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Altus Pharmaceuticals Reports Dosing First Patient In A Phase 2 Trial Of ALTU-238 For Pediatric Growth Hormone Deficiency
Altus Pharmaceuticals Inc. (NASDAQ: ALTU) announced that patient dosing in its Phase 2 trial for ALTU-238 in growth hormone deficiency pediatric subjects began on June 2, 2009. ALTU-238 is a long-acting, extended-release formulation of recombinant human growth hormone (rhGH, somatropin), which is being developed utilizing Altus" proprietary protein crystallization technology. ALTU-238 is a ready-to-use liquid suspension of crystallized rhGH that preserves the structure of the rhGH molecule without the need for pegylation, polymerization, or encapsulation and enables administration through a fine gauge needle. The Phase 2 ALTU-238 pediatric trial is being conducted in approximately 18 clinical sites in the U.S. and targets enrolling 36 growth hormone deficient pediatric patients. ALTU-238 has been studied in a series of Phase 1 and Phase 2 studies in healthy and GH deficiency adults.
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Five Questions About Eczema

Eczema is a chronic skin disorder characterized by dry, itchy, scaly skin and rashes. It is commonly known as "the itch that rashes." (1) While the exact cause of eczema is not known, it appears to result from a complex interaction of factors including personal and family genetics, immune response and environmental factors. (2) Scratching the affected area can lead to more itch, redness, swelling, scaling, cracking, oozing clear fluid and, ultimately, crusting. (3) Eczema is a chronic condition characterized by itchy flares when the inflammation gets worse, and periods when the skin gets better, or entirely clears up, known as remission. (4) Who gets eczema? Eczema is one of the most common skin disorders in children, and its prevalence has increased steadily over the past several decades. (5) It is most common in people with a family history of eczema or other atopic disorders like asthma or hay fever. More than half of the children who develop eczema will continue to have it as adults. (6) In some children, the disorder goes away for a long time, only to reappear at puberty when hormones kick in, stress becomes more common and the use of irritating skin care products or cosmetics begins. (7) Adult cases can be frequently tied to exposure in which the skin comes into contact with such things as toiletries containing alcohol, astringents or fragrances. Additional triggers include harsh detergents/soaps, abrasive clothing (wool or synthetics), dust or sand. (8) More than 15 million people in the US suffer from some form or degree of eczema. (9) Recent data concludes that medical care costs can range from $580 to $1,250 per patient per year. What causes eczema? Researchers have been unable to pinpoint the exact cause of eczema, and experts believe that genetics, the immune system and environment play a role. (10) Stress and other emotional discord may make eczema worse, but they do not cause the disorder. (11) If one or both parents have eczema or other disorders such as asthma or hay fever, their children are more likely to develop it. (12) In addition, about 75 percent of children with eczema also develop hay fever or asthma. (13) Where does eczema occur? The rashes that characterize eczema can occur on skin anywhere on the body, but most commonly develop on the face, inside the elbows, behind the knees and on the hands and feet. (14) Other areas of body affected by the disorder include the skin around the eyes. (15) How is eczema treated? Successful management of eczema involves educating patients and their families about eczema and reducing signs and symptoms. Long term care includes education, trigger avoidance, skin care, and treatment. (16) The use of medication is largely dependent on the severity of the disorder and the response to lifestyle and environmental changes. The standard types of medication used to treat eczema have traditionally been topical corticosteroids. (17) Among the newer forms of treatment are prescription medications called topical calcineurin (cal-SEE-nur-in) inhibitors (TCIs). TCIs belong to a category of medicines called immuno-modulators. (18) Scientists believe that TCIs target T cells in the skin which play a significant role in regulating some of the body"s immune responses. (19) Generally, physicians use TCIs if a topical corticosteroid is ineffective in controlling the disorder or when those treatments are not advisable. (20) While topical corticosteroids are used first in the treatment of eczema, TCIs can provide effective second line therapy. Among the benefits of TCIs are that they can reduce eczema signs and symptoms and have been shown to be effective on sensitive areas. (21) TCIs have not been associated with certain side effects such as skin thinning, stretch marks, and growth suppression in children. (22) The most common application side effects of TCIs include the sensation of burning or itching. (23) These occur at the beginning of treatment and tend to go away after a few days. Other side effects include flu-like symptoms, headache, and skin redness. Drinking alcohol while using TCIs may cause the skin or face to become flushed or red and feel hot. (24) Skin infections should be cleared prior to treatment with TCIs, and there may be an increased risk of certain skin infections. Important Information Patients Should Know About TCIs Other related articles *What Is Eczema? The safety of using TCIs for a long period of time is not known. A very small number of people who have used TCIs have had cancer (for example, skin or lymphoma). However, a link with TCIs has not been shown. Because of this concern, patients should not use TCIs continuously for a long time or on a child under 2 years of age and should use TCIs only on areas of skin that have eczema. (25) References 1. Eczema/Atopic Dermatitis, American Academy of Dermatology 2. Handout on Health: Atopic Dermatitis. National Institute of Arthritis and Muscoskeletal and Skin Diseases. NIH Publication No. 03-4272. Revised April 2003, page 3 3. NIH, ibid., page 3 4. NIH, ibid., page 4 5. Krakowski, Eichenfield, Management of Atopic Dermatitis in Pediatric Population, 2008 6. NIH, ibid., page 6 7. NIH, ibid., page 11 8. NIH, ibid., page 16 9. NIH, http://www.skincarephysicians.com/eczemanet/whatIs.html. Accessed April 20. Accessed April 20, 2009 10. NIH, http://www.skincarephysicians.com/eczemanet/whatIs.html. Accessed April 20. Accessed April 20, 2009 11. NIH, op. cit., page 6 12. NIH, op. cit., page 7 13. NIH, op. cit., page 6 14. NIH, op. cit., page 7 15. AAD, op. cit., page 1 16. NIH, op. cit., page 9 17. Krakowski, Eichenfield, Management of Atopic Dermatitis in Pediatric Population, 2008 18. NIH, op. cit., page 19 19. http://www.protopic-la.com/professionals/Science+of+Protopic/Mechanism+of+action?_EN.htm. Accessed December 4, 2008. 20. http://www.nobelprize.org/educational_games/medicine/immunity/immune-detail.html. Accessed October 21, 2008. 21. Hanifin et al J Am Acad Dermatol 2001; Soter et al J Am Acad Dermatol 2001; Paller et al J Am


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