Arlington, VA, United States
Arlington, VA, United States

Time filter

Source Type

News Article | October 27, 2016
Site: www.eurekalert.org

Washington, DC -- Men can take birth control shots to prevent pregnancy in their female partners, according to a new study published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. Researchers are still working to perfect the combination of hormonal contraceptives to reduce the risk of mild to moderate side effects, including depression and other mood disorders. While women can choose from a number of birth control methods, men have few options to control their own fertility. Available methods for men include condoms, vasectomies and withdrawal. Better birth control options are needed for men. In 2012, 40 percent of all pregnancies worldwide were unintended, according to the Guttmacher Institute. "The study found it is possible to have a hormonal contraceptive for men that reduces the risk of unplanned pregnancies in the partners of men who use it," said one of the study's authors, Mario Philip Reyes Festin, MD, of the World Health Organization in Geneva, Switzerland. "Our findings confirmed the efficacy of this contraceptive method previously seen in small studies." The prospective Phase II single arm, multi-center study tested the safety and effectiveness of injectable contraceptives in 320 healthy men ages 18 to 45. The participants had all been in monogamous relationships with female partners between the ages of 18 and 38 for at least a year. The men underwent testing to ensure they had a normal sperm count at the start of the study. The men received injections of 200 milligrams of a long-acting progestogen called norethisterone enanthate (NET-EN) and 1,000 milligrams of a long-acting androgen called testosterone undecanoate (TU) for up to 26 weeks to suppress their sperm counts. Healthcare professionals gave the men two injections every eight weeks. Participants initially provided semen samples after eight and 12 weeks in the suppression phase and then every 2 weeks until they met the criteria for the next phase. During this time, the couples were instructed to use other non-hormonal birth control methods. Once a participant's sperm count was lowered to less than 1 million/ml in two consecutive tests, the couple was asked to rely on the injections for birth control. During this period known as the efficacy phase of the study, the men continued to receive injections every eight weeks for up to 56 weeks. Participants provided semen samples every eight weeks to ensure their sperm counts stayed low. Once the participants stopped receiving the injections, they were monitored to see how quickly their sperm counts recovered. The hormones were effective in reducing the sperm count to 1 million/ml or less within 24 weeks in 274 of the participants. The contraceptive method was effective in nearly 96 percent of continuing users. Only four pregnancies occurred among the men's partners during the efficacy phase of the study. Researchers stopped enrolling new participants in the study in 2011 due to the rate of adverse events, particularly depression and other mood disorders, reported by the participants. The men reported side effects including injection site pain, muscle pain, increased libido and acne. Twenty men dropped out of the study due to side effects. Despite the adverse effects, more than 75 percent of participants reported being willing to use this method of contraception at the conclusion of the trial. Of the 1,491 reported adverse events, nearly 39 percent were found to be unrelated to the contraceptive injections. These included one death by suicide which was assessed not to be related to the use of the drug. Serious adverse events that were assessed as probably or possibly related to the study included one case of depression, one intentional overdose of acetaminophen, and a man who experienced an abnormally fast and irregular heartbeat after he stopped receiving the injections. "More research is needed to advance this concept to the point that it can be made widely available to men as a method of contraception," Festin said. "Although the injections were effective in reducing the rate of pregnancy, the combination of hormones needs to be studied more to consider a good balance between efficacy and safety." The study, "Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men," will be published online at http://press. , ahead of print. Other authors of the study include: Hermann M. Behre of Martin Luther University of Halle-Wittenberg in Halle, Germany; Michael Zitzmann of the University of Münster in Münster, Germany; Richard A. Anderson of The University of Edinburgh in Edinburgh, United Kingdom; David J. Handelsman of the University of Sydney and Concord Hospital in Sydney, Australia; Silvia W. Lestari of the University of Indonesia in Jakarta, Indonesia; Robert I. McLachlan of Monash Medical Centre in Melbourne, Australia; M. Cristina Meriggiola of the University of Bologna in Bologna, Italy; Man Mohan Misro of the National Institute of Health & Family Welfare in New Dehli, India; Gabriela Noe of the Instituto Chileno de Medicina Reproductiva in Santiago, Chile; Frederick C. W. Wu of Manchester Royal Infirmary in Manchester, U.K.; Ndema A. Habib and Kirsten M. Vogelsong of the World Health Organization of Geneva, Switzerland; and Marianne M. Callahan, Kim A. Linton and Doug S. Colvard of CONRAD, East Virginia Medical School, a reproductive health organization based in Arlington, VA. The research was co-sponsored and funded by UNDP/UNFPA/UNICEF/WHO/World Bank Special Program of Research, Development, and Research Training in Human Reproduction in Geneva, Switzerland, and CONRAD (using funding from the Bill & Melinda Gates Foundation and the U.S. Agency for International Development). The injectable hormones were provided by Schering AG, which has since merged with Bayer Pharma AG. For more information on men's health, visit the Endocrine Society's centennial website. Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world's oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions. The Society, which is celebrating its centennial in 2016, has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at http://www. . Follow us on Twitter at @TheEndoSociety and @EndoMedia.


News Article | October 27, 2015
Site: www.sciencenews.org

After a decade of controversy and halting progress, preexposure prophylaxis may finally be about to take its place in the vanguard of AIDS prevention. In September, for the first time, the World Health Organization expanded the population recommended for this option, which involves taking daily doses of antiviral medication. If a person is exposed to HIV, the drugs should defeat the virus before it establishes a permanent foothold. Previously, preexposure prophylaxis, or PrEP, was reserved only for those deemed at high risk, such as couples in which one partner is infected, or men who have sex with men. But in the updated guidelines, WHO officials now say that anyone “at significant risk” should take the drugs. The HIV prevention advocacy group AVAC called the change a “potentially profound development” that stands to greatly expand PrEP among adolescents and young women. About 380,000 women ages 15 to 24 become infected every year, most of them living sub-Saharan Africa, which remains the most severely affected region of the world. The new recommendation followed the release of two studies that reported some of the highest success rates so far using the drug Truvada, which contains the antiviral drugs tenofovir and emtricitabine (SN: 12/18/10, p. 16), as a daily preventative. Early next year, highly anticipated research on antimicrobial vaginal rings will be completed, and studies of long-acting antiretroviral injections are under way. Public health officials hope that PrEP will one day be viewed in the same light as birth control — a prevention strategy with enough approaches for men and women to choose the method best suited for their lives. The results of tenofovir-based preexposure prophylaxis studies (dots) have been mixed. But as adherence across studies increases, so too does the drug’s effectiveness in preventing HIV. “It is a really exciting time,” says Meredith Clark, who heads preclinical activities at CONRAD, a nonprofit based in Arlington, Va., that focuses on contraception and HIV prevention. “A lot is happening. A lot is changing.” The outlook was not always so rosy. Early in the epidemic, doctors hypothesized that it would be possible to prevent infections with PrEP, which interferes with viral replication. But many early studies were abandoned before they even got off the ground, as they grew beset with allegations of unethical behavior, fears of drug resistance and other problems. Other early studies yielded results that were lukewarm, in large part because study participants did not use the drugs consistently, which is recommended to prevent infection. Researchers have also fielded social opposition — the president of one well-known AIDS nonprofit referred to Truvada as a “party drug” that would encourage risky behavior and discourage the use of condoms. (The drug does not protect against other sexually transmitted infections and is not considered a substitute for condoms.) At the same time, some studies with PrEP began to show remarkable effectiveness. The U.S. Food and Drug Administration approved Truvada in 2012, but its effectiveness outside the carefully controlled and monitored world of clinical trials was unclear. In September, researchers from Kaiser Permanente reported in the journal Clinical Infectious Diseases that after more than two years, no new infections occurred among 657 people in San Francisco who were instructed to take the drug daily. “It adds really compelling data that prophylaxis can work,” says Jonathan Volk, an infectious disease physician and epidemiologist at Kaiser, and one of the study’s authors. A similar study from the United Kingdom, with support from drug manufacturer Gilead Sciences, compared 275 men who received PrEP for a year with 269 who were told to wait a year before receiving it. During that time, 20 men who were deferred became infected, compared with three offered PrEP — an 86 percent reduction in risk. Those results appeared last month in The Lancet. The challenge is that the drug doesn’t work if it stays in the bottle. Pills carry the potential for stigma, since they are among the same medicines used to treat HIV infection. Addressing those concerns, a vaginal ring under investigation might increase adherence and offer a more discreet HIV prevention. Two large studies, The Ring Study and the ASPIRE study, are being conducted by the nonprofit International Partnership for Microbicides and the Microbicide Trials Network, which is funded by the National Institutes of Health. Those studies have enrolled more than 4,000 women in sub-Saharan Africa. The ring contains the antiviral drug dapivirine, and lasts for one month. Also under development is a rectal microbicide containing tenofovir, which would be used only as necessary, not daily. It’s not clear how well a topical microbicide would work. Studies have been weak or inconsistent. One study of a vaginal gel microbicide, published in 2010, found that women who used the product before and after sex had a reduced risk of infection of about 40 percent overall (SN: 8/14/10, p. 9). However, effectiveness would have been higher in that study if women had used it consistently, says Clark, from CONRAD, which was one of the study sponsors. She points out that one reason some people in general have not been keen on PrEP was that they weren’t convinced it would work, which affected their motivation to use it. “Now that we have success stories, it will change how people view it and adopt it,” she says. Taking a daily pill may not be the best HIV-prevention strategy for everyone, so researchers are investigating alternative PrEP options. In addition to microbicides, two long-acting injectable antiviral agents (rilpivirine and cabotegravir) are under development. Those products also have the potential to eliminate the need for daily use and offer protection that is easy to keep private. But this approach has two main concerns, says Ian McGowan of the University of Pittsburgh, who is principal investigator of the Microbicide Trials Network. “These products have very long half-lives, which would complicate the management of any side effects that might occur,” he says. “Also during periods when there were low drug levels, there’s a real risk that anyone acquiring HIV infection would develop antiviral resistance.” Like others in the field, he is encouraged by the variety of methods now under development, which should help expand the number of people who will be more protected — though he cautions that PrEP should not replace condoms. Until more methods of PrEP are on the market, public health officials will work to make antiviral tablets available to those at greatest risk. Right now, the number of people outside North America who are taking PrEP “is horribly small,” says Peter Godfrey-Faussett, science adviser to UNAIDS, a global health agency that is part of the United Nations. “I think we’ve established beyond any reasonable doubt that a daily pill form is absolutely proven now to work, providing you take it,” he says. “The challenge now is to make this new exciting tool available in the settings where it is needed.”


News Article | December 8, 2016
Site: www.businesswire.com

TOKYO--(BUSINESS WIRE)--Mori Trust Co., Ltd. (Headquarters: Minato Ward, Tokyo; President: Miwako Date) announces that the Company established its US subsidiary Mori America LLC on November 7, 2016 with the aim of promoting overseas investment business in the US. It also concluded a sale and purchase agreement for two office buildings in Boston, Massachusetts, on November 15, 2016. In future, we are scheduled to acquire the buildings, effective January 5, 2017, after completing the process for such acquisition. We announced the medium- and long-term vision “Advance 2027” in June of this year when the new president took office. Based on this vision, we are conducting business with an eye to making total investments on the order of 800 billion yen. We set investments in overseas real estate as a key business strategy in the Vision in an attempt to capture business opportunities overseas and build a stable asset portfolio that can ride out a global economic change. Following the policy of “Advance 2027,” we have decided to establish a subsidiary with the aim of promoting the overseas investment business in the US in earnest and, as the first overseas investment project in the Vision, to acquire two office buildings with a high operational rate in the Back Bay District, which is a popular location for offices in Boston. Mori Trust Group owns 124 real properties for management and leasing, including offices, hotels and residences, primarily in central Tokyo. Recently, we started construction of the Tokyo World Gate (a total floor area of about 2,150,000 square feet), which is the first project accredited as an architectural structure for National Strategy Urban Planning. In addition to domestic projects like this, we will also pursue a policy of promoting investments in real estate in the US. We intend to expand the total amount of investments overseas to between 100 billion yen and 200 billion yen in the future. 1. Outline of Properties to be Acquired Boston, where the above properties are located, is the largest city in Massachusetts in the northeastern US. Boston is one of America’s most prominent cosmopolitan cities and is rich in history and culture, in addition to being called “America’s Birthplace.” The area has some of the world’s most prestigious universities, such as Harvard University and Massachusetts Institute of Technology. Along with a cluster of cutting-edge medical institutions, Boston is a center of education and medicine in the US. In addition, the city is a popular tourist destination for its cityscape, with historic towns and modern buildings combined in harmony, and for its reputation as a safe city. The business areas are concentrated in the Financial District with many high-rise buildings, where a number of banks and other financial institutions are located; the Back Bay District, with its high-end offices, residences and entertainment facilities nearby; and the Sea Port District, where there is an increasing number of urban development projects in recent years. These districts form a dynamic international city that attracts companies and entrepreneurs mainly from the high-tech industry. The properties to be acquired by this agreement are located in the Back Bay District, which is a popular office area with exclusive fashion boutiques, restaurants, hotels and residences also found in the vicinity. The properties are two buildings with a total rentable floor space of about 825,000 square feet, a complex of a Class A modern high-rise building, rare in this area, and an over 100 year-old historical building, indicating the high value of a stable asset. 10 St. James Avenue won “BOMA Boston 2016 TOBY (the Outstanding Building of the Year) & Industry Awards,” one of the greatest programs in the US to recognize commercial real estate, and have garnered an extremely high reputation for their function, design and other aspects. (2) Schedule January 5, 2017: Settlement of Payment and Transfer of Properties About Mori Trust Group The Mori Trust Group originated in the Mori Group, which was founded by Taikichiro Mori, and has been in business over 60 years. Current Chairman and CEO Akira Mori, the third son of the founder, created the Mori Trust Group, a major developer in Japan. Since then, the Group has been engaged in the businesses of real estate development, hotels and resorts, and investment. In June 2016, Miwako Date, the granddaughter of Taikichiro Mori and the daughter of Akira Mori, became President and Chief Executive Officer to take over operations. Date formulated the medium- and long-term vision and has pushed forward with the Group’s diverse operations. Real Estate Development Business As a major real estate developer in Japan, the Mori Trust Group owns 124 facilities for management and leasing with a total floor area of about 15,930,000 square feet (including offices, hotels, residences and commercial complexes) in prime locations in the Tokyo metropolitan area and across the nation. One of its ongoing projects is construction of a 38-story complex in Toranomon in central Tokyo, where numerous international offices, residences and commercial facilities are clustered. “The Tokyo World Gate” with a floor area of about 2,150,000 square feet is a complex containing offices, an international hotel, apartments with hotel-like services, exclusive residences for freehold, and a concierge service to facilitate the daily life of foreigners. It is under construction and is scheduled to be completed in March 2020. Furthermore, development of large complexes is planned in the Akasaka and Shinagawa areas in central Tokyo. Hotels & Resorts Business The Mori Trust Group has developed, owned and managed 21 hotels and resorts with a total of about 3,800 guest rooms nationwide. The Group is known as a business operator that has pioneered attracting international hotel brands to Japan. Furthermore, the Group is the biggest Marriot Group hotel owner in Japan, which owns, manages and operates 11 existing, rebranded, and newly developing hotels under the brand name of Marriot International. Regarding hotel projects currently underway, ten new hotels are planned primarily in areas that are among the most popular cities and regions in Japan, such as Ginza, Hokkaido, Nara and Okinawa. Investment Business The Group is recognized as a company that contributed to the creation of the REIT market in Japan, and has listed a comprehensive REIT on the Tokyo Stock Exchange (TSE). We are working to list a second REIT that specializes in hotels on the TSE. Financial Results The consolidated financial position of Mori Trust Group as of March 31, 2016 comprised total net assets of 1.3 trillion yen (market value), equity ratio 31% (book value). The Group posted, for the term ended March 2016, 163.0 billion yen in operating revenue, 41.2 billion yen in operating income, and 34.0 billion yen in net income. The Group forecasts 148.0 billion yen in operating revenue, 30.0 billion yen in operating income, and 57.0 billion yen in net income for the term ending March 2017. Medium- and Long-Term Vision “Advance 2027” Following current President Miwako Date assuming the position of president, the Group announced a medium- and long-term vision, which emphasizes that the Group is prepared to make investments on the order of 800 billion yen in real properties and projects at home and overseas by 2027 while retaining its current level of owned capital rate, which is high by the standards of Japanese developers. After graduating from Keio University’s graduate school, Date joined a major consulting firm. In 1998, she joined the Mori Trust Co., Ltd., and in June 2016, became the President and CEO of the Mori Trust Co. Her father is Akira Mori, current Chairman and CEO. While overseeing a number of large-scale real estate development projects in central Tokyo, Miwako Date steered the hotels & resorts business into bringing in a number of international hotels including: CONRAD TOKYO; Shangri-La Hotel Tokyo; Tokyo Marriott Hotel; Suiran, a Luxury Collection Hotel, Kyoto; The Westin Sendai; Courtyard by Marriott Tokyo Station; and Courtyard by Marriott Shin-Osaka Station.


Richardson-Harman N.,Alpha StatConsult LLC | Mauck C.,CONRAD | McGowan I.,University of Pittsburgh | Anton P.,University of California at Los Angeles
AIDS Research and Human Retroviruses | Year: 2012

A retrospective correlational analysis of UC781 (0.1, 0.25%) gel pharmacokinetics (PK) and pharmacodynamics (PD) was undertaken using data generated in the RMP-01/MTN-006 Phase 1 rectal safety study of the UC781 microbicide gel, where strong UC781-related inhibition of ex vivo biopsy infectibility (PD) was seen. Precision analysis, linear and logistical correlational methods were applied to model the dose-response relationship. Four analyses of explant virus growth were compared to determine tissue concentrations of UC781 needed to maintain ex vivo virus growth below a range of cut-points. SOFT, a cross-sectional index from a growth curve, and cumulative p24 endpoints were the most precise measurement of ex vivo HIV infection and significantly (p<0.01) correlated with rectal tissue UC781 concentrations. Cut-points reflecting infectibility, ranging from 200 to 1300 p24pg/ml, provided EC50,90,95 tissue levels of UC781. A cut-point of 200 p24pg/ml provided an EC50 of 2148 UC781ng/g tissue; a cut-point of 1100 p24 predicted a lower EC50 of 101 UC781ng/g. A 30- to 170-fold EC 90:EC50 ratio was found. Higher p24 cut-points provided more predictive models. Tissue UC781 levels and ex vivo infectibility data were correlated to model dose-response drug efficacy in this small Phase 1 trial. Logistic regression analyses showed EC50,90,95 values were inversely related to p24 cut-point levels, providing clinically relevant insights into tissue drug concentration necessary for ex vivo suppression of HIV tissue infectibility. This first PK-PD assessment of topical microbicides demonstrates feasibility in Phase 1 trials, enabling comparisons of microbicide efficacy (i.e., EC50,90,95) between formulations, compartments, and application methods. © Copyright 2012, Mary Ann Liebert, Inc.


Patent
Tirouvanziam, Conrad and Herzenberg | Date: 2013-05-08

The described invention provides a pharmaceutical compositions for use in treatment methods for improving or preserving lung function in a patient suffering from a pulmonary disorder comprising an inflammatory component, the pharmaceutical compositions comprising a therapeutically effective amount of N-acetylcysteine, a derivative of N-acetylcysteine, or a pharmaceutically acceptable salt of N-acetylcysteine, wherein the therapeutically effective amount is effective to improve or preserve the lung function in the patient.


Bansil P.,CONRAD
Journal of women's health (2002) | Year: 2010

To compare maternal and fetal outcomes among women with and without diagnosed depression at the time of delivery. Hospital discharge data from the 1998-2005 Nationwide Inpatient Sample (NIS) were used to examine delivery-related hospitalizations for select maternal and fetal outcomes by depression diagnosis. The rate of depression per 1000 deliveries increased significantly from 2.73 in 1998 to 14.1 in 2005 (p < 0.001). Women diagnosed with depression were significantly more likely to have cesarean delivery, preterm labor, anemia, diabetes, and preeclampsia or hypertension compared with women without depression. Fetal outcomes significantly associated with maternal depression were fetal growth restriction, fetal abnormalities, fetal distress, and fetal death. These findings suggest that depression is associated with adverse maternal and fetal outcomes. Our results provide additional impetus to screen for depression among women of reproductive age, especially those who plan to become pregnant.


The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-pur: in-9-yl)-1-methyl-ethoxymethy]-phosphonic acid (tenofivir, PMPA), or a physiologically functional derivative thereof, wherein the formulations contain a low level of glycerin. Human immunodeficiency vims (HIV) infection and related diseases are a major public health problem worldwide. One approach to the problem of HIV/AIDS is to reduce the risk of transmission of HIV and thus reduce the number of individuals who become newly infected.


Patent
Conrad and International Partnership For Microbicides | Date: 2010-09-24

The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid (tenofovir, PMPA), or a physiologically functional derivative thereof, suitable for topical application and their use in the prevention of HIV infections.


Patent
Conrad and International Partnership For Microbicides | Date: 2010-09-29

The present invention relates to formulations of nucleotide reverse transcriptase inhibitors (NRTIs), preferably [2-(6-Amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid (tenofovir, PMPA), or a physiologically functional derivative thereof, suitable for topical application and their use in the prevention of HIV infections.


LOS ANGELES--(BUSINESS WIRE)--MICHAEL BUCHMAN AND YATIN PATEL NAMED CO-CHIEF INVESTMENT OFFICERS FOR THE CONRAD N. HILTON FOUNDATION

Loading CONRAD collaborators
Loading CONRAD collaborators