SAN DIEGO and IRVINE, Calif., May 28, 2013 /PRNewswire/ — Sorrento Therapeutics, Inc. (OTCBB: SRNE; STI) and IGDRASOL announced today that clinical data for CynviloqTM, a non-biologic nanoparticle formulation of paclitaxel, plus gemcitabine was published for the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO). The abstract (#e15076), entitled “Evaluation of a non-biologic nanoparticle form of paclitaxel in metastatic pancreatic cancer” was chosen for inclusion online in the ASCO 2013 Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, and was released at www.asco.org on May 15, 2013. The abstract was authored by Kouros Motamed, Larn Hwang, Chao Hsiao, and Vuong N. Trieu.
A Phase I clinical trial established a maximum tolerated dose (MTD) for CynviloqTM of 300 mg/m2 when given every 3 weeks in combination with weekly dosing of 1250 mg/m2 gemcitabine as first line treatment for patients with advanced pancreatic cancer. Moreover, 5 out of 16 patients (31.3%) had confirmed complete responses (CR) or partial response (PR) with 95% exact confidence intervals (CI) of 11.0 and 58.7, respectively. The median progression-free survival (PFS) time was 5.6 months (95% CI = 2.9). The median overall survival (OS) time could not be estimated as the survival rate did not fall below 50%.
“Based on the data generated to date, we believe CynviloqTM in combination with gemcitabine may offer beneficial dosing regimens and potent anti-tumor activity in patients with advanced pancreatic cancer”, said Vuong Trieu, Ph.D., chief executive officer of IGDRASOL.
About Pancreatic Cancer
Pancreatic cancer is a leading cause of cancer deaths worldwide. The pancreas is composed of two main cell types: endocrine, and exocrine, which is by far the most common type of pancreatic cancer. For all stages of pancreatic cancer combined, the 5-year overall survival rate is below 10 percent worldwide.
Cynviloq™ (or IG-001; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation currently approved and on the market in several countries as Genexol-PM®.
About Sorrento Therapeutics, Inc.
Sorrento Therapeutics, Inc. is a publicly-traded, development-stage biopharmaceutical company focused on the discovery, development and commercialization of novel and proprietary biotherapeutics for the treatment of a variety of disease conditions, including cancer, inflammation, metabolic and infectious diseases. STI’s objective is to identify drug development candidates derived from its proprietary human antibody libraries and, either independently or through partnerships, advance selected targets into preclinical or clinical development. In 2012, STI identified and further developed a number of potential drug product candidates across various therapeutic areas. STI intends to select several lead product candidates to progress into preclinical development activities in 2013, including human anti-PD-L1 and anti-PD-1 monoclonal antibodies (mAbs) that have demonstrated strong immunomodulatory activity in vitro comparable to competitor mAbs currently in clinical development as well as significant anti-cancer activity in a tumor mouse model.
More information is available at www.sorrentotherapeutics.com.
IGDRASOL’s lead therapeutic platform is Cynviloq™, a branded micellar paclitaxel formulation which is free of cremophor and human serum albumin (HSA), the excipients for Taxol® (cremophor-based paclitaxel) and albumin-bound paclitaxel (Abraxane®), respectively. IGDRASOL intends to conduct registration trials for multiple cancer indications for Cynviloq™. Additionally, IGDRASOL intends to utilize Cynviloq’s unique pharmacokinetics for personalized dosing to further enhance its clinical activities.
The executives of IGDRASOL are a group of pharmaceutical veterans who believe that personalized paclitaxel nanoparticle therapy will present a paradigm shift in the delivery of chemotherapeutic agents. To learn more about IGDRASOL’s mission, visit www.igdrasol.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 “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements about the clinical development, efficacy in pancreatic cancer patients and commercial potential of Cynviloq™ as well as any lead product candidates derived from STI’s proprietary human antibody libraries, including human anti-PD-L1 and anti-PD-1 mAb drug development candidates. All such forward-looking statements are based on STI and IGDRASOL’s current beliefs and expectations, and should not be regarded as a representation by either STI or IGDRASOL that any of their 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 STI’s and IGDRASOL’s businesses, including: whether STI and IGDRASOL will have sufficient cash and other resources to continue the Phase I clinical trial; the potential that STI and IGDRASOL may require substantial additional funding in order to obtain regulatory approval for and commercialize any oncology products; the scope and validity of patent protection for Cynviloq™ as well as STI’s and IGDRASOL’s platform technologies, and the risk that the development or commercialization of product candidates may infringe the intellectual property rights of others; and additional risks set forth in Sorrento Therapeutics’ filings with the Securities and Exchange Commission. These forward-looking statements represent Sorrento Therapeutics’ and IGDRASOL’s collective 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 STI and IGDRASOL undertake 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.