Apr 7 2014
Sorrento Therapeutics, Inc. (Sorrento), a late-stage clinical oncology company developing new treatments for cancer and its associated pain, announced today that it will present data on the comparison of Cynviloq™ and Abraxane® (nab-paclitaxel) pharmacokinetics (PK) from animal studies.
The PK data will be presented by Dr. Kouros Motamed, Vice President of Clinical Development & Nanomedicine on April 9 from 8:00 AM to 12:00 PM in Hall A-E, poster session 28 at San Diego Convention Center, entitled: "IG-001—Potential as Intraperitoneal Therapy for Ovarian Cancer."
Additional human clinical trial data will be presented by Dr. Vuong Trieu, Sorrento's Chief Scientific Officer, entitled: "IG-002 Phase 3 Data: Absence of Correlation Between Unbound Paclitaxel and Response in MBC", and Dr. Larn Hwang, Vice President of Regulatory & Clinical Operations on April 8 from 8:00 AM to 12:00 PM in Hall A-E. poster section 38, entitled "IG-001 Phase 4 Data in Korea: Safety and Efficacy."
About Cynviloq™
Cynviloq (IG-001 or Genexol-PM®; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation for the potential treatment of metastatic breast cancer, non-small cell lung cancer, pancreatic cancer, and other solid tumors. In July 2013, the FDA Division of Oncology Products 1 agreed that the 505(b)(2) BE approach is the appropriate regulatory pathway, using Abraxane and Taxol® as the Reference Listed Drugs, to obtain approval. The registration trial referred to as TRIBECA™ (TRIal designed to evaluate BioEquivalence between Cynviloq™ and Abraxane®; clinicaltrials.gov identifier: NCT02064829) is an open-label, randomized, multi-center, single-dose, crossover registration study being conducted at clinical sites across the U.S., EU, and Singapore. Sorrento commenced the single Bioequivalence trial required for registration with the first patient dosing in March 2014.
Sorrento has exclusive distribution rights to Cynviloq in the North America and the 27 countries of the European Union, Mexico and Australia from Samyang Biopharmaceuticals, a South Korean corporation.
About Sorrento Therapeutics, Inc.
Sorrento is an oncology company developing new treatments for cancer and its associated pain. Sorrento's most advanced asset Cynviloq, the next-generation paclitaxel, commenced its registrational trial in March 2014 and is being developed under the abbreviated 505(b)(2) regulatory pathway. Sorrento is also developing RTX, a non-opioid TRPV1 agonist currently in a Phase 1/2 study at the National Institutes of Health to treat terminal cancer patients suffering from intractable pain. The Company has made significant advances in developing human monoclonal antibodies, complemented by a comprehensive and fully integrated ADC platform that includes proprietary conjugation chemistries, linkers, and toxic payloads. Sorrento's strategy is to enable a multi-pronged approach to combating cancer with small molecules, therapeutic antibodies, and ADCs.
Source: http://www.sorrentotherapeutics.com/