CAMBRIDGE, Mass. – May 7, 2008 - Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced the publication of key preclinical data from its ACE-011 program demonstrating that treatment using the ActRIIA receptor increases bone formation, bone mass and bone strength in mice. The paper titled, “A Soluble Activin Type IIA Receptor Induces Bone Formation and Improves Skeletal Integrity” was published in the journal Proceedings of the National Academy of Sciences (PNAS) by researchers at Acceleron and collaborators at St. Francis Hospital and Medical Center in Hartford, Conn., and at Beth Israel Deaconess Medical Center in Boston.
“The results described in this paper demonstrate the novel approach Acceleron is taking to develop new bone forming agents and illustrate the significant potential of this investigational compound to treat diseases with associated bone loss,” said Jasbir Seehra, Ph.D., Chief Scientific Officer at Acceleron. “The anabolic bone effects of an ActRIIA-based therapeutic, such as ACE-011, have been confirmed by numerous approaches including high resolution imaging technologies, dynamic histomorphometry and mechanical strength testing.”
The results demonstrate that mice treated with a soluble form of the ActRIIA receptor increases trabecular bone volume by 45%, 120%, 130% and 248% compared to untreated animals 2, 4, 6 and 12 weeks, respectively. Furthermore, measurements of the growth of new bone indicate an increase in the rate of bone formation resulting in increased bone strength. Additionally, a study was conducted in a mouse model of osteoporosis and the results were similarly encouraging. Bone mineral density increased 12% in the treated mice compared to a 15% decrease in untreated animals. The increases in bone mass along with improvements in bone architecture led to significant increases in bone strength in the treated osteoporotic animals compared to the untreated animals. The results of these studies also show that the mechanism of bone formation to be fundamentally different than parathyroid hormone (PTH), the only anabolic bone therapy approved by a regulatory agency.
“We are pleased to have these preclinical results published in PNAS as it adds to the growing body of data on ActRIIA-based therapeutics as we continue to advance our clinical program for ACE-011,” said John Knopf, Ph.D., Chief Executive Officer at Acceleron. “Following the successful completion of our single dose study in postmenopausal healthy volunteers last year, Acceleron initiated a Phase 1b multiple dose study which is ongoing. We look forward to continuing the development of this compound by beginning a Phase 2a study in multiple myeloma patients with osteolytic bone lesions this summer.”
About ACE-011
ACE-011, a protein therapeutic based on the activin receptor type IIA, is a novel bone-forming agent. In numerous pre-clinical models of bone loss, ACE-011 increased bone mineral density, improved bone architecture, increased the mineral apposition and bone formation rates and improved bone mechanical strength. These effects have been demonstrated in therapeutic models of bone loss in which ACE-011 stimulated bone formation – a significant unmet medical need that is underserved by current treatments. In a Phase 1 study, ACE-011 had an encouraging safety profile and demonstrated increases in biomarkers of bone formation. ACE-011 is currently in a Phase 1b study and Acceleron expects to begin a Phase 2a study in multiple myeloma in the middle of 2008.
About Acceleron
Acceleron is a privately held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel biotherapeutics that modulate the growth of bone, muscle, fat and the vasculature to treat musculoskeletal, metabolic and cancer-related diseases. Acceleron’s scientific approach takes advantage of its unique insight into the regenerative powers of two protein families: the Growth and Differentiation Factors (GDFs) and Bone Morphogenetic Proteins (BMPs). ACE-011, a novel bone forming agent, is the Company’s lead program, and is being developed to reverse bone loss in diseases such as cancer-related bone loss. In addition, the company is advancing through pre-clinical development product candidates that increase muscle mass, control angiogenesis and inhibit fat accumulation. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company’s internal GMP manufacturing capability to rapidly and efficiently advance its therapeutic programs. The investors in Acceleron are Advanced Technology Ventures, Bessemer Ventures, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For more information, visit www.acceleronpharma.com.
CONTACT:
Acceleron Pharma:
Steven Ertel, 617-649-9234 Paul Kidwell (Media)
Vice President, Corporate Development Suda Communications LLC, tel: 617-296-3854
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