Fresenius Medical Care Receives FDA Clearance for 2008K@home™ Dialysis Machine

(BUSINESS WIRE)--Fresenius Medical Care (NYSE: FMS), the world’s leading company devoted to patient-oriented renal therapy, announced today that the U.S. Food and Drug Administration (FDA) cleared its 2008K@home™ dialysis machine. Specifically designed to facilitate hemodialysis treatment in the home environment, the newly approved device offers many patients more options for achieving adequate dialysis in the comfort of their own home.

"The 2008K@home offers the broadest range of dialysis prescription delivery, regardless of patient size or metabolic needs,” said Chief Medical and Regulatory Affairs Officer Jose Diaz-Buxo, MD, FACP. “It offers versatility and the reliability of many years of experience with this platform." The 2008K@home combines the known safety, efficacy and reliability of the 2008® series hemodialysis machines with a simpler user interface and additional new features specifically designed to facilitate home hemodialysis. 2008K@home incorporates all standard performance and safety features expected in modern hemodialysis machines.

The 2008K@home will be available to patients in the late spring/early summer, 2011. For more information call 800-662-1237 ext. 2053.

2008K@home and 2008 are trademarks of Fresenius Medical Care. 

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Gene Therapy Proves Effective in Treating Severe Heart Failure; Holds Potential to Drastically Reduce Healthcare Costs for Heart Failure Patients

/PRNewswire/ -- The 14th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) will feature a discussion titled "Latest Developments in Stem Cell and Gene Therapy in Heart Failure" which includes a presentation by Dr. Roger Hajjar, Director of the Cardiovascular Research Institute, one of the 12 translational science institutes at The Mount Sinai Medical Center in New York. Dr. Hajjar's discussion will focus on the injection of a gene into patients with advanced heart failure to reverse the debilitating and life-threatening condition.

Over ten years, Dr. Hajjar and his team have validated the cardiac sarcoplasmic reticulum calcium ATPase pump, SERCA2a, as a target in heart failure and developed methodologies for cardiac-directed gene transfer. This work has led to the initiation and recent completion of phase 1 and phase 2 First-in-Man clinical trials of SERCA2a gene transfer in patients with advanced heart failure.

Patients treated with high dose therapy have shown 90 percent risk reduction for heart failure-related cardiovascular events such as significantly worsening health, the need for a transplant or cardiovascular device support, intravenous treatment or death.

"The patients receiving this gene therapy have shown marked improvements," said Dr. Hajjar. "Through our tests we've observed heart failure patients' quality of life improves greatly for significantly less cost than traditional therapies."

Patients treated with the gene therapy treatment may result in a large decrease in personal health care costs across their trial period. In nine months, individuals treated with the trial's placebo spent an average of $27,118 on health care, paying for expenses such as hospital stays, emergency medicine, and home care. Comparatively, in the same period of time, individuals treated with gene therapy spent an average of $329 on health care.

"Gene Therapy is a breakthrough in the treatment of heart failure patients that holds the potential to reverse the disease while also making treatment and recovery more affordable than ever," said Dr. Douglas Mann, HFSA President. "It is critical for the medical community to continue to integrate science and clinical medicine so biomedical research can improve patient care."

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Study Compares Risk With Two Diabetes Drugs

/PRNewswire/ -- In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same - about 4 percent - for patients taking the diabetes drugs rosiglitazone or pioglitazone, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

"This study provides patients and their doctors with another source of information about rosiglitazone and pioglitazone (sold as Avandia and Actos, respectively) as they determine the best therapy for diabetes patients," said Debra Wertz, Pharm.D., lead author and outcomes research manager at HealthCore, Inc., the research subsidiary of health insurance company WellPoint, Inc.

This study evaluated more than 36,000 diabetes patients. Of the 28,938 patients who were propensity-score matched, a methodology used to provide an estimation of treatment-effects that is as unbiased as possible, 602 patients taking rosiglitazone and 599 taking pioglitazone over a 33-month period suffered either a heart attack, heart failure, both, or died. This translates to about 4 percent of all patients taking either medication. The individual specific adverse events were also not significantly different between the two groups, and were:

-- Heart attack - 96 patients on rosiglitazone and 121 patients on
pioglitazone;
-- Heart failure - 265 patients taking rosiglitazone and 243 taking
pioglitazone;
-- Heart attack and heart failure - 24 patients on rosiglitazone and 18
on pioglitazone; and
-- Death - 217 patients taking rosiglitazone and 217 taking pioglitazone.


The study included 36,628 patients who had submitted insurance claims to WellPoint affiliates for either of the two diabetes medications between 2001 and 2005. Patients' average age was 54, and 58 percent were male. Wertz and her team obtained death records from the National Death Index, a central database administered by the National Center for Health Statistics.

The investigators divided patients into two equal groups, one receiving rosiglitazone and the other, pioglitazone. After adjusting the data for (removing/minimizing the effect of) age, gender, prior heart and blood vessel diseases and diabetes-related complications and severity indicators, they compared the incidence of heart attack, heart failure and death for an average 14 months of treatment and 19 months of post-treatment follow-up.

Diabetes is a disease in which the body cannot adequately produce the hormone insulin or uses it improperly. The disease can cause a potentially dangerous buildup of sugar in the blood and also increases the risk of heart and blood vessel diseases, which are the main causes of death for people with diabetes.

Rosiglitazone, sold under the trade name Avandia by GlaxoSmithKline, and pioglitazone, sold as Actos by Takeda Pharmaceuticals, belong to the same class of drugs, called TZDs or thiazolidinediones. They help the body use insulin more effectively by boosting the body's sensitivity to the hormone and thus help control blood sugar.

This study has results different from earlier ones that found a greater risk of heart attack among rosiglitazone users compared to patients on other treatments or placebo. In 2007, the Food and Drug Administration decided that the benefits of rosiglitazone outweighed the risks, and it remained on the market although its use decreased significantly. In July 2010, an FDA advisory committee again reviewed numerous studies, including this study, and recommended that rosiglitazone remain on the market, although with additional warnings or restrictions. The FDA has not yet ruled on this latest recommendation.

"Besides its findings that rosiglitazone and pioglitazone have comparable risks, what distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths," Wertz said. The study also followed patients for a longer period of time than some of the earlier research, according to the investigators.

"One of the reasons we embarked on this analysis was to see if there were any differences in effect that we could identify between these two agents," said Mark J. Cziraky, Pharm.D., study co-author, and vice president of research development and operations at HealthCore. "We did not find that with the approach and methods we took within this population."

Other co-authors are Chun-Lan Chang, Ph.D.; Chaitanya A Sarawate, M.S.; Vincent J. Willey, Pharm.D.; and Rhonda L. Bohn, M.P.H., Sc.D.

Author disclosures are on the manuscript. WellPoint, Inc. funded this research.


An accompanying editorial, "Improving Surveillance for Drug Safety: Lessons from Rosiglitazone," by Frederick A Masoudi, M.D., M.S.P.H., is available.


Statements and conclusions of study authors published in American
Heart Association scientific journals are solely those of the study
authors and do not necessarily reflect the association's policy or
position. The association makes no representation or guarantee as to
their accuracy or reliability. The association receives funding
primarily from individuals; foundations and corporations (including
pharmaceutical, device manufacturers and other companies) also make
donations and fund specific association programs and events. The
association has strict policies to prevent these relationships from
influencing the science content. Revenues from pharmaceutical and
device corporations are available at http://www.americanheart.org/
corporatefunding.

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Epilepsy Organizations Award Grants for New Gene Therapy to Treat Epilepsy and Novel Surgical Intracranial EEG to Detect Seizures in Uncontrolled Patients

/PRNewswire/ -- The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced the latest grant recipients of its New Therapy Grants Program, a unique joint venture of the non-profit epilepsy organizations, to advance promising epilepsy research in clinical development. The grant awards, totaling approximately $200,000 in funding, will support an experimental gene therapy that directly targets epileptogenic brain tissue, as well as an electrode system that has the potential to improve the efficacy of surgical therapies for certain epilepsy syndromes.

"Patients need new options to treat and manage epilepsy, and through this grant program we are excited to see such remarkable innovation in the field. The fields of gene therapy and surgical treatment of epilepsy remain cutting-edge with much to be explored in terms of advancing epilepsy treatment outcomes," said Orrin Devinsky, MD, ETP Co-Founder and Vice President for Translational Programs, Professor of Neurology, Neurosurgery, and Psychiatry, and Director, NYU Comprehensive Epilepsy Center, New York University. "By choosing to support these two promising programs, we hope to see important strides made while encouraging researchers and companies to pursue new ideas and approaches in epilepsy and seizure conditions."

The New Therapy Grants program grants are designated to facilitate the advancement of new treatments through critical early-stage clinical development or to bridge the gap from preclinical to clinical development to ensure patients will have the opportunity to benefit from groundbreaking progress in the field of epilepsy. The award committee, which is comprised of clinical, scientific and industry representatives, evaluates applications to support new therapeutic approaches submitted by highly qualified clinical experts and scientists with the greatest potential for near-term patient benefit.

"The need and market opportunity for new therapies in epilepsy is unmistakable," said Warren Lammert, Chairman of the Epilepsy Therapy Project. "One third of the people with epilepsy live with uncontrolled seizures despite all available therapies and perhaps another one third achieve seizure control but at the price of unacceptable side-effects including fatigue and impact to cognition. Yet moving promising ideas out of research labs and on through the process of clinical and commercial development is an enormously expensive process with miniscule odds of success for each individual project. Further, epilepsy therapy development has been neglected by government and private funding sources, and current economic uncertainties have further diminished the availability of risk capital. In this environment, the importance of our New Therapy Grants in moving the most promising new research ideas across the starting line on to a path of clinical development cannot be overstated. My hope is that we can mobilize increased support and expand this vital program so necessary to improving the lives of people living with epilepsy."

"These research projects represent the essence of translational research and the focus of our New Therapy Grants Program," said Joyce Bender, chair of the Epilepsy Foundation board of directors. "We proudly applaud our grant recipients because their studies may provide new treatment options, which could lead to an improved quality of life for the nearly 3 million people in the United States and 50 million people worldwide living with epilepsy."

The Grant Recipients

Galanin Gene Delivery to the Hippocampus for Mesial Temporal Lobe Epilepsy

-- Prospect of one-time gene therapy that produces anti-convulsant and
neuroprotective benefits
-- Experimental therapy may offer less invasive therapeutic option and a
prospective paradigm shift in patient care for certain forms of
epilepsy


Scott McPhee, Ph.D., Vice President of Clinical Development, Asklepios BioPharmaceutical Inc., and Nicholas Boulis, M.D., Assistant Professor, Neurosurgery, Emory University, will be conducting preclinical studies of a Galanin gene delivery for selected patients with uncontrolled Mesial Temporal Lobe Epilepsy (MTLE). Direct delivery of a gene therapy to the temporal lobe offers the significant potential of a less invasive, more effective alternative approach that precludes the trauma and resulting complications of surgical tissue removal, and avoids the side effects of standard pharmacological treatments. The protein galanin has been shown to suppress seizures. Gene delivery of galanin DNA has been shown to have anticonvulsant and neuroprotective effects in models of MTLE. Unlike traditional anti-epileptic medications, galanin gene delivery may be administered in a one-time intervention that provides long-term supplemental galanin in the epileptogenic tissue. The proposed therapeutic approach represents a paradigm shift in the treatment of epilepsy because gene delivery offers to locally regulate activity rather than destroying tissue. In addition, it has the unique and significant potential to one day provide a strategy for the treatment of critical brain tissue in which tissue removal is not currently a therapeutic option. These experiments may not only provide a unique opportunity for the development of novel epilepsy therapies but may also advance the cause of neurological gene therapy in general.

The preclinical research outlined by the grant recipients is expected to support the filing of an

Investigational New Drug (IND) Application for a Phase I clinical trial. Funding of the preclinical protocol is subject to appropriate institutional review and approvals, as well as securing the additional financial support needed to complete the research.

Intracranial EEG Acquisition System with Online Fast Ripple Detection

-- New technology to refine how surgeons will identify and define
epileptogenic regions of the brain
-- Potential to improve surgical outcomes and broaden viability of
treatment for certain epilepsy syndromes


A Columbia University Medical Center research team headed by Catherine Schevon, M.D., Assistant Professor, Neurology, received funding to support the refinement of an intracranial EEG recording system, an online detection system to better define the epileptogenic region of the brain, the area of the brain related to seizure activity, before therapy or surgery.

Surgical excision of the epileptogenic brain region is an important treatment modality for medically refractory partial epilepsy, with greater than 60 percent or more of patients achieving seizure freedom. The success rate is notably worse, however, when a structural lesion cannot be identified, and may be as low as 35 percent in patients with extratemporal non-lesional syndromes. In these cases, the resection choice depends almost entirely on accurate interpretation of the intracranial EEG (iEEG), obtained by recording from electrodes implanted directly onto the brain surface or into the parenchyma. Recognizing these limitations surgical therapy for extratemporal epilepsy syndromes is not currently recommended for widespread clinical use.

High frequency oscillations (HFO) in the brain can identify areas for epilepsy surgery treatments, but are technically difficult to detect, largely limiting their clinical utility. Grant funding will be applied to the development of this new system to bring automatic online HFO detection into clinical practice, making current surgical treatments more effective, and potentially simplifying surgeries for many epilepsy syndromes. By increasing the specificity of the identification of the epileptogenic region, seizure outcomes can be improved while the area of brain that must be removed is minimized.

Upcoming Grant Applicants: Note Deadline for Letter of Intent is September 3, 2010

The New Therapy Grants Program is requesting proposals from scientific and clinical investigators pursuing innovative projects that demonstrate a clear path to commercialization. The program accepts the submission of proposals ranging from $50,000 to $500,000. The deadline to submit a Letter of Intent (LOI) is September 3, 2010. Applicants who have an accepted LOI have until October 15, 2010, to submit their full proposals. To view additional requirements, please visit http://www.epilepsy.com/etp/support_translational.

The New Therapy Grants Program is a unique partnership between two leading epilepsy non-profit organizations, the Epilepsy Therapy Project and the Epilepsy Foundation. The mission of the New Therapy Grants Program is to drive the development of new therapies for epilepsy, accelerating the advancement of research from the laboratory to the patient. Funding is provided for grants supporting the research and development of new therapies in both academic and commercial settings worldwide.

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Robots to Help Children With Autism

/PRNewswire/ -- Interbots, Inc., a high-tech spin-off company associated with the Carnegie Mellon University Entertainment Technology Center has teamed up with the Autism Center of Pittsburgh to provide innovative robot-based therapy for children with autism.

The program, "Character Therapy," through the use of the Interbot robot "Popchilla" will test the ability of children with autism with limited or no verbal skills.

According to Seema Patel, CEO and co-founder of Interbots, "We've had numerous individuals tell us our robots could be tremendous tools for Autism therapy. We're excited to be working with the Autism Center of Pittsburgh and the Sprout Foundation to take this first step. We're going to learn a lot from the next few months."

"The premise behind the program is that children with autism are sometimes more likely to communicate with a non-human entity," said Cindy Waeltermann, Founder and Director of the Autism Centers of Pittsburgh. "When you have a child with autism, you use whatever interests them to gain access into their world. The idea is to bridge the gap between their word and ours.

Popchilla will be used in the first phase of the program with a trained therapist. Programmers and developers at Interbots have created an iPad application that will allow the therapist to direct sessions, which will eventually be transitioned to allow the child to control the robot through an iPad application to identify emotions.

According to Waeltermann, "By using Popchilla as an intermediary, we hope to increase the understanding of the child's internal feelings, thus reducing behavioral frustrations. If they are able to identify that they are 'angry' and what 'angry' means, it can significantly help them understand what they are feeling, reducing behavioral ramifications."

The program is funded by Spark. Spark is an initiative of The Sprout Fund catalyzing projects and programs that engage children ages birth to eight through the creative use of technology and media. Spark challenges individuals, organizations, and communities to generate inventive technology-based solutions to the issues and opportunities facing today's young child. Through its funding opportunities and extensive network of support, Spark is unleashing the innovative potential of Southwestern Pennsylvania and transforming our region into one of the best places on earth to be a kid.

"Our emphasis has always been making the use and control of our robots as simple and flexible as possible. You don't need to have a technical background to control our characters. You can control them with a variety of other familiar devices. So that opens a lot of interesting applications - like having a therapist or a parent use our robots as a tool to interact with children - even the possibility of kids using the robot to express themselves and explore emotions on their own," according to Sabrina Haskell, Interbots, Designer & Co-Founder.

The iPad application is currently in production and the program is slated to begin this fall.

"Nobody is more excited than the parents of the children with autism who have the potential to gain great strides from this program," said Cindy Waeltermann. "That's what this is all about -- thinking outside the box to reach these kids."

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Four New Research Studies Describe Experimental Immunotherapies for Alzheimer's

/PRNewswire/ -- The primary therapeutic target in Alzheimer's disease has been the beta amyloid peptide, which clusters outside cells in the brain to form sticky clumps known as plaques. Recently, more attention has been given to the tau protein, which aggregates inside the brain cells of people with Alzheimer's, forming neurofibrillary tangles. Precisely how these proteins interact in causing the disease is unclear.

Four new research studies reported today at the Alzheimer's Association International Conference on Alzheimer's Disease 2010 (AAICAD 2010) in Honolulu, HI describe experimental immunotherapies for Alzheimer's two of which target tau directly and two of which may reduce tau even though their primary target was beta amyloid.

"It is very important that we have a variety of therapeutic targets in the fight against Alzheimer's disease," said William Thies, PhD, Chief Medical and Scientific Officer at the Alzheimer's Association. "The more opportunities that we investigate to intervene and change the relentless and progressive course of Alzheimer's, the better chance that we will find something that works."

"Importantly, these studies teach us more not only about tau-targeted therapies but also about the progression of Alzheimer's disease," Thies added. "It may be that amyloid changes in the brain happen early in the disease and tau-related changes happen 'downstream' where they have a more direct effect on cognitive function. However, this is still to be determined."

"We need more basic research about what causes Alzheimer's, as well as therapy-related studies, to fill the front end of the drug pipeline and get us the better treatments and prevention strategies that we so desperately need to head off the epidemic of Alzheimer's," Thies said.

Beta Amyloid Immunotherapy with Bapineuzumab in Alzheimer's May Also Reduce Tau

Bapineuzumab (Janssen Alzheimer Immunotherapy and Pfizer) is an antibody to the beta amyloid plaques that are associated with Alzheimer's disease, and is currently in Phase 3 testing as a treatment for mild to moderate Alzheimer's. An abnormal form of the tau protein known as phospho-tau (P-tau) forms into tangles which are the other established lesions in the brain of people with Alzheimer's. The amount of P-tau in cerebrospinal fluid (CSF) is believed to be a marker of active loss of brain cells in people with Alzheimer's; prior studies have shown increases in P-tau in people with mild cognitive impairment who later develop Alzheimer's. P-tau was studied as a therapeutic biomarker in the Phase 2 clinical trials of bapineuzumab.

The pooled exploratory analysis reported at AAICAD 2010 by Kaj Blennow, MD, PhD, of the University of Gothenburg, Sweden, and colleagues included a subgroup of participants from two randomized, multicenter, double-blind, placebo-controlled, multiple-ascending-dose studies conducted in the United States (Study 201) or in the United Kingdom and Finland (Study 202). Study 201 enrolled 35 patients (20 bapineuzumab, 15 placebo) in the CSF substudy, and Study 202 enrolled 11 patients (7 bapineuzumab, 4 placebo) in the CSF substudy. CSF was collected at baseline and 2 weeks after the week 52 infusion.

The researchers found that Study 201 showed a trend (p=0.0564) towards a decrease in CSF P-tau in bapineuzumab-treated compared with placebo-treated cases. In Study 202, no significant treatment effects were seen. When they combined data from both studies, they found a statistically significant decrease (p=0.0270) in P-tau in bapineuzumab-treated compared with placebo-treated patients.

"These observations suggest that immunotherapy treatment targeting amyloid may also alter neurodegenerative processes that occur later in the disease process and that are more directly associated with loss of function," Blennow said. "However, this was a small study and these findings need to be confirmed."

Another Immunization Therapy for Alzheimer's with Beta Amyloid Also Reduces Tau

AN1792 (Elan) showed early promise as a beta amyloid immunotherapy for Alzheimer's. In 2002, a Phase 2 trial reported that about 6 percent of participants developed serious brain inflammation symptoms resembling meningoencephalitis. The trial was stopped as was further clinical development. However, participants in the first AN1792 trial continue to be observed.

Delphine Boche, PhD, of the University of Southampton's School of Medicine, UK, and colleagues studied the levels of beta amyloid and phospho-tau in six regions of cerebral grey matter that are affected by Alzheimer's pathology in the brains of 10 people with Alzheimer's who were immunized with AN1792 and compared the findings with 28 unimmunized Alzheimer cases. They had previously shown a reduction of beta amyloid in people treated with AN1792 and now looked to see if it had any effect on tau.

The researchers found statistically significant reductions in tau and beta amyloid in the immunized patients compared with untreated Alzheimer's. The reduction in tau appeared to be specifically in the dendrites, which are the branched projections of a neuron that conduct the electrochemical stimulation received from other nerve cells to the cell body. In contrast, tau in the bodies of the nerve cells, where the tangles form, seemed unaffected.

"The findings show that treatment aimed at beta amyloid may also modify tau changes in Alzheimer's," Boche said. "The lack of change in tau in the bodies of nerve cells might explain why the people in the original AN1792 trial didn't experience an improvement in cognitive functioning even though we saw amyloid clearance."

"This study demonstrates a link between these two Alzheimer's-related proteins, which has been suspected but not clearly demonstrated in the human brain. The findings give us more basic information about the interaction between beta amyloid and tau in Alzheimer's and may clarify how the disease progresses in the brain," Boche said.

Tau Antibodies Reduce Brain Tangles in Alzheimer-Model Mice

Allal Boutajangout, PhD, of the New York University School of Medicine, and colleagues previously reported that active tau immunization clears tau tangles from the brain and reduces or prevents functional impairments in two different tangle-model mice. In a study reported at AAICAD 2010, they assessed the efficacy of passive immunization for 13 weeks with the PHF1 antibody to tau in a mouse model of Alzheimer's tangles.

The researchers found that weekly injections of PHF1 in the tangle mice reduced the amount of tau aggregates in the brain and decreased functional impairment. The treated mice performed better than controls on the traverse beam task (p<0.03), and had 58 percent less tau pathology in the hippocampus (p=0.02). Plasma levels of PHF1 were inversely related to levels of tau pathology in two brain sections - the brain stem (p<0.01) and motor cortex (p=0.06) - indicating that higher dose of antibodies may have a greater therapeutic effect.

"Targeting hyperphosphorylated tau by immunotherapy is emerging as a promising approach to treat tau-related diseases such as Alzheimer's disease and frontotemporal dementia," Boutajangout said. "Further studies are needed to determine the feasibility of this approach with other tau antibodies and in different tangle models that more closely resemble Alzheimer's."

Alzheimer's Tau Vaccine Shows Promise in a New Rat Model of the Disease

Scientists led by Prof. Michal Novak, MDV, PhD, DSc, of the Institute of Neuroimmunology, Slovak Academy of Sciences, Bratislava, Slovakia and Co-Founder and Chief Scientific Officer of the Axon Neuroscience GmbH, Vienna, Austria, have developed a new transgenic rat model of Alzheimer's that, according to Novak, for the first time expresses non-mutated tau and generates Alzheimer's neurofibrillary tangles. Axon is using the rat for early, preclinical development of an Alzheimer's tau vaccine.

In a study reported at AAICAD 2010, Axon transgenic rats were immunized with phospho-tau. The scientists measured changes in functions related to behavior and learning, levels of phosphorylated tau in cerebrospinal fluid, and level of tangle pathology in the rat brains. They found that tau immunization significantly reduced the amount of insoluble tau, prevented development of neurofibrillary tangles, and produced a statistically significant delay of progressive impairment in learning behaviors.

"The Axon Alzheimer Rat may offer new avenues in developing the next generation of therapies and diagnostics for Alzheimer's," Novak said.

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FDA Approves a Cellular Immunotherapy for Men With Advanced Prostate Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.


Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient's own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient's immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient's own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

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Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction

Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.

Cardiac Science has received a total of 64 complaints concerning four resistors within certain AEDs. Two of these complaints were associated with a failure to deliver therapy. This issue is predicted to occur in approximately one in 75,000 AEDs manufactured between August 2003 and August 2009. The company has also received 114 complaints regarding "Service Required" messages resulting from a specific relay switch failure. There have been no reported instances where this issue has resulted in an inability to deliver therapy.

Until a correction is available in May, 2010, the company strongly advises customers to check the status indicator on the front of the AED and follow the procedures documented in the materials accompanying the AED. The company advises that customers leave their AEDs in service.

"When customers choose a product from Cardiac Science, they expect outstanding reliability," said Dave Marver, president and chief executive officer. "We understand the role our products play in public health and are taking appropriate measures to further improve the performance of our products."

The company has implemented more stringent testing of the components and all AEDs produced since August, 2009 are unaffected. Customers in possession of an AED that may exhibit either of these issues will be notified immediately. A software update to address the resistor issue will be available by May, 2010. This software update will enhance the AED's self-test capabilities and improve detection of the issue. In the interim, the company advises customers to keep their AEDs in service and follow the normal testing and maintenance procedures found in the Operator and Service Manual. A copy of these procedures is available at www.cardiacscience.com/AED175. At this site, customers may confirm if their AED is affected and register for automatic e-mail reminders to conduct scheduled maintenance.

If the AED is not rescue ready (the indicator is red) customers should contact the company immediately at 425.402.2000 (option 1) within the United States. Outside the US contact +44.161.926.0011 or the local Cardiac Science representative. Customers can also email the company at AED175@cardiacscience.com.

Forward-Looking Statements

This press release contains forward-looking statements. The word "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.

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Three-Week Course of Breast Radiation May Be as Effective as Conventional Five to Seven Week Course for Early Breast Cancers, Says U.S. Study

/PRNewswire/ -- According to a study presented November 4, 2009, at the 51st Annual Meeting of the American Society for Radiation Oncology (ASTRO), a shortened, more intensive course of radiation given to the whole breast, along with an extra dose of radiation given to the surgical bed of the tumor (concomitant boost), has been shown to result in excellent local control at a median follow up of two years after treatment with no significant side effects.

"The observations to date suggest that a three-week course of radiation therapy with concomitant boost results in outcomes comparable to that of a five to seven week course for early stage-breast cancers. Additional studies with a larger body of data and longer follow-up period will help establish whether this type of radiation treatment should be routinely used," Manjeet Chadha, M.D., lead author of the study and a radiation oncologist at the Beth Israel Medical Center in New York, said.

This shorter treatment, called accelerated hypofractionated whole breast irradiation, is an especially attractive option because women can receive a full course of radiation therapy in half the time -- three weeks of daily treatments vs. five to seven weeks. In addition, the cost of this treatment is lower relative to the cost of the standard whole breast radiation and is also less expensive than other new approaches, such as partial breast irradiation (breast brachytherapy).

"Studies from Europe and Canada have used accelerated schedules for breast radiation therapy with favorable results reported on longer follow up. In the U.S., however, there is limited data on this topic," Dr. Chadha said. "Additionally, the radiation therapy technique used in our study is different from previously published experiences. For each patient, we developed a conformal, personalized plan using three-dimensional dosimetry data derived from the patient specific CT scan images. Radiation treatment was delivered to the whole breast using an accelerated hypofractionated schedule, with the simultaneous delivery of a boost dose given to the precise location from which the tumor was removed."

Many women with early-stage breast cancer undergo breast conserving therapy. Typically, this means they first have surgery to remove the visible cancer (a lumpectomy), and then receive a course of radiation therapy to kill any microscopic cancer cells that may remain. The standard whole breast radiation treatment takes 15 to 30 minutes every day, Monday through Friday, for five to seven weeks.

Beginning in June 2004, researchers studied 112 women with early-stage breast cancer who received accelerated hypofractionated whole breast irradiation plus concomitant boost. The results were reported on 105 patients who had completed therapy and had a minimum six-month follow up. The patient group had small breast tumors that had not spread to the lymph nodes. Women with early-stage breast cancer who received chemotherapy or underwent radiation to the lymph nodes were excluded from the study. Patients were followed at regular intervals after completion of treatment.

Findings show that the cancer did not return to the original site or to the surrounding region in these women. The median follow-up of the study was two years. Survival was greater than 95 percent for patients with five years of follow up. The study also shows there were no significant physical or cosmetic side effects from the radiation treatment.

In an era of personalized care, Dr. Chadha emphasizes, "Women with early-stage breast cancer interested in this shorter course should ask their radiation oncologists about this option to evaluate whether it is suitable for their individual case."

For more information on radiation therapy for breast cancer, visit www.rtanswers.org.

The abstract, "Results using 3-week Accelerated Whole Breast (WB) Radiation Therapy (RT) and Concomitant Boost for Early-stage Node Negative Breast Cancer," will be presented at a scientific session at 11:30 a.m. on Wednesday, November 4. To speak to the lead author of the study, Manjeet Chadha, M.D., please call Beth Bukata or Nicole Napoli November 1-4, 2009, in the ASTRO Press Room at McCormick Place West at 312-791-7005 or 312-791-7006. You may also e-mail them at bethb@astro.org or nicolen@astro.org.

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FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer

The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.

Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell replication.

“This drug represents a new approach in the treatment of advanced non-small cell lung cancer,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four-to-six chemotherapy cycles. This study demonstrates an advantage in overall survival in certain patients who received Alimta for maintenance therapy.”

Non-small cell lung cancer has several subtypes, including squamous cell, large cell, adenocarcinoma and mixed histology cancers. In a 600-patient clinical trial, people with predominantly squamous cell cancer did not benefit from Alimta. But those with other subtypes of non-small lung cancer survived an average 15.5 months following treatment compared with 10.3 months for patients who received an inactive substance (placebo). All patients in the study received standard medical care.

Reported adverse events included damage to blood cells, fatigue, nausea, loss of appetite, tingling or numbness in the hands and feet, and skin rash.

Alimta initially was approved in 2004 for the treatment of patients with mesothelioma, a cancer frequently related to asbestos exposure. The drug was later approved for the treatment of patients with non-small cell lung cancer whose disease worsened on prior chemotherapy drugs and also as an initial therapy for advanced non-small cell lung cancer.

Alimta is manufactured by Eli Lilly & Co. of Indianapolis.

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Blue Cross Blue Shield of Georgia Is Skimping on Mental Health Care, Says Georgia Psychological Association

/PRNewswire / -- Late in 2007, Blue Cross Blue Shield of Georgia (BCBSGa) announced that it was cutting its hourly therapy reimbursement rate for clinical psychologists by approximately 19%. This new rate is about the same as you pay your auto mechanic or home handyman per hour.

However, unlike your mechanic, BCBSGa wants to pay licensed psychologists about half of what they were paid 10 years ago by BCBSGa. In 1998 clinical psychologists were reimbursed by BCBSGa nearly one and a half times today's rate for the same therapy hour. Accounting for inflation, today's rate should be nearly double in 2007 dollars (US Bureau of Labor Statistics based on the Consumer Price Index). Unlike medical doctors and dentists, psychologists see only one patient per hour.

As a result, GPA is hearing from its members that more and more licensed psychologists, especially the most experienced, are finding they can no longer see patients insured with BCBSGa insurance because they cannot run a practice, much less make a living, on what BCBSGa, one of Georgia's largest insurers, is willing to reimburse psychologists

Effective treatment requires highly specialized training and experience. Clinical psychologists licensed in the state of Georgia have either a Ph.D. or a Psy.D. including a bachelor's degree, 4-6 years post-graduate work, plus 1 year supervised internship, and at least one year post-doctoral supervision by a licensed psychologist.

"Research has shown again and again that there is a connection between good physical health and good mental health," said Georgia Psychological Association past-president, Dr. Joni Prince. "And taking a pill alone is not usually the most effective way of improving mental health; psychotropic drugs work better when used in conjunction with psychotherapy," she continued.

But clinical psychologists feel pressured to defend themselves if they see their BCBSGa patients for more than the "licensure type average" of 6.0 sessions, even though BCBSGa offers its PPO customers 50 therapy sessions per calendar year. Major depression, can affect almost 9% of the American population (Mann, New England Journal of Medicine, 10/27/05), and is a leading cause of lost productivity and time off from work. "It seems that Blue Cross is basing treatment decisions on statistics rather than clinical information," Prince said.

What else should you know?

In addition to psychotherapy, psychologists are the only mental health professionals who are qualified to administer, score, and interpret psychological testing instruments, including psycho-educational testing (for IQs, learning disabilities, etc.) and neuropsychological testing, among others.

Yet BCBSGa routinely denies coverage to its customers for psychological evaluations. Evaluations and accompanying clinical interviews are the first step in either diagnosing or ruling out learning disabilities, ADHD, Depression, Anxiety, Bi-polar disorder and other psychopathology. Nearly half (45%) of those with any mental disorder meet criteria for two or more disorders (National Institute of Mental Health press release related to a study published in September 2006 issue of the American Journal of Psychiatry).

Without proper evaluation, mental disorders will go undiagnosed and therefore, untreated. For instance, among adults who have an anxiety disorder about half had symptoms of some type of diagnosable mental illness by age 15, an NIMH-funded study showed. The results emphasize the importance of early diagnosis and treatment of anxiety disorders (NIMH Science Update 2/7/07). "In spite of these studies, many of which are publicized, patients are neglecting their mental health in part due to poor coverage and limited access to quality mental health care," Dr. Prince continued.

Once your child is diagnosed, for example, with Autism or Asperger's, his or her treatment may not be covered by BCBSGa, depending on the type of policy. This flies in the face of Georgia Law, which considers both Autism and Asperger's to be neurological conditions, all of which are mandated by law to be covered equally by insurers (GA Code 33-24-59.10).

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Massive Cuts to Medicare Home Oxygen Therapy Benefit Taking Effect January 1 Creating Acute Anxiety Among Beneficiary and Provider Communities

/PRNewswire-USNewswire/ -- As Americans nationwide prepare to celebrate the New Year, the home oxygen community is looking to 2009 with great unease due to significant Medicare policy changes that will present many challenges to beneficiaries and providers alike. On January 1, two new policies in the form of a 36-month cap on payments for home oxygen therapy and a 9.5 percent across-the-board payment cut will take effect, deeply impacting a community that cares for more than 1.5 million elderly and chronically ill patients.

Under the new 36-month cap, Medicare will stop payment for stationary home oxygen therapy equipment and related services after the beneficiary reaches the three year mark. Despite the discontinuation of payments after 36 months, providers will still be required to continue all servicing of patient needs and equipment including patient-generated, non-routine emergency home visits and routine replacement of disposable oxygen supplies, such as tubing and masks. Providers will also be responsible for ensuring that patients are appropriately serviced even if the patient moves out of the provider's service area within or following the first 36 months of service.

"The provider community is extremely committed to making every effort to meet patient needs and provide uninterrupted services," said Peter Kelly, Chairman of the Council for Quality Respiratory Care (CQRC). "However, it is difficult to comprehend how providers can maintain patient service levels on an uncompensated basis. Based on the magnitude of these cuts, the provider community cautions that service reductions may be unavoidable as a result of business failures or financial hardship and cause potential access problems for the vulnerable patient population we care for."

Historically, the home oxygen benefit has been subject to repeated cuts. The implementation of the 36-month cap, enacted by Congress in the Deficit Reduction Act of 2005 (DRA), and the 9.5 percent cut, part of the Medicare Improvements for Patients and Provider Act of 2008 (MIPPA), translate to a 27 percent, or $845 million, cut in 2009 alone. A recent analysis from Avalere Health "indicates that the average Medicare home oxygen payment by 2009 will be less than half of what it was in 1997."

The CQRC urges Centers for Medicare and Medicaid Services (CMS) officials to exercise the Secretary's authority to create reasonable post-cap policies, including payments for emergency and non-routine services and reimbursement for disposable supplies after 36 months. CMS should also reset the cap when a beneficiary moves out of his or her service area and requires a new provider. The CQRC asks policymakers to closely monitor the effects of these deep cuts on both beneficiaries and providers to ensure that patient access to essential home oxygen care is not compromised. Ultimately, the home oxygen community hopes to work with policymakers to develop thoughtful, comprehensive reforms of Medicare policies that protect patient access to quality oxygen care.

"We want all patients to have complete access to all services related to their home oxygen care, throughout their entire period of medical need," added Kelly. "With more than one quarter of home oxygen beneficiaries requiring oxygen for more than 36-months, the impact of the cap, coupled with the dramatic 9.5 percent cut, is going to resonate throughout the oxygen community. Although providers are working hard to prepare for the approaching payment changes, these cuts are simply unsustainable and may negatively impact beneficiary care."

The Council for Quality Respiratory Care is an alliance of the nation's leading home oxygen therapy providers and manufacturers, representing nearly one half of the 1.5 million Medicare beneficiaries who depend on the home oxygen benefit for independence and quality of life.

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FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants

The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.

Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas. Multiple myeloma is cancer of the plasma cell, a cell in the bone marrow that produces antibodies to help fight infection and disease. Non-Hodgkin lymphomas are a diverse group of blood cell cancers derived from lymphocytes, a type of white blood cell.

Prior to receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis in which blood stem cells are collected and stored for reinfusion after therapy. G-CSF is commonly administered to help release and collect stem cells from the bone marrow. Mozobil is an injectable drug that, when used in combination with G-CSF, boosts the number of stem cells released from the bone marrow into the blood stream.

"Collecting the millions of cells needed for a bone marrow transplant can take hours or days," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA. "Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy."

In two randomized clinical trials – one in patients with non-Hodgkin’s lymphoma, the other with multiple myeloma – Mozobil combined with G-CSF increased the number of stem cells available for collection and transplantation compared with patients receiving G-CSF alone.

The most commonly reported adverse reactions in these trials and other smaller studies were diarrhea, nausea, fatigue, injection site reactions, headaches, joint pain, dizziness and vomiting.

Mozobil is manufactured by Genzyme Corp., Cambridge, Mass.

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One-Day Breast Cancer Treatment Saves Lives in Less Time

(ARA) – For many patients, a cancer diagnosis is no longer a fatal one. However, the comfort that a patient’s condition is treatable is often accompanied by dread of the grueling treatment that will be needed to save his or her life. But a new therapy holds hope for treating some cancers in just a single day, rather than through months of harsh radiation therapy.

Arleen Sharwell, 65, a New York resident and mother of two, was among the millions of women who received a diagnosis of breast cancer last year. After the initial shock of the diagnosis, Sharwell discussed her treatment options with her breast surgeon on Long Island. They settled on a lumpectomy surgery followed by five to six weeks of traditional radiation therapy.

Through a family connection, Sharwell learned of a procedure that can eliminate weeks of costly, physically demanding post-operative radiation treatment. The procedure, known as intraoperative electron beam radiation therapy, uses a device called the Mobetron, from IntraOp Medical (www.intraopmedical.com), to deliver a single dose of radiation at the time of surgery. Because the procedure applies the radiation directly to the cancer-affected area, treatment times are shorter, recovery is faster, side effects are fewer and cosmetic results are better than those often experience by patients who go through traditional radiation treatment.

Recent clinical studies, including one from renowned breast surgeon Dr. Umberto Veronesi of Milan’s European Institute of Oncology, have shown that a single dose of radiation at the time of surgery could be equivalent to a full six-week course of traditional post-operative radiation treatment. This treatment is being widely adopted in many international health centers, as it provides a cost-effective way to treat breast cancer, while offering patients better quality of life.

After researching the Mobetron and the single dose treatment, Sharwell passed the information to her doctor. She assumed her doctor would take an active role in helping her to connect with a hospital that offered the treatment, but Arleen’s doctor was uninterested in hearing about the Mobetron. More than that, he openly questioned its effectiveness. “Arleen,” he said, “We have better things here.”

Sharwell turned to Dr. David Ollila from the University of North Carolina in Chapel Hill. She met with Ollila, associate professor and surgical director for the multi-disciplinary breast and multidisciplinary melanoma programs at UNC, and Dr. Joel Tepper, professor and former chair of radiation oncology, to see if she was a candidate for the device. They were quickly able to confirm that she was a candidate, and the doctors scheduled her surgery to be conducted just a few days after the initial meeting.

The day of her operation, Arleen arrived at the hospital at 7 a.m. and finished her surgery and two-minute single dose of radiation from the Mobetron that same day. Dr. Tepper delivered a single dose of radiation to the tumor bed, pinpointing the exact area that required radiation so that healthy tissue was left unharmed. Dr. Ollila then safely removed the lump from Sharwell’s breast.

Sharwell never imagined that she would be treated as an outpatient for breast cancer. “The next day my family came in for lunch and I was shopping in Chapel Hill. I felt fine,” she says.

“The Mobetron made what seemed to be a dreadful situation something that I could overcome,” Sharwell says. “I’ve been trying to get the word out so that other patients can benefit from this fast and remarkable treatment.” She is also impressed with the way her breast has healed since the surgery. “I couldn’t imagine going to a plastic surgeon and having it look any better.”

Sharwell says cancer patients should never just accept what their doctor tells them. They must conduct their own research -- and always get a second opinion.

Courtesy of ARAcontent