APT Patents Targeted Delivery of Hydroxychloroquine for Inflammatory Diseases.Business Editors/Health/Medical Writers BIOWIRE2K TUCSON, Ariz.--(BUSINESS WIRE)--June 17, 2003 APT Pharmaceutical Inc. recently received U.S. Patent No. 6,572,858 for its novel method of treating a variety of inflammatory illnesses by administering the widely used anti-inflammatory drug, hydroxychloroquine (HCQ), directly to the site of inflammation. APT is initially developing proprietary aerosolized Adj. 1. aerosolized - in the form of ultramicroscopic solid or liquid particles dispersed or suspended in air or gas aerosolised gaseous - existing as or having characteristics of a gas; "steam is water is the gaseous state" HCQ (AHCQ) formulations for asthma and rhinitis Rhinitis Definition Rhinitis is inflammation of the mucous lining of the nose. Description Rhinitis is a nonspecific term that covers infections, allergies, and other disorders whose common feature is the location of their symptoms. . HCQ appears to have potency equal to or greater than corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. and a superior safety profile. APT's technology carries the promise of a more rapid onset and safer therapeutic alternative to long-term corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and treatment. Currently, generic oral HCQ serves as a slow-onset corticosteroid-sparing agent in the treatment of several inflammatory and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause including sarcoidosis Sarcoidosis Definition Sarcoidosis is a disease which can affect many organs within the body. It causes the development of granulomas. Granulomas are masses resembling little tumors. They are made up of clumps of cells from the immune system. , rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and lupus erythematosus. Preliminary human studies using generic oral HCQ for asthma showed significant promise, but the onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. was slow, requiring five months daily treatment. In contrast, initial preclinical trials of AHCQ in asthmatic animals showed complete blockage of late asthmatic responses and airway hyperreactivity in just four to seven days. Long-term treatment with AHCQ has antiasthmatic effects comparable to 1 mg. inhaled budesonide, a corticosteroid currently in use for asthma. However, 14 days after cessation of treatment, the effects of AHCQ were largely preserved, while the budesonide effects had completely disappeared. All these results were achieved at a surprisingly small delivered airway dose -- less than 5 percent of conventional oral therapy. APT is finalizing an agreement with a prominent pulmonary-drug-delivery company to use AHCQ with its advanced-delivery device. APT plans to complete a human Phase I safety and tolerability trial of AHCQ for asthma by the end of this year. APT plans to develop targeted-delivery HCQ for other indications. Along with a topical HCQ nasal spray for use in allergic and nonallergic rhinitis, APT is investigating the potential utility of targeted HCQ delivery for treating Crohn's disease and ulcerative colitis in collaboration with a partner with appropriate proprietary enteric-delivery technology. Additional patent applications supporting these initiatives are pending in the United States and other countries. Research Corporation Technologies in Tucson, an early-stage technology development and management company, formed APT in 1999 to advance development of AHCQ. This technology was invented by B. Lauren Charous, M.D., currently director of the Allergy and Respiratory Care Center at Milwaukee Medical Clinic, Advanced Healthcare, S.C. RCT RCT Randomized Controlled Trial RCT Regimental Combat Team (infantry regiment with their own artillery, engineers, medical and tanks) RCT Rollercoaster Tycoon RCT Randomized Clinical Trial RCT Rhondda Cynon Taff invested in the early formulation work, efficacy studies in sheep, and preclinical animal toxicity studies required for clinical studies. APT seeks corporate partners or licensees to advance its targeted-HCQ delivery technology through clinical development. For additional information, contact Jeffrey Jacob, APT president, 520/748-4417, 520/748-0025 fax, rct2jej@aol.com. |
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