Press Releases

Promedior Announces Presentation of Interim Phase 2 Data on PRM-151 in Myelofibrosis at the Upcoming Congress of European Hematology Association

LEXINGTON, Mass., June 5, 2014 — Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that Ruben Mesa, MD, will present interim 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 on June 14, 2014 at the 19th Congress of European Hematology Association (EHA) which is being held in Milan, Italy, from June 12-15, 2014. The reported data will include 24-week results in patients with myelofibrosis and will assess key clinical measures of efficacy and safety related to myelofibrosis.

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 poster presentation at EHA are as follows:
Abstract:
#7114
Title:
Phase 2 trial of PRM-151, an anti-fibrotic agent, in patients with Myelofibrosis: Stage 1 Results
Time:
Saturday, June 14, 2014, at 17:45-19:00 Central European Time
Session:
Myeloproliferative neoplasms - Clinical 2 in Poster Area (NW – Level 0)
Authors:
Srdan Verstovsek, MD, PhD (University of Texas MD Anderson Cancer Center), Ruben Mesa, MD (Mayo Clinic, Scottsdale, Arizona, USA), Lynda Foltz, MD (University of British Columbia), Vikas Gupta, MD (Princess Margaret Cancer Centre), John Mascarenhas, MD (Icahn School of Medicine at Mt. Sinai Hospital), Ellen Ritchie, MD (Weill Cornell Medical College of Cornell University), Ronald Hoffman, MD (Icahn School of Medicine at Mt. Sinai Hospital), Richard Silver, MD (Weill Cornell Medical College of Cornell University), Wan-Jen Hong, MD (Stanford University), Marina Kremyanskaya, MD (Icahn School of Medicine at Mt. Sinai Hospital), Elizabeth Trehu, MD (Promedior, Inc.), Hagop Kantarjian, MD (University of Texas MD Anderson Cancer Center), Jason Gotlib, MD (Stanford University).


These interim Phase 2 data were also presented on June 2, 2014, at the American Society for Clinical Oncology (ASCO) 2014 Annual Meeting, as detailed here.

About PRM-151
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.

Phase 1a and 1b clinical studies in healthy subjects and IPF patients have demonstrated that PRM-151 was well tolerated. Additionally, 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. Recent clinical data in myelofibrosis demonstrated the potential of this immuno-oncology approach in fibrotic cancers.

About Myelofibrosis
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. Production of blood cells shifts to the spleen and liver (extramedullary hematopoiesis), which become enlarged, causing severe discomfort, inability to eat, and weakness. Symptomatic myelofibrosis affects approximately 18,000 people per year in the US, 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 all symptoms, but is a realistic option for only a small number of patients. Other currently available therapies address the symptoms, but have minimal, if any, impact on the underlying fibrosis.

About Promedior
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.

Media Contact:
Kathryn Morris
The Yates Network
+1-845-635-9828
kathryn@theyatesnetwork.com

Investor Contact:
Sarah McCabe
Stern Investor Relations
+1-212-362-1200
sarah@sternir.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.

PTX-2

Crystal structure of human Pentraxin-2, a naturally occurring protein that is the foundation of Promedior's proprietary platform. Learn More >