Affinity Biotech Inc.'s first trial in humans of a suppositoryformulation of calcitonin demonstrated that its delivery system"can facilitate the passage of large molecules, such as proteins,across the gastrointestinal tract and into the bloodstream," thecompany announced on Monday.
The trial, performed at Ninewells Hospital in Dundee, Scotland,involved six patients with osteoporosis. They receivedsuppositories containing calcitonin formulated in Affinity'smicroemulsion delivery system and, at a different time, anintramuscular injection of calcitonin to establish a baseline.Nathan Tzodikov, the company's director of research anddevelopment, stated that "the bioavailability level we achievedcompares favorably with the levels Affinity believes are beingattained by commercial nasal forms of calcitonin."
In addition to showing bioavailability, the drug manifested the"expected pharmacodynamic effects" of lowering serum calciumand phosphate levels, the company said. No side effects werereported by subjects.
The study in Scotland was a "proof-of-concept" trial to showthat the delivery system will work. Affinity executive vicepresident Wayne Weisman told BioWorld that the next step isto conduct proof-of-concept studies with an oral calcitonin,which he expects will take place in the first quarter of 1994. Hesaid the company then plans to file an investigational new drugapplication (IND) in the U.S. to begin Phase I clinicals.
Calcitonin is a nonproprietary therapeutic protein marketed inthe U.S. in an I.V. formulation. According to Affinity, which islocated in Boothwyn, Pa., a nasal formulation is being marketedin Europe by Sandoz and Rhone-Poulenc Rorer Inc.
Affinity (NASDAQ:AFBI), founded in 1990, is developing oral-delivery systems for proteins, peptides and other therapeuticagents and a formulation of taste-masked liquid and chewabledrugs. It has oral formulations of insulin and human growthhormone in preclinicals.
In addition, the company has agreements with severalcompanies, including Eli Lilly and Co., Glaxo Inc., Genentech Inc.,Bio-Technology General Corp., SmithKline Beecham andWhitehall Labs to conduct feasibility studies to see if differentcompounds will work in Affinity's oral delivery system. Theagreement with Genentech covers certain recombinantproteins, the 1992 research and licensing agreement withSmithKline covers a specific therapeutic protein and use ofAffinity's taste-masked formulation for a class of widelyprescribed drugs, and the 1992 agreement with Whitehallgives Whitehall the option for an exclusive license of the taste-masked formulation for a widely used OTC drug.
-- Brenda Sandburg News Editor
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