Medarex, Inc. (Nasdaq: MEDX) announced that Dr. Geoffrey M. Nichol, Senior Vice President of Product Development at Medarex presented highlights from key programs in Medarex's oncology portfolio at the Needham & Company Cancer Therapeutics: Today & Tomorrow Conference in New York. The archived edition of the presentation webcast is available in the Investor Relations section of the Medarex website at medarex.
Highlights from Medarex's oncology portfolio included the following:
-- Ipilimumab is a fully human anti-CTLA-4 antibody in development for melanoma, prostate cancer and other cancers. Guidance for the completion of the first-line Phase 3 chemotherapy combination trial in melanoma (study 024) remains unchanged and is expected in late 2009, with overall survival as the primary endpoint under the amended Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Initiation of the second-line Phase 3 radiotherapy combination trial in prostate cancer remains on track for mid-2009. Additional data, including survival and biomarker analyses from the melanoma Phase 2 program and data from the Phase 2 prostate program, will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in May/June.
-- MDX-1105 and MDX-1106 are two fully human antibodies that target the PD-L1/PD-1 pathway for the treatment of cancer. MDX-1105 is in an ongoing multi-dose Phase 1 trial for advanced or recurrent renal cancer, melanoma, non-small cell lung cancer or epithelial cancer. MDX-1106 is in an ongoing multi-dose Phase 1b trial for prostate cancer, melanoma, non-small cell lung cancer and renal cancer. Complete MDX-1106 Phase 1 data will be presented at the upcoming annual meeting of ASCO in May/June.
-- MDX-1342 is a fully human anti-CD19 antibody in Phase 1 development for chronic lymphocytic leukemia (CLL). Proof-of-concept pharmacologic Phase 1 data for CLL, as well as for rheumatoid arthritis, is expected in 2009. Initiation of the Phase 1 trial in acute lymphocytic leukemia remains on track for fourth-quarter 2009.
-- MDX-1401 is a fully human non-fucosylated anti-CD30 antibody in Phase 1 development for Hodgkin Lymphoma. Interim data from the ongoing multi-dose Phase 1 trial will be presented at the upcoming annual meeting of the American Association for Cancer Research (AACR) in April.
-- MDX-1411 is a fully human anti-CD70 antibody in Phase 1 development for clear cell renal cancer and lymphoma. Additional enrollment in the expansion cohorts is expected by the end of 2009, with interim Phase 1 data expected in early 2010.
-- MDX-1203 is the first antibody-drug conjugate generated from Medarex's Antibody-Drug Conjugate (ADC) platform to reach clinical testing. Enrollment initiation in the Phase 1 trial for renal cancer remains on track for mid-2009.
-- Additional preclinical data from Medarex's ADC platform and selected ongoing research programs will be presented at the upcoming annual meeting of AACR in April.
In addition to the highlighted oncology portfolio, Medarex is developing a number of promising products outside of oncology, including antibodies to IP-10 and CD19 for inflammation and antibodies for infectious diseases. Throughout this year and next, Medarex anticipates a strong flow of research and development milestones, including the goal of moving one or two more antibodies into clinical development.
About Medarex
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Over forty of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with the most advanced product candidates currently in Phase 3 clinical trials, the subject of regulatory applications for marketing authorization or approved in Canada and Europe. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world's unmet healthcare needs. For more information about Medarex, visit its website at medarex.
Statement on Cautionary Factors
Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, such as statements preceded by, followed by or including the words "believe"; "expect"; "may"; "anticipate"; "projected"; "estimated"; "preliminary"; "suggest"; or "potential"; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with the development of ipilimumab and other product candidates, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing, risks associated with the enforceability of our patents, as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and its quarterly reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex's public disclosure filings are available from its investor relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.
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CME LLC a leading provider of fully accredited continuing medical education programs since 1978, announced the full curriculum and special events for its 20th Annual U.S. Psychiatric and Mental Health Congress, taking place October 11-14, 2007, in Orlando at the Gaylord Palms Resort & Convention Center.
"Besides the great educational offerings, our poster sessions provide another main attraction. This year, 81 research posters will be presented, showcasing some of the industry's latest research and innovative thinking," said Niki Oquist, MD, FAAP, and senior vice president of medical affairs for CME LLC. "There's excitement among attendees, faculty and supporters for the event itself and the special milestone this year represents."
CME LLC is proud to celebrate Congress' 20th year with four days of in-depth education on a wide assortment of the most current topics in psychiatry. Led by some of the nation's most distinguished psychiatric experts, this year's Congress offers 107 educational sessions and 30 hours of CME credits.
Educational sessions are grouped into eleven specialty tracks such as Biopsychiatry, Child and Adolescent Psychiatry, Practice Issues, Psychotherapy, and Violence and Trauma, with the initial symposium beginning on Wednesday, October 10, 2007.
Congress opens on October 11, 2007 with the presentation of CME LLC's Teacher of the Year award to Stephen V. Sobel, MD. Dr. Sobel is a clinical instructor at the University of California, San Diego, and the consulting psychiatrist for the National Football League's San Diego Chargers and Major League Baseball's San Diego Padres. He also owns and operates a private practice in San Diego focusing on adult and adolescent psychiatry. Dr. Sobel will become the 18th medical professional to earn Teacher of the Year honors from CME LLC, an honor that is awarded to a psychiatric professional who specializes in teaching and stands out among industry peers against an extensive list of demanding criteria.
More than 2,500 mental health professionals, including psychiatrists, primary care physicians, pharmacists and nurse practitioners will attend this year's U.S. Psychiatric and Mental Health Congress. For full details on the Congress, including information about sessions/symposia, faculty, the Exhibit Hall, how to register and more, visit CMELLC/psychcongress. Registration and information for the 2008 U.S. Psychiatric and Mental Health Congress in San Diego, October 30-November 2, 2008, will also be available at this year's Congress.
About CME LLC
CME LLC, a division of CMPMedica, is a leading provider of fully accredited continuing medical education programs and offers a wide range of informational and educational resources for healthcare professionals. Based in Irvine, Calif., CME produces a variety of live events and conferences, print supplements, multimedia home study products, and Web sites and is the sponsor of the U.S. Psychiatric and Mental Health Congress and Regional Extensions and the Advances series of medical education sessions, which includes Advances in Primary Care Medicine, Neurology and Pediatric Medicine.
CMELLC
Mental illness is associated with more lost work days than any other chronic condition, costing the Canadian economy $51 billion annually in lost productivity. In the first study of its kind, researchers from the Centre for Addiction and Mental Health (CAMH) have calculated the actual cost of mental health leave and found that on average it's double the cost of a leave for a physical illness.
The study, published in the Journal of Occupational & Environmental Medicine, looked at data tracking the short-term disability leave of 33, 913 full-time employees in Ontario. Results showed that the cost to a company for a single employee on a short-term disability leave due to mental health concerns totals nearly $18,000.
Dr. Carolyn Dewa, head of CAMH's Work and Well-being Research and Evaluation Program and lead investigator on the study, notes the disproportionate cost to employers when compared to other disabilities. "In an average year, a firm with 1,000 employees might expect about 145 disability cases. Of this, only a fraction are on disability due to mental illness, yet it costs employers the most." Disability leaves due to physical illness cost nearly half of that for a leave due to mental illness.
Health and wellness interventions may hold the key to maintaining a healthy workforce and reducing costs. "We know that mental health triggers in the workplace can lead to disability - things like stress, casual and part-time work, and uncertain economic conditions can really take a toll on workers - especially if there is a pre-existing mental health condition," says Dr. Dewa. "And while it is important to support workers that are on disability leave, it is crucial that businesses make mental health and wellness a priority to prevent disability in the first place."
Dr. Dewa suggests that implementing a continuum of care and support is an effective way of reducing the likelihood that an employee has to take a disability leave. She adds that programs emphasizing a healthy work-life balance, supports to help cope with stress, and access to physical fitness make people better workers and help sustain health.
Source:
Michael Torres
Centre for Addiction and Mental Health
Half of the children in the nation's child welfare system have a history of special health care needs, according to a new study by researchers at RTI International and the University of Illinois.
The study, published in the July 7 online issue of Pediatrics, found that during a three-year period, half of the children involved in the Child Welfare System had special health care needs that included chronic health conditions, such as asthma, as well as behavioral, emotional and developmental problems.
"This study is the first to examine longitudinally the extent of special health care needs among children in the child welfare system," said Heather Ringeisen, Ph.D., director of the Children and Families Research Program at RTI and the study's lead author. "Our results underscore the need for cross-system service collaboration between health, mental health and social service providers to better meet their needs. Inattention to these special health care needs may not only compound the immediate effects of abuse and neglect, but also may increase the risk of future long-term impairment for these children."
The study used data from the National Survey of Child and Adolescent Well-Being. The survey, conducted by RTI International, followed approximately 5,500 children over the course of five to seven years. The children ranged in age from birth to 15 years old and were reported for child maltreatment in 1999.
The study examined child outcomes for three years beyond the maltreatment investigation. The researchers found that boys, children over the age of two, and children living in poverty were all more likely than their counterparts to have special health care needs. Adopted children and children living in foster care were also more likely to have a history of special health care needs than children without any experience with out-of-home placement.
The results showed that during that three-year period, 21 percent of children in the child welfare system had a history of learning disabilities, 14 percent exhibited emotional disturbances, and 12 percent had speech impairment. Those rates of incidence are all significantly higher than those of children not in the child welfare system.
Nearly half of the children with special health care needs also had behavioral and developmental problems.
"The high rates of special health care needs, the diversity of conditions and the associated functional impairments found among these children require a substantial investment by health, mental and education systems in partnership with the Child Welfare System," said Cecilia Casanueva, Ph.D., a child development researcher at RTI and the paper's co-author. "Families need help coping with their child's chronic health, developmental and behavioral needs."
The study was funded by the Administration for Children and Families as part of the National Survey of Child and Adolescent Well-Being.
About RTI International
RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. Our staff of more than 2,600 provides research and technical services to governments and businesses worldwide in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, international development, economic and social policy, energy, and the environment. RTI also employs about 1,200 term employees who support projects in more than 40 countries. For more information, visit rti.
RTI International
3040 Cornwallis Rd.
Research Triangle Park, NC 27709-2194
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A recent "near-miss" report submitted to the Patient Safety Authority emphasizes the need for caution by healthcare facilities.
A patient nearly died recently in a Pennsylvania hospital due to confusion caused by color-coded wristbands, prompting the Patient Safety Authority to issue a Supplementary Advisory on the risks associated with using a specific color to convey clinical information.
A recent "near-miss" report submitted to the Authority through the Pennsylvania Patient Safety Reporting System (PA-PSRS) describes an event in which clinicians nearly failed to rescue a patient having a cardiac arrest because healthcare workers mistakenly believed the patient's wristband color meant "Do Not Resuscitate" when it was actually meant to convey a different message.
"The problem was caused partly by a healthcare provider's confusion about the meaning of a yellow wristband," said Alan B.K. Rabinowitz, Authority administrator. "In this particular facility, a yellow wristband means 'Do Not Resuscitate,' but in a nearby facility a yellow wristband is used to mean that a patient should not have blood work or an IV placed in that particular arm."
Because the provider worked in both facilities, she inadvertently used the yellow wristband in the wrong facility. When other healthcare workers later saw the yellow wristband, they incorrectly thought the patient was designated as "Do Not Resuscitate."
According to Dr. John Clarke, PA-PSRS clinical director, there are a number of steps facilities can take to make use of color-coded patient wristbands safer. "Although standardizing the meaning of different colors can only be done by coordination among healthcare facilities," Clarke noted, "individual facilities can limit the number and colors of patient wristbands and use printed text to reinforce the meaning of specific colors. They can also reconfirm clinical instructions with both patients and hospital staff."
To assess the potential scope of the problem, the Patient Safety Authority surveyed Patient Safety Officers in all Pennsylvania hospitals and ambulatory surgical facilities (ASFs). The 139 survey respondents represented one-third of these healthcare facilities. The results of the survey and improvements that can be made to minimize patient risk when using color-coded armbands are included in a Supplementary Advisory published this week by the PA-PSRS program.
Highlights of the Supplementary Advisory include:
-- In a recent survey, about four out of five Pennsylvania facilities responding use color-coded patient wristbands to communicate important medical information.
-- There are no standard meanings among healthcare facilities for different colors.
-- Limiting the number of wristbands and the colors used may help to avoid confusion for healthcare providers working in multiple facilities.
-- Printed instructions on wristbands can help to reinforce the message conveyed by a particular color.
Rabinowitz cites the usefulness of gathering reports in "real time" through the PA-PSRS system as a major contributor in helping improve patient safety by disseminating information about potential risks to facilities throughout the state.
"The wristband issue is not one that will be resolved overnight," Rabinowitz said. "However, by sending out an advisory to all healthcare facilities making them aware of the potential problem associated with color-coded wristbands in one hospital, we are giving all healthcare facilities the opportunity to implement steps to prevent a similar event from happening in their own facility."
For a copy of the Supplementary Advisory on wristbands click here (PDF).
BACKGROUND
The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error ("Mcare") Act, to help reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety. Under the Act, all Pennsylvania hospitals, birthing centers and ambulatory surgical facilities are required to report what the Act defines as "serious events" and "incidents" to the Authority, making Pennsylvania the only state in the nation to require the reporting of both actual events and "near-misses." More than 440 healthcare facilities are subject to Act 13 reporting requirements.
Facilities submit reports of serious events and incidents through the Pennsylvania Patient Safety Reporting System (PA-PSRS), a confidential web-based system that was developed for the Authority under a contract with ECRI, a Pennsylvania-based independent, non-profit health services research agency, in partnership with EDS, a leading international, information technology firm, and the Institute for Safe Medication Practices (ISMP), also a Pennsylvania-based, non-profit health research organization.
More than 230,000 reports have been submitted through PA-PSRS since mandatory reporting was initiated in June 2004. Ninety-five percent of these reports are Incidents or "near-misses." Based on those reports, the Authority issues quarterly Patient Safety Advisories to advise hospitals and other healthcare facilities about steps they can take to reduce and prevent patient harm. Occasionally, if a report is submitted that demands more immediate attention, a Supplementary Advisory focusing on that one particular topic will be issued.
For more information on the Patient Safety Authority, PA-PSRS or previous Patient Safety Advisories, visit the Authority's website at
psa.state.pa.us.