SAN DIEGO and IRVINE,
Calif., Aug. 5, 2013
/PRNewswire/ -- Sorrento Therapeutics, Inc. (OTCQB: SRNE;
SRNED; Sorrento) and IGDRASOL announced today that IGDRASOL has
received official meeting minutes from an End-of-Phase 2 meeting
for Cynviloq™ (or IG-001) with the US Food and Drug Administration
(FDA). Cynviloq™ (paclitaxel polymeric micelle) is initially under
development for the treatment of metastatic breast cancer (MBC) and
non-small cell lung cancer (NSCLC) in the US. The FDA Division of
Oncology Products 1 agreed that the data available from: (i) the
postmarketing surveillance (PMS) studies conducted in ex-US
territories for MBC and NSCLC, (ii) Phase 1-3 studies for MBC, and
(iii) Phase 1-2 studies in NSCLC, Ovarian, Bladder, and Pancreatic
cancers are sufficient to support pursuing the 505(b)(2)
Bioequivalence (BE) regulatory submission pathway approach using
Abraxane® and Taxol® as the Reference Listed Drugs. Abraxane® is an
albumin-bound paclitaxel (nab-paclitaxel) product approved for MBC
and NSCLC indications. Taxol® is a cremophor-based paclitaxel
product approved for these indications as well as other cancer
indications. IGDRASOL anticipates filing its BE protocol with the
FDA within a month.
"Now with the regulatory pathway clearly defined, we intend to
initiate the pivotal BE study of Cynviloq™ in patients with MBC
before year end, and our NDA filing could be as early as 2015 for
both MBC and NSCLC indications", said Vuong Trieu Ph.D., CEO of
IGDRASOL.
Sorrento has the right to acquire IGDRASOL pursuant to a
previously-announced option agreement, entered into in March 2013.
About Cynviloq™
Cynviloq™ is a next-generation,
branded, micellar diblock copolymeric paclitaxel formulation
currently approved and marketed in several countries as
Genexol-PM®. It has completed Phase 1-2/3 and PMS trials in MBC and
NSCLC, and Phase 1-2 studies in pancreatic, ovarian and bladder
cancers in the US and/or ex-US territories.
About Sorrento Therapeutics
Sorrento Therapeutics,
Inc. is a publicly-traded, development-stage biopharmaceutical
company engaged in the acquisition, discovery, development and
commercialization of proprietary drug therapeutics for addressing
significant unmet medical needs in the Unites States, Europe and additional international markets.
Sorrento Therapeutics' primary therapeutic focus is oncology but it
is also developing therapeutics products for other indications,
including inflammation, metabolic, and infectious diseases.
Sorrento Therapeutics' proprietary G-MAB® fully-human antibody
library platform was designed to facilitate the rapid
identification and isolation of highly specific antibody
therapeutic product candidates that bind to disease targets
appropriate for antibody therapy.
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, 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 "assumes," "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 nanomedicines such as Cynviloq™ and TOCOSOL®
paclitaxel. All such forward-looking statements are based on
IGDRASOL and Sorrento's current beliefs and expectations, and
should not be regarded as a representation by IGDRASOL or Sorrento
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 IGDRASOL's and Sorrento's
businesses, including: whether Sorrento will have sufficient cash
and other resources to exercise the option and ultimately acquire
IGDRASOL; the potential that Sorrento 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 IGDRASOL's
and Sorrento's and 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's filings with the Securities and Exchange
Commission. These forward-looking statements represent Sorrento's
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
Sorrento 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.