US-based clinical-stage biotechnology firm Promedior has started a Phase II clinical study of its lead product candidate PRM-151, in patients with myelofibrosis (MF).
Promedior, which develops new biologic therapeutics to treat diseases involving fibrosis, is developing PRM-151, a recombinant form of an endogenous human protein that has the potential to prevent and reverse fibrosis.
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The Phase II trial is a multi-centre, two stage, adaptive design study, which will assess 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).
Around 24 patients would be enrolled in the first stage of the study, with about 80 additional patients in the second stage.
Response rate according to the International Working Group-Myeloproliferative Neoplasms Research and Treatment criteria, a comprehensive assessment tool designed by an international group of experts to objectively measure the effectiveness of treatments for MF, is the primary endpoint of the study.
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Scheduled to be completed in 2014, the trial is expected to expand the company’s clinical focus beyond idiopathic pulmonary fibrosis (IPF) to myelofibrosis, a life-limiting orphan disease with significant unmet medical need.
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By GlobalDataPromedior chief medical officer Elizabeth Trehu said advancing the clinical development of PRM-151 into clinical studies in myelofibrosis patients is a significant milestone for the company.
"We are optimistic that data from this study, combined with the encouraging data in IPF, will demonstrate that PRM-151’s novel mechanism of action is applicable to a wide range of fibrotic diseases," Trehu said.
The Phase II trial is based on data secured from a randomised, placebo-controlled clinical study in patients with IPF, in which PRM-151 was found to be generally safe and well-tolerated.
In the IPF study, PRM-151 resulted in a mean improvement in Forced Vital Capacity (FVC) at eight weeks after dosing for only two weeks, whereas patients receiving placebo had a decline in FVC.
In addition addition, PRM-151 has showed broad anti-fibrotic activity in multiple industry standard preclinical models of fibrotic disease, including pulmonary fibrosis, acute and chronic nephropathy, liver fibrosis as well as age-related macular degeneration.
PRM-151 is a recombinant form of an endogenous human protein, Pentraxin-2 (PTX-2), that is specifically active at the site of tissue damage.
MF is a type of myeloproliferative neoplasm and a serious, life-limiting cancer that is characterised by fibrosis of the bone marrow.
Phase Ia and Ib clinical trials in healthy subjects and IPF patients have showed that PRM-151 was safe and well tolerated, while the Phase Ib study in IPF patients showed encouraging results in exploratory efficacy endpoints.
Image: PRM-151 is a recombinant form of an endogenous human protein, Pentraxin-2 (PTX-2), a naturally occurring protein that is the foundation of Promedior’s proprietary platform. Photo: courtesy of Promedior.
