RESEARCH TRIANGLE PARK, N.C., Aug. 31 /PRNewswire/ -- NOBEX, a drug development company specializing in oral peptide drug delivery, and Mayo Clinic announce the publication of a preclinical study using a modified human brain-type natriuretic peptide (hBNP) delivered by oral administration. The study was published in the August 9, 2005, edition of the journal Circulation.
Entitled "Oral Human Brain Natriuretic Peptide Activates Cyclic Guanosine 3',5' - Monophosphate and Decreases Mean Arterial Pressure," the paper reports, for the first time, that a proprietary polymer-conjugated hBNP, designed and developed by NOBEX, activates cGMP after oral delivery, resulting in increased cGMP levels in plasma and significant reductions in mean arterial pressure (MAP). These two measures, cGMP and MAP, reflect important biological activities associated with potential treatments for cardiovascular disease.
hBNP is an endogenous peptide produced by the heart under both physiological and pathological conditions, such as ischemic stress or blood volume overload. hBNP has multiple biological activities (through natriuretic, diuretic, vasorelaxant, and lusitropic properties) that contribute to its therapeutic use in treating heart failure. The development of heart failure usually means that the heart's ability to pump blood has weakened, so it can't circulate enough blood to meet the body's needs. Underlying heart conditions that commonly cause heart failure are coronary artery disease or high blood pressure.
Administration of hBNP by continuous infusion was approved by the FDA in August 2001 for the treatment of acute congestive heart failure (CHF) in the hospital care setting. Researchers' intent for an oral hBNP is to have a product for chronic use, rather than only the acute use for the hBNP formulation that is currently approved.
"This research establishes the beginning of a potential transformational paradigm for the treatment of cardiovascular disease using endogenous cardio protective peptides with oral availability," explained John Burnett, M.D., Mayo Clinic Cardiologist. The National Institute of Health also acknowledged the importance of this collaborative research by providing additional research funding to Mayo Clinic.
Researchers used proprietary NOBEX technology attaching a small polymer to one specific region of the hBNP molecule to improve its physical and chemical properties that contribute to absorption by the oral route. The study reported in Circulation showed the activity of the hBNP is maintained and its oral bioavailability is several times greater than the unmodified natural peptide at the same oral dose with the same liquid formulation. A tablet version of the modified hBNP is under development.
"This study again demonstrates, as we have done with both insulin and calcitonin, that NOBEX's proprietary technology enables the oral administration of peptide drugs such as hBNP and thus makes long term, out-of- hospital use feasible," stated Christopher H. Price, Ph.D., President & CEO of NOBEX. "This oral version of hBNP is targeted, first, to patients after they are treated in the hospital for acute, life-threatening heart failure and second, to patients experiencing the chronic phases of the development of
heart failure. Today, few drug options are available for safe, chronic treatment."
NOBEX and its development partner, Biocon Limited (Bangalore, India), plan to advance the oral hBNP program towards an IND (Investigational New Drug) filing with the FDA and with Indian regulatory officials in early 2007 and begin clinical trials shortly thereafter.
NOBEX Corporation is a privately held drug product development company that has pioneered medicinal and polymer chemistry applied to peptide drugs to enable and optimize their delivery by the oral route. NOBEX focuses on developing products for chronic indications in the metabolic and cardiovascular therapeutic areas. The company has been based in the Research Triangle Park in North Carolina since 1993. The company has advanced three products into clinical study with several other products in preclinical development on its own and with partners or collaborators. For more information, visit http://www.nobexcorp.com.
Biocon is India's premier biotechnology company with strongly growing sales and profits. Biocon employs more than 600 highly qualified Scientists at its campus in Bangalore. Together with its subsidiaries, Syngene and Clinigene, Biocon is a fully integrated Biotechnology enterprise with global scale capabilities in biopharmaceuticals and successful initiatives in drug discovery, clinical development, bioprocessing and global marketing. Biocon develops products and solutions to partners and customers across the globe. Many of these products have USFDA and EDQM acceptance.
NOBEX Corporation Noonan Russo
Christopher Price, Ph.D. Emily Poe
Chief Executive Officer (212) 845-4266