Sorrento Therapeutics, Inc., a publicly-traded, development-stage biopharmaceutical company, and IGDRASOL announced that IGDRASOL has received official meeting minutes from an end-of-phase 2 meeting for Cynviloq (or IG-001) with the US Food and Drug Administration (FDA).
Cynviloq (paclitaxel polymeric micelle) is initially under development for the treatment of metastatic breast cancer (MBC) and non-small cell lung cancer (NSCLC) in the US. The FDA Division of Oncology Products 1 agreed that the data available from: (i) the postmarketing surveillance (PMS) studies conducted in ex-US territories for MBC and NSCLC, (ii) Phase 1-3 studies for MBC, and (iii) phase 1-2 studies in NSCLC, Ovarian, Bladder, and Pancreatic cancers are sufficient to support pursuing the 505(b)(2) Bioequivalence (BE) regulatory submission pathway approach using Abraxane and Taxol as the Reference Listed Drugs. Abraxane is an albumin-bound paclitaxel (nab-paclitaxel) product approved for MBC and NSCLC indications. Taxol® is a cremophor-based paclitaxel product approved for these indications as well as other cancer indications. IGDRASOL anticipates filing its BE protocol with the FDA within a month.
"Now with the regulatory pathway clearly defined, we intend to initiate the pivotal BE study of Cynviloq in patients with MBC before year end, and our NDA filing could be as early as 2015 for both MBC and NSCLC indications", said Vuong Trieu, CEO of IGDRASOL.
Sorrento has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.
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 1-2/3 and PMS trials in MBC and NSCLC, and Phase 1-2 studies in pancreatic, ovarian and bladder cancers in the US and/or ex-US territories.
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.
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.