Orion Genomics Announces The Discovery And Validation Of Novel Breast Cancer Biomarkers

Orion Genomics announced today that
the company has identified and validated a suite of novel breast cancer
biomarkers, the most promising of which will be incorporated into the
company's diagnostic assays for the early detection of breast cancer and
the detection of breast cancer recurrence. Using proprietary genome-wide
microarray technology, the company was able to quickly identify a suite of
novel biomarkers in a panel consisting of normal and cancerous breast
tissues. In a second independent biomarker validation panel of more than
200 normal and cancerous breast tissues, over 50 biomarkers demonstrated
significant diagnostic potential, the most promising of which presented 90
percent sensitivity and 96 percent specificity. The results of Orion's
genome-wide, DNA methylation profiling were presented at the 29th Annual
San Antonio Breast Cancer Symposium on December 14, 2006 in San Antonio,
Texas.



"Utilizing MethylScope(R), our genome-wide DNA methylation profiling
technology, we were able to quickly identify a suite of promising breast
cancer biomarkers that show significantly high sensitivity and specificity
and represent the most comprehensive and clinically accurate breast cancer
epigenetic biomarkers discovered to date," said Jorge A. Leon, Ph.D.,
Orion's acting Chief Scientific Officer. "We are now validating our most
promising biomarkers in blood serum from cancer-free and breast cancer
patients."



According to the American Cancer Society, an estimated 211,000 new
cases of invasive breast cancer are expected in the U.S. in 2006 alone,
where approximately 40,000 patients are expected to die of their disease.
Early detection and treatment when the tumor is still small remains a key
factor in survival; however, early stage breast cancer typically produces
no noticeable symptoms, making early detection through conventional methods
challenging.



"Identifying cancer earlier in the disease progression timeline will
significantly improve treatment outcomes and patient survival, especially
in breast cancer," said Nathan Lakey, Chief Executive Officer and president
of Orion Genomics. "Our identification and validation of sensitive and
specific biomarkers for the detection of breast cancer will form the
foundation of our breast cancer diagnostic assays. These assays will
provide a diagnostic screening test, from blood or other easily collected
samples, of a large population for the early or recurrent signs of breast
cancer."



About Orion Genomics



Orion Genomics, the Second Code biotechnology company, develops
molecular diagnostic products to detect cancer at its earliest stages and
to aid in appropriate therapy selection. Orion's most advanced diagnostic
program is in breast cancer, where the company is developing a highly
sensitive and selective early screening test, followed by additional
epigenetic screening assays in lung, ovarian and colon cancers. Orion
Genomics is located in the Center for Emerging Technologies in St. Louis.
For more information, visit oriongenomics.


Orion Genomics

oriongenomics

AVAC Launches Report On Female-Initiated HIV Prevention Methods

"Female-Initiated HIV Prevention: What Will We Learn From Upcoming Trials?" AIDS Vaccine Advocacy Coalition: The report -- which was published by AVAC in collaboration with the African Microbicides Advocacy Group and the Global Campaign for Microbicides -- aims to assist people in understanding the implications of results from two trials on female-initiated HIV prevention methods. One trial, called MIRA, examines whether protecting the cervix with a physical barrier reduces women's risk of contracting HIV. The other trial looks at a microbicide candidate called Carraguard. The report also provides background data on the two experimental methods and details of study design and targets. In addition, it investigates the general implications of prospective trial results for other female-initiated methods and possible actions to be taken. The report is part of AVAC's "Anticipating and Understanding Results" series, which provides assessments of AIDS vaccine trials and other new HIV prevention alternatives (AVAC et al., "Female-Initiated HIV Prevention," 7/11).

"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.

Program Combining Nutrition, Exercise, Other Activities Shows Success In Helping Black Girls Lose Weight

An NIH-funded program that combined exercise, nutrition education, field trips and other activities was more successful than a self-esteem program in helping black girls lose weight and keep it off for two years, according to a study presented at an American Heart Association meeting in Orlando, the Memphis Commercial Appeal reports. The program is part of a national effort by NIH to develop and test strategies to help black girls avoid obesity and related health problems. Black girls are at the highest risk of becoming obese later in life, study principal investigator Robert Klesges said.

The study looked at 303 girls who were ages eight to 10 at the time the study began. Forty-one percent of the girls were considered overweight, though none were considered obese. Study participants over two years met weekly and later monthly to focus on diet and exercise or self esteem. At the study's conclusion, the girls in the diet-and-exercise group reported eating 90 fewer calories daily and consuming fewer sweetened drinks and eating slightly more vegetables than girls in the self-esteem group. Thirty percent of overweight girls in the first group lost weight and were able to keep that weight off for two years, compared with 15% of girls in the second group.

According to the Commercial Appeal, there was no difference in amount of exercise reported by the girls in the two groups. According to Klesges, neither intervention had any effect on girls who were of normal weight at the beginning of the study.

Klesges said, "We emphasized real simple strategies that were within the control of the girls. So, rather than choosing a cola drink, we would emphasize (to the girls), why don't you get water, or if you can't do water, why don't you at least get a diet cola?" Klesges said that while the program targeted black girls, it is designed to work within other groups or community settings.

Marian Levy, director of the University of Memphis graduate public health program, said, "It is a very important study," adding, "It shows just by making simple dietary changes you can have an impact on weight and health" (Powers, Memphis Commercial Appeal, 11/25).

Reprinted with kind 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.

Congresswoman's Death Turns Spotlight On Women And Cancer

The death of Rep. Juanita Millender-McDonald, a seven-term congresswoman from southern California, on Saturday, serves as a sober reminder for women of the dangers of cancer, according to the Society for Women's Health Research, a Washington, D.C. based advocacy organization focused on health differences between women and men.


"Our sympathies are with the family of Rep. Millender-McDonald," said Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research. "She was a tremendous public servant who worked tirelessly on behalf of her constituents and all Americans. I hope that American women will take note of her untimely death and recognize the importance of cancer prevention and screening. Cancer is the second leading killer of women and we must be vigilant in our efforts to prevent, detect early and treat this deadly disease."


Lung cancer is the leading cancer killer of women, followed by breast cancer, colon cancer, pancreatic cancer, and ovarian cancer. All adult women should see a doctor annually and ask about what screenings they need based on their age and other factors.


Women ages 40 and older should have a mammogram every one to two years, according to the Society's book "The Savvy Woman Patient: How and Why Sex Differences Affect Your Health" (Capital Books, 2006). To help prevent colon cancer, the book says, every woman should receive a colonoscopy exam once every 10 years beginning at age 50.


"Deaths from breast cancer and colon cancer have been on the decline recently, thanks to screening efforts that catch cancer early or detect pre-cancerous growths that can be monitored or treated," Marts said. "Unfortunately, gains in these two areas have been slower for African Americans. We have to do a better job of making sure minority communities understand the importance of cancer screenings and have affordable access to care."


Rep. Millender-McDonald was African American.


"To prevent lung cancer, obviously, the best thing you can do is not smoke," Marts said. "Some studies show that women have a harder time quitting smoking than men. So, if you do smoke, don't be afraid to seek professional help and social support.


"For ovarian, cervical and other gynecologic cancers, women should receive a Pap test and pelvic examination every one to three years once they become sexually active and no later than age 21. Women over 65 should talk to their doctors about how often they need these exams."


Tremendous advances have been made in the prevention of cervical cancer with the June 2006 FDA approval of a vaccine against the human papillomavirus (HPV) for women ages 9-26. The vaccine protects against two strands of HPV (16 and 18) which cause 70 percent of cervical cancer cases.


"The approval of a vaccine to prevent cervical cancer is a great step forward in women's health," Marts said. "We are hopeful that more cancer vaccines will become a reality in the near future."


In the United States, more than 10,000 women were estimated to have developed cervical cancer in 2005, and nearly 4,000 died. Of American women who develop cervical cancer, about half have never had a Pap test and an additional 10 percent have not had a Pap test in the last five years.


"Cancer is a scary thing," Marts said, "but our ability to prevent, detect and treat it is improving quickly. As women, we have to be aware of our unique cancer risks and seek appropriate care and timely screenings."


Society for Women's Health Research (SWHR)

1025 Connecticut Ave. NW, Ste. 701

Washington, DC 20036

United States

womenshealthresearch

Xanodyne's New Drug Application For The Treatment Of Heavy Menstrual Bleeding (Menorrhagia) Accepted For Filing With A Priority Review Classification

Xanodyne Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review status for its investigational proprietary formulation of tranexamic acid for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms. On January 30, 2009, Xanodyne submitted the New Drug Application (NDA) for XP12B, a unique oral therapy which acts as a competitive plasmin inhibitor to prevent fibrinolysis by binding to the lysine receptor sites of plasminogen. This helps to normalize the hyperfibrinolytic activity often present in women with HMB.


"We are pleased with the position that the FDA has taken in granting XP12B a priority review as it reflects their recognition of the important unmet medical need which HMB represents. We look forward to working closely with the agency to further advance this important treatment option to women who suffer from menorrhagia, or heavy menstrual bleeding," said Gary A. Shangold, Chief Medical Officer of Xanodyne.


Under the Prescription Drug User Fee Act (PDUFA), drug products with priority review designation have a 6 month review clock as compared to a 10 month standard review. Upon approval, this product candidate could become the first approved pharmaceutical product in the United States specifically indicated for the treatment of menorrhagia.


About Menorrhagia


HMB, or menorrhagia, represents a frequent and significant medical condition encountered by obstetricians, gynecologists and primary care physicians. Menorrhagia has been described as regular, normal intervals of menstruation with excessive volume that may exceed 80 milliliters of blood loss per menstrual cycle. At present, no pharmacotherapy has ever been approved by the FDA for the treatment of this disorder.


About Xanodyne


Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management. Xanodyne markets a portfolio of revenue generating products consisting of pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne's focus areas.


Xanodyne Pharmaceuticals, Inc.

xanodyne

Kaiser Daily Women's Health Policy Report Summarizes Editorials On Approval Of Nonprescription Plan B Sales To Women Over Age 18

Some editorials and opinion pieces respond to FDA's decision on Thursday to approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B to women ages 18 and older. The approval came after the agency in May 2004 issued a "not approvable" letter in response to an application originally submitted by the pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse. Barr purchased Women's Capital during consideration of the application. FDA in the "not approvable" letter cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. Barr earlier this month resubmitted its application. The approval requires Barr to "[m]onitor the effectiveness of the age restriction and the safe distribution of [nonprescription] Plan B to consumers [ages] 18 and above and prescription Plan B to women under [age] 18." Barr has agreed to send "anonymous shoppers" into pharmacies to test compliance with the age restriction, to distribute with the drug a booklet about its proper use and to exclude gas stations and convenience stores from selling the drug. Barr spokesperson Carol Cox said Plan B should be available for nonprescription sales this fall (Kaiser Daily Women's Health Policy Report, 8/25).

Editorials
Philadelphia Inquirer: FDA's decision to limit nonprescription sales of Plan B to women older than 18 is "about moral preference, not science; about preserving parents' control over minor children, not medical prudence," an Inquirer editorial says. Although the decision "won't please family planning groups that argued against" age restrictions or "those who consider Plan B a form of abortion," it is the "best decision the nation could expect of this administration," the editorial says (Philadelphia Inquirer, 8/25).

Seattle Post-Intelligencer: By approving nonprescription sales of Plan B to women ages 18 and older, FDA has "finally taken a big step to prevent pregnancies, protect health and reduce" the number of abortions, a Post-Intelligencer editorial says. However, the "decision included a compromise based on ideology" because it does not allow for nonprescription sales among girls ages 17 and younger, according to the editorial. "At the state and national levels, ideology has inserted itself into the discussions," the editorial says, concluding, "Science, the facts and the need to reduce the high U.S. teen birth rate ought to guide the decisions" (Seattle Post-Intelligencer, 8/25).

Opinion Pieces
Maureen Downey, Atlanta Journal-Constitution: The FDA approval "signals a rare victory for women's reproductive health, which has been a casualty of the Republican Party's courtship of far right extremists," Downey, a member of the Journal-Constitution's editorial board, writes in an opinion piece. However, the "18-and-older rule is a political mollification" that has "no scientific or health basis," Downey writes, adding that it also is "unfortunate because it's teenagers who engage in unprotected sex and have less access to birth control than their peers worldwide" (Downey, Atlanta Journal-Constitution, 8/25).

David Stevens, Atlanta Journal-Constitution: FDA's decision concerning Plan B was "influenced by political pressure," Stevens, executive director of the Christian Medical and Dental Associations, writes in a Journal-Constitution opinion piece. By "allowing both prescription" and nonprescription sales of Plan B, FDA "appears" to be creating an "entirely new type of approval that neither has been authorized by Congress nor subjected to a formal rulemaking process," Stevens writes, adding that it is questionable how FDA will be able to ensure that "this scheme is followed" (Stevens, Atlanta Journal-Constitution, 8/25).

Mary Worthington, Philadelphia Inquirer: While "we can make no simplistic post hoc correlations here between access to a drug and wholesale sexual behavior," two European studies have shown after Plan B became available without a prescription, sexually transmitted infection rates increased and abortion rates either increased or did not decrease, Worthington of Generation Life writes in an Inquirer opinion piece. FDA has "made a mistake in according" nonprescription "status to Plan B," Worthington writes, concluding, "Here's hoping the policy is revised or ended soon" (Worthington, Philadelphia Inquirer, 8/25).















"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.

Sotomayor Officially Takes Seat On Supreme Court

Justice Sonia Sotomayor on Tuesday officially took her seat on the U.S. Supreme Court in a formal ceremony attended by President Obama and Vice President Biden, the Washington Post reports. Sotomayor was sworn in as a member of the court on Aug. 8 following her confirmation by the Senate (Barnes, Washington Post, 9/9).

On Tuesday, Chief Justice John Roberts administered the judicial oath in which Sotomayor pledged to "do equal right to the poor and to the rich," after which she took her seat at the far right side of the bench (Liptak, "The Caucus," New York Times, 9/8). In concluding the four-minute ceremony, Roberts said, "We wish for you a long and happy career in our common calling." Several other lawmakers, judges, family members and friends also attended the ceremony (Washington Post, 9/9).


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, published by The Advisory Board Company.


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