Charles Darwin 2009 Celebration Joined By Genetic Engineering And Biotechnology News
Theodosius Dobzhansky, the late great geneticist and evolutionary biologist, said it best: “Nothing in biology makes sense except in the light of evolution.”
This year marks the 200th birthday of Charles Darwin (February 12, 1809) and the 150th anniversary of the publication of the Origin of Species, which laid out the theory of evolution by means of natural selection in exquisite detail. Universities, academic centers, and other scientific organizations all over the globe have a plethora of events planned to honor Darwin’s contributions and legacy. Genetic Engineering and Biotechnology News (GEN) is taking part in the celebration of Darwin as well.
“If it weren’t for Charles Darwin and Alfred Russel Wallace, there would probably be no biotechnology industry,” says John Sterling, Editor in Chief of GEN. “Every life-science-related discipline is deeply grounded in evolutionary theory. This is particularly the case with genetics and molecular biology, two cornerstones of biotech research.”
In the January 1 issue, GEN published excerpts of an interview with Sean Carroll, Ph.D., professor of molecular biology and genetics and an investigator with the Howard Hughes Medical Institute at the University of Wisconsin. Dr. Carroll’s research has centered on the genes that control animal body patterns and play major roles in the evolution of animal diversity. This field of study is known as evolutionary developmental biology, or “Evo Devo.” The entire interview with Dr. Carroll can be heard as a podcast at www.genengnews.com
In addition to providing his insights on the significance of Charles Darwin and the impact and importance of Evo Devo on the foundation of evolutionary theory, Dr. Carroll also discusses how research advances taking place in Evo Devo can be translated into applied biotech applications.
During each subsequent month throughout 2009, GEN will interview a leading researcher, philosopher, or theorist in evolutionary science, including many experts on Darwin. Their thoughts and insights will appear in the print version of GEN and online as podcasts. Dozens of online links to articles, videos, podcasts, commentaries, and various events and conferences around the world celebrating Charles Darwin will also be provided.
We cordially invite you to our year-long Darwin party!
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Article adapted by Medical News Today from original press release.
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Genetic Engineering and Biotechnology News (GEN) (http://www.genengnews.com), which is published 21 times a year by Mary Ann Liebert, Inc., is the most widely read biotechnology news magazine worldwide. It includes articles on Drug Discovery, Bioprocessing, OMICS, Biobusiness, and Clinical Research and Diagnostics.
Source: John Sterling
Mary Ann Liebert, Inc./Genetic Engineering News
Democrats Debate Action To Reverse Ban On Embryonic Stem Cell Research
Democratic leaders are debating whether to use an executive order or draft more permanent legislation to reverse the Bush administration’s 2001 restrictions on federal funding for embryonic stem cell research, a top priority for congressional Democrats and President-elect Barack Obama, the New York Times reports. According to House Speaker Nancy Pelosi (D-Calif.) and representatives for Obama, the “likely” course of action is an executive order by Obama to reverse the Bush policy, followed by a comprehensive congressional initiative to overturn the “more far-reaching” federal law limiting the research. Democrats say that it is “certain” that they will at least reverse the Bush policy and “open the way” for more federal funding for the research, according to the Times.
Sen. Ben Nelson (D-Neb.) said the issue is “very divisive” and is a “tough way to start. You don’t want to stumble out of the box.” Increasing federal funding for stem cell research is a “popular” issue that has helped Democrats beat Republicans in previous elections, the Times reports. Democratic officials say they hope the “divisiveness” of the issue will be reduced by “framing the stem cell policy as more of a health care issue” rather than an abortion-related one.
However, the Times reports that many of the seats gained by congressional Democrats came in areas that are more conservative and that strategists estimate that as many as 70 seats could be up for competitive re-elections in 2010. The Times reports that the “potentially vulnerable lawmakers provide another consideration” for congressional leaders when they are deciding “whether to set an early test vote on what for some is a politically sensitive subject back home.”
Rep. Joe Pitts (R-Penn.) said abortion-rights opponents “in both caucuses will fight strongly to preserve sanctity of life ethics. If they force it by legislation, those will be the votes the pro-life community will score to educate the voters as to where members stand on these issues.”
Despite breakthroughs by researchers in the conversion of human skin cells into embryonic stem cells, stem cells from human embryos are “still very much needed” by researchers, the Times reports. The current ban on federal funding for embryonic stem cell research has allowed “only a small group” of researchers to work on those cells, and it is “likely” that more laboratories would become involved and “science would move forward faster” if the ban were lifted, the Times reports (Hulse, New York Times, 1/3).
Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2008 The Advisory Board Company. All rights reserved.
Cylene Pharmaceuticals Initiates Phase I Trial With CX-4945 -Breakthrough First-in Class Inhibitor Of CK2
Cylene Pharmaceuticals announced that it has initiated a Phase I clinical trial of its oral CK2 protein kinase inhibitor, CX-4945, in patients with advanced solid tumors, Castleman’s disease, or multiple myeloma. The primary endpoints of the oral dose escalating trial are determination of safety, tolerance and PK properties of CX-4945 and to select the appropriate dose for Phase II trials. In addition, multiple mechanism-related pharmacodynamic biomarkers that were validated in preclinical studies will also be evaluated in the trial to assess the ability of CX-4945 to hit its target in patients.
CX-4945 is a first-in-class, orally administered small molecule anticancer agent that delivers highly selective and potent inhibition of CK2, a constitutively active protein kinase that is overexpressed in a wide range of cancers. CK2 drives the excessive proliferation phenotype of cancer cells through its potentiating role in key cell survival pathways and angiogenesis. CX-4945 demonstrates potent tumor regression activity in murine xenograft models, as well as favorable PK/ADMET and safety properties in preclinical studies.
“CX-4945 is a breakthrough molecule for Cylene,” said Dr. William Rice, President and Chief Executive Officer of Cylene Pharmaceuticals. “CK2 overexpression drives key cell survival pathways and proliferation of cancer cells, but it has been notoriously difficult to inhibit because it has an unusual active site. CX-4945 represents the first potent and selective inhibitor of CK2 with a favorable safety profile and the ability to promote tumor regressions as a single agent in preclinical studies. We are delighted to have advanced CX-4945 into the clinic ahead of schedule, and we are thoughtfully planning our Phase II program in particular CK2 driven cancers.”
In this Phase I trial, CX-4945 will be administered to patients orally twice a day, for three consecutive weeks of a four week cycle, over a range of doses. The primary objectives of the study will be to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of CX-4945, and to define the phase II dose. The secondary objectives are to characterize the pharmacokinetics, as well as observe for signs of anti-tumor activity via pharmacodynamic as well as radiographic assessments.
“CK2 is of central importance in driving cancer cell proliferation as well as in angiogenesis. As such, CX-4945 is a truly novel therapeutic, particularly against cancers and in other indications mediated by IL-6 and IL-8,” added Dr. Daniel Von Hoff, Cylene’s Co-Founder and Vice President, Medical Affairs.
About CX-4945, an oral CK2 protein kinase inhibitor
CX-4945 is a first-in-class small molecule that has been optimized to selectively inhibit CK2 activity. The CK2 protein kinase plays a multifunctional role in cell cycle regulation, signal transduction, transcriptional control, angiogenesis, apoptosis and inflammation. Because CK2 contributes to the cancer phenotype via multiple cellular events, CX-4945 has been designed with the objective of creating a multifunctional inhibitor by targeting a single protein and affecting potentially many cancers. CX-4945 demonstrates broad spectrum anti-proliferative activity against diverse cancer cell lines, and the data attribute the anti-tumor activity of CX-4945 to intracellular inhibition of the CK2 enzyme.
About Cylene Pharmaceuticals, Inc.
Cylene Pharmaceuticals is a biotech pharmaceutical company dedicated to the discovery, development and commercialization of targeted small-molecule drugs to treat life-threatening cancers. Cylene has created a diverse portfolio of product candidates, including novel inhibitors of cancer-linked serine/threonine protein kinases, as well as innovative nucleolus targeting agents (NTAs) that target the abnormal nucleolar functions of cancer cells and selectively kill cancer cells. More information can be found at http://www.cylenepharma.com.
Cylene cautions you that statements included in this press release that are not a description of historical facts, including implied statements relating to future outcomes of clinical trials, may be forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Cylene’s business including, without limitation, risks related to difficulties or delays in, testing, obtaining regulatory approval for, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and Cylene undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
Cylene Pharmaceuticals
http://www.cylenepharma.com
Phase III Trial Begins For GAMMAGARD LIQUID Plus RHuPH20 In Primary Immunodeficiency Patients
Baxter International Inc. and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced the start of a Phase III clinical trial of Baxter’s GAMMAGARD LIQUID [Immune Globulin Intravenous] 10% (IGIV), marketed as KIOVIG in the European Union, with Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20, Enhanze(TM) Technology) for the treatment of primary immunodeficiency (PID). The purpose of this clinical trial is to evaluate the safety and efficacy and gain regulatory approval for the treatment of PID using GAMMAGARD LIQUID and rHuPH20 via subcutaneous (under the skin) injection at a single site.
GAMMAGARD LIQUID is currently administered intravenously (IV). Subcutaneous (SC) administration of GAMMAGARD LIQUID with Enhanze Technology is an investigational study and when approved could allow patients to receive a full monthly dose in a single injection site in their home setting.
“Baxter’s work with Halozyme represents a commitment to innovation and, in particular, to advancing patient care with GAMMAGARD LIQUID,” said Hartmut J. Ehrlich, M.D., vice president of Global Research and Development for Baxter’s BioScience business.
“Entering Phase III clinical development is an important achievement for our hyaluronidase enzyme and for our collaboration with Baxter. We are pleased with the progress that has been made since our alliance began in September 2007,” stated Jonathan Lim, M.D., President and CEO of Halozyme. “We look forward to continuing our strong working relationship with the Baxter team and to further advance this program.”
This Phase III clinical study is a prospective, open-label, non-controlled design that will be conducted in 10-20 centers in the U.S. and Canada. The trial will evaluate the efficacy of GAMMAGARD LIQUID administered SC with rHuPH20 in the prevention of acute serious bacterial infections and will also assess pharmacokinetic parameters of SC and rHuPH20 compared to intravenous administration.
About GAMMAGARD LIQUID
GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Important Safety Information
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human). Patients with severe selective IgA deficiency (IgA
Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Especially in such patients, IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable. While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IGIV products, those containing sucrose as a stabilizer accounted for a disproportionate share of the total number.
Glycine, an amino acid, is used as a stabilizer. GAMMAGARD LIQUID does not contain sucrose.
GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Components used in the packaging of this product are latex-free.
Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.
IGIV products can contain blood group antibodies that may cause a positive direct antiglobulin reaction and, rarely, hemolysis.
Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.
Various mild and moderate reactions, such as headache, fever, fatigue, chills, flushing, dizziness, urticaria, wheezing or chest tightness, nausea, vomiting, rigors, back pain, chest pain, muscle cramps, and changes in blood pressure may occur with infusions of Immune Globulin Intravenous (Human).
About Baxter
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology, and drug delivery markets. The company’s portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company’s Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche’s biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter’s biological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase(R), for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. Halozyme also has a number of different enzymes in its portfolio that target significant areas of unmet medical need. For more information visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the potential regulatory approval and the benefits of administering rHuPH20 with GAMMAGARD) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the companies’ reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission. Neither Baxter nor Halozyme undertakes to update its forward-looking statements.
Halozyme Therapeutics, Inc.
http://www.halozyme.com
Fertility Physicians Of Northern California Researchers Test New Forms Of Progesterone Medication For Luteal Support During IVF
Women undergoing in vitro fertilization (IVF) require progesterone medication to help support early pregnancy, but the intramuscular injections for some forms of this medication can be painful for patients. Formulations of progesterone medication which can be administered by subcutaneous injection or vaginal suppository may offer similar results with better patient tolerance.
With patient well-being a constant focus, Fertility Physicians is participating in an international research study to compare an experimental progesterone, Progesterone-IBSA, which is given by subcutaneous injection, to an FDA approved progesterone, Endometrin(R), which is administered vaginally. The study will assess the efficacy, tolerability and safety of Progesterone-IBSA, the study medication, in female patients undergoing IVF.
“We are so pleased to be one of only 8 clinics across the nation asked to participate. The outcome of this study could mean improved comfort and cost for patients undergoing fertility treatment.” said Dr. Purcell.
Patients choosing to participate will benefit by receiving progesterone medication (Endometrin(R) or Progesterone-IBSA) for one IVF cycle, at no charge. This represents approximately a $1,036 value. Additionally, $1,500 will be given to each study participant for their time and commitment. Patients will be responsible for all other charges relating to their IVF cycle and treatment.
Enrollment for this research study is now open and patients interested in participating are invited to call the research department at Fertility Physicians for further information on the study.
Dr. Karen Purcell, MD, PhD, FACOG is directing this study at Fertility Physicians of Northern California, along with Angie Toyama, clinical research coordinator. This research study is sponsored by Institut Biochimique SA (IBSA), an established pharmaceutical company in Switzerland.
About Fertility Physicians of Northern California
Founded in 1984, Fertility Physicians of Northern California (FPNC) offers the full range of medical solutions patients need to start a family, from simple drug therapy to advanced procedures such as in vitro fertilization and pre-implantation genetic diagnosis.
From private offices in San Jose and Palo Alto (CA) they have helped thousands of people become parents. FPNC services include the highest levels of patient care, emotional support and educational programs to assist patients throughout their treatment.
FPNC physicians are board certified specialists in reproductive endocrinology, infertility and reproductive surgery, providing the most advanced training and education in the treatment of infertility, endometriosis, miscarriage and other reproductive disorders. The clinical, nursing and laboratory staff is also composed of highly trained experts.
For more information, please visit: http://www.fpnc.com/team/research
Fertility Physicians of Northern California
http://www.fpnc.com
Prism Pharmaceuticals Receives FDA Approval Of NEXTERONE(R) For Life Threatening Ventricular Fibrillation And Ventricular Tachycardia
Prism Pharmaceuticals announced that the U.S. Food & Drug Administration (FDA) has approved the new drug application (NDA) for NEXTERONE(R) (amiodarone HCl) Injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone(R) Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
“Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move NEXTERONE from licensing to FDA clearance in less than three years and ahead of the PDUFA target date,” said Dr. Warren D. Cooper, President and CEO of Prism. “We developed NEXTERONE to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias.”
NEXTERONE represents the first product to successfully overcome the long recognized solubility issues of amiodarone by removing the original cosolvents polysorbate 80 and benzyl alcohol. As a result of removing these cosolvents, NEXTERONE does not have many of the product administration limitations regarding compatibility and stability with plastics and ionic infusion fluids, which are included in the labeling of conventional intravenous amiodarone. Importantly, NEXTERONE does not carry the specific warning about the risk of fatal gasping syndrome in newborn infants because it does not contain benzyl alcohol.
Improving medication safety in the hospital environment is an area of significant and current attention. This agenda is being driven by entities such as The Joint Commission, which is responsible for the accreditation of hospitals, and the Institute for Safe Medication Practices. Providing injectable products, especially those for critical care use, in premixed, ready to use forms is a high priority solution to minimize medication errors.
Dr. Cooper continued, “While this regulatory approval is for NEXTERONE supplied in vials and a prefilled syringe, the changes in the compatibility and stability profile of NEXTERONE, brought about by the removal of polysorbate 80 and benzyl alcohol, present the opportunity to formulate intravenous amiodarone for the first time in premixed, ready to use configurations.”
Prism is currently implementing a full scale manufacturing development program with the Medication Delivery business of Baxter Healthcare Corporation, a world leader in premix technologies. Prism intends to submit a supplemental NDA for the premixed configurations which will form the focus of the commercial launch of NEXTERONE as a complete product line. Health-System Pharmacists hold the primary management responsibility for improvements in medication safety in hospitals and this will be a key target customer group for NEXTERONE.
“We intend to commercialize NEXTERONE ourselves in the US with partners that are well positioned in the hospital marketplace and will seek to license the ex-US worldwide rights,” said Dr. Cooper. “As we round out the NEXTERONE product line with the premixed bag configurations, we are concurrently defining the best approach to launch the brand, drive rapid conversion and optimize the value of NEXTERONE to pharmacists, clinicians, patients and the Company. I believe NEXTERONE can rapidly replace generic Amiodarone IV when it becomes available and has the potential to eventually render conventional Amiodarone IV obsolete.”
The FDA approval of NEXTERONE triggers a second $10M milestone payment from Paul Capital. This long range financing agreement, established in September 2006, provides Prism with non-dilutive capital to enable the company to bring NEXTERONE through the period of NDA review and commercial launch.
Dr. Cooper will present the corporate strategy for PRISM Pharmaceuticals, the commercial plans for NEXTERONE and the product pipeline at the 27th Annual JP Morgan Healthcare Conference on January 13, 2009 at 7:30 a.m. PST/10:30 a.m. EST. A webcast of the presentation will be available on http://www.prismpharma.com.
About Ventricular Fibrillation and Ventricular Tachycardia
Ventricular fibrillation is a condition in which the heart’s electrical activity becomes disordered. When this happens, the heart’s lower (pumping) chambers contract in a rapid, unsynchronized way. (The ventricles “flutter” rather than beat.) The heart pumps little or no blood. Ventricular fibrillation is very serious. Collapse and sudden cardiac death will follow in minutes unless medical help is provided immediately.
Ventricular tachycardia is a fast or rapid heart rate that starts in the heart’s lower chambers (ventricles). Ventricular tachycardia may result from serious heart disease and usually requires prompt treatment.
Important Safety Information About NEXTERONE
The most important treatment-emergent adverse effects associated with intravenous amiodarone therapy in clinical studies were hypotension, asystole/cardiac arrest/electromechanical dissociation (EMD), cardiogenic shock, congestive heart failure, bradycardia, liver function test abnormalities, ventricular tachycardia, and atrioventricular block. Overall, treatment was discontinued for about 9 percent of the patients because of adverse effects. The most common adverse effects leading to discontinuation of intravenous amiodarone therapy were hypotension (1.6 percent), asystole/cardiac arrest/EMD (1.2 percent), ventricular tachycardia (1.1 percent), and cardiogenic shock (1 percent).
NEXTERONE is contraindicated in patients with known hypersensitivity to any of the components of NEXTERONE, including iodine, or in patients with cardiogenic shock, marked sinus bradycardia, and second- or third-degree AV block unless a functioning pacemaker is available.
NEXTERONE is for hospital use only. NEXTERONE should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of intravenous amiodarone therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
For more information about NEXTERONE, including full prescribing information, visit http://www.prismpharma.com.
About Prism Pharmaceuticals
Prism Pharmaceuticals, based in King of Prussia, Pennsylvania, is a specialty pharmaceutical company committed to developing and commercializing acute care cardiovascular products. The product portfolio strategy is focused on recognizing unfulfilled opportunities in existing compounds that address current unmet medical needs with a specific focus on medication safety in the hospital environment.
Prism was started in 2004 with a founding investment from Essex Woodlands Health Ventures (http://www.ewhv.com). In 2006 Prism secured a $68M layered financing of equity from Essex combined with equity and a revenue interest agreement from Paul Capital (http://www.paulcap.com). This level of sustaining investment has enabled Prism to pursue an aggressive licensing and rapid development model resulting in the successful approval of NEXTERONE.
The worldwide rights to NEXTERONE were licensed in early 2006 from CyDex Pharmaceuticals (http://www.cydexpharma.com). NEXTERONE is based on the CyDex patent-protected CAPTISOL(R) technology platform. Prism and CyDex are also developing a novel injectable form of the blockbuster antiplatelet agent PLAVIX(R) (clopidogrel) for use in acute care situations overcoming the limitations of the current product which is only available as an oral therapy.
For further information, visit http://www.prismpharma.com.
NEXTERONE(R) is a registered trademark of Prism Pharmaceuticals, Inc. Cordarone(R) and PLAVIX(R) are registered trademarks of sanofi-aventis.
Prism Pharmaceuticals
http://www.prismpharma.com
An Evolution In Automated CO2 Laser Surgery
Lumenis Inc., a global developer, manufacturer and seller of laser, light-based and radiofrequency devices for surgical, aesthetic, and ophthalmic applications, announced the FDA approval and market introduction of its new AcuPulse CO2 Laser for ENT, Gynecology, Neurosurgery, General Surgery and Aesthetic medicine.
AcuPulse represents an evolution in automated CO2 laser surgery. Benefiting from years of experience with the Sharplan Compact product line, the AcuPulse was designed to create a new standard in treatment convenience for the physician and the nursing staff alike. Considering human factors and efficacy as major concept goals, automation and robotics features are controlled from a large area video screen that assures simple communication with the user.
“We are pleased to provide the groundbreaking AcuPulse with the SurgiTouch automation system,” said Mr. Dov Ofer, Lumenis’ Chief Executive Officer. “Physicians can achieve reproducible outcomes at the push of a button by simply selecting the laser application on an intuitive user interface. A mix of animated and real videos can be displayed showing various laser procedures, allowing for quick familiarization across specialties.”
With the AcuPulse CO2 laser and SurgiTouch automation system, surgeons can now focus on the surgery – not the laser set-up. Attention has also been paid to the needs of the operating room staff. Video animations display the assembly instructions for various laser accessories, making it simple for new staff to become quickly familiar with the system. “In a busy environment like ours where many nurses rotate between operating rooms, this is an invaluable feature that assure quick readiness of the AcuPulse and improves operating room turn over. In addition, I like its wide range of automated procedures which makes it easy to train my residents,” said Prof. Marc Remacle, Otolaryngologist – University Hospital of Mont-Godinne, Yvoir, Belgium.
“Ergonomic and human factors were heavily considered at the outset of the project as these provide a tremendous benefit to surgeons and their patients,” said Mr. Lloyd Diamond, Senior Vice President and General Manager of Lumenis’ Surgical Business Unit. “This is everybody’s own ‘unique’ laser. Personalized log-in with password stores individual settings and preferences,” said Diamond. A ‘My Settings’ feature allows storage of treatment pearls and other data. This automation and simplified use will drive laser treatment as a routine line therapy as the AcuPulse reduces complexities of the past. The AcuPulse laser is a valuable addition to the Lumenis CO2 surgical offering further protecting our worldwide leadership position in the markets we serve.”
About Lumenis
Lumenis is Israel’s largest medical device company with more than 800 employees worldwide. The Company invests heavily in R&D and holds a leading position in the markets in which it serves. Lumenis has over 250 patents worldwide, over 75 FDA clearances, worldwide presence in over 100 countries, and an installed base of over 70,000 systems.
Lumenis Inc.
http://www.lumenis.com
The American Red Cross Sends Aid As Humanitarian Situation Worsens In Gaza
The American Red Cross is contributing $250,000 to support the ongoing work of the International Committee of the Red Cross (ICRC) to address the growing humanitarian needs from the conflict in the Gaza Strip.
“The American Red Cross contributions will help the ICRC address increasing humanitarian needs for medical support, hospital supplies, and relief distributions,” says Gail McGovern, President and CEO of the American Red Cross.
ICRC staff on the ground in Gaza are reporting a shortage of medical personal, spare parts to keep hospital generators functioning, and medical supplies. The ICRC has mobilized additional staff including a surgical team, provided medical supplies to treat more than 4,000 people as well as 80 palettes of additional medical materials, distributed spare parts to hospitals to keep their generators operational, and is assisting in the repair of water, sewer, and electrical systems.
The ICRC is coordinating closely with the Palestine Red Crescent Society (PRCS) and Magen David Adom (MDA), the Israel equivalent of the Red Cross, staff and volunteers which are both working in their respective areas transporting injured people to health facilities.
“The American Red Cross has a strong relationship with both the PRCS and the MDA,” says David Meltzer, Senior Vice President of International Services at the American Red Cross. “We will continue to assess the humanitarian needs of our sister societies as the crisis continues and stand ready to provide additional assistance as needed.”
The American Red Cross relationship with the societies is rooted in work to grant them membership in the International Federation of Red Cross and Red Crescent Societies (International Federation). Both societies were unanimously approved by members of the International Federation in June 2006.
In November 2008, the American Red Cross awarded the American Red Cross Humanitarian Prize to the leaders of the PRCS and the MDA in recognition of their work in fostering humanitarian cooperation between the two organizations despite significant political and military challenges.
You can help the victims of countless crises around the world each year by making a financial gift to the American Red Cross International Response Fund, which will provide immediate relief and long-term support through supplies, technical assistance and other support to help those in need. The American Red Cross honors donor intent.
American Red Cross
http://www.redcross.org
Ending Epileptic Seizures
One in ten people will suffer from a seizure in their life and many of those will be diagnosed with epilepsy. Medication will help approximately two-thirds of the people with epilepsy, but many continue to have seizures, even though there are other alternatives.
“Epilepsy ended my teaching career,” says Mary Catanzaro a former English lecturer at Marquette University. “I would have seizures in front of my students and never know that they had happened.”
Catanzaro suffered from complex partial seizures. These seizures, while not as recognizable as the “shaking” seizures of the movies, are common. In Catanzaro’s case one of these episodes left her with third-degree burns after she placed her hand on a hot frying pan.
“For 20 years I tried different pharmaceuticals,” says Catanzaro. “When a new drug came out, my doctor was handing me a prescription, but it never worked.”
The average patient waits 20 years before taking the next step and has surgery. Temporal lobectomies cure many epilepsy cases but factors limit patients from taking advantage of this option.
“Many people are scared by brain surgery, and that is understandable, but it keeps them from treatment for far too long,” says Dr. George Morris, an epileptologist at Aurora St. Luke’s Medical Center in Milwaukee. “Another difficulty is that only specialized neurosurgeons perform this procedure. Many patients rely on their physician to refer them to the best course of action, and they never learn about the successes we are having with temporal lobectomies.”
Approximately one-third of the affected population will not respond to pharmaceutical treatments for epilepsy, according to Dr. Morris. Those same people do have another option. Surgically we can remove a small section of their temporal lobe and stop or minimize their seizures. Better than four out of every five surgical patients will see either significant success or see their epilepsy cured.
In December, the Journal of the American Medical Association published a study that recommends that surgery should be considered more quickly to treat patients with epilepsy. The conclusion of the JAMA study concludes that the average patient will experience substantial gains in life expectancy and quality of life from these surgeries.
According to Dr. Morris a temporal lobectomy has been shown to be as safe as any other general surgery. Additionally, patients’ IQ testing after surgery has shown no changes and most return to work within six weeks.
Today Catanzaro works from home and contributes to many scholarly books.
“It took me about 5 years to realize that I was cured,” says Catanzaro. “I was always waiting for the next seizure, but now the waiting and the fear are over.”
Aurora Health Care is a not-for-profit Wisconsin health care provider and a national leader in efforts to improve the quality of care. Aurora provides care at sites in more than 90 communities throughout eastern Wisconsin. http://www.aurora.org
Aurora Health Care
http://www.aurora.org
Gene Helps Breast Cancer Spread And Resist Chemo
Scientists in the US looking for genomic changes in breast tumor samples found that a gene called metadherin (MTDH) appears to play a dual
role in both helping cancer spread (metastasis) and maintain resistance to chemotherapy. They said this research identifies MTDH as an important new
target for the treatment of high risk breast cancers.
The discovery was made by senior investigator Dr Yibin Kang from the Department of Molecular Biology at Princeton University, in New Jersey, and
colleagues, and is written up in a paper in the 6 January issue of the journal Cancer Cell.
As Kang explained:
“Most breast cancer patients resist currently available therapeutic regimens and succumb to recurrent tumors that spread to distant vital organs, such as
lung, bone, liver and brain.”
“Resistance to chemotherapy and metastasis remain major challenges to curative therapy,” added Kang.
Previous studies have found several genetic signatures linked to breast cancers with poor prognoses, but none has yet shown whether these different
signatures had any common genetic components.
To do this, the researchers developed and used a computer-based algorithm to map the minimum number of genetic signatures linked to breast cancers
that had a poor prognosis in an extensive collection of tumor samples.
They found that a particular genetic pattern on chromosome region 8q22 occurred in more than 30 per cent of the poor prognosis tumors whose
patients had shorter survival times because of recurrent and metastatic cancers. They also found that MDTH was among a small number of genes within this region: this gene is overexpressed in more than 40 per cent of breast cancers and is linked to poor clinical outcomes, so they investigated it further.
By doing what they called a “functional characterization”, Kang and colleagues established that MTDH had a dual role: it promoted the “seeding” of new
cancer sites (metastasis), and it enhanced tumor resistance to chemotherapy.
To seed new cancer sites, the MTDH protein encouraged cancer cells to bind to the blood vessels of the organs at the new sites. And to enhance
chemoresistance, it promoted cancer cell survival against a range of chemotherapy agents that are used to treat breast cancer.
Also, when the researchers reduced MTDH expression in the cancer cells they found they were less able to promote metastasis and
chemoresistance.
Kang and colleagues concluded that:
“These findings establish MTDH as an important therapeutic target for simultaneously enhancing chemotherapy efficacy and reducing metastasis
risk.”
“Molecular targeting of MTDH may not only prevent the seeding of breast cancer cells to the lung and other vital organs but also sensitize tumor cells
to chemotherapy, thereby stopping the deadly spread of breast cancer,” they added.
“MTDH Activation by 8q22 Genomic Gain Promotes Chemoresistance and Metastasis of Poor-Prognosis Breast Cancer.”
Guohong Hu, Robert A. Chong, Qifeng Yang, Yong Wei, Mario A. Blanco, Feng Li, Michael Reiss, Jessie L.-S. Au, Bruce G. Haffty, Yibin
Kang.
Cancer Cell, Volume 15, Issue 1, 9-20, 6 January 2009
doi:10.1016/j.ccr.2008.11.013
Click here for
Abstract.
Sources: Journal article, Cell Press.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
