Critical Outcome Technologies Inc. (COTI) (TSX VENTURECOT) announced important positive results today from a series of experiments carried out at a prominent American cancer research facility. The experiments were designed; first, to estimate the oral maximum tolerated dose (MTD) for COTI2; second, to evaluate the effectiveness of oral COTI2 alone and third, to compare the effectiveness of oral COTI2 plus Doxil® (doxorubicin HCl) to that of Doxil alone. The experiments showed that

The MTD from these experiments is 100125 mg/kg when COTI2 is given once daily for 5 days/week for up to three consecutive weeks.

The maximum tumor growth inhibition was 62.8% (p less than 0.05) at day 19 in animals treated with COTI2 at or below the MTD compared with animals receiving no drug treatment.

The maximum tumor growth inhibition was 79.2% (p less than 0.05) at day 19 in animals treated with COTI2 at or below the MTD plus Doxil compared with animals receiving no drug treatment.

The maximum tumor growth inhibition was 80.2% (p less than 0.05) at day 19 in animals treated with COTI2 at or below the MTD plus Doxil compared with animals treated with Doxil alone.

Treatment with the combination of COTI2 and Doxil was well tolerated.

These results confirm and extend results from previous animal experiments where COTI2 was given intravenously and provide strong supportive evidence for the continued development of oral COTI2 in combination with conventional single agent therapy for the treatment of human ovarian cancer.

“COTI2 was originally designed to be an oral agent for the out patient treatment of multiple cancers and we are delighted to see that oral COTI2 alone, and in combination with Doxil, showed superior treatment results compared to Doxil alone as measured by significant tumor growth inhibition in an animal model of an aggressive human ovarian cancer (A2780). These results are significant because they add to the impressive data set of COTI2, showing effectiveness, particularly in combination with first and second line agents, against multiple cancers while also exhibiting low toxicity,” said Dr. Wayne R. Danter, President and Chief Scientific Officer of COTI.

“We are very pleased to receive this important new scientific data providing powerful evidence supporting the commercial potential of our pipeline,” said Mr. Michael Cloutier, Chief Executive Officer of COTI.

Source

The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohns disease, and other inflammatory diseases.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factoralpha (TNFα), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab).

Todays action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNFblockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

For more information see

Update to June 2008 Early Communication about an Ongoing Safety Review of TNF Blockers
Information for Healthcare Professionals

Outcome Sciences, Inc. (OUTCOME), the leading provider of patient registries, studies, and technologies for evaluating realworld outcomes, announced that Nancy Dreyer, MPH, PhD, Chief of Scientific Affairs and Senior Vice President at Outcome, will be presenting at the International Society for Pharmacoepidemiologys (ISPE) 25th Anniversary International Conference on Pharmacoepidemiology and Therapeutic Risk Management. The conference is being held from August 1619 at the Rhode Island Convention Center in Providence, Rhode Island.

The first session, entitled “Can Registries Deliver? The Methods and Use of Registries for Biologics”, will be held on Monday, August 17th at 330 P.M. and will focus on the unusual challenges in studying the safety and effectiveness of biologics, and how registries are being used to generate evidence. Panelists will discuss design issues, considerations for interpreting data from biologics registries, and the regulatory perspective on risk management.

On Tuesday, August 18th at 245 P.M., Dr. Dreyer will participate in the case study discussion “Human Avian Influenza Development of a ShoeLeather Approach to Evaluating Treatment Effectiveness.” This successful case study highlights a global initiative to study clinical presentation, natural history, treatment effectiveness and clinical outcomes for human avian influenza. The participants will present an oldfashioned approach to building collaboration, country by country, along with the studys learned lessons and potential applicability to other pandemic threats.

Dr. Dreyers final presentation, “Developing Good Practice Guidance for NonRandomized Studies of Comparativeness Effectiveness A Workshop on Quality and Transparency”, will take place at 400 P.M. on Tuesday, August 18th. This workshop will address the study of comparative effectiveness using observational studies. Panelists will present an overview of comparative effectiveness, describe ongoing guidance activities from a U.S. government perspective, and present the GRACE Principles for review and discussion. The GRACE principles are the product of a broad initiative intended to provide highlevel guidance to reviewers seeking to evaluate observational studies of comparative effectiveness and distinguish highquality work. Learn more about the GRACE principles at graceprinciples.org.

For additional information on 25th Anniversary International Conference of Pharmacoepidemiology and Therapeutic Risk Management taking place on August 1619, 2009, please go to spharmacoepi.org/meetings/25thconf/index.cfm. Outcome is also exhibiting at the conference and is located at booth #1.

About the International Society for Pharmacoepidemiology (ISPE)

ISPE is an international organization dedicated to advancing the health of the public by providing a forum for the open exchange of scientific information and for the development of policy; education; and advocacy for the field of pharmacoepidemiology, including pharmacovigilance, drug utilization research, and therapeutic risk management.

Additional information on ISPE can be found on the ISPE website at spharmacoepi.org/

Source

Researchers from North Carolina State University and Mayo Clinic have developed a computer model that medical doctors can use to determine the best time to begin using statin therapy in diabetes patients to help prevent heart disease and stroke.

“The research is significant because patients with diabetes are at high risk for cardiovascular disease and statins are the single most commonly used treatment for patients at risk of heart disease and/or stroke,” says Dr. Brian Denton, “and this model can help determine the best course of action for individual patients based on their risk of developing cardiovascular disease.” Denton is an assistant professor in NC States Edward P. Fitts Department of Industrial & Systems Engineering and lead author of the study.

Statins are a key component of current cardiovascular medical treatment guidelines, Denton says. They lower cholesterol levels and may significantly reduce the risk of heart attack and stroke, particularly in patients that are considered to be at high risk.

The researchers developed a new mathematical model that examines various possible treatment policies to see how they influence shortterm and longterm health outcomes for patients. The model shows how people are affected by diabetes, and how their health changes over time as patients age and the disease advances.

The new model incorporates patientspecific data. An established risk model calculates each patients probability of heart attack and stroke based on risk factors, such as their cholesterol, blood pressure, etc. This overall risk “score” is used to weigh the medical advantages of beginning statin therapy against the financial cost of the statins.

Overall, by accounting for the progression of diabetes, the patients specific risk score and the costbenefit analysis, the new model may help patients and doctors decide on the optimal time to begin statin therapy.

Denton says the new model has not yet been put into practice, but that the research team plans to develop a pilot to put the tool into the hands of medical professionals.

The research, “Optimizing the Start Time of Statin Therapy for Patients with Diabetes,” was funded in part by the Agency for Healthcare Research and Quality and the National Science Foundation, and was published earlier this month in the journal Medical Decision Making. The research was coauthored by Denton from NC State; Nilay D. Shah, Sandra C. Bryant and Steven A. Smith of the Mayo Clinic College of Medicine; and University of Pittsburgh graduate student Murat Kurt.

“Gov. Arnold Schwarzenegger [of California] on Wednesday conceded that longstanding delays in disciplining errant health professionals were absolutely unacceptable and promised broad reforms to better protect patients from dentists, pharmacists, therapists and others accused of misconduct,” ProPublica/The Los Angeles Times reports. The reforms will include adding more investigators and auditors and new laws to fasttrack suspensions of licenses of professionals who dont comply with rules. The reforms would be subsidized by hiking licensing fees, and come a month after an investigation by the two news organizations revealed that it took an average of three years to conclude investigations of nurses accused of wrongdoing.

Schwarzenegger hopes to cut that time in half with the reforms that would target all 18 “healing arts” boards that regulate the states 900,000 health workers. He took earlier action to replace members of the states nursing board. “Despite the dramatic gestures, Schwarzeneggers own actions may have contributed to problems” at the boards, ProPublica/The Los Angeles Times reports. “A blizzard of budgetcutting,” work furloughs, and failure to promptly fill vacancies on healthrelated boards may be contributing to the problems (Weber, Ornstein and Lin, 8/13).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

The worlds foremost thought leaders in the science of aging will convene at Harvard in September to discuss the question that has perplexed people since Ponce de Leon first sought out the Fountain of Youth, “can we live longer and healthier lives?” For the first time the scientific consensus appears to be, “yes.”

Worldrenowned physicians, academic leaders and awardwinning researchers in what has been described as the hottest field in biology, are expected to attend the first ever Aging & Healthy Lifespan Conference on Sept. 23 at Harvard Medical School. They plan to present breakthrough scientific research and insights on social trends that may provide the key to unlock the secret to living longer and healthier lives. The groundbreaking research presented by these experts has been predicted to change healthcare as we know it by combating agerelated diseases like Alzheimers, type2 diabetes and cancer, ultimately extending the human lifespan altogether.

The conferences agenda features more than 20 experts, who have been described as mavericks and pioneers in the field of aging research, including Aubrey de Grey, Ph.D., Chairman and Chief Science Officer of the Methuselah Foundation, who developed an approach to identify all components that cause human aging and remedy each one to expedite a cure for aging;
David Ewing Duncan, awardwinning journalist and bestselling author of seven books, including The Experimental Man, a Chief Correspondent for public radios “Biotech Nation,” a longtime commentator for NPRs “Morning Edition,” and the Director of the Center for Life Science Policy and a Visiting Researcher at the Graduate School of Journalism at the University of California, Berkley.
Leonard Guarente, Ph.D., Novartis Professor of Biology at the Massachusetts Institute of Technology and researcher credited with the discovery of the biochemical activities of sirtuins that have the potential to combat diseases of aging;
Cynthia Kenyon, Ph.D., Director of Hillblom Center for the Biology of Aging, University of California, San Francisco, who first discovered that genetic dissection influences aging;
Michael F. Roizen, M.D., CoFounder of RealAge and awardwinning, #1 New York Times bestselling author and coauthor of five books in the RealAge series, including RealAge Are You as Young as You Can Be? and YOU The Owners Manual An Insiders Guide to the Body that Will Make You Healthier and Younger, coauthored with Dr. Mehmet Oz.
David Sinclair, Ph.D., Sirtris CoFounder, Scientific Advisory Board CoChair and Associate Professor of Pathology at Harvard Medical School and key contributor to the scientific understanding of aging;
Christoph Westphal, M.D., Ph.D., Chief Executive Officer, Sirtris, a GSK Company and Senior Vice President, Centre of Excellence for External Drug Discovery, GSK. Sirtris is focused on discovering and developing drugs to treat diseases of aging. Speakers at the Aging & Healthy Lifespan Conference will present emerging research into scientific and medical advances in aging, as well as lifestyle and demographic trends on two speaker tracks. One track will focus on new research and insights in the science of aging including updates on the science behind sirtuins and resveratrol, the key ingredient in red wine that researchers believe has the power to slow symptoms of aging. The second track will feature emerging social trends in lifestyles, behaviors and activities of the aging population.

The meeting of these experts is welltimed, as over the next 20 years, the population over age 65 is expected to double, and with it, healthcare spending expected to rise by 25 percent.

“We have understood the science behind aging for some time now, but now we are finally working towards making this research a pharmaceutical reality,” said Dr. Sinclair. “I think the highlight of the Aging & Health Lifespan Conference will be the examination of how this research can have a lifechanging effect on our aging population in the very near term.”

A multidenominational coalition of religious groups on Tuesday will launch a 40day campaign to encourage about 100 members of Congress in 18 states to pass health care reform legislation this year, CongressDaily reports. The campaign will include television advertisements, special sermons and a telephone conference call and webcast with President Obama on Aug. 19 (Dann, CongressDaily, 8/10). Among the groups involved in the campaign are the Religious Action Center of Reform Judaism, Catholics in Alliance for the Common Good, the Islamic Society of North America, the PICO National Network, Faith in Public Life and Sojourners (Norman, CQ HealthBeat, 8/10).

The groups officials said that although the religious community may have different opinions about abortion funding and how it should be handled in the final overhaul bill, the issue should not be used to stop progress on health reform. Sojourners President Jim Wallis said, “While we have differences on the issue of abortion, the faith community is saying those that are prolife and prochoice are saying that abortion must not be the occasion for scuttling, destroying or sabotaging health care reform” (CongressDaily, 8/10).

According to the Philadelphia Inquirer, the planned events and the ad campaign are not designed to “pressure Congress on any particular plan” (Spolar, Philadelphia Inquirer, 8/11). The coalitions members on Monday, in announcing the campaign, said one of their objectives is to challenge the false information that has surfaced about health reform efforts (Dennis, Roll Call, 8/10). Wallis said, “There are people in the country who want to stop an honest, fair, civil and moral conversation about health care. Theyre organized and they really want to shut down democracy and we cant let that happen,” adding, “The faith community is literally going to stand in the way of those who want to stop a conversation.”

Group leaders said that Obamas participation in the campaign without an accompanying Republican viewpoint does not turn it into a partisan event, as Obama is not expected to discuss specifics about his reform preferences. The coalition instead will focus on the “moral imperative” of health reform in its discussion with Obama (CQ HealthBeat, 8/10).

Conservative Religious Group Suggests TownHall Meeting Questions

Meanwhile, the Family Research Council, an offshoot of Focus on the Family, is sending email alerts to members, encouraging them to go to townhall meetings and providing them with sample questions to ask lawmakers. For example, one of the questions states, “Will you agree to an ironclad guarantee that this bill will not fund abortions, leave state abortion limits in place, and protect health care providers from being forced to perform abortions?” The group also is running ads in five states (CongressDaily, 8/10).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

New research is needed into the clinical and cost effectiveness of the complementary therapies used by millions of Britons every year to improve and manage their health. So says a report by an independent advisory group convened by The Kings Fund and chaired by Professor Dame Carol Black published today.

Despite the increasing popularity of treatments like acupuncture, reflexology and osteopathy, the evidence as to whether and how they work is scarce, leaving the practices open to criticism. But lack of agreement on the best methods to test the efficacy and effectiveness of complementary therapies has proved an obstacle to addressing this problem.

This report hopes to establish a consensus on the ways in which research might be conducted that both the conventional and complementary health care communities can support.

Explaining the need for different types of research when assessing complementary practice, Professor Dame Carol Black said

It has become widely accepted that a stronger evidence base is needed if we are to reach a better understanding of complementary practices and ensure greater confidence in their clinical and cost effectiveness. The challenge is to develop methods of research that allow us to assess the value of an approach that seeks to integrate the physical intervention, the personal context in which it is given, and nonspecific effects that together comprise a particular therapy.

Commenting on the importance of making progress in this area, The Kings Fund Chief Executive, Niall Dickson said

Where complementary therapies are offered as part of the NHS it is imperative that those responsible for spending public money base their decisions on sound evidence. We need to understand more about the costs and benefits.

Doctors and patients need robust evidence to make informed decisions more research will play a vital role in showing what works and what does not, what is cost effective and what is not.

The report is the result of debate between experts in the fields of medical research, funding and practice, and was conducted over the course of more than two years.

Source
The Kings Fund

UroToday.com In the June issue of the Journal of Urology, Dr. Philipp Dahm and colleagues report that duplicate presentations commonly occur at the American Urological Association (AUA) and European Association of Urology (EAU) annual meetings.

The authors state that duplicate presentations of the same data at multiple meetings has disadvantages to include decreasing the opportunity for other presentations and decreasing the newsworthiness of the duplicate data. In this report, duplicate presentations at the AUA and EAU annual meetings in 2005, 2006, and 2007 were identified. The 2006 annual association meetings served as the reference meeting. The annual meeting online abstract databases were used to identify clinical research studies, and basic science was excluded. Only studies of identical design and objective were considered duplicates. The authors also determined the publication rate of duplicate abstracts using the science citation index.

At the 2006 EAU and AUA annual meetings, 282 and 312 prostate cancer related abstracts were identified, respectively. Similar characteristics were identified with regard to the number of authors, the country of authorship, and the study design. The median number of contributing authors was 6, and 81% of duplicate abstracts originated in a single country. Among the identified prostate cancer abstracts, 92.4% were observational studies and most commonly uncontrolled case series in 45.4%. At the AUA, abstracts originated from North America in 69.2%, Europe in 25.6% and other parts of the world in 5.1%. At the EAU, abstracts originated from North America in 12.1%, Europe in 79.1% and other parts of the world in 8.9%. In the AUA abstracts, study sample size was significantly higher with 50% including over 500 subjects compared with 29.4% at the EAU meeting. Overall duplicate rate of AUA abstracts at the 2006 annual meeting was 19.2% (60 of 312) and 48 of these 60 were presented at the EAU meeting the same year. Eight were presented at the EAU meeting the previous year (2005) and 4 presented the following year (2007). At the 2006 EAU meeting, the duplication rate of prostate cancer abstracts was 20.9% (59 of 282) with 48 of 59 presented at the 2006 AUA meeting, 3 the year before and 8 the year after.

Among the duplicated abstracts, 40.8% had a modified title and in 43.6% of studies the number of authors changed. Multivariate logistic regression analysis revealed that an outcome study design type and European abstract origin were the strongest predictors of duplicate presentation. With a followup of 30 months, 25 of 71 studies (35.1%) were published in journals indexed by the PubMed. Most commonly the journal was European Urology (32%). In summary one fifth of prostate cancer clinical research abstracts were presented at the AUA and EAU annual meetings in duplicate.

Pop GH, Fesperman SF, Ball DA, Yeung LL, Vieweg J, Dahm P
J Urol. 2009 Aug;182(2)6748
doi10.1016/j.juro.2009.04.024

Written by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

UroToday the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go tourotoday.com

UroToday.com Paradigm shift; instead of having the robot all around the patient and weighing 800 kg., how about having the patient all around the robot and weighing only a few 100 mg? The pioneering work of Cadeddu at Southwestern Medical School with magnetically controlled intracorporeal robots and by Dmitry Oleynikov at the University of Nebraska with electrically tethered intracorporeal robots could change the entire face of LESS and of NOTES.

Oleynikov and colleagues have developed a fixedbase camera that can be deployed through a small incision into the abdomen as well as a mobile, insertable robot capable of “rolling” onto an organ and taking a biopsy. It seems clear that technology will conquer the current shortcomings of the microrobot and that in the future a squadron of these robots may be deployed via a single 15 mm umbilical, transvaginal, or transvesical incision. Once inserted, the surgeon may well retire to a console where he/she can activate each robot as need be and direct it to complete the task at hand.

The transition from the unimaginable to the common everyday world seems to be taking less and less time over the years, to the point whereby yesterdays science fiction becomes the next years surgical advance.

Canes D, Lehman AC, Farritor SM, Oleynikov D, Desai MM
J Endourol. 2009 May;23(5)78792
10.1089/end.2008.0318

Written by UroToday.com Medical Editor Ralph V. Clayman, MDUroToday the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go tourotoday.com