Is female sexual dysfunction disorder a work of fiction dreamt up by 'Big Pharma' or an under-recognised and under-treated condition that has been side-lined by clinicians for too long?
Arguments around female sexual dysfunction will be debated during the Institute of Psychiatry's (IoP) 41st Maudsley Debate on 2nd February.
Titled 'Love is a Drug', the debate will feature five prominent medical experts battling it out this fascinating argument that divides clinicians, academics and feminists.
The controversy around the definition, prevalence, treatment and even existence of female sexual arousal disorder has proved inflammatory since the term first emerged in the late 1990s. Since Viagra first entered the market, pharmaceutical companies have been scrambling to repeat its success with a similar drug to treat female sexual dysfunction.
Debate around the condition has not abated - it has become a flashpoint for arguments relating to 'medicalisation', inappropriate prescribing and the trustworthiness of published medical evidence and research methodologies. It has also been the subject of argument within feminist literature and the wider history of sexual health and functioning.
The debate will address whether female sexual dysfunction is simply 'drug marketing merging with medical science in a fascinating way' or actually a condition with a 'need for the assessment and treatment of women along the lines of men being assessed and treated for erectile dysfunction'.
For over 20 years, SLaM's Psychosexual and Relationship Service has been offering assessment and treatment for people experiencing difficulties in their sexual lives or with their intimate relationships. The service is staffed by a team of leasing experts with a comprehensive knowledge of intimate relationships, sexuality and sexual dysfunction.
The debate will be chaired by Professor Dinesh Bhugra, Honorary Consultant in the South London and Maudsley's (SLaM) Psychosexual and Relationship Service, and current President of the Royal College of Psychiatrists. He is also Professor of Mental Health and Cultural Diversity at the Institute of Psychiatry, King's College London and his main areas of expertise are psychosexual medicine and cross-cultural psychiatry.
'Love is a drug' will be debated by four highly eminent speakers:
For:
- Dr Petra Boynton, lecturer in International Health Services research at University College London
- Dr Ben Goldacre, psychiatrist, philosopher, media commentator and author of best-seller 'Bad Science'
Against:
- Dr Sandy Goldbeck-Wood, former editor of the British Medical Journal (BMJ) and specialist in psychosomatic medicine
- Dr John Dean, sexual medicine specialist and former president of the International Society for Sexual Medicine
'Love is a Drug' will be held at the IoP's Wolfson Lecture Theatre from 6pm on Wednesday 2nd February 2011. Tea and coffee will be served from 5:30pm. The debate is free and open to the public.
The IoP is part of King's College London. It is located at De Crespigny Park, Denmark Hill, London SE5 8AF.
Notes
- Professor Dinesh Bhugra is an Honorary Consultant in SLaM's Psychosexual and Relationship Service. He is also Professor of Mental Health and Cultural Diversity at the Institute of Psychiatry, King's College London, and is currently President of the Royal College of Psychiatrists.
- SLaM's Psychosexual and Relationship Service offers assessment and treatment for people experiencing difficulties in their sexual lives or with their intimate relationships. It also helps people experiencing difficulties associated with hormonal change, including premenstrual or menopausal symptoms, or following surgical or medical interventions. www.national.slam.nhs/psychosexual/
- The South London and Maudsley NHS Foundation Trust (SLaM) provides national services to people across the UK. It also provides mental health and substance misuse services for people living in the London Boroughs of Croydon, Lambeth, Southwark and Lewisham.
- SLaM offers the most extensive portfolio of mental health services in the United Kingdom, supported by internationally recognised training and research. Each year, 5000 people receive hospital treatment, and 32,000 receive outpatient care. SLaM has a clinical and academic partnership with the Institute of Psychiatry (IoP), part of King's College London.
Source:
South London and Maudsley NHS Foundation Trust
View drug information on Viagra.
четверг, 31 мая 2012 г.
четверг, 24 мая 2012 г.
Fetal Death Rate Declines Nationally, Though Racial/Ethnic Disparities Remain, CDC Report Says
The rate of fetal deaths in the U.S. declined significantly from 1990 to 2003, but the rate remains higher among racial and ethnic minorities than among whites, according to a CDC report released on Wednesday, the Washington Times reports. For the report, Marian MacDorman and colleagues analyzed data from the National Center for Health Statistics from 1990 to 2003. During the time period, the overall number of fetal deaths per 1,000 live births declined steadily by an average of 1.4% annually (Harper, Washington Times, 2/22). The report says that mortality rates for fetuses at 20 weeks' gestation or more declined substantially, while mortality rates among fetuses at 20 to 27 weeks' gestation have not declined (MacDorman et al., "Fetal and Perinatal Mortality, United States, 2003," 2/21). According to the report, the fetal death rate for white and Asian women is about five deaths per 1,000 births, compared with 12 deaths per 1,000 births among black women and six deaths per 1,000 births among American Indian and Hispanic women. Fetal deaths were highest among women who were older than age 45 and younger than age 15. The report also looked at perinatal deaths, defined as the death of a fetus at term or an infant younger than seven days old. The perinatal death rate between 1985 and 2003 declined from about 11 deaths per 1,000 births in 1995 to about seven deaths per 1,000 births in 2003. Asian women had the lowest rates followed by whites, Hispanics and American Indians. Among American Indians, the rate was about five perinatal deaths per 1,000 births. Black women had a rate of 12 perinatal deaths per 1,000 births. Reasons for the disparities remain uncertain, but the report indicated contributing factors such as differences in health, income and access to quality health care; stress; and racism (Harper, Washington Times, 2/22).
The report is available online. Note: You must have Adobe Acrobat to view the report.
"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.
The report is available online. Note: You must have Adobe Acrobat to view the report.
"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.
четверг, 17 мая 2012 г.
Reps. Ryan, DeLauro Announce Bill To Reduce Unplanned Pregnancies, Provide Social Supports
Abortion opponent Rep. Tim Ryan (D-Ohio) and abortion-rights supporter Rep. Rosa DeLauro (D-Conn.) held a press conference on Thursday to announce a bill that aims to reduce the need for abortion by preventing unintended pregnancies, among other proposals, the New York Times' "The Caucus" reports. The bill -- crafted in part by the centrist group Third Way -- would increase access to contraceptive services, sex education, health care coverage for pregnant women and children, and adoption. It also would expand access to comprehensive sex education and adoption programs.
The bill has the support of abortion-rights groups like the Planned Parenthood Federation of America and NARAL Pro-Choice America, both of which had representatives at the press conference. The bill also has the support of antiabortion-rights religious leaders like Joel Hunter of Northland, Fla., and Derrick Harkins of Washington, D.C.
The bill, which has been introduced in each of the past three congressional sessions, could "broker a detente" and help "turn down the volume on the culture war," DeLauro said at the press conference. Ryan called the bill an "idea whose time has come," noting that it has gained support from advocates on both sides of the abortion-rights debate.
During the press conference, Hunter said advocates of the bill, regardless of their side in the abortion-rights debate, are "taking heat" from other members of their side. He added that the bill is important because it "links together traditional adversaries in a way that advances each of our goals without compromising any of our values" (Becker, "The Caucus," New York Times, 7/23). Harkins said that he is "more optimistic now than I ever have been," adding that women "need real support that divisive debates cannot provide" (Stephenson, CQ HealthBeat, 7/23).
Despite support from some antiabortion-rights advocates, the bill has not been welcomed by all groups opposed to abortion rights, including conservative groups Family Research Council, National Right to Life and Democrats for Life of America. Kristen Day, executive director of Democrats for Life, said her group does not support the bill because preventing unintended pregnancies already is a goal of other programs. She noted that her group instead supports the Pregnant Women Support Act (HB 2035, SB 270), which focuses on services for women who carry their pregnancies to term but does not include prevention (CQ HealthBeat, 7/23). In a statement, Family Research Council President Tony Perkins said the bill is "fraught with funding for abortion providers and provisions that further encourage promiscuous sex and discourage parental involvement."
Although the White House has not voiced a position on the bill, there are "reasons to believe" that the Obama administration will support some of the legislation's proposals, "The Caucus" reports ("The Caucus," New York Times, 7/23). DeLauro said that she and Ryan plan to seek Republican co-sponsors for the bill, although they do not yet have any. She added that she thinks President Obama will support the bill because it includes language similar to his rhetoric on reducing the need for abortion. In addition, Obama's chief of staff, Rahm Emanuel, was a co-sponsor of the bill when he served in the House (CQ HealthBeat, 7/23). Ryan said that the bill, which does not yet have an estimated cost, is "now open for support from all quarters."
According to "The Caucus," the bill is being introduced at a time when abortion is a growing topic in health care reform legislation. Policymakers on both sides of the abortion-rights debate are expressing concern about how private insurance coverage of abortion is treated in health care reform. Ryan and DeLauro both support a policy that would neither require nor forbid insurance companies from covering the procedure ("The Caucus," New York Times, 7/23). During the press conference, DeLauro said that the new bill would not force insurance providers to cover abortion services. She said, "What we don't want to do is go backward. We should neither prohibit nor require insurance companies to offer these kinds of services" (CQ HealthBeat, 7/23).
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.
© 2009 The Advisory Board Company. All rights reserved.
The bill has the support of abortion-rights groups like the Planned Parenthood Federation of America and NARAL Pro-Choice America, both of which had representatives at the press conference. The bill also has the support of antiabortion-rights religious leaders like Joel Hunter of Northland, Fla., and Derrick Harkins of Washington, D.C.
The bill, which has been introduced in each of the past three congressional sessions, could "broker a detente" and help "turn down the volume on the culture war," DeLauro said at the press conference. Ryan called the bill an "idea whose time has come," noting that it has gained support from advocates on both sides of the abortion-rights debate.
During the press conference, Hunter said advocates of the bill, regardless of their side in the abortion-rights debate, are "taking heat" from other members of their side. He added that the bill is important because it "links together traditional adversaries in a way that advances each of our goals without compromising any of our values" (Becker, "The Caucus," New York Times, 7/23). Harkins said that he is "more optimistic now than I ever have been," adding that women "need real support that divisive debates cannot provide" (Stephenson, CQ HealthBeat, 7/23).
Despite support from some antiabortion-rights advocates, the bill has not been welcomed by all groups opposed to abortion rights, including conservative groups Family Research Council, National Right to Life and Democrats for Life of America. Kristen Day, executive director of Democrats for Life, said her group does not support the bill because preventing unintended pregnancies already is a goal of other programs. She noted that her group instead supports the Pregnant Women Support Act (HB 2035, SB 270), which focuses on services for women who carry their pregnancies to term but does not include prevention (CQ HealthBeat, 7/23). In a statement, Family Research Council President Tony Perkins said the bill is "fraught with funding for abortion providers and provisions that further encourage promiscuous sex and discourage parental involvement."
Although the White House has not voiced a position on the bill, there are "reasons to believe" that the Obama administration will support some of the legislation's proposals, "The Caucus" reports ("The Caucus," New York Times, 7/23). DeLauro said that she and Ryan plan to seek Republican co-sponsors for the bill, although they do not yet have any. She added that she thinks President Obama will support the bill because it includes language similar to his rhetoric on reducing the need for abortion. In addition, Obama's chief of staff, Rahm Emanuel, was a co-sponsor of the bill when he served in the House (CQ HealthBeat, 7/23). Ryan said that the bill, which does not yet have an estimated cost, is "now open for support from all quarters."
According to "The Caucus," the bill is being introduced at a time when abortion is a growing topic in health care reform legislation. Policymakers on both sides of the abortion-rights debate are expressing concern about how private insurance coverage of abortion is treated in health care reform. Ryan and DeLauro both support a policy that would neither require nor forbid insurance companies from covering the procedure ("The Caucus," New York Times, 7/23). During the press conference, DeLauro said that the new bill would not force insurance providers to cover abortion services. She said, "What we don't want to do is go backward. We should neither prohibit nor require insurance companies to offer these kinds of services" (CQ HealthBeat, 7/23).
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.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 10 мая 2012 г.
Half Of Urban Teens Develop Common STIs Within Two Years Of First Sex, Study Finds
Half of female urban teens ages 14 through 17 contracted chlamydia, gonorrhea or trichomoniasis within two years of having sex for the first time, according to a new study published in the Archives of Pediatrics and Adolescent Medicine, Reuters reports. Researchers followed 386 teen girls for up to eight years. Within one year of having sex for the first time, 25% had their first chlamydia infection (Brooks, Reuters, 12/7). Within six months of being diagnosed, 25% of participants with prior infections were reinfected, the study found.
According to the study, both the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention have guidelines for STI screening but "[n]either group has made evidence-based recommendations on the most appropriate starting age and the most appropriate frequency of screening." The study recommends that young women be screened for STIs within one year of having sex for the first time and that those with infections be re-tested every three to four months, the Los Angeles Times' "Booster Shots" reports. Untreated STIs can increase the risk of pelvic inflammatory disease, HIV, infertility, ectopic pregnancy and preterm birth (Roan, "Booster Shots," Los Angeles Times, 12/7).
Study investigator Wanzhu Tu of the Indiana University School of Medicine said, "These young women are vulnerable to STIs, but because of their younger age, they may not be perceived by health care providers as having STI risk, and thus are not screened in a timely manner."
Support Program Cuts STI Risks, Commentary Says
A commentary in the same journal detailed a program that reduced risky sexual behavior among female blacks ages 15 through 21 in Atlanta by providing them with group counseling, telephone support and vouchers for their partners to obtain STI testing and treatment. The program reduced first and recurrent chlamydia infections and increased condom use. It also lowered participants' use of douching, which is linked to increased STI risk. Commentary author Bonita Stanton of Wayne State University wrote that perhaps the "most intriguing" result is that participants were able to convince their partners to get STI testing (Reuters, 12/7).
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.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 3 мая 2012 г.
Trends In Prescription Medication Sharing Among Reproductive-Aged Women
Borrowing and sharing of prescription medications is a serious medical and public health concern. A survey of nearly 7,500 women of reproductive age found that this is common practice among more than one-third of this population, according to a report published online ahead of print in Journal of Women's Health, a peer-reviewed journal published by Mary Ann Liebert, Inc. The paper is available free online at liebertonline/doi/pdfplus/10.1089/jwh.2007.0769
A study designed to describe patterns of prescription medication borrowing and sharing among various groups of adults revealed that women of reproductive age (18-44 years) are more likely to report this practice (36.5%) than are other aged women (19.5%). In the overall survey of more than 25,000 women and men, 28.8% of women and 26.5% of men reported ever borrowing or sharing prescription medications.
In a paper entitled "Prescription Medication Borrowing and Sharing among Women of Reproductive Age," Emily Petersen, Sonja Rasmussen, Katherine Daniel, Mahsa Yazdy, and Margaret Honein, from the Centers for Disease Control and Prevention (CDC, Atlanta, Georgia) and Oak Ridge Institute for Science & Education (Oak Ridge, Tennessee), report that allergy medications (43.8%) and pain medications (42.6%) were the types of drugs most commonly borrowed or shared by reproductive-aged women.
The authors emphasize some of the risks involved in using another person's prescription drugs, including unanticipated side effects, complications of incorrect use, drug-drug interactions, antibiotic resistance, and risk of addiction. Of great importance for reproductive-aged women is the risk of teratogenic effects on a developing embryo or fetus if the women were to become pregnant while taking the medication.
"This study confirms what many health care providers suspect," says Susan G. Kornstein, MD, Editor-in-Chief and Executive Director of the Virginia Commonwealth University Institute for Women's Health, in Richmond, VA. "It is clear that patients need to be counseled about the potential risks of sharing and borrowing medications, especially if they are women of reproductive age."
Journal of Women's Health is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. The Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Journal of Women's Health is the Official Journal of the American Medical Women's Association (AMWA; amwa-doc/).
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research including Obesity Management, Breastfeeding Medicine, Thyroid, Metabolic Syndrome and Related Disorders, and Diabetes Technology and Therapeutics. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 60 journals, books, and newsmagazines is available at liebertpub/
Mary Ann Liebert, Inc. 140 Huguenot Street, New Rochelle, NY 10801 liebertpub/
Source: Vicki Cohn
Mary Ann Liebert, Inc./Genetic Engineering News
A study designed to describe patterns of prescription medication borrowing and sharing among various groups of adults revealed that women of reproductive age (18-44 years) are more likely to report this practice (36.5%) than are other aged women (19.5%). In the overall survey of more than 25,000 women and men, 28.8% of women and 26.5% of men reported ever borrowing or sharing prescription medications.
In a paper entitled "Prescription Medication Borrowing and Sharing among Women of Reproductive Age," Emily Petersen, Sonja Rasmussen, Katherine Daniel, Mahsa Yazdy, and Margaret Honein, from the Centers for Disease Control and Prevention (CDC, Atlanta, Georgia) and Oak Ridge Institute for Science & Education (Oak Ridge, Tennessee), report that allergy medications (43.8%) and pain medications (42.6%) were the types of drugs most commonly borrowed or shared by reproductive-aged women.
The authors emphasize some of the risks involved in using another person's prescription drugs, including unanticipated side effects, complications of incorrect use, drug-drug interactions, antibiotic resistance, and risk of addiction. Of great importance for reproductive-aged women is the risk of teratogenic effects on a developing embryo or fetus if the women were to become pregnant while taking the medication.
"This study confirms what many health care providers suspect," says Susan G. Kornstein, MD, Editor-in-Chief and Executive Director of the Virginia Commonwealth University Institute for Women's Health, in Richmond, VA. "It is clear that patients need to be counseled about the potential risks of sharing and borrowing medications, especially if they are women of reproductive age."
Journal of Women's Health is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. The Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Journal of Women's Health is the Official Journal of the American Medical Women's Association (AMWA; amwa-doc/).
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research including Obesity Management, Breastfeeding Medicine, Thyroid, Metabolic Syndrome and Related Disorders, and Diabetes Technology and Therapeutics. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 60 journals, books, and newsmagazines is available at liebertpub/
Mary Ann Liebert, Inc. 140 Huguenot Street, New Rochelle, NY 10801 liebertpub/
Source: Vicki Cohn
Mary Ann Liebert, Inc./Genetic Engineering News
четверг, 26 апреля 2012 г.
Oral Contraceptives Impair Muscle Gains In Young Women
Many active young women use oral contraceptives (OC) yet its effect on their body composition and exercise performance has not been thoroughly studied. A team of researchers has now examined the effects of OC on female muscle mass, and found that oral contraceptive use impairs muscle gains in young women, and is associated with lower hormone levels.
The findings are contained in a new study entitled Oral Contraceptive Use Impairs Muscle Gains in Young Women. It was conducted by Chang-Woock Lee and Steven E. Riechman, Department of Health and Kinesiology, Texas A&M University, College Station, TX; and Mark A. Newman, Human Energy Research Laboratory, University of Pittsburgh, Pittsburgh, PA. The researchers will present their findings at the 122nd Annual Meeting of the American Physiological Society, which is part of the Experimental Biology 2009 scientific conference. The meeting will be held April 18-22, 2009 in New Orleans.
The Study
Seventy-three generally healthy women between the ages of 18-31 were assigned to two groups and completed a 10-week whole-body resistance exercise training (RET). Group 1 consisted of 34 women who used oral contraceptives (OC). Group 2 consisted of 39 women who did not take birth control pills (non-OC). The women were encouraged to consume at least 0.5 grams of protein per pound of body weight per day (a third more than is called for by the U.S. government nutritional guidelines) to make sure they consumed enough calories and protein to promote muscle growth.
The participants exercised three times per week for ten weeks under the supervision of exercise physiologists. They performed a variety of exercises to include chest press, lat pull down, leg extension, triceps extension, arm curl and abdominal crunch. Exercise was done using standard exercise machines and each volunteer performed three sets of 6-10 repetitions per exercise at 75 percent of their maximum strength. Body composition was determined using hydrostatic weighing.
Blood samples were taken before and after the training and assessed to measure anabolic (muscle building) and catabolic (muscle breaking) hormone levels in blood. Resting and fasting blood concentrations were measured for three anabolic hormones: DHEA, DHEAS and IGF1.
Findings
The researchers found that:
-- there were significant differences in lean mass gains (OC: 2.1?±2.1% vs. non-OC: 3.5?±3.2% / OC: 1.0?±1.0kg vs. no-OC: 1.6?±1.4kg, p
The findings are contained in a new study entitled Oral Contraceptive Use Impairs Muscle Gains in Young Women. It was conducted by Chang-Woock Lee and Steven E. Riechman, Department of Health and Kinesiology, Texas A&M University, College Station, TX; and Mark A. Newman, Human Energy Research Laboratory, University of Pittsburgh, Pittsburgh, PA. The researchers will present their findings at the 122nd Annual Meeting of the American Physiological Society, which is part of the Experimental Biology 2009 scientific conference. The meeting will be held April 18-22, 2009 in New Orleans.
The Study
Seventy-three generally healthy women between the ages of 18-31 were assigned to two groups and completed a 10-week whole-body resistance exercise training (RET). Group 1 consisted of 34 women who used oral contraceptives (OC). Group 2 consisted of 39 women who did not take birth control pills (non-OC). The women were encouraged to consume at least 0.5 grams of protein per pound of body weight per day (a third more than is called for by the U.S. government nutritional guidelines) to make sure they consumed enough calories and protein to promote muscle growth.
The participants exercised three times per week for ten weeks under the supervision of exercise physiologists. They performed a variety of exercises to include chest press, lat pull down, leg extension, triceps extension, arm curl and abdominal crunch. Exercise was done using standard exercise machines and each volunteer performed three sets of 6-10 repetitions per exercise at 75 percent of their maximum strength. Body composition was determined using hydrostatic weighing.
Blood samples were taken before and after the training and assessed to measure anabolic (muscle building) and catabolic (muscle breaking) hormone levels in blood. Resting and fasting blood concentrations were measured for three anabolic hormones: DHEA, DHEAS and IGF1.
Findings
The researchers found that:
-- there were significant differences in lean mass gains (OC: 2.1?±2.1% vs. non-OC: 3.5?±3.2% / OC: 1.0?±1.0kg vs. no-OC: 1.6?±1.4kg, p
четверг, 19 апреля 2012 г.
Bionovo's MF101 Shows Positive Safety, Tolerability And Efficacy In Phase 2 Trial
Bionovo, Inc.'s
(Nasdaq: BNVI) lead drug candidate, MF101, showed positive Phase 2 results
for the treatment of hot flashes associated with menopause. Two hundred and
seventeen women were enrolled in the company's double-blind, placebo-
controlled, randomized Phase 2 trial. Postmenopausal women with 50 or more
moderate to severe hot flashes per week were randomized to one of three
treatment groups receiving MF101 (5 grams/day), MF101 (10 grams/day), or
placebo for twelve weeks. The trial was led by Dr. Deborah Grady at the
University of California, San Francisco and was conducted at six medical
centers in the United States: University of California, San Francisco,
University of Minnesota, Minneapolis, University of Pittsburgh, University
of Tennessee, Memphis, University of Alabama, Birmingham and the San Diego
Medical Center for Clinical Research.
Bionovo's primary objectives in the Phase 2 clinical trial were to
assess the safety, tolerability and the potential efficacy of two doses of
MF101 to reduce the frequency and severity of hot flashes. Both doses of
MF101 were more effective than placebo at reducing the frequency and
severity of hot flashes from the start of the trial until the end of the
treatment period 12 weeks later. In a paired t-test, comparing the number
of hot flashes per day after 12 weeks of treatment, MF101 5 gm was better
than placebo at 12 weeks but did not reach statistical significance
(p=0.06). The higher dose was statistically superior to placebo with a p
value of 0.05 and both doses combined were superior to placebo with a p
value of 0.04. MF101 showed a trend for improvement in severity of hot
flashes compared to placebo with the higher dose showing greater
improvement (p=0.1) than the lower dose (p=0.12) and with both doses
combined superior to placebo (p=0.08). There was a dose response trend
suggesting that the higher dose of MF101 was more effective at reducing
both frequency and severity of hot flashes than the lower dose.
In secondary analyses, the percent of women reporting greater than 50%
reduction in all hot flashes was statistically significantly higher in the
MF101 high dose group compared to placebo (p=0.03) and in both doses of
MF101 combined compared to placebo (p=0.05).
MF101 is a novel estrogen receptor beta agonist that is expected not to
stimulate the endometrium or breast tissue. Safety analyses showed no cases
of endometrial hyperplasia or uterine cancer during the trial and there
were no differences in incidence of vaginal bleeding between the placebo
group and the two cohorts treated with MF101. The only side effect that
increased with MF101 treatment was loose stool/diarrhea (12% in each of the
drug arms vs. 3% in placebo arm). Constipation was improved with MF101
therapy. These observations are consistent with the presence of soluble
fiber in the drug extract, which future optimization of the manufacturing
process will significantly reduce. Adherence to the study medication was
high with 91% of the participants compliant with treatment after 12 weeks
of therapy.
"I am very encouraged and pleased by the findings of this clinical
trial," said Deborah Grady, M.D., Associate Dean for Clinical and
Translational Science, Professor of Medicine and Director of the University
of California, San Francisco (UCSF) Women's Health Clinical Research
Center. "The combination of a trend to better efficacy with a higher dose
of MF101 and a very strong safety profile of a drug that was very well
tolerated by menopausal women is exciting news. These early positive
clinical results are not only encouraging for discovering a safer therapy
for hot flashes but also support the role of estrogen receptor beta as a
novel target for treating menopausal symptoms."
"Recent clinical trials, such as the HERS and the WHI, elucidated
important safety concerns of postmenopausal hormone therapy and resulted in
significantly fewer women using these products," said Isaac Cohen, CEO of
Bionovo. "For this reason, it is important for us to find safer
alternatives for treating menopausal symptoms. The favorable dose response
trend signals that MF101 may become a clear alternative to traditional
postmenopausal hormone therapy for relief of vasomotor symptoms. We are
excited by the prospect of moving forward with the development of a product
that could potentially have such broad reach and positively affect the
quality of life for millions of women and their loved ones. This first
Phase 2 trial conducted by Bionovo serves as a proof of our drug
development strategy and we look forward to advancing MF101 into
registration trials."
About MF101
MF101 is an estrogen receptor (ER) beta selective drug developed as an
alternative to postmenopausal hormone products currently on the market,
which are both ER beta and ER alpha agonists that have been shown to
increase the risk for breast and uterine cancers. It has been shown that
the increased risk of breast and uterine cancers is associated with ER
alpha activation and that ER beta blocks the growth promoting effects on
breast cancer cells. Bionovo recognized the opportunity to commercialize a
product that would be equally effective, with an improved safety profile
compared to traditional hormone therapy. The clinical trial results have
been evaluated by an independent Data and Safety Monitoring Board and the
drug candidate has passed through a standard two-phase examination for
safety.
Bionovo, Inc.
Bionovo is a drug development company focusing on the discovery of
novel pharmaceutical agents for cancer and women's health. The company has
two drugs in clinical testing. MF101 has completed Phase 2 for quality of
life conditions associated with menopause, and BZL101 is in Phase 1/2 for
the treatment of advanced breast cancer. The company has an additional
pipeline of drugs in development for breast cancer, pancreatic cancer and
other menopausal symptoms. The company is developing its products in close
collaboration with leading U.S. academic research centers including:
University of California, San Francisco, University of California, Davis,
and the University of Colorado Health Sciences Center. For further
information please visit: bionovo.
Forward-Looking Statements
This release contains certain forward-looking statements relating to
the business of Bionovo, Inc. that can be identified by the use of
forward-looking terminology such as "believes," "expects," or similar
expressions. Such forward-looking statements involve known and unknown
risks and uncertainties, including uncertainties relating to product
development, efficacy and safety, regulatory actions or delays, the ability
to obtain or maintain patent or other proprietary intellectual property
protection, market acceptance, physician acceptance, third party
reimbursement, future capital requirements, competition in general and
other factors that may cause actual results to be materially different from
those described herein as anticipated, believed, estimated or expected.
Certain of these risks and uncertainties are or will be described in
greater detail in our filings with the Securities and Exchange Commission,
which are available at sec. Bionovo, Inc. is under no
obligation (and expressly disclaims any such obligation) to update or alter
its forward-looking statements whether as a result of new information,
future events or otherwise.
Bionovo, Inc.
bionovo
(Nasdaq: BNVI) lead drug candidate, MF101, showed positive Phase 2 results
for the treatment of hot flashes associated with menopause. Two hundred and
seventeen women were enrolled in the company's double-blind, placebo-
controlled, randomized Phase 2 trial. Postmenopausal women with 50 or more
moderate to severe hot flashes per week were randomized to one of three
treatment groups receiving MF101 (5 grams/day), MF101 (10 grams/day), or
placebo for twelve weeks. The trial was led by Dr. Deborah Grady at the
University of California, San Francisco and was conducted at six medical
centers in the United States: University of California, San Francisco,
University of Minnesota, Minneapolis, University of Pittsburgh, University
of Tennessee, Memphis, University of Alabama, Birmingham and the San Diego
Medical Center for Clinical Research.
Bionovo's primary objectives in the Phase 2 clinical trial were to
assess the safety, tolerability and the potential efficacy of two doses of
MF101 to reduce the frequency and severity of hot flashes. Both doses of
MF101 were more effective than placebo at reducing the frequency and
severity of hot flashes from the start of the trial until the end of the
treatment period 12 weeks later. In a paired t-test, comparing the number
of hot flashes per day after 12 weeks of treatment, MF101 5 gm was better
than placebo at 12 weeks but did not reach statistical significance
(p=0.06). The higher dose was statistically superior to placebo with a p
value of 0.05 and both doses combined were superior to placebo with a p
value of 0.04. MF101 showed a trend for improvement in severity of hot
flashes compared to placebo with the higher dose showing greater
improvement (p=0.1) than the lower dose (p=0.12) and with both doses
combined superior to placebo (p=0.08). There was a dose response trend
suggesting that the higher dose of MF101 was more effective at reducing
both frequency and severity of hot flashes than the lower dose.
In secondary analyses, the percent of women reporting greater than 50%
reduction in all hot flashes was statistically significantly higher in the
MF101 high dose group compared to placebo (p=0.03) and in both doses of
MF101 combined compared to placebo (p=0.05).
MF101 is a novel estrogen receptor beta agonist that is expected not to
stimulate the endometrium or breast tissue. Safety analyses showed no cases
of endometrial hyperplasia or uterine cancer during the trial and there
were no differences in incidence of vaginal bleeding between the placebo
group and the two cohorts treated with MF101. The only side effect that
increased with MF101 treatment was loose stool/diarrhea (12% in each of the
drug arms vs. 3% in placebo arm). Constipation was improved with MF101
therapy. These observations are consistent with the presence of soluble
fiber in the drug extract, which future optimization of the manufacturing
process will significantly reduce. Adherence to the study medication was
high with 91% of the participants compliant with treatment after 12 weeks
of therapy.
"I am very encouraged and pleased by the findings of this clinical
trial," said Deborah Grady, M.D., Associate Dean for Clinical and
Translational Science, Professor of Medicine and Director of the University
of California, San Francisco (UCSF) Women's Health Clinical Research
Center. "The combination of a trend to better efficacy with a higher dose
of MF101 and a very strong safety profile of a drug that was very well
tolerated by menopausal women is exciting news. These early positive
clinical results are not only encouraging for discovering a safer therapy
for hot flashes but also support the role of estrogen receptor beta as a
novel target for treating menopausal symptoms."
"Recent clinical trials, such as the HERS and the WHI, elucidated
important safety concerns of postmenopausal hormone therapy and resulted in
significantly fewer women using these products," said Isaac Cohen, CEO of
Bionovo. "For this reason, it is important for us to find safer
alternatives for treating menopausal symptoms. The favorable dose response
trend signals that MF101 may become a clear alternative to traditional
postmenopausal hormone therapy for relief of vasomotor symptoms. We are
excited by the prospect of moving forward with the development of a product
that could potentially have such broad reach and positively affect the
quality of life for millions of women and their loved ones. This first
Phase 2 trial conducted by Bionovo serves as a proof of our drug
development strategy and we look forward to advancing MF101 into
registration trials."
About MF101
MF101 is an estrogen receptor (ER) beta selective drug developed as an
alternative to postmenopausal hormone products currently on the market,
which are both ER beta and ER alpha agonists that have been shown to
increase the risk for breast and uterine cancers. It has been shown that
the increased risk of breast and uterine cancers is associated with ER
alpha activation and that ER beta blocks the growth promoting effects on
breast cancer cells. Bionovo recognized the opportunity to commercialize a
product that would be equally effective, with an improved safety profile
compared to traditional hormone therapy. The clinical trial results have
been evaluated by an independent Data and Safety Monitoring Board and the
drug candidate has passed through a standard two-phase examination for
safety.
Bionovo, Inc.
Bionovo is a drug development company focusing on the discovery of
novel pharmaceutical agents for cancer and women's health. The company has
two drugs in clinical testing. MF101 has completed Phase 2 for quality of
life conditions associated with menopause, and BZL101 is in Phase 1/2 for
the treatment of advanced breast cancer. The company has an additional
pipeline of drugs in development for breast cancer, pancreatic cancer and
other menopausal symptoms. The company is developing its products in close
collaboration with leading U.S. academic research centers including:
University of California, San Francisco, University of California, Davis,
and the University of Colorado Health Sciences Center. For further
information please visit: bionovo.
Forward-Looking Statements
This release contains certain forward-looking statements relating to
the business of Bionovo, Inc. that can be identified by the use of
forward-looking terminology such as "believes," "expects," or similar
expressions. Such forward-looking statements involve known and unknown
risks and uncertainties, including uncertainties relating to product
development, efficacy and safety, regulatory actions or delays, the ability
to obtain or maintain patent or other proprietary intellectual property
protection, market acceptance, physician acceptance, third party
reimbursement, future capital requirements, competition in general and
other factors that may cause actual results to be materially different from
those described herein as anticipated, believed, estimated or expected.
Certain of these risks and uncertainties are or will be described in
greater detail in our filings with the Securities and Exchange Commission,
which are available at sec. Bionovo, Inc. is under no
obligation (and expressly disclaims any such obligation) to update or alter
its forward-looking statements whether as a result of new information,
future events or otherwise.
Bionovo, Inc.
bionovo
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