SAN DIEGO and IRVINE, Calif., July 1,
2013 /PRNewswire/ -- Sorrento Therapeutics, Inc. (OTCQB:
SRNE; Sorrento) and IGDRASOL announced today that the companies
will present Phase III interim data analysis of Cynviloq in
metastatic breast cancer (MBC) patients showing significantly
improved overall response rate (ORR) compared to generic paclitaxel
as well as updates of their nanomedicine platform, which is being
developed for multiple cancer indications in late-stage clinical
trials, at the 4th International Nanomedicine Conference
in Sydney Australia (July 1st - 3rd, 2013).
Sorrento has the right to acquire IGDRASOL pursuant to a
previously-announced option agreement, entered into in March 2013.
Cynviloq™ (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, non-small cell lung cancer
(NSCLC), pancreatic cancer, ovarian cancer and bladder cancer in
the U.S. and/or ex-U.S. IGDRASOL is preparing for an "End of
Phase 2" meeting scheduled with the U.S. Food & Drug
Administration (FDA) in July 2013,
regarding the clinical development of Cynviloq™. As an
injectable nanoparticle formulation of paclitaxel, Cynviloq™ may be
eligible for approval through the FDA's 505(b)(2) bioequivalence
regulatory pathway versus albumin-bound paclitaxel
(nab-paclitaxel; Abraxane®) in its currently approved MBC
and NSCLC indications.
Interim data analysis from an ongoing Phase III clinical study
of Cynviloq™ in MBC patients conducted in South Korea indicates improved ORR vs. Taxol
(40% vs. 26%, respectively, p = 0.03). "This clear ORR improvement
of Cynviloq™ over generic paclitaxel closely mimics that of
Abraxane's registration trial results, and is a further validation
of the similarity in efficacy between these two different
formulations," said Vuong Trieu Ph.D., CEO of IGDRASOL. The
oral presentations are entitled:
- "A Non-biologic Nanoparticle Paclitaxel for the Treatment
of Pancreatic Cancer," authored by Vuong Trieu, Catherine
Cheng, Larn Hwang, Chao
Hsiao, and Kouros
Motamed.
- "IG-001 for Metastatic Breast Cancer―Interim Analysis of
a Phase 3 Trial," authored by
Vuong Trieu, Larn Hwang,
Chao Hsiao, Kouros Motamed, and Chulho
Park.
- "CynviloqTM/IG-001―A Non-Biologic Nanoparticle
Paclitaxel for the Treatment of Solid Tumors," authored by
Kouros Motamed, Catherine Cheng, Larn Hwang, Chao Hsiao, and Vuong
Trieu.
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
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 Sorrento 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.
Contact:
Mr. Jaisim Shah
Chief Business Officer
Sorrento Therapeutics, Inc.
jshah@sorrentotherapeutics.com
T: + 1 (650) 996-2367
SOURCE Sorrento Therapeutics, Inc.