Rigenerand Announces Orphan Drug Designations from both EMA and FDA Obtained by RR001 for the Treatment of Pancreatic Cancer

Rigenerand srl announces the positive opinion on orphan drug designation (ODD) issued by the European Medicines Agency (EMA) for RR001 as treatment of pancreatic cancer. This relevant milestone immediately follows the ODD granted by the FDA (USA) on May 2018 for the same indication. RR001 is a gene therapy product based on adipose derived cells stably modified to produce pro-apoptotic ligands. RR001 is expected to reach the clinical phase within a planned Phase I/II trial as a first-line treatment in combination with chemotherapy in subsets of patients with pancreatic cancer. In addition to provide an access to incentives (e.g. in the EU: fee reductions, no limitation of protocol assistance, possibility to request a conditional approval and specific research grants), the ODD is the recognition by the Agencies of the plausibility of Rigenerand therapeutic approach as well as of its potential to bring in significant benefit to the existing treatments. Rigenerand srl, originally a spin-off by a joint venture between the University of Modena and Reggio Emilia and Rand srl (Italy), fights against cancer by gene modified effector cells and by developing novel 3D culture diagnostic tools. ODD released by key regulatory Agencies represents a boost for the development of RR001 against a still lethal tumor. Rigenerand is very pleased to release the news during the 2018 World Pancreatic Cancer day (http://www.worldpancreaticcancerday.org) that raises the awareness on the unacceptable prognosis of pancreatic cancer calling for global action in better diagnostics and therapeutics. Safe Harbor. This release may contain forward-looking statements regarding RR001 and its future events and results that involve inherent risks and uncertainties. The words “expect,” “intend,” “plan” and similar expressions, as they relate to RR001 or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Rigenerand srl, could cause actual results to differ materially from those set forth in the forward-looking statements. Rigenerand srl does not assume any obligation to update any of these forward-looking statements. For more info: info@rigenerand.it

Rigenerand is presenting VITVO at the AACR meeting in Chicago on April, 14/18 2018

Visit us at booth 4207 and explore the VITVO® infinite possibilities of culturing in the 3D dimension.

2018-aacr.org


Rigenerand brings novelty at the 3D Tissue Models Oncology Congress in Boston on May, 8/10 2018

Rigenerand shares data on its novel 3D culture system during the 3D Tissue Models Oncology Congress in Boston. Come and listen our researchers speaking about VITVO®: the innovative 3D in vitro model mimicking in vivo complexity. 3d-oncology.com