SAN DIEGO, Sept. 16, 2013 /PRNewswire/ -- Sorrento Therapeutics, Inc. (OTC QB: SRNE; Sorrento) announced today it will present the clinical data for Cynviloq™ (IG-001), which resulted in its approval as 1st line treatment of ovarian cancer by Korean FDA in March of 2013. Highlights of the findings include proof of non-inferiority of Cynviloq vs. Taxol in combination therapy with Carboplatin in patients with advanced epithelial ovarian cancer.
These data will be presented at the AACR conference on Advances in Ovarian Cancer Research: From Concept to Clinic, Miami, FL on Friday, September 20, 2013 12:30 p.m. – 2:30 p.m. at the Met Ballroom 5-7, Poster Session B, Poster Board #B67. The presentation is entitled: "IG-001 — A Non-biologic Nanoparticle Paclitaxel for the Treatment of Ovarian Cancer" authored by: Larn Hwang, Catherine Cheng, and Vuong Trieu.
Cynviloq (or IG-001; 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, the FDA Division of Oncology Products 1 agreed that the data available are sufficient to support a 505(b)(2) pathway, using Abraxane® and Taxol® as the Reference Listed Drugs, to obtain approval. Sorrento anticipates initiating the single Bioequivalence trial required for registration, in the fourth quarter of 2013.
Sorrento has exclusive distribution rights to Cynviloq in the U.S. and the 27 countries of the European Union, from Samyang Biopharmaceuticals, a South Korean corporation.
About Sorrento Therapeutics, Inc.
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's therapeutic focus is oncology, but is also developing therapeutic products for inflammation, metabolic, and infectious diseases. Sorrento's proprietary G-MAB® fully-human antibody library platform was designed to facilitate the rapid identification and isolation of highly specific antibody therapeutics. In addition, Sorrento is developing proprietary ADCs as well as AfDCs combining its G-MAB® antibodies with anti-tumor agents.
More information is available at www.sorrentotherapeutics.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Words such as "assumes," "plans," "believes," "expects," "anticipates," and "will," and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements about the preclinical and clinical development of Sorrento's human antibody therapeutics. All such forward-looking statements are based on Sorrento's current beliefs and expectations, and should not be regarded as a representation by Sorrento that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in Sorrento's businesses; the potential for approval and commercial success of Cynviloq; the scope and validity of patent protection for Sorrento's platform technologies, and the risk that the development or commercialization of product candidates may infringe the intellectual property rights of others; the potential that Sorrento may require substantial additional funding in order to obtain regulatory approval for and commercialize Sorrento's proprietary G-MAB® fully-human antibody library platform technologies or product candidates; and additional risks set forth in Sorrento's filings with the Securities and Exchange Commission. These forward-looking statements represent Sorrento Therapeutics' judgment as of the date of this release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Sorrento undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Genexol-PM® is a registered trademark of Samyang Corporation; Abraxane® is a registered trademark of Celgene, Inc; Taxol® is a registered trademark of Bristol-Myers Squibb, Inc.
SOURCE Sorrento Therapeutics, Inc.