SAN DIEGO and IRVINE, Calif., July 1, 2013 /PRNewswire/ -- Sorrento Therapeutics, Inc. (OTCQB: SRNE; Sorrento) and IGDRASOL announced today that the companies will present Phase III interim data analysis of Cynviloq in metastatic breast cancer (MBC) patients showing significantly improved overall response rate (ORR) compared to generic paclitaxel as well as updates of their nanomedicine platform, which is being developed for multiple cancer indications in late-stage clinical trials, at the 4th International Nanomedicine Conference in Sydney Australia (July 1st - 3rd, 2013). Sorrento has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.
Cynviloq (IG-001) is a next-generation, branded, micellar diblock copolymeric paclitaxel formulation currently approved and marketed in several countries as Genexol-PM. Cynviloq has completed Phase 1 or 2 trials in MBC, non-small cell lung cancer (NSCLC), pancreatic cancer, ovarian cancer and bladder cancer in the U.S. and/or ex-U.S.IGDRASOL is preparing for an "End of Phase 2" meeting scheduled with the U.S. Food & Drug Administration (FDA) in July 2013, regarding the clinical development of Cynviloq.As an injectable nanoparticle formulation of paclitaxel, Cynviloq may be eligible for approval through the FDA's 505(b)(2) bioequivalence regulatory pathway versus albumin-bound paclitaxel (nab-paclitaxel; Abraxane) in its currently approved MBC and NSCLC indications.
Interim data analysis from an ongoing Phase III clinical study of Cynviloq in MBC patients conducted in South Korea indicates improved ORR vs. Taxol (40% vs. 26%, respectively, p = 0.03). "This clear ORR improvement of Cynviloq over generic paclitaxel closely mimics that of Abraxane's registration trial results, and is a further validation of the similarity in efficacy between these two different formulations," said Vuong Trieu Ph.D., CEO of IGDRASOL. The oral presentations are entitled:
About Cynviloq
Cynviloq (or IG-001; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation currently approved and on the market in several countries as Genexol-PM.
About Sorrento Therapeutics
Sorrento Therapeutics, Inc. is a publicly-traded, development-stage biopharmaceutical company engaged in the acquisition, discovery, development and commercialization of proprietary drug therapeutics for addressing significant unmet medical needs in the Unites States, Europe and additional international markets. Sorrento Therapeutics' primary therapeutic focus is oncology but it is also developing therapeutics products for other indications, including inflammation, metabolic, and infectious diseases. Sorrento Therapeutics' proprietary G-MAB fully-human antibody library platform was designed to facilitate the rapid identification and isolation of highly specific antibody therapeutic product candidates that bind to disease targets appropriate for antibody therapy.
More information is available at http://www.sorrentotherapeutics.com.
About IGDRASOL
IGDRASOL's lead therapeutic platform is Cynviloq, a branded micellar paclitaxel formulation which is free of cremophor and human serum albumin, the excipients for Taxol (cremophor-based paclitaxel) and albumin-bound paclitaxel (Abraxane), respectively. Cynviloq combines the simplicity of manufacturing and preparation of Taxol and potentially the albumin-mediated transport of paclitaxel. IGDRASOL intends to conduct registration trials for multiple cancer indications.