San Diego, CA – April 4, 2014 – Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a late-stage clinical oncology company developing new treatments for cancer and its associated pain, announced today that it will present data on the comparison of Cynviloq™ and Abraxane® (nab-paclitaxel) pharmacokinetics (PK) from animal studies.
The PK data will be presented by Dr. Kouros Motamed, Vice President of Clinical Development & Nanomedicine on April 9 from 8:00 AM to 12:00 PM in Hall A-E, poster session 28 at San Diego Convention Center, entitled: “IG-001—Potential as Intraperitoneal Therapy for Ovarian Cancer.”
Additional human clinical trial data will be presented by Dr. Vuong Trieu, Sorrento’s Chief Scientific Officer, entitled: “IG-002 Phase 3 Data: Absence of Correlation Between Unbound Paclitaxel and Response in MBC”, and Dr. Larn Hwang, Vice President of Regulatory & Clinical Operations on April 8 from 8:00 AM to 12:00 PM in Hall A-E. poster section 38, entitled “IG-001 Phase 4 Data in Korea: Safety and Efficacy.”
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. The registration trial referred to as TRIBECA™ (TRIal designed to evaluate BioEquivalence between Cynviloq™ and Abraxane®; clinicaltrials.gov identifier: NCT02064829) is an open-label, randomized, multi-center, single-dose, crossover registration study being conducted at clinical sites across the U.S., EU, and Singapore. Sorrento commenced the single Bioequivalence trial required for registration with the first patient dosing in March 2014.
Sorrento has exclusive distribution rights to Cynviloq in the North America and the 27 countries of the European Union, Mexico and Australia from Samyang Biopharmaceuticals, a South Korean corporation.
About Sorrento Therapeutics, Inc.
Sorrento is an oncology company developing new treatments for cancer and its associated pain. Sorrento’s most advanced asset Cynviloq, the next-generation paclitaxel, commenced its registrational trial in March 2014 and is being developed under the abbreviated 505(b)(2) regulatory pathway. Sorrento is also developing RTX, a non-opioid 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 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, 2013 filed with the Securities and Exchange Commission, including the risk factors set forth in such filing. 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
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