lower C-reactive protein levels were found in adults who added mango to their diet.  C-reactive protein measures inflammation and it has been suggested that high levels of it in the blood are linked to increased risk for heart disease, however the evidence is inconclusive. Additional research is needed to determine whether the lower levels of C-reactive protein are attributable to mango consumption or other factors.
"We found that adults who ate mangos tended to have a lower body weight, higher intake of fiber and lower intake of fat, all of which are associated with better cardiovascular health," stated Dr. Victor Fulgoni, of Nutrition Impact, LLC and lead researcher on this study. The National Mango Board funded this research with the goal of better understanding how mangos can promote healthy diets.
Phytochemicals found in mangos may target breast cancer cells
Another exploratory study presented at FASEB this week and conducted by researchers at Texas A&M University discovered that a polyphenolic compound found in Keitt mangos may be toxic to breast cancer cells. The study, done in vitro (in cells) and in mice, found decreased proliferation of breast cancer cells treated with the polyphenolic extract, and reduced tumor size and weight in mice. Though more research is needed, including human clinical trials, researchers hypothesize that the effects of the polyphenolic extract might extend to the consumption of fresh mango.  
"In summary, the anti-carcinogenic and anti-inflammatory activity of mango polyphenolics in breast cancer cells were at least in part due to targeting proteins that play an important role in the survival of breast cancer cells," noted one of the study's lead researchers, Dr. Susanne Talcott.  "The ability for bioactive components in mangos to reduce cancer promoting cells may be the next big thing in the battle against breast cancer, but more research is needed at this time."
Mango nutrition
According to the National Mango Board, results from both studies will help add to the existing body of evidence suggesting mangos are a nutritional powerhouse. "Mangos are not only delicious, but a nutritious way to add tropical flavor to your plate. With more than 20 vitamins, minerals and antioxidants and availability year-round, mangos are great addition to anyone's diet," stated Megan McKenna, National Mango Board's director of marketing.
For more information about fresh mango varieties and availability, storage, handling tips, recipes and nutrition, visit www.mango.org.
About National Mango Board
The National Mango Board is a national promotion and research organization, which is supported by assessments from both domestic and imported mangos. The board was designed to drive awareness and consumption of fresh mangos in the U.S. One cup of mango is only 100 calories, an excellent source of vitamins A and C, a good source of fiber and an amazing source of tropical flavor.
Mango availability per capita has increased 35% since 2005 to an estimated 2.53 pounds per year in 2011.  Mango import volume for 2011 was 810 million pounds Learn more at www.mango.org
SOURCE National Mango Board

CONTACT: Allison Parker, MS, RD, Fleishman-Hillard, +1-512-495-7188, allison.parker@fleishman.com
Web Site: http://www.mango.org 

Friday, April 20, 2012

Test useful for clinical decision-making in Advanced Lung Cancer

VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC.  The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs). Results outlined below indicated that the VeriStrat test was able to identify patients likely to have better and worse survival outcomes when treated with the combination therapy. 


Full press release below.



VeriStrat® Test Results Correlate with Survival Outcomes in Advanced Lung Cancer

BOULDER, Colo.April 20, 2012 /PRNewswire/ -- Results from the combined analysis of two European Phase II trials were presented today at the 3rd European Lung Cancer Conference in Geneva, Switzerland.  The VeriStrat retrospective analysis was performed on serum samples from advanced non-squamous non-small cell lung cancer (NSCLC) patients treated with the combination therapy bevacizumab plus erlotinib.  Results showed that the VeriStrat test was able to identify patients likely to have better and worse survival outcomes when treated with the combination therapy.    
Pretreatment serum samples from 114 patients treated with bevacizumab plus erlotinib were classified as either VeriStrat Good or VeriStrat Poor.  The study showed there was a statistically significant difference in overall survival between the two groups.  Patients classified as VeriStrat Good had a median overall survival of 13.4 months versus 6.2 months for patients classified as VeriStrat Poor (p=0.0027, HR=0.480, 95%CI:0.294-0.784).  Median progression free survival for patients classified as VeriStrat Good was 4.0 months and 3.2 month for patients classified as VeriStrat Poor, but this difference was not statistically significant (p=0.2632, HR=0.768, 95% CI: 0.482-1.223).
Researchers concluded that the VeriStrat test may be useful for clinical decision-making, representing a prognostic and potentially predictive biomarker for treatment with erlotinib and erlotinib combinations.  Prospective trials are ongoing, including a Phase III trial in advanced squamous cell lung cancer, sponsored by the European Thoracic Oncology Platform (ETOP). 
"These data represent the third study in which we have shown that VeriStrat classification correlates with survival outcomes in lung cancer patients treated with bevacizumab plus erlotinib, " commented David Brunel, CEO of Biodesix. "Although additional data is needed, this study supports the view that VeriStrat may be useful in identifying lung cancer patients that could benefit from the combination of bevacizumab and erlotinib, which is regarded as less toxic than traditional chemotherapy."
About VeriStrat:  VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC.  The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs).  Samples are processed in Biodesix' CLIA certified laboratory and results are typically reported within 72 hours of sample shipment.  VeriStrat has been validated in clinical studies with over 1500 patients.  For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.
About Biodesix:  Biodesix is a personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care.  The Company's goal is to give physicians more information about the patient and their disease; understanding the clinically meaningful information contained within each patient's molecular profile leads to better care and better outcomes. The Company's unique approach is based on ProTS®, proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.
This press release contains statements that are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company's inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company's financial resources will be insufficient to meet the Company's business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.
SOURCE Biodesix
CONTACT: Jennifer Hedrick of Biodesix, +1-303-892-3207, jhedrick@biodesix.com

Thursday, April 19, 2012

Merck Serono MS drug study


Merck Serono sponsored study shows that use of drug following first sign of possible MS reduces likelihood of progression to MS.

Full press release is below.

Study: Use of Drug Following First Sign of Possible MS Reduces Likelihood of Progression to MS

NEW ORLEANSApril 19, 2012 /PRNewswire-USNewswire/ -- People who received injections of the multiple sclerosis (MS) drug interferon beta-1a soon after their first signs of possible MS were less likely to progress to clinically definite MS than people who switched to interferon beta-1a from placebo, according to new phase three results of the three-year REFLEXION clinical trial that will be presented as part of the Emerging Science program (formerly known as Late-Breaking Science) at the American Academy of Neurology's 64th Annual Meeting in New OrleansApril 21 to April 28, 2012. 
The trial was conducted with the human serum albumin-free formulation of interferon beta-1a, which is now available in all European Union countries, AustraliaCanada and Switzerland, as well as a number of countries in AsiaLatin AmericaAfrica and the Middle East. It is not available in the United States.
"While we've known it's beneficial to start MS drugs as soon as possible, this is the first trial to show a benefit of early injections of interferon beta-1a treatment at three years," said Mark Freedman, MD, with the University of Ottawa in Ontario, Canada, and a Fellow of the American Academy of Neurology.
The three-year clinical trial involved 517 people who had experienced a first clinical episode suggestive of a demyelinating event, such as tingling, numbness, muscle weakness or problems with balance, along with having at least two clinically silent brain lesions detected by a brain MRI scan. 
For two years, one-third of the participants received 44 mcg of interferon beta-1a subcutaneously three times a week; one-third received 44 mcg of the drug once a week, which is an unapproved dosage; and another one-third received placebo for two years or until experiencing a second clinical episode, at which point they were switched to three-times-weekly dosing.  After the two years were over, the 133 people who were still receiving the placebo were switched to the three-times-weekly dose and the others continued their originally allocated dosages. The participants started their treatment an average of 58 days after their first symptoms.
After the third year of the study, the researchers found that those who had been receiving the drug three times a week or once a week for the duration of the trial were less likely to be diagnosed with clinically definite MS (defined as having a second clinical attack or a sustained increase in the Expanded Disability Status Scale disability score of greater than 1.5) than those who had initially received the placebo. The cumulative probability of being diagnosed with clinically definite MS by the end of the third year was 41 percent for the delayed treatment group (people who had switched from placebo to three-times-weekly treatment), 28 percent for those who had received once-a-week treatment all three years, and 27 percent for those who had three-times-weekly treatment for three years.
The study also found that those who had received the treatment for the full three years were less likely to meet the McDonald criteria for a MS diagnosis, a different measure than the one for clinically definite MS that includes an evaluation of MRI. A total of 87 percent of people who had switched from placebo to the treatment after two years met the McDonald criteria for MS after three years, compared with 79 percent of those who had received the weekly treatment and 67 percent of those who had treatments three times a week. 
"While doses three times a week and once a week equally delayed a clinically definite MS diagnosis without MRI measures, there were significantly more benefits in taking the drug three times a week compared with once a week when it came to brain lesion changes and other McDonald criteria for diagnosing MS," said Freedman.
The REFLEXION trial is ongoing and will provide long-term data out to five years. 
The most common adverse events in the trial were flu-like symptoms, injection site reactions and headache. 
The study was supported by Merck Serono S.A. – Geneva, Switzerland.
Learn more about multiple sclerosis at http://www.aan.com/patients.
The American Academy of Neurology, an association of more than 25,000 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer's disease, epilepsy, Parkinson's disease and multiple sclerosis. For more information about the American Academy of Neurology, visit http://www.aan.com or find us on FacebookTwitterGoogle+ and YouTube.
Editor's Note:Dr. Freedman is available for advance media interviews. Please contact Rachel Seroka,rseroka@aan.com, to schedule an advance interview.
To access more than 2,300 non-Late-Breaking abstracts to be presented at the 2012 AAN Annual Meeting, visit http://www.aan.com/go/am12/science.  Advance copies of all Emerging Science abstracts (formerly known as Late-Breaking abstracts) to be presented at the AAN Annual Meeting are available by contacting Rachel Serokarseroka@aan.com.
SOURCE American Academy of Neurology
 CONTACT: Rachel Seroka, rseroka@aan.com, +1-651-695-2738, Angela Babb, APR, ababb@aan.com, +1-651-695-2789, AAN Press Room (April 22-27): +1-504-670-4511
Web Site: http://www.aan.com 

Wednesday, April 18, 2012

BayerHealthCare AF Awareness


Bayer HealthCare is supporting the Sign Against Stroke campaign, aiming to raise awareness of AF and the need to prevent AF-related stroke by encouraging all relevant stakeholders, including the general public, to visit,www.signagainststroke.com, and show their support by signing the Global AF Patient Charter.

Full press release is below.

Under-Treated Heart Condition That Causes a 500 Percent Increase in the Risk of Stroke Unites Medical and Patient Communities

Global Patient Charter Ignites Action to Address Preventable Strokes Caused by Atrial Fibrillation


DUBAIApril 18, 2012 /PRNewswire/ -- World Heart Federation, World Congress of Cardiology Scientific Sessions 2012 - April 18, 2012 - The Global Atrial Fibrillation Patient Charter, endorsed by 68 medical and patient organisations from 39 countries, was launched today at the World Heart Federation's World Congress of Cardiology Scientific Sessions 2012. In an unprecedented worldwide call to action, the Patient Charter and supporting Sign Against Stroke in Atrial Fibrillation campaign address this under-recognised but growing cardiovascular public health emergency. The Charter offers strategies and solutions that could prevent millions of people from dying or becoming disabled from a stroke caused by atrial fibrillation (AF), an under-diagnosed, under-treated and potentially life threatening condition.
Tens of millions of people around the world are affected by AF, an abnormal heart rhythm and a major risk factor for stroke – a potentially disabling or deadly event. AF causes the two upper chambers of the heart (the atria) to quiver instead of beating effectively, resulting in blood not being completely pumped out, which in turn causes pooling and can lead to clotting. These clots can travel to the brain and trigger a major and often fatal stroke.
In a global call to action, 68 patient organisations and medical societies from around the world are asking the general public, healthcare professionals and policy makers to work with them to drive action that will prevent serious and devastating AF-related strokes. People are being encouraged to show their support by visiting the campaign website, www.signagainststroke.com, and signing the Charter.
"Too many lives are ruined because people don't discover that they have AF until after they have had a stroke," said Mellanie True Hills, Founder and CEO of StopAfib.org, an AF patient advocacy organisation. "We must ensure that people are diagnosed earlier and treated promptly and effectively to manage AF and prevent strokes. We are asking people around the world to visit the website and sign the Charter to raise awareness of this potentially deadly and debilitating condition that destroys lives."
Atrial fibrillation has no geographic, gender or socio-economic boundaries and is responsible for approximately 20 percent of all strokes caused by blood clots.
Patient Charter Underscores Need for Immediate Action
"Every 12 seconds someone in the world will suffer from an AF-related stroke," said Trudie Lobban MBE, Founder and Trustee, Arrhythmia Alliance, and Co-Founder and CEO, Atrial Fibrillation Association. "However, unlike high blood pressure or diabetes, many people have never heard of atrial fibrillation. This is a condition that increases our risk of stroke by 500 percent and yet, with early diagnosis and appropriate anticoagulation, the majority of AF-related strokes can be prevented."
Crucially, AF-related strokes are more serious than those resulting from other causes. This means that people who do suffer an AF-related stroke are less likely to be able to return to their own homes and will need more care from their families or nursing homes. However, with more attention to education, diagnosis and treatment, the impact of these strokes on the individuals themselves, the health system and society can be reduced.
AF-Related Strokes are Preventable...So Let's Prevent Them
The Charter's supporting campaign, Sign Against Stroke in Atrial Fibrillation, aims to gather signatures from around the world in support of the Global AF Patient Charter and its "five critical recommendations":
  1. Implement public information and education campaigns to raise awareness of the early signs of AF, the risk factors of stroke and the importance of pulse checks
  2. Make AF-related stroke prevention and care a national healthcare priority
  3. Implement widely accepted clinical guidelines on the treatment of AF and AF-related stroke at a national level
  4. Enhance medical education and best practices in the healthcare workforce to improve prevention, detection and management of AF and AF-related strokes
  5. Ensure technologies that improve prevention, diagnosis and treatment of people with AF or at risk of AF-related stroke are made appropriately available at the earliest opportunity
"Bayer HealthCare is proud to be supporting this campaign," commented Dr. Flemming Ornskov, Head of General Medicine, Bayer HealthCare Pharmaceuticals. "Improving patient outcomes is of utmost importance. However, it will require everybody to work together, patients, healthcare professionals, policy makers, non-governmental organisations and industry. None of us can achieve this alone."
About The Global AF Patient Charter and Sign Against Stroke Campaign
The Global AF Patient Charter has been developed by a Steering Committee of organisations, including AntiCoagulation Europe, Arrhythmia Alliance, Atrial Fibrillation Association, Irish Heart Foundation, StopAfib.org and Stroke Alliance for Europe, in collaboration with 39 patient organisations from 20 countries.
The Global AF Patient Charter has been designed to bring a worldwide, unified voice to improving the treatment and care of individuals living with AF, and those at risk of AF-related stroke. It contains recommendations about critical actions that policy makers, healthcare providers, payers and national governments can take to save lives, reduce the burden of disease and the huge associated medical costs. 
The Sign Against Stroke campaign aims to raise awareness of AF and the need to prevent AF-related stroke by encouraging all relevant stakeholders, including the general public, to visit,www.signagainststroke.com, and show their support by signing the Global AF Patient Charter.
The goal of Sign Against Stroke is to gather 1.7 million signatures in support of the Charter – one for each of the estimated number of grandparents, mothers, fathers, aunts and uncles killed or disabled by AF strokes every year. 
Bayer HealthCare supports the Global AF Patient Charter and Sign Against Stroke campaign.
SOURCE Sign Against Stroke
CONTACT: Melissa Gonzalez, m.gonzalez@togorun.net, +1-212-453-2047