>>Zelos and Nektar Announce Start of Phase 1 Trial of Inhaled Ostabolin-C(TM) for Osteoporosis
Thursday September 21, 12:03 pm ET
WEST CONSHOHOCKEN, Pa. & OTTAWA & SAN CARLOS, Calif.--(BUSINESS WIRE)--Sept. 21, 2006--Zelos Therapeutics, Inc., a private biopharmaceutical company focused on developing novel therapies for patients suffering from osteoporosis, and Nektar Therapeutics (Nasdaq: NKTR - News) today announced the initiation of a Phase 1 clinical trial of an inhaled powder formulation of Zelos' proprietary parathyroid hormone Ostabolin-C(TM) (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 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 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, double blind, placebo-controlled, escalating-dose study that will enroll up to 56 healthy postmenopausal women. The study will evaluate 28 days of dosing. The dry powder formulation of Ostabolin-C will be administered using Nektar's convenient, pocket-sized dry powder inhaler. 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 of inhaled Ostabolin-C, as well as the effect of inhaled Ostabolin-C on serum markers of bone formation and resorption. 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 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 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, 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 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. More information is available at www.zelostherapeutics.com. <<
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This probably triggers a small milestone payment to Nektar . . .
>>Nektar and Zelos Announce Collaboration to Develop Inhaled Parathyroid Hormone Therapy for Osteoporosis
January 24, 2005
Nektar Therapeutics (NASDAQ:NKTR) and Zelos Therapeutics Inc. today announced a collaboration to develop an inhaleable powder form of Zelos’ parathyroid hormone (PTH) analogue, called Ostabolin-CTM. Zelos is currently developing an injectable form of Ostabolin-CTM for the treatment of osteoporosis and has completed three Phase I clinical trials. The announcement was made at the Ninth Annual Drug Delivery Partnerships Conference in San Diego, Calif., sponsored by The Institute for International Research January 24-26, 2005.
Osteoporosis is a disease characterized by low bone mass and structural deterioration, which can lead to decreased bone strength and an increased susceptibility to fractures. PTH compounds are considered an advance in the treatment of osteoporosis and have been found to stimulate bone formation, increase bone mineral density and reduce the incidence of fractures. However, first-generation PTH compounds have also been shown to stimulate bone resorption, which may be associated with lowered efficacy in reducing fractures at some common fracture sites and an increase in certain side effects. Zelos’ Ostabolin-CTM is a next-generation injectable PTH analogue designed to have enhanced therapeutic properties in the treatment of osteoporosis, as compared to first-generation PTH compounds.
“Our collaboration with Zelos is an excellent example of how our advanced pulmonary technologies can be applied to an injectable therapeutic to offer a more desirable delivery alternative and potentially increase patient compliance, as well as improve the quality of a patient’s life,” said Ajit Gill, Nektar President and Chief Executive Officer.
Under the terms of the agreement, Nektar will be responsible for development of the formulated dry powder drug and inhalation system, as well as clinical and commercial manufacturing. Zelos will be responsible for supply of the active pharmaceutical ingredient or API, clinical development and commercialization. Nektar will receive research and development funding, milestone payments, and royalty payments when the product is commercialized.
“We are pleased to be collaborating with Nektar, a leader in advanced pulmonary technologies of therapeutic proteins and peptides,” said Robert (Duffy) DuFresne, Zelos President and Chief Executive Officer. “Ostabolin-CTM was shown in preclinical testing to have the same or improved efficacy as existing PTH treatments without stimulating bone resorption. The development of a pulmonary therapy of Ostabolin-CTM will allow for more convenient dosage delivery and potentially expand our worldwide market opportunity for Ostabolin-CTM as a treatment for osteoporosis.”
According to the National Institutes of Health, osteoporosis is a major public health threat for 44 million Americans and one out of every two women over 50 will have an osteoporosis-related fracture in their lifetime.<<
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Bought another little tranche . . .
Cheers, Tuck |
