SAN DIEGO and FOUNTAIN VALLEY, Calif., March 31, 2013 /PRNewswire/ -- Sorrento
Therapeutics, Inc. ("STI"; SRNE) and IGDRASOL announced today that
IGDRASOL will be presenting updates of its development of
Cynviloq™ (IG-001) at the annual meeting of the
American Association for Cancer Research (AACR) in Washington, DC (April
6th to 10th). IGDRASOL is a
privately-held company for which STI was granted an irrevocable
option right to acquire. The two companies' combined pipeline
features an oncology franchise of potential products with Phase 2
data for multiple solid tumor indications as well as two
synergistic drug discovery and development platforms, namely the
G-MAB® human antibody library and MABiT™, a proprietary technology
to generate antibody formulated drug conjugates (AfDC).
Cynviloq™ (or IG-001) is a next-generation, branded, micellar
diblock copolymeric paclitaxel formulation currently approved and
marketed in several countries as Genexol-PM®. Cynviloq™ has
completed Phase 1 or 2 trials in MBC, NSCLC, pancreatic cancer,
ovarian cancer and bladder cancer in the U.S. and/or non-U.S.
IGDRASOL is preparing for an "End of Phase 2" meeting with the U.S.
Food & Drug Administration (FDA) targeted for the first half of
2013 regarding Cynviloq™. As an injectable nanoparticle
formulation of paclitaxel, Cynviloq™ is potentially eligible for
approval via FDA's 505(b)(2) bioequivalence regulatory pathway
versus albumin-bound paclitaxel (nab-paclitaxel; Abraxane®) in its
currently approved MBC and NSCLC indications. Abraxane® sales
exceeded $400 million in MBC in
fiscal 2012.
The time, title, authors and location of the presentations are
as follows:
- Mon, Apr 8, 1:00 - 5:00 PM (2141/10) – "IG-001 utilization of
albumin mediated transport and its potential application in
difficult to perfuse tumors." Kouros
Motamed, Larn Hwang, Chao
Hsiao, Vuong Trieu. IGDRASOL,
Fountain Valley, CA. Poster
Session, PO.ET01.03. Novel Targeted Therapies 1.
- Tue, Apr 9, 1:00 - 5:00 PM (3481/27) – "Development of
personalized paclitaxel therapy (IG-001) for ovarian cancer." Larn
Hwang, Chao Hsiao, Kouros Motamed, Vuong
Trieu. IGDRASOL, Fountain Valley,
CA. Poster Session, PO.CL13.08. Biomarkers 5: Breast and
Gynecologic Cancers.
- Tue, Apr 9, 1:00 - 5:00 PM (4526/24) – "IG-001 - Evaluation
as next generation nanoparticle paclitaxel against poorly perfused
tumors." Vuong Trieu, Larn
Hwang, Kouros Motamed, Chao Hsiao. IGDRASOL, Fountain Valley, CA. Poster Session,
PO.CH06.01. Drug Delivery Technology.
About Cynviloq™
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 AACR
The mission of the American Association for Cancer Research is
to prevent and cure cancer. Founded in 1907, the AACR is the
world's oldest and largest professional organization dedicated to
advancing cancer research. The membership includes 33,000
laboratory, translational and clinical researchers; health care
professionals; and cancer survivors and advocates in the United States and more than 90 other
countries. The AACR marshals the full spectrum of expertise from
the cancer community to accelerate progress in the prevention,
diagnosis and treatment of cancer through high-quality scientific
and educational programs.
About Sorrento Therapeutics, Inc.
Sorrento Therapeutics, Inc. ("STI"; SRNE) 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, and STI
intends to select several lead product candidates to progress into
preclinical development activities in 2013. More information is
available at www.sorrentotherapeutics.com.
About IGDRASOL
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. Cynviloq™ combines the simplicity of
manufacturing and preparation of Taxol® and potentially the
albumin-mediated transport of paclitaxel. IGDRASOL intends to
conduct registration trials for multiple cancer
indications.
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, please visit its website (http://www.igdrasol.com).
Forward-Looking Statements
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 potential
combination of STI and IGDRASOL and the synergies and prospects for
a combined enterprise going forward; and the clinical development
and commercial potential of Cynviloq™. All such forward-looking
statements are based on STI's current beliefs and expectations, and
should not be regarded as a representation by STI 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 STI's and IGDRASOL's businesses,
including: whether STI will have sufficient cash and other
resources to exercise the option and ultimately acquire IGDRASOL;
the potential that STI and the combined company may require
substantial additional funding in order to obtain regulatory
approval for and commercialize any oncology products; the risk that
delays in the regulatory approval or commercial launch of Cynviloq™
will enable competitors to further entrench existing products, or
develop and bring new competing products to market before the
approval, if any, of Cynviloq™; 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' 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 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.
