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 BOOTHWYN, Pa., Sept. 20 /PRNewswire/ -- Affinity Biotech, Inc. (NASDAQ: AFBI), today announced that it has successfully completed its first human trials for proof-of-concept of its microemulsion drug delivery system. The trials with Affinity's suppository formulation of calcitonin, a generic drug for the treatment of osteoporosis, were performed at Ninewells Hospital in Dundee, Scotland.
 "The successful completion of these trials is a significant milestone for Affinity," said Alan Dickason, president and CEO of the company. "This was an important first demonstration that our delivery system can facilitate the passage of large molecules, such as proteins, across the GI tract and into the bloodstream. Our results evidence the potential of Affinity's system for the oral delivery of protein-based drugs, most of which must now be delivered by injection."
 Calcitonin, with a current estimated worldwide market of over $700 million, is a non-proprietary therapeutic protein that is one of the few effective treatments for osteoporosis. Osteoporosis is a disease characterized by the progressive deterioration of bones due to loss of bone tissue and changes in bone structure. Persons suffering from osteoporosis have an increased susceptibility to bone fractures, especially of the spine, hip, thigh and wrist. The disease currently affects 24 million Americans, including one-half of all post-menopausal women and two-thirds of all women past age 65. Calcitonin helps restore calcium to the bone, causing remodeling of the bone, which increases its strength. Generally, calcitonin can only be administered by injection, although a nasal dosage form is being marketed in Europe. Because of the high rate at which it is metabolized, calcitonin must be administered frequently. Affinity believes that the availability of a suppository, and later an oral, dosage form would make therapy more acceptable and more accessible to a broader base of patients with osteoporosis.
 Affinity's trials involved the administration to six healthy subjects of suppositories containing calcitonin formulated in Affinity's proprietary microemulsion delivery system. These patients also received, at a different time, an intramuscular injection of calcitonin to establish a baseline. Blood samples taken after each administration were then analyzed for bioavailability and pharmacodynamic effects.
 "In addition to manifesting the expected pharmacodynamic effects from calcitonin (lowering of serum calcium and phosphate levels), assays showed that the Affinity-formulated calcitonin resulted in relative bioavailability of 5 percent compared to the injected dose," said Nathan Tzodikov, Ph.D., director of research and development for Affinity. "The bioavailability level we achieved compares favorably with the levels Affinity believes are being attained by commercial nasal forms of calcitonin." Relative bioavailability is a measurement of the percentage of drug actually in the bloodstream after administration with the delivery system compared to the blood level of the drug following administration by injection.
 "Equally important, there were no reported side effects from the subjects receiving calcitonin in Affinity's formulation," said Dr. Tzodikov. "This is in line with our expectations, given that our system is comprised of food-grade and pharmaceutical-grade components."
 Based in Boothwyn, Affinity Biotech focuses on the development of oral delivery systems for proteins, peptides and other therapeutic agents, the formulation of taste-masked liquid and chewable drugs, and the development of other pharmaceutical products utilizing Affinity's expertise in surface chemistry.
 -0- 9/20/93
 /CONTACT: Wayne B. Weisman, executive vice president of Affinity Biotech, 215-479-0500, or Anthony J. Russo, Ph.D., of Noonan/Russo Communications, 212-696-4455/

CO: Affinity Biotech, Inc. ST: Pennsylvania IN: MTC SU: PDT

TW-TS -- NY022 -- 3481 09/20/93 08:47 EDT
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Publication:PR Newswire
Date:Sep 20, 1993

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