European Commission Grants Promedior’s PRM-151 Orphan Drug Designation for the Prevention of Scarring Post Glaucoma Filtration Surgery
Malvern, PA, October 29, 2009 – Promedior, Inc., a leader in the development of novel therapeutics for the treatment of fibrotic diseases and tissue remodeling, announced today that the European Commission has granted Orphan Medicinal Product Designation to its lead drug candidate PRM-151 for use in the prevention of scarring post glaucoma filtration surgery. Glaucoma filtration surgery generally is used to treat patients with advanced glaucoma that are at high risk for visual loss. Scarring post glaucoma surgery is a serious complication that causes poor surgical outcomes and may lead to progressive loss of vision for these high risk patients.
PRM-151(rhSAP) is a recombinant form of human Serum Amyloid P, a highly
conserved natural human serum protein that mediates its anti-fibrotic activity
by targeting the specific cell populations that orchestrate fibrosis and tissue
remodeling, namely monocytes and macrophages. PRM-151 has demonstrated an
outstanding safety profile and robust preclinical efficacy by reducing fibrosis
in multiple tissues, organs, and disease models. Promedior initiated a Phase 1
clinical trial of PRM-151 in July 2009 to evaluate the safety, tolerability,
pharmacokinetics and exploratory pharmacodynamics of ascending single
intravenous doses of PRM-151.
The EMEA’s orphan medicinal products program is designed to promote the
development of products for the diagnosis, prevention or treatment of rare,
life-threatening or chronically debilitating conditions. Orphan medicinal
product designation provides several incentives to sponsors, including 10 years
of marketing exclusivity, protocol assistance and scientific advice during
product development, and fee reductions or exemptions for regulatory activities
including scientific advice, applications for marketing authorization,
inspections, and renewals.
"The orphan medicinal product designation for PRM-151 reflects the
therapeutic potential of PRM-151 to prevent scarring post glaucoma filtration
surgery and the lack of approved alternative therapies for this serious surgical
complication," said Dominick Colangelo, Chief Executive Officer of Promedior.
"This designation provides Promedior significant development and commercial
advantages as we continue the development of this first-in-class therapy for the
treatment of diseases involving scarring and fibrosis in the eye and other organ
systems."
About Glaucoma Filtration Surgery
Glaucoma, one of the leading causes of blindness in the world, is an optic
neuropathy that affects the optic nerve and leads to progressive loss of vision.
Elevated intraocular pressure (IOP) is a characteristic symptom in most types of
glaucoma and reduction of elevated IOP is the current standard of treatment to
prevent disease progression. Glaucoma filtration surgery generally is used
to treat patients with advanced glaucoma and persistently elevated IOP that are
at high risk for visual loss. The goal of glaucoma filtration surgery is
to reduce IOP by facilitating drainage of aqueous humor through a surgically
created fistula into a filtering bleb, where the fluid is captured and
reabsorbed into the systemic circulation. Scarring post glaucoma surgery
is a serious complication that diminishes the functionality of the bleb and the
IOP-lowering effect of the surgery, resulting in the loss of IOP control and
risk of progression to visual loss or blindness.
About Promedior, Inc.
Current investors include Morgenthaler Ventures, Polaris Venture Partners,
HealthCare Ventures and Easton Capital. For more information about
Promedior, please visit www.promedior.com.
For more information, please contact:
Promedior, Inc.
Dominick Colangelo, Chief Executive Officer
(610)560-1435