Combined Molecular Imaging Technique Effectively Evaluates And Predicts Course Of Common Uterine Cancer

A promising new molecular imaging technique may provide physicians and patients with a noninvasive way to learn more information about a type of cancer of the uterus lining called "endometrial carcinoma" - one of the most common malignant female tumors. This research was presented in a study published in the October issue of The Journal of Nuclear Medicine.



"Endometrial carcinoma is one of the most common female malignant tumors," says Hidehiko Okazawa, M.D., Ph.D., professor in the division of medical imaging at the biomedical imaging research center at the University of Fukui in Japan and one of the lead researchers of the study. "The method of positron emission tomography (PET) imaging we used in the study is noninvasive, and it has tremendous potential to save women with endometrial carcinoma from undergoing unnecessary operations and biopsies that could sabotage their reproductive potential."



If the disease is caught early enough, the five-year survival rate is higher than 90% for patients with endometrial carcinoma. PET imaging may provide physicians with a tool that lets them recognize the extent of the disease before it reaches advanced stages.



This study shows that PET is a promising molecular imaging technique for personalized therapy. Molecular imaging and nuclear medicine provide the possibility of determining the invasiveness and aggressiveness of malignant tumors in the uterus earlier on, before disease progresses. With this technique, physicians gain the advantage of a more precise diagnosis along with the ability to better predict the tumor's growth patterns and plan for the most appropriate therapeutic treatment strategy.



"The article in the JNM from Dr. Tsujikawa and colleagues provides an example of the unique capacity of molecular imaging to measure in vivo cancer biology," says David A. Mankoff, M.D., Ph.D., professor of radiology, medicine and bioengineering at the University of Washington and Seattle Cancer Care Alliance in Seattle. "Most notably, it shows how imaging multiple facets of tumor phenotype - in this case, estrogen receptor expression and glucose metabolism - can provide insight into the clinical behavior of cancer. The broad implication of this study, and other similar studies that have tested PET and molecular imaging to characterize cancer characteristics, is that imaging can help direct cancer patients toward optimized, individualized treatments."



In the study, the researchers used a specialized form of PET imaging called "estrogen receptor expression imaging" for 22 patients with endometrial adenocarcinoma and nine patients with endometrial hyperplasia (a thickening of the uterine lining that is a risk factor for developing endometrial cancer) to evaluate diagnostic accuracy. All patients underwent preoperative PET scans with 18F-fluoroestradiol (18F-FES) - a tracer that has been successfully used in diagnosing breast cancer - and 18F-fluorodeoxyglucose (18F-FDG) to compare differences in tracer accumulation.
















The researchers confirmed that endometrial carcinoma reduces estrogen dependency with accelerated glucose metabolism as it progresses to a higher stage or grade. By combining the two tracers, researchers were able to use a new index of uptake ratio that can better predict pathologic stages and aggressiveness of tumors. The results of the study were encouraging, with the combined techniques having 86% accuracy.



For endocrine-related tumors (including endometrial cancer), tumors vary from well-differentiated and close in character to the tissue of origin to poorly differentiated tumors, which are aggressive and bear less resemblance to the tissue of origin. The well-differentiated tumors tend to be more slow-growing and less aggressive than poorly differentiated tumors. They also retain their endocrine function and/or responsiveness.



For endometrial cancer, estrogen receptor expression is related to endocrine responsiveness and indicated by FES uptake. Poorly differentiated tumors often have increased and abnormal breakdown of glucose, indicated by FDG. The combination of the two, as indicated by the study, was better than either alone at indicating the aggressiveness of the tumor.



Personalized cancer therapy involves treatment that is individualized for patients based on patient characteristics and the tumor's biology. By studying the tumor's properties, physicians can predict the tumor's path and formulate the best strategy for treating the disease.



Co-authors of "Functional Images Reflect Aggressiveness of Endometrial Carcinoma: Estrogen Receptor Expression Combined with 18F-FDG PET" include Tetsuya Tsujikawa, Takashi Kudo, Yasushi Kiyono, Masato Kobayashi, Yasuhisa Fujibayashi, Biomedical Imaging Research Center, Faculty of Medical Sciences, University of Fukui, Fukui, Japan; Yoshio Yoshida, Fumikazu Kotsuji, Tetsuji Kurokawa, Department of Gynecology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan; and Tatsuro Tsuchida, Department of Radiology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.



Source:
Amy Shaw


Society of Nuclear Medicine

Federal Judge Denies Illinois AG Request To Allow Enforcement Of Abortion Law's Parental Notification Rules

U.S. District Court Judge David Coar on Tuesday denied Illinois Attorney General Lisa Madigan's (D) request to lift an injunction on a 1995 state law requiring parental notification for minors seeking abortions, the AP/St. Louis Post-Dispatch reports (Robinson, AP/St. Louis Post-Dispatch, 2/6). The law, which has never been enforced, requires physicians to notify an adult family member 48 hours before performing an abortion on an unmarried minor or an "incompetent person." Physicians could bypass the requirement if they certify there is a medical emergency, and a minor seeking an abortion could request a judicial bypass or be exempt by declaring in writing that she is a survivor of neglect or abuse from an adult family member. The state Supreme Court in September 2006 issued rules for the law that say a judge hearing a bypass request should attempt to issue a decision at the end of the hearing and rule within 48 hours if a decision could not be made immediately, but the rules do not say anything about the circumstances in which a judge should grant a waiver. Madigan last month issued the request to lift the injunction, saying she agrees the constitutional defect in the law was fixed by the rules issued by the state Supreme Court (Kaiser Daily Women's Health Policy Report, 1/23). Coar in his opinion did not rule on the constitutionality of the law but wrote that the state is not ready to enforce the law because procedures and rules have not been put in place in all 102 counties. He said Madigan's office could attempt to lift the injunction after all the counties have enacted enforcement procedures. Madigan's office was unavailable for comment (AP/St. Louis Post-Dispatch, 2/6). Lorie Chaiten, director of the American Civil Liberties Union of Illinois' Reproductive Rights Project, said, "We applaud the judge for looking carefully at this and we are hopeful we will never see parental notice in Illinois," adding, "We think the ruling is one that benefits the young women of Illinois" (Pallasch, Chicago Sun-Times, 2/7).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Vermillion Presents Critical Data From Its OVA1 Clinical Trial

Vermillion, Inc. (OTC Bulletin Board: VRML), a molecular diagnostics company, presented data from its prospective OVA1 clinical trial at the Society of Gynecologic Oncologists' (SGO) 40th Annual Meeting on Women's Cancer in San Antonio, TX (Poster 196). The study entitled "A biomarker panel for distinguishing between malignant and benign ovarian tumors" was co-authored by Fred Ueland, MD, Associate Professor of Gynecologic Oncology at the University of Kentucky and Principal Investigator of the OVA1 clinical trial, and Zhen Zhang, PhD, Associate Professor of Pathology at the Johns Hopkins University School of Medicine as well as Vermillion scientists.


Details of the poster are available in the attached link "A biomarker panel for distinguishing between malignant and benign ovarian tumors." The primary aim of the study was to determine the ability of our proprietary OvaCalc algorithm to estimate the risk of malignancy in pre and postmenopausal women who are scheduled for surgery with an ovarian mass. The data demonstrates that the OvaCalc algorithm can effectively identify women with a higher likelihood of malignancy. Within the study population, the OvaCalc algorithm also detected 90% of Stage I epithelial ovarian cancer cases and 100% of stage 2-4 cancers while maintaining a greater than 90% negative predictive value among both premenopausal and postmenopausal patients.


"We are extremely pleased with the significant results of the OVA1 prospective clinical trial. A major strength of the OVA1 prospective clinical trial was its inclusion of patients seen at a variety of clinical settings where the intended patient population typically undergoes a gynecological examination with radiological and clinical testing prior to surgical intervention. The 27 sites were demographically mixed to include, for example, large and small medical centers (universities/community hospitals), small gynecology/obstetrics groups, gynecology/oncology practices, and subjects from HMO groups. This study demonstrated with statistical significance the effectiveness of the OVA1 test in estimating the risk of malignancy in pre and postmenopausal women who are scheduled for surgery with an ovarian mass," said Gail S. Page, President and CEO.


"Research demonstrates that patients who have initial surgery performed by a gynecologic oncologist fare better than patients who are treated by a non-specialist. Any additional diagnostic tools that help the physician identify who is at a high risk of EOC may result in more optimal referral patterns and improved outcomes," said Karen Orloff Kaplan, Sc.D., Chief Executive Officer of the Ovarian Cancer National Alliance.


About Vermillion's Ovarian Cancer Diagnostic Program


Vermillion has multiple ovarian cancer diagnostic tests in development. The most advanced of Vermillion's programs is the OVA1 test, which is designed to utilize a panel of biomarkers to help identify women with a higher likelihood of malignancy so they can be referred to a gynecologic oncologist for their initial surgery. Vermillion filed a 510(K) Application with the U.S. Food and Drug Administration for its OVA1(TM) Test in June 2008.















Additionally, studies are underway to develop tests with the capability of detecting early-stage ovarian cancer, predicting prognosis and recurrence, and identifying women considered at high-risk for the disease.


Vermillion's premier diagnostic development program is being conducted with several leading collaborators at The Johns Hopkins School of Medicine, The University of Texas M.D. Anderson Cancer Center, Rigshospitalet (Copenhagen), and the University of Kentucky.


The Company's OVA1 test is part of a strategic alliance with Quest Diagnostics to jointly develop and commercialize diagnostic tests.


About Ovarian Cancer


Commonly known as the "silent killer," ovarian cancer leads to approximately 15,000 deaths each year in the United States, according to the American Cancer Society. Approximately 20,000 new cases are diagnosed each year, with the majority in patients diagnosed with late stage disease where the cancer has spread beyond the ovary. The prognosis is poor in these patients, leading to the high mortality from this disease. A diagnostic test is needed that can provide adequate predictive value to stratify patients with a pelvic mass into high risk of invasive ovarian cancer versus those with low risk, as well as a screening test for the diagnosis of early-stage ovarian cancer, which is essential for improving overall survival in patients. Ovarian cancer has up to a 90% cure rate following surgery and/or chemotherapy if detected in stage 1.


About Vermillion


Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women's health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at vermillion.


Forward Looking Statements


This news release contains forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward- looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. There are no guarantees that Vermillion will succeed in its efforts to commercialize its ovarian cancer diagnostic tests in 2009 or during any other period of time. Factors that could cause actual results to materially differ include but are not limited to: (1) uncertainty in obtaining intellectual property protection for inventions made by Vermillion; (2) unproven ability of Vermillion to discover, develop, and commercialize diagnostic products based on findings from its disease association studies; (3) unproven ability of Vermillion to discover or identify new protein biomarkers and use such information to develop ovarian cancer diagnostic products; (4) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its diagnostic products; (5) uncertainty of market acceptance of its products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third party payors such as private insurance companies and government insurance plans; and (6) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.


Vermillion, Inc.

vermillion

Ranexa(R) Significantly Reduces Ischemia In Women In MERLIN TIMI-36 Study

CV Therapeutics, Inc.
(Nasdaq: CVTX) announced that an analysis of data from 2,291 women
who participated in the MERLIN TIMI-36 study showed a 29 percent reduction
in the relative risk of recurrent ischemia in women receiving Ranexa(R)
(ranolazine extended-release tablets) compared to placebo (p=0.002) after
12 months. No difference in symptomatic documented arrhythmias was observed
in women between the ranolazine and placebo groups.



The data were presented by Dr. Jessica Mega of the TIMI Study
Group at the American Heart Association Scientific Sessions in Orlando,
Florida.



"Women were very well represented in the MERLIN TIMI-36 study and these
data provide important additional confirmation of the safety and efficacy
we have seen with Ranexa in other clinical trials and in commercial use,"
said Louis G. Lange, CV Therapeutics chairman and chief executive officer.



According to the American Heart Association, cardiovascular disease is
the leading cause of death among American women.



In accordance with a special protocol assessment agreement between the
U.S. Food and Drug Administration (FDA) and CV Therapeutics, the Company
believes that data from the MERLIN TIMI-36 study could support expansion of
the existing Ranexa indication to first line angina. In September 2007, the
Company submitted a supplemental new drug application to the FDA seeking a
new indication for first line angina and a significant reduction in
cautionary language.



Ranexa is currently indicated for the treatment of chronic angina in
patients who have not achieved an adequate response with other antianginal
drugs, and should be used in combination with amlodipine, beta-blockers or
nitrates.



Study Design



MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for Less Ischemia
in Non-ST Elevation Acute Coronary Syndromes) was a multi-national,
double-blind, randomized, placebo-controlled, parallel-group clinical trial
designed to evaluate the efficacy and safety of Ranexa during acute and
long-term treatment in 6,560 patients (3,279 received ranolazine, 3,281
received placebo) with non-ST elevation ACS treated with standard therapy.



Within 48 hours of the onset of angina due to ACS, eligible
hospitalized patients were enrolled in the study and randomized to receive
intravenous Ranexa or placebo, followed by long-term outpatient treatment
with Ranexa extended-release tablets or placebo. All patients also received
standard therapy during both hospital-based and outpatient treatment. The
doses of Ranexa extended-release tablets used in MERLIN TIMI-36 have been
studied in previous Phase 3 clinical trials.
















Participants in the MERLIN TIMI-36 study received current standard
therapy, with approximately 96 percent of patients on aspirin,
approximately 89 percent on beta blockers and approximately 82 percent on
statins. Approximately 59 percent of study participants received coronary
angiography during their initial hospitalization.



Previously published data from the MERLIN TIMI-36 study has shown that
Ranexa was safe in this population of patients with coronary artery
disease, which included nearly 1,100 patients with prior heart failure.



About CV Therapeutics



CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology to the
discovery, development and commercialization of novel, small molecule drugs
for the treatment of cardiovascular diseases.



CV Therapeutics' approved product, Ranexa(R) (ranolazine
extended-release tablets), is indicated for the treatment of chronic angina
in patients who have not achieved an adequate response with other
antianginal drugs, and should be used in combination with amlodipine,
beta-blockers or nitrates.



CV Therapeutics' clinical and preclinical drug development candidates
and programs include regadenoson, which is being developed for potential
use as a pharmacologic stress agent in myocardial perfusion imaging
studies, and CVT-6883, which is being developed as a potential treatment
for cardiopulmonary diseases. Regadenoson and CVT-6883 have not been
determined by any regulatory authorities to be safe or effective in humans
for any use.



Except for the historical information contained herein, the matters set
forth in this press release are forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are subject
to risks and uncertainties that may cause actual results to differ
materially, including operating losses and fluctuations in operating
results; capital requirements; regulatory review and approval of our
products; special protocol assessment agreement; the conduct and timing of
clinical trials; commercialization of products; market acceptance of
products; product labeling; concentrated customer base; reliance on
strategic partnerships and collaborations; uncertainties in drug
development; uncertainties regarding intellectual property; and other risks
detailed from time to time in CV Therapeutics' SEC reports, including its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements.


CV Therapeutics, Inc.

cvt


View drug information on Ranexa.

Businesses Reconsider Maternity Leave Offers In Face Of Economic Uncertainty

The struggle to balance profitability and employee benefits during the economic recession has led many companies to reduce their maternity leave offers, the Boston Globe reports. A 2010 survey by the Society for Human Resource Management found that 17% of employers offer paid maternity leave, but 7% plan to reduce or eliminate the benefit.

Kathleen Gerson, a sociology professor at New York University, said the current economic climate has led some employers to focus less on benefits issues. "People are so concerned with getting jobs and keeping jobs that it has pushed issues such as parental leave a little bit to the side," Gerson said. She added, "But it also means that women are more in need of jobs than ever, and families are more dependent on women's earnings than ever." The U.S. Department of Labor Bureau of Labor Statistics estimates that 71% of women with children younger than age 18 were in the workforce in 2008, compared with 47% in 1975.

Court Ruling Spotlights Debate

The issue has come under renewed scrutiny after the Massachusetts Supreme Judicial Court ruled this week that the state's Maternity Leave Act -- which covers businesses with 50 or fewer employees -- only allows job protection for up to eight weeks after the birth of a child. The federal Family and Medical Leave Act requires companies with 50 employees or more to offer 12 weeks of unpaid leave for the birth of a child or other reasons, such as caring for a sick relative. According to the Center for Economic and Policy Research, the federal law covers about 60% of the U.S. workforce, and about one-fifth of U.S. employers do not offer maternity-related leave of any kind.

The Globe reports that the U.S. has "one of the most stringent leave policies" in the developed world. The U.S. and Australia are the only countries out of 21 high-income nations that offer no paid parental leave, although Australia offers one year of unpaid leave, according to a 2008 study by CEPR. Canada offers women one year of maternity leave, including 29 weeks at full salary, while Sweden offers women 85 weeks of maternity leave -- 40 of which are paid -- and up to 163 weeks off for both parents combined (Woolhouse/Johnston Chase, Boston Globe, 8/12).


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


© 2010 National Partnership for Women & Families. All rights reserved.