FDA approved somatropin injection pen for GH disorders

The FDA has approved somatropin pre-filled injection pens for the treatment of children and adults with growth hormone disorders.

Norditropin FlexPro (Novo Nordisk) has a user-friendly design and an audible click to confirm that the medication has left the pen. It requires no reconstitution and no loading of cartridges.

Study results indicate that 100% of patients found the injection pen easy to use, according to Novo Nordisk.

Somatropin is approved to treat children with growth failure caused by very low or no production of GH and in adults who do not produce enough GH. This product is also indicated for children who have short stature associated with Noonan and Turner syndromes and children with short stature born small for gestational age with no catch-up growth by age 2 to 4 years.

Norditropin FlexPro is available in 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL pens. After initial use, the 5 mg/1.5 mL and 10 mg/1.5 mL pens may be left at room temperature for up to three weeks without risk for spoilage.

The product is contraindicated in people who have a critical illness caused by heart or stomach surgery, trauma or respiratory problems; Prader-Willi syndrome, severe obesity or breathing problems such as sleep apnea; cancer or other tumors; eye problems associated with diabetes; epiphyses; and allergies to any ingredients in the product.

The most common adverse events associated with include headache, muscle pain, joint stiffness, hyperglycemia, glucosuria, swollen hands and feet due to fluid retention and redness and itching at the injection side. Other more serious adverse events include reports of intracranial hypertension, worsening of scoliosis and slipped capital femoral epiphysis in children. Patients with Noonan and Turner syndromes should be closely monitored by health care professionals due to increased risk for congenital heart disease.

Health care professionals should be aware if patients also take glucocorticoid medication, thyroid hormone, insulin or other medicines for diabetes, oral estrogen replacement therapy or medicines that are metabolized by the liver, such as corticosteroids, sex steroids, anticonvulsants or cyclosporine.

Novo Nordisk introduced somatropin (Norditropin) in 1988 and the first pre-filled GH pen Norditropin NordiFlex in 2004.

The Norditropin FlexPro pen will be available in the second quarter of 2010, according to Novo Nordisk.

 

From http://www.endocrinetoday.com/view.aspx?rid=61590

Modigene Announces Positive Results Of Pilot Toxicity Study Of Its Long-Acting Human Growth Hormone HGH-CTP

16 Jan 2009   
Modigene Inc. (OTC Bulletin Board: MODG) reported results from a pilot toxicity study in primates designed to assess the safety of hGH-CTP, its long-acting human growth hormone (hGH), as well as to provide preliminary information on the approximate injection frequency that will be needed in human patients. The study was designed to elicit potential adverse effects from a single, very large dose of hGH-CTP, also known as MOD-4023. No adverse effects were observed, and the data from this study also support once-weekly or bi-monthly injection frequency in humans.

The pilot study included a group of primates that received a single injection of hGH-CTP containing a dose that was 1,040 times the daily dose of growth hormone recommended for use in human patients. No adverse effects were observed in any of the primates. In addition, the half-life and AUC (area under the curve) of hGH-CTP as measured in primates support a potential once-weekly or bi-monthly injection frequency in humans. This would replace the multiple injections per week that are currently required, as there is presently no long-acting hGH on the market.
"Our long-acting hGH-CTP has exhibited excellent safety in all preclinical studies to date, so we were not surprised by these first data in primates showing that huge single doses of hGH-CTP appear very safe," said Dr. Avri Havron, CEO of Modigene. "We also were pleased to report a significant increase in the half-life of hGH-CTP as we moved from rats to primates, in line with industry-accepted extrapolation models for the expected increase in the half-life of therapeutic proteins between these species. Based on the results of this pilot study, we anticipate that hGH-CTP could potentially achieve weekly or bi-monthly dosing frequency in humans."

Dr. Havron added, "We look forward to completing these toxicology studies and finalizing the IND for hGH-CTP in the coming months. We are pleased too that our current cash resources should enable us to complete the hGH-CTP Phase I clinical program and continue into Phase II trials over the next 24 months."

ABOUT hGH-CTP (MOD-4023)
hGH-CTP, also known as MOD-4023, is Modigene's proprietary long-acting version of human growth hormone. hGH is used for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone. Patients using hGH must currently inject the drug between two and seven times each week, a frequency that can be particularly burdensome for pediatric patients. In contrast, hGH-CTP is expected to require only weekly or bi-monthly injections. The primary indications for hGH in children are growth hormone deficiency, kidney disease, Prader-Willi Syndrome and Turner Syndrome. In adults, the primary indications are replacement of endogenous growth hormone and the treatment of AIDS-induced weight loss. In 2007 the annual market for hGH was estimated at $2.5 billion. In addition to its use for medical indications, hGH has been shown to promote a number of "lifestyle" benefits including reversal of non-voluntary weight loss, increased energy levels, enhanced sexual performance, lower cholesterol and improved appearance of the skin.

ABOUT CTP
Modigene's CTP technology was discovered by researchers at Washington University in St. Louis and is based on a short amino acid sequence that occurs naturally in humans, the carboxyl terminal peptide (CTP). When attached to a therapeutic protein, CTP extends the time that the protein is active in the body. The potential utility of the technology has been demonstrated by Schering-Plough, which licenses the CTP technology for fertility applications only. In July 2008 Schering-Plough announced successful data from its Phase III ENGAGE trial demonstrating that women receiving a single injection of the fertility drug FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive daily injections of commercial FSH. This 1,509 patient trial, which was the largest double-blind fertility trial ever conducted, formed the basis for a Marketing Authorization Application by Schering-Plough that was recently accepted for review by the European Medicines Agency. Modigene is using the same CTP technology to extend the duration of action of human growth hormone and other therapeutic proteins. It has an exclusive license from Washington University to the CTP technology for use with all therapeutic proteins except for the four endocrine hormones licensed to Schering-Plough.

ABOUT MODIGENE
Modigene Inc. is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit http://www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene's long-acting protein programs, that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene's business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long-acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene's filings with the Securities and Exchange Commission.
Modigene Inc.

http://www.modigeneinc.com
Article URL: http://www.medicalnewstoday.com/articles/135638.php
Main News Category: Endocrinology
Also Appears In:  Pharma Industry / Biotech Industry,  Clinical Trials / Drug Trials,  
From http://www.medicalnewstoday.com/articles/135638.php

Osteoporosis

Part of http://medicindo.blogspot.com/2008/07/osteoporosis.html

Risk factors for developing osteoporosis are:

* Ethnicity and particularly the Caucasian subjects. This is due to a lifestyle (diet rich in calcium, protein and low in vitamin (including vitamin D, B12 and K)
* The high age,
* Females,
* Low body mass index,
* Family history of fractures of the hip,
* Deficiencies in calcium and protein
* The excessive consumption of tobacco, alcohol, coffee,
* Vitamin D deficiency (lack of sunshine and consumption of plants),
* Physical inactivity, prolonged detention,
* The deficit to sex hormones,
o early menopause induced or spontaneous,
o castration (both sexes) chemical or surgical
o late puberty,
* Certain hormonal diseases hyperthyroidism, hyperparathyroidie, diabetes insulin, hypercorticism (Cushing's disease, ...), hyperandrogénisme, Klinefelter syndrome, Turner syndrome,
* Certain metabolic diseases haemochromatosis, hypercalciuria isolated idiopathic or family ...
* Inflammatory rheumatism: rheumatoid arthritis, ankylosing spondylitis,
* Other chronic diseases: chronic renal failure, hepatocellular failure, cirrhosis, mastocytosis,
* Certain treatments, especially prolonged corticosteroid, GnRH analogues, anti-aromatases.

At the genetic level, several mutations in the genes LPR5 and LPR6 (low-density lipoprotein receptor) seem to be correlated with a slightly increased risk of osteoporosis.

Signs and symptoms
Osteoporosis usually does not sign. His presence significantly increases the risk of fracture. This risk is inversely correlated with bone mineral density.

Diagnosis
The diagnosis of osteoporosis based on the measurement of bone mineral density by ostéodensitométrie, using the method most often X-rays DEXA. There is talk of osteoporosis if the density is below 2.5 standard deviations from normal. Between -2.5 and -1 standard deviations, it is called osteopenia.

Etiology
The bone is renewed throughout life through a process known as "bone remodeling": this remodeling is not at the same time on all surfaces but bone on tiny homes. In these homes remodeling begins with a phase of bone resorption leading to the formation of a cavity, followed by a phase of bone formation during which the cavity is filled by new bone. This process of remodeling is in deficit, ie it has formed a little less bone than it has been eliminated. This balance deficit explains bone loss associated with age, which will lead to osteoporosis if the bone at the end of growth was insufficient or if the activity remodeling a record high deficit. This balance deficit is enhanced by a deficiency or worse absorption of calcium and vitamin D. In women, the decline in the rate of female sex hormones at menopause is a factor. This explains that, on average, loss of bone density becomes sensitive from 50 years for women and 70 years for men, with significant variations depending on individual genetic predisposition of each diet, physical activity . Osteoporosis is common after a prolonged bed rest. It is also a symptom of evil of space.

Often called the "silent epidemic", osteoporosis exposes them to greater risk of fractures, the main danger, including fractures of the hip, wrist and fractures of the spine.

List of diseases associated with osteoporosis
Osteoporosis may be secondary to a condition which can consider setting up a prevention of this bone loss:

* Lack gonadotrope particularly in the following diseases: Turner syndrome, Klinefelter syndrome, anorexia nervosa, insufficient hypothalamic, hyperprolactinemia.
* Endocrine disorders that can be found in: Cushing's Syndrome, hyperparathyroidism, hyperthyroidism, insulin-dependent diabetes, acromegaly,

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