LEXINGTON, Mass.--(BUSINESS WIRE)--Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that Srdan Verstovsek, MD, PhD, will present final data from the first stage of the Company’s ongoing two-stage Phase 2 clinical trial of its lead product candidate, PRM-151, for the treatment of myelofibrosis, in an oral presentation on Monday, December 8, 2014, at the 56th American Society of Hematology (ASH) Annual Meeting. Dr. Verstovsek will present final 6 month data for all 27 patients enrolled plus 9-12 month data from 14 patients who are continuing treatment in a study extension. Clinical benefits of PRM-151 treatment as reported in the abstract include reduction in bone marrow fibrosis, improvements in anemia and thrombocytopenia, symptom improvements including IWG-MRT Clinical Improvement, and reductions in splenomegaly, with an excellent safety profile and no myelosuppression as either a single agent or added to a stable dose of ruxolitinib.
With a novel mechanism of action that is targeted to prevent and reverse fibrosis, PRM-151 has the potential to address the fundamental fibrotic pathology of myelofibrosis. This Phase 2 clinical trial is a multi-center, two stage, adaptive design study to determine the efficacy and safety of PRM-151 as a single agent or added to a stable dose of ruxolitinib in patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF).
Details of the oral presentation at ASH are as follows:
Presentation: Phase 2 trial of PRM-151, an anti-fibrotic agent, in patients with myelofibrosis: stage 1 results
Abstract No.: 713
Session Name: 634. Myeloproliferative Syndromes: Clinical: JAK Inhibitors and Their Combinations
Session Date: Monday, December 8, 2014
Session Time: 6:15 PM - 7:45 PM
Presentation Time: 7:15 PM
Room: Moscone Center, West Building, 3001-3003-3014-3016
PRM-151, Promedior’s lead product candidate, is a recombinant form of an endogenous human protein, Pentraxin-2 (PTX-2), that is specifically active at the site of tissue damage. PRM-151 is an agonist that acts as a monocyte/macrophage differentiation factor to prevent and potentially reverse fibrosis. PRM-151 has shown broad anti-fibrotic activity in multiple preclinical models of fibrotic disease, including pulmonary fibrosis, acute and chronic nephropathy, liver fibrosis, and age-related macular degeneration.
Recent clinical data in myelofibrosis demonstrated the potential of this immuno-oncology approach in fibrotic cancers. PRM-151 has Fast Track and Orphan designation in the US for treatment of myelofibrosis and Orphan Designation in the US and EU for treatment of IPF. A Phase 1b study in patients with IPF showed encouraging results in exploratory efficacy endpoints, which were presented in an oral session at the 2013 Annual Meeting of the American Thoracic Society1.
Myelofibrosis (MF), a type of myeloproliferative neoplasm, is a serious, life-limiting cancer that is characterized by fibrosis of the bone marrow. Replacement of the bone marrow by scar tissue prevents the normal production of blood cells, leading to anemia, fatigue, and increased risk of bleeding and infection.
Myelofibrosis affects approximately 18,000 people per year in the U.S., with a median age of 61-66.2 The only potentially curative treatment is allogeneic bone marrow transplant, which results in reversal of fibrosis and normalization of blood counts, but is a realistic option for only a small number of patients. Other currently available therapies have minimal, if any, impact on the underlying fibrosis, and often result in worsening in hemoglobin and platelets, important blood parameters which are directly linked to morbidity and mortality and remain the major unmet need in patients with MF.
Promedior is a clinical stage biotechnology company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis is a harmful process that occurs in many diseases, when normal healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Promedior's proprietary platform is based upon Pentraxin-2, an endogenous human protein that is specifically active at the site of tissue damage and, with an anti-fibrotic immunotherapy approach, works to prevent and reverse fibrosis.
Promedior has successfully advanced its lead therapeutic candidate in human clinical trials, and is initially focused on rare fibrotic diseases, including myelofibrosis and idiopathic pulmonary fibrosis (IPF). Promedior is backed by leading global healthcare venture investors, has a significant intellectual property estate relating to the discoveries and applications of Pentraxin-2 therapeutics and is led by an experienced management team. For additional information about Promedior, please visit www.promedior.com.
1. Van Den Blink, B. et al., “A Phase I Study Of PRM-151 In Patients With Idiopathic Pulmonary Fibrosis”, American Thoracic Society 2013 Annual Meeting, May 2013. Read More: http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2013.187.1_MeetingAbstracts.A5707
2. Mehta, J., Wang, H., Iqbal, S. U., Mesa, R., “Epidemiology of myeloproliferative neoplasms in the United States”, Leukemia & Lymphoma, Early Online: 1-6, 2013.