SAN DIEGO and FOUNTAIN VALLEY, Calif., April 8, 2013 /PRNewswire/ -- Sorrento
Therapeutics, Inc. ("STI"; SRNE) and IGDRASOL announced today that
IGDRASOL will be presenting updates of its analysis of proprietary
late clinical stage NBN-Pac formulations, namely IG-001
(Cynviloq™) and IG-004 (a D-a-tocopheryl polyethylene
glycol succinate (TPGS)-based paclitaxel formulation) at the annual
Nanomedicine 2013 meeting in Barcelona,
Spain (April 11th -
12th). 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 2/3 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 US and/or non-US. 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) regulatory pathway versus
albumin-bound paclitaxel (nab-paclitaxel; Abraxane®) in its
currently approved metastatic breast cancer (MBC) and non-small
cell lung cancer (NSCLC) indications.
IG-004 (formerly known as TOCOSOL® paclitaxel) is a TPGS-based
emulsion of paclitaxel, which was recently acquired from OncoGenex
Pharmaceuticals, Inc. (OGXI). IG-004 has completed Phase 2 trials
in NSCLC, pancreatic cancer, ovarian cancer, colorectal cancer or
bladder cancer as well as completed Phase 3 studies in MBC in the
US and/or non-US. IGDRASOL recently acquired the IG-004 portfolio
asset from OncoGenex. IGDRASOL plans to reexamine the clinical data
of IG-004 to map out the best path forward given the benefit of
hindsight.
"We intend to leverage our comprehensive domain knowledge of
paclitaxel nanoparticle formulations to build a franchise of next
generation paclitaxel nanomedicines. I am convinced that our
team who played a key role in the development and success of
Abraxane® will be able to do it here again," said Vuong Trieu
Ph.D., Chief Executive Officer of IGDRASOL.
Also, the acquisition of TOCOSOL® paclitaxel allows IGDRASOL to
compare and contrast stable paclitaxel nanoparticles (TOCOSOL®
paclitaxel) versus plasma-unstable paclitaxel nanoparticles
(Abraxane® and Genexol-PM®). Data mining of these large
databases have generated exciting insights into the field of
nanomedicine.
Some of the findings are being presented at Nanomedicine 2013,
April 11th
-12th, Barcelona,
Spain. The presentation is entitled: "Non-biologic
Nanoparticle Paclitaxel for the Treatment of Cancer" authored
by: Vuong Trieu, Catherine
Cheng, Larn Hwang, Chao
Hsiao, and Kouros
Motamed.
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 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.