Pre-clinical Studies on Lupinus termis Seeds Extract

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DESCRIPTION (provided by applicant): Atopic dermatitis is a skin condition that affects an estimated 10-20 percent of the population. Aside from Protopic (tacrolimus) ointment, which has been recently approved by the FDA, the main treatment for the past 40 years has been steroids. This proposal is intended to carry out preliminary pharmacology-toxicology studies on an alcoholic extract obtained form the seeds of a plant which, in earlier clinical studies performed outside the US, demonstrated encouraging activity in the management of chronic hand and foot eczema. The results that will be obtained will be used to develop a future R01 grant application that will include a phase II clinical trial to evaluate the extract in the treatment of chronic atopic dermatitis. The studies are intended to 1) assure the quality of the imported seeds, by analyzing different crops obtained from the source country, over a period of two years; 2) develop a standardized reproducible method for the preparation of the extract; 3) determine the stability of the ointments prepared from the extract; 4) carry out a repeat-dose toxicology study of the ointments, for nine months, in pigs; 5) carry out a systemic exposure of rats to the active components of the extract, for 90 days, by oral administration; 6) perform a battery of genetic toxicology studies, and 7) investigate whether the extract and ointment preparations have the potential to induce sensitization. The source material is a commercial cash crop. Experimental procedures approved by the U.S. Pharmacopeia/National Formulary, or well-established published protocols will be used in the quality assurance studies. The animals will be housed in the Animal Resources Center of the Medical Sciences Campus of the University of Puerto Rico, throughout the period of the study, under the care of the facility's veterinarian. This facility is accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC International) Developing a new herbal treatment for chronic atopic dermatitis will benefit patients who are at risk or who have developed resistance to other therapies, including Protopic.