European Commission Grants Promedior`s PRM-151 Orphan Drug Designation for the Prevention of Scarring Post Glaucoma Filtration Surgery

Thu Oct 29, 2009 7:30am EDT
 
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MALVERN, Pa.--(Business Wire)--
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.

Promedior is a product-focused biopharmaceutical company developing novel
therapeutics for the treatment of fibrotic diseases and tissue remodeling.
Fibrosis is a key component of multiple diseases affecting all tissues and organ
systems and is a leading cause of morbidity and mortality for millions of people
worldwide. Promedior has developed a novel platform to treat fibrotic diseases
which focuses on targeting the specific monocyte and macrophage cell populations
that orchestrate fibrosis and tissue remodeling. This new paradigm for treating
fibrotic diseases is upstream and dominant to traditional approaches and takes
advantage of universal biology common to all tissues to promote healing without
scarring. 

Current investors include Morgenthaler Ventures, Polaris Venture Partners,
HealthCare Ventures and Easton Capital. For more information about Promedior,
please visit www.promedior.com.

Promedior, Inc.
Dominick Colangelo
Chief Executive Officer
610-560-1435 

Copyright Business Wire 2009

 

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