National Tinnitus Week 9-15 February 2009, UK
With National Tinnitus Week approaching, I wanted to write to highlight the vital work of the British Tinnitus Association (BTA) – and shed a light on the unseen suffering that people with the condition experience.
As a supporter of the BTA, I’m often contacted by others with tinnitus. One of the common problems they mention is how much their condition affects them at night. This has now been confirmed in a new survey by the BTA. According to the results, almost 65% of sufferers surveyed found their tinnitus bothered them most at this time . While most people find quiet helps them sleep, tinnitus sufferers experience the opposite – that their ‘tinnitus noise’ becomes more noticeable. They then become more alert and agitated, which in turn stops them from sleeping.
You can easily imagine how this begins to take its toll. Serious sleep deprivation makes people miserable and, over time, more prone to illness.
You might be amazed to learn that there are literally millions of tinnitus sufferers in the UK. Needless to say, everyone of them needs help. The tragedy is that, all too often, they don’t know where to turn. That’s where National Tinnitus Week comes in. From 9 to 15 February, the British Tinnitus Association (BTA) will be highlighting their work so sufferers know there’s a charity dedicated to them – one that provides information, advice and support and promotes the crucial message that people can learn to live with tinnitus, as I have.
In the meantime, I urge all tinnitus sufferers in need of support to contact the BTA. You can call them free on 0800 018 0527 or visit their website http://www.tinnitus.org.uk. The message is clear – there’s help out there!
British Tinnitus Association
Higher Blood Glucose Linked To Lower Cognitive Function
A sub-study of a trial looking at the effect of diabetes on heart disease risk found that higher levels of hemoglobin A1C levels (a
measure of a person’s average blood glucose over a 2 to 3 month period) were linked to lower cognitive function.
The research was published online in the peer-reviewed journal of the American Diabetes Association, Diabetes Care on 26 January, and is
part of the ongoing Memory in Diabetes (MIND) study, a sub-study of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
Previous studies have suggested that people with diabetes have a 1.5 times higher chance of experiencing cognitive declien and dementia than people
that don’t have diabetes: the results from this MIND research suggests diabetes may be linked with mild cognitive impairment.
Lead investigator Dr Tali Cukierman-Yaffe, who is from the Gertner Institute for Epidemiology and Health Policy Research, Endocrinology Institute
at Sheba Medical Center and Sackler School of Medicine at Tel-Aviv University in Israel, said:
“Even a mild impairment in cognitive function is of concern for people with type 2 diabetes.”
The overall ACCORD-MIND study is looking at whether the rate of structural brain change and cognitive decline in 2,800 people with diabetes
differes according to whether they get standard care or intensive care.
We should note that the results that are published in this paper are from a cross-sectional view of the data: that is the links they found don’t tell you if
the higher blood glucose is responsible for the lower cognitive function or whether somehow, cognitive impairment decreases the body’s ability to
control blood sugar, or it may even be a third, yet undiscovered factor that links the two.
Such a causal link can only be established by following study patients over a period of time and testing them at intervals during the trial. That is the
plan with the ongoing ACCORD-MIND study, where one of the ideas being tested is whether lowering A1C improves cognitive function.
Meanwhile, in these interim results, the researchers found that poorer performance in three cognitive tasks that tested memory, speed and multi-tasking
skills, and a lower score on an overall test of cognitive function, were all linked to higher levels of A1C hemoglobin.
The tests they used were: the Digit Symbol Substitution Test (DSST), Mini Mental Status Examination (MMSE), Rey Auditory Verbal Learning Test,
and the Stroop Test.
The results showed:
- A statistically significant link between A1C and all 4 tests, even after adjusting for age.
- Specifically, the results were: 1 per cent higher A1C linked to significant 1.75 decrease in DSST score; 0.20 lower MMSE score; 0.11 lower
memory score; and 0.75 s or more (ie worse) score on the Stroop Test.
- The link between the DSST score and A1C persisted through all the statistical models they ran.
- The researchers also measured fasting plasma glucose, but this did not show any links with test results.
The researchers concluded that:
“Higher A1C levels are associated with lower cognitive function in individuals with diabetes.”
“The effect of glucose lowering on cognitive function will be determined by the ongoing ACCORD-MIND trial,” they added.
“Relationship Between Baseline Glycemic Control and Cognitive Function in Individuals With Type 2 Diabetes and Other Cardiovascular
Risk Factors: The Action to Control Cardiovascular Risk in Diabetes-Memory in Diabetes (ACCORD-MIND) trial.”
Tali Cukierman-Yaffe, Hertzel C. Gerstein, Jeff D. Williamson, Ronald M. Lazar, Laura Lovato, Michael E. Miller, Laura H. Coker, Anne Murray,
Mark D. Sullivan, Santica M. Marcovina, Lenore J. Launer for the Action to Control Cardiovascular Risk in Diabetes-Memory in Diabetes
(ACCORD-MIND) Investigators.
Diabetes Care 32: 221-226, 2009
DOI: 10.2337/dc08-1153
Click here for Abstract.
Sources: Journal Abstract, American Diabetes Association press release.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Savient Announces FDA’s Advisory Panel To Review Pegloticase For Treatment Failure Gout Patients
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that its biologics license application (BLA) for pegloticase for treatment-failure gout will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on March 5, 2009 as required for a drug of a new therapeutic class.
Savient submitted its BLA to the FDA on October 31, 2008 seeking approval to market pegloticase in the United States. On December 29, 2008, the FDA accepted the BLA filing for review and granted priority review. A priority review is an FDA designation that is assigned to products that if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under priority review, the target date for an FDA decision on the pegloticase BLA is April 30, 2009.
Savient’s filing includes data from both the six-month placebo-controlled Phase 3 pivotal trials, as well as data from the open label extension (OLE) study. The two replicate six-month Phase 3 clinical trials for pegloticase were performed under the auspices of a Special Protocol Assessment (SPA) (2006). Pegloticase was granted orphan drug designation by the FDA in 2001.
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a biopharmaceutical company engaged in developing and distributing pharmaceutical products that target unmet medical needs in both niche and broader markets. The Company’s product development candidate, pegloticase for treatment-failure gout, has reported positive Phase 1, 2 and 3 clinical data. Patient dosing in the Phase 3 clinical studies began in June 2006; patient enrollment was completed in March 2007; and the Phase 3 clinical studies were completed in October 2007 and the BLA was filed with the FDA in October 2008. Savient has exclusively licensed worldwide rights to the technology related to pegloticase, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient’s experienced management team is committed to advancing its pipeline and expanding its product portfolio by in-licensing late-stage compounds and exploring co-promotion and co-development opportunities that fit the Company’s expertise in specialty pharmaceuticals and biopharmaceuticals with an initial focus in rheumatology. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc. Further information on Savient can be accessed by visiting: http://www.savient.com.
FORWARD LOOKING LANGUAGE
All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will” and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the efficacy and safety of pegloticase, our BLA filing with the FDA, the Advisory Committee, approval of the BLA, preparation for commercialization of pegloticase, and the market for pegloticase, are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, our Phase 3 clinical data and on current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, the delay or failure in completing development of pegloticase and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and CMC data by the FDA; delay achieving or failure to achieve FDA approval of pegloticase; inability to manufacture commercial quantities of our products; inability to gain market acceptance sufficient to justify development and commercialization costs if our products are approved for marketing; our continuing to incur substantial net losses for the foreseeable future; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; reliance on third parties to manufacture, market and distribute many of our products; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in ongoing or future intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements which speak only as of the date of publication of this press release to shareholders. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.
Savient Pharmaceuticals, Inc.
http://www.savient.com
Boston Scientific Announces Japanese Approval For TAXUS(R) Liberte(R) Drug-Eluting Stent System
Boston Scientific Corporation (NYSE: BSX) announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its TAXUS(R) Liberte(R) Paclitaxel-Eluting Coronary Stent System. The Company plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.
TAXUS Liberte is the only second-generation drug-eluting stent approved for use in Japan. Design improvements over the Company’s first-generation TAXUS(R) Express2(TM) Stent include thinner struts to allow better stent deliverability and conformability, as well as a more uniform stent geometry for consistent lesion coverage and drug distribution.
“The TAXUS Liberte Stent is the latest advance in drug-eluting stent technology for Japan,” said Donald Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. “Its safety and efficacy have been well demonstrated in multiple clinical studies and years of clinical use.”
“We are very pleased with this approval, which provides access to proven technology to Japanese physicians and their patients,” said Jim Tobin, President and Chief Executive Officer of Boston Scientific. “We are committed to continuing to provide the most innovative products and therapies to the Japanese market.”
The TAXUS Liberte Stent uses proven paclitaxel-eluting technology, which has been evaluated by the industry’s most extensive randomized, controlled clinical trial program, and studied in 35,000 real-world patients enrolled in post-approval registries. More than 4.6 million TAXUS Stent Systems have been implanted globally.
The TAXUS Liberte Stent will replace the TAXUS Express2 Stent, which was launched in Japan in May 2007. It has been approved for sale in the United States, Europe and other international markets.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward- looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
Boston Scientific Corporation
http://www.bostonscientific.com
New Data Published In Immunobiology Describe Mode Of Action Of BiTE Antibody MT110
Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, announced publication of new data in the peer-reviewed journal Immunobiology describing in detail the mode of action of BiTE antibody MT110. MT110 is a T cell-engaging antibody that targets EpCAM, which is expressed with high frequency on most human adenocarcinoma.
Data from the new publication(1) demonstrate that when T cells are connected to cancer cells by MT110, they deliver two kinds of toxic proteins into cancer cells. One toxic protein, perforin, forms holes in the cancer cell’s outer membrane. The second kind of protein, granzymes, is a family of proteolytic enzymes that triggers the self-destruction of the cancer cell, a process called programmed cell death or apoptosis. Very low amounts of MT110 were also found to increase the level of toxic proteins in T cells during cancer cell lysis, which is necessary for BiTE antibody-activated T cells to adopt a serial cancer cell-killing mode during which these toxic proteins are steadily consumed.
“Our new data explain the high anti-tumor activity of MT110 that we have seen in preclinical models, and that we have also observed with BiTE antibody blinatumomab in phase 1 and 2 clinical trials,” commented Micromet’s Chief Scientific Officer Dr. Patrick A. Baeuerle. “The mechanism of action of MT110 described in this study is expected to be identical for BiTE antibodies targeting other surface targets, and shows that this new class of antibody therapeutics has the potential to fully harness the power of T cells, the body’s most potent immune cells, against malignant cells.”
MT110 is the second BiTE antibody in clinical development and is currently in a phase 1 clinical trial for the treatment of patients with colorectal, gastric or lung cancers. Phase 1 and 2 clinical trials are also under way for the BiTE antibody blinatumomab (MT103, MEDI-538) in patients with non-Hodgkin’s lymphoma and acute B-lymphoblastic leukemia. Updates for these two clinical trials were presented in December of 2008 at the Annual Meeting of the American Society for Hematology (ASH) in San Francisco.
About BiTE Antibodies
BiTE(R) antibodies are designed to direct the body’s cytotoxic, or cell- destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. Previous attempts have shown the potential of T cells to treat cancer, but the therapeutic approaches tested to date have been hampered by cancer cells’ ability to escape recognition by T cells. The use of BiTE antibodies that are specifically designed to engage T cells for attacking cancer cells may provide a more effective anti-tumor approach than conventional monoclonal antibodies.
About Micromet, Inc.
Micromet, Inc. (http://www.micromet-inc.com) is a biopharmaceutical company with offices in Bethesda, Maryland and Munich, Germany. The Company is developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. The Company uses its proprietary BiTE(R) antibody platform to create a new class of antibodies that specifically activate T cells from the patient’s own immune system to eliminate cancer cells or other disease-related cells. Four of the Company’s antibodies are currently in clinical trials, with the remainder of its product pipeline in preclinical development. The Company’s lead program is a BiTE antibody known as blinatumomab, or MT103. It is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical trial for the treatment of patients with non-Hodgkin’s lymphoma. Micromet is developing blinatumomab in collaboration with MedImmune, a subsidiary of AstraZeneca plc. Micromet’s second BiTE antibody in clinical development is MT110, which targets the epithelial cell adhesion molecule (EpCAM). The Company owns all rights to MT110, which is currently in a phase 1 clinical trial for the treatment of patients with solid tumors. The Company’s third clinical stage antibody is adecatumumab, also known as MT201, a conventional human monoclonal antibody that targets EpCAM-expressing solid tumors. Micromet is developing adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial evaluating adecatumumab in combination with docetaxel for the treatment of patients with metastatic breast cancer. Micromet has licensed a fourth clinical stage antibody, MT293, to TRACON Pharmaceuticals, Inc. MT293 is being developed in a phase 1 clinical trial for the treatment of patients with cancer. The Company’s preclinical programs include MT203, which is being developed in collaboration with Nycomed. MT203 is a traditional human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Micromet has granted an exclusive option to Bayer Schering Pharma AG to license a BiTE antibody against an undisclosed solid tumor target. Additional BiTE antibodies, targeting CEA, CD33, Her2, EGFR and MCSP, respectively, are in different stages of preclinical development.
Forward Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the efficacy and intended utilization of our product candidates and the development of our BiTE antibody technology. You are urged to consider statements that include the words “may,” “potential,” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, and the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data. These factors and others are more fully discussed in Micromet’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2008, filed with the SEC on November 6, 2008, as well as other filings by the company with the SEC.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. Micromet, Inc. undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
(1) Haas C. et al. (2009). Mode of cytotoxic action of T cell-engaging BiTE antibody MT110. Immunobiology, published online on January 19; PubMed ID: 19157637
Micromet, Inc.
http://www.micromet-inc.com
Nurses To Congress: Expanding Medicare Could Reverse Job Losses, And Repair Our Broken Healthcare System And Safety Net
On a day in which Congress prepared to vote on the Obama administration’s proposed $800 billion economic stimulus package, the nation’s largest organization of registered nurses said expanding Medicare to cover all Americans would be one of the most effective economic recovery programs – and could virtually end the nation’s healthcare crisis overnight.
In a briefing for some 50 key Congressional staffers, the California Nurses Association/National Nurses Organizing Committee today presented the findings of a dramatic new study that documents that extending Medicare to everyone would create 2.6 million new jobs, and infuse $317 billion in new business and public revenues and another $100 billion in wages into the U.S. economy.
Adding all Americans to an expanded Medicare system could be achieved for $63 billion beyond the current $2.1 trillion in direct healthcare spending. The $63 billion is far less than the federal bailout for CitiGroup, and less than half the federal bailout for AIG. Solely expanding Medicare to cover all uninsured Americans could be accomplished for $44 billion, the study shows.
The study, which may be viewed at www.CalNurses.org, was presented as part of a briefing in the Rayburn House Office Building hosted by the Leadership Conference for Guaranteed Healthcare, a coalition of nurses, doctors, students, large community-based membership groups, labor unions, religious organizations, and activists who support HR 676, a single-payer, Medicare-for-all bill, soon to be reintroduced.
“Nurses see the broken system at the bedside, but we also know that a single-payer system would help the economy recover and would free people from staying in jobs they do not like just to keep employer benefits,” said CNA/NNOC Co-president Geri Jenkins, RN. “The jobs creation that would come from a single payer-system is just one reason RNs know that single-payer is the right thing to do for our patients, for ourselves and for our country.”
The first-of-its kind study analyzes the economic benefits of healthcare to the overall economy, showing how changes in direct healthcare delivery affect all other significant sectors touched by healthcare, and how sweeping healthcare reform can help drive the nation’s economic recovery. It was conducted by the Institute for Health and Socio-Economic Policy, the CNA/NNOC research arm.
“I’m an economist, and this study looks not only at what is happening within the healthcare field but also at the larger ripple effects into this economy,” Robert Fountain, a frequent economics consultant for the California Public Employees’ Retirement System (CalPERS), who served as a consultant on the study, said at the briefing. “The study shows that single-payer reform based on the Medicare model would create jobs – and a lot of them – not only in the health field but also out in those areas where the ripples flow.”
“Through direct and supplemental expenditures, healthcare is already a uniquely dominant force in the U.S. economy,” said Don DeMoro, IHSP director and lead author of the study.
“However, so much more is possible. If we were to expand our present Medicare system to cover all Americans, the economic stimulus alone would create an immense engine that would help drive our national economy for decades to come,” DeMoro said.
Dr. Walter Tsou, board adviser for the Physicians for a National Health Program board adviser and former health commissioner of Philadelphia, and Ronald Hikel, chief legislative and health policy aide to Rep. Eric Massa of New York, joined Fountain and Jenkins as speakers at the briefing.
“We don’t spend 4 percent more than other nations or even 14 percent more than any other nation – we spend more than 40 percent more than any other nation spends, yet our outcomes are so much worse,” Tsou noted.
Hickel, a former Canadian health official, talked about the conservative fears some have raised of a government role in paying healthcare bills, as occurs in Canada, or in the current U.S. Medicare system.
“I often hear people say that they fear a bureaucrat will decide their healthcare – nothing could be further from the truth. As a Deputy Minister of Health for Manitoba, I can tell you unequivocally that I was forbidden by law from entering into any clinical decisions – and that was punishable by 10 years in prison. So when I hear people say they don’t want bureaucratic healthcare, I tell them they must be thinking about an HMO,” Hickel said.
“If I could flip a lever tomorrow and enact HR676, it is undoubtedly the way for the United States to go,” said Hickel. “It is a matter of political will and what is right for the nation.”
Representing 85,000 RNs in 50 states, the California Nurses Association/National Nurses Organizing Committee is the largest and fastest-growing association of direct-care RNs in the nation. Learn more at http://www.calnurses.org.
California Nurses Association
http://www.CalNurses.org
Cardiogenesis Announces Successful Educational Symposium At Society Of Thoracic Surgeons Meeting In San Francisco
Cardiogenesis Corporation (Pink Sheets: CGCP), a global leader of innovative therapies for ischemic cardiac disease and the market leader of surgical products for transmyocardial revascularization (TMR), sponsored an educational symposium titled “Advancements in Revascularization & Stem Cell Therapy,” which was attended by over 40 cardiothoracic surgeons.
The Program Chair was Dr. Emerson Perin, Director, New Interventional Cardiovascular Technology, Texas Heart Institute. “The objective of the symposium is to provide cardiac surgeons with a state of the art update on the application of stem cells in cardiovascular medicine, including exciting new information on TMR plus cell therapy. Cardiologists are challenged everyday in treating medically refractory patients suffering from chronic ischemia. This program highlights recent advancements with TMR plus cell therapy for the treatment of chronic ischemia, including innovative new tools available to surgeons today,” explained Dr. Perin. He continued, “While there is still much to be learned about the therapeutic potential of stem cells, the safety and feasibility of autologous bone marrow stem cells in cardiac applications is well established. There are obvious advantages to intramyocardial cell delivery in the surgical setting – including precision and control, and the strategy of delivering platelet rich plasma in conjunction with minimally invasive TMR is a logical initial step.”
The symposium included presentations of real world experiences with TMR as well as TMR plus cell therapy.
– Dr. Guillermo Reyes, a cardiothoracic surgeon from Madrid presented his early experience using the Cardiogenesis PHOENIX delivery system which in this series combined TMR plus autologous bone marrow stem cells. The 12 month outcomes on 16 patients included the elimination or significant reductions in angina, with no mortality and no major adverse events.
– Dr. Kurt Wehberg, a cardiothoracic surgeon from Salisbury, MD described the implementation of a minimally invasive Fast Track TMR program. Using a strict patient care protocol, combined with minimally invasive thoracotomy technique, he reported a time to discharge postoperatively of 23 hours for 80% of his stand alone TMR patients. Dr. Wehberg also presented 6 month follow up on 11 patients treated with TMR plus platelet rich plasma (PRP). The 6 month outcomes included a significant reduction in angina (82% of patients free of angina) and a trend towards improvement in ejection fraction.
“This symposium outlines the Company’s progress on developing breakthrough clinical tools in treating the increasing problem of ischemic heart disease and refractory angina. Intraoperative TMR both as stand alone therapy and as an adjunct to coronary bypass surgery has proven effective in randomized, controlled clinical trials. We believe that the future of TMR plus cell therapy can make this a more potent technology with significantly greater clinical adoption,” said Richard Lanigan, President of Cardiogenesis. “We will build on this successful event by driving the awareness of the benefits of minimally invasive TMR to the referring cardiology community as well as work towards initiating a U.S. clinical trial of TMR plus cell therapy.”
About Cardiogenesis Corporation
Cardiogenesis specializes in providing surgical devices to treat cardiovascular disease and severe angina. The Company’s market leading holmium:YAG laser system and single use fiber-optic delivery systems are used to perform a procedure known as Transmyocardial Revascularization (TMR). To date, thousands of patients have been treated with the Cardiogenesis TMR technology.
For more information on Cardiogenesis, please visit the Company’s website at http://www.cardiogenesis.com. Cardiogensis also maintains a website where patients suffering from angina can learn more about the TMR procedure at http://www.heartofnewlife.com.
Safe Harbor Statement
With the exception of historical information, the statements set forth above include forward-looking statements. Any forward-looking statements in this news release related to the possible effectiveness of the Company’s technologies and the effect of such technologies on the Company’s sales, profitability, the adoption of its technology and products and FDA clearances are based on current expectations and beliefs and are subject to numerous risks and uncertainties, many of which are outside the Company’s control, that could cause actual results to differ materially. Factors that could affect the accuracy of these forward-looking statements include, but are not limited to: any inability by the Company to sustain profitable operations or obtain additional financing on favorable terms if and when needed; any failure to obtain required regulatory approvals; failure of the medical community to expand its acceptance of TMR procedures; possible adverse governmental rulings or regulations, including any FDA regulations or rulings; the Company’s ability to comply with international and domestic regulatory requirements; possible adverse Medicare or other third-party reimbursement policies or adverse changes in those policies; any inability by the Company to ship product on a timely basis; the Company’s ability to manage its growth; the effects of recent disruptions in global credit and equity markets and other adverse economic developments that could adversely affect the market for our products or our ability to raise needed financing; actions by our competitors; and the Company’s ability to protect its intellectual property. Other factors that could cause Cardiogenesis’ actual results to differ materially are discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-KSB for the year ended December 31, 2007 and the Company’s other recent SEC filings. The Company disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Cardiogenesis Corporation
http://www.cardiogenesis.com
UNT Health Science Center Researchers Discover Eating Less May Not Increase Life Expectancy
Dr. Michael Forster of the UNT Health Science Center and Dr. Raj Sohal of the University of Southern California’s School of Pharmacy have discovered that eating less may not be a key to living longer. Their study and others by Health Science Center researchers were recently published in several scientific journals and articles.
The Forster-Sohal study found that lean mice that ate fewer calories did not lengthen their lifespan – a dietary factor which may be true for humans as well. Caloric restriction was beneficial to obese mice in the study, however. The study was funded by the National Institute on Aging, part of the National Institutes of Health. Results from the study were published in The Journal of Nutrition, Scientific American, Asian News International, Medical News Today, Science Daily and ScienceBlog.com, among others.
Dr. Peter Raven published a study that yields new information about blood pressure in Medicine and Science in Sports and Exercise. The overview of historical experiments studies regulation of arterial blood pressure during exercise. Results from the study were published in Life Science Weekly, Blood Weekly, Biotech Week and others.
Dr. Adan Dibas published his findings on enzyme research, particularly related to glaucoma, in the journal Molecular Vision. The study found that modifying a protein may eventually lead to axon degeneration in glaucoma. Results from the study were also published in Proteomics Weekly.
Dr. Shigehiko Ogoh found that a combination of cerebral autoregulation and the autonomic nervous system work together to regulate cerebral blood flow during exercise. The results of his study were published in Medicine and Science in Sports and Exercise, Science Letter, Life Science Weekly and other publications.
Drs. Abha Sharma, Rajendra Sharma, Pankaj Chaudhary, Sanjay Awasthi and Yogesh Awasthi, all with the UNT Health Science Center, along with researchers from the University of Texas Medical Branch in Galveston and the University of Arkansas for Medical Sciences, shed new light on the understanding of disintegration of cells in a study published in the Archives of Biochemistry and Biophysics, Health & Medicine Week, Biotech Business Week and others.
The Center for Commercialization of Fluorescence Technologies partnered with the Miller School of Medicine, University of Miami, and the Institute of Physics at the Marie Curie-Sklodowska University to study activity in cardiac contractile fibrils of skeletal muscle using fluorescence. They found the lifetime of a fluorescent marker was high in the presence of actin, a component of muscle plasma important to muscle contraction. The marker’s lifetime was low when they were dissociated from it. Findings were published by the American Chemical Society News Service.
University of North Texas Health Science Center
The University of North Texas Health Science Center is composed of the Texas College of Osteopathic Medicine, the Graduate School of Biomedical Sciences, the School of Public Health, and the School of Health Professions. The center’s Institutes for Discovery conduct leading-edge research on select health issues, including vision, aging, cancer, heart disease, physical medicine and public health. This year, the Texas College of Osteopathic Medicine was named a top 50 medical school in primary care by U.S. News & World Report for the seventh consecutive year. The institution contributes almost $600 million to Tarrant County and Texas economies annually. For more information, visit http://www.hsc.unt.edu.
University of North Texas Health Science Center
http://www.hsc.unt.edu
PEAK Surgical Receives European CE Mark For PEAK(R) Surgery System For Use In General Surgery
PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, announced that it has received European CE Mark approval for its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System includes the PULSAR(TM) Generator and the PEAK PlasmaBlade(TM) family of disposable, low-temperature surgical cutting and coagulation devices. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding.
PEAK Surgical received 510(k) clearance from U.S. Food and Drug Administration (FDA) in July 2008 for the PEAK Surgery System for use in general surgery and in December 2008 for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. To date, surgeons in the United States have used the PlasmaBlade in more than 500 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries.
“We are pleased that the European authorities have approved the use of the PEAK Surgery System. We continue to receive positive feedback from surgeons in the United States. They not only find the PlasmaBlade to be intuitive and easy to use, but also to precisely cut tissue and control bleeding without extensive collateral thermal damage to tissues,” said John Tighe, president and chief executive officer of PEAK Surgical. “We look forward to commercializing this innovative device in Europe, where we believe the PlasmaBlade could eventually be used in more than 1 million surgical procedures each year.”
PEAK Surgical recently initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAK Surgery System in plastic and reconstructive, gynecologic and oncologic surgery.
Preclinical results have demonstrated that the PlasmaBlade is associated with effective bleeding control, minimal thermal tissue injury, reduced scarring and inflammation, and improved surgical incision healing and strength compared with traditional electrosurgical or electrocautery devices.
Benefits of the PlasmaBlade and PULSAR Generator
For decades, surgeons have relied on scalpels to cut skin and delicate tissues and have used electrosurgical devices to cut and coagulate fat and other thicker, tougher tissues. Although scalpels precisely cut tissue, they do not control bleeding. Electrosurgical devices, on the other hand, cut efficiently and control bleeding but cause extensive thermal damage to surrounding tissue. In cases where the risk of collateral damage or scarring from electrosurgery is considered to be unacceptable, surgeons must use both a traditional scalpel for cutting and an electrosurgical device for coagulation.
The PlasmaBlade family of devices offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical device. The PlasmaBlade family includes the PlasmaBlade 4.0, which is designed to be used to cut through all types of soft tissue, including skin, fat and muscle; the PlasmaBlade Needle, which has a fine needlepoint tip and is specifically designed for ultra-precise surgical procedures; and the PlasmaBlade EXT, which is designed for use in surgical procedures requiring an extended-reach tip.
Unlike most radiofrequency-based surgical products that use continuous voltage waveforms to cut tissue, the PULSAR Generator supplies pulsed plasma- mediated electrical discharges through the PlasmaBlade. Because the radiofrequency energy is provided through short on-and-off pulses via a highly insulated cutting electrode, the PlasmaBlade cuts at an average temperature that is half that of a conventional electrosurgery device and can be as low as 50 degrees Centigrade. This temperature reduction results in significantly less damage to surrounding tissues compared to traditional electrosurgical devices. The PlasmaBlade is also able to dissect tissue in a wet or dry surgical field.
PEAK Surgical’s pulsed plasma-mediated discharges and electrode insulation techniques were originally invented at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University and developed by PEAK Surgical.
About PEAK Surgical, Inc.
PEAK Surgical, Inc. is a medical device company that has developed the PEAK(R) Surgery System, a new tissue dissection system based on a proprietary technology that represents an important advance in radiofrequency surgical technologies. The PEAK Surgery System consists of the PEAK PlasmaBlade(TM), a family of disposable cutting devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage, and the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy to the PlasmaBlade. The PEAK Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures in the United States, and for use in general surgery in the EU. For more information, please visit http://www.peaksurgical.com.
PEAK Surgical, Inc
http://www.peaksurgical.com
BPA Plastic May Stay In Body Longer
A new study by scientists in the US found surprisingly that for some people, the controversial plastics chemical bisphenol A (BPA). lingered in
the body at high levels for much longer than was assumed, even after fasting for 24 hours, suggesting that BPA either does not metabolize rapidly, or is
coming from non-food sources, or both.
The study was the work of researchers at the University of Rochester Medical Center, Rochester, New York, and the University of Missouri-Columbia, and was published online before print on 28 January in the journal Environmental Health Perspectives.
BPA is used to harden plastics in many types of products, including baby bottles and water bottles. It is also used in PVC water pipes and as a coating
inside metal food cans, and to make dental sealant.
The authors wrote that studies have suggested BPA may harm the brain and prostate glands in developing fetuses and babies, and a JAMA paper published in September 2008 found higher heart disease
and diabetes risks among adults with higher levels of BPA in their urine.
Last month, the US Food and Drug Administration (FDA) agreed to reconsider the health risks of BPA.
Two of the reasons the FDA and their European counterpart, the European Food Safety Authority, have declared BPA to be safe is because the
authority view in science is that the chemical is eliminated quickly from the body and the main source of exposure is food containers. However, this
latest study questions both of these key assumptions.
Lead author Dr Richard W Stahlhut explained:
“Our results simply do not fit that picture.”
“The research community has clues that could help explain some of these results but to date the importance of the clues have been underestimated. We
must chase them much more vigorously now,” said Stahlhut, who works at the University of Rochester’s Environmental Health Sciences
Center.
For the study, Stahlhut and colleagues used data on 1,469 US adults who took part in the Center for Disease Control’s (CDC’s) National Health and
Nutrition Examination Survey (NHANES). From this they could examine links between levels of BPA in people’s urine and how long they had fasted
before giving their samples.
If, as many scientists assumed, the main route for BPA to enter the body was through food and beverages, then the researchers expected to see clear
relationships between fasting times and levels of BPA; ie the lowest levels should be in the urine of people who had fasted the longest. In fact, they
expected the levels to halve for every additional 5 hours of fasting.
But what they found was the people who had fasted the longest had urine levels of BPA that were only moderately lower than people who eaten just
before giving their sample.
Stahlhut described their unexpected result:
“In our data, BPA levels appear to drop about eight times more slowly than expected — so slowly, in fact, that race and sex together have as big an
influence on BPA levels as fasting time.”
He and colleagues suggested two reasons for their findings. First, BPA might have entered the body by other means, for instance via house dust or tap
water, and secondly, perhaps it got into fat tissue from which it is released more slowly.
They said further research was needed to evaluate how BPA might affect the way fat tissue hormones work and to look for other non-food sources of
BPA exposure.
According to CDC estimates, over 90 per cent of Americans have detectable levels of BPA in their urine.
The University of Rochester School of Medicine and Dentistry, and the National Institute of Environmental Health Sciences Training Grant, paid for
the research.
“Bisphenol A Data in NHANES Suggest Longer Than Expected Half-Life, Substantial Non-Food Exposure, or Both.”
Richard W. Stahlhut, Wade V. Welshons, and Shanna H. Swan.
Environmental Health Perspectives, In press, Online version available 28 January 2009.
doi:10.1289/ehp.0800376
Click here for pre-press view of Abstract
(PDF donwload).
Sources: Journal abstract, University of Rochester Medical Center press release.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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