Good news. Positive Findings for SDZ ASM 981 Cream Pave Way for First Clinical Trials in Chronic Irritant Hand Dermatitis
Preliminary Studies Suggest Safety and Efficacy for Pediatric Atopic Dermatitis
SAN FRANCISCO, March 10 /PRNewswire/ -- Three preliminary studies suggest that a new investigational therapy may safely and effectively reduce symptoms
of pediatric and adult eczema, including atopic dermatitis and chronic hand dermatitis.
One study to be presented Saturday at the 58th annual meeting of the American Academy of Dermatology suggests that SDZ ASM 981 topical cream could safely and effectively improve the signs and symptoms of chronic irritant hand
dermatitis, a condition currently treated with corticosteroids. Chronic irritant hand dermatitis, or hand eczema, is characterized by bright red, scaly cracks that make skin very sensitive, causing it to sting and bleed.
In the small efficacy study, all patients (n=12) treated twice daily with SDZ ASM 981 cream followed by a nightly occlusive covering (gloves) noted up to 40 percent improvement within the first week of treatment.
"Based on these encouraging results, we have worked with key experts in this area to design a large Phase III trial in chronic irritant hand dermatitis, and we are moving forward as swiftly as possible," said Robert J.
Cherill, MS, Associate Director, Clinical Research, Novartis Pharmaceuticals Corporation.
Implications for Use in Children and Adults
Two additional studies offer important implications for the management of atopic dermatitis, which is now most commonly treated with corticosteroids of
varying potency. The studies found that SDZ ASM 981 does not accumulate in the bloodstream and, furthermore, that its prolonged use does not induce skin atrophy (an excessive thinning of skin) when compared to the medium- to-high-potency corticosteroids studied (triamcinolone acetonide and betamethasone-17-valerate).
Infants and children make up 80 percent of patients with atopic dermatitis, which is characterized by a dry, itchy, scaly skin rash. Systemic absorption -- which refers to how a medication is absorbed into the
bloodstream -- is of more concern for children because their ratio of body surface area to weight is higher than it is in adults.
"Data from these studies support other recent findings showing SDZ ASM 981 cream to have low systemic exposure, even when applied over an extensive body surface area," said Carle Paul, MD, Department of Dermatology, Mulhouse
Hospital, France, who is one of the study authors.
Further studies are under way to support the efficacy and safety of SDZ ASM 981 cream in children with atopic dermatitis.
SDZ ASM 981 is a new molecule that is derived from the macrolactam ascomycin and selectively inhibits inflammatory cytokines released from activated T cells and mast cells. It was specifically developed for the treatment of inflammatory skin diseases(1), and has been shown to be effective in atopic dermatitis(2), allergic contact dermatitis(3), and psoriasis (under semi-occlusive conditions)(4). In SDZ ASM 981 studies to date, the most frequently experienced side effect was a sensation of warmth at the site of application. That sensation
usually subsides after the first three days of treatment.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's
lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group, a world leader in healthcare with core
businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of USD 21.7 billion and invested more than USD 2.8 billion in R&D. Headquartered
in Basel, Switzerland, Novartis employs about 82,400 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the
agrochemicals business of AstraZeneca in the second half of 2000.
References
1 Grassberger, et al, Br J Dermatol 1999;141:264-73.
2 Van Leent, et al, Arch Dermatol 1998;134:805-809.
3 Quielle-Roussel, et al, Australas J Dermatol 1997;38(suppl 2):55.
4 Mrowietz, et al, Br J Dermatol 1998;139:992-996.
SOURCE Novartis Pharmaceutical Corporation
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Another good drug in the pipeline.
Jack |
