San Diego, CA – March 6, 2014 – Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a late-stage clinical oncology company developing new treatments for cancer and associated pain, announced today that it will present a comparison of the pharmacokinetic (PK) properties of Cynviloq and nab-paclitaxel (Abraxane®) at the 31st Annual Miami Breast Cancer Conference in Miami Beach, Florida. Highlights of the findings include new and historical data on PK bioequivalence of Cynviloq and nab-paclitaxel in mouse, dog, and monkey, as well as an analysis of PK characteristics in humans based on published data. Phase 4 data for Cynviloq from South Korea will also be discussed.
The findings will be presented by Dr. Kouros Motamed, Vice President of Clinical Development & Nanomedicine, and Dr. Larn Hwang, Vice President of Regulatory & Clinical Operations, on March 6 at 7 PM during the general poster session to be held at Fontainebleau Miami Beach Hotel. The 3 presentations are entitled: “IG-001 Pharmacokinetics: Bioequivalence to nab-Paclitaxel across mouse, dog, monkey and human” (details in vivo and historical cross trial comparisons of pharmacological data), co-authored by Jeff Hsu, Kouros Motamed, and Vuong Trieu; “IG-002 Assessment of the Phase 3 Data in Light of Current Understanding of Paclitaxel Therapy”, authored by Kouros Motamed, Larn Hwang, David Nam, Monica Choi, and Vuong Trieu; “IG-001 Phase 4 Data in Korea: Safety and Efficacy” co-authored by Larn Hwang, Caleigh Douglass, David Nam, Fangli Cheng, and Vuong Trieu.
In addition, Sorrento is sponsoring a non-CME Satellite Breakfast Symposium on the state of nanoparticle paclitaxel therapy entitled: “Evolution of Nanoparticle Paclitaxel: Where We Were & Where We Are Now” at 6:45 AM on March 8 at Fontainebleau Miami Beach Hotel. Featured Sorrento speakers include Dr. Vuong Trieu, Chief Scientific Officer, and Dr. Motamed. The session will be moderated by renowned Sylvester Distinguished Professor, Stephan Gluck, MD, PhD, FRCPC, from Sylvester Comprehensive Cancer Center, University of Miami, Leonard M. Miller School of Medicine.
Cynviloq (IG-001 or Genexol-PM®; 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 2013, the FDA Division of Oncology Products 1 agreed that the 505(b)(2) BE approach is the appropriate regulatory 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 first quarter of 2014.
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 is an oncology company developing new treatments for cancer and associated pain. Sorrento’s most advanced asset Cynviloq, the next-generation paclitaxel, will commence its registrational trial and be developed under the abbreviated 505(b)(2) regulatory pathway. Sorrento is also developing RTX, a non-opiate TRPV1 agonist currently in a Phase 1/2 study at the National Institutes of Health to treat terminal cancer patients suffering from intractable pain. The Company has made significant advances in developing human monoclonal antibodies, complemented by a comprehensive and fully integrated Antibody Drug Conjugate (ADC) platform that includes proprietary conjugation chemistries, linkers, and toxic payloads. Sorrento’s strategy is to enable a multi-pronged approach to combating cancer with small molecules, therapeutic antibodies, and ADCs.
More information is available at www.sorrentotherapeutics.com.
This press release contains forward-looking statements under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about commencing its Cynviloq registrational trial; and the advances made in developing human monoclonal antibodies, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2012, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law. 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.
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.
Mr. Amar Singh
EVP and Chief Business Officer
T: + 1 (858) 210-3719
Mr. Ian Stone
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