Promedior Announces Presentation of Additional Positive Phase 2 Data on PRM-151 in Myelofibrosis at the Upcoming Congress of the European Hematology Association
LEXINGTON, Mass., June 4, 2015 — Promedior,
Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that Dr. Olga Pozdynakova of Brigham and Women’s Hospital, Boston, will present additional data from the Company’s ongoing Phase 2 clinical trial of its lead product candidate, PRM-151, for the treatment of myelofibrosis, in a poster presentation at the 20th Congress of the European Hematology Association (EHA) which is being held in Vienna, Austria, from June 11-14, 2015. The reported data will include 36-week results in patients with myelofibrosis and will assess key clinical measures of efficacy related to myelofibrosis, with a particular focus on validation of PRM-151’s ability to reduce fibrosis of the bone marrow.
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. Promedior’s 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 poster presentation at EHA are as follows:
Myeloproliferative neoplasms; Clinical Session Title: Myeloproliferative neoplasms - Clinical 3
Bone marrow fibrosis by WHO Grade and quantitative image analysis is reduced by PRM-151 in patients with myelofibrosis and associated with improved bone marrow morphology and increased platelet counts
Saturday, June 13, 2015
17:15 - 18:45 (local time)
Poster area (Hall C)
Participating investigators in the PRM-151 Phase 2 study include Srdan Verstovsek, MD, PhD (University of Texas MD Anderson Cancer Center, Principal Investigator for this Phase 2 trial), Jason Gotlib, MD (Stanford University), Ruben Mesa, MD (Mayo Clinic, Scottsdale), Vikas Gupta, MD (Princess Margaret Cancer Centre), John Mascarenhas, MD (Icahn School of Medicine at Mt. Sinai Hospital), Ronald Hoffman, MD (Icahn School of Medicine at Mt. Sinai Hospital), Ellen Ritchie, MD (Weill Cornell Medical College of Cornell University), Richard Silver, MD (Weill Cornell Medical College of Cornell University), and Lynda Foltz, MD (University of British Columbia). For additional details about this clinical trial, please visit www.clinicaltrials.gov.
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. Data show that bone marrow fibrosis grade is correlated with anemia, thrombocytopenia, peripheral blasts and shortened survival1, 2.
Myelofibrosis affects approximately 18,000 people per year in the U.S., with a median age of 61-663. 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.
PRM-151 is recombinant human Pentraxin-2, an endogenous protein that regulates monocytes and macrophages at areas of tissue damage to prevent and 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.
In addition to the clinical study in myelofibrosis, a Phase 1b study in patients with idiopathic pulmonary fibrosis (IPF) showed encouraging results in exploratory efficacy endpoints, which were presented in an oral session at the 2013 Annual Meeting of the American Thoracic Society4.
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.
Promedior is a clinical stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age related macular degeneration, diabetic nephropathy, nonalcoholic steatohepatitis (NASH), and several types of solid tumors.
Promedior has advanced its lead program (PRM-151) into clinical trials focused on two orphan fibrotic diseases, myelofibrosis and idiopathic pulmonary fibrosis. Promedior owns world-wide rights to PRM-151 and has a significant intellectual property estate.
For additional information about Promedior, please visit www.promedior.com.
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- Thiele, J., Kvasnicka, H.M., Ann Hematol 85: 226-232; 2006.
- Vener, C., et al., Blood 111(4): 1862-5; 2008.
- Mehta, J., Wang, H., Iqbal, S. U., Mesa, R., “Epidemiology of myeloproliferative neoplasms in the United States”, Leukemia & Lymphoma, Early Online: 1-6, 2013.
- 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
Note: Ruxolitinib is available under the trade names JAKAFI® and JAKAVI®, which are the registered trademarks of Incyte and Novartis, respectively.