Archive for January, 2012

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InterVapor Endoscopic Thermal Ablative Treatment for Emphysema Gets CE Mark

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series C funding round, which will support commercialization of InterVapor for treatment of severe emphysema. This news comes on the heels of Uptake Medical receiving CE mark approval for InterVapor in September, completing the first commercial use of InterVapor in Germany in November, and recently announcing TGA approval for InterVapor to be marketed in Australia.

Steven Kesten, Chief Medical Officer at Uptake Medical, answered our questions about the company and its technology:

1.   How did the idea of InterVapor come about?

The idea for Uptake Medical’s InterVapor™ technology was based on the body’s healing response to thermal energy. Early research was based on the hypothesis that if we were able to trigger a temporary Localized Inflammatory Response (LIR) that the associated healing process would ultimately develop a scar that would remodel and reduce the diseased lung tissue. Early experiments were conducted using various forms of heat energy, such as radio frequency, but the energy could not travel out to the diseased areas of the lung due to a lack of available lung mass. Experimentation ultimately lead to the discovery that heated water vapor (steam) was the optimal form of heat energy as it is in gas form and could easily travel through the airways to the diseased parenchyma. The development team made a prototype, proved the theory with ex-vivo animal lungs and this is the basic theory which has been ultimately proven in both animal and human clinical studies.

2.   Can you describe the process of delivering the heated vapor to the diseased lung?

In advance of the InterVapor procedure, a personalized treatment plan is developed specifically for the patient to be treated. A high-resolution CT of the patient’s lungs is analyzed by the Uptake Medical core lab. This analysis includes a quantitative assessment of several factors to determine the degree of heterogeneity and to identify the lung regions where the best opportunity for lung volume reduction may be successfully achieved. These recommendations are forwarded to the treating pulmonologist as an InterVapor Personalized Procedure Program™ (IP3™).

For the procedure itself, a bronchoscope is inserted into the lungs and the physician, following the blue print provided by the IP3, reviews the patient’s lungs and determines the course of treatment. The InterVapor Catheter is inserted through the working channel of the bronchoscope into the targeted airway. The treatment time specific to the target airway is obtained from the IP3 and keyed into the InterVapor Generator. This airway is briefly occluded by the inflation of a balloon at the end of a catheter and a dose of heated water vapor is delivered to the lung tissue. The balloon is then deflated, the catheter is removed and additional airways are treated as appropriate. The entire procedure, on average, takes 30 minutes.

InterVapor Mechanism of Action:

Treatment: The delivery of heated water vapor triggers a temporary Localized Inflammatory Response (LIR) which sets the body’s natural healing process in motion.

Healing: This LIR is usually resolved within 4-12 weeks as the lung begins the healing and remodeling process.

Response: InterVapor has been shown to lead to clinical improvements in lung function, exercise capacity and health-related quality of life.

3.   What meaningful clinical improvement above and beyond medical therapy can we expect with InterVapor, especially in terms of exercise function and quality-of-life?

In the VAPOR trial patients received optimal medical management prior to treatment with InterVapor. InterVapor therapy resulted in clinically relevant improvements in lung function, quality of life and exercise tolerance in upper lobe predominant emphysema. At 6 months, airflow as assessed by FEV1, FEV1 improved by 141 ml, air trapping as assessed by residual volume (RV) was reduced by 406ml. Health-related quality of life, as assessed by the St. George’s Respiratory Questionnaire (SGRQ) total score improved by 14.0 units with a 4 unit improvement having been reported as the minimal clinically important difference. Exercise capacity, as assessed by the 6-minute walk test, improved by 46.5 m and breathlessness, as measured by the modified Medical Research Council (mMRC) dyspnea scale improved by 0.9 units. All of the above endpoints were associated with p values less than 0.05. The results were clinically and statistically significant.

The results of the VAPOR trial are available online, ahead of publication, in the European Respiratory Journal. (Snell, G., et al. Bronchoscopic Thermal Vapor Ablation Therapy in the Management of Heterogeneous Emphysema. Eur Respir J 2012; DOI 10.1183/09031936.00092411)

4.   Is this a one-time procedure or can this be repeated multiple times to different diseases segments of the lungs?

The InterVapor System is intended for use in patients with heterogeneous severe emphysema to achieve bronchoscopic upper lobe lung volume reduction by the application of heated water vapor to the lung segments targeted for treatment. The clinical results observed in the VAPOR trial were achieved as a single, unilateral procedure. In a typical InterVapor treatment, 3-8 airways within a lung are treated.

5.   Where is InterVapor therapy currently available? Is it available in any capacity in the United States?

Uptake Medical has received the CE mark and TGA approval for InterVapor and we are focusing our commercial efforts in both Germany and Australia at this time. We plan to extend our commercialization throughout Europe during 2012. At this time InterVapor is not available in the US.

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Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

Electronic cigarettes have become a big business as many smokers have opted to choose them over the traditional variety. Lack of actual smoke and tar is a major positive, but being able to “smoke” them even where smoking is not allowed may lead to a greater overall intake of nicotine. Nevertheless, many people bought e-cigarettes as a smoking cessation tool that takes away some of the habit forming qualities of real cigarettes while keeping the ever-addictive nicotine.

CN Creative, Ltd. out of Manchester, UK has raised £2 million ($3.1 million) to help bring to market its Nicadex electronic inhaler for nicotine replacement therapy. The device, which delivers vaporized pharmaceutical-grade nicotine, looks to be very much like a typical e-cigarette, but will undergo clinical trials and is planned to be used as a part of a wider smoking cessation therapy approach.

From the press release:

Nicadex is similar in concept to the electronic cigarettes currently marketed to adult consumers by CN Creative and others, but with several key differences.

First, Nicadex will be tested in clinical trials and then submitted for regulatory review under the process used for other prescription NRT products, initially through the UK Medicines and Healthcare products Regulatory Agency (MHRA) and then through the US Food and Drug Administration (FDA) and other regulatory agencies.

Second, CNC intends to market the Nicadex electronic inhaler as a medically supervised NRT designed to reduce the harm caused by smoking and to help smokers quit as part of a comprehensive smoking cessation programme.

Third, the Nicadex electronic inhaler has been specially engineered and will be manufactured in the UK under the same stringent standards used for regulated medical products, and the pharmaceutical-grade nicotine solution it uses is being produced by CNC in its own UK-based cGMP facilities approved for the manufacture of prescription drugs.

Nicadex is a hand-held device that delivers purified nicotine to the user through the vaporisation of a pharmaceutical-grade solution of nicotine. A rechargeable lithium battery powers the vaporiser that instantly turns the nicotine solution into a vapour that is inhaled by the user. Many users report that the sensation of using the Nicadex device is similar to smoking, but the vapour contains no smoke and none of the carbon monoxide, tar or thousands of toxic impurities that make smoking tobacco products so damaging to health. In addition, since there is no smoke, there are no smoke by-products that can cause “second-hand” harm to others.

MANCHESTER, England, Jan. 25, 2012 /PRNewswire/ — CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today announced it has raised a Series A financing round led by Advent Life Sciences. The financing raised 2 million pounds, equivalent to approximately US $3.1 million. CNC intends to use the investment to continue and finalise development of its Nicadex™ electronic inhaler nicotine replacement therapy (NRT) product for use as part of medically supervised smoking cessation programmes.

Despite large-scale public health efforts, about 20% of adults in the UK and the US continue to smoke. Smoking remains the most common cause of preventable death in the Western world and generates enormous costs for healthcare systems worldwide. Two-thirds of smokers report that they would like to quit, and about three-quarters of current smokers say they have tried to stop, but smoking is a powerfully addictive habit that can make quitting very difficult or almost impossible. Fewer than 10% of smokers are estimated to achieve success when trying to stop smoking on their own. In addition, studies show that currently available NRT products help only a small proportion of smokers to stop smoking permanently.

“CN Creative provides innovative approaches to reduce the harm caused by smoking, by helping smokers quit whenever possible or reduce their consumption of cigarettes when total abstinence is not achievable,” said David Newns, a co-founder and Company Director of CN Creative. “We believe our Nicadex electronic inhaler NRT, which will deliver pharmaceutical-grade nicotine using advanced electronic vaporisation technology, has the potential to help significant numbers of smokers stop entirely or significantly reduce their exposure to harmful tobacco smoke.

Nicadex is similar in concept to the electronic cigarettes currently marketed to adult consumers by CN Creative and others, but with several key differences.

First, Nicadex will be tested in clinical trials and then submitted for regulatory review under the process used for other prescription NRT products, initially through the UK Medicines and Healthcare products Regulatory Agency (MHRA) and then through the US Food and Drug Administration (FDA) and other regulatory agencies.

Second, CNC intends to market the Nicadex electronic inhaler as a medically supervised NRT designed to reduce the harm caused by smoking and to help smokers quit as part of a comprehensive smoking cessation programme.

Third, the Nicadex electronic inhaler has been specially engineered and will be manufactured in the UK under the same stringent standards used for regulated medical products, and the pharmaceutical-grade nicotine solution it uses is being produced by CNC in its own UK-based cGMP facilities approved for the manufacture of prescription drugs.

“The support from our colleagues at Advent Life Sciences will enable CNC to undertake the clinical trials and medical regulatory review needed to confirm the safety and efficacy of Nicadex and to prepare for commercialisation. We expect to file for regulatory approval of the Nicadex electronic inhaler in the UK later this year,” added CN Creative co-founder and Company Director Chris Lord.

Nicadex is a hand-held device that delivers purified nicotine to the user through the vaporisation of a pharmaceutical-grade solution of nicotine. A rechargeable lithium battery powers the vaporiser that instantly turns the nicotine solution into a vapour that is inhaled by the user. Many users report that the sensation of using the Nicadex device is similar to smoking, but the vapour contains no smoke and none of the carbon monoxide, tar or thousands of toxic impurities that make smoking tobacco products so damaging to health. In addition, since there is no smoke, there are no smoke by-products that can cause “second-hand” harm to others.

“Decades of smoking cessation initiatives have had a positive impact on public health but millions continue to smoke and new approaches are urgently needed,” noted long-time smoking cessationand public health advocate Dr. Chris Steele. ”I am encouraged by the potential of the innovative Nicadex electronic inhaler being developed by CNC, which provides a smoke-free, tobacco-free nicotine replacement product in a format that is highly acceptable to smokers. If approved, Nicadex could be a valuable addition to our smoking cessation toolkit, immediately reducing the harm caused by smoking and enabling many smokers to proceed over time to full cessation. CNC’s emphasis on clinical testing, regulatory review, medical supervision and supportive services is encouraging, and I look forward to seeing the results of the clinical trials the company will be conducting this year.”

A distinctive element of CNC’s strategy is its recognition of the value of harm reduction. As noted in the influential 2010 UK government report, A Smokefree Future, “The tar and the carbon monoxide in smoked tobacco are the primary causes of smoking-related disease and death. … Nicotine (in the doses obtained from smoked and smokeless tobacco) is not a significant contributor to disease.” The report proposes that harm reduction measures should be an important element of smoking cessation programmes, noting that “this strategy … opens more routes to quitting, which, we believe, will help thousands more smokers to quit successfully. The new routes will encourage smokers to … manage their nicotine addiction using a safer alternative product … and dramatically reduce the harmful effects to their health, and the harmful effects to those around them. …”[1]

Similarly, after a comprehensive review of the medical and scientific literature, the American Association of Public Health Physicians (AAPHP) became the first medical organisation in the US officially to endorse tobacco harm reduction as a viable strategy to reduce the death toll related to cigarette smoking. It advocates in its white paper, The Case for Harm Reduction, that inveterate smokers – who are unable or unwilling to abstain from nicotine and tobacco – should be encouraged to switch to lower-risk smokeless tobacco products.[2]

Dale R. Pfost, PhD, a General Partner at Advent Life Sciences and the newly appointed Chairman of CN Creative commented, “CNC’s strategy of applying their smoking cessation expertise and the technology innovations first deployed in their Intellicig® electronic cigarettes to provide smokers with an advanced electronic inhaler nicotine replacement therapy is a potential game changer. We believe that Nicadex will significantly increase smokers’ chances of ending or reducing their reliance on smoking, while also reducing the well-documented health risks caused by smoking tobacco. With this investment in CN Creative, we aim to continue our track record of investing in innovative life science companies with the potential to become best-in-class in their fields.”

Kaasim Mahmood, a Partner at Advent Life Sciences who is joining the CN Creative Board of Directors, added, “We believe CNC’s products have great clinical and commercial potential, and we are delighted to provide the CNC team with financial and strategic support as they embark on the clinical studies and regulatory review process central to the success of this exciting new approach.”

[1] Department of Health (2010). A Smokefree Future, 2010. Available at:http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_111789.pdf.

[2] Nitzkin JL, Rodu B. Tobacco Control Task Force, American Association of Public Health Physicians. The Case for Harm Reduction for Control of Tobacco-related Illness and Death, 2008. Available at:http://www.aaphp.org/Resources/Documents/20081026HarmReductionResolutionAsPassedl.pdf

About CN Creative

Headquartered in the Bioscience Incubator at Manchester University in the UK, CN Creative provides innovative and sustainable solutions to global problems arising from smoking and smoking-related illnesses. It has developed a distinctive portfolio of products and services focused on smoking cessation and harm reduction, including user-friendly nicotine delivery systems and patient-focused smoking cessation and support services. CNC’s diverse products include QuitDirect, an NHS-accredited supplier of comprehensive smoking cessation services, the Intellicig® electronic cigarette, ECOpure proprietary high purity nicotine preparations and NRT Direct, which provides traditional nicotine replacement therapy products and patient support services to publicly and privately sponsored smoking cessation programmes. CNC’s Nicadex™ electronic inhaler nicotine replacement therapy product is in clinical development for use as part of medically supervised smoking cessation programmes. For more information, visit www.cncbio.co.uk.

About Advent Life Sciences

Advent Life Sciences is the dedicated Life Sciences Fund at Advent Venture Partners, one of Europe’s best-established growth and venture capital firms. Advent Life Sciences invests predominantly in early-stage and growth equity life sciences companies in the UK, Europe and the US. It will back companies that have a first- or best-in-class approach in a range of sectors within the life sciences, including new drug discovery, enabling technologies, med-tech and diagnostics.

The Advent Life Sciences team is a leader in European life sciences capital. Its investments include  PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases acquired by Johnson & Johnson; EUSA Pharma, a rapidly growing transatlantic specialty pharmaceutical company focused on late-stage oncology, pain control and critical care products; and, Algeta (OSE: ALGETA), an oncology company developing treatments for bone metastases and disseminated tumours.

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Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic received FDA 510(k) clearance to market its Aquamantys SBS 5.0 Sheathed Bipolar Sealer for sealing soft tissue and epidural veins during spinal surgery.

The device delivers RF energy for cauterization and saline to keep the area clean and clear for easy access around sensitive tissue.

From the press release:

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “This will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”

MINNEAPOLIS – January 23, 2012 – Medtronic, Inc. (NYSE: MDT) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company’s Advanced Energy business.

The SBS 5.0 Sheathed Bipolar Sealer gives spine surgeons the ability to optimize speed and continuity in surgical cases by providing hemostatic sealing capabilities for both incised soft tissue (e.g., cut muscle) and epidural veins with a single device. Like other devices in the Aquamantys line, the SBS 5.0 uses Transcollation® technology, a combination of radiofrequency energy and saline that has been shown to reduce blood loss and improve visualization when used during spine procedures. Reductions in blood loss during surgery have been linked to reduced blood transfusion rates and decreased surgical time.

“The SBS 5.0 is a great combination tool that will allow surgeons to treat cut muscle planes as well as compress and treat epidural veins with a single device,” said Dr. Paul Santiago, a surgeon at Washington University School of Medicine. “This will be particularly useful in cases like 1-2 level TLIFs/PLIFs in which you want the ability to address both of these needs but the economics can make using multiple devices difficult.”

“We are excited to offer surgeons this new addition to our ever-growing spine portfolio of advanced energy products,” said Mark Fletcher, President of the Surgical Technologies business at Medtronic, Inc. “The SBS 5.0 utilizes the effectiveness of our patented Transcollation technology in preventing and stopping bleeding during surgery, and it will deliver considerable value to surgeons, patients, and hospitals alike.”

Source:http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1327328898338&lang=en_US

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FDA and Stanford to work together on med-tech education

Stanford’s decade old biodesign program is partnering up with FDA Center for Devices and Radiological Health to help the agency adapt the way it screens new medical technologies.

The parties have reached a “memorandum of understanding,” rather than a formal agreement to specific projects, but the framework creates a method by which cooperation can now take place.

From the announcement:

“This agreement is the first step in a new collaboration between the FDA and Stanford University to promote better scientific understanding and education concerning the development of new technologies in the life sciences and the issues that affect their safety and effectiveness” said Shuren. “We look forward to working together on collaborative research initiatives and the education of students and fellows.”

Although specific projects have yet to be defined, this agreement paves the way for both institutions to jointly apply for grants and extramural funds to support their mutual objectives. Stanford’s contributions primarily will focus on two areas — education on med-tech “best design practices” and the development of new methods for more accurately evaluating the safety of emerging medical technologies.

Paul Yock, MD, director of the biodesign program, will lead the effort to promote better design practices, which includes improving understanding of regulatory practices. The biodesign program, which is in its 11th year, provides medical technology innovation training to teams of doctors, engineers and business students who — in a year — identify a medical need, develop an invention to fill it, create a business plan, then present their inventions to venture capitalists.

The U.S. Food and Drug Administration has established a partnership with Stanford University to explore new ways to more quickly and safely bring lifesaving medical devices to market.

Initiated by Jeffrey Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, this collaboration is part of the agency’s larger effort to re-engineer and streamline the way the nation designs, tests and evaluates new medical technologies. The relationship was formalized with the signing of a “memorandum of understanding” on Jan. 12 during a roundtable discussion that included representatives from the FDA, the Stanford Biodesign Programand the California Healthcare Institute.

“This agreement is the first step in a new collaboration between the FDA and Stanford University to promote better scientific understanding and education concerning the development of new technologies in the life sciences and the issues that affect their safety and effectiveness” said Shuren. “We look forward to working together on collaborative research initiatives and the education of students and fellows.”

Although specific projects have yet to be defined, this agreement paves the way for both institutions to jointly apply for grants and extramural funds to support their mutual objectives. Stanford’s contributions primarily will focus on two areas — education on med-tech “best design practices” and the development of new methods for more accurately evaluating the safety of emerging medical technologies.

Paul Yock, MD, director of the biodesign program, will lead the effort to promote better design practices, which includes improving understanding of regulatory practices. The biodesign program, which is in its 11th year, provides medical technology innovation training to teams of doctors, engineers and business students who — in a year — identify a medical need, develop an invention to fill it, create a business plan, then present their inventions to venture capitalists. Since its inception, the program has led to more than 200 patents and 24 start-up companies.

Shuren, who calls Stanford’s biodesign program the “gold standard” of medical technology development programs, said that he will work with Yock to coordinate onsite cross-training of scientific personnel at the FDA and Stanford to foster the exchange of new ideas on more efficient regulatory processes.

Harry Greenberg, MD, director of Spectrum, the Stanford Center for Clinical and Translational Education and Research, is helping to lead a new initiative in predictive and precision medicine; it’s aimed at coordinating existing efforts in computational methodology, imaging and genetics with the goal of achieving higher and more efficient precision in diagnostic and prognostic efforts.

“Working with the FDA will offer Stanford trainees the potential for a firsthand exposure to the new field of regulatory science and at the same time allow FDA investigators the opportunity to become more familiar with some of the newest approaches to innovation and translation in the device and imagining space,” said Greenberg, who is also senior associate dean for research.

Source:http://med.stanford.edu/ism/2012/january/fda-0123.html

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Roswell Park Launches Landmark Immunotherapy Vaccine Trial

Roswell Park Launches Landmark Immunotherapy Vaccine Trial

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) is about to begin a very exciting new cancer clinical trial that will test a personalized immunotherapy to attack cancer cells.

The new NY-ESO-1 dendritic cell vaccine will be produced “using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study,” according to the announcement.

The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

PLEASE NOTE: As expected, Roswell Park Cancer Institute continues to receive a very high volume of calls and emails from patients and their families regarding the vaccine clinical research study that was announced at our press conference, January 24. Many calls and emails (and even some in-person inquiries) are coming into all sectors of the Institute – from the clinics and Switchboard to Patient Access and the Cancer Resource Center. The staff and faculty of Roswell Park are making every effort to ensure that you receive the information you need quickly and efficiently. Therefore, we ask that you ONLY contact the ASK-RPCI information center. To reach the ASK-RPCI information center, call 1-877-ASK-RPCI (1-877-275-7724), Monday through Friday, from 9 a.m. until 5:30 p.m. or send an email to askrpci@roswellpark.org. Information about the trial is also included on the Roswell Park website at www.roswellpark.org. Thank you for both your cooperation and your interest in this important new study.

Dendritic cells are the gatekeepers of the human immune system, defending against invaders like bacteria, viruses and cancer. The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology. Last year, the FDA approved the first therapeutic cancer vaccine, Provenge® (sipuleucel-T), for men with advanced prostate cancer. RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma (a type of brain tumor) and another vaccine for patients with ovarian, fallopian tube, and primary peritoneal cancer.

“This trial will be only the beginning of a very robust program of activity in the area of using the human immune system to fight cancer,” adds Dr. Odunsi. “Our production process holds tremendous potential for applications related to stem-cell therapy and regenerative medicine, and I believe we’re uniquely positioned at RPCI to have the tools, infrastructure and multidisciplinary collaboration to capitalize on these ideas and opportunities both effectively and efficiently.”

The clinical research study will enroll 18-20 eligible patients whose tumors express a specific antigen, known as NY-ESO-1. Apart from the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body, but is expressed in cancers. This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

Dr. Odunsi, who developed the NY-ESO-1 vaccine, led previous trials evaluating its effectiveness in treating ovarian cancer. Christine Sable of Lancaster, Pennsylvania, enrolled on one of those studies in February of 2004, after undergoing surgery and chemotherapy for advanced-stage ovarian cancer. Although she faced a 75-80% chance that the cancer would return, her immune system responded strongly to the vaccine, and she has remained cancer-free in the seven years since then, with no side effects.

Source:http://www.roswellpark.org/media/news/roswell-park-launches-landmark-immunotherapy-vaccine-trial

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Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad Receives CE Mark Approval for Advanced, Solid-State Cardius(R) X-ACT Imaging System

Digirad received the European CE Mark of approval for its Cardius X-ACT solid state SPECT imager. It features low dose volume CT attenuation correction, 3D-OSEM reconstruction and upright imaging capability.

The company already has approval from the FDA to market the Cardius X-ACT in the U.S.

POWAY, CA – (MARKET WIRE) – 01/25/12 – Digirad Corporation (NASDAQ: DRAD) today announced that it has received Conformitee Europeene (CE) Mark approval for its Cardius® X-ACT imaging system, enabling Digirad to market and manufacture its advanced, solid-state camera system in the European Union. The Cardius X-ACT imaging system was designed to increase diagnostic accuracy and make earlier detection of disease possible.

Digirad also announced that it had begun to strategically build out a targeted international selling network by signing a distribution agreement with Epsilon Elektronik in Turkey, a part of the Istanbul-basedBozlu Group. Last year, Digirad signed a similar agreement with UK-based Southern Scientific, which has already placed an ergo™ portable solid-state camera at the Manchester Royal Infirmary where it is being used in a number of general and surgical imaging settings.

“One of the legs of our transition to growth in the product category is to build a targeted network of top distributors in key international markets that have a growing demand for flexible, high-quality imaging products such as the X-ACT. Our experience and the data indicate that price point, flexibility and potential for better clinical outcomes at lower overall costs are key elements to healthcare buying decisions, and our growing line of camera products uniquely fits those requirements,” said Digirad CEO Todd P. Clyde. “It is our intention, as one of several new initiatives in 2012, to more aggressively build a distribution network to tap the developing markets for dedicated cardiac and portable nuclear imaging in a more meaningful way. To that end, gaining of CE Mark and additional distribution agreements are key initial elements of that process.”

The Cardius X-ACT imaging system features a low-dose volume-computed tomography attenuation correction system that significantly reduces artifacts in the images caused by overlying tissues.

“We believe our Cardius X-ACT imaging system, our ergo flexible imaging camera and future camera models will be well-received internationally because of their accuracy, diagnostic benefits and economic models that fit well with healthcare spending. They all provide new clinical information that increases the benefit of nuclear cardiology procedures. That increase in diagnostic confidence can improve outcomes and raise the standard in the industry internationally for SPECT system performance at a price point that is accessible in many countries,” added Clyde.

Digirad has previously received clearance from the FDA to market the Cardius X-ACT imaging system in the U.S. and has garnered both CE Mark and FDA clearance to market its ergo portable solid-state camera.

About Digirad Corporation
Digirad is a leading provider of diagnostic imaging products, and personnel and equipment leasing services. For more information, please visit www.digirad.com. Digirad® and Cardius® are registered trademarks of Digirad Corporation.

Source:http://drad.client.shareholder.com/releasedetail.cfm?ReleaseID=642105

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Solve Puzzles for Science

Solve Puzzles for Science

Players of the online protein folding game Foldithave reached another milestone, creating an 18-fold-more-active version of a model enzyme. The gamers worked on an enzyme that catalyses the Diels-Alder reaction, which is used in the synthesis of various chemical products (according to Wikipedia it is considered the “Mona Lisa” of reactions in organic chemistry).

In 2010 scientists designed a functional Diels–Alderase computationally from scratch, but with a binding pocket for the pair of reactants that was too open and too low activity. Because they were not able to improve it further they challenged the Foldit gamers to come up with better designs. Through two different puzzles, one to remodel one of four amino-acid loops on the enzyme to increase contact with the reactants, and another to stabilize the new loop, the gamers fiddled their way through in search of the best-scoring (lowest-energy) configurations. Out of the almost 200,000 resulting designs, the researchers then synthesized a number of test enzymes and ultimately the final, 18-fold-more-active enzyme.

Although there are no immediate applications for the particular Diels-Alder reaction that the enzyme catalyses and its activity is still relatively low, it clearly shows the power of crowdsourcing this kind of research. The scientist are now looking into improving small protein inhibitors that bind to and block the 1918 pandemic influenza virus. “Now Foldit players are working to make more potent inhibitors,” Baker said. “Those are exciting because those could be drugs.”

Computational enzyme design holds promise for the production of renewable fuels, drugs and chemicals. De novo enzyme design has generated catalysts for several reactions, but with lower catalytic efficiencies than naturally occurring enzymes1234. Here we report the use of game-driven crowdsourcing to enhance the activity of a computationally designed enzyme through the functional remodeling of its structure. Players of the online game Foldit56 were challenged to remodel the backbone of a computationally designed bimolecular Diels-Alderase3 to enable additional interactions with substrates. Several iterations of design and characterization generated a 24-residue helix-turn-helix motif, including a 13-residue insertion, that increased enzyme activity >18-fold. X-ray crystallography showed that the large insertion adopts a helix-turn-helix structure positioned as in the Foldit model. These results demonstrate that human creativity can extend beyond the macroscopic challenges encountered in everyday life to molecular-scale design problems.

Source:http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.2109.html

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Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical’s IVC Filter Receives CE Mark Approval

Crux Biomedical has received CE mark approval for its inferior vena cava filter (IVCF) with bi-directional retrieval. Inferior vena cava filters are implanted to trap blood clots that may cause pulmonary embolism in patients who are at high risk but have contraindications to anticoagulation.

The Crux Biomedical IVCF was designed to overcome several limitations of currently available vena cava filters including perforation, migration and inability to retrieve. Features, from the product page:

  • Self-centering – no-tilt symmetrical spiral design centers filter automatically in vessel lumen
  • Bi-directional deployment and retrieval. Twice the retrieval options of other filters. Designed for either jugular or femoral deployment, and retrieval
  • Atraumatic design goal – Tissue anchor lengths optimized for efficient vessel fixation while limiting perforation
  • Total trans-luminal filtration design provides filtration across the entire lumen of the vessel
  • Controlled filter placement via preloaded, low profile, over-the-wire delivery system

MENLO PARK, Calif., Jan. 23, 2012 /PRNewswire/ – Crux Biomedical announced it has received CE mark approval for their revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR).  Vena cava filters are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE).  Each year in the United States, approximately 600,000 patients develop a PE and an estimated 200,000 deaths occur.

The Crux Biomedical IVCF was designed to address the limitations of currently available vena cava filters including perforation, migration and inability to retrieve. “Crux was able to design a device that is both more versatile and simple to use,” stated Tom Fogarty, M.D., noted cardiovascular surgeon and founder of Crux Biomedical.

“We are extremely pleased with the results from the recently completed pivotal trial performed at  22 centers of excellence in the United States, Australia, New Zealand and Belgium. Our device demonstrated an excellent safety profile. The Crux device could be retrieved with a 98% success rate,” stated Mel Schatz, CEO of Crux Biomedical. The Company anticipates submission to the FDA in January and U.S. approval in 2012.

Crux Biomedical is located in Menlo Park, California and is focused on developing improved therapies for the human vasculature. It is funded by Alloy Ventures, Three Arch Partners, Emergent Medical Partners and Thomas Fogarty, M.D.. Additional information is available at www.cruxbiomedical.com.

Source:http://www.prnewswire.com/news-releases/crux-biomedicals-ivc-filter-receives-ce-mark-approval-137876098.html

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DuoFertility Decodes Messages Between Armpit, Ovaries

DuoFertility Decodes Messages Between Armpit, Ovaries

Cambridge Temperature Concepts Ltd. received 510(k) approval for their DuoFertility ovulation Monitor. The DuoFertility monitor has been featured previously onMedgadget and comprises a wearable sensor and reader unit for measuring ovulation patterns. The sensor is worn under the armpit and measures subtle changes in basal body temperature which is indicative of ovulation. The reader wirelessly receives the sensor data and predicts when you are most likely to become pregnant up to six days in advance. A number of additional parameters can also be entered into the reader unit to improve the prediction quality. The recorded data can be visualized by connecting the reader unit to a PC, as shown in the video below.

The DuoFertility has been commercially available in Europe since 2009 and was the subject of aresearch paper published last year which demonstrated its efficacy in some couples eligible for IVF.

From the product website:

The study followed the first 500 couples using DuoFertility from launch in 2009, including 242 who qualified for IVF/ICSI treatment, of whom 90 had previously had the procedure. The one-year clinical pregnancy rate for those who qualified for IVF was 39%, which is higher than either the UK or EU clinical pregnancy rates for a cycle of IVF (26% and 28% respectively), whilst the corresponding rate for those who had already been through a cycle of IVF/ICSI was 28%.

The study included couples with unexplained infertility, as well as those with mild to moderate male and female factor infertility. This accounts for approximately 80% of all infertile couples, and half of all IVF patients.

At the Future Health Mission 2011 in San Francisco last week, we were offered a chance to check out some of the latest and most promising medtech startups from the United Kingdom, who came for a tour of Silicon Valley.
Here’s one technology that impressed us a lot. DuoFertility is an ovulation pattern temperature monitor from Cambridge Temperature Concepts Ltd. The DuoFertility technology wasprofiled by us back in 2008 when it was in prototype stage. Now it is a fully developed device that has an auxiliary temperature monitoring patch and a receptacle that downloads temperature data from the patch and sends it to a service center. The idea is to use the temperature variations of a woman to extrapolate the best day(s) for her to conceive. According to the company’s CEO and founder Dr Shamus Husheer, the device is already selling quite well in emergent markets such as Middle East and Asia, and is on its way to wider use in Europe. And, of course, the company is hoping to obtain US FDA approval sometime in the near future.

The system is based on a sophisticated version of the body basal temperature (BBT?) measurement method (the small upward shift in basal body temperature which is associated with ovulation). The system identifies when you are most likely to get pregnant, up to six days in advance. This gives you plenty of time to plan intercourse for the best time of the month.
Temperature measurements are made automatically up to 20,000 times per day by the DuoFertility sensor. In addition, personal fertility related data you provide such as menstruation? dates, ovulation pain, etc are also added into the fertility analysis to give you the most accurate predictions possible.

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Kaiser Permanente Health Records Securely Available on Mobile Devices

Kaiser Permanente Health Records Securely Available on Mobile Devices

Kaiser Permanente, the largest managed care organization in the United States, has unveiled an Android app and mobile-optimized website through which its 9 million patients can access their own medical information anywhere in the world on their mobile devices. The app and mobile website contain the same information and possibilities that were already available through kp.org, i.e. lab results, diagnostic information, secure email access to doctors, ordering of prescription refills, scheduling appointments and locating of healthcare facilities. It is also possible for family members to get access on behalf of a patient and accomplish the same tasks.

The Android app is available for free from the Android market.

Kaiser Permanente already has the largest electronic medical record system in the world. Today, the health care organization announced that 9 million Kaiser Permanente patients now can easily access their own medical information anywhere in the world on mobile devices through a mobile-optimized website.

Kaiser Permanente has released a new app for Android devices, and users of other mobile devices, including the iPhone, can also get full access to that information from the Kaiser Permanente health record system with the mobile-optimized version of kp.org. An additional app for iPhone will be released in the coming months, but iPhone users can easily download a shortcut icon onto their home screens that will take them directly to the mobile-friendly kp.org with a touch of the finger.

Kaiser Permanente has led the health care world in providing online access to information for its patients. In 2011 alone, more than 68 million lab test results were made available online to Kaiser Permanente patients. The mobile-optimized site and the new app make that information, and much more, securely available at members’ fingertips.

Kaiser Permanente patients will have 24/7 access to lab results, diagnostic information, direct and secure email access to their doctors, and will also be able to order prescription refills. Kaiser Permanente patients have been able to email their doctors for five years, with more than 12 million e-visits in 2011 alone. Kaiser Permanente expects that number to increase significantly with the new app and mobile-optimized site.

The Android app is available now in the Android Market at no charge. Users of other mobile devices can access the same set of care-support tools at no charge through the new secure, mobile-optimized member website, which is available through smart-phone Internet browsers.

With the new offering, Kaiser Permanente patients have 24/7 access from their mobile devices to view their secure personal health record, email their doctors, schedule appointments, refill prescriptions and locate Kaiser Permanente medical facilities. Members who have the ability to act on behalf of a family member on kp.org now can accomplish the same tasks. Those caring for an elderly parent or someone with a chronic condition can now more easily check lab results, refill prescriptions and communicate with the doctor’s office on behalf of the patient.

“This is the future of health care. Health care needs to be connected to be all that it can be. This new level of connectivity is happening real time, and it is happening on a larger scale than anything like it in the world,” said George Halvorson, chairman and chief executive officer of Kaiser Permanente. “The fact that a Kaiser Permanente patient in an emergency room in Paris or Tokyo can simply pull out their mobile device and have immediate and current access to their own medical information is an evolutionary and revolutionary breakthrough for medical connectivity.”

“Our members love our current connectivity tools,” said Christine Paige, senior vice president of marketing and Internet services. “Now we will extend our entire connectivity tool kit for patients through a mobile phone. Our mobile-optimized site and app take connectivity to the next level by making the mobile experience easy and enjoyable. We believe that convenience, paired with a great user experience, will meet members’ needs and will ultimately result in improved health and patient-physician relationships.”

Members using the Android app have access to their kp.org accounts by touching the app icon on their phones. Those visiting kp.org from a mobile phone Internet browser are seamlessly redirected to the mobile-optimized website, which was designed for optimal viewing on a mobile-phone screen. In both cases, a streamlined menu of mobile-optimized features helps members find what they need quickly and easily with minimal taps.

“Providing our patients with clear and convenient access to their health information is a step forward in connectivity and improving the health care experience for patients, no matter where they are,” said Jack Cochran, MD, executive director of The Permanente Federation. “We already have complete connectivity among Kaiser Permanente care sites through Kaiser Permanente HealthConnect®. This new level of connectivity extends the reach of information to our patients in a more convenient and user-friendly format. This new app and mobile-optimized site is very good for patient care and will revolutionize connectivity by bringing health care for the first time to the level of connectivity other parts of our economy have achieved.”

Users’ personal health information is safe and secure while using the new app and the mobile-friendly kp.org, which employ the same security safeguards that protect patient information on the traditional kp.org website, including secure sign-on and automatic sign-out after a period of inactivity.

“The benefits of mobile extend beyond member engagement,” said Philip Fasano, executive vice president and chief information officer of Kaiser Permanente. “Mobile solutions can have a positive impact on health. Health care, itself, will be much more convenient for many people. The mobile-friendly site and app are also a springboard for new innovations that will inspire members to be aware of their health and take steps to improve it.”

The Pew Internet Project reported that 40 percent of American adults access the Internet via their mobile phones, and in some cases, mobile phones are their primary source of Internet access. Twenty-five percent of smart-phone owners go online primarily using their phone; of these, roughly one-third have no high-speed home broadband connection.

“There has been an explosion in the growth of mobile devices and users are looking for new and improved ways to manage their lives online,” Halvorson said. “It is time to make health information easily accessible from mobile devices.”

Edelman’s 2011 Health Barometer reported that 68 percent of those who use digital tools to manage or track their health believed it helped them improve their health,” Paige said. “Nearly 80 percent of kp.org users agreed that the website helps them stay healthy. The tools and services available on kp.org are even more powerful in the palm of your hand.”

This is a major new connectivity offering, but it is not Kaiser Permanente’s first mobile app. Other, more targeted tools, were released earlier. Kaiser Permanente launched its first mobile application, KP Locator for iPhone, in July 2011. The facility-finder app has been downloaded 42,000 times. KP Locator combines the power of kp.org’s robust facility directory and the iPhone’s GPS capabilities to make searching for Kaiser Permanente facilities fast and easy for patients on the go. It answers three of the most basic, but vital, user questions thoroughly and simply — where are the Kaiser Permanente locations close to me, how can I contact and get to them, and what departments and services can I access there? Kaiser Permanente also released itsEvery Body Walk! app two months ago to help encourage people to walk and maintain healthy activity levels, and that app was rated No. 5 in the Top 100 Green Apps by Eco-Libris.

Kaiser Permanente is known for its leadership in the use of health information technology. The Kaiser Permanente electronic health record is the largest non-governmental medical record system in the world. KP HealthConnect enables all of Kaiser Permanente’s nearly 16,000 physicians to electronically access the medical records of all 8.9 million Kaiser Permanente members nationwide and serves as a model for other care systems. Kaiser Permanente has received numerous awards for its health IT expertise, including four 2011 eHealthcare Leadership Awards. You can learn more about how patients, clinicians and researchers are using My Health Manager and KP HealthConnect by checking out Kaiser Permanente’s YouTube channel: www.youtube.com/kaiserpermanenteorg. Kaiser Permanente also has what might be the world’s most complete electronic medical library to support its caregivers by providing convenient access to the best and most current medical science. That electronic medical library is for internal use only.

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