Company Overview of River Vision Development Corp.
River Vision Development Corp. develops RV001, a protein therapy for the treatment of Graves’ Orbitopathy (GO). The company was founded in 2011 and is based in New York, New York.
One Rockefeller Plaza
New York, NY 10020
Founded in 2011
Key Executives for River Vision Development Corp.
Chief Executive Officer and Director
Compensation as of Fiscal Year 2015.
River Vision Development Corp. Key Developments
River Vision Development Corp. Announces Completion of Enrollment in Graves' Orbitopathy Study
Nov 9 15
River Vision Development Corp. announced the completion of enrollment of a Phase 2 clinical study of RV001 (teprotumumab) for the treatment of Graves' Orbitopathy (GO). RV001 is a fully human IGF-1 receptor antagonist antibody with a safety database comprised of more than 700 cancer patients. The study is being conducted at 15 sites in the US and Europe and has enrolled 88 patients with moderate to severe disease. GO is a condition suffered by a significant number of Graves' Disease patients in which inflammation and a build up of tissue behind the eye cause the eyeball to protrude from the socket. This changes the patient's appearance and results in significant morbidity; including corneal ulceration, pain, optic neuropathy and double vision among other serious effects. The work of Terry Smith, MD and Ray Douglas, MD (University of Michigan), Principal Investigators for this study, and data from a growing number of other GO researchers, suggests that the IGF-1 receptor in orbital tissue plays an important role in regulating the autoimmune response that underlies GO. The study is a double-masked, randomized, placebo-controlled trial intended to assess the efficacy and safety of RV001 for the treatment of patients with moderate to severe GO. Patients in the study receive 8 infusions of either saline or RV001 over a period of 24 weeks, after which the primary efficacy assessment is made. The company expects that this portion of the study will be completed early in the second quarter of 2016 and that the top-line results will be available shortly thereafter. Recognizing the importance of this condition and the lack of treatment options for patients, the FDA recently granted Fast Track designation for RV001 for GO. The drug had previously been granted Orphan Designation by the Agency. RVDC anticipates filing an Orphan Drug Application in the EU in third quarter of 2015 and an application for Breakthrough Designation in the US in second quarter of 2016 if merited by the trial's outcome.
CMC Biologics and River Vision Development Corporation Announce Manufacturing Agreement for RV001
Jul 29 15
CMC Biologics and River Vision Development Corporation announced that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave's Orbitopathy and other indications. Under the agreement, CMC Biologics will transfer River Vision's manufacturing process for Teprotumumab into its facility in Copenhagen, Denmark for process optimization, validation and cGMP manufacture to support River Vision's Phase III clinical trials and future commercial supply requirements for both the United State and Europe. Teprotumumab has been designated with an Orphan Drug Indication in the US by FDA for Graves Orbitopathy.
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