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ViaCyte, a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, has filed an Investigational New Drug application with the United States Food and Drug Administration, seeking to start a Phase 1/2 clinical trial in patients with type 1 diabetes, it was reported on Friday. The trial will assess the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy. The company has also submitted a Medical Device Master File to the United States Food and Drug Administration in support of the Encaptra drug delivery system, the device component of the VC-01 product candidate.

Published 18 July 2014 ViaCyte a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, announced that it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes. The trial would evaluate the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy. In a related development, ViaCyte submitted a Medical Device Master File (called MAF) to the FDA in support of the Encaptra drug delivery system, the device component of the VC-01 product candidate.

SAN DIEGO, July 10, 2013 /PRNewswire/ --ViaCyte, Inc., a leading regenerative medicine company focused on developing new approaches to treat major diseases through the application of a stem cell-derived cell therapy, announced today that it completed a private equity financing transaction, providing the Company $10.6 million through the sale of Series C-1 Preferred Stock, together with warrants to purchase stock. The financing, conducted as a rights offering to ViaCyte Series B and C Preferred Stock holders, included the Company's largest existing investors - Johnson & Johnson Development Corporation, Sanderling Ventures and Asset Management Company (Johnson Trust). (Logo: http://photos.prnewswire.com/prnh/20121026/LA00871LOGO-a) This funding serves as a match for a $10.1 million Strategic Partnership Award (SPA) that was approved last October by the California Institute for Regenerative Medicine (CIRM) to support clinical evaluation of VC-01, ViaCyte's promising encapsulated cell-therapy product being developed as a transformative therapy for patients with type 1 and insulin-dependent type 2 diabetes.