ZELOS/NEKTAR START PHASE 1 TRIAL OF INHALED OSTABOLIN-C.Zelos Therapeutics, Inc., a private biopharmaceutical company focused on developing novel therapies for patients suffering from osteoporosis, and Nektar Therapeutics (Nasdaq: NKTR) have initiated a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. of an inhaled powder formulation of Zelos' proprietary parathyroid hormone parathyroid hormone or parathormone, a hormone secreted by the parathyroid glands that regulates the metabolism of calcium and phosphate in the body. Ostabolin-C (cyclic PTH-(1-31)). Nektar and Zelos entered into a collaboration to develop an inhaleable powder form of Ostabolin-C in January 2005. "Ostabolin-C is a powerful new bone formation agent that we believe will emerge as a best-in-class PTH PTH abbr. parathyroid hormone Parathyroid hormone (PTH) A chemical substance produced by the parathyroid glands. This hormone is a major element in regulating calcium in the body. for the treatment of osteoporosis. A key to expanding the market for bone formation therapies will be the development of convenient non-injectable delivery alternatives that can improve both patient compliance and thus, treatment outcomes in osteoporosis," commented Brian MacDonald, MB, ChB, PhD, chief executive officer of Zelos. "Our strategy is to evaluate several delivery options for Ostabolin-C and we are pleased to advance this promising inhaled version of Ostabolin-C into the clinic with our partner Nektar." "This product has the potential to address the need for a more convenient, patient-friendly and much-needed therapy option for osteoporosis patients," said David Johnston, senior vice president of research and development at Nektar. "Inhaled Ostabolin-C uses Nektar's small, pocket-sized inhaler inhaler /in·hal·er/ (in-hal´er) 1. an apparatus for administering vapor or volatilized medications by inhalation. 2. ventilator (2). in·hal·er n. to deliver a peptide and it is designed to provide a portable and easy-to-use solution for patients." About the Study The Phase 1 trial is a single-center randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double blind, placebo-controlled, escalating-dose study that will enroll up to 56 healthy postmenopausal post·men·o·paus·al adj. Of or occurring in the time following menopause. postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr women. The study will evaluate 28 days of dosing. The dry powder Dry Powder A slang term for cash reserves kept on hand to cover future obligations. Notes: For example, if a venture capitalist expects bad times in the IPO markets you might hear him say something like, "we want to keep enough dry powder around to keep funding our formulation of Ostabolin-C will be administered using Nektar's convenient, pocket-sized dry powder inhaler The Dry Powder Inhaler is generally a proprietary device to deliver medications for the treatment or maintenance management of respiratory diseases and conditions. These conditions or diseases may include Asthma, Bronchitis, Emphysema, COPD and Diabetes. . The primary study endpoints are the safety and tolerability of single and repeated doses of inhaled Ostabolin-C. In addition, the study will evaluate the pharmacokinetics and pharmacodynamics pharmacodynamics /phar·ma·co·dy·nam·ics/ (-di-nam´iks) the study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical of inhaled Ostabolin-C, as well as the effect of inhaled Ostabolin-C on serum markers of bone formation and resorption resorption /re·sorp·tion/ (re-sorp´shun) 1. the lysis and assimilation of a substance, as of bone. 2. reabsorption. re·sorp·tion n. . The Phase 1 trial includes a sub-study to compare the pharmacokinetic characteristics of a single dose of Ostabolin-C given via a subcutaneous (SC) injection and a single dose of inhaled Ostabolin-C. About Ostabolin-C Ostabolin-C, a cyclic 1-31 amino acid amino acid (əmē`nō), any one of a class of simple organic compounds containing carbon, hydrogen, oxygen, nitrogen, and in certain cases sulfur. These compounds are the building blocks of proteins. analog of parathyroid hormone (PTH), is a bone formation agent designed to improve upon the safety and efficacy of current therapies in the large and rapidly growing osteoporosis market. Preclinical and Phase 1 studies have shown that Ostabolin-C stimulates significant bone formation with little to no stimulation of bone resorption. Due to the minimized bone resorption, Ostabolin-C demonstrates a reduced potential to cause hypercalcaemia, a common side effect of current PTH therapies. With this profile, Ostabolin-C may become a best-in-class compound in the growing PTH market and a leading therapy in the treatment of osteoporosis. Zelos is currently conducting Phase 2 clinical studies with Ostabolin-C as a once-daily, self-administered subcutaneous injection. To address the need for more convenient and patient-friendly non-injectable delivery, Nektar and Zelos are partnered for the development of an inhaled formulation of Ostabolin-C. Nektar's Advanced Pulmonary Technology is designed to provide an integrated inhalation system that disperses fine, dry, respirable respirable /res·pir·a·ble/ (re-spir´ah-b'l) 1. suitable for respiration. 2. small enough to be inhaled. res·pi·ra·ble adj. 1. Fit for breathing, as air. powders in a reproducible fashion for optimal systemic delivery. About Nektar Advanced Pulmonary Technology Nektar Advanced Pulmonary Technology uses innovative molecular formulations and novel delivery devices designed for ease-of-use to improve or enable administration of medicines to and through the lungs for both lung diseases and systemic conditions. The company has two proprietary pulmonary anti-infective products currently in clinical development and four additional pulmonary products in the clinic with various partners. Exubera (insulin human [rDNA origin]) Inhalation Powder, which has been approved in the U.S., European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , Brazil and Mexico, is the most advanced product using Nektar Advanced Pulmonary Technology and is a result of a developmental collaboration between Pfizer and Nektar. About Zelos Therapeutics, Inc. Zelos Therapeutics, Inc. is a biopharmaceutical company developing novel, best-in-class therapies to address the unmet medical needs of patients suffering from osteoporosis. The company is in late-stage clinical development with Ostabolin-C, a bone formation PTH analog designed to improve upon the safety and efficacy of current therapies in the large and rapidly growing osteoporosis market. Zelos Therapeutics is led by a group of seasoned executives, and is based in West Conshohocken, Pennsylvania West Conshohocken is a borough in Montgomery County, Pennsylvania, United States. The population was 1,462 in 1880; 2,482 in 1950; 1,516 in 1980; 1,294 in 1990; and 1,446 at the 2000 census. and Ottawa, Ontario. To address the need for a more convenient PTH therapy for osteoporosis, the company is collaborating with Nektar Therapeutics for the development of an inhaled formulation of Ostabolin-C. For more information, visit http://www.zelostherapeutics.com or call 212/867-9212. About Nektar Nektar Therapeutics is a biopharmaceutical company that develops and enables differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. Nektar technology and know-how have enabled nine approved products for partners, which include the world's leading pharmaceutical and biotechnology companies. Nektar also develops its own products by applying its drug delivery technologies and expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance. |
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