|
Founded in 2003, CuraPharm, Inc. is a specialty development pharmaceutical company that has patented a safe, botanical drug technology. Although the company's technology has multiple potential applications in the wound care and cosmetic market, CuraPharm's initial focus has been on the development of products for the treatment of diabetic ulcers to address this ever increasing wound treatment market. CuraPharm products contain many natural ingredients in a phyto-nutrient rich fragrant base delicately processed with proprietary technology and blended to give formulations with synergistic therapeutic qualities.
Currently, CuraPharm has 2 products; Phytacare® Alignate Hydrogel Wound Dressing and Curaderm® Skin Revitalization Thearphy cream. Both products have been studied in small open label clinical trials over the past 10 years with increasing sophistication as the regulatory environment and scientific standards have changed. Two small unpublised open labes "In Use" clinical trials were done in the early 1990's to evalute the Curaderm® cream product. The first of these, a Comparative Clinical Study evaluted Curaderm® cream against two comparative products on Stage I - II Pressure Sores. The second, a follow-up Open Label Clinical Study on Stage I - II Diabetic Ulcers was also completed. Based on the results of those studies and a large amount of very positive feedback from physicians (see, "New Wound Dressing Offers Promising of Improved Healing" Technology in Practice, Podiatry Today, June 2002), an open label clinical study useing the Phytacare product (an FDA approved Class 1 wound dressing) was initiated in 2002 and completed in 2003.
(Pilot Clinical Trial), CuraPharm felt there would be significant advantages to developing the PhytacureTM Hydrogel as an FDA approval botantical drug. The botanical drug route was chosen to take full advantage of a new approval pathway now available for botanical drugs which meet the conditions outlined in a recently published FDA Guidance for Botanical Drugs. A late stage IND based clinical study is expected to be initiated in 2008.
|