|By PR Newswire||
|August 20, 2014 05:25 AM EDT||
SOUTHAMPTON, England, August 20, 2014 /PRNewswire/ --
Phase I Trial of Plasma Kallikrein Inhibitor to be Conducted in the US
KalVista Pharmaceuticals ("KalVista"), an ophthalmology company with a focus on diabetic macular edema (DME), today announces that it has begun a Phase I, First in Human, trial of its novel plasma kallikrein inhibitor, KVD001, for the treatment of DME. The study's Principal Investigator is Dr. Jennifer K Sun of the Beetham Eye Institute, Joslin Diabetes Center; Harvard Medical School Department of Ophthalmology, Boston, MA and is being conducted under KalVista's open Investigational New Drug Application (IND) from the United States Food and Drug Administration (FDA). KVD001 has been advanced under a research partnership between KalVista and JDRF.
The study is an open label, single ascending dose study to investigate the safety, tolerability and pharmacodynamics of KVD001 delivered by intravitreal injection (ClinicalTrials.gov identifier NCT02193113). First patients were dosed in August and recruitment is ongoing at five centers in the US.
Dr Jennifer Sun said: "DME is a leading cause of adult visual loss in developed countries and new approaches for DME are a major unmet medical need. KalVista's novel plasma kallikrein inhibitor could offer a therapeutic approach to the treatment of the condition that targets different molecular pathways than currently available therapies. We look forward to completing the first clinical study with KVD001."
Andrew Crockett, KalVista CEO, said: "Today's announcement of the start of clinical development for KVD001 is a significant step for KalVista. Our collaboration with the JDRF has been very productive and we are delighted to begin this study of a new treatment we hope will ultimately improve outcomes for patients with what is a very serious complication in diabetes."
Plasma kallikrein is a serine protease that represents an attractive drug target in people with diabetic retinopathy as it is has been shown to contribute to blood vessel leakage and thickening of the retina through the collaborative work of Drs. Edward P Feener and Lloyd Paul Aiello at the Joslin Diabetes Center. The detrimental effects of plasma kallikrein on the retina in patients with diabetes are mediated by mechanisms that are independent of vascular endothelial growth factor (VEGF), which has been an area of intense recent interest as a target for treating DME. However, while intravitreal VEGF inhibitors have shown clear benefit in clinical trials in many patients through reducing macular edema and increasing visual acuity, a substantial proportion of DME patients do not respond fully to anti-VEGF treatment. KalVista's approach, targeting plasma kallikrein inhibition, has the potential to add to the treatment options for sufferers of DME including those that are non-responsive to VEGF inhibitors.
Notes to Editors
About KalVista Pharmaceuticals
KalVista is an ophthalmology company with a primary focus on diabetic macular edema (DME) and deep expertise in the discovery and development of serine protease inhibitors. KalVista's novel plasma kallikrein inhibitors represent a new approach to the treatment of DME, a leading cause of adult visual loss in developed countries. Although VEGF inhibitors clearly can benefit DME, a significant number of patients do not respond fully to these agents and have limited treatment options. Plasma kallikrein inhibitors target a distinct molecular pathway and as such have the potential to offer those patients an effective treatment option. The Company has a clinical and advanced pre-clinical product pipeline targeting both intravitreal injection and oral administration, and its plasma kallikrein inhibitors can be applied to additional indications in ophthalmology and more broadly.
KalVista's founders include world experts in diabetic retinopathy, Dr Lloyd Paul Aiello, Professor of Ophthalmology at Harvard Medical School and Director of the Joslin's Beetham Eye Institute, and Dr Edward P Feener, Associate Professor of Medicine at Harvard Medical School and Joslin Diabetes Center. In addition to this therapeutic expertise, KalVista has a management team with proven experience in bringing small molecules through the clinic to commercialization and as a result has attracted significant financial backing from leading life science investors, SV Life Sciences and Novo A/S. The Company's development programmes also receive funding and support from the JDRF and the UK Biomedical Catalyst. http://www.kalvista.com
JDRF is the leading global organization funding type 1 diabetes (T1D) research. JDRF's goal is to progressively remove the impact of T1D from people's lives until we achieve a world without T1D. JDRF collaborates with a wide spectrum of partners and is the only organization with the scientific resources, regulatory influence, and a working plan to better treat, prevent, and eventually cure T1D. As the largest charitable supporter of T1D research, JDRF is currently sponsoring $568 million in scientific research in 17 countries. For more information, please visit jdrf.org
About Joslin Diabetes Center
Joslin Diabetes Center, based in Boston, Massachusetts, undertakes diabetes research, clinical care, education and health and wellness programs on a global scale. Joslin is dedicated to ensuring that people with diabetes live long, healthy lives and offers real progress in preventing and curing diabetes. Joslin is an independent, nonprofit institution affiliated with Harvard Medical School, and is recognized worldwide for driving innovative solutions in diabetes prevention, research, education, and care. Joslin Research comprises the most comprehensive effort in diabetes research under one roof anywhere in the world. Joslin researchers focus on unraveling the biological, biochemical and genetic processes that underlie the development of type 1 and type 2 diabetes and related complications.
Andrew Crockett, CEO
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