Sorrento Therapeutics, Inc. (OTCQB: SRNE; Sorrento) and IGDRASOL announced today that the companies will present updates of their analyses of proprietary late clinical stage paclitaxel formulations, IG-001 (Cynviloq™) and IG-004 (TOCOSOL® paclitaxel) at the joint meeting of the European Foundation for Clinical Nanomedicine (CLINAM) and the European Technology Platform on Nanomedicine (ETPN) in Basel, Switzerland on June 23 - 26. Sorrento has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.
IGDRASOL'S data mining of the clinical data for both IG-001 and IG-004 has generated exciting insights into the field of nanomedicine, which will be presented at the joint meeting. These findings are highly relevant to the theme of this year's conference, namely "Nanomedicine & Targeted Medicine – the paradigm of precise, highly effective and innocuous medicine for the benefit of patients and mankind".
IG-001 (Cynviloq™) is a next-generation, branded, micellar diblock copolymeric paclitaxel formulation currently approved and marketed in several countries as Genexol-PM®. It has completed Phase 1 or 2 trials in metastatic breast cancer (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.
IG-004 (TOCOSOL® paclitaxel) is a tocopheryl polyethylene glycol succinate (TPGS)-based emulsion of paclitaxel. IG-004 has completed Phase 2 or 3 trials in MBC, NSCLC, ovarian cancer, colorectal cancer and bladder cancer in the U.S. and/or ex-U.S. The IG-004 portfolio of assets was recently acquired from OncoGenex.
The presentation, titled "IG-001―A Non-Biologic Nanoparticle Paclitaxel for the Treatment of Ovarian Cancer – First Results of a Phase 2 Ovarian Trial", will be presented by Dr. Larn Hwang on Wednesday, June 26, 2:30 p.m., in Track 3, Hall Singapore, and was authored by Larn Hwang, Chao Hsiao, Kouros Motamed, and Vuong Trieu. Dr. Hwang will present the clinical outcome of Cynviloq™ in a Phase 2 multicenter non-inferior study (GPMOC202) where Cynviloq™ in combination with Carboplatin was evaluated against generic Taxol® plus Carboplatin (comparator group). Cynviloq™ in combination with Carboplatin administered to patients with ovarian cancer produced an objective response rate of 88%. Time to progression and progression free survival were 444 days and 437 days, respectively. The results showed Cynviloq™ (IG-001) in combination with Carboplatin was an effective first line treatment for patients with ovarian cancer, and non-inferior to traditional solvent based paclitaxel.
Two poster presentations entitled: "IG-004―A Non-Biologic Nanoemulsion Paclitaxel for the Treatment of Solid Tumors- Comparison to Abraxane", and "Cynviloq™/IG-001―A Non-Biologic Nanoparticle Paclitaxel for the Treatment of Solid Tumors" will be presented by Dr. Kouros Motamed. The posters were authored by Vuong Trieu, Chao Hsiao, Larn Hwang, Kouros Motamed, Chulho Park and Catherine Cheng.
Sorrento Therapeutics, Inc.