Mardil, Inc. Announces Positive Preliminary Results Of Pilot Study With BACE(TM) Device At Annual TCT Conference

Posted by admin on Septiembre 25th, 2009 under conferences Tags: ,  •  No Comments

Mardil, Inc. announced positive interim data from a pilot study investigating the safety and efficacy of its novel cardiac device BACE (Basal Annuloplasty of the Cardia Externally) in treating mitral valve regurgitation. The condition arises when the hearts mitral valve leaks blood backward into the heart, causing a range of severe and debilitating symptoms.

The first 11 patients implanted with BACE demonstrated a significant reduction in the severity grade of their mitral regurgitation, from a baseline mean grade of 3.32 to a mean grade of 0.61 post implantation, the data demonstrate. Mitral regurgitation severity is graded on a scale from 0 to 4, with 4 representing the most severe condition. The improvements in mitral valve function were sustained at 6 months, as demonstrated by followup echocardiograms conducted in the 3 of the 11 patients. No device related adverse events were reported.

Interim results of the 20patient pilot study were presented today at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

“While the data are preliminary, they represent a level of improvement that is extremely encouraging,” said Jai Raman, MD, PhD, professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago. “BACE represents a novel modality for treating functional mitral valve regurgitation because it addresses the root cause of the condition a heart muscle that is enlarged and weakened whereas current devices on the market attempt to replace or repair valves that are structurally normal.”

About the study

The pilot study of 20 patients was designed to assess the safety and efficacy of the BACE Device, a less invasive cardiac device that sits outside the heart and supports the weakened ventricular muscle while treating valvular dysfunction. Eleven patients with moderate to severe ischemic mitral regurgitation underwent implantation with BACE, along with coronary artery bypass grafting (CABG) on a beating heart; seven of them underwent surgery without a heartlung bypass machine. Three patients had left ventricular reconstructive procedures. One patient died of complications related to insertion of a mechanical support device that was placed preoperatively. No devicerelated adverse reactions were reported in the trial.

The pilot study is being conducted in India. Mardil is seeking an investigational device exemption (IDE) through the U.S. Food and Drug Administration to begin clinical trials in the U.S. next year.

About BACE

The BACE Device serves as a tension band that encircles the exterior of the heart, supporting the left ventricular wall and the mitral valve annulus. Gentle pressure and support from the BACE Device allow the leaflets of the mitral valve to close properly, thereby preventing blood from leaking backward when the heart pumps. BACE is the only device that can be adjusted and finetuned after implantation and in an office setting. The device was designed to reduce the significant mortality and morbidity rates associated with current treatments for mitral valve repair and replacement. The device sits outside the heart, negating the need for openheart surgery or the use of a heartlung bypass machine, both of which pose serious risks and side effects.

ABOUT MARDIL INC.

Mardil Inc. is a medical device company whose mission is to design, develop and market new and innovative patented technologies in the cardiac medical device field. The companys first product, BACE (Basal Annuloplasty of the Cardia Externally), is a minimally invasive device that treats functional mitral valve regurgitation. The device is currently undergoing human trials in India, and human trials in the U.S. are pending. Mardil Inc. has been largely funded by Ventureast, India, an early stage venture capital company based in Hyderabad with a focus on life sciences.

Everolimus-Eluting Stent Proves Signifcantly Safer, More Effective Than Paclitaxel-Eluting Stent In Patients With Coronary Artery Disease

Posted by admin on Septiembre 24th, 2009 under diabetes Tags: , ,  •  1 Comment

Latebreaking data from SPIRIT IV, a largescale multicenter study of nearly 4,000 patients in the U.S., shows that an everolimuseluting stent demonstrated enhanced safety and efficacy in the treatment of de novo native coronary artery lesions when compared to a paclitaxeleluting stent, and showed that “low late loss” may be achieved with drugeluting stents without sacrificing safety.

Unlike similar prior studies (SPIRIT FIRST, SPIRIT II and SPIRIT III), the SPIRITIV trial was powered for superiority for clinical endpoints without angiographic follow up.

The trial also examined the differences in performance of the two stents in patients with diabetes.

“The results with the everolimus stent demonstrate enhanced safety and efficacy compared to the paclitaxel stent in this largescale study without routine angiographic followup and sets a new standard for eventfree survival after [implantation of a drugeluting stent],” said principal investigator Gregg W. Stone, MD, immediate past chairman of CRF, professor of medicine at Columbia University Hospital and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYorkPresbyterian Hospital/Columbia University Medical Center.

Results of the study were presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

The primary endpoint of the trial was target lesion failure (TLF) at one year, a composite measure of cardiac death, target vessel heart attack or ischemiadriven target lesion revascularization (TLR). Major secondary endpoints of the trial were TLR at one year, and a composite of cardiac death or target vessel heart attack at one year.

For the everolimus stent, TLF at one year was 4.2 percent, and for the paclitaxeleluting stent, TLF was 6.8 percent, a significant 38 percent reduction.

At oneyear, ischemiadriven TLR was 2.5 percent for the everolimus stent and 4.6 percent for the paclitaxel stent, a significant 45 percent reduction.

The composite rates of cardiac death or target vessel myocardial infarction through one year were not statistically different with the 2 stents (2.2 percent for the everolimus stent and 3.2 percent for the paclitaxel stent). The rates of stent thrombosis, however, were significantly reduced with the everolimus stent compared to the paclitaxeleluting stent (0.3 percent vs. 1.1 percent respectively).

The results were consistent regardless of lesion length, vessel size and the number of lesions treated. However, in the diabeticpatient subgroup, the study found a comparable rate of TLF with both stents, whereas in patients without diabetes, the everolimus stent reduced TLF by 53 percent compared to the paclitaxeleluting stent.

“Outcomes in patients with diabetes may still be improved, and should represent an area of focus for future development of novel drugs and enhanced stent design,” Dr. Stone said.

Source
Judy Romero

NIH, NephCure Foundation And University Of Michigan Support Study Of Nephrotic Syndrome

Posted by admin on Septiembre 24th, 2009 under urology nephrology Tags: , ,  •  No Comments

University of Michigan Health System researchers will lead a $10.25 million effort to study rare kidney diseases that cause kidney failure and the need for dialysis.

The fiveyear project supports research of nephrotic syndrome, which describes a group of diseases that, though rare, generates an enormous individual and societal burden. The syndrome, which affects kidney filter cells, contributes to nearly 12 percent of cases of kidney failure, and an annual cost of more than $3 billion.

The Nephrotic Syndrome Rare Disease Consortium will bring together a network of investigators from the United States and Canada, and two highly active patient interest groups, the Nephcure Foundation and the Halpin Foundation, to create a network for collecting patient information, facilitating clinical and observational studies and training future researchers.

The National Institutes of Health Office of Rare Diseases, the National Institutes of Diabetes, Digestive and Kidney Disease awarded a $6.25 million grant to the UM, with NephCure committing $2 million and UM contributing a total of $2 million.

NephCure, a Pennsylvaniabased patient advocacy and research funding organization, will continue to have a role in recruiting and educating patients. NephCure has contributed more than $6 million to research over the past several years.

“The kidney community has had a strong interest in this work for a long time, but, until now, we have not had adequate funding for a coordinated effort,” says project director Matthias Kretzler, M.D., professor of internal medicine at the UM Medical School and a nephrologist at the UM Health system.

“This has the potential to change the way we understand and treat patients with nephrotic syndrome,” he says. “NephCures support was critically important in winning this award and will be vital to our long term success.”

Kretzler, along with UM medical school researchers Akinlolu Ojo, M.D., Ph.D., professor in internal medicine, and Lawrence B. Holzman, M.D., professor of internal medicine, will provide the leadership for the multicenter consortium.

“As a premier research institution, were wellpositioned to take advantage of a rapidly expanding knowledge of genetics and the power of bioinformatics to transform our understanding and treatment of rare diseases,” says James Shayman, M.D., associate vice president for research at the University of Michigan.

“We recognize that combining our own institutional resources with those of the NIH and NephCure Foundation creates a unique opportunity for promoting rare disease research in nephrotic syndrome,” he says.

A seed grant from the universitys Office of the Vice President for Research Rare Disease Initiative was instrumental in securing funding for the new consortium.

While the UM will function as the central operational hub, clinical investigators from 11 academic medical centers will make up the research team.

One of the joint initiatives will be to establish and maintain a Web site with educational and networking resources for patients, families, physicians and scientists.

Researchers will investigate minimal change disease, focal and segmental glomerulosclerosis, and membranous nephropathy, diseases known to damage kidney filter cells and can lead to kidney failure and death.

Some types of the syndrome are hereditary, but it can also manifest later in life for reasons largely unknown. The network will use molecular medicine tools to unravel the mechanism responsible for the diseases and potentially develop new targeted treatment therapies.

Source
Shantell M. Kirkendoll
University of Michigan Health System

Highlights From The John Theurer Cancer Center And Leukemia And Lymphoma Society

Posted by admin on Septiembre 23rd, 2009 under conferences Tags: ,  •  No Comments

Oncology experts from leading cancer organizations from around the country, including the John Theurer Cancer Center, MD Anderson Cancer Center, the Mayo Clinic, Dana Farber Cancer Institute and the National Cancer Institute, will discuss trends in patient care, novel therapies through clinical trials and emerging concepts in the management of hematological malignancies. Key topics include chronic lymphocytic leukemia, the role of molecular biomarkers in diffuse large bcell lymphoma, follicular lymphoma, management of multiple myeloma and immunomodulation and hematopoietic stem cell transplant.

Featured Speakers Andre Goy, M.D. Deputy Director, John Theurer Cancer Center, Chief, Division of Lymphoma; Director, Cancer Research

Susan OBrien, M.D. MD Anderson Cancer Center; Professor, Department of Leukemia, Division of Cancer Medicine

Wyndham Wilson, M.D., Ph.D. National Cancer Institute, Chief, Lymphoma Therapeutics, Metabolic Branch, Center for Cancer Research

Carol Portlock, M.D. Memorial SloaneKettering Cancer Center, Professor of Medicine, Attending Physician of Lymphoma

Rafael Fonseca, M.D. Mayo Clinic, Professor of Medicine, Deputy Director of Mayo Clinic Cancer Center

Robert J. Soiffer, M.D. Dana Farber Cancer Institute, Harvard Medical Professor of Medicine, Harvard Medical School, Chief Division of Blood Centers This conference is open to the public, but directed primarily for medical oncologists and hematologists, as well as other healthcare professionals in the oncology field who are interested in the treatment of cancer. The conference will be held from 8 am to 230 pm in the Hekemian Conference Center Auditorium located at Hackensack University Medical Center, 30 Prospect Ave., Hackensack, New Jersey.

Source
David Marisol

Neuroscience Discredits Coercive Interrogation

Posted by admin on Septiembre 22nd, 2009 under Anxiety Tags: ,  •  No Comments

According to a new review of neuroscientific research, coercive interrogation techniques used during the Bush administration to extract information from terrorist suspects are likely to have been unsuccessful and may have had many unintended negative effects on the suspects memory and brain functions. A new article, published by Cell Press on September 21st in the journal, Trends in Cognitive Science, reviews scientific evidence demonstrating that repeated and extreme stress and anxiety have a detrimental influence on brain functions related to memory.

Memos released by the US Department of Justice in April of 2009 detailing coercive interrogation techniques suggest that prolonged periods of shock, stress, anxiety, disorientation and lack of control are more effective than standard interrogatory techniques in making subjects reveal truthful information from memory. “This is based on the assumption that subjects will be motivated to reveal veridical information to end interrogation, and that extreme stress, shock and anxiety do not impact memory” says review author, Professor Shane OMara from the Institute of Neuroscience at Trinity College in Dublin, Ireland. “However, this model of the impact of extreme stress on memory and the brain is utterly unsupported by scientific evidence.”

Psychological studies suggest that during extreme stress and anxiety, the captive will be conditioned to associate speaking with periods of safety. For the captor, when the captive speaks, the objective of gaining information will have been obtained and there will be relief from the unsavory task of administering these conditions of stress. Therefore, it is difficult or impossible to determine during the interrogation whether the captive is revealing truthful information or just talking to escape the torture. Research has also shown that extreme stress has a deleterious effect on the frontal lobe and is associated with the production of false memories.

Neurochemical studies have revealed that the hippocampus and prefrontal cortex, brain regions integral to the process of memory, are rich in receptors for hormones that are activated by stress and sleep deprivation and which have been shown to have deleterious effects on memory. “To briefly summarize a vast, complex literature, prolonged and extreme stress inhibits the biological processes believed to support memory in the brain,” says OMara. “For example, studies of extreme stress with Special Forces Soldiers have found that recall of previouslylearned information was impaired after stress occurred.” Waterboarding in particular is an extreme stressor and has the potential to elicit widespread stressinduced changes in the brain.

“Given our current cognitive neurobiological knowledge, it is unlikely that coercive interrogations involving extreme stress will facilitate release of truthful information from long term memory,” concludes Professor OMara. “On the contrary, these techniques cause severe, repeated and prolonged stress, which compromises brain tissue supporting both memory and decision making.”

OMara et al. “Torturing the Brain On the folk psychology and folk neurobiology motivating enhanced and coercive interrogation techniques.”

Source
Cathleen Genova

Biotech Innovation Could Extend Dosing Intervals, Simplify Production

Posted by admin on Septiembre 21st, 2009 under pharma industry Tags: ,  •  No Comments

Many biopharmaceuticals comprise small proteins that are quickly eliminated from the body. Scientists at the Technische Universitaet Muenchen (TUM) combine such small proteins with a kind of molecular balloon that swells and thus prolongs the halflife of the proteins in the body. The TUM spinoff XLProtein GmbH has now started to further develop this new technology with blockbuster potential.

People who suffer from hepatitis B are often treated with the tissue hormone interferon. However, there is a problem Interferon is a very small protein, which is filtered from the blood via the kidneys after only a short time. For the patient this means a highdose injection every other day to keep the effect of the substance from wearing off prematurely.

However, interferon stays in the body much longer when chemically coupled with a synthetic PEG (polyethylene glycol) molecule. PEG is a random coil longchain polymer string that swells by adsorbing water. That way the PEG molecule becomes large enough that it does not fit through the fine pores of the kidneys the attached interferon remains in the circulatory system longer, and the patient will need an injection only every one to two weeks.

Using genetic engineering, TU Muenchen scientist Prof. Arne Skerra and his coworkers from the Chair of Biological Chemistry at the Center for Life and Food Sciences Weihenstephan have now developed an amino acid string that tangles up similarly to PEG and also swells in the presence of water. However, unlike many PEG compounds, there is no danger of this biological polymer accumulating in the body. In fact over an extended period of time it is discharged or biologically broken down. That happens because this amino acid string (polypeptide) consists of three of the 20 naturally occurring amino acids proline, alanine and serine, or in short, PAS.

The protein substance interferon, which itself consists of amino acids, can thus be easily generated in “PASylated” form. In first trials with animals, TUM scientists established that PASyated interferon has a halflife in the blood that is prolonged by a factor of 60, which should allow a significant extension of dosing intervals during medicinal therapy.

A further advantage is the simplified biotechnological production The DNA segments carrying the information for the PAS amino acid sequence and for the interferon can simply be attached to each other and then, for instance, used for transforming bacteria. The bacteria then produce the PASylated interferon in one piece, thus making much fewer production steps necessary in comparison with the chemical coupling of PEG. According to Skerra, “this will lead to a significant drop in production cost.”

In principle all small proteins currently used as medication or in development in pharmaceutical companies for example, growth factors or functional antibody fragments can be PASylated. Thus there could be a huge market for the new technology. Consequently, Prof. Skerra and his team initiated the founding of a new biotech company, XLProtein GmbH, which started its operations last spring. “Our technology has the potential to give birth to a whole new generation of blockbuster medications,” the TUM biochemist is convinced. Several of the new drugs are already at an advanced stage of preclinical development.

Source
Patrick Regan

Health Care Costs Driven Significantly Higher By Metabolic Syndrome Risk Factors

Posted by admin on Septiembre 19th, 2009 under diabetes Tags: ,  •  No Comments

Risk factors for metabolic syndrome, such as obesity, high blood pressure, and elevated blood lipid levels, can increase a persons healthcare costs nearly 1.6fold, or about $2,000 per year. For each additional risk factor those costs rise an average of 24%, according to an illuminating article in a recent issue of Metabolic Syndrome and Related Disorders, a peerreviewed journal published by Mary Ann Liebert, Inc. The article is available free online at liebertpub.com/met

A twoyear study that compared annual healthcare costs for people with and without diabetes found both higher healthcare utilization and significantly greater expenses ($5,732 versus $3,581 per year) for those who had risk factors for metabolic syndrome. A group of researchers from the Center for Health Studies (Seattle, WA); United BioSource Corp. (Bethesda, MD); University of Arizona, Tucson; Kaiser Permanentes Colorado Clinical Research Unit in Denver and Northwest Center for Health Research in Portland, Oregon; Genzyme (Cambridge, MA); and SanofiAventis (Bridgewater, NJ), led by D.M. Boudreau, PhD, from United BioSource, evaluated healthcare utilization among more than 170,000 men and women, approximately 58% of whom had risk factors for metabolic syndrome.

The study, entitled “Health Care Utilization and Costs by Metabolic Syndrome Risk Factors,” also compared the annual healthcare costs for subjects who had both diabetes and metabolic syndrome risk factors and found them to be nearly double the costs for people who did not have diabetes but had similar risk factors for metabolic syndrome ($8,067 vs. $4,638).

“This important study clearly brings home the enormous economic burden that the metabolic syndrome extracts in a very large sample. Future studies should be directed at targeting the dyslipidemia, hypertension, etc., to see what the savings would be with respect to complications and economic burden,” says Ishwarlal (Kenny) Jialal, MD, PhD, EditorinChief of the Journal and Robert E. Stowell Endowed Chair in Experimental Pathology, Director of the Laboratory for Atherosclerosis and Metabolic Research, and Professor of Internal Medicine at the University of California, Davis Medical Center, in Sacramento, CA.

Source
Vicki Cohn

It Pays To Be Careful Post Kidney Transplant

Posted by admin on Septiembre 18th, 2009 under urology nephrology Tags: , ,  •  No Comments

For kidney transplant recipients, infection with a virus called cytomegalovirus (CMV) may lead to devastating complications. New research suggests that extending the period of preventive treatment after kidney transplantation can reduce the risk of CMV disease, according to an upcoming report in the Journal of the American Society of Nephrology (JASN).

Cytomegalovirus is a common virus that is present in many healthy people, rarely causing any problems. However, in kidney transplant patients and others with reduced immune function, CMV infection can cause serious disease. Cytomegalovirus is one of the most common “opportunistic” infections that occur posttransplant. Although CMV infection can happen anytime, most cases occur soon after the end of preventive treatment. Complications related to CMV not only affect the outcome of kidney transplantation but also increase financial costs.

Fu Luan, MD (University of Michigan, Ann Arbor) and colleagues compared three months versus six months of treatment with an antiviral drug (valganciclovir) used to prevent CMV after kidney transplantation. In a retrospective analysis of 222 kidney transplant patients, those receiving six months of valganciclovir preventive treatment had a lower rate of CMVrelated disease, about 12 percent, as compared to 24 percent with the threemonth treatment period. With adjustment for other factors, six months of preventive therapy reduced the risk of CMV disease by nearly two thirds.

On comparing costs versus benefits, the researchers found that the extended period of preventive therapy was a costeffective treatment. Although longer treatment with valganciclovir was expensive, the cost was largely offset by reducing the number of patients with CMV disease, thus averting its longterm adverse consequences.

The researchers hope their study will trigger interest among kidney transplant professionals in evaluating the longterm consequences and costeffectiveness of the specific treatments they provide. “At the same time, we hope that additional studies will be done to further reduce CMV infection and disease in kidney transplant patients,” says Luan.

The study had some important limitations. Because it was a retrospective analysis, the ability to compare the outcomes of these treatments was limited. In addition, the assumptions made in costeffectiveness study may be limited by the available literature.

The authors reported no financial disclosures. Other authors were Linda J. Stuckey, PharmD, Jeong M. Park, PharmD, Daniel Kaul, MD, Diane Cibrik, MD, and Akinlolu Ojo, MD, all of University of Michigan.

The American Society of Nephrology (ASN) does not offer medical advice. All content in ASN publications is for informational purposes only, and is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This content should not be used during a medical emergency or for the diagnosis or treatment of any medical condition. Please consult your doctor or other qualified health care provider if you have any questions about a medical condition, or before taking any drug, changing your diet or commencing or discontinuing any course of treatment. Do not ignore or delay obtaining professional medical advice because of information accessed through ASN. Call 911 or your doctor for all medical emergencies.

Founded in 1966, ASN is the worlds largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its worldrenowned meetings and firstclass publications, disseminates information and educational tools that empower physicians.

Source American Society of Nephrology (ASN)

Beth Israel Deaconess Medical Center Awarded $11.5 Million To Research Kidney Cancer

Posted by admin on Septiembre 17th, 2009 under urology nephrology Tags: , ,  •  No Comments

The National Cancer Institute (NCI) has awarded Beth Israel Deaconess Medical Center (BIDMC) an $11.5 million, fiveyear SPORE grant to focus on cancers of the kidney. Michael Atkins, MD, Deputy Director of BIDMCs Division of Hematology/Oncology, will oversee the grant, which involves collaborations with Brigham and Womens Hospital, DanaFarber Cancer Institute, and Massachusetts General Hospital via the DanaFarber/Harvard Cancer Center.

As the only NCIfunded SPORE focused on cancers of the kidney, this grant aims to improve detection, diagnosis, treatment and prevention of kidney cancer, which affects about 54,000 Americans each year and causes approximately 14,000 deaths. SPORE grants (Specialized Program of Research Excellence) are designed to promote interdisciplinary and translational research that rapidly moves scientific discoveries to a clinical setting to directly benefit patients. This grant is a renewal of a previous $13.3 million kidney cancer SPORE awarded to Atkins and his team of collaborators in 2003.

“This renewed support enables our team to maintain the momentum that was established over the past five years and continue to make tremendous progress in our research. Being the only kidney cancer SPORE, we have an opportunity and a responsibility to lead the effort to develop better approaches to detect and treat cancers of the kidney,” says Atkins, who also directs the Cutaneous Oncology and Biologic Therapy programs and the Cancer Clinical Trials Office in BIDMCs Division of Hematology/Oncology.

“The renewal of our SPORE grant is validation from the NCI that the past five years of funding were productive and that our proposals for future research are also highly meritorious,” he adds.

This grant, awarded in August 2009 and again headquartered at BIDMC, includes five main projects which are supported by three cores. Each project is jointly directed by a team comprising both basic scientists and clinical investigators, all of whom are members of the Kidney Cancer Program of the DanaFarber/Harvard Cancer Center (DFHCC). The Kidney Cancer Program encompasses research that spans from the basic laboratory to the clinic, from pediatric to adult cancers, and from detection and diagnosis to selection of appropriate treatment. Atkins, who also leads this DFHCC program, describes the SPORE as its “translational engine,” with much of the new work building upon groundbreaking discoveries made during the previous SPORE, including several early phase clinical trials testing novel approaches for the treatment of specific types of kidney tumors.

“The SPORE can be viewed as an evolving process in which projects examine promising laboratory discoveries in progressively more applied settings, eventually moving those approaches that are most likely to impact disease management into definitive clinical trials to be conducted within the Kidney Cancer Program,” explains Atkins.

During the fiveyear term of the SPORE, Atkins and colleagues will work to improve the understanding and treatment of kidney cancer that is resistant to standard therapies; to identify biomarkers for the purposes of early diagnosis, monitoring, and predicting treatment outcome; and to use the growing understanding of kidney cancer biology to develop novel immune and targeted therapies that improve the outcome of patients with advanced disease.

The SPOREs five research projects are Clinical Correlations of WTX Inactivation in Wilms Tumor, led by Daniel Haber, MD, PhD, and Miguel Rivera, MD, of Massachusetts General Hospital;

Targeting of HIF2α with siRNA, led by William Kaelin, MD, and Toni Choueiri, MD, of DanaFarber Cancer Institute (DFCI) and Sabina Signoretti, MD, of Brigham and Womens Hospital;

Acquired Resistance to VEGF Receptor Blockade Underlying Mechanisms and Therapeutic Options, led by Nahum Goldberg, MD, James Mier, MD, and Michael Atkins, all of BIDMC;

Targeting the PI3Kinase/Akt Pathway in RCC led by James Mier and David McDermott, MD, of BIDMC;

Adoptive Immunotherapy for Renal Carcinoma Using Dendritic Cell/tumor Fusions, led by David Avigan, MD, of BIDMC and Donald Kufe, MD, of DFCI. Source
Bonnie Prescott

Merz Pharmaceuticals Belotero(R) Balance PMA Filing Formally Accepted For Review By The FDA

Posted by admin on Septiembre 16th, 2009 under dermatology Tags: ,  •  No Comments

Merz Pharmaceuticals, LLC, a leading specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review Merzs premarket approval (PMA) application for Belotero(R) Balance.

Belotero(R) Balance is a hyaluronic acid based monophasic gel dermal filler that utilizes a cohesive polydensified matrix (CPM(TM)) technology. This application seeks FDA approval for injection into midtodeep dermis for correction of moderate to severe wrinkles and folds.

“The FDAs acceptance for review of the Belotero(R) Balance PMA begins the application review process and signifies the beginning of Merz Pharmaceuticals firm footprint in the American aesthetics market,” said Jack Britts, president and CEO of Merz Pharmaceuticals, LLC.

“Upon approval, Belotero(R) Balance will be an exciting addition to the dermal filler category,” said Dr. Rhoda S. Narins, M.D., the lead investigator for the Belotero(R) clinical trials.

About Belotero(R)

First launched in Germany in 2005, Belotero(R) is also approved for aesthetic use in the United Kingdom, Italy, Russia, Austria and Switzerland.

About Merz Pharmaceuticals

Merz Pharmaceuticals, LLC, a wholly owned, U.S. subsidiary of the Merz Group of Companies was established in 1995 and develops and commercializes prescription products for Neurology, Dermatology, Podiatry and the #1 nonprescription product for scars, Mederma.

With a 101 year heritage, Merz (KGaA) is known worldwide for its development of original compounds and formulations for medical professionals and consumers in 90 countries. Globally, Merz is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders as well as for aesthetic medicine, including products for the treatment of wrinkles and aging skin, hair loss and acne. Research is concentrated in fields that have a strong need for therapeutic innovation such as Alzheimers disease, Parkinsons disease, tinnitus, chronic pain conditions, addictions, and neuromuscular disturbances.

Source Merz Pharmaceuticals, LLC