Sorrento Therapeutics, Inc. (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:
- "A Non-biologic Nanoparticle Paclitaxel for the Treatment of Pancreatic Cancer," authored by Vuong Trieu, Catherine Cheng, Larn Hwang, Chao Hsiao, and Kouros Motamed.
- "IG-001 for Metastatic Breast Cancer¯Interim Analysis of a Phase 3 Trial," authored by Vuong Trieu, Larn Hwang, Chao Hsiao, Kouros Motamed, and Chulho Park.
- "CynviloqTM/IG-001¯A Non-Biologic Nanoparticle Paclitaxel for the Treatment of Solid Tumors," authored by Kouros Motamed, Catherine Cheng, Larn Hwang, Chao Hsiao, and Vuong Trieu.
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®.
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