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The Lancet Oncology

Monday, August 31, 2009

Diagnostic Test to Select Patient Candidates for Novel Investigational Non-Small Cell Lung Cancer Therapy

Abbott's molecular diagnostics business, headquartered in Des Plaines, Ill.,has entered into an agreement with Pfizer Oncoloy, a business unit of Pfizer Inc, committed to the discovery, investigation and development of innovative treatment options for cancer patients worldwide, to develop a molecular diagnostic test intended to screen non-small cell lung cancer (NSCLC) tumors for the presence of gene rearrangements.

Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers. To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC tumors and a wide variety of other cancers, but not in normal cells, must be present.

Under terms of the agreement, Abbott will develop a companion diagnostic test that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066.

"We are very pleased to partner with Abbott to develop a companion diagnostic test for non-small cell lung cancer and ensure its global availability for patients and physicians who need this information to make the best treatment decisions," said Garry Nicholson, General Manager, Pfizer Oncology Business Unit.

"This test will allow us to focus on the patient population most likely to benefit from our NSCLC candidate. Working in close partnership with the experienced Abbott team, we are confident that we will deliver yet another application of personalized medicine to address a currently unmet medical need in NSCLC."

"Pfizer's novel compound for treating non-small cell lung cancer appears to be ideally suited to individualized therapy," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "Abbott is a leader in the development and commercialization of companion diagnostics and we're delighted to collaborate with Pfizer, a leader in cancer therapeutics, on the development of a test to identify patients who might benefit from this important compound."

Patient Education Summits to Address Special Challenges of Hemophilia Patients and Their Families

More than 160 families of patients living with a rare form of hemophilia are coming together at educational summits sponsored this fall by the National Hemophilia Foundation (NHF) and the Center for Biomedical Continuing Education (CBCE).

For the fifth year, the Inhibitor Education Summits will connect patients and their families with expert healthcare professionals and fellow patients to address pertinent topics such as effective pain management, exercise and nutrition, financial security, and psychological wellbeing. The summits are supported by an educational grant from Novo Nordisk, a pharmaceutical company providing a unique opportunity for patients to connect and learn from others with the disease.

Hemophilia is a chronic, inherited bleeding disorder that occurs because certain blood clotting factors are missing or do not work properly. Spontaneous internal bleeding can occur, especially in the joints and muscles.

The 2009 summits, (the first took place in Hollywood, C.A., August 27-30; a follow-up is planned later this year in Washington, D.C., September 17-20) are the first and only events of their kind that focus specifically on patients with inhibitors. Inhibitors are rare, affecting approximately 800 to 900 Americans. Inhibitors are a serious complication that can develop after treatment in as many as 30 percent of people with hemophilia, most commonly in young children. These patients develop antibodies (or inhibitors) that circulate in the blood stream and actually neutralize, or attack clotting replacements, resulting in an increased risk of bleeding, arthropathy (or joint disease), physical disability and death.

People living with this disease often navigate tremendous challenges, both physically and emotionally. Sid Ramirez, age 21, has lived with hemophilia his entire life. He developed inhibitors at the age of three. His condition led to significant problems with his knee joints, leaving Sid wheelchair bound by age 11. He underwent lateral knee replacement surgery as a teenager, which enabled him to walk again.

"The summits allow others living with inhibitors and their families to learn from each other's experiences and from experts. No one can understand what you go through as well as those who have experienced it themselves and their families," said Sid. "Hemophilia has significance in the decisions I make, but I will not let it be the deciding factor." Currently enrolled in culinary school to pursue his lifelong passion for cooking, Sid is excited about the future ahead.

NHF Chief Executive Officer Val Bias has a special reason for participating in the summits. He's also a person with hemophilia. "Education has been a cornerstone of the NHF, and the Inhibitor Education Summit is a prime example of that," said Bias, who will also speak at both summits. "We believe it is critical to be able to provide these kinds of programs that help patients and their families achieve greater success in managing inhibitors."

In addition to education for patients and caregivers, there is a comprehensive Youth Camp for children with inhibitors and their siblings. Children attending the Youth Camp will have the opportunity to show their parents all that they have learned during their time at "camp." There is also ample time for networking with other families and "ask the experts" sessions to interact with physicians and other key opinion leaders in the field. Since the Inhibitor Education Summits began in 2005, hundreds of families have benefited from this unique opportunity to learn and connect with others who share their experience.

"Comprehensive management of hemophilia with inhibitors is vital for maximizing the quality of daily life for patients with this difficult condition," said Dr. Guy Young, Director, Hemostasis and Thrombosis Center, Childrens Hospital Los Angeles and co-chair of the summits.

"The 2009 Inhibitor Education Summits provide patients and their families with the opportunity to learn effective management strategies, connect with expert medical professionals, and share experiences with other families." Dr. Leonard Valentino, Director, RUSH Hemophilia and Thrombophilia Center, RUSH University Medical Center, is also co-chair of the summits.

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New Molecular Test to Help Assess Prostate Cancer Risk

Gen-Probe Incorporated (San Diego, CA), a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs), announced late last week that the Company has begun a clinical trial intended to secure U.S. regulatory approval of its PROGENSA PCA3 assay, a new molecular test that may help determine the need for a repeat prostate biopsy.

"Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our PROGENSA PCA3 assay can help predict the risk of a positive follow-up biopsy, thereby improving patient care," said Eric Lai, PhD, Gen-Probe's senior vice president of research and development. "In addition, this is an important step forward in our efforts to maximize the economic value of our oncology strategy."

The clinical study of the PROGENSA PCA3 assay is expected to conclude in less than a year, after which Gen-Probe intends to submit a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration. The Company anticipates the trial will enroll approximately 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites.

Data from more than 20 peer-reviewed publications suggest that the PROGENSA PCA3 assay, when used in conjunction with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as minimizing unnecessary biopsies.

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 35 will die from it. The ACS estimates that more than 192,000 Americans will be newly diagnosed with prostate cancer in 2009, and that more than 27,000 men will die from the disease.

PCA3, over-expressed in prostate cancer
PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing.

Gen-Probe's PROGENSA PCA3 assay, which has been CE-marked for sale in the European Union, is the first urine-based molecular diagnostic assay for prostate cancer. The test has not been approved for marketing in the United States.

Gen-Probe acquired exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November of 2003.

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CyberKnife Treatment Planning Capabilities in Precision Radiation Delivery for Lung Cancer

Accuray Incorporated, a global leader in the field of radiosurgery, announced today that it wil showcase the treatment planning capabilities of the CyberKnife Robotic Radiosurgery System at the 10th Biennial European Society for Therapeutic Radiology and Oncology (ESTRO) Conference on Physics and Radiation Technology for Clinical Radiotherapy in Maastricht, The Netherlands.

The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system designed to treat tumors anywhere in the body non-invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife System to deliver high-dose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.

The latest generation of the MultiPlan Treatment Planning System provides the most comprehensive set of tools available for high-precision radiosurgery treatment planning. The CyberKnife System's planning capabilities also include Monte Carlo Dose Calculation, which produces results in minutes compared to what commonly requires hours or days with other systems.

"We strongly believe that these new capabilities will transform the treatment planning practice, specifically for the treatment of lung tumors," said Frederic Sottilini, Senior Director, Marketing, Accuray EMEA.

Clinical findings will be presented during the conference, including the results of a study presented by Erasmus MC-Daniel den Hoed Cancer Center (Rotterdam, The Netherlands) that demonstrates the benefits of the dose calculations performed using the CyberKnife System's Monte Carlo Dose Calculation in the treatment of Non-Small Cell Lung Cancer.

"Medical physicists from renowned academic centers will contribute to the scientific quality of this symposium, which should gather physicists from all over Europe who are interested in learning more about the highly-sophisticated treatment planning techniques that are available," said Sottilini.

New Assessment Quantifies Risks and Benefits of Warfarin Treatment for Atrial Fibrillation

Warfarin (an oral anticoagulant) therapy for patients with atrial fibrillation - the most common type of significant heart rhythm disorder - appears to be most beneficial for the oldest patients, for those who have had a prior stroke and for patients with multiple risk factors for stroke, according to a new study by Kaiser Permanente and Massachusetts General Hospital researchers.

This comparative effectiveness research study, among the first and largest to quantify warfarin's net clinical benefit - how much a treatment's potential benefits outweigh its risks - in the usual clinical care of patients with atrial fibrillation, appears in the September 1 issue of The Annals of Internal Medicine.

As part of the ongoing ATRIA (AnTicoagulation and Risk Factors In Atrial Fibrillation) study, researchers followed 13,559 adults with atrial fibrillation treated within Kaiser Permanente of Northern California from 1996 to 2003. To evaluate the risks and benefits of warfarin treatment and give patients and physicians quantitative guidance in making therapeutic decisions, the researchers analyzed rates of the two most significant adverse events associated with warfarin therapy - ischemic stroke, the type produced by arterial blockage, and intracranial hemorrhage, bleeding within and around the brain. In patients who did and did not take warfarin, the investigators balanced the reduction in ischemic stroke attributable to treatment against the increase in intracranial bleeding associated with warfarin. Since intracranial hemorrhages usually have worse outcomes than ischemic strokes, bleeding events were given greater weight in the comparison.

While warfarin therapy benefited most atrial fibrillation patients, the balance of benefits over risks was greatest in those at highest risk of stroke - those with multiple risk factors, those with a history of stroke and the oldest patients. The benefits of treatment increased dramatically with age, with no clear benefit in the average patient younger than 65 but a reduction of more than two strokes per 100 patients in those 85 and older.

Occurring when the upper chambers of the heart quiver instead of contract smoothly, atrial fibrillation affects more than 2.3 million Americans. Because the heart rhythm disturbance promotes the formation of blood clots, which can travel to the brain and block an artery, atrial fibrillation increases the risk of stroke fivefold. The condition is highly age-dependent and affects 10 percent of those over age 80.

Researchers have long known that warfarin is effective in preventing such strokes, but the treatment can be difficult to control and often leads to hemorrhages. In fact, warfarin is associated with the most emergency admissions for drug-related adverse reactions, according to the researchers. Balancing the benefits of warfarin against its most severe risks is critical to making the best therapeutic decisions for individual atrial fibrillation patients, explains the study's senior author Alan S. Go, MD, Director of the Comprehensive Clinical Research Unit at the Kaiser Permanente Division of Research in Oakland, CA

Daniel Singer, MD, of the Massachusetts General Hospital Clinical Epidemiology Unit, the report's lead author, adds, "This comparative effectiveness study gives us more information about which atrial fibrillation patients are most likely to benefit from carefully administered warfarin therapy." He explains that, by assessing warfarin within a "real world" practice setting, the study provides a more contemporary assessment of the therapy's overall effects than do older clinical studies.

Go explains that Kaiser Permanente physicians in Northern California partner with pharmacist-run anticoagulation clinics to provide thorough and nimble administration and careful monitoring of warfarin therapy for atrial fibrillation patients. This allows for delivery of high-quality anticoagulation therapy through frequent testing and appropriate dose adjustment to account for changes in diet, medications and clinical status that may impact the therapy's narrow therapeutic window.

Singer adds, "One of our distinctive findings is that stroke risk continues to increase in patients age 85 and older and that warfarin provides substantial net protection for these elderly patients. A caution is that all these patients were presumably judged by their physicians to be reasonable candidates for warfarin therapy, so these results do not automatically apply to all elderly atrial fibrillation patients."

Funding for the study was provided by the National Institute on Aging, the National Heart, Lung. Blood Institute and the Eliot B. and Edith C. Shoolman fund of the Massachusetts General Hospital.

FDA Approves Six New Presentations of Heparin

Hospira, the world leader in generic injectable pharmaceuticals and a global specialty pharmaceutical and medication delivery company headquartered in Lake Forest, Illinois, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's applications for six new presentations of therapeutic heparin in single- and multiple-dose vials.

Heparin, a highly-sulfated glycosaminoglycan, is widely used as an injectable for anticoagulant for therapy. The drug is also used to prevent clot formation in central venous catheters and is available in numerous delivery systems for different modes of administration.

The six new vial presentations of heparin approved by the FDA range in volume from one milliliter to 30 milliliters, and in concentration from 1,000 units per milliliter to 10,000 units per milliliter.

Hospira recognizes the clinical need for this important medication and sought to expand its marketed portfolio of heparin presentations to help meet market demand. With the addition of the new vials, Hospira now offers one of the broadest portfolios of heparin available on the U.S. market, with various sizes and strengths of the product available in syringes, vials and flexible containers.

"Hospira is committed to ensuring patient access to safe and effective supplies of heparin," said Joshua Gordon, vice president, Specialty Pharmaceuticals, Hospira. "These additional presentations will provide our customers a wide range of options to address the continuum of care.”

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Prostate Cancer Kills - Every 20 Minutes

Every 20 minutes, a son, father or grandfather will die from this disease. To create awareness, Hank Oprinski, CEO at Capital Earnings & Research, is launching his nationwide tour to inform corporations, chambers of commerce, golfing communities, economic clubs, universities and other interested civic organizations to be proactive about prostate cancer.

This year in the United States, approximately 190,000 men will be diagnosed with the disease. That means a new case will occur every 2 minutes and 30 seconds. "I'm a prostate cancer survivor and live a relatively normal life." says Oprinski.

"Cancer seminars are happening across the country and in most corporate backyards. The acceptance of the concept of these presentation demonstrates that organizations care about their neighborhood and the people who dedicate themselves to the prosperity of that organization. It shows involvement and organizational interest because people want to do something to help someone else," says Oprinski.

His success comes from his demonstration of how he copes with prostate cancer, involves his family for support and continues to build a successful business while addressing how a partner can help patients through challenging times, how support groups can play a role, the importance of second opinions, how patients can, and need, to get to know their own body, how patients can control their destiny and medical outcome. Oprinski also talks about the never-spoken-of side-effects of prostate cancer and talk about prevention by explaining ways to minimize the risk of prostate cancer

Oprinski has worked in 26 countries with a career that has taken him to Europe, the Middle East and Asia. He is a former Executive Vice President of BCG, Inc. and is the current Managing Partner and CEO associate of Capital Partners Limited, LLP. Oprinski is a recognized guest speaker and seminar instructor of international strategic planning, the author of "Customer Service, the Strategy for the 2000's" and a general aviation pilot.

September Is Prostate Cancer Awareness Month.

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  • To schedule an event or for more information, contact Hank Oprinski at (256) 417-6084