Downsyndrome.com

WASHINGTON — There’s a big change coming for pregnant women: Down syndrome testing no longer hinges on whether they’re older or younger than 35.

This week, the American College of Obstetricians and Gynecologists begins recommending that every pregnant woman, regardless of age, be offered a choice of tests for this common birth defect.

The main reason: Tests far less invasive than the long-used amniocentesis are now widely available, some that can tell in the first trimester the risk of a fetus having Down syndrome or other chromosomal defects.

It’s a change that promises to decrease unnecessary amnios — giving mothers-to-be peace of mind without the ordeal — while also detecting Down syndrome in moms who otherwise would have gone unchecked.

The new guideline is published in the January issue of the journal Obstetrics & Gynecology.

About one in 800 babies has Down syndrome, a condition where having an extra chromosome causes mental retardation, a characteristic broad, flat face and small head and, often, serious heart defects.

Age 35 was always a somewhat arbitrary threshold for urging mothers-to-be to seek testing. Yes, the older women are, the higher their risk of having a baby with Down syndrome.

But it’s a gradual increase in risk — from one in 1,200 at age 25 to about one in 300 at age 35. Nothing suddenly changes at the 35th birthday. Indeed, because more babies are born to younger women than older ones, women under 35 actually give birth to most of the nation’s children with Down syndrome.

“It’s clear there’s no magic jump at 35,” said Dr. James Goldberg of San Francisco Perinatal Associates, a member of the ACOG committee that developed the guideline. “We’ve done away with age 35 because the screening tests have gotten much better.”

It’s not just a question of whether to continue the pregnancy. Prenatal diagnosis also is important for those who wouldn’t consider abortion, because babies with Down syndrome can need specialized care at delivery that affects hospital selection, he added.

The original age-35 trigger was chosen years ago when doctors had less information about the risk of Down syndrome, and the only choice for prenatal detection was an amnio, using a needle to draw fluid from the amniotic sac, he said. Amnios are highly accurate but were reserved for women at higher risk of an affected pregnancy because they occasionally cause miscarriage. A study this fall put the miscarriage risk at one in 1,600 pregnancies, far lower than previous estimates.

Also today, women have more options. Doctors already frequently offer younger women blood tests that don’t definitively diagnose Down syndrome like an amnio or a similar invasive test called chorionic villus sampling — but that can signal who’s at higher risk.

The newest method, topping ACOG’s recommendation for everyone, is a first-trimester screening that combines blood tests with a simple ultrasound exam, called a “nuchal translucency test” to measure the thickness of the back of the fetal neck.

Studies from England, where the nuchal translucency combo has been used for about a decade, and the U.S. conclude that screening method is more than 80 percent accurate, with a very small risk of falsely indicating Down syndrome in a healthy fetus. It is performed between 11 and 13 weeks into pregnancy, and women are usually given numerical odds of carrying an affected fetus.

A woman determined to be high risk then still has time for an invasive test to tell for sure.

Women who don’t seek prenatal care until the second trimester can still undergo blood tests known as the triple or quadruple screens.

The guideline also says women of any age can choose to skip the screening and go straight for invasive testing, an approach that might appeal to those with chromosomal defects in the family.

“This new recommendation makes a lot of sense,” said Dr. Nancy Green of the March of Dimes. “Maternal age no longer plays such an important role because the screening is better.”

Each test comes with pros and cons, and the new guideline advises doctors to check what’s available in their communities — nuchal translucency testing isn’t easy to get everywhere — and discuss the best options with each patient.

Copyright C 2006 Deseret News Publishing Co.
Provided by ProQuest Information and Learning Company. All rights Reserved.

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* Intranasal Aerosol Treatment with 800 Nanogram PH80 up to Four Times Daily, During the Symptomatic Days of PMS Only, Shows Significant Efficacy, Distinct Improvement over Placebo and Symptoms Remission in Clinically Significant PMS

* No Adverse Events Reported, Excellent Safety and Tolerability Profile

* Phase III Program Investigating PH80 Now Being Implemented

* Approximately 80% of Women Ages 15 to 44 in the US Suffer from Symptoms of PMS

REDWOOD CITY, Calif. — Pherin Pharmaceuticals, Inc. reports that recent clinical trial results from a Phase II study showed that PH80, a novel compound patented by Pherin Pharmaceuticals, administered intranasally in aerosol form demonstrated significant benefits in the treatment of symptoms of PMS. Based on the positive Phase II study results, Pherin Pharmaceuticals is programming a Phase III pivotal study to further evaluate PH80 benefits in patients with PMS.

The multicenter, double blind, placebo-controlled Phase II study involved 60 randomized patients with clinically significant PMS. Patients were randomized into one of two treatment groups: 800 nanogram PH80 up to four times daily during six consecutive days or placebo. The primary objective of the four-month study was to assess the efficacy of PH80 in treating the symptoms associated with PMS. Results show that during a six day treatment (critical days of PMS only) PH80 administered intranasally up to four times daily improved PMS symptoms significantly better than placebo (P< 0.05). The medication showed clinical efficacy to reduce premenstrual symptoms in 63% of patients as compared to placebo (44% only) during the treatment phase. Symptom remission was also significantly greater than placebo during the month following treatment with PH80 (P< 0.01).

PMS symptom scores from baseline and after treatment were assessed using validated psychometric scales. Clinical improvement in PMS symptom scores revealed significant change from baseline (P< 0.01) for Irritability and Persistent Anger; Difficulty Concentrating; Depression, Feeling Sad, Down or Blue, and Craving Foods and Increased Appetite and Overeating, among other symptoms.

Although not statistically significantly different from placebo for four-time daily PH80 (P=0.08) there was also improvement of Cramps with a 30% reduction in mean symptom score with PH80. The proportion of responders, defined as patients with at least 60% improvement in total PMS symptom score at the end of each treatment day compared to baseline, showed that 800 nanogram PH80 up to four times daily reached statistical significance (P< 0.05).

"These results are impressive and position PH80 favorably in efficacy, safety, route of administration and dosing convenience against other existing therapeutic options which require much higher dosing and have concurrent side effects," said Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. "We are enthusiastic about sharing these data with companies that express interest in co-developing PH80 with us to advance our development program."

It is important that intranasal application up to four times-daily of PH80 during the critical days of PMS provides a significant and rapid improvement in symptoms, as well as a carry over symptom remission during the subsequent period. If the magnitude of benefits shown in this Phase II study is confirmed in the larger-scale Phase III study, intranasal PH80 could represent a major improvement in the way PMS will be treated in the future.

There were no adverse events reported associated with PH80 and the medication was well tolerated by the treated patients. We attribute these results to the unique formulation of PH80, which is based on our aerosol drug delivery technology.

Phase II Study Results

The Phase II study was conducted in three centers and in 60 patients to evaluate the effect of PH80 for the acute treatment of symptoms of PMS, as well as its safety and tolerability.

In the placebo-controlled phase, 60 patients were randomized to receive intranasally either 800 nanogram PH80 or placebo up to four times-daily during six consecutive days (critical days of PMS symptoms only). Fifty-six patients completed the study. The study showed that six-day treatment with intranasal PH80 provides significant improvement in symptom measures and remission in clinical endpoints in patients with PMS. Irritability, Difficulty Concentrating, Depression and Increased Appetite showed improvement significantly better than placebo and Physical Symptoms (Cramps) showed improvement after applying PH80 compared to the effect of placebo.

About PH80 and PMS

PH80 is the first in a new class of Pherin proprietary compounds called vomeropherins that modulate basal forebrain centers acting on peripheral chemosensory receptors in the nasal passages, and has a novel mode of action and a very good safety and tolerability profile different from all currently marketed PMS treatments. PH80 has been developed by and is proprietary to Pherin Pharmaceuticals.

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BEIJING — China Medical Technologies, Inc. (the "Company") (NASDAQ: CMED), a leading China-based medical device company that develops, manufactures and markets high intensity focused ultrasound products and advanced in-vitro diagnostic systems, today announced that it has successfully completed the development of two Down syndrome diagnostic reagents that use chemiluminescence immunoassay technology. The Company is expected to introduce these two new reagents in early 2007, bringing the Company’s total kit offering to 58 from 56.

The two new Down syndrome reagents are designed to measure the free beta subunit of human Chorionic Gonadotrophin ("Free hCG[eth]") and Pregnancy Associated Plasma Protein A ("PAPP-A"), respectively, in maternal serum, which are important markers of Down syndrome. These two reagents can be used to improve the efficacy of assessment of fetal anomalies within the first trimester of pregnancy. The human Alpha-fetoprotein ("AFP") reagent which the Company currently offers can be used in combination with the Free hCG[eth] kit for determining if a fetus is affected by Down syndrome in the second trimester of pregnancy.

According to statistics from the Chinese Ministry of Health, there were approximately 16 million newborn infants in China in 2005. Every year, approximately 6% of new babies are born with congenital disorders. Given this high rate of occurrence, prenatal assessment has become a commonly recommended diagnostic procedure in China. Prenatal risk assessment and early detection programs increase treatment and management options for parents and China Medical believes that the introduction of the Down syndrome reagents will strengthen early detection of fetal anomalies during pregnancy.

"We are pleased to expand our capabilities in the high growth areas of maternal health screening," stated Mr. Xiaodong Wu, Chairman and CEO of China Medical. "Our innovative screening technologies are expected to improve parental options during pregnancy and deliver high value to the Company."

About China Medical Technologies:

China Medical Technologies is a leading China-based medical device company that develops, manufactures and markets products using high intensity focused ultrasound for the treatment of solid cancers and benign tumors and advanced in-vitro diagnostics products using enhanced chemiluminescence technology, to detect and monitor various diseases and disorders. For more information, please visit our website at www.chinameditech.com.

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the Company’s statements that it expects to introduce the abovementioned reagents, and that it expects that such reagents can be used to improve the efficacy of assessment of fetal anomalies in the first and second trimesters of pregnancy and deliver high value to the Company, are forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in China Medical’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. China Medical does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

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Is there discrimination in the Paralympic Games? The family of a teenage sufferer from Down’s syndrome believe so, and have enlisted the help of MPs to get the rules changed so that 17-year-old Tom Cole, an outstanding young swimming prospect from Sudbury, Suffolk, can realise his dream of taking part in the London 2012 Games.

He and other Down’s syndrome sufferers have been barred from Beijing by the International Paralympic Committee, who say the presence of athletes with an “intellectual disability” would not be fair competition following a series of scandals. However, a campaign to get the newly introduced ban overturned is being backed by MPs and the British Paralympic Association. Says Tom’s mother, Barbara: “We believe Tom should have every right to compete. He excels at the sport and it makes him feel good about himself. We feel particularly bitter about this with the 2012 Paralympic Games being held in London. Surely every disabled person, whether the disability is intellectual or physical, should have the same rights.”

Copyright 2006 Independent Newspapers UK Limited
Provided by ProQuest Information and Learning Company. All rights Reserved.

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The Down Syndrome Guild of Greater Kansas City is a nonprofit volunteer organization whose mission is to provide support and resources for individuals with Down syndrome and their families. DSG seeks to provide the entire community with information and education to broaden awareness and foster positive attitudes regarding people with Down syndrome. For more information, visit www.KCDSG.org.

Company:               <
Down Syndrome Guild of Greater Kansas City
                       <

Headquarters Address:  <
10200 West 75th Street
                       <
Suite 281
                       <
Shawnee Mission, KS 66204
                       <

Main Telephone:        <
913-384-4848
                       <

Website:               <
http://www.kcdsg.org
                       <

Type of Organization:  <
Non-profit
                       <
PR
                       <

Industry:              <
Other
                       <

Key Executives:        <
Executive Director: Amy Allison
                       <

Public Relations       <

Contact:               <
Abigail Waters
Phone:                 <
612-279-2377
Email:                 <

abigail@adsoka.com

COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

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First Place Philly Award Recognizes Nonprofit

KANSAS CITY, Kan. — The Down Syndrome Guild of Greater Kansas City (DSG) received a first place Philly Award honoring excellence in nonprofit communications for their 2005 annual report titled "A Year of Growth, a Year of Joy." The report was created by Adsoka, Inc. of Minneapolis, Minn. Amy Allison, executive director of DSG, accepted the award at a December 8 award ceremony.

The Council on Philanthropy judged Philly Award entrants in seven categories; the DSG 2005 annual report received a first place for non-profits with revenues under $1 million. The judges commented on the report’s impressive visual design and strong content executed within a small budget. To learn more about the Council on Philanthropy, visit www.kcphilnet.org.

"We love to work with DSG, and it is a treat to be awarded for strongly conveying their mission through printed materials," said Jason Inskeep, principal of Adsoka.

DSG selected Adsoka to assist them with their branding needs in 2005, starting with a redesign of the DSG logo. In 2006 Adsoka worked on the annual report and the First Downs for Down Syndrome Buddy Walk Festival brochure–an annual fundraising event benefiting DSG and First Downs for Down Syndrome. The Buddy Walk Festival set record-high participation this year. Adsoka is currently redesigning the DSG Web site.

"Our members have reacted very positively to the new branding. We extend our sincere thanks to Adsoka for having the vision to see us through this process and creating such a fabulous outcome," said Amy Allison, executive director of DSG.

The Down Syndrome Guild of Greater Kansas City is a non-profit volunteer organization whose mission is to provide support and resources for individuals with Down syndrome and their families. DSG seeks to provide the entire community with information and education to broaden awareness and foster positive attitudes regarding people with Down syndrome. For more information, visit www.KCDSG.org.

Adsoka is a marketing, design and communications agency in Minneapolis. It formed in 2003 and serves clients in a wide spectrum of industries including business-to-business, retail, nonprofit and others. Adsoka means adding creative value. Learn more at www.ADSOKA.com.

COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

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Down syndrome and Alzheimer’s disease; biological correlates.

Ed. by Vee P. Prasher.

Radcliffe Publishing

2006

184 pages

$55.00

Paperback

RC523

Psychiatry, neurology, epidemiology, and immunology are among the perspectives of researchers as they assemble recent findings related to the neuropathology, genetics, blood markers, and neuro-physiological aspects of Alzheimer’s’ disease in older adults with Down syndrome. Nine contributions and concluding remarks by editor Prasher (a psychiatrist affiliated with South Birmingham Primary Care Trust and King’s College London) discuss topics including amyloid beta and tau proteins, superoxide dismutase, macrocytosis as a peripheral marker, thyroid disorders, neurophysiological changes associated with dementia, and neuroimaging studies of individuals with Down syndrome. Published by Radcliffe Publishing, UK; U.S. distribution is by BookMasters.

([c]20062005 Book News, Inc., Portland, OR)

COPYRIGHT 2006 Book News, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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PHILADELPHIA — Children with Down syndrome appear to have a more atherogenic lipid profile than do their unaffected siblings, Dr. Tahira G. Adelekan reported at the annual meeting of the Society for Developmental and Behavioral Pediatrics.

Thirty-five children with Down syndrome had statistically significantly higher mean total cholesterol, lower high-density lipoprotein (HDL) cholesterol, higher low-density lipoprotein (LDL) cholesterol, and higher triglyceride levels, compared with a control group of 33 siblings. The children’s ages ranged from 3 to 10 years.

"The …

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Toilet training is a fairly easy experience for most families, but the task can be more difficult when training children with Down syndrome. Many parents of children with developmental delays or disabilities wait for their child to show significant signs of readiness, such as interest in the toilet, willingness to sit, or interest in wearing underwear. These are things that even typical kids don’t often demonstrate.

Instead, I advise parents that even if the child is not intrinsically interested in the toilet, they can set up rewards and consequences so the child’s interest can …

Read the rest of this article with a Free Trial at HighBeam Research.

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