Discovering New Ways of Scientific Thinking
Glenveigh Medical is a life science and medical technology company focused on advancing the practice of obstetrics. Our core mission is to improve the lives of pregnant mothers and their babies.
An Urgent Need
PE is the leading cause of maternal death in the United States. It is a dangerous and rapidly progressive hypertensive disorder of pregnancy that affects up to 200,000 women annually in the United States (between 5% and 8% of all pregnancies). Globally, PE and other hypertensive disorders of pregnancy are a leading cause of maternal and infant morbidity and mortality, and are responsible for 76,000 maternal and 500,000 infant deaths each year. Early delivery is the most effective treatment, but can have dire consequences for the infant and may not stop progression of the disease in the mom.
A COMPANY FOUNDED TO HELP SOLVE IT
It is this urgent and unmet medical need that prompted one of Glenveigh's founders, C. David Adair, MD, a Maternal Fetal Medicine (MFM) specialist, to begin research into PE almost 2 decades ago and establish Glenveigh Pharmaceuticals in 2004. The accomplishments that make up Glenveigh's success date back to 1996 when Dr. Adair initiated the first clinical study with Digibind® (digoxin immune FAB ovine or DIF) in post-partum women. In 2002, Glenveigh entered into a research collaboration with GSK to begin the DEEP Study, a Phase IIb clinical trial in pregnant women to test the drug's efficacy for severe preeclampsia. By late 2004 Glenveigh began building a high level Scientific Advisory Board (SAB) and adding other industry veterans to the team.
In early 2007, Glenveigh Pharmaceuticals out-licensed its DIF intellectual property to Protherics Plc, now BTG Plc. BTG is a leading antibody company who manufactures Digifab®, a similar and competing product to Digibind®. Glenveigh has now reacquired the rights to the DIF patents, secured supply for remaining clinical work, set up the basis for a commercial supply agreement, filed for orphan disease status, and is preparing a new IND and pivotal study for DIF. These accomplishments will allow Glenveigh to advance commercialization in a more aggressive manner and substantially improve the economics of this opportunity.
In addition, Glenveigh Research is funding investigations and basic science research by SAB members at a number of leading institutions. Work at Brigham Young University, led by Dr. Steven Graves, and at LSU Shreveport, under the direction of Dr. Yuping Wang, has produced exciting data exploring the etiology of preeclampsia and the development of diagnostic and theranostic tests for preeclampsia. Additional research with DIF shows promise for its use in diseases of inflammation and forms the basis for additional patent filings held by Glenveigh.
Can a drug originally used as an antidote for digoxin toxicity treat preeclampsia?
Much is unknown about the etiology of preeclampsia. While incomplete trophoblastic invasion by the placenta and alterations in the immune response may be involved in its pathophysiology, a number of biologically active factors have also been implicated in preeclampsia.
One factor, endogenous digitalis-like factor (EDLF), occupies the digitalis-binding site and has been found to inhibit the sodium pump, which itself has recently been shown to play an important physiological role in blood pressure regulation ((Kaplan JH, 2005)). In addition, studies show that EDLF is increased in the circulation of women with preeclampsia and its effects, including vasoconstriction and hypertension, may be reversed by anti-digoxin antibodies.
Glenveigh's commitment to PE runs DEEP
Much is unknown about the etiology of preeclampsia. While incomplete trophoblastic invasion by the placenta and alterations in the immune response may be involved in its pathophysiology, a number of biologically active factors have also been implicated in preeclampsia. One factor, endogenous digitalis-like factor (EDLF), occupies the digitalis-binding site and has been found to inhibit the sodium pump, which itself has recently been shown to play an important physiological role in blood pressure regulation (Kaplan JH, 2005). In addition, studies show that EDLF is increased in the circulation of women with preeclampsia and anti-digoxin antibodies may reverse its effects, including vasoconstriction and hypertension. The DEEP study has now been completed with positive results. It confirmed the hypothesis that EDLF plays a role in severe preeclampsia, that DIF is beneficial as a treatment for preeclampsia, and that additional investigation is warranted. Specifically, the study found that DIF:
- • Preserved renal function
- • Lowered maternal pulmonary edema
- • Lowered the incidence of intraventricular hemorrhage in DIF infants
- • Neutralized EDLF and reversed sodium pump inhibition
- • Had a favorable safety profile with no adverse events related to study medication
These results suggest that continued research and development with DIF is clearly warranted. Glenveigh has received Orphan Drug designation and Fast Track status.
Glenveigh welcomes inquiries for additional information. Please contact David Adair, MD, Chairman and Chief Science Officer or Andy Johnston, Director of Clinical Operations. Click Here >