RxPG News Feed for RxPG News

Medical Research Health Special Topics World
  Home
 
   Health
 Aging
 Asian Health
 Events
 Fitness
 Food & Nutrition
 Happiness
 Men's Health
 Mental Health
 Occupational Health
 Parenting
 Public Health
 Sleep Hygiene
 Women's Health
 
   Healthcare
 Africa
 Australia
 Canada Healthcare
 China Healthcare
 India Healthcare
 New Zealand
 South Africa
 UK
 USA
 World Healthcare
 
   Latest Research
 Aging
 Alternative Medicine
 Anaethesia
 Biochemistry
 Biotechnology
 Cancer
 Cardiology
 Clinical Trials
 Cytology
 Dental
 Dermatology
 Embryology
 Endocrinology
 ENT
 Environment
 Epidemiology
 Gastroenterology
 Genetics
 Gynaecology
 Haematology
 Immunology
 Infectious Diseases
 Medicine
 Metabolism
 Microbiology
 Musculoskeletal
 Nephrology
 Neurosciences
 Obstetrics
 Ophthalmology
 Orthopedics
 Paediatrics
 Pathology
 Pharmacology
 Physiology
 Physiotherapy
 Psychiatry
 Radiology
 Rheumatology
 Sports Medicine
 Surgery
 Toxicology
 Urology
 
   Medical News
 Awards & Prizes
 Epidemics
 Launch
 Opinion
 Professionals
 
   Special Topics
 Ethics
 Euthanasia
 Evolution
 Feature
 Odd Medical News
 Climate

Last Updated: Oct 11, 2012 - 10:22:56 PM
Clinical Trials Channel

subscribe to Clinical Trials newsletter
Latest Research : Clinical Trials

   EMAIL   |   PRINT
Study of New, Non-Growth Hormone Treatment for Short Stature

Sep 13, 2005 - 9:05:00 PM
"For decades, the only available drug treatment for short stature has been shots of growth hormone. However, patients who are deficient in IGF-1 and resistant to the effects of growth hormone do not respond well, if at all, to the shots. Instead of using growth hormone to stimulate the production of IGF-1, the goal is to replace the IGF-1 directly."

 
[RxPG] Rush University Medical Center is participating in a clinical trial to evaluate the potential benefit of the first major innovation in 20 years for the treatment of growth failure. The drug, called Increlex, was approved by the FDA August 31 for the most severe form of short stature due to a deficiency of Insulin-like Growth Factor-1 (IGF-1). Ongoing trials will determine if the drug may be used for less severe growth disease.

Insulin-like Growth Factor-1 (IGF-1) is the proximate hormone necessary for statural growth and must be present in order for children's bones, cartilage and organs to grow normally. In healthy individuals, growth hormone is secreted into the bloodstream by the pituitary gland and binds to growth hormone receptors on liver and other cells, where it stimulates the cellular production and secretion of IGF-1 into the bloodstream.

"For decades, the only available drug treatment for short stature has been shots of growth hormone. However, patients who are deficient in IGF-1 and resistant to the effects of growth hormone do not respond well, if at all, to the shots," said Dr. Richard Levy, a pediatric endocrinologist at Rush. "Instead of using growth hormone to stimulate the production of IGF-1, the goal is to replace the IGF-1 directly."

Increlex is a genetically engineered copy of IGF-1. The purified protein has been shown to be structurally and functionally identical to natural human IGF-1. It is injected daily before a meal to provide the catalyst the body needs to grow.

The FDA's approval of Increlex is based on clinical trial data from 71 patients. Data reported at the 2004 Annual Meeting of the Endocrine Society demonstrated a statistically significant increase in growth rate over an eight-year period in response to Increlex therapy. Compared to pre-treatment growth patterns, on average, children gained an additional inch per year for each year of therapy over the course of eight years. In addition, an analysis of safety in the study concluded that long-term treatment appears to be well tolerated and has an acceptable safety profile. The most common adverse events were hypoglycemia, lipohypertrophy and tonsillar hypertrophy.

Primary IGFD afflicts an estimated 30,000 children evaluated for short stature in the United States. A child with short stature is defined as being shorter than 97.5 percent of all children the same age and gender. If untreated, Primary IGFD may lead, in children and adults, to a range of other metabolic disorders, including lipid abnormalities, decreased bone density, obesity, and insulin resistance.



Publication: For more information about Pediatric Endocrinology services at Rush, please call Dr. Levy's office at 312-942-8989.
On the web: www.tercica.com 

Advertise in this space for $10 per month. Contact us today.


Related Clinical Trials News
Probiotics unsafe for severe acute pancreatitis patient's due to its increased mortality.
Start of Second Phase III Trial in MS Neuropathic Pain
RISUG (Reversible Inhibition of Sperm Under Guidance) Trial to recruit more volunteers
EU clinical trials directive is threatening future of cancer research
Lessons from natalizumab fast tracking in multiple sclerosis
First human trial of recombinant ricin vaccine completed
New stem cell study seeks to prevent heart failure
Electronic health record-based clinical trial alert system increased recruitment rates
Study of New, Non-Growth Hormone Treatment for Short Stature

Subscribe to Clinical Trials Newsletter

Enter your email address:


 Additional information about the news article
Increlex is manufactured by Tercica, Inc., a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. For further information on Tercica please visit www.tercica.com.
 Feedback
For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 
Contact us

RxPG Online

Nerve

 

    Full Text RSS

© All rights reserved by RxPG Medical Solutions Private Limited (India)